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2011 Anniversary Yearbook - EUFEPS today and history

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<strong>EUFEPS</strong> <strong>Yearbook</strong> <strong>2011</strong><br />

20 th <strong>Anniversary</strong> Issue<br />

European Federation for Pharmaceutical Sciences<br />

Veddesta Business Center, Veddestavägen 13, Järfälla, Sweden<br />

www.eufeps.org


<strong>EUFEPS</strong><br />

Inaugural Meeting<br />

in Strasbourg,<br />

France<br />

European Federation for Pharmaceuti<br />

1 st European<br />

Congress of<br />

Pharmacetucal<br />

Sciences,<br />

Amsterdam,<br />

The Netherl<strong>and</strong>s<br />

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000<br />

First issue<br />

of <strong>EUFEPS</strong><br />

NewsLetter<br />

European Journal<br />

of Pharmaceutical<br />

Sciences � �f�cial<br />

Scienti�c Journal<br />

2 nd European<br />

Congress of<br />

Pharmacetucal<br />

Sciences, Berlin,<br />

Germany<br />

Progress Overview<br />

3 rd European<br />

Congress of<br />

Pharmacetucal<br />

Sciences, Edinburgh,<br />

United Kingdom<br />

<strong>EUFEPS</strong><br />

Individual<br />

Membership<br />

4 th European<br />

Congress of<br />

Pharmacetucal<br />

Sciences, Milan,<br />

Italy<br />

New Safe<br />

Medicies<br />

Faster<br />

Position<br />

Paper<br />

Permanent<br />

Secretariat,<br />

Stockholm,<br />

Sweden<br />

<strong>EUFEPS</strong> Online<br />

New Safe<br />

Medicies Faster<br />

Initiative<br />

Workshop<br />

5 th European<br />

Congress of<br />

Pharmacetucal<br />

Sciences,<br />

Budapest,<br />

Hungary<br />

Millennial<br />

Pharmaceutical<br />

Sciences World<br />

Congress,<br />

San Fransisco,<br />

USA<br />

www.eu


cal Sciences<br />

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 <strong>2011</strong><br />

Full-time<br />

Secretary-<br />

General/<br />

Executive<br />

Director<br />

6 th European<br />

Congress of<br />

Pharmacetucal<br />

Sciences,<br />

Stockholm,<br />

Sweden<br />

European<br />

Commision 6 th<br />

Framework<br />

Programme for<br />

Research <strong>and</strong><br />

Technological<br />

Development<br />

2002–2006<br />

CIRR<br />

Safety Sciences<br />

Poition Paper<br />

Safety Sciences<br />

Workshop I,<br />

Brussels,<br />

Belgium<br />

7 th<br />

European<br />

Congress of<br />

Pharmacetucal<br />

Sciences,<br />

Brussels,<br />

Belgium<br />

2 nd<br />

Pharmaceutical<br />

Sciences World<br />

Congress, Kyoto,<br />

Japan<br />

<strong>EUFEPS</strong><br />

Course<br />

DataBase<br />

Safety<br />

Sciences<br />

Network<br />

1 st <strong>EUFEPS</strong><br />

Flash<br />

feps.org<br />

1 st<br />

Pharmaceutical<br />

Sciences Fair<br />

<strong>and</strong> Exhibition,<br />

Nice, France<br />

1 st BBBB<br />

Conference, Sifok,<br />

Hungary<br />

QbD <strong>and</strong><br />

PAT Sciences<br />

Network<br />

European<br />

Pharma Sciences<br />

Leadership Forum<br />

(EuPSLF)<br />

Initiative<br />

<strong>EUFEPS</strong><br />

Institutional<br />

Membership<br />

Bioavailability<br />

<strong>and</strong><br />

Biopharmaceutics<br />

Network<br />

Safety Sciences<br />

Workshop II,<br />

Vienna, Austria<br />

2 nd BBBB<br />

Conference,<br />

Tartu, Estonia<br />

3 rd<br />

Pharmaceutical<br />

Sciences World<br />

Congress,<br />

Amsterdam,<br />

The Netherl<strong>and</strong>s<br />

<strong>EUFEPS</strong><br />

Vienna Branch<br />

Office for<br />

In-Silico<br />

Systems <strong>and</strong><br />

Learning<br />

European<br />

Commision 7 th<br />

Framework<br />

Programme for<br />

Research <strong>and</strong><br />

Technological<br />

Development<br />

2008–<br />

<strong>EUFEPS</strong><br />

Senate<br />

Innovative<br />

Medicines<br />

Initiative (IMI)<br />

Joint<br />

Undertaking<br />

<strong>EUFEPS</strong><br />

FIP (BPS)<br />

Membership<br />

(observer since<br />

inauguration)<br />

2 nd<br />

Pharmaceutical<br />

Sciences Fair<br />

<strong>and</strong> Exhibition,<br />

Nice, France<br />

3 rd BBBB<br />

Conference,<br />

Antalia, Turkey<br />

Environment<br />

<strong>and</strong><br />

Pharmaceuticals<br />

Network<br />

PharmacoGenetics<br />

<strong>and</strong><br />

PharmacoGenomics<br />

Research<br />

Network<br />

3 rd<br />

Pharmaceutical<br />

Sciences Fair<br />

<strong>and</strong> Exhibition,<br />

Prag,<br />

Czech Republic<br />

4 th BBBB<br />

Conference,<br />

Bled, Sloveina<br />

Food-Drug<br />

Synergy<br />

Network<br />

4th Pharmaceutical<br />

Sciences World<br />

Congress,<br />

New Orleans,<br />

USA<br />

Nano<br />

Medicines<br />

Network<br />

20 Years


© Janssen Pharmaceutica NV 2010<br />

Janssen Pharmaceutica NV<br />

Janssen Research & Development,<br />

A Division of Janssen Pharmaceutica NV,<br />

Turnhoutseweg 30, B-2340 Beerse, Belgium<br />

www.janssenpharmaceutica.com - www.jnjpharmarnd.com<br />

Dr. Paul Janssen<br />

Patients are Waiting


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World-class R&D in Göteborg <strong>and</strong> Manchester<br />

Make the connection<br />

Based in Mölndal on the outskirts of Göteborg <strong>and</strong> in Alderly Park/Macclesfield near Manchester, our research sites are more than<br />

simply state-of-the-art locations for much of our R&D. They’re home to scientists <strong>and</strong> researchers who value collaboration: global<br />

centres for R&D excellence; brain trusts; ideas hubs.<br />

We’re creating a vibrant, inspirational workspace where research-led ideas can be conceived. And it’s not just the buildings that are<br />

carefully designed either. From our way of working to the way we speak to each other, every aspect of the professional environment<br />

has been considered.<br />

By 2012 we expect to have filled hundreds of vacancies for people across discovery <strong>and</strong> development – from scientists who<br />

have strong disease knowledge <strong>and</strong> expertise in drug discovery, to experienced drug developers in clinical, pharmaceutical <strong>and</strong><br />

regulatory fields. In fact, we’re recruiting now – in dozens of different areas, from predictive science to supply chain management.<br />

Here, you’ll have the chance to make connections with brilliant minds, great ideas <strong>and</strong> health-enhancing discoveries. So if you<br />

really want to make a positive difference to future health research, we’d like to welcome you into our new home.<br />

For more information <strong>and</strong> to apply please go to www.astrazenecacareers.com<br />

www.astrazenecacareers.com


<strong>EUFEPS</strong> <strong>Yearbook</strong><br />

<strong>2011</strong><br />

20 th <strong>Anniversary</strong><br />

Issue


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List of Contents<br />

1. Contact Information including Secretariat 9<br />

2. President’s Foreword 10<br />

3. Mission, Membership <strong>and</strong> Operational Platforms 11<br />

4. Member Societies 12<br />

5. Individual Membership Representatives to Council 24<br />

6. <strong>EUFEPS</strong> Statutes 25<br />

7. Executive Committee 30<br />

8. Advisory Committees 32<br />

9. <strong>EUFEPS</strong> Networks 34<br />

10. Awards <strong>and</strong> Prizes 38<br />

11. European Pharmaceutical Scientist Prize 41<br />

12. PharmSciFair <strong>2011</strong> 42<br />

13. Sample Meetings 43<br />

14. <strong>EUFEPS</strong> in EU Projects 44<br />

15. <strong>EUFEPS</strong> Senate 45<br />

16. <strong>EUFEPS</strong> on the Global Scene 46<br />

17. Sponsorship Recognition 48<br />

18. Executive Committee Membership 1991–<strong>2011</strong> 49<br />

19. History of <strong>EUFEPS</strong> 50


Sustainable sponsorship of <strong>EUFEPS</strong> gratefully acknowledged<br />

1 3/6/08 5:49 am Page 1<br />

1 3/6/08 5:49 am Page 1<br />

1 3/6/08 5:49 am Page 1<br />

Publisher of the SolarPACES Publisher <strong>2011</strong>of<br />

the<br />

Editeur du Guide des Biotechnologies 2008<br />

Abstracts Book<br />

Publisher of the SolarPACES <strong>2011</strong><br />

Abstracts Book<br />

12 Place Carnot<br />

93110 Rosny Sous Bois<br />

Publisher Publisher of <strong>EUFEPS</strong><br />

of the the SolarPACES Directory<br />

SolarPACES <strong>2011</strong><br />

European Office:<br />

<strong>2011</strong><br />

Editeur Société OSC du Guide des Biotechnologies 2008<br />

Abstracts Book<br />

29, rue Politzer Book<br />

94100 Saint Maur<br />

France<br />

European Office:<br />

FRANCE<br />

Tél : (+33) 01 70 71 63 84 Société OSC<br />

12 Place Fax<br />

Place Carnot : (+33) 01 77 72 27 59<br />

Carnot<br />

29, rue Politzer<br />

Email :contact@osc-edition.com<br />

93110 94100 Saint Maur<br />

93110 Rosny Web Sous :www.osc-edition.com<br />

Bois<br />

FRANCE<br />

France<br />

FRANCE<br />

Tel: Tél : (+33) 01 70 71 63 84<br />

Tel: (+33) 01.70.71.63.84<br />

Fax:(+33) Fax : (+33) 01 77 72 27 59<br />

Fax:(+33) 01.77.72.27.59<br />

12 Place Carnot<br />

Publisher of the Biotechnology Industry<br />

E-mail: Email 93110 Guide<br />

:contact@osc-edition.com<br />

E-mail: contact@osc-edition.com 93110 Rosny 2008<br />

Rosny Sous Bois<br />

contact@osc-edition.com<br />

Web: Web :www.osc-edition.com<br />

FRANCE<br />

Web: www.osc-edition.com<br />

North American Office:<br />

Tel: (+33) 01.70.71.63.84<br />

Publisher Publisher of the the SolarPAC<br />

Editeur du Guide des Biotechnolo<br />

Abstracts Book<br />

Tel: (+33) 01.70.71.63.84<br />

Fax:(+33) 01.77.72.27.59<br />

E-mail: contact@osc-edition.com<br />

Web: www.osc-edition.com<br />

European Office:<br />

Société OSC<br />

29, rue Politzer<br />

94100 Saint Maur<br />

France<br />

Tél : (+33) 01 70 71 63 8<br />

Tel: (+33) 01.70.71.63.84<br />

OSC Associates<br />

Fax:(+33) Fax : (+33) 01 77 72 27 5<br />

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Tel: +1 (310) 878-2285<br />

Publisher Fax: +1 (310) of 861-1986 the Biotechnology Industry Guide 2008


Address<br />

<strong>EUFEPS</strong><br />

Veddesta Business Center<br />

SE-175 72 Järfälla (Stockholm) Sweden<br />

Tel + 46 8 50582040<br />

Fax + 46 8 4113217<br />

Email secretariat@eufeps.org<br />

Visiting Address<br />

1. Contact information<br />

Veddesta Business Center,<br />

Veddestavägen 13, 4th floor, Järfälla (Stockholm) Sweden<br />

Staff<br />

Hans H. Linden, MSc<br />

Executive Director<br />

Tel office + 46 8 50582040<br />

Tel mobile + 46 708 799813<br />

Email hans.linden@eufeps.org<br />

Per Öhrngren, MSc<br />

Office Manager<br />

Tel mobile + 46 708 766113<br />

Email per.ohrngren@eufeps.org<br />

Editor <strong>EUFEPS</strong> Online<br />

Hans H. Linden, MSc<br />

Editor <strong>EUFEPS</strong> Newsletter<br />

Vacant<br />

Editor-in-Chief European Journal of Pharmaceutical Sciences<br />

Professor Arto Urtti<br />

Viikki Drug Discovery Technology Center<br />

University of Helsinki, Helsinki, Finl<strong>and</strong><br />

Email arto.urtti@helsinki.fi<br />

Editor Per Öhrngren<br />

Current Hans H. Linden<br />

Editorial Team<br />

Historic Daan J.A. Crommelin<br />

Layout Camilla Boquist/Lådan&Co, Stockholm, Sweden<br />

9


2. PRESIDENT’S INTRODUCTION<br />

Democratically, moderated organisations that seek to serve member societies for the<br />

benefit of science must be an engine of change for good in Europe. We live in a constantly<br />

changing world <strong>and</strong> as age demographics change, the burden of health care becomes more<br />

pressing. The faster development of effective <strong>and</strong> safe medicines for all has been the watchword<br />

of <strong>EUFEPS</strong> since the beginning, <strong>and</strong> the efforts of previous generations of scientists<br />

associated with our twenty-year old organisation have achieved much in the path towards<br />

this goal.<br />

Europe is periodically beset by upheavals, in part mirroring changes elsewhere in the world,<br />

especially America. Changes in legislation for cheaper medicines have a knock-on effect on<br />

our industry <strong>and</strong> the nature of the pharmaceutical market changes. Processes requiring expensive<br />

raw material <strong>and</strong> low-cost labour move steadily east, leaving Europe to contemplate<br />

the nature of its pharmaceutical sciences.<br />

There is no doubt that we will be faced with the challenges of innovation in medicines, which<br />

extends through advanced products, through systems of monitoring health, personalised<br />

medicines, concern for our environment <strong>and</strong> the adoption of science-led regulation. This<br />

generates a need for better education <strong>and</strong> training <strong>and</strong> communication <strong>and</strong> a more intellectually<br />

nimble workforce, able to adapt to new dem<strong>and</strong>s in the industry. Our academic institutions<br />

must reflect these changes <strong>and</strong> be more cognisant of the changing requirements <strong>and</strong><br />

skill sets needed <strong>and</strong> avoid complacency. At any time in <strong>history</strong>, a seed change is either with<br />

us or just around the corner <strong>and</strong> <strong>EUFEPS</strong> exists to help its member organisations to realise<br />

new goals though interactions such as PharmSciFair <strong>and</strong> specialist distillation of information<br />

in networks.<br />

The future of <strong>EUFEPS</strong> depends on the enthusiasm of its membership. As a not-for-profit<br />

organisation, contributing to <strong>EUFEPS</strong> does not bring personal financial riches, but it does<br />

provide satisfaction that we are helping the next generations through mentorship <strong>and</strong> discussion.<br />

Being part of this august <strong>and</strong> worthy organisation is exhausting but fun <strong>and</strong> it is so<br />

easy to get deeply involved. I urge you to do so <strong>and</strong> promise that the deep satisfaction you<br />

will gain in making new connections <strong>and</strong> discovering science directions will amply offset the<br />

commitment of time.<br />

With best wishes,<br />

Clive G Wilson F.A.P.S., F.C.R.S.<br />

President<br />

European Federation of Pharmaceutical Sciences – <strong>EUFEPS</strong><br />

10


3. Mission, membership <strong>and</strong> operational platforms<br />

The mission of the European Federation for Pharmaceutical Sciences (<strong>EUFEPS</strong>) is to serve<br />

<strong>and</strong> advance excellence in the pharmaceutical sciences <strong>and</strong> innovative drug research in<br />

Europe, including in training <strong>and</strong> education, <strong>and</strong> to represent the interests of scientists<br />

engaged in drug research <strong>and</strong> development, drug regulation, drug utilisation, <strong>and</strong> drug<br />

policy making.<br />

Member Societies, Member Institutions <strong>and</strong> Individual Members are <strong>EUFEPS</strong> membership<br />

categories.<br />

<strong>EUFEPS</strong> is the only pan-European body to represent the interests of scientists in industry,<br />

academia, government <strong>and</strong> other institutions engaged in drug research, development,<br />

regulation <strong>and</strong> policymaking through Europe. It is an organisation for <strong>and</strong> run by<br />

scientists, forming a wide-range network <strong>and</strong> actively contributing to the ideals of the<br />

European pharmaceutical scientific community. The recruitment of younger generations of<br />

pharmaceutical scientists for <strong>EUFEPS</strong> activities is another prime goal. As regional organisation<br />

<strong>EUFEPS</strong> is bridging between the national <strong>and</strong> the global levels.<br />

To achieve its objectives <strong>EUFEPS</strong> initiates <strong>and</strong> runs European projects <strong>and</strong> networks.<br />

It organises, co-organises <strong>and</strong> co-sponsors congresses, conferences, workshops <strong>and</strong><br />

courses on specialised or general themes, including many sessions in the Pharmaceutical<br />

Sciences Fair <strong>and</strong> Exhibition (PharmSciFair).<br />

The European Journal of Pharmaceutical Sciences is the Official Scientific Journal of<br />

<strong>EUFEPS</strong>.<br />

Operational platforms of <strong>EUFEPS</strong>:<br />

�� Membership<br />

�� Networks<br />

�� Senate<br />

�� Research <strong>and</strong> Policy Collaboration<br />

�� The PharmSciFair<br />

�� Meetings <strong>and</strong> Events<br />

�� Education <strong>and</strong> Training<br />

�� Communication<br />

�� Finance <strong>and</strong> Funding<br />

�� President’s Conference<br />

�� Council <strong>and</strong> Open Forum<br />

�� Executive Committee<br />

�� Central Office<br />

11


4. Member Societies<br />

Academy of Pharmaceutical Sciences of Great Britain – APSGB<br />

Academy of Pharmaceutical Sciences<br />

Academy<br />

of Great<br />

of Pharmaceutical<br />

Britain – APSGB<br />

Sciences of Great Britain – APSGB<br />

Mission To stimulate development of, <strong>and</strong> promote the pharmaceutical sciences.<br />

Mission To stimulate development of, <strong>and</strong> promote the pharmaceutical sciences.<br />

To stimulate development of, <strong>and</strong> promote the<br />

To<br />

pharmaceutical<br />

promote interaction<br />

sciences.<br />

<strong>and</strong> collaboration between the multidisciplinary subjects which constitute<br />

To promote interaction <strong>and</strong> collaboration between the multidisciplinary subjects which constitute the<br />

To promote interaction <strong>and</strong> collaboration between<br />

the pharmaceutical<br />

the multidisciplinary<br />

sciences.<br />

subjects which constitute the<br />

pharmaceutical To express the views sciences. of pharmaceutical scientists at national <strong>and</strong> international levels.<br />

pharmaceutical sciences.<br />

Country To United express Kingdom the views of pharmaceutical scientists at national <strong>and</strong> international levels.<br />

To express the views of pharmaceutical scientists at national <strong>and</strong> international levels.<br />

Country Organisation (new) founded United 2000 Kingdom<br />

United Kingdom<br />

Organisation <strong>EUFEPS</strong> Member (new) Society founded 2000 1991<br />

2000<br />

<strong>EUFEPS</strong> Number Member of members Society 1991 500<br />

1991<br />

Number Postal address of members 500 840 Melton Road, Thurmaston, Leicester LE4 8BNUnited Kingdom<br />

500<br />

Postal Tel address 840 +44 Melton 116 2692299 Road, Thurmaston, Leicester LE4 8BNUnited Kingdom<br />

840 Melton Road,<br />

Tel Fax<br />

Thurmaston, Leicester LE4<br />

+44<br />

8BNUnited<br />

116 2692299 2640141<br />

Kingdom<br />

+44 116 2692299<br />

Fax Email +44 info@apsgb.org<br />

116 2640141<br />

+44 116 2640141<br />

Email info@apsgb.org<br />

eddie.french@pfizer.com<br />

info@apsgb.org Website eddie.french@pfizer.com<br />

www.apsgb.co.uk<br />

eddie.french@pfizer.com<br />

Website<br />

President (January 1, <strong>2011</strong>)<br />

www.apsgb.co.uk<br />

Professor Martin Snowden<br />

www.apsgb.co.uk<br />

President<br />

Secretary<br />

(January<br />

(January<br />

1,<br />

1,<br />

<strong>2011</strong>)<br />

<strong>2011</strong>)<br />

Professor<br />

Bob Seager<br />

Martin Snowden<br />

Professor Martin Activities Snowden <strong>2011</strong>-2012 PS Industrial Insights, April 14–15, <strong>2011</strong>, Pfizer, S<strong>and</strong>wich UK<br />

Secretary (January 1, <strong>2011</strong>) Bob Seager<br />

Bob Seager<br />

APS Inhalation <strong>2011</strong>, July 4–6, <strong>2011</strong>, University of Bath, Bath UK<br />

Activities <strong>2011</strong>-2012 PS Industrial Insights, April 14–15, <strong>2011</strong>, Pfizer, S<strong>and</strong>wich UK<br />

PS Industrial Insights, April 14–15, <strong>2011</strong>, Pfizer, UK-PharmSci S<strong>and</strong>wich <strong>2011</strong> UK The Science of Medicines, August 30–September 2, <strong>2011</strong>, East Midl<strong>and</strong>s<br />

APS Inhalation <strong>2011</strong>, July 4–6, <strong>2011</strong>, University of Bath, Bath UK<br />

APS Inhalation <strong>2011</strong>, July 4–6, <strong>2011</strong>, University Conference of Bath, Centre, Bath UKNottingham<br />

UK<br />

UK-PharmSci <strong>2011</strong> The Science of Medicines, August 30–September 2, <strong>2011</strong>, East Midl<strong>and</strong>s<br />

UK-PharmSci <strong>2011</strong> The Science of Medicines, PS August & APS 30–September Drugs in the Lungs, 2, <strong>2011</strong>, September/October, East Midl<strong>and</strong>s <strong>2011</strong><br />

Conference Centre, Nottingham UK<br />

Conference Centre, Annual Nottingham conferences UK<strong>2011</strong>-<br />

PS & APS Drugs in the Lungs, September/October, <strong>2011</strong><br />

PS & APS Drugs 2012in<br />

the Lungs, September/October, <strong>2011</strong><br />

Annual National conferences meeting<strong>2011</strong>-2012 <strong>2011</strong>-<br />

2012 Official journal<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

Association de de Pharmacie Galénique Industrielle – APGI – APGI<br />

Mission<br />

Mission<br />

Country<br />

Country<br />

Organisation founded<br />

Organisation founded<br />

<strong>EUFEPS</strong> Member Society<br />

<strong>EUFEPS</strong> Member Society<br />

Number<br />

Number<br />

of<br />

of<br />

members<br />

members<br />

Postal<br />

Postal<br />

address<br />

address<br />

Tel Tel<br />

Fax Fax<br />

Email Email<br />

APGI is an association accessible to all, academics <strong>and</strong> persons in industry, who are concerned<br />

with APGI pharmaceutical is an association technology, accessible <strong>and</strong> to all, the academics design, formulation <strong>and</strong> persons <strong>and</strong> in industry, pharmacotechnical,<br />

who are concerned<br />

biopharmaceutical with pharmaceutical <strong>and</strong> technology, pharmacokinetic <strong>and</strong> the design, assessment formulation of dosage <strong>and</strong> pharmacotechnical,<br />

forms <strong>and</strong> delivery systems,<br />

whether biopharmaceutical pharmaceutical <strong>and</strong> pharmacokinetic or dermopharmaceutical. assessment of dosage forms <strong>and</strong> delivery systems,<br />

whether pharmaceutical or dermopharmaceutical.<br />

France<br />

France<br />

1964<br />

1964<br />

1991<br />

1991<br />

300<br />

300<br />

5,<br />

5,<br />

Rue<br />

Rue 4B<br />

4B<br />

Clément,<br />

Clément,<br />

FR-92290<br />

FR-92290<br />

Chateuay-Malabry,<br />

Chateuay-Malabry,<br />

France<br />

France<br />

+33 1 46602510<br />

+33 6 29366739<br />

+33 1 46835308<br />

apgi.asso@u-psud.fr<br />

juergen.siepmann@univ-lille2.fr<br />

Website www.apgi.org<br />

President (January 1, 1, <strong>2011</strong>) Professor Juergen Siepmann<br />

Secretary (January 1, 1, <strong>2011</strong>) Odile Odile Chambin<br />

Activities <strong>2011</strong>-2012 Partner Organisation Organisation of PharmSciFair, June 13–17, <strong>2011</strong>, Prague CZ CZ<br />

Annual conferences <strong>2011</strong>- 8th World Meeting on Pharmaceutics, Biopharmaceutics <strong>and</strong> <strong>and</strong> Pharmaceutical Technologes,<br />

March<br />

2012<br />

19–22 March 19–22 2012, Istabul 2012, Istabul TR TR<br />

Skin <strong>and</strong> Formulation, Lyon FR FR<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

Poorly Soluble Drugs Woarkshop, September 15, 15, Lille Lille FR FR<br />

12


Austrian Pharmaceutical Society – ÖPhG<br />

Austrian Pharmaceutical Society – ÖPhG – ÖPhG<br />

Mission In order to intensify the the contact between the the universities, the the pharmaceutic industry industry <strong>and</strong> <strong>and</strong> health health<br />

Mission authorities In order to<br />

authorities as intensify<br />

as well as the<br />

as hospital contact<br />

hospital <strong>and</strong> between<br />

<strong>and</strong> public public pharmacies, the universities,<br />

pharmacies, the the<br />

the ÖPhG pharmaceutic<br />

ÖPhG holds holds presentations, industry <strong>and</strong><br />

presentations, scientific health<br />

scientific<br />

congresses authorities as<br />

congresses <strong>and</strong> well<br />

<strong>and</strong> seminars as hospital<br />

seminars on on a <strong>and</strong><br />

a regular public<br />

regular basis. pharmacies, the ÖPhG holds presentations, scientific<br />

basis.<br />

Country Country Austria congresses <strong>and</strong> seminars on a regular basis.<br />

Austria<br />

Organisation<br />

Organisation Country<br />

founded<br />

founded 1979 Austria<br />

1979<br />

<strong>EUFEPS</strong> Organisation Member founded Society 1991 1979<br />

<strong>EUFEPS</strong> Member Society 1991<br />

Number <strong>EUFEPS</strong> of Member members Society 700 1991<br />

Number of members 700<br />

Postal Number address of members Department 700 für Pharmakognosie, Univ. Wien, Althanstraße 14, AT-1090 Wien, Austria<br />

Postal address Department für Pharmakognosie, Univ. Wien, Althanstraße 14, AT-1090 Wien, Austria<br />

Tel Postal address +43 Department 1 4277 55207 für Pharmakognosie, Univ. Wien, Althanstraße 14, AT-1090 Wien, Austria<br />

Tel +43 1 4277 55207<br />

Fax Tel +43 1 4277 9552 55207<br />

Fax +43 1 4277 9552<br />

Email Fax office@oephg.at<br />

+43 1 4277 9552<br />

Email hermann.stuppner@uibk.ac.at<br />

office@oephg.at<br />

gerhard.f.ecker@univie.ac.at<br />

hermann.stuppner@uibk.ac.at<br />

Website www.oephg.at<br />

gerhard.f.ecker@univie.ac.at<br />

Website President Website (January 1, <strong>2011</strong>) Prof. www.oephg.at Dr. Hermann Stuppner<br />

President Secretary President (January 1, 1, <strong>2011</strong>) Prof. Prof. Dr. Dr. Sabine Hermann Hermann Glasl-Tazreiter<br />

Stuppner<br />

Secretary Activities Secretary (January <strong>2011</strong>-2012 (January 1, <strong>2011</strong>) Participation Prof. Dr. Dr. Sabine in the Glasl-Tazreiter<br />

PharmSciFair, June 13–16, <strong>2011</strong>, Prague CZ<br />

Activities <strong>2011</strong>-2012 Summer Participation School in the DRUG PharmSciFair, DESIGN, September June 13–16, 11–16, <strong>2011</strong>, <strong>2011</strong> Prague CZ CZ<br />

SEGGAUER Summer School Fortbildungstage, DRUG DESIGN, Oktober September 8–9, <strong>2011</strong> 11–16, <strong>2011</strong> <strong>2011</strong><br />

Annual conferences <strong>2011</strong>- SEGGAUER Fortbildungstage, Oktober 8–9, 8–9, <strong>2011</strong> <strong>2011</strong><br />

Annual 2012 Annual conferences <strong>2011</strong>-<br />

2012 National 2012 meeting<strong>2011</strong>-2012 Joint Meeting of the Austrian <strong>and</strong> German Pharmaceutical Societies,September 21–23, <strong>2011</strong>,<br />

National National meeting<strong>2011</strong>-2012 University Joint Meeting of Innsbruck, of the Austrian Innsbruck <strong>and</strong> <strong>and</strong> German AT German Pharmaceutical Societies,September 21–23, 21–23, <strong>2011</strong>, <strong>2011</strong>,<br />

Official journal Scientia University Pharmaceutica<br />

of Innsbruck,<br />

Innsbruck,<br />

Innsbruck<br />

Innsbruck<br />

AT<br />

AT<br />

Official<br />

Official<br />

journal<br />

journal<br />

Scientia<br />

Scientia<br />

Pharmaceutica<br />

Pharmaceutica<br />

Belgian Society of Pharmaceutical Sciences – BSPS<br />

Belgian Society of Pharmaceutical Sciences – BSPS<br />

Belgian Society of Pharmaceutical Sciences – BSPS<br />

Mission The Belgian Society of Pharmaceutical Sciencesaims at supporting <strong>and</strong> promoting research in<br />

Mission Pharmaceutical The Belgian Society Sciences of of Pharmaceutical both at the national Sciencesaims <strong>and</strong> international at at supporting level. <strong>and</strong> <strong>and</strong> promoting promoting research research in in<br />

Country Belgium Pharmaceutical Sciences both at at the the national <strong>and</strong> <strong>and</strong> international level. level.<br />

Country Organisation Country founded 1951 Belgium<br />

Organisation <strong>EUFEPS</strong> Organisation Member founded Society 1994 1951<br />

<strong>EUFEPS</strong> Number <strong>EUFEPS</strong> of Member members Society 300 1994<br />

Number Postal Number address of<br />

of<br />

members<br />

members Stevinstraat 300<br />

300 137, BE-1000 Brussels, Belgium<br />

Postal Tel Postal<br />

address<br />

address +32 Stevinstraat<br />

Stevinstraat 2 6094625 137,<br />

137,<br />

BE-1000<br />

BE-1000<br />

Brussels,<br />

Brussels,<br />

Belgium<br />

Belgium<br />

Tel Fax Tel +32<br />

+32 2 2854285 6094625<br />

6094625<br />

Fax Email Fax saevels.jan@mail.apb.be<br />

+32 2 2854285<br />

+32 2 2854285<br />

Email<br />

Email veronique.preat@uclouvain.be<br />

saevels.jan@mail.apb.be<br />

saevels.jan@mail.apb.be<br />

Website www.bgfw.be<br />

veronique.preat@uclouvain.be<br />

veronique.preat@uclouvain.be<br />

Website<br />

President Website (January 1, <strong>2011</strong>) Professor www.bgfw.be<br />

www.bgfw.be<br />

Veronique Preat<br />

President<br />

Secretary President<br />

(January<br />

(January 1, 1,<br />

1,<br />

<strong>2011</strong>)<br />

<strong>2011</strong>)<br />

J. Professor<br />

Professor<br />

Saevels, Veronique<br />

Veronique<br />

F. Prohoroff Preat<br />

Preat<br />

Activities Secretary <strong>2011</strong>-2012 (January 1, <strong>2011</strong>) BSPS J. Saevels, bi-annual F. Prohoroff National Prize of Pharmaceutical Sciences<br />

Secretary Activities (January <strong>2011</strong>-20121, <strong>2011</strong>) J. Saevels, F. Prohoroff<br />

BSPS bi-annual International National Prize Prize of Pharmaceutical Sciences<br />

Activities <strong>2011</strong>-2012<br />

Annual<br />

BSPS bi-annual Prize Pharmacist International National<br />

<strong>and</strong><br />

Prize<br />

Doctor Prize of Pharmaceutical<br />

NEDELJKOVIC<br />

Sciences<br />

Conference<br />

BSPS Annual bi-annual Prize travel Pharmacist International<br />

grants <strong>and</strong> Doctor Prize NEDELJKOVIC<br />

Annual conferences <strong>2011</strong>- Four-yearly<br />

Annual Conference Prize<br />

International travel Pharmacist grantsSymposium<br />

<strong>and</strong> Doctor<br />

on<br />

NEDELJKOVIC<br />

Drug Analysis<br />

2012 Annual conferences <strong>2011</strong>- Conference Four-yearly International travel grantsSymposium<br />

on Drug Analysis<br />

Annual National 2012 conferences meeting<strong>2011</strong>-2012 <strong>2011</strong>- Forum Four-yearly for Pharmaceutical International Symposium Sciences, May on 12–13, Drug Analysis <strong>2011</strong>, Spa BE<br />

2012<br />

Official National journal meeting<strong>2011</strong>-2012 Forum for Pharmaceutical Sciences, May 12–13, <strong>2011</strong>, Spa BE<br />

National Official journal meeting<strong>2011</strong>-2012 Forum for Pharmaceutical Sciences, May 12–13, <strong>2011</strong>, Spa BE<br />

Official journal<br />

13


Croatian Pharmaceutical Society – CPhS<br />

Croatian Pharmaceutical Society – CPhS CPhS<br />

Mission Development of pharmaceutical profession, stimulating professional <strong>and</strong> scientific work, running<br />

Mission Development continuing education of pharmaceutical courses, organising profession, professional stimulating <strong>and</strong> professional scientific events, <strong>and</strong> scientific publishing work, journals running<strong>and</strong><br />

Mission continuing books, Development promoting education of pharmaceutical <strong>and</strong> courses, advancing organising profession, all forms professional of stimulating pharmaceutical <strong>and</strong> professional scientific education, events, <strong>and</strong> cooperation scientific publishing work, with journals running health <strong>and</strong><br />

books, institutions, continuing promoting education Croatian <strong>and</strong> Pharmaceutical courses, advancing organising all forms Chamber professional of pharmaceutical <strong>and</strong> other <strong>and</strong> associations, scientific education, events, adhering cooperation publishing to ethical with journals health<strong>and</strong><br />

institutions, principles, books, promoting Croatian development <strong>and</strong> Pharmaceutical advancing of the perception all forms Chamber of of honour, pharmaceutical <strong>and</strong> other dignity associations, <strong>and</strong> education, responsibility adhering cooperation of pharmaceutical<br />

to ethical with health principles,<br />

development vocation. institutions, Croatian of the perception Pharmaceutical of honour, Chamber dignity <strong>and</strong> <strong>and</strong> other responsibility associations, of pharmaceutical adhering to ethical vocation.<br />

Country Country Croatia principles, development of the perception of honour, dignity <strong>and</strong> responsibility of pharmaceutical<br />

Organisation founded 1858 1858 vocation.<br />

<strong>EUFEPS</strong> Country Member Society 1991 1991 Croatia<br />

Number Organisation of of members founded 1800 1800 1858<br />

Postal <strong>EUFEPS</strong> address Member Society Masarykova 1991 2, 2, HR-10000 Zagreb, Croatia<br />

Tel Number Tel of members +385 1800 +385 1 1 4872849<br />

Fax Postal Fax address +385 Masarykova +385 1 1 4872853 2, HR-10000 Zagreb, Croatia<br />

Email Tel hfd-fg-ap@zg.t-com.hr<br />

+385 1 4872849<br />

Fax mladar@solar.pharma.hr<br />

+385 1 4872853<br />

Website Email www.hfd-fg.hr<br />

hfd-fg-ap@zg.t-com.hr<br />

President (January 1, 1, <strong>2011</strong>) Mag. mladar@solar.pharma.hr<br />

Mag. Pharm. Kresimir Rukavina<br />

Secretary Website Secretary (January 1, 1, <strong>2011</strong>) PhD www.hfd-fg.hr<br />

PhD Mag. Pharm. Maja Jakševac-Mikša<br />

Jakševac-Mikša<br />

Activities President <strong>2011</strong>-2012 (January 1, <strong>2011</strong>) International Mag. Pharm. Conference Kresimir Rukavina on Drug Information, September 29–30, <strong>2011</strong>, Dubrovnik HR<br />

Secretary (January 1, <strong>2011</strong>) Workshop PhD Mag. on Pharm. on Dissolution Maja Jakševac-Mikša<br />

<strong>and</strong> Bioequivalence, October 3–5, <strong>2011</strong><br />

Annual Activities conferences <strong>2011</strong>-2012 <strong>2011</strong>- International Conference on Drug Information, September 29–30, <strong>2011</strong>, Dubrovnik HR<br />

2012 2012<br />

Workshop on Dissolution <strong>and</strong> Bioequivalence, October 3–5, <strong>2011</strong><br />

National Annual meeting<strong>2011</strong>-2012<br />

conferences meeting<strong>2011</strong>-2012 <strong>2011</strong>-<br />

Official<br />

2012 Official journal Farmaceutski glasnik<br />

National meeting<strong>2011</strong>-2012<br />

Acta Acta pharmaceutica<br />

Official journal Farmaceutski glasnik<br />

Acta pharmaceutica<br />

Czech Pharmaceutical Society<br />

Czech Pharmaceutical Society<br />

Mission<br />

Mission<br />

Mission<br />

Country<br />

Organisation founded<br />

<strong>EUFEPS</strong> Country Member Society<br />

Number Organisation Number of of members founded<br />

Postal <strong>EUFEPS</strong> address Member Society<br />

Number of members<br />

Tel Tel Postal address<br />

Fax Fax<br />

Email Email Tel<br />

Website Website Fax<br />

President President Email<br />

(January (January 1, 1, <strong>2011</strong>) <strong>2011</strong>)<br />

Website<br />

Secretary Secretary (January (January 1, 1, <strong>2011</strong>) <strong>2011</strong>)<br />

President<br />

Activities Activities <strong>2011</strong>-2012 <strong>2011</strong>-2012 (January 1, <strong>2011</strong>)<br />

Secretary<br />

Annual<br />

Annual<br />

conferences<br />

conferences (January 1,<br />

<strong>2011</strong>-<br />

<strong>2011</strong>- <strong>2011</strong>)<br />

2012<br />

2012 Activities <strong>2011</strong>-2012<br />

National<br />

National Annual conferences<br />

meeting<strong>2011</strong>-2012<br />

meeting<strong>2011</strong>-2012 <strong>2011</strong>-<br />

2012<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

Official journal<br />

The main objective of the Czech Pharmaceutical Society is to collect, develop, <strong>and</strong> promote new<br />

The concepts main objective in pharmaceutical of the Czech science Pharmaceutical <strong>and</strong> to apply Society them to health is to collect, care. To develop, achieve <strong>and</strong> its basic promote new<br />

concepts objectives, The main in objective pharmaceutical activities of directed the Czech science at the Pharmaceutical dissemination <strong>and</strong> to apply Society them of information to is health to collect, of care. the develop, To latest achieve results <strong>and</strong> its promote ofbasic<br />

objectives, new<br />

activities pharmaceutical concepts directed in pharmaceutical research at the dissemination <strong>and</strong> science all other <strong>and</strong> related of to information apply sciences them of to are the health pursued. latest care. results It To participates achieve of pharmaceutical its in basic educational research<br />

<strong>and</strong> objectives, activities all other in activities close related co-operation sciences directed at are with the pursued. research dissemination It <strong>and</strong> participates educational of information in educational institutions of the latest in activities the results field in of close cooperation<br />

pharmaceutical with research sciences. <strong>and</strong> <strong>and</strong> educational all other related institutions sciences in the are field pursued. of pharmaceutical It participates sciences. in educational<br />

Czech activities Republic in close co-operation with research <strong>and</strong> educational institutions in the field of<br />

1875 pharmaceutical sciences.<br />

1991 Czech 1991 Republic<br />

240 1875<br />

Faculty 1991 of of Pharmacy, Charles University, University, Heyrovského Heyrovského 1203, CZ-500 05 Hradec Králové, Czech<br />

Republic 240<br />

+420 Faculty 495 495 of 067403 Pharmacy, Charles University, Heyrovského 1203, CZ-500 05 Hradec Králové, Czech<br />

+420 Republic<br />

495 495 067162<br />

ludek.jahodar@faf.cuni.cz<br />

+420 495 067403<br />

en.cfs-cls.cz<br />

+420 495 067162<br />

ludek.jahodar@faf.cuni.cz<br />

Prof. Prof. Dr. Dr. Luděk Jahodář, CSc<br />

en.cfs-cls.cz<br />

Prof. Prof. Dr. Dr. Petr Petr Solich, Solich, CSc. CSc.<br />

Prof.<br />

<strong>2011</strong> <strong>2011</strong> Dr.<br />

PharmSciFair, Luděk Jahodář,<br />

June June CSc<br />

13–17, <strong>2011</strong>, Prague CZ<br />

Prof. Dr. Petr Solich, CSc.<br />

<strong>2011</strong> PharmSciFair, June 13–17, <strong>2011</strong>, Prague CZ<br />

Synthesis<br />

Synthesis<br />

<strong>and</strong><br />

<strong>and</strong><br />

Analysis<br />

Analysis<br />

of<br />

of<br />

drugs,<br />

drugs,<br />

Brno,<br />

Brno,<br />

September<br />

September <strong>2011</strong><br />

<strong>2011</strong><br />

Congress o Community Pharmacists, Pilsen, October 14–16, <strong>2011</strong><br />

Congress o Community Pharmacists, Pilsen, October 14–16, <strong>2011</strong><br />

Hospital Synthesis Pharmacy <strong>and</strong> Analysis meeting, of drugs, November Brno, September <strong>2011</strong>, Brno <strong>2011</strong> CZ<br />

Hospital Pharmacy meeting, November <strong>2011</strong>, Brno CZ<br />

Symposium Congress o Community of Clinical Pharmacy, Pharmacists, November Pilsen, <strong>2011</strong>, October Mikulov 14–16, CZ<strong>2011</strong><br />

Symposium of Clinical Pharmacy, November <strong>2011</strong>, Mikulov CZ<br />

Česká Hospital a Pharmacy slovenská meeting, farmacie November <strong>2011</strong>, Brno CZ<br />

Česká Symposium a slovenská of Clinical farmacie Pharmacy, November <strong>2011</strong>, Mikulov CZ<br />

Official journal Česká a slovenská farmacie<br />

14


Finnish Pharmaceutical Society<br />

Finnish Pharmaceutical Society<br />

Mission<br />

Mission<br />

Country<br />

Country Organisation founded<br />

Organisation <strong>EUFEPS</strong> Member founded Society<br />

The aim of the society is to promote the pharmaceutical sciences, pharmaceutical research <strong>and</strong><br />

the The applications aim of the society of these is in to Finl<strong>and</strong>. promote the pharmaceutical sciences, pharmaceutical research <strong>and</strong><br />

Finl<strong>and</strong> the applications of these in Finl<strong>and</strong>.<br />

1887 Finl<strong>and</strong><br />

1991 1887<br />

<strong>EUFEPS</strong> Number Member of members Society 320 1991<br />

Number Postal address of members Fredrikinkatu 320 61, SF-00100 Helsinki, Finl<strong>and</strong><br />

Postal Tel address<br />

Tel Fax<br />

Fredrikinkatu 61, SF-00100 Helsinki, Finl<strong>and</strong><br />

Fax Email leena.peltonen@helsinki.fi<br />

Email Website www.pro.tsv.fi/finpharmsociety/mainengl.htm<br />

leena.peltonen@helsinki.fi<br />

Website President (January 1, <strong>2011</strong>) Dr www.pro.tsv.fi/finpharmsociety/mainengl.htm<br />

Tom Wikberg<br />

President Secretary (January 1, <strong>2011</strong>) Dr Leena Tom Wikberg Peltonen<br />

Secretary Activities (January <strong>2011</strong>-20121, <strong>2011</strong>)<br />

Activities <strong>2011</strong>-2012<br />

Annual conferences <strong>2011</strong>-<br />

Annual 2012 conferences <strong>2011</strong>-<br />

2012 National meeting<strong>2011</strong>-2012<br />

National Official journal meeting<strong>2011</strong>-2012<br />

Official journal<br />

Helsinki Dr Leena Drug Peltonen Research Congress, September <strong>2011</strong><br />

FinMedChem Helsinki Drug Conference, Research Congress, September September 15–16, <strong>2011</strong> <strong>2011</strong><br />

FinMedChem Conference, September 15–16, <strong>2011</strong><br />

German Pharmaceutical Society – DPhG<br />

German Pharmaceutical Society – DPhG<br />

Mission Promote pharmaceutical sciences <strong>and</strong> <strong>and</strong> interdisciplinary way way of of thinking.<br />

Country Germany<br />

Organisation founded 1890 1890<br />

<strong>EUFEPS</strong> Member Society Society 1991<br />

Number of of members 10000 10000<br />

Postal address DPhG Geschäftsstelle, Hamburger Allee 26–28, DE-60486 Frankfurt/Main, Germany<br />

Tel Tel +49 69 71915960<br />

Fax Fax +49 69 719159629<br />

Email<br />

Website<br />

President (January 1, 1, <strong>2011</strong>)<br />

Secretary<br />

Secretary<br />

(January<br />

(January<br />

1,<br />

1,<br />

<strong>2011</strong>)<br />

<strong>2011</strong>)<br />

Activities<br />

Activities<br />

<strong>2011</strong>-2012<br />

<strong>2011</strong>-2012<br />

Annual conferences <strong>2011</strong>-<br />

Annual<br />

2012<br />

conferences <strong>2011</strong>-<br />

2012<br />

National meeting<strong>2011</strong>-2012<br />

National<br />

Official journal<br />

meeting<strong>2011</strong>-2012<br />

Official journal<br />

info@dphg.de<br />

holzgrab@pharmazie.uni-wuerzburg.de<br />

www.dphg.de<br />

Prof. Dr. Manfred Schubert-Zsilavecz<br />

Prof. Dr.<br />

Dr.<br />

Andreas<br />

Andreas<br />

Link<br />

Link<br />

Focus<br />

Focus on<br />

on<br />

further<br />

further<br />

education<br />

education<br />

(400<br />

(400<br />

lectures<br />

lectures<br />

each<br />

each<br />

year<br />

year<br />

all<br />

all<br />

over<br />

over<br />

Germany)<br />

Germany)<br />

General statements, support of young scientists, press activities, <strong>and</strong> advise legislative <strong>and</strong><br />

General statements, support of young scientists, press activities, <strong>and</strong> advise legislative <strong>and</strong><br />

administrative bodies<br />

administrative bodies<br />

Close collaboration with foreign scientific societies<br />

Close collaboration with foreign scientific societies<br />

Annual Conference, together with the Austrian Pharmaceutical Society, September20–23,<br />

Annual<br />

Innsbruck<br />

Conference,<br />

AT<br />

together with the Austrian Pharmaceutical Society, September20–23,<br />

Innsbruck<br />

Post-Graduate-Meeting,<br />

AT<br />

Mars 30–April 2, <strong>2011</strong>, Heringsdorf DE<br />

Post-Graduate-Meeting,<br />

Pharmazie in unserer Zeit<br />

Mars 30–April 2, <strong>2011</strong>, Heringsdorf DE<br />

Pharmazie in unserer Zeit<br />

15


Hellenic Society of Medicinal Chemistry – HSMC<br />

Hellenic Society of Medicinal Chemistry – HSMC<br />

Mission Advancement of research in Medicinal Chemistry <strong>and</strong> Drug Design, promotion of cooperation<br />

between scientists of related fields <strong>and</strong> consulting on relevant subjects.<br />

Mission Country Greece Advancement of research in Medicinal Chemistry <strong>and</strong> Drug Design, promotion of cooperation<br />

Organisation founded 1980 between scientists of related fields <strong>and</strong> consulting on relevant subjects.<br />

Country <strong>EUFEPS</strong> Member Society 1998 Greece<br />

Organisation Number of members founded 107 1980<br />

<strong>EUFEPS</strong> Postal address Member Society Department 1998 of Pharmaceutical Chemistry, Panepistimiopolis Zografou, GR-15771 Athens,<br />

Number of members Greece 107<br />

Postal Tel address +30 Department 210 7274530 of Pharmaceutical Chemistry, Panepistimiopolis Zografou, GR-15771 Athens, Greece<br />

Tel Fax +30 210 7274747 7274530<br />

Fax Email<br />

Email Website<br />

Website President (January 1, <strong>2011</strong>)<br />

President Secretary (January 1, 1, <strong>2011</strong>)<br />

Secretary Activities (January <strong>2011</strong>-20121, <strong>2011</strong>)<br />

Activities<br />

Annual conferences<br />

<strong>2011</strong>-2012<br />

<strong>2011</strong>-<br />

2012<br />

Annual conferences <strong>2011</strong>-<br />

National meeting<strong>2011</strong>-2012<br />

2012<br />

Official journal<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

tsantili@pharm.uoa.gr<br />

+30 210 7274747<br />

www.pharm.auth.gr/helsocmedchem/<br />

tsantili@pharm.uoa.gr<br />

Prof. www.pharm.auth.gr/helsocmedchem/<br />

Dr Anna Tsantili-Kakoulidou<br />

Assoc. Prof. Dr Prof. Anna Dr. Tsantili-Kakoulidou<br />

Sotiris Nikolaropoulos<br />

15th Assoc. Hellenic Prof. Dr. Symposium Sotiris Nikolaropoulos<br />

on Medicinal Chemistry, 2012, Patras GR<br />

15th Hellenic Symposium on Medicinal Chemistry, 2012, Patras GR<br />

Hungarian Society for Pharmaceutical Sciences – HSPS<br />

Hungarian Society for Pharmaceutical Sciences – HSPS<br />

Mission<br />

Mission<br />

The goals of the Society are<br />

The – facilitation goals of of the the Society advancement are of professional conditions of pharmaceutical education, drug<br />

– research facilitation <strong>and</strong> of health the advancement care. of professional conditions of pharmaceutical education, drug<br />

research – to enhance <strong>and</strong> the health quality care. of st<strong>and</strong>ards in community <strong>and</strong> hospital pharmacy in order to improve<br />

– the to safety enhance of drug the quality therapy of <strong>and</strong> st<strong>and</strong>ards distribution. in community <strong>and</strong> hospital pharmacy in order to improve the<br />

safety – to encourage of drug therapy the improvement <strong>and</strong> distribution. of the scientific <strong>and</strong> professional knowledge of pharmacists.<br />

– to st<strong>and</strong>ing encourage for the the interests improvement of pharmaceutical of the scientific profession <strong>and</strong> professional <strong>and</strong> enhancing knowledge its social of prestige. pharmacists.<br />

– st<strong>and</strong>ing to promote for the the health interests education of pharmaceutical <strong>and</strong> healthy life-style profession in the <strong>and</strong> population. enhancing its social prestige.<br />

Country – Hungary to promote the health education <strong>and</strong> healthy life-style in the population.<br />

Country Organisation founded Hungary 1924<br />

Organisation <strong>EUFEPS</strong> Member founded Society 1924 1991<br />

<strong>EUFEPS</strong> Number Member of members Society 1991 315<br />

Number Postal address of members 315 POB 480, HU-1447 BudapestHungary<br />

Postal Tel address POB +36 1 480, 2350999 HU-1447 BudapestHungary<br />

Tel Fax +36 1 2350999 4831465<br />

Fax Email<br />

Email<br />

Website<br />

Website President (January 1, <strong>2011</strong>)<br />

President Secretary (January (January 1, 1, <strong>2011</strong>) <strong>2011</strong>)<br />

Secretary Activities (January <strong>2011</strong>-2012 1, <strong>2011</strong>)<br />

Activities <strong>2011</strong>-2012<br />

Annual conferences <strong>2011</strong>-<br />

2012<br />

Annual conferences <strong>2011</strong>-<br />

2012<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

+36 titkarsag@mgyt.hu<br />

1 4831465<br />

titkarsag@mgyt.hu<br />

meeting@mgyt.hu<br />

meeting@mgyt.hu<br />

www.mgyt.hu<br />

www.mgyt.hu<br />

Prof. Dr Zoltán Vincze<br />

Prof. Dr Sarolta Dr Zoltán Márkus Vincze<br />

Dr Organisation Sarolta Márkus of training lectures for pharmacists (ten times a year)<br />

The Hungarian National Committee of Pharmaceutical Care (Postgrad.edu. in pharmaceutical<br />

Organisation of training lectures for pharmacists (ten times a year)<br />

care)<br />

The Hungarian National Committee of Pharmaceutical Care (Postgrad.edu. in pharmaceutical<br />

Organising Contest for Young Pharmacists in Practice – In memoriam Mátyás Rozsnyay<br />

care)<br />

Organising Contest for Young Research Fellows – in memoriam Otto Clauder<br />

Organising Contest for Young Pharmacists in Practice – In memoriam Mátyás Rozsnyay<br />

Conferences of the Sections of the Society:Drug Analysis, Pharmacognosy, Pharmaceutical<br />

Organising<br />

Technology,<br />

Contest<br />

Drug Research,<br />

for Young<br />

History<br />

Research<br />

of Pharmacy<br />

Fellows – in memoriam Otto Clauder<br />

Conferences of of the the Hospital Sections Pharmacy of the Society:Drug Organization Analysis, <strong>and</strong> Industrial Pharmacognosy, Pharmacy Organization Pharmaceutical of the<br />

Technology, Society Drug Research, History of Pharmacy<br />

Conferences of the Hospital Pharmacy Organization <strong>and</strong> Industrial Pharmacy Organization of the<br />

Society Gyógyszerészet<br />

Acta Pharmaceutica Hungarica<br />

Gyógyszerészet<br />

Acta Pharmaceutica Hungarica<br />

16


Country Israel<br />

<strong>EUFEPS</strong> Member Society<br />

Country Email<br />

<strong>EUFEPS</strong> Member Society<br />

1993<br />

ahoffman@cc.huji.ac.il<br />

Israel<br />

1993<br />

Email ahoffman@cc.huji.ac.il<br />

Israel Society of Clinical Pharmacy <strong>and</strong> Biopharmaceutics – ISCPB<br />

Israel Society of Clinical Pharmacy <strong>and</strong> Biopharmaceutics – ISCPB<br />

Italian Society for for Pharmaceutical Sciences –SISF –SISF<br />

Mission<br />

Mission<br />

Contribute to the progress in all aspects of the pharmaceutical science.<br />

Contribute Stimulate (motivate) to the progress the collaboration in all aspects between of the researchers pharmaceutical from science. diffeent areas which cooperate<br />

Stimulate in the drug (motivate) discovery the <strong>and</strong> collaboration development between process. researchers from diffeent areas which cooperate in<br />

the Cooperate drug discovery with the <strong>and</strong> State development Authorities on process. matters of general interest on the pharmaceutical area.<br />

Cooperate Protect <strong>and</strong> with valorize the State (expoloit) Authorities the moral on <strong>and</strong> matters scientific of general aspects interest in the on development, the pharmaceutical production area.<br />

Protect <strong>and</strong> dispensation <strong>and</strong> valorize of the (expoloit) drug. the moral <strong>and</strong> scientific aspects in the development, production <strong>and</strong><br />

Country dispensation Italia of the drug.<br />

Country Organisation founded Italia 1953<br />

Organisation <strong>EUFEPS</strong> Member founded Society 1953 1991<br />

<strong>EUFEPS</strong> Number Member of members Society 1991 125<br />

Number Postal address of members 125 Viale Abruzzi 32, IT-20133 Milano, Italy<br />

Postal Tel address Viale +39 02 Abruzzi 49635252 32, IT-20133 Milano, Italy<br />

Tel Fax +39 02 49635252 49633384<br />

Fax Email<br />

Email<br />

Website<br />

Website President (January 1, <strong>2011</strong>)<br />

President<br />

Secretary<br />

(January<br />

(January<br />

1,<br />

1,<br />

<strong>2011</strong>)<br />

<strong>2011</strong>)<br />

Secretary<br />

Activities<br />

(January<br />

<strong>2011</strong>-2012<br />

1, <strong>2011</strong>)<br />

Annual conferences <strong>2011</strong>-<br />

Activities <strong>2011</strong>-2012<br />

2012<br />

Annual conferences <strong>2011</strong>-<br />

National meeting<strong>2011</strong>-2012<br />

2012<br />

National<br />

Official<br />

meeting<strong>2011</strong>-2012<br />

journal<br />

Official journal<br />

+39 rodolfo.paoletti@unimi.it<br />

02 49633384<br />

rodolfo.paoletti@unimi.it<br />

sis@comm2000.it<br />

sis@comm2000.it<br />

www.sisf.it<br />

www.sisf.it Professor Rodolfo Paoletti<br />

Professor<br />

Alberico L.<br />

Rodolfo<br />

Catapano<br />

Paoletti<br />

Alberico<br />

Meeting<br />

L.<br />

organization<br />

Catapano<br />

grant for research<br />

National Forum Pharma Research <strong>and</strong> Innovation<br />

Meeting organization grant for research<br />

National Forum Pharma Research <strong>and</strong> Innovation<br />

HTA in oncology<br />

Clinical research in diabetology<br />

HTA in oncology<br />

Clinical research in diabetology<br />

The Netherl<strong>and</strong>s Association of Pharmaceutical Sciences – NVFW<br />

The Netherl<strong>and</strong>s Association of Pharmaceutical Sciences – NVFW<br />

Mission The vision of the NVFW is to promote the pharmaceutical sciences in its broadest sense. The<br />

Mission<br />

Country<br />

Country Organisation founded<br />

Organisation <strong>EUFEPS</strong> Member founded Society<br />

<strong>EUFEPS</strong><br />

Number<br />

Member<br />

of members<br />

Society<br />

Number<br />

Postal address<br />

of members<br />

Postal address<br />

Tel<br />

Fax<br />

Tel<br />

Email<br />

Fax<br />

Email<br />

Website<br />

President (January 1, <strong>2011</strong>)<br />

Website<br />

Secretary (January 1, <strong>2011</strong>)<br />

President<br />

Activities<br />

(January<br />

<strong>2011</strong>-2012<br />

1, <strong>2011</strong>)<br />

Secretary Annual conferences (January 1, <strong>2011</strong>- <strong>2011</strong>)<br />

Activities 2012 <strong>2011</strong>-2012<br />

Annual National conferences meeting<strong>2011</strong>-2012 <strong>2011</strong>-<br />

2012 Official journal<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

The Society vision stimulates of the NVFW those research is to promote areas, the that pharmaceutical are of special sciences relevance in for its drug broadest discovery sense. <strong>and</strong>The<br />

Society development. stimulates It especially those research focuses on areas, optimising that are the of interplay special relevance between the for different drug discovery research<strong>and</strong><br />

development. disciplines involved It especially in drug focuses innovation. on optimising the interplay between the different research<br />

disciplines The Netherl<strong>and</strong>s involved in drug innovation.<br />

The 1987Netherl<strong>and</strong>s<br />

1987 1991<br />

1991<br />

250<br />

250<br />

Universitair Medisch Centrum Groningen, Pathologie & Medische Biologie, Sectie Medische<br />

Biologie, Hanzeplein 1 (EA11), NL-9713 GZ Groningen, The Netherl<strong>and</strong>s<br />

Universitair Medisch Centrum Groningen, Pathologie & Medische Biologie, Sectie Medische<br />

+ 31 503618043<br />

Biologie, Hanzeplein 1 (EA11), NL-9713 GZ Groningen, The Netherl<strong>and</strong>s<br />

+ 31 503619911<br />

+ 31 503618043<br />

h.vromans@uu.nl<br />

+ 31 503619911<br />

r.j.kok@uu.nl<br />

h.vromans@uu.nl<br />

www.nvfw.nl<br />

r.j.kok@uu.nl<br />

www.nvfw.nl<br />

Dr Robbert Jan Kok<br />

Dr Robbert Jan Kok<br />

17


Norwegian Pharmaceutical Society<br />

Norwegian Pharmaceutical Society<br />

Mission Norwegian Pharmaceutical Society’s main purposes are to influence the development of<br />

Mission Norwegian Pharmacy Pharmaceutical <strong>and</strong> Pharmaceutical Society’s main Sciences purposes <strong>and</strong> are to to promote influence collaboration the development amongst ofall<br />

Norwegian members of Pharmacy the pharmaceutical <strong>and</strong> Pharmaceutical profession. Sciences <strong>and</strong> to promote collaboration amongst all<br />

Country members Norway of the pharmaceutical profession.<br />

Country Organisation founded<br />

Organisation <strong>EUFEPS</strong> Member founded Society<br />

<strong>EUFEPS</strong> Number Member of members Society<br />

Number Postal address of members<br />

Postal Tel address<br />

Tel Fax<br />

Fax<br />

Email<br />

Email<br />

Website<br />

President (January 1, <strong>2011</strong>)<br />

Website<br />

Secretary (January 1, <strong>2011</strong>)<br />

President (January 1, <strong>2011</strong>)<br />

Activities <strong>2011</strong>-2012<br />

Secretary (January 1, <strong>2011</strong>)<br />

Activities <strong>2011</strong>-2012<br />

Annual conferences <strong>2011</strong>-<br />

2012<br />

Annual National conferences meeting<strong>2011</strong>-2012 <strong>2011</strong>-<br />

2012<br />

National Official journal meeting<strong>2011</strong>-2012<br />

Official journal<br />

Norway 1924<br />

1924 1992<br />

1992 515<br />

515 Postboks 5070, Majorstuen, NO-0301 Oslo, Norway<br />

Postboks +47 21 620223 5070, Majorstuen, NO-0301 Oslo, Norway<br />

+47 21 22 608173 620223<br />

+47<br />

farm-sel@online.no<br />

22 608173<br />

farm-sel@online.no<br />

www.nfs.no<br />

Mrs Britt Wolden<br />

www.nfs.no<br />

Ms Rønnaug Larsen<br />

Mrs Britt Wolden<br />

Annual Conference for all Norwegian Pharmacists<br />

Ms Rønnaug Larsen<br />

Managing Council of Ethics <strong>and</strong> Codes of Ethics for Norwegian Pharmacists<br />

Annual<br />

Administrate<br />

Conference<br />

<strong>and</strong> h<strong>and</strong><br />

for<br />

out<br />

all Norwegian<br />

Annual Scholarships<br />

Pharmacists<br />

to Norwegian Pharmacists<br />

Managing Award Crux Council Venenifera, of Ethics the highest <strong>and</strong> Codes homage of Ethics for Norwegian for Norwegian Pharmacists Pharmacists<br />

Administrate Farmasidagene,November <strong>and</strong> h<strong>and</strong> out 2–4, Annual <strong>2011</strong> Scholarships to Norwegian Pharmacists<br />

Award Farmasidagene, Crux Venenifera, November the 7–9, highest 2012homage<br />

for Norwegian Pharmacists<br />

Farmasidagene,November General assembly Mars 22, 2–4, <strong>2011</strong> <strong>2011</strong><br />

Farmasidagene, General assembly, November Mars, 2012 7–9, 2012<br />

General assembly Mars 22, <strong>2011</strong><br />

General assembly, Mars, 2012<br />

Pharmaceutical Society of Denmark<br />

Pharmaceutical Society of Denmark<br />

Mission To promote pharmaceutical science<br />

Mission To promote influence pharmaceutical developments of science pharmacy in Denmark<br />

To enhance<strong>and</strong> influence developments promote the of pharmaceutical pharmacy in Denmark role<br />

Country To Denmark enhance<strong>and</strong> promote the pharmaceutical role<br />

Country Organisation founded Denmark 1912<br />

Organisation <strong>EUFEPS</strong> Member founded Society 1912 1991<br />

<strong>EUFEPS</strong><br />

Number of<br />

Member<br />

members<br />

Society 1991<br />

650<br />

Postal address Rygårds Alle 1, DK-2900 Hellerup, Denmark<br />

Number of members 650<br />

Tel +45 39463600<br />

Postal address Rygårds Alle 1, DK-2900 Hellerup, Denmark<br />

Fax +45 39463639<br />

Tel +45 39463600<br />

Email pd@pharmadanmark.dk<br />

Fax +45<br />

laa@farma.ku.dk<br />

39463639<br />

Email<br />

Website<br />

pd@pharmadanmark.dk<br />

www.farmaceutisk-selskab.dk<br />

President (January 1, <strong>2011</strong>)<br />

laa@farma.ku.dk<br />

Dr Søren Ilsøe-Kristensen<br />

Website Secretary (January 1, <strong>2011</strong>) www.farmaceutisk-selskab.dk<br />

President Activities (January <strong>2011</strong>-20121, <strong>2011</strong>) Dr Pricing Søren of medicinal Ilsøe-Kristensen products<br />

Secretary (January 1, <strong>2011</strong>) Supplementary diet pills versus herbal remedies<br />

Activities <strong>2011</strong>-2012 Pricing Clinical of Studies medicinal in China products <strong>and</strong> India<br />

Supplementary Stem cell therapydiet<br />

pills versus herbal remedies<br />

Clinical The role Studies of pharma-economics in China <strong>and</strong> India in the design of drug profile<br />

Annual conferences <strong>2011</strong>- Stem cell therapy<br />

2012<br />

The role of pharma-economics in the design of drug profile<br />

Annual National conferences meeting<strong>2011</strong>-2012 <strong>2011</strong>-<br />

2012 Official journal<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

18


Annual conferences <strong>2011</strong>-2012<br />

National meeting <strong>2011</strong>-2012<br />

Official journal<br />

The role of pharma-economics in the design of drug profile<br />

Polish Pharmaceutical Society<br />

Mission Improving scientific <strong>and</strong> professional skills of Pharmacists<br />

Promoting scientific advances in pharmaceutical sciences among Pharmacists<br />

Encouraging <strong>and</strong> supporting pharmacists involvement in scientific work, .Represent the interests of<br />

academic <strong>and</strong> Pharmacists engaged in drug research, drug regulation <strong>and</strong> drug policy making.<br />

Country Pol<strong>and</strong><br />

Organisation founded 1947<br />

<strong>EUFEPS</strong> Member Society 1991<br />

Number of members 250<br />

Postal address Zarzad Glowny, Ul. Dluga 16, PL-00-238 Warsaw Pol<strong>and</strong><br />

Tel +48 22 8311542<br />

Fax +48 22 8310243<br />

Email zarzad@ptfarm.pl<br />

roledzka@op.pl<br />

Website www.ptfarm.pl<br />

President (January 1, <strong>2011</strong>) Prof. Dr hab. Janusz Pluta<br />

Secretary (January 1, <strong>2011</strong>) Vice president: Prof. Dr hab. Jan Pachecka, Prof. Dr hab. Daria Orszulak-Michalak<br />

Activities <strong>2011</strong>-2012 Diferent kind of training <strong>and</strong> education courses conected with the specilization for persons working in<br />

pharmacy, hospital pharmacy, industry, toxicology, bromatology, pharmacology,pharmaceutical<br />

analytics, plant drug <strong>and</strong> other places in health service were organised.<br />

Also are organising permanent training courses for all pharmaceutists.<br />

Annual conferences <strong>2011</strong>-2012 XXIX Conference of Hospital Pharmacy, May 29–June 1, <strong>2011</strong>, Wisła PL<br />

XX Conference History of Pharmacy, June 2–5, <strong>2011</strong>, Zakopane PL<br />

XX Symposium Section of Bromatology, September 21–23, <strong>2011</strong>, Białystok PL<br />

XII Conference of Oncological Pharmacy, October 16–19, <strong>2011</strong>, Międzyzdroje PL<br />

National meeting <strong>2011</strong>-2012<br />

Official journal Farmacja Polska,<br />

Acta Poloniae Pharmaceutica<br />

Drug Research<br />

Bromatologia i Chemia Toksykologiczna<br />

Portuguese Society for Pharmaceutical Sciences – SPCF<br />

Portuguese Society for Pharmaceutical Sciences – SPCF<br />

Mission<br />

Mission<br />

To promote, develop <strong>and</strong> publish the study, teaching, research <strong>and</strong> applications of the<br />

Pharmaceutical To promote, develop Sciences <strong>and</strong> by publish providing the a study, platform teaching, for exchange research of the <strong>and</strong> information applications <strong>and</strong> of promotion the<br />

of Pharmaceutical scientific interests Sciences in the multidisciplinary by providing a platform environment for exchange of Pharmaceutical of the information Sciences; <strong>and</strong> facilitating promotion<br />

the of scientific development interests of cooperation in the multidisciplinary with fellow international environment institutions; of Pharmaceutical organising scientific Sciences; facilitating<br />

sessions; the development publishing of scientific cooperation material with pertaining fellow international to Pharmaceutical institutions; Sciences. organising scientific<br />

Country Portugal sessions; publishing scientific material pertaining to Pharmaceutical Sciences.<br />

Country Organisation founded Portugal<br />

Organisation <strong>EUFEPS</strong> Member founded Society 2000<br />

<strong>EUFEPS</strong> Number Member of members Society 200 2000<br />

Number Postal address of members Faculdade 200 de Farmácia, Universidade de Lisboa, Av. Prof. Gama Pinto, PT-1649-003 Lisboa,<br />

Postal address Portugal Faculdade de Farmácia, Universidade de Lisboa, Av. Prof. Gama Pinto, PT-1649-003 Lisboa,<br />

Tel +351 Portugal 21 7946400 ext. 14333<br />

Tel Fax +351 21 21 7946472 7946400 ext. 14333<br />

Fax<br />

Email jagmorais@ff.ul.pt<br />

+351 21 7946472<br />

Website www.goempresas.com/sociedade_portuguesa_de_ciencias_farmaceuticas.html<br />

Email jagmorais@ff.ul.pt<br />

President (January 1, <strong>2011</strong>) Professor José A. Guimarães Morais<br />

Website www.goempresas.com/sociedade_portuguesa_de_ciencias_farmaceuticas.html<br />

Secretary (January 1, <strong>2011</strong>) Professor Rogério Sá Gaspar<br />

President (January 1, <strong>2011</strong>) Professor José A. Guimarães Morais<br />

Activities <strong>2011</strong>-2012 Co-sponsorship of several scientific meetings<br />

Secretary (January 1, <strong>2011</strong>) Professor Rogério Sá Gaspar<br />

Annual conferences <strong>2011</strong>- October 12–15 <strong>2011</strong><br />

Activities 2012 <strong>2011</strong>-2012 Co-sponsorship of several scientific meetings<br />

Annual National conferences meeting <strong>2011</strong>-2012 <strong>2011</strong>-2012October October 12–15 <strong>2011</strong> <strong>2011</strong><br />

National Official journal meeting <strong>2011</strong>-2012 Revista October Portuguesa 12–15 <strong>2011</strong>de<br />

Farmácia<br />

Official journal Revista Portuguesa de Farmácia<br />

19


Romanian Society of Pharmaceutical Sciences<br />

Romanian Society of Pharmaceutical Sciences<br />

Mission<br />

Mission<br />

Facilitation<br />

Facilitation<br />

of<br />

the<br />

the national<br />

national<br />

<strong>and</strong><br />

<strong>and</strong><br />

international<br />

international<br />

pharmaceutical<br />

pharmaceutical<br />

scientific<br />

scientific<br />

information<br />

information<br />

exchange.<br />

exchange.<br />

Collaboration<br />

Collaboration<br />

among<br />

among the<br />

the<br />

national<br />

national<br />

branches<br />

branches<br />

of<br />

of<br />

the<br />

the<br />

Society<br />

Society<br />

by<br />

by<br />

attending<br />

attending<br />

conferrences<br />

conferrences<br />

<strong>and</strong><br />

<strong>and</strong> symposia<br />

on<br />

symposia<br />

scientific<br />

on<br />

pharmaceutical<br />

scientific pharmaceutical<br />

topics.<br />

topics.<br />

Promoting national scientific pharmaceutical research.<br />

Promoting national scientific pharmaceutical research.<br />

Synchronising the Romanian pharmaceutical field with the international ones.<br />

Synchronising the Romanian pharmaceutical field with the international ones.<br />

Country Romania<br />

Country Romania<br />

Organisation founded 1934<br />

Organisation founded 1934<br />

<strong>EUFEPS</strong> Member Society 2005<br />

<strong>EUFEPS</strong> Member Society 2005<br />

Number of members 380<br />

Number of members 380<br />

Postal address Str. Traian Vuia nr. 6, sector 2 Bucuresti, Romania<br />

Postal address Str. Traian Vuia nr. 6, sector 2 Bucuresti, Romania<br />

Tel +40 720054214<br />

Tel<br />

Fax<br />

+40<br />

+40<br />

720054214<br />

264 595770<br />

Fax<br />

Email<br />

+40<br />

sleucuta@yahoo.com<br />

264 595770<br />

Email<br />

Website<br />

sleucuta@yahoo.com<br />

Website<br />

President (January 1, <strong>2011</strong>) Professor Sorin-Emilian Leucuta, PhD<br />

President Secretary (January (January 1, 1, <strong>2011</strong>) <strong>2011</strong>) Professor Professor Sorin-Emilian Niculina Mitrea Leucuta, Vasilescu PhD<br />

Secretary Activities (January <strong>2011</strong>-20121, <strong>2011</strong>) Professor Symposiums Niculina organised Mitrea by Vasilescu national branches of the Society<br />

Activities Annual conferences <strong>2011</strong>-2012 <strong>2011</strong>- Symposiums General Assembly, organised March by <strong>2011</strong> national branches of the Society<br />

Annual 2012 conferences <strong>2011</strong>- General Assembly, March <strong>2011</strong><br />

2012 National meeting<strong>2011</strong>-2012<br />

National Official journal meeting<strong>2011</strong>-2012 Farmacia<br />

Official journal Farmacia<br />

Slovak Pharmaceutical Society<br />

Slovak Pharmaceutical Society<br />

Mission<br />

Country Slovak<br />

Organisation founded<br />

<strong>EUFEPS</strong> Member Society 1991<br />

Number of members<br />

Number of members<br />

Postal address Faculty Of Pharmacy, Comenius University, Odbojarov 10, SK-83232 Bratislava, Slovakia<br />

Postal address Faculty Of Pharmacy, Comenius University, Odbojarov 10, SK-83232 Bratislava, Slovakia<br />

Tel + 421 2 50117170<br />

Tel + 421 2 50117170<br />

+ 421 2 50117229<br />

+ 421 2 50117229<br />

Fax +42 7 60388<br />

Fax<br />

Email<br />

+42<br />

cizmarik@fpharm.uniba.sk<br />

7 60388<br />

Email cizmarik@fpharm.uniba.sk<br />

grancai@fpharm.uniba.sk<br />

Website<br />

grancai@fpharm.uniba.sk<br />

Website President (January 1, <strong>2011</strong>) Prof. Dr. J. Čižmárik, PhD<br />

President Secretary (January 1, <strong>2011</strong>) Prof. Dr. D. J. Grančai Čižmárik, PhD<br />

Secretary Activities (January <strong>2011</strong>-20121,<br />

<strong>2011</strong>) Prof. Dr. D. Grančai<br />

Activities Annual conferences <strong>2011</strong>-2012 <strong>2011</strong>-<br />

Annual 2012 conferences <strong>2011</strong>-<br />

2012 National meeting<strong>2011</strong>-2012<br />

National Official journal meeting<strong>2011</strong>-2012<br />

Official journal<br />

20


Slovenian Pharmaceutical Society – SFD<br />

Slovenian Pharmaceutical Society – SFD<br />

Mission<br />

Mission<br />

Country<br />

Country<br />

Organisation founded<br />

Organisation<br />

<strong>EUFEPS</strong> Member<br />

founded<br />

Society<br />

<strong>EUFEPS</strong><br />

Number<br />

Member<br />

of members<br />

Society<br />

Number Postal address of members<br />

Postal Tel address<br />

Tel Fax<br />

Fax Email<br />

Email<br />

Website<br />

Website President (January 1, <strong>2011</strong>)<br />

President Secretary (January 1, <strong>2011</strong>) The SFD is the most important link between different segments of the Slovenian pharmaceutical<br />

The SFD is the most important link between different segments of the Slovenian pharmaceutical<br />

community (employed in industry, pharmacy services, educational institutions <strong>and</strong> administrative<br />

community (employed in industry, pharmacy services, educational institutions <strong>and</strong> administrative<br />

services.<br />

services.<br />

Slovenia<br />

Slovenia<br />

1950<br />

1950<br />

1994<br />

1994<br />

150<br />

150 Dunajska 184 A, SI-1000 Ljubljana, Slovenia<br />

Dunajska + 386 (0)1 184 5692601 A, SI-1000 Ljubljana, Slovenia<br />

+ 386 (0)1 569 5692601 26 02<br />

+ info@sfd.si 386 (0)1 569 26 02<br />

info@sfd.si<br />

ales.mrhar@ffa.uni-lj.si<br />

ales.mrhar@ffa.uni-lj.si<br />

www.sfd.si<br />

www.sfd.si Gašper Marc<br />

Gašper Jelka Dolinar Marc<br />

Secretary Activities (January <strong>2011</strong>-20121, <strong>2011</strong>) Jelka Professional DolinarEvents,<br />

Publishing <strong>and</strong> Social Events<br />

Activities Annual conferences <strong>2011</strong>-2012 <strong>2011</strong>- Professional 4BBBB International Events, Conference Publishing <strong>and</strong> on Pharmaceutical Social Events Sciences, <strong>2011</strong><br />

Annual 2012 conferences <strong>2011</strong>- 4BBBB International Conference on Pharmaceutical Sciences, <strong>2011</strong><br />

2012 National meeting<strong>2011</strong>-2012 Annual 1-3 days’ national professional events, organised by the Society <strong>and</strong> its Sections<br />

National meeting<strong>2011</strong>-2012 Annual (Community 1-3 days’ Pharmacy national Section, professional Section events, of Pharmaceutical organised by Technologists, the Society <strong>and</strong> Section its Sections of Clinical<br />

(Community Pharmacists, Pharmacy Pharmaceutical Section, Technicians Section of Pharmaceutical Technologists, Section of Clinical<br />

Official journal Pharmacists, Farmacevtski Pharmaceutical vestnik Technicians<br />

Official journal Farmacevtski vestnik<br />

Spanish Society of Pharmaceutics <strong>and</strong> Pharmaceutical Technology –<br />

SEFIG Spanish Society of Pharmaceutics <strong>and</strong> Pharmaceutical Technology –<br />

SEFIG<br />

Mission SEFIG has as its missions the following.<br />

1. To contribute to the professional development of its members by means of the exchange of<br />

knowledge <strong>and</strong> methods.<br />

2. To analyse <strong>and</strong> to debate the problems that its members have jointly <strong>and</strong> to propose possible<br />

solutions to the same ones.<br />

3. To foment the necessary critical reflection on the problems that the Industrial Pharmacy <strong>and</strong> the<br />

Pharmaceutical Technology raises, in the different professional areas. To collaborate actively with<br />

national <strong>and</strong> international associations which aims are coincidental or parallel.<br />

4. To promote cooperative <strong>and</strong> mutualists movements among its affiliates.<br />

5. To promote all those means <strong>and</strong> actions that facilitate the communication of works <strong>and</strong><br />

researches in the field of t the Industrial Pharmacy <strong>and</strong> the Pharmaceutical Technology <strong>and</strong> related<br />

sciences.<br />

6. To support all those steps that lead to the human <strong>and</strong> professional enrichment of its partners <strong>and</strong><br />

of the society in general.<br />

Country Spain<br />

Organisation founded 1988<br />

<strong>EUFEPS</strong> Member Society 2000<br />

Number of members 196<br />

Postal address Dept. Farmacia y Tecnologia Farmaceutica, Facultad de Farmacia, Universidad de Santiago de<br />

Compostela, ES-15782-Santiago de Compostela, Spain<br />

Tel<br />

Fax<br />

Email<br />

Website<br />

President (January 1, <strong>2011</strong>)<br />

Secretary (January 1, <strong>2011</strong>)<br />

Activities <strong>2011</strong>-2012<br />

+34 981563100<br />

+34 981547148<br />

presidente@sefig.org<br />

jmirache@unav.es<br />

secretario@sefig.org<br />

http://www.sefig.org/EN/<br />

Juan Manuel Irache Garreta<br />

Carmen Álvarez Lorenz<br />

Co-sponsor the 4th Mission SEFIG has as its missions the following.<br />

1. To contribute to the professional development of its members by means of the exchange of<br />

knowledge <strong>and</strong> methods.<br />

2. To analyse <strong>and</strong> to debate the problems that its members have jointly <strong>and</strong> to propose possible<br />

solutions to the same ones.<br />

3. To foment the necessary critical reflection on the problems that the Industrial Pharmacy <strong>and</strong><br />

the Pharmaceutical Technology raises, in the different professional areas. To collaborate actively<br />

with national <strong>and</strong> international associations which aims are coincidental or parallel.<br />

4. To promote cooperative <strong>and</strong> mutualists movements among its affiliates.<br />

5. To promote all those means <strong>and</strong> actions that facilitate the communication of works <strong>and</strong><br />

researches in the field of t the Industrial Pharmacy <strong>and</strong> the Pharmaceutical Technology <strong>and</strong><br />

related sciences.<br />

6. To support all those steps that lead to the human <strong>and</strong> professional enrichment of its partners<br />

<strong>and</strong> of the society in general.<br />

Country Spain<br />

Organisation founded 1988<br />

<strong>EUFEPS</strong> Member Society 2000<br />

Number of members 196<br />

Postal address Dept. Farmacia y Tecnologia Farmaceutica, Facultad de Farmacia, Universidad de Santiago de<br />

Tel<br />

Compostela, ES-15782-Santiago de Compostela, Spain<br />

+34 981563100<br />

Fax<br />

Email<br />

Website<br />

President (January 1, <strong>2011</strong>)<br />

Secretary (January 1, <strong>2011</strong>)<br />

Activities <strong>2011</strong>-2012<br />

Annual conferences <strong>2011</strong>-<br />

2012<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

+34 981547148<br />

presidente@sefig.org<br />

jmirache@unav.es<br />

secretario@sefig.org<br />

http://www.sefig.org/EN/<br />

Juan Manuel Irache Garreta<br />

Carmen Álvarez Lorenz<br />

Co-sponsor the 4<br />

International Exhibition for Pharmaceutical, Biopharmaceutical <strong>and</strong> Laboratory<br />

Technology Providers, February 15–17, <strong>2011</strong>, Zaragoza ES<br />

Partner Organisation in the 3rd SciFair, June 13–17, <strong>2011</strong>, Prague CZ<br />

Co-sponsor of 8th World Meeting on Pharmaceutics, Biopharmaceutics <strong>and</strong> Pharmaceutical<br />

Technology, March 19–22, 2012, Istanbul TR<br />

X Congress of SEFIG, February 2–4, <strong>2011</strong>, Madrid ES<br />

th Annual conferences <strong>2011</strong>-<br />

2012<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

International Exhibition for Pharmaceutical, Biopharmaceutical <strong>and</strong> Laboratory<br />

Technology Providers, February 15–17, <strong>2011</strong>, Zaragoza ES<br />

Partner Organisation in the 3rd SciFair, June 13–17, <strong>2011</strong>, Prague CZ<br />

Co-sponsor of 8th World Meeting on Pharmaceutics, Biopharmaceutics <strong>and</strong> Pharmaceutical<br />

Technology, March 19–22, 2012, Istanbul TR<br />

X Congress of SEFIG, February 2–4, <strong>2011</strong>, Madrid ES<br />

21


Swedish<br />

Swedish<br />

Academy<br />

Academy<br />

of<br />

of<br />

Pharmaceutical<br />

Pharmaceutical<br />

Sciences<br />

Sciences<br />

– SAPS<br />

– SAPS<br />

Mission Mission The The Swedish Academy of of Pharmaceutical Sciences Sciences is is a a non-profit non-profit organisation organisation with with the the purpose purpose of<br />

promoting of promoting a high a high professional st<strong>and</strong>ard st<strong>and</strong>ard within within the the field field of of pharmaceuticals. APS should also<br />

work<br />

for work favorable for favorable development development <strong>and</strong> usage <strong>and</strong> usage of pharmaceuticals, of pharmaceuticals, for the for the public public as as well well as as for for the the individual.<br />

In individual. this regard, In this APS regard, favors APS the favors knowledge- the knowledge- <strong>and</strong> competence <strong>and</strong> competence development development within the within pharmaceutical<br />

the<br />

field. pharmaceutical field.<br />

Country Sweden<br />

Organisation founded 1778<br />

<strong>EUFEPS</strong> Member Society 1991<br />

Number of of members 6000<br />

Postal address Box 1136, SE-111 81 StockholmSweden<br />

Tel Tel +46 8 7235000<br />

Fax Fax<br />

Email<br />

Website Website<br />

President President (January (January 1, 1, <strong>2011</strong>)<br />

Secretary<br />

Secretary<br />

(January<br />

(January<br />

1,<br />

1,<br />

<strong>2011</strong>)<br />

<strong>2011</strong>)<br />

Activities <strong>2011</strong>-2012<br />

Activities <strong>2011</strong>-2012<br />

Annual conferences <strong>2011</strong>-<br />

Annual conferences <strong>2011</strong>-<br />

2012<br />

2012<br />

National meeting<strong>2011</strong>-2012<br />

National meeting<strong>2011</strong>-2012<br />

Official journal<br />

Official journal<br />

+46 8 205511<br />

info@apotekarsocieteten.se<br />

<strong>and</strong>reas.furangen@apotekarsocieteten.se<br />

www.swepharm.se<br />

Dr Dr Eva Eva Sjökvist Saers<br />

Dr<br />

Dr<br />

Agneta<br />

Agneta<br />

Larhed<br />

Larhed<br />

Läkemedelskongressen (Annual Meeting), November 7-9, <strong>2011</strong>, Stockholm SE<br />

Läkemedelskongressen (Annual Meeting), November 7-9, <strong>2011</strong>, Stockholm SE<br />

e-lexir<br />

e-lexir<br />

Swiss Society of Pharmaceutical Sciences – SGPhW<br />

Swiss Society of Pharmaceutical Sciences – SGPhW<br />

Mission The society promotes as a principal goal Pharmaceutical Sciences inSwitzerl<strong>and</strong>. For this<br />

Mission purpose The society the society promotes has as assumed a principal the goal function Pharmaceutical of an academy Sciences pursuing inSwitzerl<strong>and</strong>. the following mission: For this purpose<br />

Unifying the society <strong>and</strong> has coaching assumed the national the function <strong>and</strong> regional of an academy societies pursuing linked to the following discipline mission: of<br />

Pharmaceutical Unifying <strong>and</strong> coaching Sciences. the national <strong>and</strong> regional societies linked to the discipline of Pharmaceutical<br />

Promotion Sciences. of national <strong>and</strong> internationalscientific contacts <strong>and</strong> of cooperations with otherscientific<br />

societies Promotion <strong>and</strong> of academies. national <strong>and</strong> internationalscientific contacts <strong>and</strong> of cooperations with otherscientific<br />

Public societies promotion <strong>and</strong> academies. of Pharmaceutical Sciences.<br />

Promotion Public promotion of the communication of Pharmaceutical of eminent Sciences. pharmaceutical findings <strong>and</strong> realisations in science,<br />

research, Promotion development, of the communication industry, health of eminent care <strong>and</strong> pharmaceutical public society. findings <strong>and</strong> realisations in science,<br />

To research, award distinguished development, persons industry, for health their merits care <strong>and</strong> in Pharmaceutical public society. Science.<br />

Country Switzerl<strong>and</strong> To award distinguished persons for their merits in Pharmaceutical Science.<br />

Country Organisation founded 1993 Switzerl<strong>and</strong><br />

Organisation <strong>EUFEPS</strong> Member founded Society 1998 1993<br />

<strong>EUFEPS</strong><br />

Number<br />

Member<br />

of members<br />

Society<br />

117<br />

1998<br />

Number<br />

Postal address<br />

of members<br />

General<br />

117<br />

secretary: Philippe Tschopp, Pharmatrans Sanaq AG, Birsigstrasse 79, CH-4011 Basel,<br />

Switzerl<strong>and</strong><br />

Postal address General secretary: Philippe Tschopp, Pharmatrans Sanaq AG, Birsigstrasse 79, CH-4011 Basel,<br />

Tel +41 61 2259000<br />

Switzerl<strong>and</strong><br />

Fax +41 61 2259001<br />

Tel +41 61 2259000<br />

Email sgphw@sgphw.ch<br />

Fax<br />

hans.leuenberger@unibas.ch<br />

+41 61 2259001<br />

Email<br />

Website www.sgphw.ch<br />

sgphw@sgphw.ch<br />

President (January 1, <strong>2011</strong>) Prof.<br />

hans.leuenberger@unibas.ch<br />

Dr. Hans Leuenberger<br />

Website Secretary (January 1, <strong>2011</strong>) Dr. www.sgphw.ch<br />

Benoîte Kaeser<br />

President Activities (January <strong>2011</strong>-20121, <strong>2011</strong>) Monthly Prof. Dr. PharmaLunchs Hans Leuenberger (see www.sgphw.ch)<br />

Secretary Annual conferences (January 1, <strong>2011</strong>- <strong>2011</strong>) Swiss Dr. Benoîte Pharma Kaeser Science Day (see www.sgphw.ch)<br />

Activities 2012 <strong>2011</strong>-2012 Monthly PharmaLunchs (see www.sgphw.ch)<br />

Annual National conferences meeting<strong>2011</strong>-2012 <strong>2011</strong>- Swiss Pharma Science Day Day (see (see www.sgphw.ch)<br />

2012 Official journal Swiss Pharma<br />

National meeting<strong>2011</strong>-2012 Swiss Pharma Science Day (see www.sgphw.ch)<br />

Official journal Swiss Pharma<br />

22


Turkish Pharmaceutical Technology Scientists' Association – TÜFTAD – TÜFTAD<br />

Mission<br />

Mission<br />

Country<br />

Country<br />

Organisation<br />

Organisation<br />

founded<br />

founded<br />

<strong>EUFEPS</strong><br />

<strong>EUFEPS</strong><br />

Member<br />

Member<br />

Society<br />

Society<br />

Number<br />

Number<br />

of<br />

of<br />

members<br />

members<br />

Postal Postal address address<br />

Tel Tel<br />

Fax Fax<br />

Email<br />

To provide a dynamic national <strong>and</strong> international forum for the exchange of knowledge among<br />

To provide a dynamic national <strong>and</strong> international forum for the exchange of knowledge among<br />

scientists, pharmaceutical industry members <strong>and</strong> regulatory authorities to enhance their<br />

scientists, pharmaceutical industry members <strong>and</strong> regulatory authorities to enhance their<br />

contributions to health care <strong>and</strong> pharmaceutics in Turkey. This Association offers timely scientific<br />

contributions to health care <strong>and</strong> pharmaceutics in Turkey. This Association offers timely scientific<br />

programs, opportunities for networking <strong>and</strong> professional development.<br />

programs, opportunities for networking <strong>and</strong> professional development.<br />

Turkey<br />

Turkey<br />

1991<br />

1991<br />

1991<br />

1991<br />

400<br />

400<br />

Hacettepe University, Faculty Faculty of of Pharmacy, Pharmacy, Department Department of of Pharmaceutical Pharmaceutical Technology, Technology, TR-06100 TR-06100<br />

Sıhhıye AnkaraTurkey<br />

+90 312 3051241<br />

+90 312 3100906<br />

scalis@hacettepe.edu.tr<br />

secretariat@tuftad.org.tr<br />

hincal@tr.net<br />

Website www.tuftad.org.tr/<br />

President (January 1, <strong>2011</strong>) Prof. Dr. A. Atilla Hincal<br />

Secretary (January 1, <strong>2011</strong>) <strong>2011</strong>) Prof. Prof. Dr. Sema ÇALIŞ<br />

Activities <strong>2011</strong>-2012 <strong>2011</strong>-2012<br />

Annual conferences conferences <strong>2011</strong>-<br />

2012<br />

National meeting<strong>2011</strong>-2012<br />

TUFTAD TUFTAD Sessions Sessions in PharmSciFair Meeting, June 13–17, <strong>2011</strong>, Prague CZ CZ<br />

Official journal TUFTAD News<br />

23


5. Individual Memberships Representatives to Council<br />

The body of Individual Members is represented by delegates to the Council. The delegates<br />

are elected biennially by written ballot 4 months prior to the Council to serve for a term of<br />

two years. A delegate may serve for a maximum consecutive period of four years. Current<br />

delegates are:<br />

Professor Ole J. Bjerrum<br />

University of Copenhagen, Copenhagen, Denmark<br />

Email ojb@farma.ku.dk<br />

Dr Natasa Jovanovic<br />

BioConnection, Oss, The Netherl<strong>and</strong>s<br />

Email natasakomal@yahoo.com<br />

Professor Amin Rostami<br />

University of Manchester, Manchester, United Kingdom<br />

Email amin.rostami@manchester.ac.uk<br />

Dr Sven Stegemann<br />

Capsugel, Bornem, Belgium<br />

Email sven.stegemann@pfizer.com<br />

24


Effective as of September 24, 2006<br />

1 Objectives of the Federation<br />

6. The Statutes of <strong>EUFEPS</strong><br />

The European Federation for Pharmaceutical Sciences (hereinafter referred to as the<br />

Federation) is a voluntary association of pharmaceutical scientists, established to advance<br />

research in the pharmaceutical sciences in Europe. This can be achieved by promoting cooperation<br />

between national, regional <strong>and</strong> European societies or associations which aim at<br />

the advancement of pharmaceutical sciences, <strong>and</strong> by promoting cooperation between <strong>and</strong><br />

with other pharmaceutical organisations <strong>and</strong> between individual pharmaceutical scientists.<br />

The Federation seeks to achieve its objectives by the following means:<br />

A To facilitate the exchange of scientific information between European pharma<br />

ceutical scientists by<br />

• organising a European Pharmaceutical (Pharm) Sciences (Sci) Congress or<br />

Fair, at regular intervals <strong>and</strong> in different European countries;<br />

• organising specialised meetings on relevant topics of multidisciplinary aspects<br />

of drug research;<br />

• encouraging the organisation of joint meetings between member societies;<br />

publication of a European Journal of Pharmaceutical Sciences.<br />

B To collect <strong>and</strong> disseminate information on the activities of the member societies,<br />

including the production of a calendar of events.<br />

C To enhance the recognition of the pharmaceutical sciences <strong>and</strong> to contribute to<br />

public policies relevant to the pharmaceutical sciences <strong>and</strong> drug-related issues<br />

at the European level.<br />

D To encourage high st<strong>and</strong>ards of undergraduate, graduate <strong>and</strong> postgraduate<br />

education <strong>and</strong> training in the pharmaceutical sciences <strong>and</strong> to encourage<br />

exchange of relevant scientific information as well as exchange of staff <strong>and</strong><br />

students of teaching <strong>and</strong> research institutions between the different European<br />

countries.<br />

2 Membership <strong>and</strong> Administration<br />

A. Categories of Membership:<br />

• Member Societies; these are societies, which aim at the advancement of<br />

pharmaceutical sciences <strong>and</strong> are established in one (or more) of the Euro<br />

pean countries;<br />

• Member Institutions; these are universities <strong>and</strong> research institutions, which<br />

engage in pharmaceutical sciences <strong>and</strong> are established in one (or more)<br />

of the European countries;<br />

• Individual Members; these are individuals who support the objectives of<br />

the Federation.<br />

25


B. The membership terminates:<br />

• if a Member Society or Member Institution is dissolved;<br />

• by notification of withdrawal in writing to the secretariat of the<br />

Federation at least 3 months before the end of a year;<br />

• if the Member does not pay the annual dues.<br />

C. The affairs of the Federation shall be conducted by a Council through an Execu<br />

tive Committee.<br />

D. The Council comprises representatives from each Member Society of the<br />

Federation, together with the delegate/s of Member Institutions, the delegate/s<br />

of Individual Members <strong>and</strong> the members of the Executive Committee.<br />

Member Societies shall nominate before the 1st of January of each year who<br />

will be their representatives for the coming year.<br />

Member Societies with up to 250 members will have one vote at Council, those<br />

with 251-1000 members two votes, those with 1001-3000 members three votes,<br />

<strong>and</strong> those with above 3000 members four votes. The number of delegates rep<br />

resenting a Member Society at Council will depend on how many votes that are<br />

given to a single delegate. As applicable, this is left to each of the Member<br />

Societies to decide upon.<br />

The body of Member Institutions shall agree among themselves on delegate/s<br />

to the Council. The contingent of Members Institutions will have one vote for<br />

one of ten fee-paying Member Institutions, <strong>and</strong> one additional representative<br />

for each additional one to ten fee-paying Member Institutions. All appointed<br />

delegates may attend the Council. Names of delegate/s should be provided<br />

4 months prior to Council.<br />

The Fédération Internationale Pharmaceutique (F.I.P.) shall have observer<br />

status in the Council. At the discretion of the President, other organisations may<br />

be invited to send an observer.<br />

E. Among the specific duties of the Council shall be:<br />

• to accept Member Societies of the Federation on the basis of the<br />

bylaws presented;<br />

• to propose names for c<strong>and</strong>idates of the Executive Committee, to be<br />

received at least 3 months before a Council meeting;<br />

• to elect the members of the Executive Committee;<br />

• to ratify changes in the Statutes <strong>and</strong> other regulations of the<br />

Federation as proposed by the Executive Committee or Council itself;<br />

• to establish committees for specific policy purposes;<br />

• to propose items to be discussed in Council to the Executive Commit<br />

tee. Such proposals from individual Council members should reach<br />

the Executive Director no later than three months prior to the Council<br />

meeting.<br />

26


F. There shall be one regular meeting of the Council each year. Additional<br />

meetings may be held at the recommendation of the majority of the Executive<br />

Committee or at least 30% of the Council members. The Federation shall not<br />

be held responsible for the costs involved for Council members to attend<br />

any Council meeting.<br />

G. Except when explicitly stated otherwise in these Statutes, any matter to be<br />

decided by the Council shall be on the basis of a simple majority vote of those<br />

present <strong>and</strong> voting at a meeting of the Council.<br />

H. The Executive Committee is composed of eight members, plus the immediate<br />

Past President. The Executive Committee consists of: the Past-President, the<br />

President, the President-Elect, the Treasurer <strong>and</strong> five Ordinary Members.<br />

Each member of the Executive Committee shall be nominated by the<br />

Council <strong>and</strong> elected by secret ballot at a meeting of the Council. Each<br />

member is elected for a term of two years <strong>and</strong> may be re-elected for a<br />

maximum of two successive terms. No more than two members of<br />

the Executive Committee may originate from the same country.<br />

The Past-President shall serve as a co-opted member with full voting<br />

rights for a period of up to two years.<br />

The Executive Director (see Section K, below) is an ex officio member of<br />

this Committee, without voting rights.<br />

I. The Executive Committee meets as often as it deems necessary for<br />

the interest of the Federation. The Federation will to the extent possible<br />

assist in bearing the costs involved to attend meetings of the Exective<br />

Committee. The Executive Committee shall make decisions on the<br />

basis of majority vote of those members present (not less than three) at a<br />

meeting. In case of a draw, the President casts the deciding vote.<br />

Interim vacancies on the Executive Committee may be filled by the<br />

President after consultation with the other members of the Executive<br />

Committee. The appointment is subject to approval at the next meeting<br />

of the Council. The individual so appointed shall serve for the unexpired<br />

term(s).<br />

The Executive Committee may establish committees for specific activity<br />

purposes.<br />

J. The President shall be responsible for coordinating the activities <strong>and</strong><br />

affairs of the Federation <strong>and</strong> shall normally represent the Federation. The<br />

President shall call <strong>and</strong> chair the meetings of the Executive Committee<br />

<strong>and</strong> of the Council. The Vice-President assists the President in his or her<br />

activities <strong>and</strong> may deputise for the President whenever necessary.<br />

27


K. The Executive Director shall<br />

• be appointed by the Executive Committee;<br />

• keep a record of all members of the Federation;<br />

• keep a minute book of the transactions of the Federation;<br />

• keep the records of all meetings of the Council <strong>and</strong> the<br />

Executive Committee;<br />

• distribute the agenda for the meetings of the Council <strong>and</strong> the<br />

Executive Committee at least one month prior to such meet-<br />

ings <strong>and</strong> shall distribute the minutes of the meetings not later<br />

than three months after the meetings;<br />

• collect <strong>and</strong> distribute information relevant for the objectives of<br />

the Federation from <strong>and</strong> to the members of the Federation.<br />

• keep a record of all financial transactions of the Federation;<br />

• be responsible for the collection of all dues <strong>and</strong> other financial<br />

income;<br />

• pay all obligations <strong>and</strong> debts.<br />

A major deviation from the budget will require the approval of the<br />

Executive Committee before the expenditure is made.<br />

The Financial Account of the Secretary-General/Treasurer shall be<br />

audited annually by a legally authorised auditor. The approval of the<br />

Financial Account by the Council will relieve the Executive Commit-<br />

tee <strong>and</strong> auditor from all subsequent financial responsibility.<br />

L. The Treasurer, together with the Executive Director, shall:<br />

• undertake efforts to increase the financial resources of the<br />

Federation;<br />

• render annually a complete Financial Account <strong>and</strong> submit a<br />

proposed budget to the Executive Committee for approval by<br />

Council.<br />

A major deviation from the budget will require the approval of<br />

the Executive Committee before the expenditure is made.<br />

The Financial Account of the Treasurer shall be audited annually by<br />

a legally authorised auditor. The approval of the Financial Account<br />

by the Council will relieve the Executive Committee <strong>and</strong> auditor<br />

from all subsequent financial responsibility.<br />

M. <strong>EUFEPS</strong> operating procedures will be defined by a set of Internal<br />

Operating Procedures, produced by the Executive Committee.<br />

28


3 Duties of the Member Societies<br />

4 Meetings<br />

5 Finances<br />

The Member Societies shall:<br />

A. Support the objectives of the Federation<br />

B. Pay their annual dues; such payment shall be made before the 1st of<br />

February each year. The annual dues will be set by the Council each<br />

year.<br />

C. Submit on a regular basis relevant information concerning their own<br />

activities to the Executive Director.<br />

D. Publicise on a regular basis the activities of the Federation as received<br />

from the Executive Director, including distribution of the News-letter to<br />

individual members of the Member Society.<br />

A. The Federation shall organise a European Congress of Pharmaceutical<br />

Sciences normally every two years. The venues of these<br />

congresses will be selected by the Executive Committee <strong>and</strong> require<br />

approval by the Council.<br />

B. The Federation may organise meetings on relevant topics of<br />

multidisciplinary aspects of drug research.<br />

C. Joint meetings between member societies, as well as other relevant<br />

meetings, may be organised under the auspices of the Federation.<br />

This requires the approval of the Executive Committee.<br />

Finances of the Federation shall be obtained from membership dues <strong>and</strong> donations, as<br />

well as from other sources approved by the Executive Committee. The Treasurer, together<br />

with the Executive Director, shall prepare an annual budget in Euro to be approved by the<br />

Council in the year prior to the budget year. The fiscal year of the Federation shall coincide<br />

with the calendar year.<br />

6 Amendments to the Statutes<br />

Amendments to the Statutes shall only be made by the Council. Prepared amendments<br />

must be sent to the Executive Director at least three months before the Council meeting<br />

at which they are to be considered <strong>and</strong> must be endorsed by at least five members of the<br />

Council. The Executive Director shall transmit the proposed amendments to Council members<br />

at least one month before the Council meeting. A proposed amendment shall be considered<br />

adopted upon receiving a three-fifth (3/5) majority of votes cast.<br />

In any case of conflict between these Statutes <strong>and</strong> other rules or regulations adopted by<br />

the Federation, these Statutes shall prevail. All such apparent conflicts shall be resolved<br />

by the Council whose decisions shall be binding on all interested parties.<br />

7 Legal Representations<br />

The President is the legal representative of the Federation in its dealings with other organisations.<br />

The President may authorise the President-Elect or Executive Director to represent<br />

him or her in such dealings.<br />

29


7. Executive Committee 2010–<strong>2011</strong><br />

<strong>EUFEPS</strong> Role & Sciences Affairs & General Policy & Conference Planning<br />

Clive G. Wilson (2009-<strong>2011</strong>)<br />

President 2010-<strong>2011</strong><br />

Professor <strong>and</strong> JP Todd Chair of Pharmaceutics,<br />

Strathclyde Institute of Pharmacy & Biomedical Sciences,<br />

University of Strathclyde, Glasgow, United Kingdom<br />

Network Liaison BioAvailability <strong>and</strong> BioPharmaceutics<br />

Pharmaceutical Sciences Fair <strong>and</strong> Exhibition (PharmSciFair)<br />

Finance & Funding<br />

Alain Cuiné (2009-<strong>2011</strong>)<br />

Vice-President 2010-<strong>2011</strong><br />

Director of R&D for Becton Dickinson, Grenoble, France<br />

Lennart Dencker (2009-<strong>2011</strong>)<br />

Treasurer 2010-<strong>2011</strong><br />

Professor in Toxicology <strong>and</strong> Vice-Chairman of the<br />

Faculties of Medicine <strong>and</strong> Pharmacy at the University of<br />

Uppsala, Sweden<br />

Network Liaison Environment <strong>and</strong> Pharmaceuticals<br />

Awards <strong>and</strong> Prizes & <strong>EUFEPS</strong> Senate<br />

Daan J.A. Crommelin<br />

Past-President 2009-<strong>2011</strong><br />

Professor of Pharmaceutics, Utrecht University, <strong>and</strong><br />

Scientific Director, Dutch Top Institute Pharma, Leiden,<br />

The Netherl<strong>and</strong>s<br />

c.g.wilson@strath.ac.uk<br />

Membership Development & Industry Education <strong>and</strong> Training<br />

Buket Aksu (2010-2012)<br />

Corporate Relations Director, Santa Farma, Istanbul &<br />

EGE University, Ìzmir, Turkey<br />

Network Liaison Quality by Design (QbD) <strong>and</strong> Process<br />

Analytical Technology <strong>and</strong> Underpinning Sciences (PAT)<br />

30<br />

alain_cuine@europe.bd.com<br />

lennart.dencker@farmbio.uu.se<br />

daan.crommelin@tipharma.com<br />

baksu@santafarma.com.tr


Regulatory Science <strong>and</strong> Affairs<br />

Rogério Gaspar (2009-<strong>2011</strong>)<br />

Full Professor of Pharmaceutics, University of Lisbon,<br />

Portugal<br />

Network Liaison Regulatory Science<br />

Academia Education <strong>and</strong> Training & Communications<br />

Ulrike Holzgrabe (2009-<strong>2011</strong>)<br />

Professor of Pharmaceutical Chemistry, University<br />

of Würzburg, Würzburg, Germany<br />

Committee Liaison Education <strong>and</strong> Training<br />

Conference Planning <strong>and</strong> PharmSciFair Program<br />

Milena Jadrijevic-Mladar Takac (2010-2012)<br />

Professor of Medicinal Chemistry <strong>and</strong> Drug<br />

Biochemistry, Faculty of Pharmacy <strong>and</strong> Biochemistry,<br />

University of Zagreb, Croatia<br />

Industrial Research Relations<br />

Eva-Maria Muchitsch (2009-<strong>2011</strong>)<br />

Director of Global Preclinical R&D, Baxter, Vienna,<br />

Austria<br />

Network Liaison Safety Sciences<br />

CEO & Office & EJPS & Students Relations<br />

Hans H. Linden<br />

Executive Director, <strong>EUFEPS</strong>, Stockholm, Sweden<br />

31<br />

rgaspar@ff.ul.pt<br />

u.holzgrabe@<br />

pharmazie.uni-wuerzburg.de<br />

mladar@pharma.hr<br />

eva_muchitsch@baxter.com<br />

hans.linden@eufeps.org


8. Advisory Committees<br />

Committee on Industrial Research Relations (CIRR)<br />

One important <strong>and</strong> clear objective of <strong>EUFEPS</strong> is to interact with the pharmaceutical industry,<br />

thereby contributing to strengthening the pharmaceutical sciences <strong>and</strong> scientists in enhancing<br />

innovative drug research <strong>and</strong> development in Europe.<br />

CIRR was established as think-tank in the early <strong>history</strong> of <strong>EUFEPS</strong>. It plays an important<br />

role in identifying timely <strong>and</strong> strategic topics for <strong>EUFEPS</strong> congresses, conferences <strong>and</strong><br />

workshops, <strong>and</strong> it discusses education <strong>and</strong> training needs as well. The New Safe Medicines<br />

Faster project (NSMF) to improve drug development, initiated in the late nineties <strong>and</strong><br />

forerunner of the <strong>today</strong>’s Innovative Medicines Initiative (IMI), was also a product of CIRR.<br />

Committee on Pharmaceutical Policies (CPP)<br />

This Committee was installed early as well, to help to establish regular contacts <strong>and</strong> scientific<br />

exchange in the regulatory field <strong>and</strong> create fora for discussion of relevant pharmaceutical<br />

issues between authorities, industry, academia <strong>and</strong> other interested parties. The Committee<br />

also provided input for several meeting programmes.<br />

The roles of this Committee are <strong>today</strong> seen to by the Conference Planning Committees,<br />

Network Steering Committees <strong>and</strong> the Executive Committee.<br />

Committee on Academic Research Relations (CARR)<br />

CARR was established ten years ago to see to interests on the academic side. The major<br />

task of CARR was to analyse current status of academic research in the pharmaceutical<br />

sciences in Europe <strong>and</strong> to make a proposal on how to foster the impact of academic fundamental<br />

research in the discovery of new medicines.<br />

The outcome of the work of CARR includes an extensive position paper on the current<br />

status <strong>and</strong> future opportunities as to contributions of academic research to drug discovery,<br />

published in the European Journal of Pharmaceutical Sciences.<br />

Committee on Training <strong>and</strong> Education (CTE)<br />

Rapidly changing dem<strong>and</strong>s in newly emerging science <strong>and</strong> technique in pharmaceutical<br />

research <strong>and</strong> development call for new <strong>and</strong> improved training <strong>and</strong> education. The CTE was<br />

established to identify such needs <strong>and</strong> also to address the considerable heterogeneity of<br />

pharmaceutical sciences training <strong>and</strong> education across Europe.<br />

Top-ten needs have been identified, discussed <strong>and</strong> published, <strong>and</strong> some courses initiated.<br />

CTE has also, for example, engaged in the <strong>EUFEPS</strong> workshops on safety sciences education<br />

<strong>and</strong> training, which needs are now seen to in the IMI Project on a European Modular<br />

Education <strong>and</strong> Training Programme in Safety Sciences for Medicines.<br />

32


Committee on Awards <strong>and</strong> Prices (CAP)<br />

CAP manages the <strong>EUFEPS</strong> Awards Programme, chaired by the <strong>EUFEPS</strong> Past-President,<br />

normally.<br />

The Awards include the annual New Safe Medicines Faster Award, sponsored<br />

by SANOFI, <strong>and</strong> the also annual Best Paper Award, sponsored by<br />

Elsevier, for article in the European Journal of Pharmaceutical Sciences, plus the<br />

biennial Giorgio Segré Prize, which is given in partnership with the Segré Family. Until 2004,<br />

there was also a Young Investigator's Award for best poster at the <strong>EUFEPS</strong> Congress.<br />

Committee Contact Points<br />

To approach any of the current <strong>EUFEPS</strong> Committees (CAP, CIRR <strong>and</strong> CTE) as well as e.g.<br />

Conference Programme Committees, contact the <strong>EUFEPS</strong> Secretariat, which will provide<br />

contact information of the Committee Chair <strong>and</strong>/or Secretary.<br />

33


9. <strong>EUFEPS</strong> Networks<br />

Scope <strong>and</strong> aim<br />

This Network was initiated by the <strong>EUFEPS</strong> Committee on Industrial Research Relations<br />

(CIRR) <strong>and</strong> established to develop <strong>and</strong> implement educational programmes to meet the<br />

training needs of scientists working in the field of safety sciences, primarily, <strong>and</strong> to provide<br />

input for the New Safe <strong>and</strong> Innovative Medicines initiatives, all to help out of the attrition<br />

dilemma. To achieve this, it actively engaged with stakeholders in enhancing <strong>and</strong> coordinating<br />

a multi-disciplinary, holistic approach in the development of new medicines through<br />

education <strong>and</strong> continuous training of scientists, capable of contributing to the innovative <strong>and</strong><br />

continual development of new medicines. Brainstorm <strong>and</strong> planning workshops have been<br />

organised, <strong>and</strong> many are actively involved in the current IMI Project on safety sciences education<br />

<strong>and</strong> training for medicines research <strong>and</strong> development.<br />

Contact Point<br />

Network<br />

Safety Sciences<br />

European Federation for Pharmaceutical Sciences<br />

Hans H. Linden hans.linden@eufeps.org<br />

Network<br />

QbD <strong>and</strong> PAT Sciences<br />

European Federation for Pharmaceutical Sciences<br />

www.eufeps.org/PATnetwork.html<br />

Scope <strong>and</strong> aim<br />

This Network is developing a forum for academic, industrial <strong>and</strong> regulatory professionals in<br />

the various scientific fields underpinning Quality by Design (QbD) <strong>and</strong> Process Analytical<br />

Technology (PAT), sharing <strong>and</strong> discussing findings in cutting edge research <strong>and</strong> establishing<br />

effective <strong>and</strong> innovative collaboration, the EuPAT conference series being a new platform.<br />

It also contributes to education <strong>and</strong> training in the field as well as to foster h<strong>and</strong>s-on implementation<br />

of systems approaches <strong>and</strong> emerging technology in pharmaceutical production<br />

processes. Promoting <strong>and</strong> supporting collaborative research projects established from interacademic,<br />

academic-industrial <strong>and</strong> public-private partnerships is an additional important objective,<br />

ultimately leading to innovation <strong>and</strong> better process underst<strong>and</strong>ing.<br />

Contact Point<br />

Thomas de Beer thomas.debeer@ugent.be<br />

34


Network<br />

Bioavailability <strong>and</strong> Biopharmaceutics<br />

European Federation for Pharmaceutical Sciences<br />

Scope <strong>and</strong> aim<br />

The initiation of this Network appeared to be a natural progression of the <strong>EUFEPS</strong> vision<br />

that biopharmaceutics forms the bedrock of many of the activities of the contributing societies.<br />

Its activities have provided many important opportunities to assist legislature in defining<br />

a harmonised approach across Europe. For example, proposed changes in European<br />

Guidelines in bioavailability <strong>and</strong> bioequivalence have prompted the scientific community to<br />

engage in a more comprehensive communication with regulatory scientists <strong>and</strong> to stimulate<br />

exchange between both groups. In particular, efforts focus on scientific questions, which<br />

arise from poorly resolved areas <strong>and</strong> to provide a focal point from which best practice can<br />

be developed. There is now a platform for discussion for all interested scientists. Several<br />

conferences <strong>and</strong> decision fora have been organised, <strong>and</strong> more will follow.<br />

Contact point<br />

Henning Blume henning.blume@socratec-pharma.de<br />

Network<br />

PharmacoGenetics<br />

<strong>and</strong> PharmacoGenomics Research<br />

European Federation for Pharmaceutical Sciences<br />

www.epr-network.org<br />

Scope <strong>and</strong> aim<br />

Pharmacogenetics <strong>and</strong> pharmacogenomics (PGX) are emerging disciplines that focus on<br />

genetic determinants of drug response at the levels of single genes or the entire human<br />

genome, respectively. The network is the voice of the European science community in<br />

pharmacogenetics <strong>and</strong> pharmacogenomics, with the following objectives. The Network provides<br />

a platform for experts for gathering <strong>and</strong> disseminating knowledge, determining PGXstrategies;<br />

for collaboration between academic institutions <strong>and</strong> industry; for mechanisms of<br />

set up <strong>and</strong> exchange of databases; <strong>and</strong> for gatherings <strong>and</strong> promotion of knowledge about<br />

pharmacogenetics <strong>and</strong> genomics in Europe. Objectives also include to serve as a knowledge-bank<br />

for EU research programme calls, <strong>and</strong> to engage in education <strong>and</strong> training, particularly,<br />

PHD students.<br />

Contact Point<br />

Anke-Hilse Maitl<strong>and</strong>-van der Zee a.h.maitl<strong>and</strong>@uu.nl<br />

35


Network<br />

Environment <strong>and</strong> Pharmaceuticals<br />

European Federation for Pharmaceutical Sciences<br />

Scope <strong>and</strong> Aim<br />

Pharmaceuticals are indispensable for a high quality of life. Their use however also has an<br />

environmental downside that needs to be h<strong>and</strong>led. In recent years, a huge amount of data<br />

has been collected, demonstrating the widespread of a variety of active drug ingredients in<br />

the aquatic environment <strong>and</strong> sporadically even in drinking water. Being only insufficiently<br />

eliminated in the conventional sewage treatment plants, there is growing evidence that the<br />

substances <strong>and</strong> their metabolites have adverse effects on aquatic <strong>and</strong> in some cases terrestrial<br />

organisms on both the individual <strong>and</strong> population level. How to adequately address<br />

these issues? The Network has been initiated to address scientific achievements <strong>and</strong> discuss<br />

various issues on exposure of pharmaceuticals to the environment, including attempts<br />

towards global harmonisation.<br />

Contact Point<br />

Lennart Dencker lennart.dencker@farmbio.uu.se<br />

Network<br />

Food-Drug Synergies<br />

European Federation for Pharmaceutical Sciences<br />

Scope <strong>and</strong> aim<br />

This Network initiative is new. The idea is to assemble the industry-academia-regulatory<br />

triangle to work on topics which cross between food science <strong>and</strong> pharmaceutical sciences.<br />

Topics would be, for example: Personalised nutrition <strong>and</strong> personalised medicine; special<br />

needs (the sick, children, the elderly); sharing technology to evaluate product performance;<br />

best practice to be communicated to public bodies; encouraging liaison across Europe to<br />

create enterprise; <strong>and</strong> to explore new neutraceutical concepts.<br />

Contact point<br />

David Featherston DFE@biopeople.ku.dk<br />

36


Network<br />

NanoMedicine<br />

European Federation for Pharmaceutical Sciences<br />

Scope <strong>and</strong> aim<br />

This Network is also new. Broadly, nanomedicine has been defined as therapeutic <strong>and</strong>/<br />

or diagnostic systems capable of comprehensive monitoring, control, construction, repair,<br />

defence <strong>and</strong> improvement of all human biological systems, working from the molecular<br />

level using engineered devices <strong>and</strong> nanostructures, ultimately to achieve medical benefit.<br />

Nanoscale includes active components or objects in the size ranging from one nanometre to<br />

hundreds of nanometres. Naturally, this Network should focus on pharmaceutical <strong>and</strong> biomedical<br />

sciences <strong>and</strong> the diagnostics <strong>and</strong> therapeutic aspects of nanomedicine, primarily in<br />

cooperation with related nanotechnology fields such as optics, bioinformatics to achieve a<br />

wide range platform for pharmaceutical researchers in this field.<br />

Contact point<br />

Erem Bilensoy eremino@hacettepe.edu.tr<br />

Network<br />

Regulatory Science<br />

European Federation for Pharmaceutical Sciences<br />

Scope <strong>and</strong> aim<br />

This initiative is an additional Network option for, primarily, academic, industrial <strong>and</strong> regulatory<br />

professionals in the various scientific fields to engage in brainstorming meetings, workshops<br />

<strong>and</strong> discussions on strategic goals <strong>and</strong> key issues in translational research covered<br />

by the pharmaceutical sciences. It would foster collaboration <strong>and</strong> contribute to implementation<br />

of high quality basic <strong>and</strong> applied science, promote joint activities <strong>and</strong> engage in education<br />

<strong>and</strong> training.<br />

Contact point<br />

Rogério Gaspar rgaspar@ff.ul.pt<br />

37


10. Awards <strong>and</strong> Prizes<br />

<strong>EUFEPS</strong> is, since 1998, presenting a number of Awards. Below is information on them,<br />

along with the laureates.<br />

The Giorgio Segré Prize<br />

In 1998, <strong>EUFEPS</strong> established, in partnership with the Segré family, a special biennial<br />

award for young investigators showing distinction in the field of PK <strong>and</strong> PD, to honour the<br />

memory of the late Professor Giorgio Segré of the University of Siena, Italy. The Giorgio<br />

Segré Prize was presented for the first time in 1998.<br />

Laureates<br />

Year Laureate<br />

1998 Mats Karlsson<br />

University of Uppsala, Sweden<br />

2000 Wojchiech Krzyzanski<br />

State University of New York at Buffalo, Buffalo NY<br />

USA<br />

2002 Oscar E Della Pasqua<br />

University of Leiden, The Netherl<strong>and</strong>s, <strong>and</strong> Glaxo-<br />

SmithKline Research & Development, Greenford,<br />

United Kingdom<br />

2004 Inaki Troconiz<br />

University of Navarra, Spain<br />

2006 Niclas Jonsson<br />

University of Uppsala, Sweden<br />

2008 Lena Friberg<br />

University of Uppsala, Sweden<br />

2010 Jürgen Bulitta<br />

State University of New York at Buffalo, Buffalo NY<br />

USA<br />

The Best Paper Award<br />

The Best Paper Award, sponsored by Elsevier, is given to the author/s of the best paper<br />

selected among those published in the European Journal of Pharmaceutical Sciences in<br />

the year before the Award is presented. The European Journal of Pharmaceutical Sciences<br />

is the Official Scientific Journal of <strong>EUFEPS</strong>, published by Elsevier. The Best Paper<br />

Award was presented for the first time in 2002.<br />

38


Laureates<br />

Year Authors Article Published<br />

2002 P.J. Gaillard, L.H.<br />

Voorwinden, J.L.<br />

Nielsen, A. Ivanov,<br />

R. Atsumi, H. Engman,<br />

C. Ringbom, A.G. de<br />

Boer <strong>and</strong> D.D. Breimer<br />

2004 G. Bäckström, J.<br />

Taipalensuu,<br />

H. Melhus, H.<br />

Brändström,<br />

A-C. Svensson, P. ArPtursson<br />

<strong>and</strong><br />

A. Kindmark<br />

2004 G.L. Perlovich, S.V.<br />

Kurkov <strong>and</strong><br />

A. Bauer-Br<strong>and</strong>l<br />

2005 G.W. Bos, J.J.L.<br />

Jacobs,<br />

J.W. Koten, S. Van<br />

Tomme,<br />

T. Veldhuis, C.F. van<br />

Nostrum,<br />

W. Den Otter <strong>and</strong> W.E.<br />

Hennink<br />

2006 M. Boustta, T. Etrych,<br />

L. Leclercq <strong>and</strong> M. Vert<br />

2007 J.H. Proost, L. Beljaars,<br />

P. Olinga, P.J. Swart,<br />

M.E. Kuipers, C. Reker-<br />

Smit,<br />

G.M.M. Groothius <strong>and</strong><br />

D.K.F. Meijer<br />

2008 M. Norrman, F.<br />

Hubáleka <strong>and</strong><br />

Schluckebier<br />

2009 C. Fella, G.F. Walker,<br />

M. Ogris <strong>and</strong> E. Wagner<br />

<strong>2011</strong> X. Shi, Y. Wang, R.R.<br />

Varshney, L.R. Yihong<br />

Gong <strong>and</strong> D-A. Wang<br />

Establishment <strong>and</strong> functional characterization<br />

of an in vitro model of the<br />

blood-brain barrier, comprising a coculture<br />

of brain capillary endothelial<br />

cells <strong>and</strong> astrocytes<br />

Genetic variation in the ATP-binding<br />

Cassette Transporter gene ABCG2<br />

(BCRP) in a Swedish population<br />

Thermodynamics of solutions II.<br />

Flurbiprofen <strong>and</strong> diflunisal as models<br />

for studying solvation of drug substances<br />

In situ crosslinked biodegradable hydrogels<br />

loaded with IL-2 are effective<br />

tools for local IL-2 therapy<br />

Polyelectrolyte complex formation<br />

<strong>and</strong> stability when mixing polyanions:<br />

<strong>and</strong> polycations in salted media<br />

A model study related to the case of<br />

body fluids<br />

Prediction of the pharmacokinetics of<br />

succinylated human serum albumin<br />

in man from in vivo disposition data<br />

in animals <strong>and</strong> in vitro liver slice<br />

incubations<br />

Structural characterization of insulin<br />

NPH formulations<br />

Amine-reactive pyridylhydrazonebased<br />

PEG reagents for pH-reversible<br />

PEI polyplex shielding<br />

Microsphere-based drug releasing<br />

scaffolds for inducing osteogenesis<br />

of human mesenchymal stem cells<br />

in vitro<br />

39<br />

2001, 12, 215-<br />

222<br />

2003, 18, 359-<br />

364<br />

2003, 18, 423-<br />

432<br />

2004, 21, 561-<br />

567<br />

2005, 25, 281-<br />

288<br />

2006, 27, 123-<br />

132<br />

2007, 30, 414-<br />

423<br />

2008, 34, 309-<br />

320<br />

2010, 39, 59-67


The New Safe Medicines Faster Award<br />

The New Safe Medicines Faster (NSMF) Award, sponsored by Sanofi, was established by<br />

<strong>EUFEPS</strong> in 2002 to, every year, honour an individual scientist – or a team of scientists –<br />

for outst<strong>and</strong>ing contributions to innovation <strong>and</strong> advancement of new methodology or technology,<br />

primarily, which has significantly contributed to shorten or make the drug development<br />

process more efficient. The NSMF award was presented for the first time in 2003.<br />

Laureates<br />

Year Laureate<br />

2003 Mats Bergström, Anders Grahnén <strong>and</strong> Bengt Långström<br />

(Uppsala, Sweden)<br />

2004 Geoffrey T. Tucker <strong>and</strong> Amin Rostami (Sheffield, United<br />

Kingdom)<br />

2005 Per Artursson (Uppsala, Sweden) <strong>and</strong> Manfred Kansy<br />

(Basel, Switzerl<strong>and</strong>)<br />

2006 Meindert Danhof (Leiden, The Netherl<strong>and</strong>s)<br />

2007 Peter York (Bradford, United Kingdom), Staffan Folestad<br />

(Moelndal, Sweden), Hans Leuenberger (Basel, Switzerl<strong>and</strong>),<br />

<strong>and</strong> Jouko Kalervo Yliruusi (Helsinki, Finl<strong>and</strong>)<br />

2008 Hans Lennernäs (Uppsala, Sweden)<br />

2009 Malcolm Rowl<strong>and</strong> (Manchester, United Kingdom)<br />

2010 Hans H. Lindén (Stockholm, Sweden)<br />

40


11. European Pharmaceutical Scientist Prize<br />

The European Pharmaceutical Scientist Prize was created on the occasion of the First<br />

PharmSciFair, which took place in 2005 in Nice, France. The Prize is intended to recognise<br />

significant contributions by a European researcher in any domain of the pharmaceutical<br />

sciences, such as: drug modelling, medicinal chemistry, gene therapy, pharmacology,<br />

pharmacokinetics, drug metabolism, toxicology, pharmaceutical formulation, drug delivery,<br />

pharmaceutical physical chemistry, new in-vitro/in-vivo models, etc., i.e. scientific domains<br />

<strong>and</strong> disciplines relevant for drug discovery, development, processing <strong>and</strong> usage. The intention<br />

is not to recognise a life devoted to science, but rather a discovery, which can be<br />

considered as a decisive breakthrough in drug discovery <strong>and</strong> development.<br />

The most prestigious European research centres are invited to nominate one or more<br />

c<strong>and</strong>idate(s) in one or more of the above-mentioned domains. These centres are: Karolinska<br />

Institute (Sweden), Istituto di Recerche Farmacologiche “Mario Negri” (Italy), Fonds<br />

National de la Recherche Scientifique (Belgium), FIGON (The Netherl<strong>and</strong>s) <strong>and</strong> Centre<br />

National de la Recherche Scientifique (France), as well as the <strong>EUFEPS</strong> Member Societies<br />

<strong>and</strong> other scientific societies <strong>and</strong> associations participating in the organisation of the Pharm-<br />

SciFair.<br />

Laureates<br />

Year Laureate<br />

2005 Professor Pierre Potier,<br />

Paris, France<br />

2009 Professor Michael Karas,<br />

Frankfurt, Germany<br />

<strong>2011</strong> Professor Patrick Couvreur,<br />

Paris, France<br />

A simple biological test (tubulin test) allowing<br />

identification <strong>and</strong> selection of new anti-cancer<br />

agents, leading to the development of Navelbine<br />

<strong>and</strong> Taxotere.<br />

Outst<strong>and</strong>ing achievements in mass spectrometry,<br />

related to the analysis of biomolecules by laserassisted<br />

desorption ionization, more specifically<br />

known as Matrix Assisted Laser Desorption<br />

Ionization (MALDI).<br />

First biodegradable nanoparticles for human use,<br />

representing a real breakthrough in the field of<br />

advanced drug delivery, e.g. opening new ways for<br />

highly efficient <strong>and</strong> significantly improved drug<br />

administration.<br />

41


12. The Pharmaceutical Sciences Fair <strong>and</strong> Exhibition<br />

PharmSciFair<br />

The Pharmaceutical Sciences Fair <strong>and</strong> Exhibition – PharmSciFair – is a unique event in<br />

Europe, co-organised by <strong>EUFEPS</strong> <strong>and</strong> a number of Partner Organisations. They are Member<br />

Societies of <strong>EUFEPS</strong>, Sister Organisations, Learned Societies, <strong>and</strong> Special Interest<br />

Networks <strong>and</strong> Institutions. The first PharmSciFair, in June 2005, in Nice, France, was attended<br />

by over 1200 delegates. It pioneered this new platform, which allows the best <strong>and</strong><br />

newest European pharmaceutical achievements to be presented, <strong>and</strong> provides an excellent<br />

spirit of collaboration between academia, the regulatory field <strong>and</strong> industry.<br />

A second PharmSciFair <strong>and</strong> Exhibition was held in June 2009 in Nice, France, with a lot of<br />

students among the attendees <strong>and</strong> a young scientist meeting, partly on its own <strong>and</strong> partly in<br />

the PharmSciFair. The 3rd Pharmaceutical Sciences Fair <strong>and</strong> Exhibition was held in June<br />

<strong>2011</strong> <strong>and</strong>, for the first time, in Prague, Czech Republic. It was co-organised, as previously,<br />

by <strong>EUFEPS</strong> <strong>and</strong> a broad partner representation of 30 national <strong>and</strong> international organisations<br />

<strong>and</strong> networks in pharmaceutical sciences, around the common theme: Pharmaceutical<br />

Sciences for the Future of Medicines. In Prague, after the Welcome Reception, the scientific<br />

programme comprised over forty Parallel Sessions, focusing on topics of the pharmaceutical<br />

sciences in Europe, a Plenary Session <strong>and</strong> Panorama Sessions for overview, Young<br />

Scientist Sessions, <strong>and</strong> a <strong>EUFEPS</strong> 20 th <strong>Anniversary</strong> Session <strong>and</strong> Reception.<br />

The PharmSciFair is unique because it encompasses all aspects of pharmaceutical<br />

sciences from discovery tools, over drug delivery in the body <strong>and</strong> drug processing, to<br />

medicines usage. <strong>EUFEPS</strong> is convinced of the need to carry the pharmaceutical sciences<br />

forward in this kind of global event; it should be the ‘Olympia’ of pharmaceutical<br />

sciences, enabling all involved to think <strong>and</strong> to consult together <strong>and</strong> to share experiences,<br />

different approaches, perspectives <strong>and</strong> sensitivities among the different players in<br />

pharmaceutical sciences as represented by delegates from the academic, industrial <strong>and</strong><br />

regulatory domains. Building on the strengths of each <strong>and</strong> every actor, it ensures a consolidated<br />

movement towards common goals <strong>and</strong> targets <strong>and</strong> creates synergy within the<br />

array of different disciplines, all having the objective to better serve the health of populations.<br />

The pharmaceutical science, as a multi-faceted concept, is reflected at this event,<br />

which is wide-ranging in terms of scientific content, activities <strong>and</strong> participating parties.<br />

Furthermore, <strong>EUFEPS</strong> wants to see a powerhouse in Europe, able to match other<br />

international organisations at the equivalent level. Partnership of equals can only occur<br />

if there is a strong, well organised interaction between national, regional <strong>and</strong> international<br />

organisations, which are of relevance to pharmaceutical sciences. Instruments such as<br />

PharmSciFair are needed to introduce partners, foster future interactions <strong>and</strong> generate a<br />

European ideal. This combination of the diverse learned societies <strong>and</strong> networks of interest<br />

<strong>and</strong> focus groups, associated with the pharmaceutical sciences in Europe into one assembly,<br />

shows the combined strength of European pharmaceutical sciences in a way, which will<br />

gain recognition globally.<br />

42


Slovenian Pharmaceutical Society <strong>and</strong><br />

University of Ljubljana, Faculty of Pharmacy<br />

are organizing the<br />

th<br />

4 BBBB - Bled International<br />

Conference on Pharmaceutical<br />

Sciences<br />

Second Announcement<br />

New Trends in Drug Discovery,<br />

Delivery Systems <strong>and</strong> Laboratory Diagnostics<br />

Bled, Slovenia, 29 th September – 1 st October <strong>2011</strong><br />

www.bbbb-eufeps.org<br />

Announcement – April <strong>2011</strong><br />

Continuous Innovation in<br />

Process Analytics & Control<br />

May 9-10 • 2012 • NH Hotel Ghent Belfort • Ghent • Belgium<br />

Invitation to Join EuPAT 5<br />

The topic of EuPAT 5 – Continuous Innovation<br />

in Process Analytics & Control – underlines the<br />

importance of bringing innovation into pharmaceutical<br />

manufacturing based on QbD <strong>and</strong> PAT<br />

sciences. Building quality into drug products<br />

should commence during the early phases of<br />

research <strong>and</strong> development <strong>and</strong> sustain during the<br />

product <strong>and</strong> process life cycle. Consideration <strong>and</strong><br />

implementation of the quality requirements for<br />

new medicines should facilitate effective process<br />

development <strong>and</strong> robust large-scale manufacture.<br />

Advanced process analytics should therefore<br />

play a crucial role in design, analysis, <strong>and</strong> control<br />

of manufacturing processes based on timely<br />

in-process measurements for integrated system<br />

approaches, innovative developments <strong>and</strong> cutting<br />

edge scientific advances.<br />

This is to invite you for the fifth pan-European<br />

Science Conference on QbD <strong>and</strong> PAT Sciences,<br />

building on the successes of the EuPAT conference<br />

series that started in 2006. EuPAT 5 will be held on<br />

May 9-10, 2012, in Ghent, Belgium, <strong>and</strong> organised<br />

back-to-back to a training day on “continuous<br />

pharmaceutical manufacturing of solid dosage<br />

forms”, to be held on May 8, 2012, at the Faculty<br />

of Pharmaceutical Sciences from the University of<br />

Ghent. The attendees of EuPAT 5 are welcome to<br />

register to the pre-conference day <strong>and</strong> vice versa.<br />

www.eufeps.org<br />

Session Topics of EuPAT5<br />

• Continuous pharmaceutical processing<br />

• PAT in bio-active pharmaceutical processing<br />

• Advanced process sensors for control<br />

• Process modeling for in-depth underst<strong>and</strong>ing<br />

<strong>and</strong> control<br />

• Material characterization <strong>and</strong> underst<strong>and</strong>ing at<br />

molecular level in (bio)process environment<br />

Invited Speakers at EuPAT 5<br />

Dr. Marcel de Matas, AstraZeneca, Macclesfield,<br />

United Kingdom<br />

Professor Wuqiang Yang, University of<br />

Manchester, Manchester, United Kingdom<br />

Professor Johannes Khinast, Technical University<br />

of Graz, Graz, Austria<br />

Professor Krist Gernaey, Technical University of<br />

Denmark, Copenhagen, Denmark<br />

Professor Reiner Luttmann, Hamburg University<br />

of Applied Sciences, Hamburg, Germany<br />

Professor Anna de Juan Capdevila, University of<br />

Barcelona, Barcelona, Spain<br />

The programme will be continuously updated on<br />

the conference website.<br />

43<br />

Drug Absorption,<br />

Transport <strong>and</strong> Delivery (WCDATD):<br />

Responding to Challenging Situations<br />

October 1-3 • 2012 • Edinburgh • Scotl<strong>and</strong> • United Kingdom<br />

Invitation<br />

We invite you to start planning to<br />

participate in the 5th World Conference<br />

on Drug Absorption, Transport <strong>and</strong><br />

Delivery, to be held on October 1-3,<br />

2012 in Edinburgh, Scotl<strong>and</strong>, United<br />

Kingdom. This international event will<br />

take place immediately before the FIP<br />

Centennial World Congress in Amsterdam,<br />

The Netherl<strong>and</strong>s. The programme of the<br />

WCDATD 2012 is being developed around<br />

progress, issues <strong>and</strong> challenges in all aspects<br />

of drug absorption, transport <strong>and</strong> delivery<br />

crucial to drug development <strong>and</strong> improved<br />

drug usage. Previous Conferences in this<br />

series were held in 2001 (Denmark), 2003<br />

(USA), 2005 (Spain), <strong>and</strong> 2007 (Japan).<br />

Scope <strong>and</strong> Aim<br />

WCDATD 2012 will focus on underst<strong>and</strong>ing<br />

of drug absorption mechanisms,<br />

including the role of transporters, <strong>and</strong><br />

5 th World Conference on<br />

www.eufeps.org<br />

opportunities <strong>and</strong> constraints in the design<br />

of formulations within a biopharmaceutical<br />

context. Using new imaging, simulation<br />

<strong>and</strong> measurement tools that integrate<br />

knowledge from laboratory to clinic, the<br />

optimal management of drug therapy in<br />

complex patients <strong>and</strong> disease areas will be<br />

considered together with implications for<br />

harmonising drug product regulation. New<br />

developments in drug design <strong>and</strong> delivery<br />

technologies, including omics <strong>and</strong> material<br />

sciences, <strong>and</strong> the concurrent evolution of<br />

regulatory principles for the approval of<br />

biosimilars offer exciting research areas<br />

for both academic <strong>and</strong> industrial scientists.<br />

The intent will be to assemble cutting<br />

edge knowledge to consider <strong>and</strong> debate<br />

contemporary challenges in drug usage,<br />

including the treatment of patients at the<br />

extremes of age <strong>and</strong> the impact of the disease<br />

process on effective <strong>and</strong> safe delivery of<br />

active pharmaceutical compounds.


14. <strong>EUFEPS</strong> in EU Projects<br />

Since establishing (more than 10 years ago) <strong>and</strong> running the New Safe Medicines Faster<br />

initiative (NSMF), <strong>EUFEPS</strong> has, obviously, been in leading <strong>and</strong> supporting roles <strong>and</strong> positions<br />

of a number of EU funded projects within the European Commission Framework<br />

Programmes for Research <strong>and</strong> Technological Development. Current projects stem from the<br />

first <strong>and</strong> second rounds of calls of the Innovative Medicines Initiative (IMI) Joint Undertaking<br />

(JU), which is a highest-level Public-Private Partnership (PPP) in Europe. Four of them, the<br />

first round of calls ones, are focussing on education <strong>and</strong> training needs <strong>and</strong> how to fill them,<br />

not the least in the pharmaceutical industry but also in the regulatory area an academic<br />

world.<br />

<strong>EUFEPS</strong> is consortium member <strong>and</strong> represented in the executive committee of the project<br />

on European Modular Education <strong>and</strong> Training Programme in Safety Sciences for Medicines<br />

(www.safescimet.eu). <strong>EUFEPS</strong> is leader of the Work Package on new <strong>and</strong> emerging<br />

education <strong>and</strong> training needs in safety sciences <strong>and</strong> sustainability of the new programme.<br />

SafeSciMET develops <strong>and</strong> delivers a pan-European education <strong>and</strong> training programme on<br />

drug safety that emphasises integrative <strong>and</strong> translational aspects, from pre-clinical phases<br />

to clinical ones, lacking largely in <strong>today</strong>’s educational programmes.<br />

<strong>EUFEPS</strong> is consortium member <strong>and</strong> also liaised with the executive board of the project on<br />

New <strong>and</strong> Harmonised Education <strong>and</strong> Training in Pharmaceutical Medicine in Europe (www.<br />

pharmatrain.eu). <strong>EUFEPS</strong> contributes actively to three of its work packages – one on strategy,<br />

one on new member state needs <strong>and</strong> involvement in the education <strong>and</strong> training programme,<br />

<strong>and</strong> one on course quality. PharmaTrain aims at fostering the overall underst<strong>and</strong>ing<br />

<strong>and</strong> competence for successful execution of integrated drug development <strong>and</strong> life-cycle<br />

management of medicines.<br />

<strong>EUFEPS</strong> is in the External Advisory Board <strong>and</strong> Strategic Coordination Board of the European<br />

Medicines Research Training Network project (www.emtrain.eu). <strong>EUFEPS</strong> participates,<br />

moreover, in the work of two of its teams or working parties. One of them should deliver<br />

outcomes of a “gap analysis”, <strong>and</strong> the other one has started looking into continuing professional<br />

development (CPD) or life-long learning (LLL) for those in medicines research, development,<br />

processing <strong>and</strong> usage. EMTRAIN should establish a sustainable, pan-European<br />

platform for education <strong>and</strong> training, covering the whole life-cycle of medicines research.<br />

<strong>EUFEPS</strong> is liaised with the project on European Education <strong>and</strong> Training Programme in<br />

Pharmacovigilance <strong>and</strong> Pharmacoepidemiology (www.eu2p.eu), through two IMI Cross<br />

Project Task Forces. The first one of them focuses on communication of the IMI Education<br />

<strong>and</strong> Training, lead by <strong>EUFEPS</strong>, <strong>and</strong> the other one is tasked to map out <strong>and</strong> implement<br />

“Bologna” agreements <strong>and</strong> European higher education quality criteria for quality in the IMI<br />

Education <strong>and</strong> Training. Eu2P addresses training needs <strong>and</strong> offers a range of qualification<br />

level courses (certificate, master <strong>and</strong> PhD) <strong>and</strong> allows part or full time study by those in employment<br />

as well as graduate students.<br />

Finally, <strong>EUFEPS</strong> accepted an advisory role in the project on Drug Disease Model Resources<br />

(www.ddmore.eu). It is a project from the IMI second round of calls.<br />

For <strong>EUFEPS</strong> earlier involvement, including in the New Safe Faster Medicines (NSMF) initiative,<br />

see the <strong>EUFEPS</strong> Online at www.eufeps.org<br />

44


A <strong>EUFEPS</strong> Senate is being established.<br />

15. <strong>EUFEPS</strong> Senate<br />

Strategic discussions <strong>and</strong> decisions in the <strong>EUFEPS</strong> Executive Committee <strong>and</strong> Council lead<br />

to a recommendation that an academy or group of renowned scientists be established in<br />

Europe. If so, it would be a “<strong>EUFEPS</strong> Senate” or evolutionary think-tank for further scientific<br />

developments, covering the pharmaceutical sciences as “the science of the drug”, preferably.<br />

This would, to some extent, be broader than the traditional underst<strong>and</strong>ing of the field.<br />

Maybe, there would be networking <strong>and</strong> educational roles as well. Having concluded that<br />

such a body, a well-organised advisory group of senior leaders or elders in the science,<br />

would be beneficial as sounding board <strong>and</strong> pool of experience to <strong>EUFEPS</strong> <strong>and</strong> its membership,<br />

further steps were taken.<br />

The first <strong>and</strong> inaugural meeting of the <strong>EUFEPS</strong> Senate was held in June 2009 in Nice,<br />

France (at the 2 nd PharmSciFair), the second meeting in April 2010 in Vienna, Austria, <strong>and</strong><br />

the third one in November 2010 in New Orleans, USA (at the 4 th Pharmaceutical Sciences<br />

World Conference). The fourth meeting was held in June <strong>2011</strong> in Prague, Czech Republic<br />

(at the 3 rd PharmSciFair).<br />

The <strong>EUFEPS</strong> Senate comprises 16 members, currently, many of them having played leading<br />

roles not only as scientists, including in education <strong>and</strong> training, but also in <strong>EUFEPS</strong>.<br />

Professors Douwe D. Breimer (Leiden, The Netherl<strong>and</strong>s), <strong>and</strong> Christian R. Noe (Vienna,<br />

Austria) are Chair <strong>and</strong> Secretary of it.<br />

45


16. <strong>EUFEPS</strong> on the Global Scene<br />

Since its inception the <strong>EUFEPS</strong> leadership has realised that a strong European presence<br />

on the global scene would be a benefit to the <strong>EUFEPS</strong> membership; ‘the European voice<br />

should be heard’. That is why, over the years, <strong>EUFEPS</strong> played an active role on the global<br />

pharmaceutical sciences ‘scene’. In the following text only interactions of <strong>EUFEPS</strong> with<br />

international organisations <strong>and</strong> national organisations outside Europe are mentioned. The<br />

intention is not to give an exhaustive overview. It should be seen as a sampling of <strong>EUFEPS</strong><br />

activities in a global perspective <strong>and</strong> <strong>EUFEPS</strong> willingness to engage in answering global<br />

questions.<br />

FIP<br />

In the <strong>EUFEPS</strong> statutes a special mentioning is made to the International Pharmaceutical<br />

Federation (FIP). This international platform for pharmacy practice <strong>and</strong> pharmaceutical sciences<br />

is mentioned is an observer to the <strong>EUFEPS</strong> Council meeting. <strong>EUFEPS</strong> has played<br />

an active <strong>and</strong> stimulating role in the scientific wing of the FIP (Board of Pharmaceutical Sciences,<br />

BPS). Even more so, <strong>EUFEPS</strong> joined FIP as Member Organisation in 2008 <strong>and</strong> by<br />

this became the first Member Organisation of FIP/BPS with a world regional (Europe) coverage,<br />

instead of a national basis. <strong>EUFEPS</strong> <strong>and</strong> FIP worked together on different occasions,<br />

including in organising joint conferences. A prime example is the Pharmaceutical Sciences<br />

World Conference (PSWC) series. Since the first PSWC in 2000 in San Francisco, CA USA,<br />

<strong>EUFEPS</strong> has fully supported this FIP led initiative, where pharmaceutical scientist from all<br />

over the world meet. The follow up PSWC conferences (Tokyo, 2004), in particular Amsterdam<br />

(2007) <strong>and</strong> New Orleans (2010), all enjoyed European programmatic input through<br />

<strong>EUFEPS</strong>.<br />

AAPS, ACCP, ISSX, APSTJ <strong>and</strong> JSSX<br />

Several other organisations worldwide collaborate on a regular or temporary basis with<br />

<strong>EUFEPS</strong>. Among those are the American Association of Pharmaceutical Scientists (AAPS),<br />

the American College of Clinical Pharmacology (ACCP), <strong>and</strong> the International Society for<br />

the Study of Xenobiotics (ISSX). Over the last 20 years co-sponsored conferences were<br />

run on a regular basis. Examples are meetings in the <strong>EUFEPS</strong> Basel Conference Series,<br />

the Groundbreaking Workshop on ‘Assuring Quality <strong>and</strong> Performance of Sustained <strong>and</strong><br />

Controlled Release Parenterals’ also in Basel, <strong>and</strong> the World Conference on Drug Absorption<br />

Transport <strong>and</strong> Delivery (WCDATD), by <strong>EUFEPS</strong> in 2001 in Copenhagen <strong>and</strong> in 2005 in<br />

Barcelona – <strong>and</strong> aiming for Edinburgh in 2012. In this context the longst<strong>and</strong>ing interactions<br />

<strong>and</strong> collaborations with the Academy of Pharmaceutical Sciences <strong>and</strong> Technology of Japan<br />

(APSTJ), the Japanese Society for the Study of Xenobiotics (JSSX), <strong>and</strong> the, newly established,<br />

Asian Federation for Pharmaceutical Sciences (AFPS) must also be mentioned.<br />

ISPE<br />

The International Society for Pharmaceutical Engineering (ISPE) has been <strong>EUFEPS</strong>’ partner<br />

for a number of years in the field of Process Analytical Technology (PAT) <strong>and</strong> Quality by<br />

Design (QbD). ISPE Nordic <strong>and</strong> ISPE Europe cosponsored a number of successful conferences<br />

set up by the <strong>EUFEPS</strong> Network in this field.<br />

46


The European Pharmacopoeia <strong>and</strong> the USP<br />

A link between <strong>EUFEPS</strong> <strong>and</strong> the European Pharmacopoeia (within the European Directorate<br />

for Quality of Medicines <strong>and</strong> Health Care) is a logical one. But, <strong>EUFEPS</strong> has a longst<strong>and</strong>ing<br />

relationship with the Unites States Pharmacopoeia (USP) as well, as it contributed<br />

to stakeholder fora organised by USP. <strong>EUFEPS</strong> is also engaged in discussion on how to<br />

establish global pharmacopoeia meetings.<br />

DUPHAT<br />

<strong>EUFEPS</strong> contributes, since about ten years, to the programme of the Annual Dubai International<br />

Pharmaceuticals & Technologies Conference & Exhibition (DUPHAT), by recommending<br />

(European) speakers <strong>and</strong> leaders for plenary sessions <strong>and</strong> workshops, <strong>and</strong> by co-sponsoring<br />

it. It is held in the beginning of March, every year, in Dubai, United Arab Emirates.<br />

47


17. Sponsorship Recognition<br />

The core funding of <strong>EUFEPS</strong> is based on annual membership fees. The major part is provided<br />

by the <strong>EUFEPS</strong> Member Societies, the fee of which is related to the size of the Member<br />

Society. Currently, there are 24 Member Societies of <strong>EUFEPS</strong>, in 24 countries, including<br />

Israel <strong>and</strong> Turkey. In addition there are around 500 Individual Members of <strong>EUFEPS</strong> as well<br />

as 15 Member Institutions, comprising universities <strong>and</strong> research institutes.<br />

“Meetings <strong>and</strong> events”, meaning congresses, conferences, workshops <strong>and</strong> courses etc. is<br />

an additional source of income of <strong>EUFEPS</strong>, in many cases covering not only direct expenses<br />

<strong>and</strong> the administration <strong>and</strong> management of them, but also some of the development<br />

costs for future activities, including important <strong>and</strong> crucial meetings not bearing their<br />

own financial burden. In addition, <strong>EUFEPS</strong> initiated <strong>and</strong> participated (<strong>and</strong> still does) in EU<br />

funded projects, also covering their own costs <strong>and</strong> time spent, after approved application<br />

<strong>and</strong> reimbursements.<br />

Since 2007, a number of major European pharmaceutical companies provided significant<br />

sustained sponsorship for <strong>EUFEPS</strong>, in three-year cycles or year by year. This is gratefully<br />

acknowledged. It helped to, for example, keep <strong>and</strong> continuously run the permanent<br />

secretariat of <strong>EUFEPS</strong>, located in Stockholm, Sweden. Sustained sponsors were/are:<br />

AstraZeneca, Bayer Healthcare, GlaxoSmithKline, Novartis <strong>and</strong> Pfizer. In addition, many<br />

companies sponsored <strong>EUFEPS</strong> events, over the years, including those organised by<br />

<strong>EUFEPS</strong> Networks.<br />

For the future, even broader support of <strong>EUFEPS</strong> will be sought to build longer term financial<br />

stability – more members (societies, individuals <strong>and</strong> institutes), as well as small, medium<br />

<strong>and</strong> big companies, all for new significant initiatives <strong>and</strong> to better serve the pharmaceutical<br />

scientist community, e.g. towards a framework for continuing professional development<br />

(CPD).<br />

48


18. Executive Committee membership 1991–<strong>2011</strong><br />

18. Executive Committee membership 1991–<strong>2011</strong><br />

\<br />

Past-<br />

Secretary<br />

President Vice President<br />

Treasurer<br />

Member Member Member Member Member<br />

President<br />

General<br />

E. Mutschler D.D. Breimer None P. Sensi S. Agurell K. Nicolics P. Rossignol<br />

E. Mutschler D.D. Breimer None P. Sensi S. Agurell K. Nicolics P. Rossignol<br />

E. Mutschler D.D. Breimer None P. Sensi S. Agurell Y. Michotte M. Rowl<strong>and</strong><br />

D.D. Breimer M. Rowl<strong>and</strong> E. Mutschler B. Lindeke B. Lindeke Y. Michotte F Pellerin<br />

D.D. Breimer M. Rowl<strong>and</strong> E. Mutschler B. Lindeke B. Lindeke Y. Michotte F. Pellerin<br />

M Rowl<strong>and</strong> A.Grahnén D.D. Breimer B. Lindeke B. Lindeke A.F. Fell F. Pellerin A.A. Hincal<br />

M. Rowl<strong>and</strong> A. Grahnén D.D. Breimer B. Lindeke B. Lindeke A.F. Fell M. Veillard A.A. Hincal<br />

M. Rowl<strong>and</strong> A. Grahnén D.D. Breimer B. Lindeke B. Lindeke A.F. Fell M. Veillard A.A. Hincal<br />

1991-<br />

1992<br />

1992-<br />

1993<br />

1993-<br />

1994<br />

1994-<br />

1995<br />

1995-<br />

1996<br />

1996-<br />

1997<br />

1997-<br />

1998<br />

1998-<br />

1999<br />

Secretary<br />

Past-<br />

President Vice President<br />

General Member Member Member Member Member Member<br />

President<br />

(Ex Officio)<br />

M. Rowl<strong>and</strong> A. Grahnén D.D. Breimer B. Lindeke D. Duchêne A.F. Fell M. Veillard A.A. Hincal B. Clement O.J. Bjerrum<br />

D. Duchêne O.J. Bjerrum M. Rowl<strong>and</strong> B. Lindeke A. Grahnén R. Paoletti M. Veillard A A.Hincal B. Clement H. de Jong<br />

D. Duchêne O.J. Bjerrum M. Rowl<strong>and</strong> H. H. Lindén F. Bühler R. Paoletti M. Veillard A A.Hincal B. Clement H. de Jong<br />

1999-<br />

2000<br />

2000-<br />

2001<br />

2001-<br />

2002<br />

49<br />

Secretary<br />

Past-<br />

President President-Elect<br />

Treasurer General Member Member Member Member Member<br />

President<br />

(Ex Officio)<br />

D. Duchêne O.J. Bjerrum None C. Bogentoft H. H. Lindén R. Paoletti C.R. Noe A. Mrhar B. Clement A. Demirdere<br />

O.J. Bjerrum C.R. Noe D. Duchêne C. Bogentoft H. H. Lindén R. Paoletti T. Dingermann A. Mrhar C. Doherty A. Demirdere<br />

O.J. Bjerrum C.R. Noe D. Duchêne P. From H. H. Lindén R. Paoletti T. Dingermann H. Köszegi-Szalai C. Doherty D.J.A. Crommelin<br />

C.R. Noe D.J.A. Crommelin O.J. Bjerrum P. From H. H. Lindén R. Paoletti T. Dingermann H. Köszegi-Szalai C. Doherty P. Vuorela<br />

C.R. Noe D.J.A. Crommelin O.J. Bjerrum P. From H. H. Lindén B. Aksu T. Dingermann H. Köszegi-Szalai C. Doherty P. Vuorela<br />

D.J.A. Crommelin P. Vuorela C.R. Noe P. From H. H. Lindén B. Aksu U. Holzgrabe H. Köszegi-Szalai C. Doherty J.A. Guimarães Morais<br />

D.J.A. Crommelin P. Vuorela C.R. Noe S. Stegemann H. H. Lindén B. Aksu U. Holzgrabe Vacant C. Doherty J.A. Guimarães Morais<br />

C.G. Wilson A. Cuine D.J.A. Crommelin L. Dencker H. H. Lindén B. Aksu U. Holzgrabe R.S. Gaspar<br />

E-M.<br />

J. Murrey<br />

Muchitsch<br />

E-M.<br />

C.G. Wilson A. Cuine D.J.A. Crommelin L. Dencker H. H. Lindén B. Aksu U. Holzgrabe R.S. Gaspar<br />

Muchitsch<br />

M. Jadrijević-Mladar Takač<br />

2002-<br />

2003<br />

2003-<br />

2004<br />

2004-<br />

2005<br />

2005-<br />

2006<br />

2006-<br />

2007<br />

2007-<br />

2008<br />

2008-<br />

2009<br />

2009-<br />

2010<br />

2010-<br />

<strong>2011</strong>


Selection of articles<br />

from the <strong>EUFEPS</strong> NewsLetter since 1991<br />

<strong>EUFEPS</strong> First NewsLetter ...................................................................................................................... I<br />

The Inaugural Council Meeting in Strasbourg ....................................................................................... II<br />

1st European Congress of Pharmaceutical Sciences .......................................................................... III<br />

Dear Members, successful first <strong>EUFEPS</strong> Congress ............................................................................IV<br />

The Future of Pharmaceutical Sciences................................................................................................V<br />

European Journal of Pharmaceutical Sciences ....................................................................................VI<br />

<strong>EUFEPS</strong> – the Right Federation at the Right Time .............................................................................VII<br />

Research Training in the Pharmaceutical Sciences in Europe ...........................................................VIII<br />

<strong>EUFEPS</strong> Strategic Plan for 1994–1998.................................................................................................X<br />

On <strong>EUFEPS</strong> Progress ..........................................................................................................................XI<br />

Visions <strong>and</strong> Realisations – New President takes Stock .....................................................................XIII<br />

The Influence of Pharmaceutical Sciences on the International Harmonisation Activities ................. XV<br />

Biopharmaceutical Classification System (BCS) for Oral Immediate-release Drug Products .......... XVII<br />

Strategic events ................................................................................................................................. XIX<br />

<strong>EUFEPS</strong> forges links with FDA, EMEA <strong>and</strong> EU ................................................................................ XX<br />

<strong>EUFEPS</strong> Permanent Secretariat established .................................................................................... XXI<br />

New Safe Medicines Faster - A Proposal for a Key Action<br />

within the European Union’s 6th Framework Programme ................................................................ XXII<br />

Workshop Report - New Safe Medicines Faster .............................................................................XXIV<br />

Decennial Milestone ........................................................................................................................XXVI<br />

The European Federation for Pharmaceutical of Sciences - <strong>EUFEPS</strong> ..........................................XXVII<br />

<strong>EUFEPS</strong> 10th anniversary - European Federation for Pharmaceutical Sciences ............................XXX<br />

A need for Excellence in Pharmaceutical Sciences........................................................................XXXII<br />

‘Safety Sciences’ – a way out of the attrition dilemma ..................................................................XXXIII<br />

Pharmaceutical Sciences Fair ........................................................................................................XXXV<br />

<strong>EUFEPS</strong> Vision on Training <strong>and</strong> Education ...................................................................................XXXVI<br />

New Safe Medicines Faster Award 2003 .....................................................................................XXXVIII<br />

Pharmaceutical Research Community Contributions<br />

<strong>and</strong> Expectations in New European Union Countries....................................................................XXXIX<br />

Importance of Research Linked with the EMEA ...................................................................................XL<br />

Pharmaceutical Sciences: Towards a more Competitive Europe ......................................................XLII<br />

The First PharmSciFair – a Highly Successful Event ...................................................................... XLIV<br />

The Role of Learned Societies in Forming<br />

a European Technology Platform for Innovative Medicines ..............................................................XLVI<br />

The First BBBB Conference on Pharmaceutical Science,<br />

a successful start to a new drug research conference in East Europe ..........................................XLVIII<br />

New Safe Medicines Faster European Technology Platform/Strategic Research Agenda/<br />

Innovative Medicines for Europe EU Joint Technology Initiative ........................................................... L<br />

Public-Private Partnerships <strong>and</strong> ‘Le défi Americain’ revisited .............................................................. LII<br />

How to develop academic drug research in Europe ...........................................................................LIV<br />

15th <strong>Anniversary</strong> .................................................................................................................................LVI<br />

Pharmaceutical Science in Europe. Part 1: Analysis ..........................................................................LIX<br />

Pharmaceutical Science in Europe. Part 2: “Where to go” ................................................................LXII<br />

“Changing of the Guard” – <strong>EUFEPS</strong>’ New President <strong>and</strong> Past President Share Views .................. LXIV<br />

Birth of the <strong>EUFEPS</strong> BABP Network .............................................................................................. LXVII<br />

Innovative Medicines Initiative (IMI) kick-off .................................................................................. LXVIII<br />

<strong>EUFEPS</strong> Today ................................................................................................................................. LXX<br />

“Times are changing <strong>and</strong> we change with time”<br />

Reflections of the Past President <strong>and</strong> President at the turn of the year ........................................LXXIV<br />

2nd PharmSciFair - Premier European Platform for Advancing Pharmaceutical Sciences ...........LXXVI<br />

Update from the President............................................................................................................LXXVII<br />

3rd PharmSciFair.........................................................................................................................LXXVIII<br />

50


<strong>EUFEPS</strong> Newsletter, 1992, vol 1, issue 1<br />

<strong>EUFEPS</strong><br />

First Newsletter<br />

Ernst Mutschler, Professor<br />

President of The European Federation for Pharmaceutical Sciences<br />

Dear Members,<br />

With this first Newsletter, which will<br />

be followed by more on a regular basis<br />

(three per year), the <strong>EUFEPS</strong> Executive<br />

Committee would like to inform you of<br />

our present <strong>and</strong> future activities <strong>and</strong> also<br />

to ask you for your personal contributions.<br />

We would like you, whenever possible, to<br />

participate in the activities arranged by<br />

<strong>EUFEPS</strong>, to inform us about your own<br />

national organisation <strong>and</strong> its scientific<br />

activities, to give us your suggestions as<br />

well as your critical views, <strong>and</strong> to inform<br />

other pharmaceutical scientists of our<br />

organization <strong>and</strong> its goals. Only through<br />

initiative <strong>and</strong> active cooperation between<br />

the members can our federation develop<br />

successfully <strong>and</strong> become the desired link<br />

of international cooperation <strong>and</strong> scientific<br />

exchange between scientists.<br />

In this connection, I would like to<br />

cordially invite you to participate in the<br />

1st European Congress of Pharmaceutical<br />

Sciences, which takes place on October<br />

7–9, 1992 in Amsterdam. Our Dutch<br />

colleagues have enthusiastically put<br />

together an attractive program with<br />

prominent speakers, <strong>and</strong> we are sure that<br />

the participants will find the congress<br />

interesting <strong>and</strong> worth attending.<br />

Since the inaugural meeting in<br />

Strasbourg, the Executive Committee<br />

has taken a number of initiatives. The<br />

Committee on Industrial Relations was<br />

established <strong>and</strong> its first meeting was held<br />

in Brussels. We expect this Committee<br />

to generate an active exchange of ideas<br />

between the universities <strong>and</strong> the research<br />

based pharmaceutical industry.<br />

The establishment of the European<br />

Journal of Pharmaceutical Sciences –<br />

the scientific journal of the Federation<br />

– will be of special significance. Our<br />

Sc<strong>and</strong>inavian colleagues are in favour of<br />

merging the Acta Pharmaceutica Nordica<br />

with the new journal, which would create<br />

a good opportunity for a successful start<br />

for our journal.<br />

I<br />

The saying “The beginning is always<br />

difficult” is also valid for a new scientific<br />

organisation. But we have already made<br />

considerable progress <strong>and</strong> we are confident<br />

that the Federation will be successful.<br />

Hoping to see you in Amsterdam!<br />

Sincerely yours,<br />

Ernst Mutschler


<strong>EUFEPS</strong> Newsletter, 1992, vol. 1, issue 1<br />

The Inaugural<br />

Council Meeting<br />

in Strasbourg<br />

Stig Aurell, Professor<br />

<strong>EUFEPS</strong> Secretary-General<br />

The Inaugural Council Meeting of the<br />

Federation was held in Strasbourg on<br />

September 21, 1991. Representatives<br />

from 15 European member societies <strong>and</strong><br />

a number of observers <strong>and</strong> guests were<br />

present.<br />

Mr Björk, the President of the<br />

Parliamentary Assembly of the Council<br />

of Europe, opened the meeting. He<br />

underlined the importance of joint efforts<br />

by European countries to be able to<br />

develop <strong>and</strong> compete effectively in the<br />

future. He also emphasized the interest of<br />

the Council in maintaining contacts with<br />

the new Federation.<br />

The proposed statutes were discussed,<br />

revised <strong>and</strong> approved - the statutes will<br />

be included in the next Newsletter. After<br />

the formal constitution, an Executive<br />

committee was elected. Professors Ernst<br />

Mutschler as President, Douwe Breimer as<br />

Vice-President, Stig Agurell as Secretary-<br />

General, <strong>and</strong> Piero Sensi as Treasurer,<br />

<strong>and</strong> Professors Karoly Nikolics <strong>and</strong> Paul<br />

Rossignol (members).<br />

The task of the Federation is to<br />

advance research in the pharmaceutical<br />

sciences in Europe through cooperation<br />

between national, regional <strong>and</strong> other<br />

societies. This will include a European<br />

Congress of Pharmaceutical Sciences <strong>and</strong><br />

will contribute towards the recognition<br />

of pharmaceutical sciences <strong>and</strong> to public<br />

policy. To address these tasks it was<br />

decided to establish several committees.<br />

The Secretariat of the Federation will<br />

be located at <strong>and</strong> sponsored by the Swedish<br />

Academy of Pharmaceutical Sciences in<br />

Stockholm for the coming three years.<br />

II<br />

A. Björk, The President of the Parliament-<br />

ary Assembly of the European Council of<br />

Europe opening the Council meeting.<br />

The Executive Committee.<br />

From left; D. Breimer, E. Mutschler,<br />

S. Agurell, P. Sensi <strong>and</strong> P. Rossignol.


<strong>EUFEPS</strong> Newsletter, 1992, vol. 1, issue 1<br />

1 st European Congress of<br />

Pharmaceutical Sciences<br />

Amsterdam • October 7–9 • 1992<br />

Hans Junginger, Professor<br />

President of the Organizing Scientific Committee<br />

The first European Congress of<br />

Pharmaceutical Sciences organized<br />

by the Netherl<strong>and</strong>s Association of<br />

Pharma-ceutical Sciences will be held<br />

in Amsterdam on October 7–9. The<br />

program is finalized <strong>and</strong> also the technical<br />

arrangements with respect to the congress<br />

venue (the very modern <strong>and</strong> well equipped<br />

RAI Congress Center) are coming along<br />

fine.<br />

The definite program, registration<br />

forms, hotel reservation forms <strong>and</strong> call<br />

for papers (poster presentation) will be<br />

distributed by our member societies. The<br />

deadline for submission of abstracts is July<br />

1. The abstracts should be sent to: Prof. Or<br />

H. E Junginger, Gorlaeus Laboratories, PO<br />

Box 9502, NL 2300 RA Leiden, fax +31 71<br />

274277. The size of the poster boards are<br />

1 m high x 1.50 m wide. The registration<br />

fees are Dfl 500 for senior scientists <strong>and</strong><br />

Dfl 200 for junior ones before June 1, <strong>and</strong><br />

Dfl 550 <strong>and</strong> Dfl 250 respectively, until<br />

September 1. Onsite registration is Dfl<br />

650 for senior participants <strong>and</strong> Dfl 350 for<br />

students.<br />

If you do not receive a program, please<br />

contact the F.I.P Congress Department,<br />

Alex<strong>and</strong>erstraat 11, NL-2514 JL The<br />

Hague. Tel +31 70 3631925, fax +31 70<br />

3659047.<br />

You are all urged to publicize the<br />

congress as much as possible <strong>and</strong> make<br />

sure that interested persons receive<br />

information of the definite program.<br />

The congress starts with welcome<br />

cocktails on Tuesday, October 6 at 16.00-<br />

19.00 hrs in the Foyer of the Forum Zaal at<br />

the RAI Congress Center.<br />

You are cordially invited to attend!<br />

III


<strong>EUFEPS</strong> Newsletter, 1992, vol. 1, issue 2<br />

Dear Members,<br />

successful first<br />

<strong>EUFEPS</strong> Congress<br />

Hans Junginger, Professor<br />

President of the Organizing Scientific Committee<br />

Following the establishment in 1991 of the<br />

European Federation for Pharmaceutical<br />

Sciences, one of the first aims of the Society<br />

was to bring together pharmaceutical<br />

scientists <strong>and</strong> to organize a truly scientific<br />

congress in one of the member countries.<br />

The Dutch Association for<br />

Pharmaceutical Sciences is honoured to<br />

arrange the First European Congress of<br />

Pharmaceutical Sciences, to take place in<br />

Amsterdam at the RAI-Congress Center,<br />

during October 7–9, 1992.<br />

As chairman of the Scientific<br />

Committee, I am pleased to announce<br />

that we succeeded in attracting 39 leading<br />

scientists from primarily European<br />

countries, <strong>and</strong> covering all pharmaceutical<br />

disciplines, who will contribute to 12<br />

symposia <strong>and</strong> present the results of their<br />

latest research. Already two weeks before<br />

the deadline for submitting the abstracts<br />

for poster presentation, we had received<br />

more than 100 abstracts. This clearly<br />

indicates that the congress will, in fact,<br />

be an accepted meeting place of scientists<br />

from all over the world. I would therefore<br />

like to encourage you, too, to participate in<br />

the Congress.<br />

Amsterdam is <strong>today</strong> a modem<br />

metropolis which houses the dynamic<br />

RAI Amsterdam Convention Center.<br />

The Dutch capital has succeeded in<br />

combining its contemporary character<br />

with the unique historical atmosphere of<br />

the 17th century inner city <strong>and</strong> its famous<br />

system of canals. It is my sincere hope<br />

IV<br />

Hans Junginger, Professor<br />

that all those attending the First European<br />

Congress will be able to enjoy the exciting<br />

dualism of this city, blending the serious<br />

work of acquiring the latest information<br />

<strong>and</strong> research results from all branches<br />

of the pharmaceutical sciences with the<br />

delightful experience of being captured by<br />

the intimate allure of the streets, squares<br />

<strong>and</strong> canals of this fascinating place.<br />

What a superb environment in which<br />

to attend a very important Congress, to<br />

relax <strong>and</strong> to make new friends, <strong>and</strong> to<br />

experience the charm of Amsterdam!<br />

With best regards,


<strong>EUFEPS</strong> Newsletter, 1992, vol. 1, issue 3<br />

The Future of<br />

Pharmaceutical<br />

Sciences<br />

Douwe D. Breimer, Professor<br />

<strong>EUFEPS</strong> Vice-President<br />

Pharmaceutical sciences may traditionally<br />

be regarded as conglomerate of various<br />

disciplines, each of which deals with<br />

a certain aspect of biologically active<br />

molecules <strong>and</strong> each of which was<br />

considered essential for the training <strong>and</strong><br />

education of pharmacist. In fact such<br />

disciplines were defined as belonging to<br />

pharmaceutical sciences because they<br />

were undertaken in the context of a faculty<br />

of a college or pharmacy, although some<br />

flourished more in dependently in faculties<br />

of medicine (e.g. pharmacology) or natural<br />

sciences (e.g. biochemistry). Research<br />

was mostly of a monodisciplinary nature<br />

<strong>and</strong> strongest in fields like pharmaceutics<br />

<strong>and</strong> pharmaceutical technology,<br />

pharmaceutical chemistry, pharmacognosy<br />

<strong>and</strong> drug analysis. In the 60s <strong>and</strong> 70s,<br />

biopharmaceutics, pharmacokinetics <strong>and</strong><br />

drug metabolism began to flower <strong>and</strong><br />

the development of specific <strong>and</strong> sensitive<br />

analytical methodology made it possible for<br />

pharmaceutical sciences to become more<br />

involved in biological experimentation,<br />

including in vivo studies in laboratory<br />

animals <strong>and</strong> man. New fields of interest<br />

developed, borders flanking the biomedical<br />

sciences were crossed.<br />

However, despite the fact that these<br />

new areas of research have given a new<br />

impetus to pharmaceutical sciences <strong>and</strong><br />

have contributed to a better recognition<br />

of pharmaceutical research in general,<br />

the newer fields still tend to develop in a<br />

monodisciplinary way.<br />

The major challenges in<br />

pharmaceutical research <strong>today</strong> are not<br />

associated with one discipline only,<br />

but with several at the same time. This<br />

requires multidisciplinary approaches,<br />

as illustrated by a few examples, all of<br />

which constitute major objectives of drug<br />

research:<br />

• new drug molecule design based on<br />

cloned receptors <strong>and</strong> molecular<br />

graphics, in relation to mechanisms<br />

<strong>and</strong> origins of disease;<br />

• drug delivery system design, based<br />

on physicochemical principles, <strong>and</strong><br />

with rates <strong>and</strong> time specifications<br />

based on pharmacodynamic <strong>and</strong><br />

pharmacokinetic considerations;<br />

• drug targeting, primarily based on<br />

(patho) physiological, (patho)<br />

biochemical <strong>and</strong> ilmmunological<br />

principles <strong>and</strong> only secondarily on<br />

principles derived from pharmaceutical<br />

technology;<br />

• application of products originating<br />

from biotechnology (proteins <strong>and</strong> other<br />

macromolecules), by non-parenteral<br />

routes of administration based on the<br />

principles of membrane biochemistry<br />

<strong>and</strong> cell biology;<br />

• individualization <strong>and</strong>, thereby,<br />

optimization of drug therapy<br />

based on new methodologies in<br />

characterizing metabolizing enzyme<br />

activities (deficiencies) in vivo <strong>and</strong><br />

new methodologies in quantifying <strong>and</strong><br />

monitoring pharmacological effects;<br />

• assessment <strong>and</strong> prediction of drug<br />

(xenobiotic) toxicity <strong>and</strong> adverse<br />

reactions based on insight into<br />

(molecular) mechanisms of drug<br />

toxicity, e.g. as related to drug<br />

metabolism.<br />

All these subjects require integrated<br />

approaches, both at the molecular level<br />

<strong>and</strong> at the higher organizational levels of<br />

living organisms, with the ultimate goal<br />

of unifying all information towards the<br />

in vivo human situation. Such approaches<br />

are all at the interface between chemical/<br />

physical <strong>and</strong> biological/biomedical<br />

sciences. It is this unifying <strong>and</strong><br />

V<br />

Douwe D. Breimer, Professor<br />

integrating concept that holds the future<br />

of pharmaceutical sciences. Whenever<br />

monodisciplinary considerations continue<br />

to prevail, the risk of disintegration is<br />

near at h<strong>and</strong>. The synergistic additional<br />

value of being part of a conglomerate of<br />

interacting disciplines should be utilized<br />

<strong>and</strong> fully explored. This will give rise<br />

to most important implications for drug<br />

discovery, drug delivery, <strong>and</strong> improved<br />

<strong>and</strong> more rational drug therapy.<br />

It is in this spirit that <strong>EUFEPS</strong><br />

will organize its biannual European<br />

Congresses of Pharmaceutical Sciences,<br />

as was illustrated just recently by the first<br />

Congress in Amsterdam.


<strong>EUFEPS</strong> Newsletter, 1993, vol. 2, issue 1<br />

European Journal<br />

of Pharmaceutical<br />

Sciences<br />

Ernst Mutschler, Professor<br />

<strong>EUFEPS</strong> President<br />

At the time of the foundation of the<br />

European Federation for Pharmaceutical<br />

Sciences (<strong>EUFEPS</strong>) in Strasbourg in<br />

1991, its Executive Committee <strong>and</strong><br />

Council considered the creation of an<br />

internationally well-accepted journal of<br />

high scientific st<strong>and</strong>ing to be one of the<br />

Federation’s most important goals. The<br />

first issue of the European Journal of<br />

Pharmaceutical Sciences, which appeared<br />

in March 1993, illustrates that the initial<br />

step toward achieving this objective has<br />

been taken. What, then is the intention<br />

of such a new journal? Certainly it is<br />

not just to publish yet another journal in<br />

addition to the already existing journals,<br />

but rather the ideal of providing a<br />

European platform for the publication of<br />

exciting <strong>and</strong> outst<strong>and</strong>ing pharmaceutical<br />

scientific results <strong>and</strong> to facilitate <strong>and</strong><br />

exchange information between European<br />

pharmaceutical scientists with colleagues<br />

elsewhere in the world. We would like<br />

to express our sincere gratitude to our<br />

colleagues, Prof. Dr. H.E. Junginger <strong>and</strong><br />

Prof. Dr. G.J. Mulder in Leiden for their<br />

willingness to serve as Editors in chief<br />

of the journal. The same applies to all the<br />

members of the editorial board.<br />

Without a doubt, 1993 will be a year in<br />

VI<br />

Ernst Mutschler, Professor<br />

which the European community will move<br />

more closely together. Hopefully, this will<br />

also hold true for its scientific community<br />

<strong>and</strong> the first issue of the European Journal<br />

of Pharmaceutical Sciences reflects this<br />

development. The journal will also serve<br />

to underline the Federation’s main aim,<br />

which is to strengthen the pharmaceutical<br />

sciences in Europe, to support innovative<br />

drug research <strong>and</strong> to promote advanced<br />

pan-European pharmaceutical education.


<strong>EUFEPS</strong> Newsletter, 1993, vol. 2, issue 3<br />

<strong>EUFEPS</strong><br />

– the Right Federation<br />

at the Right Time<br />

Ernst Mutschler, Professor<br />

<strong>EUFEPS</strong> President<br />

Two years ago - in September 1991 - the<br />

European Federation for Pharmaceutical<br />

Sciences was founded. A number of<br />

questions now need to be answered.<br />

What, from the aims laid down in the<br />

statutes, has been achieved during this<br />

time? What is left to do? Where are the<br />

problems <strong>and</strong> what is the current status<br />

of the Federation? Which developments<br />

can be expected in the future?<br />

More member associations have joined,<br />

so <strong>EUFEPS</strong> now has 20 member societies<br />

with altogether more than 16.000<br />

members. In addition, 15 pharmaceutical<br />

companies have joined <strong>EUFEPS</strong> as<br />

supportive members despite the severe<br />

difficulties European companies have met<br />

during the year.<br />

The First European Congress of<br />

Pharmaceutical Sciences took place in<br />

Amsterdam in October 1992, organized<br />

by the Netherl<strong>and</strong>s Association of<br />

Pharmaceutical Sciences, undoubtedly a<br />

good start for <strong>EUFEPS</strong>. -- At the end of<br />

September 1994, the Second European<br />

Congress will take place in Berlin,<br />

organized by the German Pharmaceutical<br />

Society. The scientific program for this<br />

is almost finalized. Apart from the main<br />

programme, joint symposia on topics<br />

of great interest will be held including<br />

subjects such as Alzheimer’s disease <strong>and</strong><br />

on alternatives to experiments on animals.<br />

From this congress we expect another step<br />

forward <strong>and</strong> even stronger ties to be forged<br />

between the family of pharmaceutical<br />

scientists.<br />

Further scientific meetings on specific<br />

topics are in preparation such as “Proper<br />

Use of Experimental Animals” <strong>and</strong><br />

“Tumor Targeting”.<br />

After intensive discussions <strong>and</strong><br />

negotiations with Elsevier, the introduction<br />

of the European Journal of Pharmaceutical<br />

Sciences, <strong>and</strong> thus one main aim of<br />

<strong>EUFEPS</strong>, was achieved. With Prof.<br />

Junginger <strong>and</strong> Prof. Mulder as editors-inchief<br />

the first issue was published in March<br />

this year. Particularly important was the<br />

decision to set an annual subscription fee<br />

of Dfl. 100 for individual members which<br />

is very cheap. In this context it ought to<br />

be mentioned that the introduction of the<br />

Journal was only made possible by the fact<br />

that both Swedish, Norwegian, Danish<br />

<strong>and</strong> Finnish colleagues ceased publication<br />

of their own national journals: this shows<br />

true European spirit! We hope that the new<br />

Journal will have a good future <strong>and</strong> we<br />

would like to see innovative contributions<br />

from as many different countries as<br />

possible in order to ensure that our Journal<br />

becomes the product we envisaged.<br />

The <strong>EUFEPS</strong> Newsletter, published<br />

three times a year, has become an<br />

important voice for the Federation. In<br />

addition to the Committee on Congresses<br />

<strong>and</strong> Symposia <strong>and</strong> the Committee on<br />

Indus trial Relations, the Committee on<br />

Pharmaceutical Policies was created<br />

with renowned members of regulatory<br />

bodies as well as universities with Prof.<br />

Henning Blume (Germany) as chairman.<br />

The main objectives of this Committee<br />

are to set up regular contacts with<br />

authorities in the EC member states <strong>and</strong><br />

to contribute to the current international<br />

harmonization processes. Contacts with<br />

other internationally operating scientific<br />

organizations like AAPS, the EFMC,<br />

Eurotox <strong>and</strong> ISSX were also established.<br />

An organization like <strong>EUFEPS</strong><br />

cannot exist without financial resources.<br />

Since we deliberately kept the fees for<br />

the member societies at a very low level,<br />

projects conducted by <strong>EUFEPS</strong> are not<br />

possible without additional financial<br />

VII<br />

Ernst Mutschler, Professor<br />

contributions. The main burden of this<br />

is carried by the Swedish Academy of<br />

Pharmaceutical Sciences, which places<br />

50.000 DEM at <strong>EUFEPS</strong>’ disposal each<br />

year <strong>and</strong> takes care of the administration<br />

of the Federation. Without the dedicated<br />

work of Stig Agurell, Bjorn Lindeke,<br />

Ingegerd Kalles <strong>and</strong> Anita Ljung, an<br />

active <strong>EUFEPS</strong> would simply not exist!<br />

At present, our main problem is that<br />

the exchange of information between the<br />

member societies of the Federation <strong>and</strong><br />

their input in general is not as great as we<br />

had expected. However, this is rather the<br />

rule than the exception for international<br />

organizations. We will relentlessly pursue<br />

our efforts to encourage members to<br />

participate in the activities of <strong>EUFEPS</strong> to a<br />

greater extent. It also seems important that<br />

<strong>EUFEPS</strong> participates in the discussions<br />

surrounding the harmonization of<br />

pharmaceutical curriculum in the<br />

different European countries, a difficult<br />

<strong>and</strong> momentous task.<br />

Two years of <strong>EUFEPS</strong>! On the<br />

whole, the slogan “<strong>EUFEPS</strong> - The Right<br />

Federation at The Right Time” seems to be<br />

justified. Nothing is perfect, this certainly<br />

holds true for <strong>EUFEPS</strong> as well. But the<br />

first two years were positive. Due to the<br />

economic recession, political changes <strong>and</strong><br />

the curb on expenditure of state controlled<br />

health services, drug research was<br />

hampered <strong>and</strong> the pharmaceutical sciences<br />

are facing tougher times than ever before.<br />

It is now more important than ever that the<br />

importance of drug research for the well<br />

being of public health st<strong>and</strong>ards is made<br />

clear, both on a national <strong>and</strong> international<br />

level. By concentrating resources <strong>and</strong><br />

intensively perusing this goal further<br />

improvement can be achieved.


<strong>EUFEPS</strong> Newsletter, 1994, vol. 3, issue 2<br />

Research Training<br />

in the Pharmaceutical<br />

Sciences in Europe<br />

Douwe D. Breimer, Professor<br />

<strong>EUFEPS</strong> Vice-President <strong>and</strong> Director of Research of the Leiden-Amsterdam, Center<br />

for Drug Research<br />

In the previous issue of This Newsletter,<br />

Prof. Stig Agurell, <strong>EUFEPS</strong>’ General<br />

Secretary, re viewed the major problems<br />

<strong>and</strong> challenges that the pharmaceutical<br />

industry is currently facing worldwide.<br />

Cost containment <strong>and</strong> foreseeable reduced<br />

return on investments is affecting the<br />

industry severely <strong>and</strong> reorganizations are<br />

being implemented in many companies,<br />

also in Europe. Yet, the future of this<br />

industry will remain highly dependent on<br />

its innovative capabilities <strong>and</strong>, therefore,<br />

very much on its cur rent <strong>and</strong> future<br />

“human capital”, i.e. on highly competent<br />

<strong>and</strong> creative scientists. Hence the quality of<br />

undergraduate <strong>and</strong> graduate training in the<br />

pharmaceutical sciences, <strong>and</strong> in particular<br />

with respect to the development of research<br />

skills, is a most relevant topic to consider.<br />

Before doing that more specifically, I<br />

would like to emphasize three issues for<br />

background consideration.<br />

1. For Europe, the pharmaceutical<br />

industry is the high-tech sector par<br />

excellence.<br />

In most, if not all, European countries most<br />

economic growth must originate from<br />

new products <strong>and</strong> services. These must be<br />

innovative in order to be competitive <strong>and</strong><br />

therefore the combination of high quality<br />

fundamental, strategic <strong>and</strong> applied research<br />

will have to be a major driving force for the<br />

future economy of Europe. In this respect,<br />

the pharmaceutical industry will remain a<br />

most important sector, because it still has<br />

a relatively strong current position, it is<br />

strongly R&D oriented (it is the “highesttech”<br />

sector of all industries in terms of<br />

R&D expense in % of cash flow), it adds<br />

very high value to its products <strong>and</strong> it is<br />

relatively clean from an environmental<br />

perspective. These properties should<br />

make for Europe; our politicians should<br />

realize this <strong>and</strong> therefore stimulate rather<br />

than discourage further investments in<br />

this field of industrial activity.<br />

2. The opportunities for<br />

pharmaceutical scientists to<br />

discover <strong>and</strong> develop new<br />

medicines have never been greater.<br />

This is a free translation from the Guest-<br />

Editorial that Dr P.J. Brown (the Editor of<br />

SCRIP) wrote in the <strong>EUFEPS</strong> Newsletter<br />

in 1993. His observation is related to<br />

the enormous impact that progress in<br />

molecular biology <strong>and</strong> biotechnology<br />

has had on the identification of new<br />

therapeutic targets <strong>and</strong> the design <strong>and</strong><br />

production of novel molecules. He adds,<br />

however, that the real challenge is to<br />

discover new products which also provide<br />

cost-benefit for the patient <strong>and</strong> the payer,<br />

i.e. if, for example, a novel high-priced<br />

biotech product does not deliver superior<br />

treatment to a (generic) alternative, it will<br />

not find a place in to day’s sensitive health<br />

care market place. The current turmoil in<br />

the industry is a partial reflection of this<br />

tension between the supply of (novel)<br />

medicines <strong>and</strong> what society is willing<br />

to pay for them. To overcome this, a<br />

reorientation to wards research objectives<br />

<strong>and</strong> areas of therapeutic priority is needed.<br />

In addition it is necessary that the drug<br />

development process becomes more<br />

efficient <strong>and</strong> more effective, i.e. innovative<br />

strategies are needed to bring a new drug<br />

product to the market at lower cost <strong>and</strong> in<br />

a shorter time.<br />

3. The turnover of science is<br />

considerably higher than the<br />

turnover of scientists.<br />

This is true for almost any field of natural<br />

science <strong>and</strong> implies that in order to keep up<br />

to date <strong>and</strong> even be at the forefront all the<br />

VIII<br />

Douwe D. Breimer, Professor<br />

time, high investments in human capital<br />

are constantly needed. For companies,<br />

this may not be feasible financially, except<br />

if a very high degree of specialization is<br />

pursued in a very limited therapeutic<br />

area. Therefore Dr J. Drews (R&D<br />

President of Hoffmann-La Roche) has<br />

suggested in a paper in PhaQ11. Tech. Int.<br />

in 1990 that more often than in the past,<br />

manufacturers have to look for partners<br />

who can offer skills <strong>and</strong> results which are<br />

complementary to their own. Only the<br />

formation of functional links with other<br />

groups can produce the broad scope of<br />

scientific opportunities that is needed<br />

to obtain a sufficiently large number of<br />

intelligent options for the development<br />

of novel drugs. Hence, the integration<br />

of research groups into networks of<br />

international scientific cooperation should<br />

be pursued between different industries<br />

<strong>and</strong> also with high quality university<br />

groups. This is a call for multidisciplinary<br />

approaches <strong>and</strong> strategic alliances between<br />

various institutes. And this is indeed what<br />

is currently happening on a large scale, as<br />

may be read in SCRIP.<br />

The three issues discussed should have<br />

a major impact on the research training<br />

of pharmaceutical scientists in Europe,<br />

which is a primary responsibility of our<br />

universities. In order to remain highly<br />

innovative, the pharmaceutical industry<br />

must be able to recruit sufficient numbers<br />

of excellent young scientists. These should<br />

include highly specialized persons in<br />

some of the basic sciences (molecular<br />

biologists, immunologists, geneticists etc),<br />

<strong>and</strong> also those that have a basic training<br />

in all aspects <strong>and</strong> disciplines relevant<br />

for drug discovery <strong>and</strong> development<br />

(pharmaceutical scientists). They should<br />

already be confronted with <strong>and</strong> engaged<br />

in one or two experimental research


subjects during their under graduate<br />

training in order that motivation <strong>and</strong><br />

suitability for a research career (Ph.D.<br />

training) can be evaluated at the time<br />

of graduation. Preferably such training<br />

should be undertaken in a high quality<br />

<strong>and</strong> stimulating re search environment <strong>and</strong><br />

include a training period abroad, either<br />

at another university or in an industrial<br />

research institute. Internationalization,<br />

mobility, flexibility, interdisciplinarity in<br />

basic research competence are key words<br />

in this respect. Subsequent graduate studies<br />

<strong>and</strong> research should be undertaken by the<br />

best qualified students <strong>and</strong> should lead to<br />

independent <strong>and</strong> creative researchers at the<br />

time of obtaining this Doctor’s degree. In<br />

the Newsletter of the Academia Europaea<br />

(November 1993) it is outlined by the<br />

Swedish Minister for Education <strong>and</strong> Science<br />

that this country will invest heavily during<br />

the coming years in education <strong>and</strong> research<br />

in an international context <strong>and</strong> that the<br />

number of doctoral exams in Sweden will<br />

have to be doubled by the year 2000. This<br />

is surely also in the interest of the (Swedish)<br />

pharmaceutical industry <strong>and</strong> should serve<br />

as an excellent example for other European<br />

countries to follow.<br />

An important question is to what<br />

extent our universities, <strong>and</strong> in particular its<br />

faculties of pharmacy <strong>and</strong> pharmaceutical<br />

sciences in Europe, are willing <strong>and</strong><br />

capable of accommodating the future<br />

needs of innovation in drug research<br />

<strong>and</strong> development. There is, in my view,<br />

no doubt that the overall willingness is<br />

there, but that there are in many places<br />

also major obstacles to engage in high<br />

quality re search <strong>and</strong> therefore also in<br />

the research training of excellent young<br />

pharmaceutical scientists. These obstacles<br />

include the fact that in most faculties or<br />

institutes the orientation centres primarily<br />

on the training of pharmacists rather than<br />

pharmaceutical scientists. In only a few<br />

countries are undergraduate programmes<br />

offered which may also effectively lead<br />

to a research career as described above.<br />

Furthermore, in many instances pharmacy<br />

programmes are heavily taught rather<br />

than research oriented; this is partially<br />

caused by large numbers of students<br />

<strong>and</strong>/or by lack of resources for research<br />

with no competitive basis for successful<br />

application for external grants. Also<br />

the organizational structure in terms of<br />

monodisciplinarity is an inhibiting factor<br />

in developing cross-disciplinary re search<br />

programmes, as is the lack of participation<br />

in international research networks.<br />

In order to improve this current<br />

unsatisfactory situation it is necessary<br />

to remind our selves of some of the<br />

conditions which are required to perform<br />

high quality research. A major issue<br />

in this respect is the development <strong>and</strong><br />

implementation of an effective research<br />

strategy which should exhibit most of the<br />

following characteristics:<br />

• the establishment <strong>and</strong> creation of a<br />

stimulating <strong>and</strong> creative environment<br />

through building research around<br />

excellent <strong>and</strong> motivated scientists;<br />

• the ab<strong>and</strong>onment of hierarchical<br />

levels, i.e. much autonomy for<br />

individual scientists;<br />

• appreciation of individual scientist’s<br />

initiatives (self expression), within the<br />

con text of the overall research mission<br />

of an institute or a faculty;<br />

• encouragement of working in<br />

multidisciplinary teams;<br />

• emphasis on research output through<br />

publications in first class peer reviewed<br />

international journals <strong>and</strong> through<br />

patent applications;<br />

• effective decision making on research<br />

orientation, budget allocation <strong>and</strong><br />

incentives.<br />

Once this research strategy is agreed<br />

upon, an effective organizational structure<br />

will be required for its implementation. In<br />

this respect, an important development<br />

in Europe is the creation of so-called<br />

“research schools”. These are defined as<br />

university based re search institutes of<br />

international st<strong>and</strong>ing which provide the<br />

structural environment for high quality<br />

research training. The reasons for the<br />

establishment of such “schools” are:<br />

• improved quality of research training<br />

in a multidisciplinary environment<br />

(combined undergraduate <strong>and</strong> graduate<br />

research programmes with great<br />

emphasis on highly qualified Ph.D.’ s;<br />

• enhanced efficiency of the use of<br />

research resources;<br />

• matching human resources for research<br />

to science policy priorities, i.e. taking<br />

serious account of the research needs in<br />

the public sector (e.g. the pharma-<br />

ceutical industry);<br />

• enhancement of international<br />

collaboration <strong>and</strong> exchange of staff <strong>and</strong><br />

students.<br />

Such research schools may have a “local”<br />

character, i.e. be established within a single<br />

IX<br />

university that contains all necessary<br />

disciplines. More often, however, it will<br />

have a “network” character with several<br />

departments of different universities <strong>and</strong><br />

complementary expertise collaborating.<br />

In my own country, the government is<br />

strongly stimulating the establishment of<br />

re search schools. The Royal Netherl<strong>and</strong>s<br />

Academy of Arts <strong>and</strong> Sciences has<br />

been given the responsibility to review<br />

applications for such· a recognition. High<br />

quality research <strong>and</strong> graduate teaching,<br />

as well as an organizational structure as<br />

outlined above, belong to the most important<br />

recognition criteria with preferably<br />

more than one university participating<br />

in a school. Two such schools have been<br />

established for the pharmaceutical sciences:<br />

in 1992, the Leiden-Amsterdam Center for<br />

Drug Research (LACDR), comprising the<br />

Center for Bio-Pharmaceutical Sciences at<br />

Leiden University <strong>and</strong> the Department of<br />

Pharmacochemistry of the Yrije Universiteit<br />

in Amsterdam <strong>and</strong> in 1994 the Groningen-<br />

Utrecht Institute for Drug Exploration<br />

(GUI DE), that consists of the faculties of<br />

pharmacy of the University of Groningen<br />

<strong>and</strong> that of Utrecht. LACDR is further<br />

Europeanized in ULLA, a consortium<br />

for postgraduate research training in the<br />

pharmaceutical sciences together with<br />

the Faculties of Pharmacy in Uppsala <strong>and</strong><br />

London. There is currently a committee of<br />

EU Member States investigating the need<br />

for similar developments in other European<br />

countries. For the pharmaceutical sciences<br />

<strong>and</strong> the training of pharmaceutical<br />

scientists, this should represent an important<br />

development towards meeting the needs of<br />

the pharmaceutical industry in Europe in<br />

the future.<br />

One could think of different<br />

organizational models to accommodate<br />

this, but most of the basic elements<br />

indicated in this Editorial should be<br />

implemented in order to make such an<br />

organization successful.<br />

Most likely, new organizational<br />

structures are needed for the<br />

pharmaceutical sciences in Europe in<br />

order to improve the quality of research<br />

training. Such structures could still<br />

be closely associated with Faculties of<br />

Pharmacy, but their mission should be<br />

clearly differentiated from the training of<br />

pharmacists <strong>and</strong> focus on pharmaceutical<br />

sciences. In my view, this is a prerequisite<br />

guaranteeing that the three issues as<br />

discussed are fully met <strong>and</strong> appreciated<br />

through university industry partnerships.


<strong>EUFEPS</strong> Newsletter, 1994, vol. 3, issue 3<br />

<strong>EUFEPS</strong> Strategic<br />

Plan for 1994–1998<br />

Douwe D. Breimer, Professor<br />

<strong>EUFEPS</strong> President<br />

On the occasion of the Congress the<br />

<strong>EUFEPS</strong> Council met <strong>and</strong> one of the major<br />

items on the agenda was the Strategic Plan<br />

for 1994 –1998 prepared by the Executive<br />

Committee. With some amendments, the<br />

Plan was approved <strong>and</strong> in this Editorial<br />

some of its main features are summarised.<br />

Mission of <strong>EUFEPS</strong><br />

The mission of the European Federation<br />

for Pharmaceutical Sciences (<strong>EUFEPS</strong>) is<br />

to support <strong>and</strong> advance the pharmaceutical<br />

sciences <strong>and</strong> innovative drug resarch in<br />

Europe <strong>and</strong> to represent scientific interests<br />

<strong>and</strong> scientists within academia, industry<br />

<strong>and</strong> government <strong>and</strong> other private <strong>and</strong><br />

public institutions engaged in drug<br />

research <strong>and</strong> development, drug regulation<br />

<strong>and</strong> drug policy making.<br />

Short-term overall Objectives<br />

a To seek coherence of the pharmaceutical<br />

sciences in Europe by<br />

promoting co -operation between<br />

national, regional <strong>and</strong> European<br />

societies or associations which aim to<br />

advance pharmaceutical sciences with<br />

<strong>EUFEPS</strong> recognised as the leading <strong>and</strong><br />

coordinating organisation.<br />

b To promote cooperation with<br />

other European <strong>and</strong> international<br />

pharmaceutical organizations <strong>and</strong><br />

federations with <strong>EUFEPS</strong> recognised<br />

as an “equal merit” organisation.<br />

c To provide individual pharmaceutical<br />

scientists in Europe with a platform<br />

to exchange information <strong>and</strong> to meet<br />

<strong>and</strong> support their individual scientific<br />

interests in the multi-disciplinary<br />

environment of drug research <strong>and</strong><br />

related activities.<br />

d To make the European Journal of<br />

Pharmaceutical Sciences the leading<br />

European journal on the subject.<br />

e To enhance the recognition of the<br />

pharmaceutical sciences <strong>and</strong> to<br />

contribute appropriately to public<br />

policy relevant to drug research <strong>and</strong><br />

development, drug regulation <strong>and</strong> drug<br />

utilisation, with <strong>EUFEPS</strong> as the<br />

primary voicing organisation at the<br />

European level.<br />

Intermediate to long-term<br />

Objectives <strong>and</strong> Visions<br />

a Assuming that the short-term<br />

objectives of <strong>EUFEPS</strong> will be met<br />

<strong>and</strong> recognising that research in the<br />

pharmaceutical sciences will further<br />

internationalise <strong>and</strong> that further<br />

integration of several relevant issues<br />

related to drug research <strong>and</strong><br />

development, drug regulation <strong>and</strong><br />

utilisation will take place at the<br />

European level, it is envisaged that<br />

<strong>EUFEPS</strong> will become the premier<br />

organisation for the advancement<br />

of pharmaceutical sciences <strong>and</strong> of<br />

pharmaceutical scientists in Europe.<br />

b <strong>EUFEPS</strong> will be a recognised authority<br />

<strong>and</strong> collective resource on pharma-<br />

ceutical science issues <strong>and</strong> will play a<br />

proactive role in public issues affecting<br />

drug re search <strong>and</strong> development, drug<br />

regulation <strong>and</strong> utilisation. <strong>EUFEPS</strong><br />

will have a primary focus on<br />

advancement in science <strong>and</strong> the<br />

contribution of such to benefit/risk<br />

considerations of drug therapy for<br />

society as a whole.<br />

c <strong>EUFEPS</strong> will be international in scope<br />

<strong>and</strong> have strong links (affiliations)<br />

with likewise minded scientific<br />

societies worldwide. It will play a<br />

leading role in organising joint<br />

meetings with closely allied<br />

associations in Europe <strong>and</strong> elsewhere<br />

through its own offices.<br />

X<br />

In direct connection with these objectives,<br />

the following topics (among others) have<br />

been agreed for priority decision making<br />

<strong>and</strong> actions:<br />

1 Further develop <strong>and</strong> professionalise the<br />

<strong>EUFEPS</strong> Secretariat, ultimately<br />

leading to the appointment of a paid<br />

(initially part time) Executive Director.<br />

Since the establishment of <strong>EUFEPS</strong>,<br />

all secretarial activities have been<br />

undertaken through the Swedish<br />

Academy of Pharmaceutical Sciences<br />

in Stockholm. Prof. Stig Agurell<br />

was the <strong>EUFEPS</strong> Secretary-General<br />

from 1990–1994, <strong>and</strong> Prof. Bjorn<br />

Lindeke was newly elected in this<br />

office. Strengthening of the financial<br />

basis of <strong>EUFEPS</strong> will, in particular,<br />

be a condition to make the entire<br />

organization, <strong>and</strong> the Secretariate,<br />

more self-sufficient.<br />

2 Active membership recruitment should<br />

be pursued with respect to member<br />

organizations (several countries are<br />

still note represented) <strong>and</strong> supportive<br />

members (only a limited number of<br />

pharmaceutical companies currently<br />

fulfil this category). In addition, the<br />

Council has accepted the proposal<br />

to make membership of <strong>EUFEPS</strong> of<br />

individual persons also possible, on the<br />

condition that a recruitment strategy<br />

be developed in close consultation<br />

with the member organisation(s) in a<br />

particular country.<br />

3 Two <strong>EUFEPS</strong> Committees will<br />

propose <strong>and</strong> develop activities to<br />

strengthen the recognition <strong>and</strong> position<br />

of the Federation, i.e. the Committee<br />

on Industrial Relations, <strong>and</strong> the<br />

Committee on Pharmaceutical Policies.<br />

There was clearly a very positive spirit<br />

towards these actions to further develop<br />

<strong>and</strong> strengthen <strong>EUFEPS</strong>’ position. The<br />

newly elected Executive Committee<br />

intends to become very active in<br />

implementing the Strategic Plan within<br />

the time frame indicated.


<strong>EUFEPS</strong> Newsletter, 1995, vol. 4, issue 3<br />

On <strong>EUFEPS</strong> Progress<br />

Douwe D. Breimer, Professor<br />

<strong>EUFEPS</strong> President<br />

It is important that <strong>EUFEPS</strong>’<br />

membership be kept up-to-date as to<br />

what progress the Federation is making.<br />

In 1994 at the Council meeting in<br />

Berlin, the <strong>EUFEPS</strong> Strategic Plan for<br />

1994–1998 was adopted in which clear<br />

short-term <strong>and</strong> intermediate to longterm<br />

objectives were defined, as well as<br />

priority activities to reach these. In the<br />

November 1994 issue of our Newsletter,<br />

a summary of this Strategic Plan was<br />

provided. In this President’s Report I will<br />

briefly cover topics that have been high<br />

on the Agenda of the <strong>EUFEPS</strong> Executive<br />

Committee <strong>and</strong> which also reflect items<br />

discussed at the latest <strong>EUFEPS</strong> Council<br />

meeting held in Leuven, September 16,<br />

1995.<br />

Membership<br />

At this moment 22 organisations<br />

originating from 19 countries are members<br />

of <strong>EUFEPS</strong>. The latest application was<br />

accepted in Leuven, from the “Societe<br />

Française des Sciences et Techniques<br />

Pharmaceutiques (SFSTP)” in Paris,<br />

whereas an applica tion by a Spanish<br />

organisation is pending. Recruit ment of<br />

corporate members is an ongoing process<br />

<strong>and</strong> there are now 16 in this category. The<br />

pharma ceutical industry is going through<br />

a tremendous pro cess of reorganisaiton<br />

<strong>and</strong> it is quite difficult to draw their<br />

attention to scientific organisations at this<br />

time. Personal contacts within the industry<br />

are extremely valuable to convince<br />

company executives of the importance of<br />

organisations like <strong>EUFEPS</strong>. During the<br />

summer of 1995 a first effort was made<br />

to recruit individual members, a new<br />

membership category approved of by the<br />

Council in 1994. At the time this report is<br />

being written, I am pleased to report that<br />

nearly 100 persons have joined <strong>EUFEPS</strong><br />

as individual members. As soon as their<br />

number exceeds 100 a representative of<br />

this membership category will be elected<br />

for representation on the <strong>EUFEPS</strong> Council.<br />

Several individual members are located<br />

outside Europe <strong>and</strong> it is mostly through<br />

personal contacts with the members of<br />

the Executive Committee of <strong>EUFEPS</strong><br />

that they have become convinced that<br />

it is important to support our young <strong>and</strong><br />

ambitious European organisation.<br />

Meetings<br />

“It is important to meet” was the Editorial<br />

title that Malcolm Rowl<strong>and</strong> (Vice-<br />

President of <strong>EUFEPS</strong>) wrote in the March<br />

1995 issue of this Newsletter. I will not<br />

repeat all of what he emphasised, except to<br />

again stress that an essential mechanism<br />

of achieving <strong>EUFEPS</strong>’ objectives is<br />

through the organisation <strong>and</strong> sponsorship<br />

of meetings. Strong commitment from our<br />

members is needed to make such meetings<br />

a suc cess. We are now leading up to the<br />

3rd European Congress of Pharmaceutical<br />

Sciences in Edin burgh (September 15–17,<br />

1996), <strong>and</strong> from the 2nd Announcement,<br />

it can be derived that the programme<br />

committee has put together symposia<br />

on topics that are of high current interest<br />

<strong>and</strong> relevance in the pharmaceutical<br />

sciences. Very near is the 2nd EU FEPS<br />

Nuremberg Conference (December 8–9,<br />

1995) on “Quality <strong>and</strong> Interchangeability<br />

of Topical Products for Local Action”. It<br />

is our intention to organise a conference<br />

each year at the beginning of December<br />

in Nurem berg on a highly specialised<br />

topic that should be of great interest to the<br />

pharmaceutical industry as well.<br />

<strong>EUFEPS</strong> was very recently given<br />

high recognition at the First Central<br />

European Symposium on Pharma ceutical<br />

Technology, held in Bled, Slovenia.<br />

XI<br />

I was there to represent the Federation <strong>and</strong><br />

to stress that <strong>EUFEPS</strong> is very interested to<br />

be associated with such regional initiatives<br />

<strong>and</strong> activities.<br />

In his Editorial, Malcolm Rowl<strong>and</strong><br />

has also indicated that <strong>EUFEPS</strong> is<br />

actively seeking links with other related<br />

European <strong>and</strong> inter national scientific<br />

organisations. This had led to definitive<br />

plans for meetings jointly orga nised with<br />

EUROTOX <strong>and</strong> ISSX in 1997. BIO-<br />

International ‘96, organised by FIP <strong>and</strong><br />

co-sponsored by <strong>EUFEPS</strong> <strong>and</strong> others will<br />

take place in Tokyo, Japan, in April 1996.<br />

Discussions are ongoing with the<br />

American Association of Pharmaceutical<br />

Scientists (AAPS) to see what collaboration<br />

with them is possible in terms of meeting<br />

<strong>and</strong> course or ganisation, as well as other<br />

activities. I will represent <strong>EUFEPS</strong> at the<br />

meeting of the AAPS Executive Council in<br />

Miami during their Annual Meeting. On<br />

this occasion further discussions will also<br />

take place with FIP, AAPS <strong>and</strong> Japanese<br />

representative on the feasibility of jointly<br />

organising the First Millennial World<br />

Congress of Pharmaceutical Sciences in<br />

the year 2000.<br />

Executive Committee’s strong belief<br />

that it is in the interest of it membership<br />

to build up strong links with other<br />

organisations in order to join forces rather<br />

than duplicate activities <strong>and</strong> meeting.<br />

<strong>EUFEPS</strong> Working Committees<br />

Two working committees have been<br />

put into place, primarily to advise the<br />

Executive Committee on specific issues<br />

<strong>and</strong> activities. One is the Committee<br />

on Industrial Relations (CIR), chaired<br />

by Prof. J. Vessman, Astra Hässle,<br />

Mölndal, Sweden, <strong>and</strong> the other one is the<br />

Committee on Pharmaceutical Policies<br />

(CPP), chaired by Professor H. Blume,


Frankfurt. CIR consists of a core group of<br />

3 members <strong>and</strong> an advisory group of 14<br />

members, all originating from different<br />

European pharmaceutical industries. The<br />

Committee met in Leuven for a full day<br />

on September 16, <strong>and</strong> will shortly come<br />

up with recommendations as to how<br />

<strong>EUFEPS</strong> could become more important<br />

to the pharmaceutical industry in general<br />

<strong>and</strong> in particular to the pharmaceutical<br />

scientists employed by industry. CPP is<br />

still in the process of establishing itself,<br />

<strong>and</strong> has been requested to advice on<br />

which policy issues <strong>EUFEPS</strong> should be<br />

actively engaged in, in terms of voicing<br />

views <strong>and</strong> opinions. I should like to seize<br />

this opportunity to thank the members of<br />

the committees for their very important<br />

contributions to <strong>EUFEPS</strong>, at a time when<br />

the Federation is not able to financially<br />

compensate for the expenses that these<br />

committee member are incurring in travel<br />

ling to the meetings, etc. <strong>EUFEPS</strong> has<br />

to draw very strongly on dedicated <strong>and</strong><br />

motivated individual scientist to make<br />

progress <strong>and</strong> it is encouraging to find this<br />

spirit among European colleagues.<br />

<strong>EUFEPS</strong> Publications<br />

This Newsletter will remain cornerstone<br />

for communication with our members.<br />

From 1996 onwards, it will appear at<br />

a frequency of four issues per year<br />

<strong>and</strong> <strong>EUFEPS</strong> members are invited to<br />

contribute by voicing opinion on relevant<br />

topics within the pharmaceutical sciences.<br />

The <strong>EUFEPS</strong> Executive Committee will<br />

continue to report on important activities,<br />

meetings, information on member <strong>and</strong><br />

related organisations. It is still a h<strong>and</strong>icap<br />

that News letter distribution has to go<br />

through the secretariats of member<br />

organisations, which - for underst<strong>and</strong>able<br />

reasons - sometimes causes considerable<br />

delay before a Newsletter actually<br />

reaches the individual member of that<br />

organisation. On the other h<strong>and</strong>, <strong>EUFEPS</strong>’<br />

own individual members will receive the<br />

newsletter through direct mail from the<br />

<strong>EUFEPS</strong> Secretariat in Stockholm.<br />

The European Journal of<br />

Pharmaceutical Sciences (EJPS) is the flag<br />

ship scientific journal of our Federation.<br />

The journal has grown steadily over<br />

the past few years but could still benefit<br />

from improved commitment by top<br />

pharmaceutical scientists in Europe in<br />

terms of submitting high quality papers.<br />

It is encouraging that several of the new<br />

individual member of <strong>EUFEPS</strong> have taken<br />

a personal subscription to the journal. The<br />

journal could also achieve a higher profile<br />

by realising a closer association with<br />

congresses <strong>and</strong> symposia organised by<br />

<strong>EUFEPS</strong>, <strong>and</strong> the Executive Committee is<br />

working on this. ln any case, the abstract of<br />

all invited paper <strong>and</strong> free communications<br />

of the Congress in Edinburgh will<br />

be published in a Supplement of the<br />

journal. Furthermore, efforts are being<br />

made to integrate other existing regional<br />

pharmaceutical journal into EJPS. We<br />

strongly believe that it is in the interest of<br />

our membership to decrease the number<br />

of exiting journals in the pharmaceutical<br />

sciences within Europe. It is anticipated<br />

that within one or two years the frequency<br />

of appearance of EJPS will double, i.e.<br />

will go from bimonthly to monthly.<br />

Secretariat <strong>and</strong> Finances<br />

<strong>EUFEPS</strong> is still heavily dependent on the<br />

strong <strong>and</strong> generous support provided by<br />

the Swedish Academy of Pharmaceutical<br />

Sciences, for which we are extremely<br />

grateful. However, it is the clear ambition<br />

XII<br />

of the Executive Committee to pursue<br />

financial independence in the coming<br />

year, a has been pelled out in <strong>EUFEPS</strong>’<br />

Strategic Plan. First steps have been taken<br />

in the context of the budget for 1996, in<br />

which a decreased contribution by our<br />

Swedish colleague is foreseen, how ever,<br />

compensated by increased income from<br />

<strong>EUFEPS</strong>’ member hips <strong>and</strong> activities.<br />

In due course, we aim to appoint an<br />

(initially part time) Executive Director of<br />

the Federation to further professionalise<br />

<strong>and</strong> enhance our activities. For the time<br />

being, I should very much like to thank<br />

Björn Lindeke, Hans H. Lindén <strong>and</strong> Anita<br />

Ljung at the Secretariat in Stock holm for<br />

their ongoing <strong>and</strong> very dedicated support<br />

of <strong>EUFEPS</strong>!


<strong>EUFEPS</strong> Newsletter, 1996, vol. 5, issue 4<br />

Visions <strong>and</strong> Realisations<br />

– New President takes<br />

Stock<br />

Malcolm Rowl<strong>and</strong>, Professor<br />

<strong>EUFEPS</strong> President<br />

Every successful organisation needs a vision<br />

<strong>and</strong> a strategic plan of action, both of which<br />

must be subjected to periodic review with<br />

adjustment or refinement, as appropriate.<br />

<strong>EUFEPS</strong> has embodied these precepts in<br />

a document entitled ‘Towards the Strategic<br />

Plan 1994–1998’ which was approved by<br />

Council at its third annual meeting, in 1994.<br />

At this mid way point thought it would be<br />

useful to share with you to what extent the<br />

objectives of our fledgling organisation,<br />

established in 1991, have been met, <strong>and</strong> what<br />

still needs to be done or amended. I have done<br />

this by listing below, for you, the original<br />

objectives for the 4-year period followed by<br />

a review of each in terms of achievements<br />

to date, together with some future plans.<br />

Overall, we have achieved much, but there<br />

is still much more to do.<br />

Objective 1<br />

To seek coherence of the pharmaceutical<br />

sciences in Europe by promoting<br />

cooperation between national, regional<br />

<strong>and</strong> European Societies or associations<br />

which aim at the advancement<br />

of pharmaceutical sciences with<br />

<strong>EUFEPS</strong> recognised as the leading <strong>and</strong><br />

coordinating organisation.<br />

We are certainly well on our way to<br />

meeting this objective. For example, since<br />

September 1994, <strong>EUFEPS</strong> has increased<br />

it number of national Member Societies<br />

from 20 in 18 European Countries to 24<br />

in 20 countries; held successful European<br />

Congresses in Berlin (1994) <strong>and</strong> the recent<br />

one in Edinburgh; held the first (1994),<br />

<strong>and</strong> second (1995) <strong>EUFEPS</strong> Nuremberg<br />

Conference on Tumour Targeting, <strong>and</strong><br />

Topical Products for Local Action,<br />

respectively, followed by the most recent<br />

in 1996; <strong>and</strong> sponsored or patronised<br />

six Regional or European meetings. We<br />

also increased the number of issue of the<br />

newsletter from 3 to 4 a year. And, we have<br />

much more in store for the future, including<br />

the 4th International Conference on Drug<br />

Absorption, in Edinburgh (June 1997), to<br />

run under the a uspices of <strong>EUFEPS</strong>; the<br />

4th European Congress on Pharmaceutical<br />

Sciences, planned for 1998 in Milan, Italy,<br />

a well as the 4th (1997) <strong>and</strong> 5th (1998)<br />

Nuremberg Conference. Furthermore,<br />

by 1998 we would hope to have national<br />

Member Societies in essentially all<br />

European countries.<br />

Objective 2<br />

To promote cooperation with other<br />

European <strong>and</strong> international, broadly<br />

pharmaceutical organisations <strong>and</strong><br />

federations, with <strong>EUFEPS</strong> recognised<br />

a an “equal merit” organisation.<br />

Here again, effort to meet this objective<br />

are bearing fruit, partly in the form of<br />

jointly organised activities. Examples are<br />

the forthcoming <strong>EUFEPS</strong>/lSSX meeting<br />

in Gothenburg (July 1997) <strong>and</strong> the recent<br />

Symposium on Excipients, held at the 3rd<br />

European Congress, in conjunction with<br />

the International Pharmaceutical Excipient<br />

Conference. Our sister organisation in<br />

north America, the American Association<br />

of Pharmaceutical Scientists (AAPS),<br />

with which we had a successful oneday<br />

Workshop on Cell Line <strong>and</strong> Tissue<br />

Cultures at the 3rd European Congress,<br />

<strong>and</strong> we look forward to an increasing<br />

collaboration between AAPS <strong>and</strong> our<br />

elves. In addition, we offer observer<br />

status at Council to many European <strong>and</strong><br />

International societies <strong>and</strong> enjoy reciprocal<br />

arrangements with them. The future<br />

portends even greater collaboration - a<br />

XIII<br />

particular l<strong>and</strong>mark being the Millenium<br />

World Congress on Pharmaceutical<br />

Sciences in 2000, organised by the FIP<br />

- Board of Pharmaceutical Sciences, at<br />

which <strong>EUFEPS</strong>, AAPS <strong>and</strong> the Japanese<br />

Pharmaceutical Sciences will be major<br />

regional players.<br />

Objective 3<br />

To provide individual pharmaceutical<br />

scien tists in Europe with a platform<br />

to exchange information, <strong>and</strong> to meet<br />

<strong>and</strong> support their individual scientific<br />

interests in the multidis ciplinary<br />

environment of drug research <strong>and</strong><br />

related activities.<br />

The growing number of participants<br />

at the increasing number of <strong>EUFEPS</strong><br />

organised <strong>and</strong> sponsored meetings is a<br />

clear expression of success in meeting this<br />

objective. Another measure of success<br />

is the growing number of Individual<br />

Members, a category introduced in 1994.<br />

But much has still to be done here, <strong>and</strong><br />

we are looking at such developments as<br />

the use of the Internet to communicate<br />

directly with our members<br />

Objective 4<br />

To make the European Journal of<br />

Pharma ceutical Sciences (EJPS)<br />

the leading Europe an Journal on the<br />

subject.<br />

Now in its 4th year, subcriptions to EJPS,<br />

our official journal, have grown steadily.<br />

Ho wever, it is fair to say that EJPS has<br />

achieved modest succes to date. Its success<br />

would be much greater if each <strong>and</strong> every<br />

member of <strong>EUFEPS</strong> subscribed to EJPS<br />

<strong>and</strong> submitted their best manuscripts to it.<br />

Help us to meet our aspirations for EJPS!


Objective 5<br />

To enhance the recognition of the<br />

pharma ceutical sciences <strong>and</strong> to<br />

contribute appropria tely to public<br />

policy relevant to drug research <strong>and</strong><br />

development, drug regulation <strong>and</strong><br />

drug utilization, with <strong>EUFEPS</strong> as the<br />

primary voi cing organisation at the<br />

European level.<br />

This is a tough objective to meet, but we are<br />

making headway through the activities of<br />

the Committee on Pharmaceutical Policy,<br />

which organise some of the Nuremberg<br />

Con ferences. One positive step has been<br />

our con tact with various European bodies,<br />

such as the EMEA in London, making<br />

those aware of our contribution to debates<br />

on scientific issues <strong>and</strong> policy pertinent to<br />

the European pharma ceutical arena.<br />

Although not explicitlytated in the<br />

1994–1998 strategic document, implicitly<br />

training <strong>and</strong> education in research,<br />

interfacing with industry, <strong>and</strong> finance<br />

are central to the suc cess of <strong>EUFEPS</strong>.<br />

Training was identified by the Committee<br />

of Industrial Relationships (CIR) as an<br />

urgent <strong>and</strong> critical need that we must<br />

address seriously in the coming years, in<br />

partnership with industry <strong>and</strong> academia.<br />

Here our Corporate Membership, which<br />

continues to gro, We do, however, need<br />

to make even more extensive contacts <strong>and</strong><br />

have among our membership a greater<br />

number of industrial pharmaceutical<br />

scientists.<br />

Finally,<br />

underpinning all our activities is sound<br />

finance, without which we cannot continue.<br />

Since its inception, with limited resource,<br />

<strong>EUFEPS</strong> has been financially dependent<br />

on the gene rosity <strong>and</strong> foresightedness of<br />

the Swedish Academy of Pharmaceutical<br />

Sciences. While gratefully received <strong>and</strong><br />

acknowledged, the strategy has been to<br />

continually diminish this dependency<br />

such that by 1998 <strong>EUFEPS</strong> will be<br />

financially independent. With a string of<br />

successful meetings, rising membership<br />

<strong>and</strong> increasing subscription to EJPS, I am<br />

confi dent that we will meet this objective<br />

on time, so enabling us to look forward<br />

with confidence to an ever successful<br />

future. I sincerely hope that you share my<br />

enthusiasm <strong>and</strong> optimism for the future<br />

of <strong>EUFEPS</strong>. With your help, together we<br />

cannot fail.<br />

XIV


<strong>EUFEPS</strong> Newsletter, 1997, vol. 6, issue 1<br />

The Influence of<br />

Pharmaceutical Sciences<br />

on the International<br />

Harmonisation Activities<br />

A. Atilla Hincal, Professor<br />

<strong>EUFEPS</strong> Executive Committee Member <strong>and</strong> Director of Postgraduate Institute for<br />

Medicine <strong>and</strong> Health Sciences, Hacellepe University, Ankara, Turkey<br />

“The advantage of a technically based<br />

conference such as this one, is that<br />

the real experts can express the true<br />

scientific needs <strong>and</strong> the regulators can<br />

benefit from the clear unbiased views of<br />

the international experts.<br />

Martin Bangemann, Ph.D., Brussels /<br />

ICH 1991”<br />

Quality, Safety <strong>and</strong> Efficacy<br />

It is noted that the scientific <strong>and</strong><br />

technological developments which have<br />

speeded up after the 1960s have had great<br />

reflections in different fields of industry,<br />

<strong>and</strong> even greater <strong>and</strong> speedier reflections<br />

in the pharmaceutical industry due to the<br />

fact that the industry is based on research.<br />

After 1976 the European community<br />

accepted quality, safety <strong>and</strong> efficacy<br />

as the basic criteria to be sought for the<br />

registration of pharmaceutical products.<br />

This issue is also accepted <strong>and</strong> required<br />

by other nations in the world. The basic<br />

reason for this event being placed in the<br />

legal practice is the need to protect public<br />

health. It is natural for a scientific evaluation<br />

entailing quality, safety <strong>and</strong> efficacy to<br />

be the basic of regulatory procedure,<br />

necessary for a drug to be brought on to the<br />

market. If the universality of the scientific,<br />

humane <strong>and</strong> ethical regulations brought<br />

about for clinical research by the Helsinki<br />

Declaration is considered, the necessity for<br />

harmonisation of the criteria sought for the<br />

registration of drugs in different countries<br />

can be better understood. Thus scientific<br />

research better focused <strong>and</strong> directed<br />

towards innovative research, in which the<br />

needs of the patient are directly considered<br />

<strong>and</strong> the resources more efficiently used,<br />

rather than defensive research. According<br />

to scientific research <strong>and</strong> developments,<br />

while the number of drugs for treatment<br />

increased starting from the 1960s until<br />

the 1980s, it could be considered that<br />

scientifically three main factors played a<br />

role in the decrease of new drugs starting<br />

from the 1980s. These are:<br />

(i) The fact that the tests required for<br />

pharmaceutical research became very<br />

complex<br />

(ii) The realisation that fewer new<br />

drugs would be able to fulfil<br />

regulatory dem<strong>and</strong>s<br />

(iii) The fact that more specific criteria<br />

were set for selecting potential<br />

substances by the pharmaceutical<br />

companies conducting the research.<br />

Common Scientific Criteria<br />

It has been noted, not only by the<br />

pharmaceutical companies conducting<br />

research <strong>and</strong> undertaking the development<br />

of drugs, but also by other related groups,<br />

that these problems have a universality.<br />

An important point that needs to be<br />

considered is the fact that, according to a<br />

study undertaken in the SA approximately<br />

14.2 years <strong>and</strong> US 360 M (according to<br />

1990 U value) are spent during the R&D<br />

<strong>and</strong> supply-to-usage stages preceding<br />

the appearance of a pharmaceuticals on<br />

the market. On the other h<strong>and</strong> it cannot<br />

even be considered, that the medical<br />

authorities in a country do not pay heed to<br />

the dem<strong>and</strong>s of the patients <strong>and</strong> relatives<br />

awaiting the new drugs with high hopes.<br />

In order to solve the multifaceted problems<br />

of drug registration, faced by those<br />

companies that apply for pharmaceutical<br />

registrations, the EU, USA <strong>and</strong> Japan<br />

decided to instigate a study to set common<br />

scientific criteria to guide the companies<br />

in the regulatory procedures they have to<br />

undertake. This subject is in the interest<br />

of those countries, which develop the<br />

majority of drugs <strong>and</strong> have a developed<br />

<strong>and</strong> well functioning health care system,<br />

XV<br />

A. Atilla Hincal, Professor<br />

as well as other countries whose citizens<br />

have a natural right to obtain new<br />

pharmaceuticals. The intention at this<br />

point was to achieve uniform rules within<br />

the scope of scientific criteria accepted in<br />

international regulations, for the study,<br />

evaluation <strong>and</strong> registration of new drugs<br />

obtained through scientific research, <strong>and</strong><br />

that have been presented, or are to be<br />

presented, for public use to serve public<br />

health. Doesn’t this situation once again<br />

illustrate the fact that science is universal<br />

<strong>and</strong> that pharmaceutical sciences have<br />

developed substantially?<br />

Conference on International<br />

Harmonisation<br />

As stated above the European Union (EU)<br />

had started the process of harmonisation<br />

in the field of pharmaceuticals among<br />

the European countries. The USA claims<br />

to have research in this field dating back<br />

over a period of time. When the USA <strong>and</strong><br />

Japan associated themselves with the EU<br />

in 1991, the first tripartite International<br />

Conference on Harmonisation of<br />

Technical Requirements for Registration<br />

of Pharmaceuticals for Human Use (ICH)<br />

took place in Brussels. The guidelines<br />

to be prepared at these conferences<br />

were established <strong>and</strong> intense work was<br />

undertaken for their preparation <strong>and</strong><br />

realisation. The work undertaken has<br />

been extensively discussed in the three<br />

ICH conferences held biannually. These<br />

were: ICH 1 Brussels - 1991, ICH 2<br />

Orl<strong>and</strong>o - 1993 <strong>and</strong> ICH 3 Yokohama<br />

- 1995. Even though these conferences<br />

seem like tripartite harmonisation, from<br />

the beginning the developments were<br />

followed by other countries with keen<br />

interest. Today, it should be noted that<br />

several other countries have made plans to<br />

utilise the scientific criteria to be set, <strong>and</strong>


that they have reached the conclusion that<br />

great benefit can be derived from ICH.<br />

The ICH meetings take place between<br />

the regulatory <strong>and</strong> the industrial groups<br />

<strong>and</strong> those organisations representing<br />

them. But the infrastructure of these<br />

conferences is based on the total scientific<br />

knowledge of the participating regulatory<br />

<strong>and</strong> industrial experts <strong>and</strong> academics,<br />

together with R&D findings of clinics<br />

<strong>and</strong> research centres through the years.<br />

The ICH meetings within the frame work<br />

of science aim at setting <strong>and</strong> presenting<br />

the regulations within certain limitations.<br />

These should be based on international<br />

<strong>and</strong> scientific rules. By completion of<br />

inform action <strong>and</strong> documentation for<br />

presentation to the legal authorities, they<br />

enable rapid supply of pharmaceuticals<br />

to the market <strong>and</strong> the patient. One should<br />

not lose this perspective in the light of the<br />

volume of data derived from the research<br />

<strong>and</strong> development of drugs.<br />

Guidelines Produced<br />

The first of the economic problems facing<br />

the research- based pharmaceutical<br />

companies when they develop a new<br />

drug, is the speedy delivery of drugs to<br />

patients <strong>and</strong> to markets in more countries.<br />

New scientific therapies, approaches<br />

<strong>and</strong> technologies, on the one h<strong>and</strong>, have<br />

increased the importance <strong>and</strong> the impact<br />

of the results <strong>and</strong>, on the other h<strong>and</strong>,<br />

have strengthened the relations <strong>and</strong> the<br />

interaction between scientific R&D<br />

organisations <strong>and</strong> regulatory authorities.<br />

The fast <strong>and</strong> linear increase noted in<br />

scientific research, <strong>and</strong> results in the<br />

second half of the 20th century in<br />

pharmaceutical <strong>and</strong> medical sciences,<br />

have deemed it imperative that drugs<br />

be speedily dispersed for the health of<br />

the people to other countries besides its<br />

country of origin. Thus when economic<br />

reservations of the companies were<br />

added to the humane, ethical, legal <strong>and</strong><br />

medical necessities the harmonisation<br />

activities were brought about. These<br />

tripartite activities between the EU, USA<br />

<strong>and</strong> Japan are an indispensable step for<br />

strengthening the right to live healthily, by<br />

all the people in the world. There are also<br />

benefits for the world economy, <strong>and</strong> the<br />

efficient utilisation of human, animal <strong>and</strong><br />

substance resources will be achieved with<br />

concomitant increase of quality of life.<br />

For the Benefit of Patients<br />

With the sophistication of technology in the<br />

second half of the 20th century, it is a fact<br />

that the safety st<strong>and</strong>ards have increased<br />

the expense of research <strong>and</strong> development.<br />

But this fact makes it economically<br />

necessary for those companies in vesting<br />

largely in pharmaceutical R&D to exp<strong>and</strong><br />

their markets to cover the world, instead of<br />

only their own countries. For this reason,<br />

the basic aims of harmonisation are to<br />

set common criteria for the scientific<br />

evaluation of new drugs, to pre vent<br />

unnecessary procedures <strong>and</strong> duplication<br />

as resulting from different approaches <strong>and</strong><br />

methods, to overcome the differing ha bits<br />

<strong>and</strong> subjectivity of institutions <strong>and</strong> those<br />

circumstances arising from the customs<br />

<strong>and</strong> tradition of different countries. In<br />

every ICH meeting for the setting of these<br />

judgement criteria the starting point is<br />

the question. “Is this for the benefit of the<br />

XVI<br />

patient?” With this approach it is going<br />

to be possible for the good quality, safety<br />

<strong>and</strong> efficacy of drugs to be assured, the<br />

clinical research to be con ducted with<br />

international st<strong>and</strong>ards <strong>and</strong> to harmonise<br />

the work undertaken with advanced<br />

scientific research. A point that should<br />

not be overlooked is that harmonisation<br />

activities undertaken within the scope of<br />

scientific criteria can yield permanent <strong>and</strong><br />

realistic benefits, by contrast with work<br />

undertaken with no regard to scientific<br />

criteria.<br />

Effective Pharmaceutical Sciences<br />

The biggest achievement of the ICH has<br />

been that, even though in name it is an<br />

officially tripartite meeting from 1991<br />

up to this day, a harmonisation accepted<br />

internationally, through scientific research<br />

based on detailed work on every level<br />

has been achieved with the participation<br />

of many other countries. Since the talks<br />

held at the conference do not only en tail<br />

the development <strong>and</strong> the registration of<br />

new drugs in a narrow sense, but also<br />

entail subjects such as informed consent,<br />

protection of patients rights in clinical<br />

research <strong>and</strong> the use of electronic media<br />

in regulatory communications, which<br />

are all technical subjects based on truths<br />

of science itself, this is a sign that the<br />

harmonisation activities have a broad range<br />

<strong>and</strong> every chance of being successful.<br />

Doesn’t it warm your heart to see that<br />

pharmaceutical sciences are effective <strong>and</strong><br />

a leader with such a universal approach in<br />

the application of human health issues?


<strong>EUFEPS</strong> Newsletter, 1997, vol. 6, issue 3<br />

Biopharmaceutical<br />

Classification System (BCS)<br />

for Oral Immediate-release<br />

Drug Products<br />

Anders Grahnen, Assoc. Professor<br />

<strong>EUFEPS</strong> Vice–President <strong>and</strong> Quintiles AB<br />

A biopharmaceutical classification<br />

system (BCS) for immediate release<br />

(IR) drug products has recently been<br />

proposed (I) <strong>and</strong> is under consideration<br />

by regulatory authorities. The new<br />

classification system is a result of basic<br />

research into the mechanistics of drug<br />

absorption. Advances in physiology,<br />

molecular biology <strong>and</strong> pharmacokinetics<br />

have revealed crucial new information<br />

regarding physiological mechanisms<br />

involved in the absorption process.<br />

Although drug absorption has been<br />

investigated for more than four decades,<br />

predictive models (such as the pH-<br />

partition hypothesis) for absorption<br />

have so far been of limited value due<br />

to the complexity of the physiological/<br />

physiochemical events involved in the<br />

intestinal absorption process of drugs.<br />

Theoretical considerations of the<br />

BCS<br />

Drug dissolution is a prerequisite to drug<br />

absorption <strong>and</strong> clinical response for most<br />

drugs given orally. Amidon <strong>and</strong> co-workers<br />

have developed a microscopic approach<br />

to drug absorption <strong>and</strong> demonstrated<br />

a good correlation between the extent<br />

of drug absorption <strong>and</strong> the intestinal<br />

membrane permeability in both animals<br />

<strong>and</strong> man (1). In addition they developed<br />

a drug dissolution <strong>and</strong> absorption model<br />

for water insoluble drugs that limits to<br />

the previous microscopic results under<br />

appropriate conditions. These models<br />

show that the key parameters controlling<br />

drug absorption are three dimensionless<br />

numbers: Absorption number (An);<br />

Dissolution number (Dn); Dose number<br />

(Do); representing the fundamental<br />

processes of membrane permeation, drug<br />

dissolution <strong>and</strong> dose respectively.<br />

The rate of absorption from the<br />

intestinal lumen (assuming no luminal<br />

reactions) at any time is:<br />

Absorption rate = ʃʃ A P eff C lumen dA<br />

(double integral is over the entire gastrointestinal surface)<br />

where A is available intestinal surface area.<br />

P eff is the effective membrane permeability<br />

<strong>and</strong> C lumen is the drug concentration at the<br />

membrane (intestinal) surface.<br />

The total mass (M) of drug absorbed<br />

at time t is thus:<br />

M(t) / Dose = ʃ ʃʃ 0<br />

t<br />

P C dAdt<br />

A eff lumen<br />

These relations are general since the<br />

surface can be of any arbitrary shape<br />

<strong>and</strong> the concentration at the lumen <strong>and</strong><br />

permeability can have any dependence<br />

on position <strong>and</strong> time. It is thus important<br />

to point out that P eff is both position<br />

dependent <strong>and</strong> time dependent.<br />

Based on these general mass balance<br />

equations, it follows that: If two drug<br />

products, containing the same drug,<br />

have the same concentration time profile<br />

at the intestinal membrane surface then<br />

XVII<br />

Anders Grahnen, Assoc. Professor<br />

they will have the same rate <strong>and</strong> extent<br />

of absorption. In addition, if two drug<br />

products have the same in vivo dissolution<br />

profile under all luminal conditions they<br />

will have the same rate <strong>and</strong> extent of drug<br />

absorption. Furthermore, the relationship<br />

between in vivo drug dissolution <strong>and</strong><br />

the luminal concentration as well as the<br />

relations hip between in vivo dissolution<br />

<strong>and</strong> in vitro dissolution become crucial for<br />

the prediction of absorption.<br />

As shown above, membrane<br />

permeability <strong>and</strong> solubility are the<br />

primary determinant for predicting drug<br />

absorption in man. Pioneer work of<br />

Lennernäs <strong>and</strong> co-workers utilizing a multi<br />

channel tube system with double balloons<br />

has enabled segmental perfusion of the<br />

gastrointestinal tract (preferably jejunum)<br />

in man (2). Through this experimental<br />

technique it is possible to determine the<br />

effective membrane permeability (P err )<br />

in man for any type of drug including<br />

carrier mediated transported compounds<br />

(using scaling factors) throughout the<br />

entire gastrointestinal channel (including<br />

the rectum). The experimental procedure<br />

has been validated <strong>and</strong> extensively tested.


The procedure is safe <strong>and</strong> of relative ease<br />

for experimental subjects. Furthermore,<br />

it is possible to predict human in<br />

vivo permeability using preclinical<br />

permeability models, such as perfusion<br />

of the rat jejunum, the Caco-2 model <strong>and</strong><br />

excised intestinal segments using the<br />

Using chamber. Through a collaborative<br />

academic-regulatory project*, P err in man<br />

for a number of drugs have now been<br />

determined (2). As shown in Figure 1,<br />

there is a good (non-linear) relationship<br />

between extent of intestinal absorption in<br />

man (as determined by pharmacokinetics)<br />

<strong>and</strong> in vivo membrane permeability.<br />

Permeability-Solubility<br />

Classification<br />

The BCS divide drugs into 4 different<br />

classes based on their solubility <strong>and</strong><br />

permeability (Table 1).<br />

Class 1. High Solubility-High<br />

Permeability Drugs.<br />

These drugs are well absorbed (although<br />

systemic availability may be low due<br />

to first-pass metabolism) <strong>and</strong> the rate<br />

limiting step is drug dissolution or gastric<br />

emptying if dissolution is very rapid. The<br />

dissolution profile must be well defined<br />

<strong>and</strong> reproducible to insure bioavailability.<br />

A dissolution specification for IR drugs<br />

of 85 % dissolved in


<strong>EUFEPS</strong> Newsletter, 1997, vol. 6, issue 4<br />

Strategic events<br />

Malcolm Rowl<strong>and</strong> Professor<br />

<strong>EUFEPS</strong> President <strong>and</strong> University of Manchester, United Kingdom<br />

In some ways it seems but a moment, <strong>and</strong><br />

in others an age, but it is one year since<br />

I took over the presidency of <strong>EUFEPS</strong>.<br />

Then, I wrote an editorial on the visions<br />

<strong>and</strong> realisations of <strong>EUFEPS</strong> in the<br />

December 1996 issue of the Newsletter.<br />

One year on seems an appropriate time<br />

to reflect on what we have achieved <strong>and</strong><br />

express some views on the future.<br />

Permanent secretariat<br />

Perhaps the most important strategic event<br />

over the last year has been the establishment<br />

of a permanent home for the secretariat,<br />

who have been doing an outst<strong>and</strong>ing job<br />

with limited resources available. But,<br />

you might say, the secretariat is housed<br />

already within the premises of the Swedish<br />

Academy of Pharmaceutical Sciences.<br />

That is true, but it was a temporary<br />

arrangement through the kind generosity<br />

of the Swedish Pharmaceutical Society,<br />

which has provided space <strong>and</strong> financial<br />

assistance. So I am now delighted to report<br />

that, at the recent meeting in Istanbul,<br />

Council approved the proposal from the<br />

Executive Committee that the secretariat<br />

be permanently housed within the current<br />

premises in Stockholm, <strong>and</strong> thank the<br />

Swedish Pharmaceutical Society for<br />

making this possible. Every organisation<br />

needs an efficient, well-resourced <strong>and</strong> stable<br />

secretariat to implement its policies <strong>and</strong><br />

undertake its day-to-day functions. Now<br />

having secured the base, the secretariat<br />

needs to be enhanced to adequately serve<br />

the increasing activities of <strong>EUFEPS</strong>.<br />

Graduate student meeting<br />

Another important development at Council,<br />

was the support of an initiative from the<br />

German Pharmaceutical Society for the<br />

establishment of a European Meeting of<br />

Graduate Students in the Pharmaceutical<br />

Sciences, the first of which to take place,<br />

in English, in Frankfurt, February 20–22,<br />

1998. Previously a successful national<br />

meeting, the intention is that it become<br />

European but its success depends heavily<br />

on research students from other countries<br />

attending <strong>and</strong> becoming actively involved.<br />

Training of high quality researchers<br />

with the necessary skills <strong>and</strong> knowledge<br />

to meet the future challenges in the<br />

pharmaceutical sciences is paramount.<br />

This subject has been one of the important<br />

activities of the Committee of Industrial<br />

Relations, (CIR) which is helping to define<br />

<strong>and</strong> identify the needs through various<br />

means, including questionnaires. And, this<br />

given its importance, training will comm<strong>and</strong><br />

increasing attention within <strong>EUFEPS</strong> in the<br />

coming years. CIR serves as an excellent<br />

example of what a group of committed,<br />

motivated <strong>and</strong> enthusiastic individuals can<br />

accomplish, <strong>and</strong> <strong>EUFEPS</strong> will follow this<br />

example <strong>and</strong> establish a number of additional<br />

committees to deal with such matters as<br />

conferences, membership, <strong>and</strong> awards.<br />

Major scientific meetings<br />

To establish itself as a major regional<br />

organisation in the pharmaceutical<br />

sciences <strong>EUFEPS</strong> has, in addition to<br />

its usual successful biennial European<br />

Congress in Pharmaceutical Sciences, the<br />

next to be in Milan, September 11–13 1998,<br />

which I encourage you to attend, run more<br />

specialised meetings often in collaboration<br />

with other organisations. Examples have<br />

been the recent successful meetings on<br />

Drug Absorption (Edinburgh) <strong>and</strong> Drug<br />

Metabolism (Gothenburg), together with the<br />

Edinburgh Drug Absorption Foundation<br />

<strong>and</strong> ISSX, respectively. Another example<br />

is the forth coming meeting in Jerusalem,<br />

April 25–29, 1999, organised together with<br />

the European Congress in Biopharmacy<br />

XIX<br />

<strong>and</strong> Pharmacokinetics, around the central<br />

theme “Mechanistically-based Drug<br />

Discovery <strong>and</strong> Development: Integrating<br />

the Biological Revolution”. As part of our<br />

strategic plan we have also successfully<br />

sought sponsorship of some of our meetings<br />

from our sister organisation within the USA,<br />

AAPS, <strong>and</strong> from the FDA <strong>and</strong> EMEA,<br />

an example being the next Nuremberg<br />

meeting, this 27–29 November, on “Drug-<br />

Drug <strong>and</strong> Drug-Food Interactions” - For<br />

those of you that attended the recent AAPS<br />

meeting in Boston you will have noticed in<br />

the program the joint <strong>EUFEPS</strong>-AAPS short<br />

course on cell-lines <strong>and</strong> tissue cultures,<br />

which was first successfully run in our<br />

1996 Edinburgh Congress. We intend to<br />

undertake more such <strong>and</strong> other activities<br />

with AAPS.<br />

Flagship journal<br />

The editorship of the European Journal<br />

of Pharmaceutical Sciences, our flagship<br />

journal, will move its base from the<br />

Netherl<strong>and</strong>s to Uppsala, Sweden, by early<br />

1998. The existing editors, Professors H.<br />

Junginger <strong>and</strong> G. Mulder, who have done<br />

an extremely important job of giving EJPS<br />

its initial push, will pass on the baton to<br />

Professor P. Artursson <strong>and</strong> his colleagues<br />

to move it further. However, EJPS will only<br />

become the highly successful journal that<br />

we would all like to see if you submit your<br />

best papers to it. We are also of the opinion<br />

that there are too many journals dealing with<br />

the pharmaceutical sciences within Europe<br />

<strong>and</strong> there is need for further consolidation.<br />

Increasing membership<br />

Finally, a note on membership which has<br />

remained relatively static over the past<br />

year. We now have Member Societies<br />

from most countries within Europe <strong>and</strong> we<br />

are hopeful that the remaining countries<br />

in which there is a strong presence of<br />

pharmaceutical sciences will join us<br />

during the coming years. We also feel<br />

strongly about our Individual Members,<br />

as they identify personally with the aims<br />

<strong>and</strong> aspirations of <strong>EUFEPS</strong>. We intend<br />

to increase this sector of our membership<br />

over the next few years, as well as that<br />

of our Corporate Members, which has<br />

grown, but has room to grow still further.<br />

In closing<br />

Through this Newsletter, it remains for<br />

me to wish all of you a successful year. I<br />

look forward to either seeing you at one of<br />

our meetings, or reading about you m the<br />

Newsletter, or preferably both.


<strong>EUFEPS</strong> Newsletter, 1998, vol. 7, issue 1<br />

<strong>EUFEPS</strong> forges links<br />

with FDA, EMEA<br />

<strong>and</strong> EU<br />

Malcolm Rowl<strong>and</strong>, Professor<br />

<strong>EUFEPS</strong> President <strong>and</strong> University of Manchester, United Kingdom<br />

Although, developments within <strong>EUFEPS</strong><br />

have never been slow, recently the pace<br />

has quickened by several notches. In the<br />

space of just three short months, major<br />

strategic developments involving the USA<br />

Food <strong>and</strong> Drug Administration (FDA),<br />

European Medicines Evaluation Agency<br />

(EMEA) <strong>and</strong> European Union (EU) have<br />

occurred that puts <strong>EUFEPS</strong> well on<br />

its planned course of being recognised<br />

as the umbrella platform for the<br />

pharmaceutical sciences within Europe.<br />

In all these developments neutrality in all<br />

but science is the key to acceptance <strong>and</strong><br />

success.<br />

Natural neutral umbrella<br />

In the bringing of pharmaceuticals to<br />

the marketplace, regulatory approval<br />

is m<strong>and</strong>atory. To meet their statutory<br />

obligations, regulatory authorities publish<br />

guidelines to facilitate the rational<br />

development of safe, effective, <strong>and</strong> reliable<br />

medicines. At the same time, major strides<br />

are being made to harmonise guidelines<br />

across continents, as part of the recognised<br />

globalisation of drug development. It is in<br />

this arena that <strong>EUFEPS</strong> is playing an ever<br />

increasing pivotal role. This is reflected<br />

by the FDA’s Division of Pharmaceutical<br />

Sciences, of the Center for Drug Evaluation<br />

<strong>and</strong> Research (CDER), decision to<br />

recognise <strong>EUFEPS</strong> as the natural neutral<br />

umbrella platform within Europe, to<br />

bring together interested organisations<br />

<strong>and</strong> persons from academia, industry<br />

<strong>and</strong> government to explore issues within<br />

the pharmaceutical sciences relevant to<br />

the development of such guidelines. To<br />

further this collaboration Dr Larry Lesko,<br />

Head, Clinical Pharmacology within<br />

CEDR, has been appointed as the FDA-<br />

<strong>EUFEPS</strong> Federal Liaison Officer (see<br />

article p..), whilst fittingly Prof. Henning<br />

Blume, has been appointed <strong>EUFEPS</strong>-<br />

FDA Liaison Officer. Henning is chair<br />

of the Committee on Pharmaceutical<br />

Policy, which among its activities deals<br />

with guideline issues <strong>and</strong> developments.<br />

Discussions along similar lines as with the<br />

FDA are also taking place with Professor<br />

Rolf Bass of the EMEA. Staff from both<br />

the FDA <strong>and</strong> EMEA strongly participated<br />

in the recent 4th <strong>EUFEPS</strong> Nuremberg<br />

Conference on Drug-Drug <strong>and</strong> Drug-<br />

Food Interactions, not only giving lectures<br />

but were also actively involved in many of<br />

the discussions.<br />

Hot t<strong>and</strong>em meetings<br />

One tangible example of <strong>EUFEPS</strong>’s<br />

pivotal role in advancing drug<br />

development science is its next (5th)<br />

Nuremberg Conference on the hot topic<br />

of ‘Optimising Drug Development: Fast<br />

Tracking into Human’, which is being<br />

sponsored by the FDA, EMEA, AAPS<br />

<strong>and</strong> EACPT. This will run in t<strong>and</strong>em<br />

with a meeting on the same theme in<br />

Washington, organised by AAPS, <strong>and</strong><br />

sponsored by FDA, ASCPT, AACP, as<br />

well as <strong>EUFEPS</strong>. The intention is to put<br />

out a co-ordinated discussion document to<br />

facilitate guideline developments across<br />

both continents, in this important phase of<br />

drug evaluation <strong>and</strong> selection.<br />

Links to EU<br />

On a separate front, members of both<br />

<strong>EUFEPS</strong> Executive Committee <strong>and</strong><br />

Committee on Industrial Relations had<br />

fruitful discussions with various EU<br />

representatives in Brussels to explore<br />

developments <strong>and</strong> opportunities in<br />

education <strong>and</strong> training at the postgraduate<br />

<strong>and</strong> research level. These discussions were<br />

aimed at improving the skill base in the<br />

pharmaceutical sciences within Europe.<br />

XX<br />

Malcolm Rowl<strong>and</strong>, Professor<br />

Also discussed were research themes<br />

of the 5th Framework Programme for<br />

research <strong>and</strong> Technological Development<br />

(1998-2002) relevant to the pharmaceutical<br />

sciences. This important meeting was<br />

facilitated by Dr Maj-Inger Nilsson,<br />

Swedish Research EU Liaison Officer,<br />

who is an Individual Member of <strong>EUFEPS</strong>.<br />

And, because of the importance that<br />

<strong>EUFEPS</strong> places on these developments,<br />

Maj-Inger has now been appointed<br />

<strong>EUFEPS</strong>-EU Liaison Officer (see article<br />

p...). We wish both Henning <strong>and</strong> Maj-Inger<br />

every success in their new roles within<br />

<strong>EUFEPS</strong>.<br />

Mutual interest <strong>and</strong> concern<br />

Finally, links are also being established<br />

with EFPIA (European Federation of<br />

Pharmaceutical Industry Association),<br />

which has an interest in ensuring a vital<br />

<strong>and</strong> successful pharmaceutical industry<br />

within Europe. Once again the areas<br />

of mutual interest <strong>and</strong> concern are the<br />

education <strong>and</strong> training of pharmaceutical<br />

scientists.<br />

We are looking forward to fruitful<br />

collaborations with all these organisations<br />

to meet the challenges <strong>and</strong> opportunities<br />

that lie ahead.


<strong>EUFEPS</strong> Newsletter, 1999, vol. 8, issue 2<br />

<strong>EUFEPS</strong> Permanent<br />

Secretariat established<br />

On February 20, 1999, the permanent<br />

Secretariat of <strong>EUFEPS</strong> was officially<br />

opened in the premises of the Swedish<br />

Pharmaceutical Society in Stockholm,<br />

Sweden. Members of the Executive<br />

Committee, as well as of the Board of<br />

the Swedish Pharmaceutical Society/<br />

Academy of Pharmaceutical Sciences<br />

attended the inaugural reception <strong>and</strong><br />

opening ceremony. The opening was<br />

held in conjunction with the February<br />

Executive Committee Meeting in<br />

Stockholm.<br />

Increased activity<br />

As is well-know to the readers of this<br />

Newsletter, <strong>EUFEPS</strong> was founded in<br />

1991 in Strasbourg, France, by a number<br />

of national societies <strong>and</strong> associations<br />

for pharmaceutical sciences in Europe,<br />

one of which is the Swedish Academy of<br />

Pharmaceutical Sciences (SAPS) within<br />

the Swedish Pharmaceutical Society. Since<br />

then, the number of Member Societies of<br />

<strong>EUFEPS</strong> has grown substantially, <strong>and</strong><br />

additional forms of membership have also<br />

been established. Currently, <strong>EUFEPS</strong><br />

links 25 Member Societies in 22 European<br />

countries. In addition, there is approx.<br />

480 Individual Members, as well as 25<br />

Corporate Members of <strong>EUFEPS</strong>.<br />

From the inauguration of <strong>EUFEPS</strong>,<br />

the Swedish Academy of Pharmaceutical<br />

Sciences have been providing secretarial<br />

assistance for <strong>EUFEPS</strong>. As the<br />

activities of <strong>EUFEPS</strong> have increased,<br />

the administrative <strong>and</strong> managerial<br />

requirements on the Secretariat have<br />

also increased. To meet these needs, a<br />

permanent secretariat has been sought<br />

for, <strong>and</strong>, in 1997 (?), the <strong>EUFEPS</strong><br />

Council accepted an offer by SAPS that<br />

the <strong>EUFEPS</strong> Secretariat be permanently<br />

established in its premises in Stockholm.<br />

Mutual happiness<br />

Against this background, the <strong>EUFEPS</strong><br />

President, Professor Malcolm Rowl<strong>and</strong>,<br />

at the opening ceremony, said that he, on<br />

behalf of <strong>EUFEPS</strong>, is very pleased that<br />

there is from now on <strong>EUFEPS</strong> Secretariat<br />

physically established. In addition,<br />

substantial, financial support, for a period<br />

of two years, is provided by the Academy.<br />

Perhaps, this will also challenge other<br />

Member Societies of <strong>EUFEPS</strong> to increase<br />

their support.<br />

The President of the Swedish<br />

Pharmaceutical Society/Academy of<br />

Pharmaceutical Sciences, Professor Conny<br />

Bogentoft, said that he as well is very<br />

pleased with this solution. International<br />

co-operation <strong>and</strong> collaboration are of<br />

utmost importance for the development<br />

of new drugs. Without extensive research,<br />

there would not be many new effective<br />

medicines, if any. Also, most of the<br />

medicines produced are developed for<br />

the international market. Collaboration<br />

between national regulatory agencies<br />

is growing, <strong>and</strong> a European one was<br />

recently created. Drug companies in one<br />

country merge with drug companies<br />

in other countries. In other words,<br />

internationalisation <strong>and</strong> globalisation<br />

seem to be inevitable, <strong>and</strong>, in this<br />

perspective, it is a matter of course that the<br />

Swedish Pharmaceutical Society, through<br />

the Academy of Pharmaceutical Sciences,<br />

firmly supports <strong>EUFEPS</strong> <strong>and</strong> its efforts to<br />

advance the pharmaceutical sciences <strong>and</strong><br />

innovative drug research in Europe.<br />

Modern facilities<br />

Three suitable, newly <strong>and</strong> nicely<br />

renovated, rooms have been reserved for<br />

the <strong>EUFEPS</strong> Secretariat, closely located<br />

in the same building <strong>and</strong> on the same<br />

floor as the Scientific Secretariat of SAPS.<br />

XXI<br />

From left to right, Björn Lindeke,<br />

Anders Grahnén, Malcolm Rowl<strong>and</strong>,<br />

A. Atilla Hinchal, Dowe D. Breimer,<br />

Michelle Veilard <strong>and</strong> Tony Fell.<br />

Equipment includes up-to-date computer<br />

work-stations, telephone, fax, printer,<br />

copy machine etc.<br />

Current staff<br />

Currently, the Executive Director of<br />

the Swedish Pharmaceutical Society,<br />

Professor Björn Lindeke, is elected<br />

Secretary-General/Treasurer of <strong>EUFEPS</strong>.<br />

In the <strong>EUFEPS</strong> Secretariat, three<br />

individuals are heavily involved in the<br />

day-to-day service of <strong>EUFEPS</strong>. They<br />

are Jenny Hagberg, Hans H. Linden, <strong>and</strong><br />

Anita Ljung.


<strong>EUFEPS</strong> Newsletter, 1999, vol. 8, issue 3<br />

New Safe Medicines Faster<br />

A Proposal for a Key Action<br />

within the European Union’s<br />

6 th Framework Programme<br />

Ole J. Bjerrum, Professor<br />

Chair <strong>EUFEPS</strong>/CIR Task Force on EU Framework Programme<br />

The budgets of European RTD<br />

Framework Programmes have steadily<br />

increased over the years. They now<br />

count for approx. 5% of public spending<br />

on research in Europe. Every 4th<br />

year, a new Framework Programme,<br />

including various key actions <strong>and</strong><br />

generic activities, is launched. Through<br />

a bottom up process it should theoretical<br />

be possible to influence the contents of<br />

future framework programmes. The issue<br />

of getting impact is very complex <strong>and</strong><br />

involves many players - including you.<br />

Important measures<br />

To get involved in the future EU RTD<br />

Framework programmes the following<br />

exercises are needed as a minimum:<br />

• a well defined, thoroughly described<br />

research area covering many European<br />

stakeholders<br />

• a plan <strong>and</strong> the commitment to carry it<br />

through<br />

• a presentation of the proposal to the<br />

Commission<br />

• further substantiation <strong>and</strong> refinement<br />

of the proposal through discussion<br />

at specially arranged workshops <strong>and</strong><br />

conferences in an interactive play with<br />

the Commission<br />

• heavy support from all the stakeholders<br />

at the EU member state level to<br />

convince their respective governmental<br />

bodies including their research<br />

ministers about the value of the<br />

proposal.<br />

The <strong>EUFEPS</strong> Committee on Industrial<br />

Relations (CIR) have decided to bring the<br />

pharmaceutical sciences in focus to EU’s 6th<br />

Framework Programme 2003–2007, under<br />

the title “New Safe Medicines Faster”.<br />

The rationale is the following: The<br />

global competitiveness of the European<br />

pharmaceutical industry is under threat.<br />

Technology currently available for the<br />

development of new medicines is unable<br />

to match the pace of drug discovery <strong>and</strong><br />

design; <strong>and</strong> the ever-growing dem<strong>and</strong> for<br />

safety, efficacy <strong>and</strong> quality documentation<br />

has increased the cost <strong>and</strong> time involved in<br />

getting new medicines on the market thus<br />

creating severe restrictions on industry’s<br />

ability to create wealth <strong>and</strong> launch safe,<br />

cost effective drugs for the treatment of<br />

common <strong>and</strong> rare afflictions.<br />

Clear objectives<br />

The present proposal is based on three main<br />

objectives: to develop new technologies<br />

capable of more effective selection of<br />

potential drug c<strong>and</strong>idates for innovative<br />

medicines while accommodating safety<br />

dem<strong>and</strong>s; to use such technologies to<br />

speed up the pharmaceutical development<br />

<strong>and</strong> eliminating foreseeable bottlenecks,<br />

created by the many drug c<strong>and</strong>idates<br />

now generated in the discovery phase.<br />

Furthermore to cultivate a pan-European<br />

interdisciplinary network on science <strong>and</strong><br />

training that bridges the gap between<br />

industry <strong>and</strong> academia.<br />

By breaking down the barriers put up<br />

by the legislation of individual nations, <strong>and</strong><br />

initiating a new set of recognised European<br />

st<strong>and</strong>ards, new medicines can be brought<br />

onto the market faster <strong>and</strong> thereby cheaper<br />

— thus benefiting European health care.<br />

The key action<br />

A key action is an excellent way of creating<br />

consortia of research groups representing<br />

all the specialist areas involved in<br />

drug development — pharmacology,<br />

toxicology, pharmaceutics, scale-up<br />

processing, analytical chemistry <strong>and</strong><br />

clinical trials. A new <strong>and</strong> important<br />

discipline, pharmacogenomics, will<br />

XXII<br />

also play a major role in the future when<br />

determining the effect of specific drugs<br />

on individual patients. In addition, the key<br />

action should comprise clusters, centres<br />

of excellence, programmes for specialist<br />

training <strong>and</strong> dedicated support for small<br />

<strong>and</strong> medium-sized enterprises.<br />

Methodologies <strong>and</strong> technologies<br />

Promoting <strong>and</strong> implementation of new<br />

methodologies <strong>and</strong> technologies are a<br />

major issue. Work on these aspects should<br />

include as many of the pharmaceutical<br />

sectors <strong>and</strong> EU member states as possible.<br />

As a result, the new pharmaceutical<br />

methods, techniques, tools <strong>and</strong> procedures<br />

that emerge will more easily obtain broad<br />

international approval <strong>and</strong>, at the same<br />

time, represent the most competitive<br />

solutions for increasing the speed, cutting<br />

the cost <strong>and</strong> improving the quality of<br />

drug development. The new front-line<br />

methodologies often derive from basic<br />

sciences, such as molecular genetics,<br />

biomedicine, bioengineering <strong>and</strong><br />

information technology. Also techniques<br />

related to robotics <strong>and</strong> miniaturisation in<br />

pharmacology <strong>and</strong> pharmaceutics <strong>and</strong><br />

structure activity relations in absorption,<br />

distribution, metabolism <strong>and</strong> excretion<br />

studies <strong>and</strong> toxicology will contribute to<br />

faster, more efficient drug development, as<br />

can the auxiliary disciplines of analytical<br />

<strong>and</strong> processing chemistry.<br />

Education <strong>and</strong> training<br />

A highly qualified work force is also<br />

important. PhD <strong>and</strong> post-graduate<br />

students trained in up-to-date technologies<br />

<strong>and</strong> research areas will help to close the<br />

current gap between academia <strong>and</strong> the<br />

needs of industry. The present deficiencies<br />

are thought to be due to the small size of<br />

individual faculties, a lack of academic


<strong>and</strong> industrial integration <strong>and</strong> inadequate<br />

post-doctoral programmes. But, through<br />

training <strong>and</strong> mobility measures, the key<br />

action provides a basis for solving these<br />

problems by combining top level university<br />

research with front-line technology in<br />

areas where there is little or no training in<br />

Europe <strong>today</strong>.<br />

Concerted effort<br />

Thus a concerted effort put forward by the<br />

key action “New Safe Medicines Faster”<br />

has clear benefits that speak loudly in<br />

favour of its inclusion in the EU’s 6th<br />

Framework Programme. By crossing<br />

the divide between individual fields of<br />

research <strong>and</strong> development, industry<br />

<strong>and</strong> academia <strong>and</strong> transforming drug<br />

development into an integrated process,<br />

the European pharmaceutical industry<br />

will be better equipped to tackle the health<br />

<strong>and</strong> employment challenges of the future.<br />

First step taken<br />

The first version of the Proposal has been<br />

approved by the <strong>EUFEPS</strong>’ Executive<br />

Committee, <strong>and</strong> copies of it were<br />

submitted to the DG XII of the European<br />

Commission, <strong>and</strong> to EFPIA, to get their<br />

early comments <strong>and</strong> support. In the year<br />

to come, the collaboration on this with<br />

EFPIA will be exp<strong>and</strong>ed, as well as<br />

with others, to improve the proposal <strong>and</strong><br />

solidify the arguments with data <strong>and</strong> facts.<br />

Furthermore, the scientific content of the<br />

work programme of the key action should<br />

be worked out. To support this process,<br />

dedicated workshops will be arranged.<br />

Additional involvement welcome<br />

Support of this Proposal is needed<br />

XXIII<br />

also from you as member of the local<br />

pharmaceutical research communities at<br />

universities, industries, <strong>and</strong> hospitals. Only<br />

you can convince research councils <strong>and</strong><br />

research administration bodies in relevant<br />

ministries of your country about the value<br />

of this Proposal. Please bear in mind that it<br />

is your Minister in the European Council<br />

who in the very end decides the fate of this<br />

initiative.<br />

The full text of the <strong>EUFEPS</strong>/CIR<br />

Proposal can be obtained from the<br />

<strong>EUFEPS</strong> Secretariat, <strong>and</strong> CIR will<br />

welcome any comment to the Proposal<br />

itself, or to this Editorial, through the<br />

<strong>EUFEPS</strong> Secretariat.


<strong>EUFEPS</strong> Newsletter, 2000, vol. 9, issue 3<br />

March 15–16 ● 2000 ● Hotel Le Plaza ● Brussels<br />

Workshop Report<br />

New Safe Medicines<br />

Faster<br />

Ole J. Bjerrum, Professor<br />

Chair Workshop<br />

This Workshop was organised with<br />

the ultimate goal of increasing safety,<br />

efficacy, speed <strong>and</strong> process capacity for<br />

the downstream development of new safe<br />

drugs. Representatives from academia,<br />

industry <strong>and</strong> regulatory authorities<br />

made a thorough analysis of the key<br />

requirements to achieve this aim. The<br />

outcome will be presented in a report<br />

to the European Commission, as follow<br />

up on the <strong>EUFEPS</strong> proposal of July 1,<br />

1999, regarding the key action: New Safe<br />

Medicines Faster for the forthcoming<br />

EU’s 6th Framework Programme<br />

for Research <strong>and</strong> Technological<br />

Development.<br />

Organisation<br />

An organising committee with<br />

representatives from <strong>EUFEPS</strong>, EFPIA<br />

(European Federation of Pharmaceutical<br />

Industries <strong>and</strong> Associations), regulatory<br />

authorities, academia <strong>and</strong> industries stood<br />

behind the Workshop, cf. box.<br />

Organising Committee:<br />

Prof. G. Alderborn, Uppsala, SE<br />

(Academia)<br />

Prof. O. J. Bjerrum, Bagsværd, DK<br />

(Novo Nordisk)<br />

Prof. C.-M. Lehr, Saarbrücken, DE<br />

(Academia)<br />

Mr H.H. Lindén, Stockholm, SE<br />

(<strong>EUFEPS</strong>)<br />

Assoc. Prof. M.-I. Nilsson, Brussels, BE<br />

(Pharmacia & Upjohn)<br />

Dr J. Reden, Brussels, BE (EFPIA)<br />

Dr J. Renneberg, Copenhagen, DK<br />

(Regulatory)<br />

Prof. J. Vessman, Mölndal, SE<br />

(AstraZeneca)<br />

The Workshop had obtained support from<br />

the EU as an accompanying measure under<br />

Quality of Life in the 5th RTD Framework<br />

programme. Additional sponsoring for<br />

the Workshop, including for the reception<br />

<strong>and</strong> the dinner, was obtained from<br />

AstraZeneca (UK), Farmindustria (Italy),<br />

Novo Nordisk (Denmark), Organon<br />

(the Netherl<strong>and</strong>s), Pharmacia & Upjohn<br />

(Belgium) <strong>and</strong> Servier (France).<br />

Workshop participation took place<br />

only after invitation, since the organisers<br />

wanted to focus on the needs of the pharma<br />

industry achieved through a true bottomup<br />

process covering as many European<br />

companies as possible. Out of a total of<br />

approx. 115 Workshop participants, 75<br />

came from the pharmaceutical industry,<br />

including CROs (representing 36<br />

companies), 24 academia (20 universities<br />

<strong>and</strong> schools of pharmacy), <strong>and</strong> five<br />

regulators (four European agencies). Also,<br />

a number of officials <strong>and</strong> civil servants of<br />

the European Commission attended. The<br />

Organising Committee is very pleased with<br />

this outcome, including with the number<br />

of scientific fields that were represented<br />

by these delegates, although clinical<br />

pharmacology was underrepresented in<br />

the Workshop.<br />

Workshop structure<br />

To work with a reasonable number of<br />

participants seven discussion for a were<br />

created. The drug development process<br />

was divided into four sessions covering<br />

1. “How to select c<strong>and</strong>idate drugs faster”<br />

covering discovery <strong>and</strong> selection; 2.<br />

“How to bring c<strong>and</strong>idate drugs faster into<br />

human” enclosing the preclinical aspects;<br />

3. “How to bring c<strong>and</strong>idate drugs into<br />

full-scale production” containing upscaling<br />

<strong>and</strong> analytical chemistry <strong>and</strong> 4.<br />

“How to bring drugs faster to regulatory<br />

acceptance” comprising clinical trials <strong>and</strong><br />

regulatory dem<strong>and</strong>s. The special aspects<br />

XXIV<br />

Ole J. Bjerrum, Professor<br />

of biopharmaceuticals were covered in<br />

session five. “How to bring new biotech<br />

molecules into deliverable products”.<br />

The importance <strong>and</strong> expected impact of<br />

information technology (IT) were included<br />

in Workshop group 6: “How will IT be<br />

utilised to speed-up the drug development<br />

process?” Finally a fresh look was taken<br />

on the process per se in the session “How<br />

to reshape the drug development process<br />

from the beginning”.<br />

Day 1. Opening <strong>and</strong> Lectures<br />

The Workshop was opened at 1 p.m.<br />

by the President of <strong>EUFEPS</strong>, Professor<br />

Malcolm Rowl<strong>and</strong> <strong>and</strong> by the Director<br />

of the Quality of Life Programme at the<br />

Research Directorate of the European<br />

Commission, Mr Bruno Hansen. On<br />

behalf of Commissioner Busquin the<br />

latter welcomed the initiative <strong>and</strong> stressed<br />

the importance of being in contact with<br />

the users of future programmes at an early<br />

stage.<br />

To set the scene distinguished lecturers<br />

for each of the seven sessions were<br />

invited: Professor Trevor M. Jones, the<br />

Association of the British Pharmaceutical<br />

Industry, London in very fine fettle, gave<br />

the background for the current trends of<br />

the pharmaceutical industries. He pointed<br />

out that the developmental time after some<br />

years of reduction again shows increases.<br />

This put against the ever-increasing cost<br />

call for faster drug development, which<br />

he foresaw as the challenge of the 21st<br />

century.<br />

Dr Frank Fildes, AstraZeneca,<br />

Macclesfield also fit for fight, emphasised<br />

that “more c<strong>and</strong>idates faster are not enough<br />

- the quality of the c<strong>and</strong>idates is the key”.<br />

The winners should be picked earlier by<br />

predicting attributes with better data,<br />

earlier attrition <strong>and</strong> anticipating wasted


clinical trials. He also argued for a smooth<br />

discovery-development transition.<br />

Professor Staffan Folestad,<br />

AstraZeneca, Mölndal underlined the<br />

necessity of having a seamless process<br />

development with the right analytical tools<br />

at h<strong>and</strong> as real time direct measurements<br />

at line/in line (better pharmametrics).<br />

Further he saw a future in simulation <strong>and</strong><br />

modelling of processes.<br />

Dr Brian White-Guay, Merck Sharp<br />

& Dohme (Europe) Inc., Brussels,<br />

focused on the regulatory process as<br />

a bottleneck <strong>and</strong> suggested various<br />

improvements regarding modifications<br />

of the requirements, the efficiency, the<br />

transparency <strong>and</strong> quality st<strong>and</strong>ards.<br />

Professor Fritz Bühler, European<br />

Centre for Pharmaceutical Medicine,<br />

Basel advocated for a holistic approach<br />

involving European consortia: universitypharma<br />

industry-regulators together with<br />

data collection <strong>and</strong> analysis networks.<br />

For the clinical trials surrogate endpoints<br />

<strong>and</strong> biomarker validation were of outmost<br />

importance.<br />

Dr Alistair Shearin, PriceWaterhouse<br />

Coopers, London, also stressed the<br />

current imbalance due to the long <strong>and</strong><br />

costly developmental phase. Further<br />

he showed the power of the IT solution<br />

if implemented throughout the drug<br />

developmental process. Also he foresaw<br />

how simulation based on public databases<br />

of clinical data could reduce development<br />

time.<br />

Professor Daan Crommelin, Utrecht<br />

University underlined that better drug<br />

delivery was a big issue for biotech<br />

products <strong>and</strong> he promoted the importance<br />

of other delivery routes than injection for<br />

pharmaceutical proteins.<br />

Day 2. The Workshop Sessions<br />

Since faster drug development calls for<br />

• New Strategy, *Research <strong>and</strong><br />

innovation,<br />

• New techniques, methodologies <strong>and</strong><br />

processes,<br />

• Strengthened academic research <strong>and</strong><br />

training, <strong>and</strong><br />

• Flexible regulatory authorities, each<br />

Workshop Session was asked to deliver<br />

input regarding these aspects.<br />

The seven parallel groups worked<br />

enthusiastically under the chairmanship of<br />

the invited lecturers <strong>and</strong> after three hours<br />

of hard work all groups delivered very<br />

useful material. Through the rapporteurs<br />

(the Organising committee members<br />

supplemented with Professor S. Frøkjær,<br />

Copenhagen <strong>and</strong> Professor A. Grahnén,<br />

Stockholm) the material was presented in<br />

plenum by well-structured overheads <strong>and</strong><br />

the contents were further elucidated <strong>and</strong><br />

discussed.<br />

The results<br />

As an overall conclusion it was considered<br />

realistic to believe that the New Safe<br />

Medicines Faster proposal could form<br />

the basis for a new key action in the<br />

forthcoming 6th FP because drug<br />

development has<br />

• Well-defined deliverables to the<br />

citizens,<br />

• Interfaces to many scientific areas,<br />

• Bottlenecks to be addressed,<br />

• The need for pan-European<br />

collaboration,<br />

• Job generation potential,<br />

• Room for starts-up <strong>and</strong> small <strong>and</strong><br />

medium size enterprises (SMEs) <strong>and</strong><br />

• Links to topics of the former<br />

programmes.<br />

Besides this a wealth of concrete<br />

research topics to the key action was<br />

identified <strong>and</strong> brought forward. These<br />

lists of topics, methodologies <strong>and</strong><br />

techniques will in the coming months be<br />

further substantiated <strong>and</strong> discussed in<br />

subgroups <strong>and</strong> networks created during<br />

the Workshop. After final editing by the<br />

organising committee it will be delivered<br />

as a report to the Commission before<br />

summer holidays.<br />

The general conclusions<br />

• The key action New Safe Medicines<br />

Faster fulfils a real need<br />

• High front load implies down-stream<br />

bottlenecks<br />

• Joint effort with Regulatory is needed -<br />

right from the beginning<br />

• IT: integration is necessary for the<br />

truncation of the process<br />

• The importance of training <strong>and</strong><br />

education is equally important to<br />

research<br />

• Centre of Excellence, public databanks<br />

<strong>and</strong> databases are needed<br />

• The initiative has become concrete <strong>and</strong><br />

shows already impact.<br />

XXV<br />

Future actions<br />

In the closing session Professor Ole J.<br />

Bjerrum described the future actions<br />

necessary to drive the proposal to<br />

a successful completion. First of all<br />

continuous support is needed from all<br />

members organised under the <strong>EUFEPS</strong><br />

umbrella. Therefore in case you - as the<br />

reader of this - also want to contribute to<br />

the initiative your help is most appreciated.<br />

Join <strong>EUFEPS</strong>’ New Safe Medicines<br />

Faster mailing list <strong>and</strong> get involved in the<br />

description of the wanted research topics<br />

<strong>and</strong>/or be active as opinion leader <strong>and</strong><br />

ambassador for the proposal.<br />

Conclusion<br />

The Workshop laid a good foundation<br />

for the future work on promoting the key<br />

action New Safe Medicines Faster within<br />

EU’s 6th Framework Programme. Only<br />

through a massive EU funding it will<br />

be possible to create platforms where<br />

the necessary collaboration between<br />

regulatory, academia <strong>and</strong> industry can<br />

take place to introduce the so much needed<br />

changes in drug development process.<br />

Please remember that without such a<br />

conversion the high frontload of new drug<br />

c<strong>and</strong>idates cannot reach its ultimate target<br />

- the patients.<br />

Let the final words at the Workshop<br />

also be your motto: “Plan <strong>and</strong> act as the<br />

New Safe Medicines Faster program is<br />

real, <strong>and</strong> your dreams come true”.


<strong>EUFEPS</strong> Newsletter, 2001, vol. 10, issue 4<br />

Decennial Milestone<br />

The Decennial <strong>Anniversary</strong> of <strong>EUFEPS</strong><br />

is a milestone in the rather short <strong>history</strong><br />

of <strong>EUFEPS</strong>. It was celebrated, in the<br />

European Parliament in Strasbourg,<br />

France, with a “Decennial Conference<br />

on Optimising Drug Development” <strong>and</strong><br />

an <strong>Anniversary</strong> Ceremony, on Friday,<br />

September 21, 2001. Ten years earlier,<br />

<strong>EUFEPS</strong> had been inaugurated in<br />

Strasbourg.<br />

At the end of the Decennial<br />

Conference, the <strong>EUFEPS</strong> President<br />

Professor Dominique Duchêne opened<br />

the <strong>Anniversary</strong> Ceremony by welcoming<br />

all, including two of the three “founding<br />

fathers” of <strong>EUFEPS</strong>, Professor Stig<br />

Agurell <strong>and</strong> Professor Ernst Mutschler,<br />

with their wives, as well as Dr. Bruno<br />

Hansen, representing the European<br />

Commission. The third “founding father”,<br />

Professor Douwe D. Breimer was unable<br />

to attend the Friday Ceremony, but he<br />

arrived later in Strasbourg.<br />

In the <strong>Anniversary</strong> Address, Professor<br />

Duchêne referred to the establishment <strong>and</strong><br />

mission of <strong>EUFEPS</strong> <strong>and</strong> discussed what<br />

could <strong>and</strong> should be done, in the future.<br />

After this, Dr. Hansen presented the role<br />

<strong>and</strong> current activities of the European<br />

Commission to strengthen <strong>and</strong> exp<strong>and</strong><br />

European research, including in the health<br />

related field. He also acknowledged the<br />

significant contributions by <strong>EUFEPS</strong><br />

for the next European Framework<br />

Programme for Research <strong>and</strong><br />

Technological Development (FP6), <strong>and</strong><br />

he looked forward to future collaboration<br />

on science <strong>and</strong> research with <strong>EUFEPS</strong>.<br />

Professor Ole J. Bjerrum reported on the<br />

to date encouraging outcome of – <strong>and</strong><br />

future plans for – the <strong>EUFEPS</strong> New Safe<br />

Medicines Faster initiative (NSFM).<br />

In the <strong>Anniversary</strong> Ceremony, the<br />

“founding fathers” of <strong>EUFEPS</strong>, <strong>and</strong><br />

their impressive contributions to the<br />

development of <strong>EUFEPS</strong>, were duly<br />

recognised. Professors Agurell, Breimer<br />

<strong>and</strong> Mutschler were awarded a Decennial<br />

<strong>Anniversary</strong> Medal, the symbolic of<br />

which was explained by Professor Björn<br />

Lindeke, Secretary-General <strong>and</strong> Treasurer<br />

of <strong>EUFEPS</strong>. Executive Committee<br />

members were also awarded a diploma,<br />

with the same symbol, acknowledging<br />

their leadership <strong>and</strong> hard work to proceed<br />

along the lines early established <strong>and</strong><br />

to exp<strong>and</strong> the activities of <strong>EUFEPS</strong>.<br />

Professor Breimer received the Medal at<br />

the Council <strong>and</strong> <strong>Anniversary</strong> Dinner, on<br />

Saturday evening.<br />

After closing the Ceremony,<br />

conference delegates, guests, Council<br />

Members <strong>and</strong> <strong>EUFEPS</strong> officials got a<br />

chance to remember the past, exchange<br />

views on the present <strong>and</strong> plan for the<br />

future, while mingling <strong>and</strong> enjoying the<br />

<strong>Anniversary</strong> Cocktail, also in the facilities<br />

of the European Parliament.<br />

XXVI


XXVII


XXVIII


XXIX


<strong>EUFEPS</strong> Newsletter, 2001, vol. 10, issue 4<br />

<strong>EUFEPS</strong> 10 th anniversary<br />

European Federation<br />

for Pharmaceutical<br />

Sciences<br />

Dominique Duchêne, Professor<br />

<strong>EUFEPS</strong> President<br />

Ten years ago here in Strasbourg,<br />

<strong>EUFEPS</strong> was founded in the presence<br />

of Anders Björck, the President of the<br />

Parliamentary Assembly of the Council<br />

of Europe.<br />

This was the accomplishment of a<br />

challenge launched by 3 scientists, 3<br />

great Europeans: Stig Agurell, Douwe<br />

Breimer <strong>and</strong> Ernst Mutschler. They<br />

recognized the need for an independent<br />

European scientific body to promote the<br />

European pharmaceutical sciences at the<br />

highest international level, with a simple<br />

objective: to serve <strong>and</strong> advance excellence<br />

in pharmaceutical sciences <strong>and</strong> innovative<br />

drug research. In their task, they were<br />

strongly <strong>and</strong> financially supported by the<br />

Swedish Pharmaceutical Society.<br />

The scientific potential of Europe<br />

is known, but too often isolated <strong>and</strong> not<br />

well enough organized <strong>and</strong> co-ordinated.<br />

The task of <strong>EUFEPS</strong> is to contribute to<br />

the reversal of such a situation. This can<br />

be achieved by a fruitful international<br />

competition in which Europe has to<br />

participate as full partner, not for the<br />

egotistical contentment of scientists, but<br />

for the benefit of health.<br />

From the scientific st<strong>and</strong>point, as<br />

well as from the political one, Europe is<br />

characterized by its diversity. This is both<br />

a strength <strong>and</strong> a weakness. It is a strength,<br />

because diversity can generate scientific<br />

ideas in profusion. But it is a weakness,<br />

because it is energy- <strong>and</strong> time-consuming.<br />

<strong>EUFEPS</strong> has to co-ordinate this inherent<br />

diversity without destroying it. What can<br />

be done by <strong>EUFEPS</strong>?<br />

Members<br />

On Saturday 21 September 1991, 16<br />

societies representing 15 countries from<br />

all over Europe (north to south, east to<br />

west) constituted the founding members.<br />

The societies were from: Austria, Croatia,<br />

Czechoslovakia, Denmark, Finl<strong>and</strong>,<br />

France, Germany, Greece, Hungary, Italy,<br />

Pol<strong>and</strong>, Sweden, The Netherl<strong>and</strong>s, Turkey<br />

<strong>and</strong> the United Kingdom.<br />

Today, the number of our member<br />

societies has increased significantly to 25<br />

societies representing 23 countries <strong>and</strong><br />

approximately 25,000 members.<br />

The objective of <strong>EUFEPS</strong>, as a<br />

European federation, is to have member<br />

societies from all the European countries,<br />

<strong>and</strong> to represent all the pharmaceutical<br />

sciences. This is not easy to achieve, for<br />

several reasons:<br />

First, the reason why a scientific<br />

society should become member of<br />

<strong>EUFEPS</strong> is not clear to some of them, who<br />

wonder what could be their benefit from<br />

membership. In fact, there is no benefit,<br />

except the satisfaction of participating in a<br />

European task, for those who want. But, if<br />

they do, both scientists <strong>and</strong> the citizens of<br />

Europe will benefit.<br />

We are aware of the difficulties some<br />

European societies may have to pay<br />

their subscription whatever our effort<br />

in adapting the membership fees to the<br />

country <strong>and</strong> the number of members of<br />

the societies.<br />

It is also difficult to have member<br />

societies representing the different<br />

pharmaceutical sciences because of the<br />

great diversity of the European societies.<br />

Some are national pharmaceutical<br />

societies. They represent all the different<br />

aspects of pharmacy: community<br />

pharmacy, hospital, industry, academia,<br />

etc. Some other member societies represent<br />

a well-defined pharmaceutical science.<br />

To have fruitful collaborations with our<br />

member societies, we need to know<br />

precisely their best scientific domain.<br />

XXX<br />

Dominique Duchêne, Professor<br />

At the beginning of the year we sent<br />

them a questionnaire, a matrix in which<br />

appeared, on one side, the pharmaceutical<br />

disciplines (academic approach), <strong>and</strong>, on<br />

the other side, the processes (industrial<br />

approach). We asked our member societies<br />

to locate themselves on this matrix, but<br />

unfortunately, probably due to insufficient<br />

explanation from our part, the answers<br />

were not as precise as expected.<br />

Other European Organisations<br />

There also exist European federations of<br />

different pharmaceutical sciences, such as:<br />

EACPT (European Association of Clinical<br />

Pharmacology <strong>and</strong> Therapeutics), EFMC<br />

(European Federation for Medicinal<br />

Chemistry), Eurotox, ESBP (European<br />

Society of Biopharmacy), EFPIA<br />

(European Federation of Pharmaceutical<br />

Industry Associations), etc. with which<br />

we already have contacts. Some of them<br />

would like to co-operate closely with<br />

<strong>EUFEPS</strong>, <strong>and</strong> we have or are preparing<br />

letters of underst<strong>and</strong>ing. In the near future,<br />

we will probably be obliged to create a<br />

new type of membership to give them the<br />

possibility of becoming true members of<br />

<strong>EUFEPS</strong>.<br />

We also have individual members,<br />

approximately 500. With them, with the<br />

scientists recommended by our member<br />

societies, we expect to create a virtual<br />

school of excellence.<br />

Roles of <strong>EUFEPS</strong><br />

The different memberships of <strong>EUFEPS</strong><br />

should not represent a kind of private club<br />

for scientists, but a powerful group capable<br />

of serving <strong>and</strong> advancing excellence in<br />

pharmaceutical sciences <strong>and</strong> innovative<br />

drug research.<br />

One of the roles of <strong>EUFEPS</strong> is to<br />

encourage the organization of scientific


events, more especially when they<br />

result from a co-operation between<br />

different <strong>EUFEPS</strong> member societies or<br />

any scientific societies, or when they<br />

are organized at a regional level. These<br />

conditions can ensure the dissemination<br />

(<strong>and</strong> progress) of science <strong>and</strong> prevent too<br />

confidential an aspect.<br />

<strong>EUFEPS</strong> also has the possibility<br />

of organizing scientific events by itself,<br />

but <strong>EUFEPS</strong> does not want to compete<br />

or to overlap with its member societies.<br />

This is the reason why, up to now, most<br />

of the symposia we have organized have<br />

been process-oriented <strong>and</strong> belonged to a<br />

series ‘Optimising Drug Development’.<br />

The theme <strong>and</strong> the programme of these<br />

symposia have, in many cases, been<br />

proposed by the <strong>EUFEPS</strong> Committee for<br />

Industrial Relations.<br />

However, <strong>EUFEPS</strong> needs to<br />

strengthen its co-operation with academia.<br />

This is why the Committee for Academic<br />

Relations was recently created, <strong>and</strong> will<br />

propose a new series of symposia ‘New<br />

Trends in….’ which will contribute to the<br />

dissemination of the most recent scientific<br />

results.<br />

An example of the type of<br />

collaboration we would like to establish<br />

with our members, for the benefit of the<br />

pharmaceutical sciences, is the Fair of<br />

Pharmaceutical Sciences we intend to<br />

hold most probably in June 2005 in Nice,<br />

France. This fair will be characterized<br />

by the fact that at the same period, in the<br />

same place our member societies <strong>and</strong> all<br />

the European scientific societies involved<br />

in drug development will be invited to<br />

hold jointly, their most scientific meeting,<br />

on the platform of <strong>EUFEPS</strong>. There will be<br />

two or three-day conferences with parallel<br />

sessions, as well as one-day symposia.<br />

We are expecting several thous<strong>and</strong><br />

participants <strong>and</strong> we feel that exhibitors<br />

will be interested in joining this event.<br />

For our current member societies, this<br />

project will be detailed at our Council,<br />

on Saturday afternoon. In any event, they<br />

will be contacted in the coming weeks or<br />

months to build this project with us <strong>and</strong> to<br />

participate in its success.<br />

These different symposia, conferences<br />

<strong>and</strong> fairs, cannot be restricted to European<br />

scientists <strong>and</strong> participants. The contacts<br />

we have had at the inter-continental level<br />

with ISSX, AAPS (American Association<br />

of Pharmaceutical Scientists), APST Japan<br />

(Academy of Pharmaceutical Sciences <strong>and</strong><br />

Technology), CRS (Controlled Release<br />

Society), <strong>and</strong> FDA, greatly facilitate the<br />

organization of very high-level meetings.<br />

At the world level, we are holding<br />

discussions with the FIP (Fédération<br />

Internationale Pharmaceutique). Our main<br />

objective is to become their necessary<br />

partner for the scientific events they will<br />

organize in Europe <strong>and</strong> more especially<br />

the 3rd Pharmaceutical Sciences World<br />

Congress, which will take place in Europe<br />

in 2007, after San Francisco in 2000 <strong>and</strong><br />

Kyoto in 2004.<br />

The dissemination of knowledge must<br />

not take place only between scientists from<br />

different domains <strong>and</strong> countries, but also<br />

between generations: the role of <strong>EUFEPS</strong><br />

in training <strong>and</strong> education has been pointed<br />

out from the very beginning of <strong>EUFEPS</strong>.<br />

It is not the role of <strong>EUFEPS</strong> to teach<br />

pharmacy, but it is the role of <strong>EUFEPS</strong> to<br />

give post-docs, pharmacists <strong>and</strong> engineers<br />

high-level training in the most advanced<br />

domains. Our Committee for Education<br />

<strong>and</strong> Training is discussing 3 training<br />

sessions, hopefully to take place next year,<br />

on bio-informatics, high-throughput drug<br />

metabolism, <strong>and</strong> combinatorial chemistry.<br />

In the future, the school of excellence,<br />

we have progressively organized will<br />

contribute to this activity.<br />

I said that it is not the role of <strong>EUFEPS</strong><br />

to teach pharmacy, but it can be the role<br />

of <strong>EUFEPS</strong> to discuss the content <strong>and</strong><br />

the structure of this teaching. This is the<br />

reason why we answered the request of<br />

EAFP (European Association of Faculties<br />

of Pharmacy) <strong>and</strong> EPSA (European<br />

Federation of Pharmacy Students<br />

Associations) <strong>and</strong> decided to have one<strong>and</strong>-a-half<br />

days of discussions <strong>and</strong><br />

exchange with them in spring 2002.<br />

The dissemination of knowledge<br />

must not be done exclusively by meetings,<br />

whatever their nature, because they are not<br />

only costly, but they necessitate travel, <strong>and</strong><br />

time. Another possibility is constituted<br />

by scientific publications. From its very<br />

beginning, <strong>EUFEPS</strong> decided to have a<br />

scientific journal: the European Journal<br />

of Pharmaceutical Sciences, published by<br />

Elsevier. The successive editors-in-chief<br />

(Hans Junginger, Per Artursson, <strong>and</strong> Arto<br />

XXXI<br />

Urtti) strongly contributed to its present<br />

success. For the future, we can imagine<br />

another kind of publication: a book series<br />

edited by <strong>EUFEPS</strong> together with members<br />

of our virtual school of excellence. Such a<br />

series should constitute a reference library<br />

for the pharmaceutical sciences.<br />

The adequate development of a<br />

Federation, such as <strong>EUFEPS</strong>, <strong>and</strong> the<br />

recognition of its efficiency requires a<br />

special activity: lobbying…<br />

We have done it, at the level of the<br />

European Commission, <strong>and</strong> this has<br />

been one of our best successes. Thanks<br />

to Ole Bjerrum <strong>and</strong> through a workshop<br />

we organized about two years ago<br />

in Brussels, we are promoting a new<br />

concept: New Safe Medicines Faster. It<br />

is a research proposal to strengthen the<br />

European competitiveness in innovation,<br />

development <strong>and</strong> use of new <strong>and</strong> better<br />

drugs. It also necessitates the creation of<br />

stronger links between industry, hospitals<br />

<strong>and</strong> regulatory authorities, for the benefit of<br />

European citizens. The means of reaching<br />

such a goal is to have more efficient use<br />

of modern technology. We are very proud<br />

to tell you that New Safe Medicines<br />

Faster already constitutes a topic of the<br />

6th European Research <strong>and</strong> Technical<br />

Development Framework Programme,<br />

<strong>and</strong> that we received congratulations from<br />

the Commission.<br />

Collaboration important<br />

In conclusion, <strong>and</strong> taking advantage of the<br />

presence of Director Bruno Hansen from<br />

the Life Sciences General Direction at<br />

the European Commission, who is living<br />

proof of the interest of the Commission<br />

in innovative activities, I want to insist on<br />

the fact that <strong>EUFEPS</strong> will not fail in its<br />

mission: promote <strong>and</strong> advance excellence<br />

in the pharmaceutical sciences.<br />

<strong>EUFEPS</strong> will refuse to consider<br />

European diversity as a drawback, but it<br />

will take advantage of this diversity <strong>and</strong><br />

use it through close collaboration with its<br />

societies concerned with the progress of<br />

the pharmaceutical sciences in Europe.<br />

Such collaboration requires a<br />

permanent dialogue between <strong>EUFEPS</strong><br />

<strong>and</strong> its members <strong>and</strong> I encourage you<br />

to criticize, suggest, construct <strong>and</strong> win<br />

altogether.


<strong>EUFEPS</strong> Newsletter, 2002, vol. 11, issue 3<br />

A need for Excellence<br />

in Pharmaceutical<br />

Sciences<br />

Ole J. Bjerrum, Professor<br />

<strong>EUFEPS</strong> Vice-President<br />

The scene<br />

At the present time, the pharmaceutical<br />

sciences in Europe are both under<br />

pressure <strong>and</strong> increasingly supported.<br />

This paradox derives from the rapid<br />

changes that our society is going through<br />

technologically <strong>and</strong> structurally. Until<br />

now, the main body of the pharmaceutical<br />

sciences has been taught in Schools or<br />

Faculties of Pharmacy within universities.<br />

However, many of the classical roles of<br />

the individual practising pharmacist are<br />

diminishing while other roles are actually<br />

increasing e.g. due to polypharmacy<br />

<strong>and</strong> the evolution in the preventive use<br />

of drugs. In many European countries,<br />

the industry’s dem<strong>and</strong> for pharmacists<br />

is increasing leading to requests for new<br />

topics in the educational curriculum. These<br />

trends have put a squeeze on the present<br />

structures of the pharmacy institutions.<br />

Generally speaking, if the adaptations<br />

required to meet the challenges of the<br />

new developments <strong>and</strong> the needs of the<br />

industry are not implemented, one may<br />

fear that the present school structures in<br />

many places will not survive.<br />

The wrong response<br />

Since the half-life of scientific <strong>and</strong><br />

technological advances is much shorter<br />

than the half-life for turnover of academic<br />

scientists, it is sometimes difficult for<br />

the latter to keep pace with the changes<br />

if not active in research. Falling back on<br />

well-established privileges may delay the<br />

process locally but overall it will not avoid<br />

the need for adjustments in the longer<br />

term.<br />

The right response<br />

It is much better to be open to the<br />

current trends, before they finally result<br />

in dem<strong>and</strong>s from politicians. The new<br />

openings, which are structural as well as<br />

economic, should be exploited proactively.<br />

The essence is to have enough money to<br />

be in a position to protect the key values of<br />

the educational disciplines. The training<br />

in the schools of pharmacy should be<br />

potentiated with addition of new courses<br />

e.g. (bio)technology <strong>and</strong> economics.<br />

Also new curicula developed together<br />

with schools in other European countries<br />

should be considered as European Master<br />

degrees. It is probable that the medicines<br />

distribution system will undergo major<br />

changes in the future, which ultimately<br />

will result in a reduced need for the<br />

classical dispensing role of the pharmacist.<br />

To survive the pressure, it is important for<br />

the pharmaceutical world to be strong. We<br />

have to strive for excellence in all that we<br />

do, including the sciences, which are our<br />

foundations.<br />

Where are the positive trends?<br />

A major opportunity lies in reorientation<br />

with the many new stakeholders involved<br />

in discovery, development, production <strong>and</strong><br />

consumption of medicines. The economic<br />

activity here increases every day <strong>and</strong> with<br />

that the involvement of pharmacists. In<br />

other words, the drug development process<br />

as a whole represents an exp<strong>and</strong>ing market.<br />

Note that under such conditions it is much<br />

easier to become a significant player in the<br />

market if so wished.<br />

Where to get strength<br />

Since the foremost dominating player<br />

in this connection is the pharmaceutical<br />

industry, the likeliest orientation is to their<br />

needs, but don’t neglect the other players if<br />

your scientific <strong>and</strong> organisational strengths<br />

point in their direction. The future lies in<br />

collaborative arrangements including the<br />

XXXII<br />

pharmaceutical industry <strong>and</strong> the medical<br />

<strong>and</strong> health professional world. When the<br />

concept of individualised therapies gains<br />

momentum, closer relations to the clinical<br />

arena are essential.<br />

What is excellence?<br />

Scientists are open to fair competition as it<br />

is seen through the refereeing system for<br />

articles in scientific journals, for example.<br />

Thus the route to excellence for results <strong>and</strong><br />

“products” goes through comparison <strong>and</strong><br />

competition. To have enough space for<br />

this, the national scene often is too narrow,<br />

at least for many small countries. For this<br />

reason, competition at the European level<br />

is the rational next step in the process of<br />

reaching for excellence.<br />

How to reach excellence<br />

If you want to reach excellence this can<br />

happen through: 1. Competition for<br />

national <strong>and</strong> supranational money (from<br />

EU). 2. Potentiation of interdisciplinary<br />

research. 3. Optimisation of your actual<br />

critical mass, for example, through<br />

mergers, alliances, collaborations, <strong>and</strong><br />

network creations. 4. Preferential research<br />

carriers at universities. Just now, there is<br />

no excuse for not trying these routes, as the<br />

pharmaceutical sciences are stated topics<br />

in the 6th EU Framework Programme<br />

(FP6) starting in 2003. Remember when<br />

the scientific topics are first defined,<br />

money for all accompanying measures<br />

linked to these topics is released. Some<br />

of the many pharmacy institutions in<br />

Europe have a tradition of international<br />

collaboration but many keep back because<br />

they don’t consider themselves to be<br />

strong enough for partnering. Nothing is<br />

more wrong. There is room for you if you<br />

want. Look out for alliances, networks,<br />

collaborations <strong>and</strong> consortia. Here it is


important to remember that collaboration<br />

does not necessarily need to be with others<br />

of your kind. By the involvement of other<br />

stakeholders of the drug development<br />

process i.e. disparate scientific disciplines,<br />

start-up companies <strong>and</strong> established<br />

industries, medical doctors <strong>and</strong> hospital<br />

providers, medicinal agencies <strong>and</strong> other<br />

authorities, you will be helped on your<br />

way. The list of “Expressions of Interest”<br />

for future EU applications, published<br />

elsewhere in this issue, could function as<br />

a first map for such networking.<br />

<strong>EUFEPS</strong> role<br />

Not all results <strong>and</strong> products can be<br />

submitted for competition in a European<br />

context <strong>and</strong> thereby be selected for<br />

<strong>EUFEPS</strong> Newsletter, 2003, vol. 12, issue 1<br />

excellence, for example for obtaining<br />

financial support through FP6. For this<br />

reason, the level of excellence has to be<br />

defined in additional ways. Since <strong>EUFEPS</strong><br />

represents all the pharmaceutical sciences<br />

in Europe it also represents the natural<br />

platform for setting common European<br />

denominators for excellence regarding<br />

education, science <strong>and</strong> training, as well<br />

as other issues of common interest for the<br />

pharmaceutical scientific community as<br />

a whole. Indeed this is part of <strong>EUFEPS</strong><br />

strategy for 2002–2006, which will be<br />

presented at the Council meeting in<br />

Stockholm on 20th October 2002.<br />

‘Safety Sciences’<br />

– a way out of the<br />

attrition dilemma<br />

<strong>EUFEPS</strong> Committee on Industrial Relations<br />

The <strong>EUFEPS</strong> Committee on Industrial<br />

Relations (CIR) produced this discussion<br />

paper <strong>and</strong> presented it at a recent<br />

meeting of the <strong>EUFEPS</strong> Executive<br />

Committee, who wanted to see it<br />

published. Moreover, the Committee<br />

strongly supports the CIR in urging<br />

you - from academia, industry <strong>and</strong><br />

regulatory - to read it <strong>and</strong> to open a<br />

discussion on “safety sciences <strong>and</strong> the<br />

attrition dilemma”. (Editor: why not in<br />

this Newsletter? see below) Also, please<br />

indicate your interest in participating in<br />

forthcoming activities.<br />

The CIR is a <strong>EUFEPS</strong> think-tank,<br />

a proactive <strong>and</strong> sometimes provocative<br />

group, meeting once or twice a year.<br />

Primarily, it is there to strengthen the<br />

industrial pharmaceutical sciences <strong>and</strong><br />

scientists.<br />

The current state:<br />

Steadily increasing investments <strong>and</strong><br />

fantastic numbers of screened molecules<br />

as well as higher <strong>and</strong> higher numbers of<br />

selected compounds for development<br />

did not reverse the steady decline in the<br />

number of drugs reaching the market<br />

during the past years. There were only<br />

16 NDA submissions across the pharmaindustry<br />

in 2002 compared to 34 in 2001<br />

<strong>and</strong> 32 in 2000. This may be one of the main<br />

reasons why shareholders lose interest <strong>and</strong><br />

trust in our business. It looks like the low<br />

hanging fruits in pharmaceutical R&D<br />

have been harvested! The complexity of<br />

our business makes a rapid turnaround in<br />

drug development unlikely. The growing<br />

number of new <strong>and</strong> unexplored drug<br />

targets is accompanied by decreasing<br />

knowledge of the safety aspects of<br />

potential medicines <strong>and</strong> thus by higher<br />

risks for investment.<br />

We observe an increasing resistance<br />

of our society voiced by regulatory<br />

authorities to accept even theoretical<br />

safety risks from drugs, which are not<br />

life-saving. Thus, there is a need for early<br />

XXXIII<br />

Last words<br />

Thus if you want excellence in<br />

pharmaceutical sciences:<br />

• European st<strong>and</strong>ards are in dem<strong>and</strong> –<br />

a strong <strong>EUFEPS</strong> is necessary.<br />

• Exploit <strong>EUFEPS</strong> – the federation may<br />

help you.<br />

• Support <strong>EUFEPS</strong> – you are needed.<br />

signal detection <strong>and</strong> risk management<br />

before the costly clinical development<br />

phases start. However, it would be too<br />

easy to claim that increasing regulatory<br />

dem<strong>and</strong>s are a major reason for the lack<br />

of success of the pharma-industry. The<br />

number of filings dropped actually before<br />

authorities saw the dossiers.<br />

Simplifying, one could state that, as<br />

a long-term solution to the problem, top<br />

management has little more in the toolbox<br />

than the request for an increase of the<br />

productivity goals for drug discovery.<br />

All too often success of a Discovery<br />

organization is limited to a high quantitative<br />

output of new molecules without paying<br />

attention to a sufficient sustainability of the<br />

c<strong>and</strong>idates. To arrange for the short-term<br />

success that is important for shareholder<br />

satisfaction, the obvious portfolio <strong>and</strong><br />

productivity gaps have often been bridged<br />

in “big pharma” by acquisition of external<br />

portfolios. This strategy buys time but<br />

is not necessarily accompanied by a


paradigm shift regarding the quality of<br />

internal productivity, which undoubtedly<br />

will drive the mature portfolio in the 6 to<br />

10 years to come.<br />

We often hear that the remedy for<br />

the present situation is seen in a decrease<br />

of the attrition of early c<strong>and</strong>idates. This<br />

is the wrong direction! Before c<strong>and</strong>idate<br />

selection <strong>and</strong> prior to entering clinical<br />

development, the attrition should be very<br />

high. Thereafter of course, it must be<br />

low or as close to zero as possible. If one<br />

would follow logic then early attempts<br />

to screen out molecules should focus on<br />

the main causes of failure that we can<br />

influence – if the principal stakeholders<br />

accept a paradigm shift through very early<br />

partnership. This partnership is still far<br />

from optimal in most companies despite<br />

the fact that safety issues are – after lack<br />

of efficacy – the most important reason<br />

for attrition. Knowing that pre-clinical<br />

safety plays <strong>today</strong> a subordinate role in the<br />

selection process of a drug c<strong>and</strong>idate <strong>and</strong><br />

that Discovery’s efficacy models make<br />

often a rather questionable prediction<br />

of the desired efficacy in the human<br />

target (disease) population, one cannot<br />

be surprised about the result, i.e. high<br />

attrition during those drug development<br />

phases that start being very expensive, due<br />

to lack of both safety <strong>and</strong> efficacy. Hence,<br />

there is real urgency to partner between<br />

Discovery <strong>and</strong> the scientists involved<br />

in pre-clinical Drug Safety to improve<br />

safety-related attrition at least.<br />

Our industry cannot afford any<br />

longer to start with safety evaluation<br />

only once the c<strong>and</strong>idates are selected,<br />

knowing that many of them will fail rather<br />

quickly thereafter due to safety issues.<br />

Many of these compound deficiencies<br />

could have been discovered prior to<br />

c<strong>and</strong>idate selection if enough API (Active<br />

Pharmaceutical Ingredient) had been<br />

available for a base set of experiments<br />

looking at more than just acute toxicity,<br />

genotoxicity <strong>and</strong> QT interval prolongation.<br />

Examples include: photo-toxicity,<br />

phospholipidosis, a reasonably short in<br />

vivo study in a suitable rodent or small<br />

non-rodent, the use of geneexpression <strong>and</strong><br />

metabonomics data as well as any other<br />

pro-active data gathering that is tailored<br />

to the needs of c<strong>and</strong>idate selection <strong>and</strong><br />

to the development path of the future<br />

drug, taking into account the indication,<br />

target patient population with possible<br />

specific hazards, etc. Most importantly,<br />

experienced multi-disciplinary safety<br />

experts will have to be an integral <strong>and</strong><br />

creative part of the project teams during<br />

pre-c<strong>and</strong>idate selection. Unfortunately,<br />

preclinical safety people have in the past<br />

not been viewed as creative contributors<br />

to drug discovery. They rather have the<br />

image of obstacles to productivity. As a<br />

consequence, companies prefer investing<br />

in increasing the number of discovery<br />

scientists <strong>and</strong> new technologies promising<br />

to fulfil the (short term) productivity<br />

goals. This strategy has been in place now<br />

for over ten years <strong>and</strong> companies get what<br />

they reward for, i.e. high numbers of drug<br />

c<strong>and</strong>idates whereas overall productivity<br />

in terms of successfully launched<br />

innovative drugs still drops. So, in order<br />

to progress logically one should strive<br />

for a high safety-related attrition (of the<br />

right molecules!) through a much earlier<br />

(target identification!) more intense <strong>and</strong><br />

integrated partnership between Discovery<br />

<strong>and</strong> preclinical as well as clinical safety<br />

scientists (safety pharmacology, DMPK,<br />

toxicology, clinical) with the goal to<br />

increase the confidence in the safety of a<br />

molecule, at the latest when it is selected<br />

as a drug c<strong>and</strong>idate. The solution cannot<br />

be to simply shift the conventional safety<br />

studies necessary for Phase I into the prec<strong>and</strong>idate<br />

selection phase. The solution<br />

should rather be to use our grey matter<br />

before we test the white powder in order<br />

to come to a tailor made safety strategy for<br />

every new molecule!<br />

The future:<br />

Today the profile of a pre-clinical safety<br />

scientist has to go significantly beyond<br />

the one of a traditional toxicologist. The<br />

future safety scientist has to integrate<br />

knowledge accumulated in all safety<br />

relevant disciplines (primary & secondary<br />

pharmacology, functional genomics,<br />

safety pharmacology, ADME, physicochemistry,<br />

clinical <strong>and</strong> toxicology with all<br />

its special branches) to excel in modern risk<br />

assessment <strong>and</strong> risk management. In order<br />

to succeed in this ambitious endeavour,<br />

there is an urgent need for improved,<br />

XXXIV<br />

enhanced <strong>and</strong> adapted academic training<br />

in safety sciences, aiming at closing the<br />

gap perceived in industry <strong>and</strong> regulatory<br />

sciences. This gap becomes evident if<br />

one tries to hire an experienced safety<br />

scientist. Several university courses<br />

such as veterinary medicine, pharmacy,<br />

medicine <strong>and</strong> biology should provide<br />

its students from the beginning with a<br />

transparent avenue towards a future career<br />

in multi-disciplinary ‘Safety Sciences’.<br />

The latter must therefore become a visible<br />

<strong>and</strong> attractive area of specialization.<br />

How to proceed:<br />

A rational approach for enhanced training<br />

in safety sciences with a potential midterm<br />

impact would be to seek input from<br />

the interested parties (Academia, Industry<br />

<strong>and</strong> Regulatory Agencies), during a<br />

workshop focusing through case studies on<br />

training needs in our university education<br />

system. Such a gap analysis could then<br />

serve to draft a post-graduate curriculum<br />

for a safety scientist, identify already<br />

existing elements for a tailored training<br />

program <strong>and</strong> draft a staged approach to<br />

meet the evident additional needs. An<br />

increase in the quality of existing postgraduate<br />

training <strong>and</strong> education could<br />

have an impact relatively quickly, while a<br />

real mid- to long-term improvement can<br />

probably only be achieved, if the support<br />

of European partners in the education<br />

of future safety scientists can be gained<br />

through the realization that there is a<br />

true chance for a scientific career. This<br />

career will have broad benefit not only<br />

for the pharmaceutical industry, the<br />

related regulatory agencies <strong>and</strong> eventually<br />

the patient, but also for food, chemical<br />

<strong>and</strong> cosmetic industries <strong>and</strong> agencies<br />

protecting the environment from toxins,<br />

to name the most obvious ones. Last but<br />

not least a strong science driven safety<br />

evaluation will serve the 3 R’s (Refinement,<br />

Reduction <strong>and</strong> Replacement of animals). If<br />

this rule is applied strictly then molecules<br />

that do not merit development from a<br />

safety point of view should not go beyond<br />

initial pre-selection stages <strong>and</strong> will thus<br />

not enter costly development phases that<br />

require preparation by safety studies using<br />

dogs <strong>and</strong>/or non-human primates.


<strong>EUFEPS</strong> Newsletter, 2003, vol. 12, issue 2<br />

Pharmaceutical<br />

Sciences Fair<br />

Dominique Duchêne, Professor<br />

<strong>EUFEPS</strong> President<br />

Professor Dominique Duchêne<br />

introduces a new <strong>EUFEPS</strong> initiative.<br />

What is it?<br />

This is a completely new concept<br />

launched by <strong>EUFEPS</strong>: to gather together<br />

the European Pharmaceutical Sciences<br />

societies, associations <strong>and</strong> federations, for<br />

the joint organization of a world event in<br />

pharmaceutical sciences.<br />

One year ago, the <strong>EUFEPS</strong> member<br />

societies, as well as the major European<br />

federations <strong>and</strong> organisations involved in<br />

the promotion of specific pharmaceutical<br />

sciences, were invited by <strong>EUFEPS</strong> to<br />

cooperate in the organisation of a Fair of<br />

Pharmaceutical Sciences. These societies<br />

will be invited to organise or co-organise<br />

scientific events. There will be congresses<br />

with parallel sessions for several days <strong>and</strong><br />

symposia on well defined topics for one or<br />

two days, combining invited prestigious<br />

speakers with scientific contributions (oral<br />

or posters). The partner societies will be<br />

responsible for the scientific content of<br />

their respective events. <strong>EUFEPS</strong> will set up<br />

the platform <strong>and</strong> co-ordinate the different<br />

activities. This proposal was enthusiastically<br />

received by many of our member societies<br />

<strong>and</strong> other European scientific organisations.<br />

Who will participate? On what<br />

topics?<br />

Up to now, more than 50% of our member<br />

societies (Austria, Belgium, Denmark,<br />

Finl<strong>and</strong>, France, Great Britain, Hungary,<br />

Italy, Slovenia, Spain, Sweden, Switzerl<strong>and</strong>,<br />

The Netherl<strong>and</strong>s, Turkey) indicated<br />

their willingness to participate actively, as<br />

well as ISSX, PEFRAS, IPEC, EFB/EAPB,<br />

EPSA <strong>and</strong> the European Pharmacopoeia.<br />

The different events, congresses or<br />

symposia, will deal with: Pharmaceutical<br />

Technology/Pharmaceutics, Excipients,<br />

Drug Disposition/Metabolism/Safety,<br />

Biotechnology, Proteomics, Biomarkers,<br />

Bioanalysis, Medicinal Plants/Natural<br />

Products, Regulatory Aspects of<br />

Pharmaceutical Sciences. All this will fill<br />

5 days <strong>and</strong> 6 parallel sessions, to which a<br />

prestigious half-day opening session will<br />

be added.<br />

Beside this purely scientific aspect, all<br />

our member societies <strong>and</strong> the European<br />

pharmaceutical sciences organisations<br />

are invited to introduce their society, their<br />

members, their major objectives <strong>and</strong> their<br />

activities through a st<strong>and</strong>.<br />

Last but not least, an exhibition will<br />

take place, open to all the partner companies<br />

of drug research <strong>and</strong> development<br />

activities: raw materials, apparatus for<br />

physico-chemical evaluation, production<br />

equipment, animal technologies, startup<br />

companies, etc. About 100 to 150<br />

exhibitors are expected.<br />

Different social events will take place,<br />

either global events for the whole Fair or<br />

separate events for the partner societies<br />

which are encouraged to organise cocktail<br />

parties, in the same place on the same<br />

evening.<br />

Where <strong>and</strong> when will the Fair take<br />

place?<br />

For such an event a very attractive, wellequipped,<br />

conference centre is essential.<br />

This is the reason why the Nice Acropolis<br />

Conference Centre was chosen for the<br />

first Pharmaceutical Sciences Fair. The<br />

Fair will take place in 2005, <strong>and</strong> more<br />

precisely from June 12–17, which normally<br />

corresponds to very pleasant weather on<br />

the French Côte d’Azur.<br />

We intend that the next Fair would be<br />

held in 2008, in Vienna, <strong>and</strong> then regularly<br />

every two years in different European<br />

cities.<br />

XXXV<br />

Up to now, what has been done?<br />

The partner societies are known. The<br />

scientific programme is being set up. The<br />

conference centre is already reserved with<br />

rooms adapted to the different events. A<br />

preliminary budget has been established.<br />

The share of risk <strong>and</strong> benefit has been<br />

defined. The Pharmaceutical Sciences<br />

Fair has been definitively chosen as the<br />

name of this event, with the abbreviation<br />

of PharmSciFair.<br />

The leading team has been nominated.<br />

Currently, it consists of Dominique<br />

Duchêne (<strong>EUFEPS</strong>, Chair), Hans H.<br />

Lindén (<strong>EUFEPS</strong>), Bill Dawson (GB),<br />

Elias Fattal/Philippe Arnaud (FR), Carlo<br />

Fornara (IT), Véronique Préat (BE),<br />

Bernard Rentier (EFB), Tom Sam (NL),<br />

Nico Vermeulen (ISSX) <strong>and</strong> Pia Vuorela<br />

(FIN).<br />

Three plenary meetings of the partners<br />

were already held (Nice, Brussels, Paris)<br />

as well as three meetings of the leading<br />

team (Brussels, Paris, Amsterdam). This<br />

leading article constitutes the official<br />

public launching of the Fair. The first<br />

PharmSciFair circular will be mailed by<br />

November 2003.


<strong>EUFEPS</strong> Newsletter, 2003, vol. 12, issue 3<br />

<strong>EUFEPS</strong> Vision on<br />

Training<br />

<strong>and</strong> Education<br />

Hans H. Lindén, MSc, Executive Director <strong>EUFEPS</strong><br />

Bernd Clement, Professor, Chair <strong>EUFEPS</strong> Committee on training <strong>and</strong> Education<br />

(CTE)<br />

Is there a role for <strong>EUFEPS</strong>? Yes, there<br />

is. <strong>EUFEPS</strong> has made improvements in<br />

the pharmaceutical sciences training <strong>and</strong><br />

education part of its strategy <strong>and</strong> started<br />

new activities. In this article, Hans H.<br />

Lindén, Executive Director of <strong>EUFEPS</strong>,<br />

<strong>and</strong> Bernd Clement, Chair <strong>EUFEPS</strong><br />

Committee on Training <strong>and</strong> Education<br />

(CTE), present the strategy <strong>and</strong> some<br />

related issues.<br />

Clear Mission<br />

The mission of the European Federation<br />

for Pharmaceutical Sciences, <strong>EUFEPS</strong>,<br />

is to serve <strong>and</strong> advance excellence in the<br />

pharmaceutical sciences <strong>and</strong> innovative<br />

drug research in Europe. This includes<br />

training <strong>and</strong> education, as well as<br />

representing the interests of scientists<br />

engaged in drug research <strong>and</strong> development,<br />

drug regulation, drug utilisation, <strong>and</strong> drug<br />

policy-making.<br />

Agreed Strategy<br />

Among the primary objectives of the<br />

<strong>EUFEPS</strong> Strategic Plan 2002–2006<br />

are active collaboration, cooperation<br />

<strong>and</strong> coordination between all existing<br />

players, leading to further advance of<br />

the pharmaceutical sciences in Europe.<br />

Without doubt, training <strong>and</strong> education of<br />

those already in, <strong>and</strong> those considering<br />

entering the field, are effective tools to<br />

pave the way for further development.<br />

In <strong>EUFEPS</strong>, postgraduate training <strong>and</strong><br />

education will have priority.<br />

Widespread Support<br />

Currently, the <strong>EUFEPS</strong> membership<br />

includes 25 Member Societies in 24<br />

European countries, <strong>and</strong> nearly 500<br />

Individual Members. The total number<br />

of individuals embraced, directly <strong>and</strong><br />

indirectly, is just over 18,000. They pay<br />

individual, national <strong>and</strong>/ or federal fees to<br />

support local, regional <strong>and</strong> global efforts<br />

in their fields of interest.<br />

Advanced Training Courses<br />

Relevant (short) courses <strong>and</strong> programmes<br />

to meet immediate (continuing/further)<br />

training <strong>and</strong> education needs, particularly<br />

in industry are not easily identified, or<br />

not at all available in Europe 1 . Stimulated<br />

by its Committee on Industrial Relations<br />

(CIR), <strong>EUFEPS</strong> is moving towards a<br />

virtual “School of Excellence in the<br />

Pharmaceutical Sciences” in Europe. The<br />

school is made up of advanced courses<br />

<strong>and</strong> training programmes in key fields<br />

<strong>and</strong> new disciplines. The <strong>EUFEPS</strong> role,<br />

supported by CIR <strong>and</strong> the Committee on<br />

Training <strong>and</strong> Education (CTE), is to define<br />

specific training topics, engage experts<br />

<strong>and</strong> organise the courses, including<br />

‘h<strong>and</strong>s-on’ sessions. Additionally,<br />

<strong>EUFEPS</strong> will encourage the organisers of<br />

relevant local or national training courses<br />

to add international faculty <strong>and</strong> give<br />

the courses in English, for a European<br />

audience. The CTE has produced a set<br />

of criteria for such “<strong>EUFEPS</strong> Training<br />

Courses”; <strong>EUFEPS</strong> could contribute to<br />

their organisation <strong>and</strong> publicity. In 2002,<br />

three training courses were announced<br />

<strong>and</strong> one of them, on High-throughput<br />

Drug Metabolism/Disposition, was<br />

successfully completed. This was in close<br />

collaboration with the Amsterdam Free<br />

University <strong>and</strong> the Leiden/Amsterdam<br />

Centre for Drug Research (LACDR), both<br />

in the Netherl<strong>and</strong>s.<br />

Experience of Training Courses to<br />

Date<br />

There has been a long road between<br />

the ideas for each training course <strong>and</strong><br />

the circulation of the final programme.<br />

XXXVI<br />

Hans H. Lindén, MSc, Executive<br />

Director <strong>EUFEPS</strong><br />

Specialists willing to help to set up<br />

advanced training courses are busy people,<br />

as is the additional faculty needed to make<br />

the course truly European. The <strong>EUFEPS</strong><br />

Secretariat would need additional staff to<br />

assist in the simultaneous development<br />

of several training courses. Nevertheless,<br />

<strong>EUFEPS</strong> intends to continue along<br />

this avenue, encouraging increased<br />

collaboration between current <strong>and</strong> new<br />

institutes <strong>and</strong> centres of excellence.<br />

So, developing additional postgraduate<br />

training courses in pharmaceutical<br />

sciences is in progress. For topics, date,<br />

location <strong>and</strong> fee etc., consult the <strong>EUFEPS</strong><br />

Online (www.eufeps.org) <strong>and</strong> see<br />

announcements circulated.<br />

Course Database<br />

<strong>EUFEPS</strong> also decided to start developing<br />

a “database of post-graduate training<br />

<strong>and</strong> education courses”, which will be<br />

made accessible to its membership. A<br />

couple of years ago Janne Tolstrup, who<br />

was supported by a special task force,<br />

designed a template for this database,<br />

utilising MS Access. The Royal Danish<br />

School of Pharmacy granted generous<br />

funding. A substantial number of courses<br />

<strong>and</strong> training programmes were listed.<br />

Unfortunately, for a number of reasons, it<br />

was not possible to complete the database<br />

<strong>and</strong> make its contents available.<br />

In 2003, a restart of the project was<br />

budgeted; updating <strong>and</strong> completing<br />

the database is in progress. Many more<br />

postgraduate courses <strong>and</strong> programmes,<br />

in all areas of pharmaceutical science <strong>and</strong><br />

available in Europe, have been identified<br />

by searching the Internet <strong>and</strong> added to the<br />

database, by the pharmaceutical institute<br />

in Kiel, Germany.<br />

Recently, <strong>EUFEPS</strong> learned that<br />

the Young Pharmacists Group of the


International Pharmaceutical Federation<br />

(FIP) is working on a database of<br />

education. <strong>EUFEPS</strong> indicated that it<br />

would be open to collaborate by e.g.<br />

exchanging available information.<br />

Pharmaceutical sciences courses are the<br />

premier concern of <strong>EUFEPS</strong>. In FIP, there<br />

is a much stronger professional pharmacy<br />

theme. If there is overlap, it would not be<br />

a big problem. Options to identify relevant<br />

courses of interest just increase.<br />

Specialist Training<br />

There are several emerging new initiatives,<br />

all over Europe, to start specialist training<br />

in pharmaceutical sciences. <strong>EUFEPS</strong><br />

welcomes these, of course, as well as<br />

strongly supports the idea of establishing<br />

Master in Drug Development <strong>and</strong> Drug<br />

Discovery programmes.<br />

Since specialist training would take<br />

more than one or two short courses,<br />

during the summer or during the school<br />

year, an orchestrated action by a number<br />

of centres of excellence would be needed.<br />

We require a visionary <strong>and</strong> able conductor,<br />

or conducting team, who could make sure<br />

that such an orchestra would perform<br />

enjoyable music. Certainly, this is not<br />

just an interest for future pharmaceutical<br />

specialists. Europe will need them to<br />

develop new, safe medicines for its own<br />

citizens <strong>and</strong> other populations.<br />

Quality ’starting materials’<br />

To achieve a high st<strong>and</strong>ard for a product,<br />

the quality of the “starting materials” is<br />

crucial. Furthermore, the materials must<br />

be h<strong>and</strong>led well during the production<br />

process. Obviously, there is a growing<br />

concern in several European countries<br />

about the quality of the undergraduate<br />

pharmacy training. This concern seems<br />

to be shared by European Pharmaceutical<br />

Students’ Association (EPSA), who<br />

recently initiated a scientific supplement<br />

to their Newsletter.<br />

In a recent article, the Executive<br />

Director of the Swedish Pharmaceutical<br />

Society/Academy of Pharmaceutical<br />

Sciences, Prof. Björn Lindeke, discussed<br />

(in Swedish) risks with establishing<br />

new schools of pharmacy (in Sweden).<br />

The challenge is to meet the required<br />

numerical output for the pharmacy<br />

profession 2 . Since the basic training is<br />

the same for a professional pharmacist<br />

<strong>and</strong> a scientific career, there may not be a<br />

sufficient number of good quality students<br />

<strong>and</strong> teachers to provide a solid base for a<br />

career in the pharmaceutical sciences, he<br />

argues. In other countries, there are strong<br />

movements to reduce the scientific contents<br />

of the curricula in schools of pharmacy, in<br />

favour of professional pharmacy. If these<br />

are trends, <strong>and</strong> they cannot be reversed,<br />

the unique pharmaceutical sciences profile<br />

may be in jeopardy.<br />

Of course, one solution would be<br />

for the students, who aim for a scientific<br />

career, to leave their home country for a<br />

school or a university where appropriate<br />

training is provided. If there will be not<br />

a sufficient number of quality schools<br />

XXXVII<br />

available in Europe to meet the industrial<br />

drug research needs, Europe will also be<br />

in jeopardy. Students, graduates <strong>and</strong> postgraduates<br />

will go elsewhere, as will the<br />

industry.<br />

These issues are not explicitly<br />

discussed in the current <strong>EUFEPS</strong><br />

Strategic Plan, for 2002–2006. With hard<br />

information about the current situation,<br />

such issues would certainly be considered<br />

in the next Strategic Plan.<br />

Other Regions<br />

It is in the Strategic Plan 2002–2006<br />

that <strong>EUFEPS</strong> should collaborate on<br />

pharmaceutical sciences training both in<br />

its own geographical region <strong>and</strong> in others.<br />

The FIP Board of Pharmaceutical Sciences<br />

(BPS) <strong>and</strong> the American <strong>and</strong> Japanese<br />

pharmaceutical sciences organisations<br />

are, for example, collaborating on thirdworld<br />

programmes.<br />

Perhaps, the global platform for<br />

advancing the pharmaceutical sciences,<br />

FIP BPS, will be the best level for<br />

coordinating such efforts, jointly<br />

supported by pharmaceutical associations<br />

<strong>and</strong> federations of all regions.<br />

1 Workshop Report: Future Training<br />

Needs in Pharmaceutical Sciences; www.<br />

eufeps.org<br />

2 Lindeke, B.: Den blomstr<strong>and</strong>e tid<br />

som kom; Elixir (Apotekarsocietetens<br />

medlemstidning) 2/2003


<strong>EUFEPS</strong> Newsletter, 2003, vol. 12, issue 4<br />

New Safe Medicines<br />

Faster Award 2003<br />

Ole J. Bjerrum, Professor<br />

This new <strong>EUFEPS</strong> Prize was first<br />

awarded at the 1st <strong>EUFEPS</strong> Conference<br />

on Optimising Drug Delivery <strong>and</strong><br />

Formulation: New Challenges in Drug<br />

Delivery, on September 29, 2003, in<br />

Versailles. The award given to the three<br />

professors, Mats Bergström, Anders<br />

Grahnén <strong>and</strong> Bengt Långström of<br />

Uppsala University, for their contribution<br />

to the microdosing concept.<br />

The microdosing concept includes dosing<br />

to man in the range of 1/100 – 1/1000th of<br />

the normal dosage. A compound is labelled<br />

with a radionuclide of high specificity<br />

allowing measurement of its distribution<br />

through sensitive techniques like<br />

Positron Emission Tomography (PET) or<br />

Accelerator Mass Spectrometry. The low<br />

dose sets modest regulatory requirements<br />

before actual testing. Microdosing<br />

represents a new paradigm, since human<br />

becomes a species for c<strong>and</strong>idate selection.<br />

In this way “First in Man” is brought<br />

forward in time.<br />

Thus, the invention is in full<br />

accordance with the founding text (see<br />

below):<br />

Microdosing is a new innovation,<br />

which has been experimentally proven. It<br />

represents a precompetitive methodology<br />

that has been accepted by regulatory<br />

authorities. Through wider application,<br />

it has the potential both to shorten <strong>and</strong><br />

to increase the capacity of the drug<br />

development process significantly. This<br />

means microdosing will contribute to a<br />

more efficient drug development.<br />

Further reading about the microdosing<br />

concept can be found in Bergström M,<br />

XXXVIII<br />

A Grahnén, M Bergström, B Långström<br />

<strong>and</strong> O. J. Bjerrum.<br />

Grahnén A, Långström B. Positron<br />

emission tomography: a new concept with<br />

application in tracer <strong>and</strong> early clinical<br />

drug development. Eur J Clin Pharmacol<br />

(2003) 59: 357–366.<br />

The founding text for the award runs as<br />

follows: “To honour an individual – or team<br />

– of scientists for outst<strong>and</strong>ing contribution<br />

to the innovation <strong>and</strong> advancement of<br />

new methodology or technology which<br />

significantly has contributed to shorten<br />

or to make the drug development process<br />

more efficient”.<br />

The award, together with 3000<br />

EURO, is sponsored by Aventis <strong>and</strong> the<br />

nomination is done solely at the discretion<br />

of the <strong>EUFEPS</strong> Committee on Awards<br />

<strong>and</strong> Prizes (CAP).


<strong>EUFEPS</strong> Newsletter, 2004, vol. 13, issue 3<br />

Pharmaceutical Research<br />

Community Contributions<br />

<strong>and</strong> Expectations in New<br />

European Union Countries<br />

Aleš Mrhar<br />

Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia<br />

The 10 new European Union countries,<br />

i.e. Czech Republic, Cyprus, Estonia,<br />

Hungary, Latvia, Lithuania, Malta,<br />

Pol<strong>and</strong>, Slovak Republic <strong>and</strong> Slovenia,<br />

have to solve the problem of the lag<br />

in technological development of their<br />

industries, when compared to the<br />

15 countries of the former EU. The<br />

promotion of new technologies in<br />

production processes is a necessary<br />

condition for restructuring of their<br />

economies. This promotion, to be<br />

successful, must be accompanied by<br />

a modern educational <strong>and</strong> training<br />

system providing professionals for<br />

running research <strong>and</strong> development in<br />

academia on one side <strong>and</strong>, on the other,<br />

by the capability of industry to include<br />

educated <strong>and</strong> trained people into their<br />

environment.<br />

<strong>EUFEPS</strong> has been recognized as<br />

a powerful platform to promote<br />

pharmaceutical sciences across united<br />

Europe by integrating academic, industrial<br />

<strong>and</strong> regulatory institutions to reach safe<br />

<strong>and</strong> effective medicines faster. However,<br />

the majority of these mechanisms have<br />

been successfully established within 15<br />

countries of the former EU but not between<br />

them <strong>and</strong> new EU countries. For this<br />

reason, <strong>EUFEPS</strong> must develop activities<br />

to bridge this gap as soon as possible.<br />

Although Slovenia may not be a<br />

typical case when looking at the stage<br />

of development of pharmaceutical<br />

profession <strong>and</strong> sciences, because these<br />

are rapidly growing fields in this country,<br />

a survey of its institutions can illustrate<br />

successfully the state of affairs in the new<br />

EU countries:<br />

- Slovenian pharmacies have developed<br />

to a high level of professional work<br />

in terms of dispensing <strong>and</strong> distributing the<br />

drugs <strong>and</strong> providing the information on<br />

proper use of drugs. The network is partly<br />

privatized, partly state owned, with the<br />

staff having mainly academic education<br />

<strong>and</strong> trained continuously on national <strong>and</strong><br />

international courses. Modern concepts<br />

such as pharmaceutical care, patient<br />

counselling for prescriptions <strong>and</strong> OTC<br />

drugs are in place. A high st<strong>and</strong>ard of<br />

review has developed in this area with the<br />

Slovenian Chamber of Pharmacy as a nongovernmental<br />

institution, authorized with<br />

the regulation of the quality of professional<br />

service.<br />

• Slovenian pharmaceutical companies<br />

(Lek, Krka) grow progressively <strong>and</strong><br />

are able to compete with the<br />

international companies (Lek recently<br />

became a new member of S<strong>and</strong>oz<br />

group), predominantly in the value-<br />

added generic segment. The two<br />

companies are similar according to a<br />

number of parameters:<br />

employees, approximately 2500<br />

each, one third with academic<br />

education including a substantial<br />

number of Masters <strong>and</strong> Doctoral<br />

Degrees<br />

turnover per year, approximately<br />

500 million euros each, more than<br />

two thirds exported, in considerable<br />

part to EU, USA <strong>and</strong> Japanese<br />

markets<br />

allotment of more than 10% of total<br />

earnings for research <strong>and</strong><br />

development activities.<br />

• Slovenian academic educational<br />

<strong>and</strong> research institutions (one faculty<br />

of pharmacy, two medical faculties,<br />

two faculties of chemistry, two<br />

main research institutes with divisions<br />

involved with pharmaceutical sciences)<br />

are internationally recognized as part<br />

of an advanced system, able to develop<br />

XXXIX<br />

Aleš Mrhar<br />

<strong>and</strong> transfer up-to-date knowledge<br />

<strong>and</strong> advanced technologies in many<br />

directions, both as generator <strong>and</strong> user,<br />

• Slovenian Agency for Medicinal<br />

Products serves as the licensing<br />

authority for drugs <strong>and</strong> medical<br />

devices, playing its part in the<br />

international harmonization process.<br />

In its structures, a large number of the<br />

experts from national pharmaceutical<br />

<strong>and</strong> medical academic circles are<br />

included.<br />

The high level of pharmaceutical<br />

profession <strong>and</strong> science in Slovenia<br />

represents the basis for strong integration<br />

of all institutions in international arenas,<br />

in terms of organizing international<br />

symposia, summer schools <strong>and</strong> workshops,<br />

exchanging professors <strong>and</strong> scientists,<br />

exchanging Ph.D. students, collaborating<br />

with Slovene scientists who are affiliated<br />

to foreign universities <strong>and</strong> companies, etc.<br />

Without doubt, this statement holds good<br />

for any of the 10 countries that joined EU<br />

on 1st May 2004.<br />

The main problem the pharmaceutical<br />

professionals <strong>and</strong> scientists are facing<br />

is that a majority of the 10 countries are<br />

small <strong>and</strong> for this reason, viewed from<br />

a global perspective, they are not freely<br />

appreciated as places with considerable<br />

potential in the fields of pharmaceutical<br />

sciences <strong>and</strong> technologies. Consequently,<br />

the results of their work, that are significant<br />

in many fields, are not met with a wide<br />

response, <strong>and</strong> the transfer of know-how is<br />

still difficult.<br />

What these countries need at the<br />

moment is a settled access to institutions<br />

(faculties, institutes, companies) where<br />

first class educational <strong>and</strong> scientific<br />

programmes are available to bring well<br />

trained scientists <strong>and</strong> well educated


professionals into academia, industrial<br />

enterprises <strong>and</strong> regulatory authorities.<br />

The instruments to promote these<br />

activities would be invitations, exchanges,<br />

fellowships, information links via<br />

Internet <strong>and</strong> library networks. Inclusion<br />

of pharmaceutical research programmes<br />

in the international collaboration projects<br />

such as EU Frameworks, Socrates/<br />

Erasmus <strong>and</strong> bilateral-twinning projects<br />

within EU are welcome. This is a critical<br />

item, particularly at the current period,<br />

when these countries are adjusting their<br />

activities to European Union criteria.<br />

Free movement accompanied with free<br />

employment of persons across EU,<br />

<strong>EUFEPS</strong> Newsletter, 2005, vol. 14, issue 2<br />

which should have been put into force<br />

(but unfortunately was not) by the date<br />

of accession of 10 countries to EU, is a<br />

prerequisite for implementation of this<br />

goal.<br />

Furthermore, an assessment of<br />

articles prepared by institutions in the new<br />

countries engaged with pharmaceutical<br />

sciences <strong>and</strong> published in international<br />

peerreviewed literature should be<br />

undertaken. Circumstances should<br />

be set up to make these results much<br />

more visible. Finally, the international<br />

symposia organized by institutions of<br />

these countries, such as Central European<br />

Symposia on Pharmaceutical Technology<br />

Importance of<br />

Research Linked with<br />

the EMEA<br />

Malcolm Rowl<strong>and</strong>, Professor Emeritus,<br />

University of Manchester, United Kingdom<br />

There is a vital service that the<br />

EMEA can perform by researching,<br />

or making available for research,<br />

the large body of generic data it<br />

holds. Such research would increase<br />

the informativeness, efficiency, <strong>and</strong><br />

predictability of future clinical trials<br />

to the benefit of the citizens of Europe,<br />

<strong>and</strong> improve the competitiveness <strong>and</strong><br />

economic effectiveness of the European<br />

pharmaceutical <strong>and</strong> biotechnology<br />

industries, in the development of<br />

innovative medicines for unmet medical<br />

needs.<br />

One of the perceived, <strong>and</strong> de facto,<br />

primary functions of the EMEA is to<br />

ensure that the citizens of the European<br />

Union are provided with high quality,<br />

effective medicines that are as safe as<br />

reasonably possible. It achieves this<br />

through a thorough evaluation process<br />

of each submitted application for the<br />

registration of a new medicinal product,<br />

followed by a continuous monitoring of<br />

the safety profile of registered medicines.<br />

Dealing with this evaluation process is<br />

time-consuming, occupying much of<br />

limited resources of the EMEA. There<br />

is, however, another important activity,<br />

<strong>and</strong> it may be argued responsibility, that<br />

the EMEA should embrace. Namely, to<br />

research <strong>and</strong> analyse the large body of<br />

data submitted by the pharmaceutical <strong>and</strong><br />

biotechnology industries to provide basic<br />

information <strong>and</strong> underst<strong>and</strong>ing that would<br />

improve the design, efficiency <strong>and</strong> costeffectiveness<br />

of future clinical trials. A<br />

few examples of the type of research that<br />

could profitably be undertaken follow.<br />

Control Group or Baseline Data<br />

To prove the effectiveness of a medicinal<br />

product for a given indication, as well as<br />

assessing its safety profile, comparative<br />

studies are undertaken in appropriate<br />

patients either against a placebo, a reference<br />

treatment, or occasionally both. Each<br />

company submits such data when filing<br />

for registration of its drug. The number of<br />

patients needed in the placebo-control or<br />

reference-treatment group is determined<br />

XL<br />

<strong>and</strong> Biotechnology (started as early as<br />

1995 <strong>and</strong> organized biennially) <strong>and</strong> the<br />

Balaton-Baltic-Bled-Bosphorus Symposia<br />

(planned to start in 2005) should earn<br />

significantly more attention, not only in<br />

terms of offering the patronage but also coorganization,<br />

co-sponsoring <strong>and</strong> related<br />

activities in order to bring pharmaceutical<br />

sciences in these countries closer to the<br />

mainstream.<br />

Many efforts have been invested<br />

in further progress of pharmaceutical<br />

sciences in the new EU countries so far,<br />

however, the majority of activities are just<br />

ahead of us, both in the 10 <strong>and</strong> in the 15<br />

EU countries.<br />

Malcolm Rowl<strong>and</strong>, Professor Emeritus<br />

from some prior information. This historic<br />

information may be gained in house, if the<br />

company has engaged previously in the<br />

therapeutic area, or from some external<br />

source. Yet, in most cases, the company<br />

in-house baseline data are limited, <strong>and</strong><br />

are also not made generally available to<br />

others. In contrast, the EMEA (<strong>and</strong> other<br />

national agencies) often receives clinical<br />

trial information submitted by several or<br />

more companies for the same therapeutic<br />

indication, such that the placebo-control<br />

<strong>and</strong> reference-treatment data pertains<br />

to a common patient group, which if<br />

collectively analysed would provide<br />

important baseline information not only<br />

about the placebo group but also the<br />

reference group, who are often receiving<br />

some agreed st<strong>and</strong>ard drug treatment,<br />

thereby providing updated information on<br />

its efficacy <strong>and</strong> safety profile. Furthermore,<br />

the more that is known about these groups<br />

the more accurate (<strong>and</strong> often the smaller)<br />

the corresponding patient size needed in<br />

subsequent studies, without significant loss<br />

of statistical power, <strong>and</strong> hence the lower


the cost of the overall clinical trial. As<br />

each new trial is undertaken, the resultant<br />

information can be added to the existing<br />

pooled database, thereby providing more<br />

confident population data.<br />

Pharmacokinetics<br />

Apart from a few exceptions, such as<br />

enzyme induction, transporter up or<br />

down regulation, <strong>and</strong> possibly cardiac<br />

output-induced changes in clearance,<br />

the pharmacokinetics of drugs reflect<br />

rather than alter the state of an individual.<br />

Hence, all other factors being constant,<br />

all substrates for a given enzyme should<br />

equally reflect the underlying functional<br />

variation of that enzyme within the<br />

population. This being the case, collective<br />

analysis of pharmacokinetic data on say<br />

all substrates of CYP2C9 or 3A4 should<br />

provide information not only on the<br />

inherent functional variability of these<br />

enzymes within the patient population, but<br />

also allow one to determine quantitatively<br />

the contribution of such factors as age,<br />

gender, disease, <strong>and</strong> inhibitors of these<br />

enzymes to the variability. Each company<br />

has specific data on its drug, such as<br />

knowledge of the enzymes responsible<br />

for its elimination, but only on a limited<br />

number of subjects, whereas the collective<br />

data held within the EMEA would<br />

provide a far more comprehensive <strong>and</strong><br />

informative dataset to address the above<br />

questions on variability. Armed with this<br />

generic information, one should be able to<br />

predict a priori the likely variability of the<br />

pharmacokinetics of a new drug within<br />

the patient population, under a variety<br />

of situations, thereby facilitating future<br />

design of clinical studies <strong>and</strong> subsequent<br />

product labelling, <strong>and</strong> also improve the<br />

cost-efficiency of such studies.<br />

What are the impediments to the<br />

EMEA engaging in this research?<br />

Arguably, there are three impediments.<br />

One is the resistance of the pharmaceutical<br />

<strong>and</strong> biotechnology companies to allow<br />

their data to be collectively analysed.<br />

Second are potential legal restrictions<br />

imposed on the EMEA (<strong>and</strong> other national<br />

agencies) in pooling <strong>and</strong> analysing<br />

collective data. And, finally, is the issue<br />

of adequate resources to undertake this<br />

research. Each is considered in turn.<br />

Company resistance. It may be<br />

argued that companies concerned with<br />

confidentiality would not agree to allow<br />

the pooling of their data with that of<br />

other companies. However, the proposed<br />

research would only deal with placebo<br />

or reference treatment data, <strong>and</strong> there are<br />

many ways of ensuring the anonymity<br />

of such data. Furthermore, informal<br />

discussions with some company persons<br />

would suggest that there would be support<br />

for this type of research if the results of<br />

the research were made publicly available,<br />

as it would aid in the efficient design <strong>and</strong><br />

cost-effectiveness of their future clinical<br />

studies.<br />

XLI<br />

Legal Restrictions. There may be<br />

legal restrictions to what the EMEA<br />

(<strong>and</strong> national agencies) can do with<br />

data received from companies, which<br />

currently limits what research can be done<br />

on the submitted data. If so, this problem<br />

would need to be addressed <strong>and</strong> should be<br />

resolvable, particularly if the proposal has<br />

the support of the industry.<br />

Research Resources<br />

Money, additional to what the EMEA<br />

receives in its recurrent budget, would be<br />

needed to engage in the type of proposed<br />

research. As the beneficiaries within<br />

Europe of the results of this research<br />

would be numerous, including companies<br />

developing innovative medicines, the<br />

scientific <strong>and</strong> clinical community,<br />

regulatory agencies, <strong>and</strong> interested patient<br />

groups, it is argued that the resources<br />

should be made available from the EU<br />

Framework programme scheme, with<br />

a starting point, as part of the Seventh<br />

Framework proposed Pharmaceutical<br />

Technology Platform for Innovative<br />

Medicines. Furthermore, while the<br />

research could be undertaken solely within<br />

the EMEA (or in collaboration with the<br />

national agencies) it is argued that it would<br />

best be undertaken as a collaborative<br />

activity between the EMEA, academia,<br />

industry, <strong>and</strong> appropriate professional<br />

scientific organisations.


<strong>EUFEPS</strong> Newsletter, 2005, vol. 14, issue 2<br />

Pharmaceutical Sciences:<br />

Towards a more<br />

Competitive Europe<br />

Ole J. Bjerrum, Professor<br />

<strong>EUFEPS</strong> President<br />

<strong>EUFEPS</strong> coordinated a workshop<br />

on “How to Establish a European<br />

Technology Platform for Innovative<br />

Medicines” in conjunction with the 3rd<br />

World Conference on “Drug Absorption,<br />

Transport <strong>and</strong> Delivery Medicines” at<br />

Barceló Hotel Sants, Barcelona, Spain,<br />

April 21–22, 2005.<br />

The Consortium<br />

The workshop was supported by<br />

the EU under the Sixth Framework<br />

Programme Life Science, Genomics <strong>and</strong><br />

Biotechnology for Health. A consortium<br />

consisting of: <strong>EUFEPS</strong>, the European<br />

Clinical Research Infrastructure Network<br />

(ECRIN), the European Federation<br />

for Medicinal Chemistry (EFMC), the<br />

European Federation of Pharmaceutical<br />

Industries <strong>and</strong> Associations (EFPIA),<br />

EUROTOX <strong>and</strong> the University of Cyprus<br />

planned the workshop.<br />

The workshop was originally planned<br />

in the autumn 2003. However, it became<br />

part of the European Commission <strong>and</strong><br />

EFPIA’s work on a Strategic Research<br />

Agenda for Innovative Medicines for the<br />

Citizens of Europe, providing input for the<br />

Seventh Framework Programme.<br />

The First Day<br />

It started with a series of lectures on the<br />

background for the workshop. They<br />

concerned:<br />

• European Technology platform for<br />

Innovative Medicines (Octavi<br />

Quintana Trias)<br />

• European Strategic Research Agenda<br />

(Jonathan Knowles)<br />

• Reports of recent workshops on<br />

Safety (Friedlich Pfannkuch), Efficacy<br />

(Ian Ragan), Knowledge Management<br />

(Nicolas Gr<strong>and</strong>jean), <strong>and</strong> Education &<br />

Training (Jorgen Dirach)<br />

The introduction was followed by four<br />

parallel workshop discussions on topics<br />

suggested for the Strategic Research<br />

Agenda:<br />

1) Knowledge Management to resolve<br />

current <strong>and</strong> future needs<br />

2) Approaches <strong>and</strong> means to optimise<br />

development of efficacious drugs <strong>and</strong><br />

effective treatment strategies<br />

3) Underst<strong>and</strong>ing <strong>and</strong> predicting drug<br />

safety <strong>and</strong> ways to secure safe drug<br />

therapy<br />

4) Appropriate education <strong>and</strong> training to<br />

fill existing gaps <strong>and</strong> to meet emerging<br />

needs throughout drug research,<br />

development <strong>and</strong> evaluation.<br />

The Second Day<br />

Through SWOT analyses, a series of<br />

stakeholders gave their views on their<br />

involvement <strong>and</strong> possible contributions to<br />

the Platform;<br />

Academia (Daan JA Crommelin)<br />

Clinical sector (Josep Torrent-Farnell)<br />

Biotech SME (Axel Mesheder)<br />

Regulatory (Rolf Bass)<br />

Learned Societies (Christian R Noe)<br />

Patients (Yann Le Cam).<br />

After this, four parallel workshop<br />

discussions took place around key<br />

questions;<br />

1) How to start <strong>and</strong> sustain a European<br />

stakeholders’ collaboration for new<br />

safe medicines? How to attract relevant<br />

stakeholders, good talent <strong>and</strong> potential<br />

collaborating partners through an<br />

attractive working environment in<br />

Europe?<br />

2) How to exploit existing assets <strong>and</strong><br />

resources in Europe better <strong>and</strong> build<br />

on European strengths, e.g. academia,<br />

clinical sector, regulatory world,<br />

XLII<br />

La Sagrada Familia in Barcelona,<br />

Spain.<br />

government, learned societies, IT<br />

development etc., to gain competitive<br />

advantage <strong>and</strong> to create value,<br />

including for biotech SMEs?<br />

3) How should postgraduate training<br />

be organised to increase the European<br />

competitiveness in drug discovery,<br />

development <strong>and</strong> evaluation?<br />

4) How should European university<br />

research <strong>and</strong> education support<br />

the European Strategic Research<br />

Agenda, particularly, in fostering<br />

better collaboration between basic <strong>and</strong><br />

clinical research?<br />

Finally, the outcome of these parallel<br />

workshop discussions was discussed in<br />

plenum.<br />

Like the first <strong>EUFEPS</strong>-organised<br />

New Safe Medicines Faster workshop<br />

(April 2000, Brussels), this workshop<br />

brought in all the stakeholders of the drug<br />

development process. Of the 134 delegates<br />

from 21 countries, who accepted the<br />

invitation, one third represented industry<br />

(19 from big pharma <strong>and</strong> 31 from SMEs),<br />

one third academia <strong>and</strong> the remaining<br />

third represented other institutions, such as<br />

the European Commission (8), Regulatory<br />

agencies (5) patients’ organisations (4) <strong>and</strong><br />

additional organisations (18). The female<br />

to male ratio was 1 to 5.<br />

Outcomes<br />

The concept of a Technology Platform for<br />

the pharmaceutical sector was discussed<br />

from the basics upwards, <strong>and</strong> many<br />

constructive ideas were brought forward.<br />

There was general agreement<br />

throughout the workshop that<br />

implementing the European Technology<br />

Platform for innovative Medicines<br />

is an important component of reestablishing<br />

Europe as the primary


location for biopharmaceutical research<br />

<strong>and</strong> development. The stakeholders<br />

acknowledged the value of industry<br />

leadership, the importance of the four<br />

topics of the Strategic Research Agenda,<br />

<strong>and</strong> the pre-competitive approach. The<br />

public-private collaboration as support for<br />

the platform was also positively received.<br />

Education & Training is a critical<br />

component of the Strategic Research<br />

Agenda, <strong>and</strong> the need for a pan-European<br />

organisation of academic institutions<br />

engaging in drug development became<br />

obvious.<br />

Stakeholder Input<br />

For Academia, improvements are needed<br />

in the critical mass of research groups,<br />

scientist <strong>and</strong> student mobility, new<br />

technologies, cross-disciplinary issues<br />

<strong>and</strong> positive public perception.<br />

The Clinical Sector’s contribution to<br />

European competitiveness builds on the<br />

quality of clinical research infrastructures,<br />

capacity of investigation, databases <strong>and</strong><br />

biobanks. In addition, the industry needs<br />

Europe-wide networks to make clinical<br />

research more efficient.<br />

For SMEs, weaknesses include<br />

inefficient technology transfer from basic<br />

research, too few management experts<br />

<strong>and</strong> broadly educated drug developers, as<br />

well as lack of existing accessible biology<br />

facilities, GMP units <strong>and</strong> toxicology<br />

databases.<br />

For Regulatory, more research,<br />

conducted at the agencies, was<br />

recommended, e.g. by compilation of<br />

relevant generic data from old application<br />

files. Openness to modern methodologies<br />

<strong>and</strong> reorientation of the regulatory<br />

assessment dem<strong>and</strong>s were also seen as<br />

important.<br />

Learned Societies, which already<br />

organise scientists from academia,<br />

industry, the regulatory agencies <strong>and</strong><br />

clinical fields, have a long tradition,<br />

based on a discipline-oriented European<br />

structure. However, they will need to create<br />

a European organisation, which covers<br />

the complete drug development process.<br />

They could contribute by participating in<br />

a number of the coordination functions<br />

needed for the forthcoming Platform.<br />

Active involvement of Patients <strong>and</strong><br />

Patients’ Associations will promote drug<br />

development in line with patients’ needs,<br />

foster their enrolment in studies, <strong>and</strong><br />

encourage the implementation of new<br />

treatment strategies.<br />

First reporting available<br />

A summary outcomes report from<br />

the workshop is already posted on the<br />

<strong>EUFEPS</strong> website; www.eufeps.org (New<br />

Safe Medicines Faster). A full report will<br />

be issued in the summer, at the same<br />

time as the Strategic Research Agenda is<br />

published, together with the outcomes of<br />

the series of the four workshops regarding<br />

Efficacy, Safety, Knowledge Management<br />

<strong>and</strong> Training & Education.<br />

Innovative Medicines replace New<br />

Safe Medicines Faster<br />

The heavy involvement of EFPIA <strong>and</strong> EU<br />

in drug science R&D means that you may<br />

not hear so much about the well-known<br />

“New Safe Medicine Faster” in the future,<br />

but instead about “Innovative Medicines<br />

XLIII<br />

Project for the Citizens of Europe”. It is<br />

interesting to note that the new initiative<br />

covers many of the same issues as<br />

<strong>EUFEPS</strong> presented in 1999;<br />

• Optimising the drug development<br />

process by removing bottlenecks<br />

• Giving Europe the best drug<br />

development system in the world by<br />

early introduction of state-of-the-art<br />

technologies<br />

• Rethinking all regulatory procedures<br />

from a science-based view to minimize<br />

bureaucracy <strong>and</strong> maximize validity<br />

Further visions<br />

The wording is different but the content<br />

is along the same lines. The current<br />

platform leadership now rests with EFPIA<br />

<strong>and</strong> EU, <strong>and</strong> <strong>EUFEPS</strong> is in the loop as a<br />

stakeholder. <strong>EUFEPS</strong> is also a consortium<br />

member of the EU-supported integrated<br />

research project InnoMed that will bring<br />

the initiative further forward. As an<br />

ambassador <strong>and</strong> promoter of the platform<br />

initiative, Hans H. Lindén plans to visit to<br />

several of the European stakeholders this<br />

autumn.<br />

In addition, <strong>EUFEPS</strong> is creating<br />

further visions on how pharmaceutical<br />

sciences can be advanced in Europe. A<br />

number of working parties have also been<br />

established to transform such visions into<br />

workable strategies, to be presented <strong>and</strong><br />

discussed at the forthcoming <strong>EUFEPS</strong><br />

Council in September this year, in<br />

Hungary.


<strong>EUFEPS</strong> Newsletter, 2005, vol. 14, issue 3<br />

The First<br />

PharmSciFair<br />

– a Highly Successful<br />

Event<br />

Professors Ole J. Bjerrum, Dominique Duchêne, Pia Vuorela <strong>and</strong> Dr. Peter Williams<br />

More than 1200 participants were<br />

attracted to the PharmSciFair, which<br />

took place between June 12 <strong>and</strong> 17 2005,<br />

in wonderful weather in Nice in France.<br />

Indeed, they were not disappointed.<br />

The PharmSciFair has given us a new<br />

platform, which allows the best <strong>and</strong> newest<br />

European pharmaceutical achievements<br />

to be presented, in an excellent spirit of<br />

collaboration.<br />

The 26 partners of the PharmSciFair,<br />

according to their individual strengths,<br />

collected a series of very interesting<br />

sessions, which encompassed the modern<br />

areas of the pharmaceutical sciences (see<br />

<strong>EUFEPS</strong> NewsLetter 2005/2 for conditions<br />

of becoming an active PharmSciFair<br />

Partner). This new combination of the<br />

diverse learned societies associated with<br />

the pharmaceutical sciences in Europe into<br />

one assembly shows the combined strength<br />

of European pharmaceutical sciences in a<br />

way, which will gain recognition globally.<br />

The scientific session of the<br />

PharmSciFair opening programme<br />

was highlighted by the presentation of<br />

Nobel Laureate, Prof. Kurt Wüthrich,<br />

who had taken time from his busy<br />

schedule as professor of Biophysics at the<br />

Eidgenössische Technische Hochschule<br />

(ETH) in Zurich, Switzerl<strong>and</strong>, <strong>and</strong> Ida M.<br />

Green Professor of Structural Biology at<br />

the Scripps Research Institute in La Jolla,<br />

CA USA.<br />

The Spirit of <strong>EUFEPS</strong> Infused<br />

PharmSciFair<br />

The PharmSciFair had a great diversity<br />

of attendees, including scientists from<br />

industry (e.g. big pharma <strong>and</strong> biotech),<br />

academia (professors <strong>and</strong> students), non<br />

profit/government institutions, authorities<br />

<strong>and</strong> the vendor community. Attendees<br />

from these diverse groups came with<br />

unique perspectives, experiences, insights,<br />

<strong>and</strong> questions.<br />

We truly believe the strength <strong>and</strong><br />

uniqueness of PharmSciFair stems<br />

from the diversity of its providing<br />

Partners, <strong>EUFEPS</strong> being the assembling<br />

organisation. The advantage of diversity<br />

is realised when experiences are shared<br />

— when, for example, congruent, but<br />

also differing or opposing opinions/<br />

perspectives lead to new European<br />

platforms as the Pharmaceutical Sciences<br />

Fair & Exhibition. Clearly, to optimise the<br />

PharmSciFair experience for the future,<br />

we need to maximise the opportunities for<br />

interaction.<br />

Opportunities<br />

The following were some of the<br />

tremendous opportunities for interaction<br />

on the new PharmSciFair platform.<br />

One opportunity for interaction<br />

occurred at the oral sessions, particularly<br />

during the question-<strong>and</strong>-answer period,<br />

which was a great way to share ideas with<br />

a large group. The oral sessions covered<br />

a broad spectrum of pharmaceutical<br />

<strong>and</strong> related disciplines, <strong>and</strong> were much<br />

appreciated by the attendees. Monday<br />

covered;<br />

• Drug metabolism <strong>and</strong> disposition: from<br />

molecule to man<br />

• Pharma BioTec<br />

• Compound profiling<br />

in drug discovery<br />

• Clinical pharmacy<br />

• Natural products<br />

• Clinical development <strong>and</strong> optimal use<br />

of macro-molecular drugs<br />

• Regulatory procedures <strong>and</strong><br />

organisation<br />

The parallel sessions on Tuesday<br />

contained, in addition to the first three<br />

XLIV<br />

Professor Pierre Potier (left) receiving<br />

the European Pharmaceutical Scientist<br />

Award from Professor Dominique<br />

Duchêne (right), PharmSciFair Chair,<br />

<strong>and</strong> Dr. Didier de Chaffoy (centre)<br />

Johnson&Johnson Pharmaceutical<br />

Research <strong>and</strong> Development, Lead Sponsor<br />

of the Award <strong>and</strong> of PharmSciFair<br />

above, presentations on Functional<br />

proteomics, Systems biology <strong>and</strong><br />

Pharmacoeconomics.<br />

Wednesday continued with drug<br />

metabolism <strong>and</strong> disposition, which<br />

was one of the most extensive topics<br />

<strong>and</strong> started another on Pharmaceutical<br />

technology <strong>and</strong> Drug delivery, which<br />

also continued the next day with several<br />

simultaneous sessions. Additionally New<br />

trends in bioanalysis were described on<br />

two days. Thursday added “Key role for<br />

quality within the regulatory system” to<br />

the PharmSciFair topics.<br />

The Last Day was Devoted to;<br />

• Quality, safety <strong>and</strong> regulatory facets in<br />

the excipients universe<br />

• Anticancer agents<br />

• Biomarkers in drug development:<br />

research into practice<br />

• Gene <strong>and</strong> cell therapy: current<br />

regulation<br />

• Bioequivalence <strong>and</strong> biologic activity of<br />

biopharmaceuticals.<br />

Just to mention some, highly informative<br />

lectures were given on;<br />

• Idiosyncracy <strong>and</strong> reactive<br />

intermediates<br />

• Biopharmaceutics <strong>and</strong> in silico<br />

technology<br />

• In-silico ADME-tox prediction<br />

• ADMET in drug <strong>and</strong> neutraceuticals<br />

development<br />

• Cyclodextrins <strong>and</strong> bioadhesion<br />

• Modified release delivery systems<br />

• Micelles, vesicles, emulsions, nano <strong>and</strong><br />

microparticles<br />

• Protein, vaccine <strong>and</strong> nucleic acid<br />

delivery<br />

• Clinical development <strong>and</strong> optimal use<br />

of macromolecular drugs<br />

• Modern procedures in protein analytics


<strong>and</strong> characterisation; Proteomics/<br />

Metabonomics/Metabolomics/Drug<br />

metabolism<br />

• Process analytical technologies<br />

(PAT): opportunities <strong>and</strong> barriers to<br />

implementation;<br />

• Risk management <strong>and</strong> excipients:<br />

a challenging benefit or a concern to<br />

industry?<br />

• Safety considerations on excipients: are<br />

all impurities equal?<br />

Another place for interaction was at the<br />

poster sessions. With around 400 posters,<br />

<strong>and</strong> very many oral contributions there was<br />

a lot to absorb, <strong>and</strong> interaction benefits both<br />

to the presenter <strong>and</strong> attendee. This was a<br />

great means to meet other people involved<br />

in pharmaceutical problems, learn about<br />

new science (targets, technologies/tools,<br />

approaches, etc.), <strong>and</strong> receive direct<br />

critique <strong>and</strong> feedback on your work. The<br />

one-on-one poster conversations are often<br />

cited as the most rewarding segments of<br />

meetings.<br />

PharmSciFair was fortunate to have a<br />

very knowledgeable <strong>and</strong> supportive vendor<br />

community. The vendor participants<br />

are valuable assets to the meeting,<br />

providing novel tools to assist scientists in<br />

pharmaceutical research. Vendors interact<br />

closely with scientists often on a technical<br />

level, working to underst<strong>and</strong> the needs<br />

<strong>and</strong> future directions of their research. It<br />

is truly a symbiotic relationship, since we<br />

need each other to succeed.<br />

St<strong>and</strong>s — a special section of the<br />

exhibit/poster floor — were created in<br />

support of the PharmSciFair mission<br />

to foster communication among the<br />

academic/non-profit institutions,<br />

authorities, scientific societies <strong>and</strong><br />

industrial communities.<br />

The PharmSciFair offered several<br />

networking events, including the opening<br />

reception <strong>and</strong> the gala dinner, several<br />

gatherings organised by scientific<br />

societies, as well as vendor-sponsored<br />

activities. While these events can be great<br />

fun, they are also wonderful opportunities<br />

to meet new people <strong>and</strong> exchange ideas.<br />

European Pharmaceutical<br />

Scientist Award<br />

It had been decided to create a prestigious<br />

award in recognition of excellence in the<br />

research of a European Pharmaceutical<br />

Scientist for the PharmSciFair. It<br />

should recognise the significant input<br />

of a researcher in any domain of the<br />

pharmaceutical sciences such as: drug<br />

modelling, medicinal chemistry, gene<br />

therapy, pharmacology, pharmacokinetics,<br />

metabolism, toxicology, pharmaceutical<br />

formulation, drug delivery, pharmaceutical<br />

physico-chemistry, new in-vitro/invivo<br />

models, etc. It should not, however,<br />

recognise a life devoted to science,<br />

XLV<br />

but rather a discovery, which could be<br />

considered as a decisive breakthrough<br />

in drug discovery <strong>and</strong> development.<br />

The most prestigious European research<br />

centres were invited to nominate one<br />

or more c<strong>and</strong>idate(s) for the European<br />

Pharmaceutical Scientist Award.<br />

In the Opening Session, this new<br />

Award, sponsored by Johnson & Johnson<br />

Pharmaceutical Research & Development,<br />

was presented to Prof. Pierre Potier,<br />

Emeritus Director of Research CNRS <strong>and</strong><br />

President of Maison de la Chemie, Paris,<br />

France.<br />

In conclusion<br />

The congress centre Nice-Acropolis<br />

provided excellent surroundings with high<br />

quality meeting <strong>and</strong> exhibition facilities<br />

(www.nice-acropolis.com), located in the<br />

centre of Nice, France, within walking<br />

distance for most of the participants. Nice<br />

is also a pan-European city with great<br />

restaurants, coffee bars, beaches, hotels,<br />

<strong>and</strong> shopping. Public parks, the old city<br />

<strong>and</strong> the harbour gave the city a relaxed<br />

ambience. Nice is in addition a cultural<br />

<strong>and</strong> artistic city with several art museums<br />

<strong>and</strong> painters collections. Whatever<br />

your interests, Nice had something to<br />

offer, besides the main attraction of<br />

PharmSciFair.


<strong>EUFEPS</strong> Newsletter, 2005, vol. 14, issue 3<br />

The Role of Learned Societies<br />

in Forming a European<br />

Technology Platform for<br />

Innovative Medicines<br />

Christian R. Noe, Professor, <strong>EUFEPS</strong> President<br />

Ole J. Bjerrum, Professor, <strong>EUFEPS</strong> Past-President<br />

At the <strong>EUFEPS</strong>-initiated workshop<br />

on “How to Establish a European<br />

Technology Platform for Innovative<br />

Medicines”, held in Barcelona April<br />

21–22 2005, six lectures were given by<br />

delegates from European organisations<br />

representing academia, clinical sector,<br />

biotech SME’s, regulatory, learned<br />

societies <strong>and</strong> patients. We feel that the<br />

views of learned societies, put into a<br />

<strong>EUFEPS</strong> perspective, have a general<br />

interest for our readers.<br />

The scene<br />

The present ‘European crisis’ in drug R&D<br />

is characterised by following trends: the<br />

pharmaceutical industry is moving out of<br />

Europe <strong>and</strong> financial support of the existing<br />

health system is becoming increasingly<br />

difficult. Each national pharmaceutical<br />

sector is too fragmented to be seen as one<br />

‘community’ <strong>and</strong> one ‘market’. In addition,<br />

the financing of academic research is<br />

disastrous in many countries, <strong>and</strong> the<br />

universities are going through fundamental<br />

reforms, which have unclear outcomes.<br />

Hence there are challenges for strategic<br />

planning in drug research, as well as for<br />

implementation <strong>and</strong> financial implications.<br />

Complexity of the task<br />

The ‘Tower of Babel’ problem arises<br />

because different disciplines have<br />

different scientific cultures <strong>and</strong> languages,<br />

<strong>and</strong> the ‘players’ involved in the various<br />

phases <strong>and</strong> fields of drug research do not<br />

recognise, underst<strong>and</strong> <strong>and</strong> respect each<br />

other sufficiently. Thus there is much need<br />

for interdisciplinary <strong>and</strong> trans-disciplinary<br />

components in drug R&D.<br />

A superficial view of the drug R&D<br />

process makes it appear linear from<br />

target discovery ➞ lead discovery ➞<br />

lead optimisation ➞ drug development<br />

➞ marketed drugs. It is well known,<br />

however, that this is by no means the case.<br />

As pointed out in, for example, the New<br />

Safe Medicines Faster concept, innovative<br />

strategies that combine discovery <strong>and</strong><br />

development are needed to cultivate drug<br />

discovery. Furthermore, the complexity<br />

of pharmaceutical science processes or<br />

systems is ever increasing (Figure 2).<br />

Obviously, pharmaceutical science is the<br />

core discipline, along with biology <strong>and</strong><br />

economics.<br />

Figure 2. Complexity of disciplines in the drug R&D process<br />

Pharmaceutical Science: a scientific core discipline<br />

It covers: Finance; Molecular Biology; Genetics; Transgenic Animal Pharmacology;<br />

Cell Biology; Biochemistry; Bioinformatics; Computational Biology; Structural<br />

Biology; Pharmacoinformatics; Medicinal Chemistry; Molecular Pharmacology;<br />

Molecular Modelling; Physical Chemistry; Analytical Chemistry; Biotechnology;<br />

Pharmaceutical Biology; Pharmacognosy; Functional Pharmacology; Law<br />

(Intellectual Properties); Regulatory Science; Toxicology; Pharmacokinetics;<br />

Statistics; Galenics; Pharmaceutical Technology; Nanotechnology; Pharmaceutical<br />

Analysis; Quality Assurance; Physiology; Radiopharmacy; Biopharmaceutical<br />

Sciences; ADME-Research; Animal Pharmacology; Clinical Chemistry; Clinical<br />

Pharmacy; Pharmaceutical Medicine; Clinical Pharmacology; Nuclear Medicine;<br />

Medical Clinical Sciences; Process Engineering; Plant Engineering; Project<br />

Management; Marketing; Public Relations; Human Resources Management;<br />

Ethics; Logistics, etc.<br />

XLVI<br />

Christian Noe, Professor<br />

The Mission <strong>and</strong> Task of the<br />

European Technology Platform<br />

As we see it, the mission of the European<br />

Technology Platform for Innovative<br />

Medicines should be:<br />

• To work out novel strategies to prevent<br />

<strong>and</strong> treat diseases efficiently<br />

• To speed up the process of drug<br />

discovery <strong>and</strong> development while<br />

focusing on efficacy <strong>and</strong> safety<br />

• To utilise the fruits of 25 years of<br />

(molecular) biology-driven life sciences<br />

research: e.g. personalised medicines to<br />

prevent <strong>and</strong> treat common as well as<br />

rare (orphan) diseases<br />

Thus, the European task would include:<br />

• How to create a spirit <strong>and</strong> enthusiasm<br />

for European drug research<br />

• How to generate a ‘European<br />

Community of Drug Researchers’ by<br />

reducing fragmentation, be it political,<br />

national, organisational or scientific<br />

• How to build up a unified European<br />

pharmaceutical sector by bringing<br />

together all stakeholders involved in<br />

drug R&D<br />

• How to generate one European market<br />

for medicines by harmonising activities<br />

The Role of learned societies<br />

The involvement of learned societies<br />

in drug R&D may well represent a<br />

straightforward tool for fast development<br />

of a European Technology Platform for<br />

Innovative Medicines. It would facilitate<br />

implementation if relevant societies, as<br />

stakeholders, would organise themselves<br />

into e.g. a ‘European Pharmaceutical<br />

Sciences Forum’, where the complex<br />

matrix <strong>and</strong> network of societies will be<br />

harmonised <strong>and</strong> utilised at the European<br />

level.


It is also noteworthy that learned societies,<br />

with their independent scientific <strong>and</strong> social<br />

commitment, represent a ‘third force’ not<br />

yet exploited <strong>and</strong> willing to act. Thus<br />

learned societies should be involved in the<br />

development of the European Technology<br />

Platform, not least because universities at<br />

present are poorly organised in terms of<br />

drug development <strong>and</strong> sometimes hesitate<br />

to leave their ‘ivory towers’. On the other<br />

h<strong>and</strong>, the pharmaceutical industry is<br />

driven by economic requirements, acts<br />

globally <strong>and</strong> cannot be made responsible<br />

for sustainable development in a specific<br />

area. Learned societies represent science<br />

as a whole, as well as fields or subfields<br />

of scientific disciplines. The membership<br />

structures differ; they can have elected<br />

membership, require qualification in<br />

specific career sectors or be open to all.<br />

Geographical organisation can be local,<br />

regional, national, international <strong>and</strong> even<br />

global.<br />

The European learned societies<br />

exist for most disciplines of drug R&D.<br />

They organise researchers in terms of<br />

disciplines, house academic, industry<br />

<strong>and</strong> regulatory body scientists, <strong>and</strong><br />

they provide an effective infrastructure<br />

for their membership. They take rapid<br />

initiatives <strong>and</strong> move quickly. Money<br />

allocated to them would increase their<br />

output immediately.<br />

Contributions of learned societies<br />

to the European Technology<br />

Platform<br />

Learned societies could spearhead<br />

the European Technology Platform<br />

for Innovative Medicines. They could<br />

help harmonise research in different<br />

phases <strong>and</strong> fields of drug discovery <strong>and</strong><br />

development, <strong>and</strong> identify emerging topics<br />

<strong>and</strong> new techniques for drug discovery,<br />

development <strong>and</strong> evaluation early on.<br />

Provided they organise them selves<br />

into a drug discovery <strong>and</strong> development<br />

functional network (Pharmaceutical<br />

Sciences Forum), they can play a pivotal<br />

role in organising training <strong>and</strong> education<br />

as they house every required expertise.<br />

Learned societies could also help<br />

transfer promising science-related<br />

activities from the local to the regional/<br />

European level, <strong>and</strong> promote the common<br />

scientific <strong>and</strong> educational programmes<br />

of European universities. They would be<br />

able to support intra-European mobility<br />

<strong>and</strong> the exchange of researchers <strong>and</strong><br />

professionals by building a European post<br />

doc market. Vertical (local to European)<br />

<strong>and</strong> horizontal (different disciplines)<br />

integration would emerge.<br />

Challenges to learned societies<br />

One challenge is that lectures, symposia<br />

<strong>and</strong> training courses are becoming<br />

increasingly commercialised, frequently<br />

competing with the traditional activities of<br />

learned societies. This is because learned<br />

societies are dependent on a money flow<br />

between industry, academia, journals<br />

<strong>and</strong> courses. Dominating private vendors<br />

would drain this money flow.<br />

While using new media (Internet, data<br />

bases) helps learned societies, it can result<br />

in information ‘overload’, if not h<strong>and</strong>led<br />

correctly.<br />

However, the greatest threat to<br />

learned societies is that they will become<br />

XLVII<br />

marginalised, not being professional<br />

enough due to lack of investments in<br />

building a modern infrastructure (office,<br />

secretarial assistance <strong>and</strong> communication).<br />

Furthermore, if their main driving force is<br />

only the desire to get significant EU money<br />

for their own organisation, the European<br />

Technology Platform for Innovative<br />

Medicines will be biased <strong>and</strong> not<br />

sufficiently strong in global competition.<br />

Thus a unique chance to move towards<br />

a globally competitive European drug<br />

research community would be lost.<br />

Conclusion<br />

It is our fervent hope that the professional,<br />

social <strong>and</strong> ethical commitment of scientists<br />

<strong>and</strong> decision-makers involved in the<br />

discussion of the new platform will initiate<br />

a process that will convince everyone to<br />

join forces to create a powerful European<br />

Technology Platform for Innovative<br />

Medicines.


<strong>EUFEPS</strong> Newsletter, 2005, vol. 14, issue 4<br />

The First BBBB Conference<br />

on Pharmaceutical Science, a<br />

successful start to a new drug<br />

research conference in East<br />

Europe<br />

More than 200 participants from 20<br />

countries were attracted to the 1st BBBB<br />

Conference on Pharmaceutical Science,<br />

which took place in wonderful weather<br />

between September 26 <strong>and</strong> 28 2005, at<br />

Siófok, on the edge of Lake Balaton in<br />

Hungary.<br />

The 1st BBBB Conference on<br />

Pharmaceutical Science reflects the birth<br />

of a new drug research forum in East<br />

Europe. With the earlier agreement of<br />

the <strong>EUFEPS</strong> Committee, this forum was<br />

initiated by the national Pharmaceutical<br />

Societies of Estonia, Finl<strong>and</strong>, Hungary,<br />

Slovenia <strong>and</strong> Turkey. This collaboration<br />

is additionally regarded as a continuation<br />

<strong>and</strong> an extension of the trilateral cooperation<br />

among the Estonian, Finnish<br />

<strong>and</strong> Hungarian Societies that began in<br />

1934, but was interrupted by the Second<br />

World War <strong>and</strong> resumed only in 1990.<br />

The aim of this scientific event is to<br />

invite the members of these Societies<br />

<strong>and</strong> also colleagues from other European<br />

countries under the umbrella of <strong>EUFEPS</strong><br />

to gather biennially on the shore of a<br />

lake or on the sea coast with a view to<br />

building up closer collaboration between<br />

pharmacists <strong>and</strong> other members of<br />

the scientific community dealing with<br />

drug research <strong>and</strong> development, <strong>and</strong> to<br />

strengthening the European spirit in this<br />

region of Europe. The initial letter of “big<br />

waters” gave the four B: Balaton, Baltic,<br />

Bosphorus, <strong>and</strong> Bled.<br />

Prof. István Hermecz, chairman of<br />

the conference, opened the meeting <strong>and</strong><br />

the audience was greeted by the President<br />

of <strong>EUFEPS</strong>, Prof. Ole J. Bjerrum, <strong>and</strong><br />

by Prof. Sándor Görög (a member of the<br />

Hungarian Academy of Sciences, a former<br />

member of CIR).<br />

The conference included 3 plenary,<br />

10 keynote <strong>and</strong> 10 oral lectures, which<br />

were accompanied by 67 posters. The<br />

first plenary lecturer, Prof. Nicholas<br />

Bodor (University of South Florida,<br />

USA), discussed the retrometabolic drug<br />

design concept, soft drugs <strong>and</strong> chemical<br />

delivery systems, which are similar to the<br />

<strong>EUFEPS</strong>-initiated “New Safe Medicines,<br />

Faster” program (http://www.nsmf.org).<br />

In a brilliant lecture, Prof. Michel Bauer<br />

XLVIII<br />

Prof. Zelko Romana (SOTE)<br />

(Sanofi-Aventis, France) surveyed the<br />

determination of the amorphous phases in a<br />

drug substance <strong>and</strong> excipients by dielectric<br />

spectroscopy. Prof. Kálmán Magyar<br />

(Semmelweis University, Budapest,<br />

Hungary) dealt with the discovery of the<br />

first selective MAO B inhibitor, selegiline,<br />

<strong>and</strong> its fundamental place in the treatment<br />

of Parkinson disease.<br />

The keynote lecturers discussed<br />

different hot topics in drug research<br />

<strong>and</strong> development. Prof. Martti Marvola<br />

(University of Helsinki, Finl<strong>and</strong>) spoke<br />

about colon-specific formulations in<br />

the prevention of super-infections <strong>and</strong><br />

colon carcinomas. Prof. Krisztina<br />

Takács-Novák (Semmelweis University,<br />

Budapest, Hungary) characterized the<br />

physico-chemical profiling of poorly<br />

soluble molecules. Prof. Seppo Lapinjoki<br />

(University of Kuopio, Finl<strong>and</strong>) presented<br />

an overview on the quality <strong>and</strong> stability of<br />

biopharmaceuticals. Prof. Yasemin Yazan<br />

(Anadolu University, Eskisehir, Turkey)<br />

introduced the audience to molecular<br />

imprinted polymer systems for drug<br />

delivery <strong>and</strong> controlled release. Prof.<br />

Finnish delegation... Profs. István Erös Klebovics Imre Prof. Nyiredi Szabolcs president of<br />

Hung Soc. To Pharmaceutic Sciences.


Matjaz Jeras (Blood Tranfusion Center<br />

of Slovenia) surveyed cell therapies <strong>and</strong><br />

tissue engineering, as a new perspective<br />

of pharmaceutical science <strong>and</strong> expertise.<br />

Prof. Eve-Irine Lepist (University of Tartu,<br />

Estonia) summarized the extrapolation<br />

methods of pharmacokinetics-pharmacodynamics<br />

from animals to man. Prof.<br />

Sulev Köks (University of Tartu, Estonia)<br />

lectured on the application of transgenic<br />

animals in pharmaceutical research.<br />

Prof. Selma Sahin (Hacettepe University,<br />

Ankara, Turkey) analyzed the effects<br />

of the route of administration on the<br />

hepatic disposition of compounds. Prof.<br />

Danielj Kikelj (University of Ljubljana,<br />

Slovenia) introduced novel inhibitors of<br />

the blood coagulation enzymes. Prof.<br />

László Vereczkey (Hungarian Academy<br />

of Sciences, Budapest) discussed the<br />

pharmacokinetic interactions related to<br />

cytochrome P-450 enzymes.<br />

Oral lecturers arrived from 5 countries:<br />

Prof. I. A. Revelsky from Moscow State<br />

University (Russia); Prof. J. L. Augilar<br />

from Universidad Peruana Cayetano<br />

Heredia (Lima, Peru); Dr. T. Püssa from<br />

the Estonian Agricultural University, Dr.<br />

K. Naelapää from <strong>and</strong> Dr. U. Soomets from<br />

the University of Tartu (Estonia); Dr. D. J.<br />

Smith from Biotie Therapies Corporation<br />

(Turku, Finl<strong>and</strong>); <strong>and</strong> Prof. L Barthó from<br />

the Medical University of Pécs, Prof. Gy.<br />

Falkay <strong>and</strong> Dr. T. A. Martinek from the<br />

University of Szeged, <strong>and</strong> Dr P. Krajcsi<br />

from Semmelweis University, Budapest<br />

(Hungary). Their presentations were well<br />

received <strong>and</strong> initiated very interesting<br />

scientific discussions concerning their<br />

specific topics.<br />

In the poster section, many talented<br />

young scientists presented their interesting<br />

research results covering the wide field of<br />

drug discovery <strong>and</strong> drug development.<br />

Their findings were discussed in depth<br />

by the conference participants during<br />

the afternoon of Tuesday, September 27.<br />

Hungarian pharmacists <strong>and</strong> chemists<br />

exhibited the majority of the posters (41),<br />

while Estonian (12) <strong>and</strong> Finnish (10)<br />

scientists likewise presented significant<br />

numbers of posters, but good-quality<br />

posters arrived from Turkey, Slovenia,<br />

Scotl<strong>and</strong> <strong>and</strong> Sweden, too. Some<br />

interesting results were achieved in<br />

international co-operations.<br />

The Hungarian folk-dancers <strong>and</strong><br />

musicians supported the intimate<br />

XLIX<br />

atmosphere of the conference at the<br />

Conference Banquet, <strong>and</strong> the Grill<br />

Party on the second evening offered a<br />

unique possibility for the participants<br />

to initiate new scientific collaboration<br />

<strong>and</strong> to broaden earlier common research<br />

programs between different countries <strong>and</strong><br />

university departments.<br />

On behalf of <strong>EUFEPS</strong>, Prof.<br />

Dominique Duchêne congratulated<br />

Prof. Szabolcs Nyiredy, President of the<br />

Hungarian Society for Pharmaceutical<br />

Science, for the excellent organization<br />

works, <strong>and</strong> for the high scientific level of<br />

the conference. After the closing plenary<br />

lecture, Prof. Peep Veski, President of<br />

the Estonian Society for Pharmaceutical<br />

Science, showed some really beautiful<br />

pictures of Estonia <strong>and</strong> invited the scientific<br />

community to Tallinn to participate on the<br />

2nd BBBB Conference in June 2007. Prof<br />

Attila Hincal, from the Turkish Society,<br />

announced that the 3rd BBBB Conference<br />

would be held in Turkey in September<br />

2009, probably at Antalya.


<strong>EUFEPS</strong> Newsletter, 2006, vol. 15, issue 1<br />

New Safe Medicines Faster<br />

European Technology Platform<br />

Strategic Research Agenda<br />

Innovative Medicines for Europe<br />

EU Joint Technology Initiative<br />

Ole J. Bjerrum, Professor<br />

<strong>EUFEPS</strong> Immediate Past-President<br />

Support to pharmaceutical research in<br />

the European Union under Framework<br />

Programme 7 will now be in the form of<br />

public-private partnerships through the<br />

Innovative Medicines Initiative (IMI).<br />

The snowball started by <strong>EUFEPS</strong>´ New<br />

Safe Medicines Faster initiative, in 1999,<br />

has grown exponentially. All the terms<br />

given in the title above prove this. The<br />

initiative is now so large that <strong>EUFEPS</strong> can<br />

no longer be in the eye of the movement.<br />

Other forces have joined <strong>and</strong> indeed given<br />

the initiative the necessary muscles, but<br />

<strong>EUFEPS</strong> will still be in the loop.<br />

There are still many loose ends <strong>and</strong><br />

uncertainties, but due to the created<br />

momentum, further development will not<br />

stop. The current situation is described<br />

below.<br />

New Safe Medicines Faster<br />

(NSMF)<br />

The NSMF concept still st<strong>and</strong>s, as does the<br />

need to increase the capacity of <strong>and</strong> to shorten<br />

the drug development process. It is even<br />

more valid <strong>today</strong> than when the first Position<br />

Paper was written. Now the activities to fulfil<br />

the original goals have got new br<strong>and</strong>ing<br />

<strong>and</strong> promoters but the stakeholders together<br />

with their organisations remain the same:<br />

industry, regulators, academia, the clinical<br />

sector <strong>and</strong> patients.<br />

The NSMF initiative fulfilled its<br />

role when it had a direct influence on<br />

Framework Programme 6 through the<br />

many calls for research projects conducted<br />

in relation to the drug development<br />

process. Thus the NSMF concept is still<br />

in our thinking when <strong>EUFEPS</strong> plans or<br />

engages in new activities, but the acronym<br />

NSMF has, in the European context, been<br />

overtaken by the IMI. This st<strong>and</strong>s for the<br />

new Innovative Medicines Initiative.<br />

European Technology Platforms<br />

(ETP)<br />

One major objective for the European<br />

Union is to build the most competitive<br />

<strong>and</strong> dynamic knowledge-based economy<br />

in the world by 2010. A key element of<br />

this objective is the strengthening of the<br />

science base in Europe through FP7.<br />

Since the biopharmaceutical environment<br />

is characterised by its focus on science <strong>and</strong><br />

innovation, it is essential to revitalise this<br />

area to become more competitive.<br />

One of the instruments to be used in<br />

this connection has been the Technology<br />

Platform concept covering the major<br />

industrial sectors in Europe. The pharma<br />

industry represents such a key area <strong>and</strong><br />

Dr. Fergal Donelly, from DG Research of<br />

the EU Commission, presented the first<br />

concept for a pharmaceutical Technology<br />

Platform at the <strong>EUFEPS</strong>/APGI conference<br />

on Material Science in Versailles in 2003.<br />

However, the original Technology Platform<br />

concept has lost some of its appeal, as the<br />

financing of the ETP would come through<br />

a Joint Technology Initiative.<br />

Strategic Research Agenda (SRA)<br />

To engage the pharmaceutical industry in a<br />

JTI, the Commission invited the European<br />

Federation of Pharmaceutical Industries<br />

<strong>and</strong> Associations (EFPIA) to work out<br />

a Strategic Research Agenda (SRA),<br />

describing the necessary research to be<br />

carried out in public-private partnerships<br />

to secure the future competitiveness of the<br />

pharmaceutical industries in Europe. In<br />

this connection, during Spring of 2005, the<br />

stakeholders have discussed the strategic<br />

pharmaceutical research needed for<br />

Europe, through 13 workshops organised<br />

by EFPIA together with one organised by<br />

<strong>EUFEPS</strong> (all paid for by the Commission).<br />

L<br />

For <strong>EUFEPS</strong>, it is encouraging to see that<br />

most of the precompetitive research topics<br />

suggested in the SRA correspond to those<br />

published in the preceding <strong>EUFEPS</strong><br />

reports on New Safe Medicines Faster<br />

(cf. www.<strong>EUFEPS</strong>.org). They concern<br />

development of in vitro, in vivo <strong>and</strong> in<br />

silico models predictive of clinical efficacy<br />

<strong>and</strong> safety, stimulation of translational<br />

medicine, validation of biomarkers <strong>and</strong><br />

new clinical trial designs as well as<br />

sharing of core reference databases. The<br />

first draft for the SRA was published on<br />

July 27, 2005.<br />

The SRA was further considered<br />

during Autumn 2005, when additional<br />

workshops were organised to reinforce<br />

the SRA in the following areas:<br />

pharmacovigilance, infectious diseases,<br />

SMEs <strong>and</strong> finance. On basis of the<br />

incoming comments, the final SRA is<br />

close to publication. However, it should be<br />

noted that the final governance structure of<br />

the IMI initiative is still under discussion.<br />

Innovative Medicines Initiatives<br />

(IMI)<br />

This initiative, also named Innovative<br />

Medicines for Europe, is the heir to NSMF.<br />

The content is based on the Strategic<br />

Research Agenda, which is divided into<br />

4 sections regarding Safety, Efficacy,<br />

Knowledge Management <strong>and</strong> Education<br />

& Training.<br />

One project has already been<br />

implemented from December 1, 2005, as<br />

an Integrated Project under FP6 namely<br />

INNOMED. It has 44 Consortium<br />

Members <strong>and</strong> is supported with 14 Mio.<br />

Euros from the Commission. <strong>EUFEPS</strong> is<br />

participating but does not receive any EU<br />

grants. The project is intended to validate<br />

the ETP concept through two research<br />

projects:


• NeuroMed, which will develop <strong>and</strong><br />

validate novel surrogate markers based<br />

upon in vitro <strong>and</strong> in vivo models in<br />

animal <strong>and</strong> humans, using Alzheimer´s<br />

disease as a testing platform.<br />

• PredTox will deliver new biomarkers<br />

of toxicity <strong>and</strong> a greater underst<strong>and</strong>ing<br />

of mechanisms of toxicity.<br />

The experience gained here will be used<br />

in the Joint Technology Initiative for<br />

Innovative Medicines in Europe under<br />

FP7.<br />

EU Joint Technology Initiative<br />

(JTI)<br />

A Joint Technology Initiative, via Art.<br />

171 of the EC Treaty, should finance<br />

the Innovative Medicines Initiative,<br />

with its SRA <strong>and</strong> ETP. However, this<br />

does not happen automatically as 6 JTIs<br />

are currently competing; Innovative<br />

Medicines, Aeronotics, Hydrogen <strong>and</strong><br />

Fuel Cells, Embedded Systems, Nano<br />

Electronics, GMES (Global Monitoring<br />

for Environment <strong>and</strong> Security).<br />

The decision will be taken by<br />

a “Competitiveness Council” of all<br />

European Research Ministries, later this<br />

year. Their decision will be based on;<br />

• European added value<br />

• Inability of existing instruments to<br />

achieve their objectives<br />

• Degree <strong>and</strong> clarity of definition of<br />

objectives to be pursued<br />

• Strength of financial/resource<br />

commitment by industry<br />

• Contribution to broader policy<br />

objectives<br />

• Scale of the impact on industrial<br />

competitiveness <strong>and</strong> growth<br />

The IMI JTI is high on the priority list, but<br />

nothing is certain. Therefore it needs your<br />

support, see Mirror Platforms below.<br />

The overall intentions for the JTI on<br />

Innovative Medicines are to;<br />

• provide a mechanism for rapid <strong>and</strong><br />

systematic take up, evaluation <strong>and</strong><br />

translation of research results into new<br />

methods <strong>and</strong> techniques for use in the<br />

medicines development process<br />

• facilitate the provision of advice by<br />

regulators for setting up “tailor made”<br />

validations<br />

• provide “neutral ground” for the necessary<br />

collaboration between all<br />

stakeholders, thereby removing the<br />

suspicions of “biased collaborations”<br />

that undermine collaborations <strong>today</strong><br />

• foster the development of a new «tool-<br />

box» (toxicology tests, biomarkers,<br />

clinical trials protocols, etc.) for drug<br />

developers to reduce the risk of failure<br />

during clinical trials<br />

• provide the infrastructure for validation<br />

of the new tools in view of rapid uptake<br />

into regulatory <strong>and</strong> industry practice<br />

• set up ‘knowledge platforms’ pooling<br />

data from toxicology testing <strong>and</strong><br />

biomarker validation, which will be<br />

available to all researchers (industry<br />

<strong>and</strong> academic)<br />

Since the necessary R&D cannot be done<br />

by any one member of the stakeholders<br />

group alone, the IMI will facilitate the<br />

participation of all stakeholder groups<br />

in the research, following open calls <strong>and</strong><br />

peer review. Research can be done by<br />

“anybody” as long as it is carried out in<br />

Europe.<br />

At the present stage, March 2006, the<br />

EU money allocated to FP7 are expected<br />

to be considerably less than originally<br />

anticipated. So instead of 400 Mio. Euro<br />

per year, the Commission works with a<br />

plan where they allocate 50 Mio. Euro in<br />

the first year, followed by an increase in<br />

subsequent years, when money becomes<br />

more abundant in the EU system. The<br />

money will be given to public-private<br />

partnerships where industry pays for all of<br />

their own costs <strong>and</strong> the Commission pays<br />

for the rest. The industry has bound itself<br />

to spend the same amount of money as the<br />

Commission per year.<br />

Proposed governance structure of<br />

the IMI JTI<br />

The IMI JTI Board shall be composed by<br />

the Founding Members (EC <strong>and</strong> EFPIA)<br />

<strong>and</strong> by potential new funding members.<br />

The Executive Office is responsible<br />

for day-to-day management regarding the<br />

implementation of the SRA.<br />

The Scientific Committee is an<br />

advisory body to the Board. Collectively<br />

it shall have the competencies to cover the<br />

complete drug development process <strong>and</strong><br />

have a balance composition of academia,<br />

patients, industry <strong>and</strong> regulatory<br />

representatives. In particular it shall advise<br />

on the continued relevance of the SRA<br />

<strong>and</strong> review the scientific achievements of<br />

the SRA implementation <strong>and</strong> advise the<br />

board accordingly. Finally it shall advise<br />

on the composition of the peer review<br />

committees.<br />

The Stakeholder Forum should be<br />

LI<br />

open to all stakeholders <strong>and</strong> convene<br />

annually. It shall ensure the openness <strong>and</strong><br />

transparency of IMI <strong>and</strong> it can provide<br />

strategic advice to the Board.<br />

The Member States Group shall<br />

approve the composition of Scientific<br />

Committee. It shall facilitate rapid<br />

dissemination of information <strong>and</strong> ensure<br />

co-ordination with national activities.<br />

Especially it shall be responsible for<br />

the implementation of Education <strong>and</strong><br />

Training.<br />

It is noteworthy that the organisation<br />

of the Stakeholder Forum is so vaguely<br />

presented. This leaves room for European<br />

organisations linked to the drug<br />

development process to act on this stage.<br />

Conventional support through FP7<br />

If the JTI for Innovative Medicines is<br />

adopted at its intended scale, one should<br />

not expect to see many calls specifically<br />

related to the pharmaceutical research in<br />

the ordinary FP7. However, it will still be<br />

possible to apply for general instruments<br />

like Marie Curie fellowships etc.<br />

Mirror Technological Platforms<br />

In parallel to the European Innovative<br />

Medicines Initiative, corresponding<br />

regional <strong>and</strong> national platforms have been<br />

established in Denmark-Sweden, The<br />

Netherl<strong>and</strong>s, Spain, France <strong>and</strong> Romania.<br />

In this connection, it is important that<br />

all researchers engaged in pharma in one<br />

way or another support these initiatives;<br />

indicating to the national governments that<br />

there are local researchers, who will step<br />

in, if their respective ministers support the<br />

JTI on Innovative Medicines. In this way,<br />

your personal effort can strengthen the<br />

pharmaceutical sciences in Europe <strong>and</strong><br />

vice versa.<br />

Conclusion<br />

The NSMF initiative has grown in size<br />

<strong>and</strong> importance, but it has also been<br />

substantially added to <strong>and</strong> changed<br />

br<strong>and</strong>ing, appearing under a new name:<br />

Innovative Medicines Initiative (IMI).<br />

Still the decisive step of significant funding<br />

has not yet been taken, for which reason<br />

I appeal to all <strong>EUFEPS</strong> membership not<br />

to lose any opportunity to promote <strong>and</strong><br />

support the idea in your local environment:<br />

namely that Europe needs the Innovative<br />

Medicines Initiative to compete in the<br />

global arena for pharmaceuticals.<br />

Together we can do it!


<strong>EUFEPS</strong> Newsletter, 2006, vol. 15, issue 2<br />

Public-Private<br />

Partnerships <strong>and</strong><br />

‘Le défi Americain’<br />

revisited<br />

Daan J.A. Crommelin, Professor<br />

Dutch Top Institute Pharma, Leiden, The Netherl<strong>and</strong>s<br />

Le Défi Americain: The Challenge<br />

European academic groups strive for<br />

excellence in science; pharmaceutical<br />

groups for excellence in the pharmaceutical<br />

sciences. There are several ways to<br />

measure academic success. One way is<br />

to look at the number of publications <strong>and</strong><br />

their impact on progress in science. Figure<br />

1 clearly indicates that Europe, scattered as<br />

it may be, is doing rather well in terms of<br />

impact when compared to our American<br />

<strong>and</strong> Asian colleagues. But, what about the<br />

ensuing economic activities? Statistics tell<br />

us that 5 of the top-ten pharmaceutical<br />

companies are Europe based, the other 5<br />

have their base in the USA. But with R &<br />

D activities, the balance is different. Only<br />

17% of pharmaceutical R & D activities are<br />

performed in Europe, compared to 53%<br />

in the USA <strong>and</strong> 29% in Japan (PhRMA<br />

Annual Membership Survey, 2004). When<br />

one looks at small pharma companies,<br />

the situation is not very different. The<br />

US definitely has the lead <strong>and</strong> Europe is<br />

lagging behind. Twenty years ago these<br />

statistics were very different with Europe<br />

in a leading position. Why did this happen?<br />

The answer most often given is: the pricing<br />

of drugs in the USA is more favourable<br />

than in Europe. That means there is an<br />

economic drive. But, that is not the only<br />

factor. There is more to it: the mentality<br />

within the academic community. Among<br />

my scientifically successful academic<br />

colleagues in the USA, very few have<br />

never started or been involved in one or<br />

more start-up companies. It is part of their<br />

academic scientific business, it is part<br />

of the mission of academic institutions.<br />

This long-term tradition has also created<br />

the financial infrastructure for these<br />

developments. Venture capitalist driven<br />

initiatives have flourished. And the<br />

money required was partly provided by<br />

European institutions. In Europe we have,<br />

‘grosso modo’, not followed that strategy.<br />

Academic <strong>and</strong> industrial activities were<br />

more separated. ‘It was not done’, as an<br />

academic, to pursue transformation of<br />

academic concepts into products. The<br />

lack of financial <strong>and</strong> legal infrastructures<br />

was the result <strong>and</strong> not the reason for<br />

lack of success. A number of originally<br />

European inventions were developed<br />

<strong>and</strong> commercialised in the USA. Can we<br />

change this trend? In other words can<br />

we find in Europe an answer to ‘le défi<br />

americain’, the American challenge, a<br />

theme already addressed in the famous<br />

book by the French author <strong>and</strong> politician<br />

Servan-Schreiber published in 1967. Can<br />

we find an answer for Europe, culturally<br />

<strong>and</strong> economically divided as it is? This<br />

contribution briefly discusses a number of<br />

issues that may help to successfully deal<br />

with ‘le défi americain’.<br />

Academic Excellence <strong>and</strong><br />

Industrial Success<br />

There are differences in Europe with regard<br />

to the relationship between academic<br />

research centres <strong>and</strong> industry. Table 2<br />

indicates that in Sweden, Denmark <strong>and</strong><br />

the UK, industrial activity as a percentage<br />

of expenditure in the pharmaceutical/<br />

biomedical field is considerably higher<br />

than elsewhere in Europe. The UK,<br />

Denmark <strong>and</strong> Sweden are also among<br />

the high scoring countries with regard to<br />

scientific impact (table 1). Is this the key<br />

to success? Good academic <strong>and</strong> industrial<br />

research go together? If that is the solution,<br />

what can we do to regain momentum in<br />

pharmaceutical R & D in Europe? To turn<br />

a ‘brain drain’ into a ‘brain gain’? To turn<br />

the transatlantic flow of money around?<br />

LII<br />

Daan J.A. Crommelin, Professor<br />

University Leadership<br />

The European academic system should<br />

be sensitised to the idea that striving for<br />

commercialisation of academic research<br />

is part of the mission of universities. Not<br />

in <strong>and</strong> through academic groups. These<br />

groups should excel in their field of the<br />

pharmaceutical sciences. Academic<br />

research should lead to new concepts. To<br />

develop a pharmaceutical product from a<br />

concept is not an academic responsibility.<br />

To sensitise the scientists is one thing, to<br />

make the academic leadership appreciate<br />

<strong>and</strong> support these efforts is a second<br />

challenge. My colleagues in the USA<br />

bring in a lot of dollars to their universities<br />

by their industrial activities, be it through<br />

upfront money, milestone payments or<br />

royalty payments. They also personally<br />

benefit from these endeavours. Is that<br />

good? It certainly gives an extra drive.<br />

A professional business attitude, based<br />

on realism <strong>and</strong> familiarity with business<br />

ground rules, is a first requirement for<br />

the university leadership. Only leadership<br />

appreciating that excellence in sciences<br />

goes together with a strong academicindustry<br />

link should be chosen. This also<br />

implies that in the quality assessment of<br />

academic groups, the academic-industry<br />

interaction should be factored in.<br />

Technology Transfer<br />

Concept development leads to patent<br />

applications <strong>and</strong> the university should<br />

have mechanisms to support patent<br />

submission <strong>and</strong> to do its part in the process<br />

of value creation from this know-how by<br />

industry. In my experience, technology<br />

transfer offices at universities are not<br />

the most flexible <strong>and</strong> inventor-friendly<br />

institutes. The culture is still too much<br />

‘us against them’. One reason I can see


is lack of respect from the side of the<br />

scientist for the legal expert who runs<br />

away with ‘his baby’. Another is the lack<br />

of feeling of technology transfer officers<br />

for the mindset of basic scientists <strong>and</strong> the<br />

typical academic culture. In the section on<br />

Education <strong>and</strong> Training, I will offer some<br />

solutions.<br />

Transparency<br />

Then the issue of ‘transparency’. Flexibility<br />

in an academic system, where value<br />

creation is taken as part of the mission,<br />

is essential <strong>and</strong> here again leadership is<br />

required, as a primary human reaction<br />

such as jealousy can be detrimental to<br />

the performance of research groups.<br />

Total transparency of procedures <strong>and</strong><br />

agreements is a prerequisite so that there<br />

is a firm basis for discussions on perceived<br />

unfairness <strong>and</strong> possible conflicts of<br />

interest.<br />

Education & Training<br />

An interesting hybrid set of skills is<br />

required to successfully run a high<br />

tech pharmaceutical business. A basic<br />

underst<strong>and</strong>ing of scientific concepts<br />

<strong>and</strong> academic culture is definitely an<br />

advantage. Therefore, that hurdle is low<br />

for entrepreneurs with a PhD in science.<br />

It just makes it easy to communicate <strong>and</strong><br />

underst<strong>and</strong> the intricacies of the academic<br />

science world. But, at present, relatively<br />

little attention is paid at the Master <strong>and</strong><br />

PhD training levels to the managerial,<br />

financial <strong>and</strong> legal (e.g. intellectual<br />

property) structure in the high tech<br />

pharma industry. This could be attributed<br />

to lack of expertise in the academic world<br />

<strong>and</strong> the difficulties in bringing in experts<br />

from outside. Here lies a challenge for both<br />

the academic <strong>and</strong> industrial world: to set<br />

up education <strong>and</strong> training programmes for<br />

workers in the high tech pharmaceutical<br />

industry <strong>and</strong>... technology transfer officers<br />

to bridge the gap.<br />

From Concept to Product: Filling<br />

the gap<br />

How to give this process: ‘from concept<br />

to product’ a smooth ride? Prerequisites<br />

are excellence in science, a determined<br />

academic management <strong>and</strong> interest for<br />

new concepts from the pharma <strong>and</strong> biotech<br />

industry. A stimulation programme should<br />

consist of a number of supporting elements,<br />

each for a specific stage of the process. It<br />

is essential to take into account the long<br />

horizon of pharmaceutical research.<br />

Typically, a full drug development<br />

programme takes 10+ years <strong>and</strong> those<br />

Table 1<br />

Worldwide rankings based on publication output <strong>and</strong> citation impact, 1998-2001<br />

Production of research Relative citation impact<br />

articles<br />

of articles*<br />

United States 1,269,036 1 1.42 2<br />

United Kingdom 354,724 2 1.21 4<br />

Japan 337,810 3 0.85 18<br />

Germany 313,712 4 1.09 9<br />

France 231,550 5 1.01 13<br />

Canada 164,182 6 1.21 5<br />

Italy 150,013 7 0.95 17<br />

Russia 127,965 8 0.32 29<br />

China 115,403 9 0.41 27<br />

Spain 106,023 10 0.85 19<br />

Australia 103,648 11 1,01 12<br />

The Netherl<strong>and</strong>s 93,129 12 1.25 3<br />

India 73,787 13 0.37 28<br />

Sweden 72,469 14 1.13 8<br />

Switzerl<strong>and</strong> 65,878 15 1.44 1<br />

South Korea 57,399 16 0.65 21<br />

Belgium 47,685 17 1.09 10<br />

Israel 46,336 18 1.06 11<br />

Taiwan 44,457 19 0.65 22<br />

Pol<strong>and</strong> 43,518 20 0.55 24<br />

Brazil 43,373 21 0.55 25<br />

Denmark 37,086 22 1.17 6<br />

Finl<strong>and</strong> 34,371 23 1.15 7<br />

Austria 33,854 24 0.98 15<br />

Norway 23,195 25 1.01 14<br />

Turkey 23,013 26 0.44 26<br />

Greece 21,736 27 0.71 20<br />

Mexico 21,014 28 0.60 23<br />

New Zeal<strong>and</strong> 20,961 29 0.96 16<br />

Ukraine 20,304 30 0.28 30<br />

* The citation impact is normalised for the worldwide average per discipline. This is<br />

the average number of citations received by all research articles in the professional<br />

journals (worldwide average*). Self-citations of researchers of their own articles are<br />

excluded.<br />

Source: CWTS/ISI. Adjusted by CWTS<br />

LIII<br />

who design financial support programmes<br />

should be aware of this long horizon. An<br />

interesting development is the appearance<br />

of Public Private Partnerships (PPPs). The<br />

Dutch Top Institute Pharma (TIPharma)<br />

just started <strong>and</strong> is an example of such a PPP.<br />

Academic <strong>and</strong> industrial groups submit<br />

projects to this virtual (so no ‘bricks <strong>and</strong><br />

mortar’) institute. The projects must have<br />

a pre-competitive, translational character<br />

<strong>and</strong> are financed (60 million euro/ year)<br />

via a 1-1-2 mechanism: the academic <strong>and</strong><br />

industrial groups are committed to bring in<br />

25% each <strong>and</strong> the Dutch government 50%<br />

of the funding. The funding mechanism has<br />

a multiplier effect which makes it attractive<br />

for each group. This initiative brings the<br />

academic <strong>and</strong> industrial world together<br />

in an early stage of research: concept<br />

development with a strong translational<br />

character: ‘from bench to clinic’. Later, the<br />

industry will work on the development of<br />

interesting concepts or spin-offs can be<br />

set up for value creation purposes. For this<br />

later development stage, other supporting<br />

mechanisms are available resembling the<br />

American SBIR (small business innovation<br />

research) program. With increasing<br />

competitiveness the subsidy level decreases.<br />

Subsidy schemes can be set up via national<br />

initiatives. Why not set up PPPs along the<br />

lines of a Dutch Top Institute Pharma,<br />

but then within the framework of the EU?<br />

An European Top Institute Pharma in the<br />

seventh framework programme of the EU?<br />

Will the Innovative Medicines Initiative<br />

(IMI) evolve into a PPP structure?<br />

Conclusion<br />

Le défi americain: the American<br />

challenge. It is clear, Europe has the strong<br />

science base that is needed. But, presently<br />

the set-up of a coherent response to the<br />

challenge is more a national than an EU<br />

initiative. This should change! PPPs may<br />

be part of the answer. PPP st<strong>and</strong>s for<br />

Public Private Partnerships, but one can<br />

also read: Profit for the academic world,<br />

Profit for the private industry <strong>and</strong> Profit<br />

for our economy <strong>and</strong> society.<br />

Table 2. The participation of Industry<br />

in medical/pharmaceutical research<br />

Sweden 66%<br />

UK 65%<br />

Denmark 61%<br />

US 48%<br />

Norway 40%<br />

The Netherl<strong>and</strong>s 40%<br />

Germany 35%


<strong>EUFEPS</strong> Newsletter, 2006, vol. 15, issue 2<br />

How to develop<br />

academic drug<br />

research in Europe<br />

Rodolfo Paoletti, Professor<br />

University of Milan, Italy<br />

In this article, Professor Paoletti,<br />

formerly an Executive Committee<br />

member of <strong>EUFEPS</strong> <strong>and</strong> long-term<br />

contributor to the <strong>EUFEPS</strong> Committee on<br />

Academic Research Relations, gives his<br />

views on important future developments<br />

in the academic institutions, which are a<br />

core element of pharmaceutical sciences<br />

in Europe.<br />

Rapid Development <strong>and</strong><br />

Restructuring<br />

The pharmaceutical sciences are currently<br />

undergoing rapid development <strong>and</strong> major<br />

restructuring. The revolution of molecular<br />

biology <strong>and</strong> progress in mapping the human<br />

genome have created new challenges <strong>and</strong><br />

opportunities for drug research covering<br />

all aspects from discovery to clinical use<br />

of drugs. To meet the challenges, there<br />

is a pressing need for pharmaceutical<br />

scientists with interdisciplinary training<br />

coupled with an academic <strong>and</strong> industrial<br />

research perspective.<br />

Enormous Potential to Exploit<br />

Unleashing the full potential of European<br />

universities is a key part of the Lisbon<br />

Strategy to create jobs <strong>and</strong> growth in<br />

Europe. With 4 000 institutions, over 17<br />

million students <strong>and</strong> some 1.5 million<br />

staff - of whom 435 000 are researchers<br />

- European universities have enormous<br />

potential. However, this potential is not fully<br />

exploited <strong>and</strong> is not working effectively to<br />

strengthen Europe’s drive for more growth<br />

<strong>and</strong> more jobs. Universities also have to<br />

accept that research is no longer an isolated<br />

activity <strong>and</strong> that the emphasis is shifting<br />

from individual researchers to teams<br />

<strong>and</strong> global research networks. Scientific<br />

problems tend to go beyond traditional<br />

disciplinary structures: cutting-edge<br />

research is increasingly being conducted<br />

at the interface between academic<br />

disciplines or in multidisciplinary settings.<br />

Universities’ research environments are<br />

more competitive, globalised <strong>and</strong> require<br />

greater interaction.<br />

Process Approach Preferred<br />

Academic groups have traditionally<br />

worked on one aspect of the drug discovery<br />

or development process. Pharmacology or<br />

pharmaceutical technology departments<br />

in academic centers defined their own<br />

research goals <strong>and</strong> worked in more or less<br />

splendid isolation. While they were small,<br />

this has led to important new findings <strong>and</strong><br />

an underst<strong>and</strong>ing of basic mechanisms.<br />

The idea of following the industrial<br />

pipeline approach for creating new drugs<br />

was neither appreciated nor followed.<br />

Nowadays, one can observe trends<br />

towards increasing group size in order to<br />

reach a critical mass, focusing research<br />

on particular subjects <strong>and</strong> structuring<br />

academic drug research institutes more<br />

along the lines of industrial operation:<br />

the drug pipeline including the feedback<br />

loops. This process is driven, for example,<br />

by advice from internal <strong>and</strong> external<br />

review panels <strong>and</strong> by networks. Currently,<br />

research institutes concentrating entirely<br />

on different aspects of drug research can<br />

be found in selected European countries<br />

including Denmark <strong>and</strong> the Netherl<strong>and</strong>s.<br />

Despite the willingness of the universities<br />

to spin off their expertise, encouraged<br />

by national governments, Europe is<br />

facing a knowledge paradox: academic<br />

research groups do an excellent job, but<br />

the activities, business <strong>and</strong> products<br />

resulting from this are limited. Further<br />

attuning of research directions <strong>and</strong><br />

stimulation of academic drug research<br />

through innovation platforms, both at<br />

the national <strong>and</strong> international level,<br />

LIV<br />

Rodolfo Paoletti, Professor<br />

is required. For instance, centers for<br />

Good Manufacturing Practice (GMP)production<br />

of biotechnological drugs<br />

(antibodies, vectors, cell therapies) are<br />

needed. Several deficiencies hamper the<br />

drive for innovation in healthcare;<br />

• a lack of qualified people<br />

• insufficient start-ups from universities<br />

• an inadequate clinical biotechnical<br />

research structure in most academic<br />

centers<br />

• slow introduction of biologicals<br />

• a lack of funds.<br />

EMEA Important Role<br />

Current regulation is not able to cope<br />

with new developments. The European<br />

Medicines Agency (EMEA) is the main<br />

drug regulation <strong>and</strong> registration agency<br />

in Europe, <strong>and</strong> so decisions of the EMEA<br />

should quickly apply to individual<br />

countries.<br />

Intellectual Property in Focus<br />

A more professional approach towards<br />

protection of intellectual property by<br />

academic medical centers is important<br />

just as is a more professional approach<br />

towards seed capital funding for<br />

biotechnological companies. Some fifteen<br />

years ago, a good publication in a highlevel<br />

scientific journal used to be the<br />

start of a small company. Experience has<br />

shown that it is not that easy any more.<br />

The intellectual property rights that gave<br />

rise to such a start-up company should in<br />

future stay in the parent institution. It is of<br />

great importance that intellectual property<br />

becomes a focus in the process of drug<br />

development, together with the experience<br />

of the employees. Universities cover both<br />

the educational <strong>and</strong> the research aspects,<br />

which make them the ideal place for this<br />

focus. The education system needs to be


adapted to the current multidisciplinary<br />

approach in drug development. Many new<br />

people are not trained in a multidisciplinary<br />

way, but focus on one area. Teaching them<br />

to focus on multiple areas can increase<br />

these people’s productivity. In addition,<br />

medical schools <strong>and</strong> teaching hospitals<br />

have largely abdicated their responsibility<br />

to educate physicians, leaving that to drug<br />

companies. To solve these problems the<br />

training of clinicians should be improved:<br />

more emphasis should be laid on<br />

molecular pathology, biotechnology <strong>and</strong><br />

on drug development/regulation. This will<br />

stimulate innovation in drug research.<br />

Drug Development Challenges<br />

Drug companies often concentrate on<br />

producing minor variations of top-selling<br />

drugs already on the market – called<br />

“me-too” drugs. Most of the research <strong>and</strong><br />

development funding goes into clinical<br />

trials, the last stage of drug development.<br />

Innovative drugs are much rarer <strong>and</strong><br />

stem from publicly funded research at<br />

university <strong>and</strong> government laboratories.<br />

Yet much industry-sponsored clinical<br />

research is carried out at academic medical<br />

centres. Studies show that such research<br />

is more favourable toward the sponsors’<br />

drugs than publicly funded research,<br />

<strong>and</strong> it is often biased in design – e.g., a<br />

clinical trial may compare a new drug<br />

with a placebo, when what doctors really<br />

want to know is how it compares with an<br />

old drug. GCP, Good Clinical Practice, is<br />

an international set of ethical <strong>and</strong> quality<br />

st<strong>and</strong>ards that applies to medicinal trials<br />

in humans. These st<strong>and</strong>ards indeed<br />

relate to research <strong>and</strong> have been in effect<br />

for many years pertaining to all trials<br />

intended to generate data for marketing<br />

authorization procedures whether they be<br />

new medicinal products or line extensions<br />

for already marketed products. As a<br />

general rule, academic research involving<br />

already marketed products <strong>and</strong> not<br />

intended to generate results for marketing<br />

authorization purposes has been exempt<br />

from these rules. Yet within the EU, these<br />

rules, as of May 1st 2004, pertain to any<br />

medicinal trials in humans, including<br />

those involving already marketed drugs<br />

<strong>and</strong> trials performed without industry<br />

engagement. This represents a serious<br />

challenge to the academic independent<br />

drug related research, as systems to assure<br />

GCP compliance must be developed,<br />

which in turn requires allocation of<br />

appropriate resources.<br />

European Diversity Benefits<br />

Modernisation of Europe’s universities,<br />

involving their interlinked roles of<br />

education, research <strong>and</strong> innovation, has<br />

been acknowledged not only as a core<br />

condition for the success of the broader<br />

Lisbon Strategy, but as part of the wider<br />

move towards an increasingly global <strong>and</strong><br />

knowledge-based economy. The European<br />

LV<br />

dimension offers the potential benefits of<br />

larger scale operation, greater diversity<br />

<strong>and</strong> intellectual richness of resources,<br />

plus opportunities for cooperation <strong>and</strong><br />

competition between institutions. In this<br />

respect, the European Commission has<br />

already proposed the establishment of the<br />

European Institute of Technology (EIT).<br />

This new organization could contribute to<br />

improving Europe’s capacity for scientific<br />

education, research <strong>and</strong> innovation,<br />

while providing an innovative model<br />

to inspire <strong>and</strong> drive change in existing<br />

universities, in particular by encouraging<br />

multi-disciplinarity <strong>and</strong> developing the<br />

strong partnerships with business that<br />

will ensure its relevance. Interaction with<br />

the outside world will gradually make<br />

universities’ activities more relevant to<br />

the needs of citizens <strong>and</strong> society at large.<br />

It will help universities to promote their<br />

different activities <strong>and</strong> to convince society,<br />

governments <strong>and</strong> the private sector that<br />

they are worth investing in.<br />

Urgent Modernisation Needed<br />

Universities are key players in Europe’s<br />

future <strong>and</strong> for the successful transition<br />

to a knowledge-based economy <strong>and</strong><br />

society. However, this crucial sector of the<br />

economy <strong>and</strong> of society needs in-depth<br />

restructuring <strong>and</strong> modernisation if Europe<br />

is not to lose out in the global competition<br />

in education, research <strong>and</strong> innovation.


<strong>EUFEPS</strong> Newsletter, 2006, vol. 15, issue 3<br />

15 th <strong>Anniversary</strong><br />

Sunday, September 24, 2006<br />

Radisson SAS Sc<strong>and</strong>inavia<br />

Hotel, Copenhagen, Denmark<br />

In conjunction with the <strong>EUFEPS</strong><br />

Conference on “Membrane Drug<br />

Transporters: Impact on Drug Discovery,<br />

Development, Regulation <strong>and</strong> Usage”<br />

Aim<br />

Founded in Strasbourg in 1991, <strong>EUFEPS</strong><br />

exists to serve <strong>and</strong> advance excellence in<br />

pharmaceutical sciences <strong>and</strong> innovative<br />

drug research in Europe.<br />

It is there to help to meet the challenges<br />

<strong>and</strong> seize the opportunities created by<br />

the consolidations occurring both within<br />

Europe <strong>and</strong> globally, driven on by a<br />

combination of rapid advances in science<br />

<strong>and</strong> technology, economic pressures, <strong>and</strong><br />

by political will.<br />

Constituency<br />

Currently, <strong>EUFEPS</strong> links 24 Member<br />

Societies in 24 countries. The total<br />

membership of all <strong>EUFEPS</strong> Member<br />

Societies comprises more than 20 000<br />

individuals. In addition, there are more<br />

than 600 Individual Members.<br />

<strong>EUFEPS</strong> is the only pan-European<br />

body to represent the interests of scientists<br />

in industry, academia, government <strong>and</strong><br />

other institutions engaged in drug research<br />

<strong>and</strong> development, drug regulation, drug<br />

utilization <strong>and</strong> drug policy making<br />

throughout Europe.<br />

Foundation<br />

Before the inauguration of <strong>EUFEPS</strong>,<br />

the need for an independent, scientific<br />

European body to promote the interests<br />

of pharmaceutical sciences had been<br />

discussed for years. Also, there were<br />

scientific organisations established in<br />

several countries. In the invitation to a<br />

scientific meeting, held in conjunction<br />

with the 100th <strong>Anniversary</strong> of the<br />

German Pharmaceutical Society, in<br />

1990, it was suggested that a European<br />

federation of pharmaceutical sciences<br />

associations should be considered. At the<br />

meeting, attended by representatives from<br />

Austria, Croatia, Czechoslovakia, Greece,<br />

France, Hungary, Italy, The Netherl<strong>and</strong>s,<br />

Pol<strong>and</strong> <strong>and</strong> Sweden, this idea was further<br />

discussed, <strong>and</strong> there was a general <strong>and</strong><br />

enthusiastic agreement to proceed along<br />

these lines. A working group was formed,<br />

an important task of which was to prepare<br />

for a formal founding meeting in 1991.<br />

On September 21, 1991, the inaugural<br />

meeting was held in Strasbourg at the<br />

Council of Europe Congress Centre.<br />

Mr. Anders Björck, President of the<br />

Parliamentary Assembly of the Council<br />

of Europe, opened it. He stressed, in<br />

his inaugural speech, the importance<br />

of working together for increased<br />

competitiveness. For this, he would<br />

rather see joint European efforts than<br />

uncoordinated actions, country by country.<br />

At this meeting, 16 national associations<br />

(cf. current list of Member Societies, on<br />

last page) agreed to formally establish the<br />

European Federation for Pharmaceutical<br />

Sciences (<strong>EUFEPS</strong>).<br />

Leadership <strong>and</strong> Council<br />

<strong>EUFEPS</strong> is governed by a ten-member<br />

Executive Committee, meeting 4-5 times<br />

a year. The Members of this Committee<br />

are elected by <strong>EUFEPS</strong> Council, which<br />

meets once a year. The Council comprises<br />

representatives of all Member Societies<br />

<strong>and</strong> of the Individual Membership. Former<br />

members of the <strong>EUFEPS</strong> Executive<br />

Committee, include:<br />

Dominique Duchêne, France (Past<br />

President)<br />

Douwe D. Breimer, The Netherl<strong>and</strong>s<br />

(Past President)<br />

Ernst Mutschler, Germany (Past President)<br />

LVI<br />

Malcolm Rowl<strong>and</strong>, United Kingdom<br />

(Past President)<br />

Stig Agurell, Sweden (Past Secretary-<br />

General)<br />

Piero Sensi, Italy (Past Treasurer)<br />

Björn Lindeke, Sweden (Past Secretary-<br />

General/Treasurer)<br />

Bernd Clement, Germany<br />

Henk J. de Jong, The Netherl<strong>and</strong>s<br />

Tony Fell, United Kingdom<br />

Anders Grahnén, Sweden<br />

A. Atilla Hincal, Turkey<br />

Yvette Michotte, Belgium<br />

Karoly Nikolics, Hungary<br />

Fern<strong>and</strong> Pellerin, France<br />

Paul Rossignol, France<br />

Michel Veillard, France (Past Treasurer)<br />

Altan Demirdere, Turkey<br />

Aleš Mrhar, Slovenia<br />

Conny Bogentoft, Sweden (Past Treasurer)<br />

The current Executive Committee<br />

members are:<br />

Christian R. Noe, Austria (President)<br />

Daan J.A. Crommelin, The Netherl<strong>and</strong>s<br />

(President-elect)<br />

Ole J. Bjerrum, Denmark (Immediate<br />

Past-president)<br />

Hans H. Lindén, Sweden (Executive<br />

Director)<br />

Per From, Sweden (Treasurer)<br />

Rodolfo Paoletti, Italy<br />

Theo Dingermann, Germany<br />

Chris Doherty, United Kingdom<br />

Hilda Köszegi-Szalai, Hungary<br />

Pia Vuorela, Finl<strong>and</strong><br />

Hans H. Lindén has served as Executive<br />

Director since 2002.<br />

Strategic Plan<br />

The leadership works out a strategic plan<br />

to be adopted by the Council every 4 years.<br />

It is updated midterm. Plans have been<br />

issued in 1994, 1998, 2002 <strong>and</strong> 2006.


Engagement in EU Supported<br />

Pharmaceutical Sciences<br />

Consortia<br />

<strong>EUFEPS</strong> participates actively in the<br />

following publicprivate partnerships:<br />

BioSim Network of Excellence dealing<br />

with simulation <strong>and</strong> modelling (from<br />

2004).<br />

EUMAPP Special Support Action on<br />

microdosing (from 2005).<br />

InnoMed Integrated Project on new<br />

approaches for accelerated development<br />

of new safe <strong>and</strong> more effective medicines<br />

(from 2005).<br />

Help <strong>and</strong> advice<br />

To help initiate, monitor <strong>and</strong> execute<br />

activities of <strong>EUFEPS</strong>, there are a number<br />

of advisory panels.<br />

They include, currently:<br />

The Committee on Academic Research<br />

Relations (CARR)<br />

The Committee on Awards <strong>and</strong> Prizes<br />

(CAP)<br />

The Committee on Industrial Research<br />

Relations (CIRR)<br />

The Committee on Training <strong>and</strong> Education<br />

(CTE)<br />

Working Parties/Adhoc Groups<br />

These are being created when appropriate.<br />

Currently, the following ones are active:<br />

• Creating a Pharmaceutical Sciences<br />

Forum<br />

• Permanenting the Pharmaceutical<br />

Sciences Fair<br />

• Exploring a Pharmaceutical Sciences<br />

Academy<br />

• Mapping Pharmaceutical Sciences<br />

Funding<br />

In this connection, it is noteworthy that<br />

<strong>EUFEPS</strong> will host the first meeting<br />

about a Pharmaceutical Sciences Forum<br />

of European sister federations <strong>and</strong><br />

associations. In addition, ad hoc scientific<br />

programme <strong>and</strong> organising committees<br />

plan <strong>and</strong> steer <strong>EUFEPS</strong>´ congresses,<br />

conferences <strong>and</strong> courses.<br />

<strong>EUFEPS</strong> Presidents’ Conferences<br />

To establish direct contact with the<br />

Presidents of the national Member<br />

Societies, regular meetings have been set<br />

up e.g. in Barcelona, April 2005; in Nice,<br />

June 2005; in Versailles, November 2005;<br />

<strong>and</strong> in Vienna, June 2006.<br />

European Congress of Pharmaceutical<br />

Sciences & PharmSciFair<br />

The European Congresses are biennial<br />

gatherings with focus on advances in<br />

the pharmaceutical sciences. They were<br />

held in Amsterdam (1992), Berlin (1994),<br />

Edinburgh (1996), Milan (1998), Budapest<br />

(2000), Stockholm (2002) <strong>and</strong> Brussels<br />

(2004).<br />

With the wish to make these general<br />

meetings into a true European event,<br />

involving the larger number of the most<br />

active European scientific societies in the<br />

pharmaceutical science field, <strong>EUFEPS</strong><br />

ended the series by introducing the<br />

Pharmaceutical Sciences Fair & Exhibition<br />

(PharmSciFair) held for the first time in<br />

Nice in 2005. The following stakeholders<br />

invested financially <strong>and</strong> scientifically, <strong>and</strong><br />

shared the revenue:<br />

• Academy of Pharmaceutical Sciences<br />

of Great Britain (APSGB)<br />

• Association de Pharmacie Galénique<br />

Industrielle (APGI)<br />

• Association Francaise des Affaires<br />

Réglementaires (AFAR)<br />

• Associazione Docenti e Ricercatori<br />

Italiani di Tecnologie e Legislazione<br />

Farmaceutiche (ADRITELF)<br />

• Austrian Pharmaceutical Society (ÖPhG)<br />

• Belgian Society of Pharmaceutical<br />

Sciences (BSPS)<br />

• Deutsche Pharmazeutische<br />

Gesellschaft (DPhG)<br />

• European Association of Pharma<br />

Biotechnology (EAPB)<br />

• European Directorate for the Quality<br />

of Medicines (EDQM) & European<br />

Pharmacopoeia (PhEur)<br />

• European Federation for Medicinal<br />

Chemistry (EFMC)<br />

• European Federation for<br />

Pharmaceutical Sciences (<strong>EUFEPS</strong>)<br />

• European Pharmaceutical Students´<br />

Association (EPSA)<br />

• European Society of Clinical<br />

Pharmacy (ESCP)<br />

• Finnish Pharmaceutical Society (FPhS)<br />

• Hungarian Society for Pharmaceutical<br />

Sciences (SSPH)<br />

• International Pharmaceutical<br />

Excipients Council Europe (IPEC<br />

Europe)<br />

• International Society for the Study of<br />

Xenobiotics (ISSX)<br />

• Italian Society for Pharmaceutical<br />

Sciences (SISF)<br />

• Netherl<strong>and</strong>s Society for<br />

Pharmaceutical Sciences (NVFW)<br />

• Pharmaceutical Society of Denmark<br />

(DPS)<br />

• Slovenian Pharmaceutical Society (SFD)<br />

• Société de Chimie Thérapeutique, in<br />

France (SCT)<br />

LVII<br />

• Swedish Academy of Pharmaceutical<br />

Sciences (SAPS)<br />

• Swedish Proteomics Society (SPS)<br />

• Turkish Pharmaceutical Technology<br />

Scientists’ Association (TÜFTAD)<br />

• University of Helsinki (HY)<br />

To make PharmSciFair a widely<br />

recognised scientific event <strong>and</strong> to<br />

acknowledge a scientist, who has<br />

contributed to pharmaceutical sciences<br />

research <strong>and</strong> discovery at an exceptional<br />

level, <strong>EUFEPS</strong> launched the European<br />

Pharmaceutical Scientist Award, with a<br />

€15000 prize.<br />

Because of the Pharmaceutical Science<br />

World Congress, only a PharmSciFair<br />

Exhibition will be held in 2007. The next<br />

full Fair is planned for 2009 in Nice.<br />

Optimising Drug Development<br />

Conferences<br />

These represent a unique discussion forum<br />

for scientists from the pharmaceutical<br />

industry, regulatory agencies, <strong>and</strong><br />

academic institutions on specialised<br />

themes. This series started in 1994, <strong>and</strong><br />

twelve conferences on Optimising Drug<br />

Development will have been held through<br />

2006 with Basel as host city.<br />

Two conferences were held on<br />

Optimising Biotech Medicines, in Berlin<br />

(2002), <strong>and</strong> in Brussels (2004). The next<br />

one is planned for Munich (2008).<br />

Two conferences on Optimising Drug<br />

Delivery <strong>and</strong> Formulation were held in<br />

2003 <strong>and</strong> 2005, together with APGI,<br />

Versailles being host city.<br />

Conferences on Compound Profiling<br />

<strong>and</strong> Lead Optimisation were held in Nice<br />

(2005) <strong>and</strong> Zürich (2006), respectively, <strong>and</strong><br />

a third one on Drug C<strong>and</strong>idate Selection is<br />

planned.<br />

BBBB Conference on<br />

Pharmaceutical Sciences<br />

Comprising Balaton, Baltic, Bled <strong>and</strong><br />

Bosphorus partners of <strong>EUFEPS</strong>, the first<br />

event was held in Siofok, at Lake Balaton<br />

(2005). The next one will take place in<br />

Estonia in 2007.<br />

Other Conferences<br />

Two world conferences on Drug<br />

Transporters have been held in<br />

Copenhagen (2004 <strong>and</strong> 2006), <strong>and</strong> two<br />

World Conference on Drug Absorption,<br />

Transport <strong>and</strong> Delivery, in Copenhagen<br />

(2004) <strong>and</strong> in Barcelona (2005).<br />

In addition, recent special conferences<br />

were done on ‘When poor solubility


ecomes an issue’ in Verona (2006), <strong>and</strong><br />

on ‘Scientific progress underpinning<br />

process analytical technology (PAT)’,<br />

Gothenburg (2006).<br />

New Safe Medicines Faster<br />

Initiative<br />

A research proposal was launched in 1999<br />

to strengthen the European competitiveness<br />

in innovation, development <strong>and</strong> use of new<br />

<strong>and</strong> safe drugs, including stronger links<br />

between industry, academia, hospitals<br />

<strong>and</strong> regulatory authorities, to the benefit<br />

of the European citizens. More efficient<br />

use of modern technology, new methods<br />

of drug exploration <strong>and</strong> better training<br />

of scientists, doctors <strong>and</strong> regulators are<br />

all vital elements for streamlining this<br />

process.<br />

It obtained support from the EU<br />

Framework Programmes <strong>and</strong> a number<br />

of activities have been launched on this<br />

basis:<br />

New Safe Medicines Faster<br />

Workshop I, Brussels (2000), Workshop<br />

II, Copenhagen (2003), <strong>and</strong> Workshop III<br />

Barcelona (2005). In addition, the topic has<br />

been h<strong>and</strong>led in Afternoon Sessions at the<br />

<strong>EUFEPS</strong> Congresses (2002 <strong>and</strong> 2004).<br />

All have been followed by extensive<br />

reports <strong>and</strong> <strong>EUFEPS</strong> was responsible for<br />

post workshop dissemination from the<br />

Barcelona 2005 event. These efforts have<br />

built the foundation for the Joint Research<br />

Initiative for creating a Technological<br />

Platform for Innovative Medicines under<br />

the 7th Framework Programme.<br />

<strong>EUFEPS</strong> Networks<br />

To assist coordination of new European<br />

initiatives within the pharmaceutical<br />

sciences, <strong>EUFEPS</strong> engages in <strong>and</strong><br />

supports various networks:<br />

• Safety Sciences (2004)<br />

• Process Analytical Technology (PAT)<br />

Sciences (2004)<br />

• Pharmacogeneticts <strong>and</strong><br />

Pharmcogenomics (2006)<br />

• Bioavailability <strong>and</strong> Biopharmaceutics<br />

(2006)<br />

• The Programme Providing Partners<br />

Network for PharmSciFair<br />

• The Membership Network for the<br />

BBBB Conference<br />

European School of Excellence in<br />

Pharmaceutical Sciences<br />

Rapidly changing dem<strong>and</strong>s, created<br />

by newly emerging science <strong>and</strong><br />

methodologies in pharmaceutical research<br />

<strong>and</strong> development, call for new training<br />

options. Five <strong>EUFEPS</strong> post-graduate<br />

courses on HT Drug Metabolism/<br />

Disposition in Leiden/Amsterdam have<br />

been held since 2002. Further courses are<br />

planned.<br />

European Journal of<br />

Pharmaceutical Sciences<br />

This is the Official Scientific Journal of<br />

<strong>EUFEPS</strong>, published monthly by Elsevier,<br />

Amsterdam.<br />

<strong>EUFEPS</strong> NewsLetter<br />

Published quarterly <strong>and</strong> electronically<br />

circulated to the <strong>EUFEPS</strong> membership,<br />

as well as to all members of all <strong>EUFEPS</strong><br />

Member Societies.<br />

<strong>EUFEPS</strong> Flash<br />

Established in 2004 as direct<br />

communication to those on the <strong>EUFEPS</strong><br />

mailing list, who want to be updated about<br />

scientific activities <strong>and</strong> meetings.<br />

<strong>EUFEPS</strong> Membership Bulletin<br />

Established in 2005 to inform all members<br />

about recent items of interest e.g. the<br />

outcome of Presidents’ Conferences.<br />

<strong>EUFEPS</strong> Online<br />

Website established in 2000 for more<br />

rapid, easy access <strong>and</strong> direct contact with<br />

the scientific community.<br />

<strong>EUFEPS</strong> Member Societies<br />

• Academy of Pharmaceutical Sciences<br />

of Great Britain, United Kingdom<br />

• Association de Pharmacie Galénique<br />

Industrielle (APGI), France<br />

• Austrian Pharmaceutical Society,<br />

Austria<br />

• Belgian Society of Pharmaceutical<br />

Sciences, Belgium<br />

• Croatian Pharmaceutical Society,<br />

Croatia<br />

• Czech Pharmaceutical Society, Czech<br />

Republic<br />

• Dutch Association of Pharmaceutical<br />

Sciences, The Netherl<strong>and</strong>s<br />

• Finnish Pharmaceutical Society,<br />

Finl<strong>and</strong><br />

• German Pharmaceutical Society<br />

(DPhG), Germany<br />

• Hellenic Society of Medicinal<br />

Chemistry (HSMC), Greece<br />

• Hungarian Society for Pharmaceutical<br />

Sciences, Hungary<br />

• Israel Society of Clinical Pharmacy<br />

<strong>and</strong> Biopharmaceutics (ISCPB), Israel<br />

• Italian Society for Pharmaceutical<br />

Sciences, Italy<br />

LVIII<br />

• Norwegian Pharmaceutical Society,<br />

Norway<br />

• Pharmaceutical Society of Denmark,<br />

Denmark<br />

• Polish Pharmaceutical Society, Pol<strong>and</strong><br />

• Portuguese Society for Pharmaceutical<br />

Sciences, Portugal<br />

• Romanian Society of Pharmaceutical<br />

Sciences<br />

• Slovak Pharmaceutical Society, Slovak<br />

Republic<br />

• Slovenian Pharmaceutical Society,<br />

Slovenia<br />

• Spanish Society of Pharmaceutics <strong>and</strong><br />

Pharmaceutical Technology, Spain<br />

• Swedish Academy of Pharmeceutical<br />

Sciences, Sweden<br />

• Swiss Society of Pharmaceutical<br />

Sciences, Switzerl<strong>and</strong><br />

• Turkish Pharmaceutical Technology<br />

Scientists’ Association (TÜFTAD),<br />

Turkey<br />

International Relations<br />

<strong>EUFEPS</strong> has regular close relations<br />

with a number of international scientific<br />

organisations such as:<br />

• Food <strong>and</strong> Drug Administration (FDA)<br />

which actively participates in many of<br />

the <strong>EUFEPS</strong> conferences,<br />

• American Association of<br />

Pharmaceutical Scientists (AAPS)<br />

for a Conference Exchange Programme<br />

between USA <strong>and</strong> Europe,<br />

• Board of Pharmaceutical Sciences<br />

of the International Pharmaceutical<br />

Federation (FIP-BPS) with whom<br />

<strong>EUFEPS</strong> actively collaborates on<br />

the organization of the Pharmaceutical<br />

Sciences World Congress (PSWC)<br />

which will take place in Amsterdam in<br />

2007.<br />

Other <strong>EUFEPS</strong> Memberships<br />

<strong>EUFEPS</strong> also hosts a growing group of<br />

Individual Members (>600), who support<br />

<strong>EUFEPS</strong> directly. Further <strong>EUFEPS</strong> is<br />

preparing to open up for a new category:<br />

Universities <strong>and</strong> Research Institutions.<br />

Secretariat <strong>and</strong> Location<br />

The <strong>EUFEPS</strong> Secretariat is located in the<br />

premises of the Swedish Pharmaceutical<br />

Society/Academy of Pharmaceutical<br />

Sciences in Stockholm, Sweden. It<br />

is chaired by the Executive Director<br />

<strong>and</strong> serves the Executive <strong>and</strong> other<br />

committees. The Secretariat also manages<br />

<strong>and</strong> administers the <strong>EUFEPS</strong>´ meetings,<br />

special projects <strong>and</strong> other activities.


<strong>EUFEPS</strong> Newsletter, 2007, vol. 16, issue 1<br />

Pharmaceutical<br />

Science in Europe<br />

Part 1: Analysis<br />

Christian Noe, Professor<br />

<strong>EUFEPS</strong> President, Vienna, Austria<br />

On Science<br />

The fresco on the ceiling of the festival hall<br />

of the old university in Vienna – now the<br />

festival hall of the Austrian Academy of<br />

Sciences – portrays the allegory of science.<br />

In addition to the visual impression of a late<br />

Baroque work of art, the painting can also<br />

be interpreted as the political objectives of<br />

a far-reaching university reform; a reform<br />

which can be given a European dimension.<br />

None other than Francis III Stephen, Duke<br />

of Lorraine (later Francis I, Holy Roman<br />

Emperor), the last heir of the Duchy of<br />

Lorraine, who married the “best catch”<br />

in Europe at the time – Maria Theresa of<br />

Habsburg – was the “spiritus rector” of<br />

the largest university reform around the<br />

middle of the 18th century. Through this<br />

reform, the spirit of enlightenment was<br />

introduced into the university on a longterm<br />

basis.<br />

On the four sides of the painting one<br />

can see the remarkable portrayals of the<br />

four faculties: “Divinarum Rerum Notitia”<br />

represents the Theological Faculty <strong>and</strong><br />

means: “Take notice” of divine matters.<br />

The term “notitia” is very subtle: The<br />

range of interpretations goes from the mere<br />

“perception” all the way to “knowledge<br />

that something like this exists”. Under<br />

the portrayal of the Philosophical Faculty<br />

one can read: “Causarum investigatio”:<br />

“Examining the causes/reasons”. This is<br />

what we nowadays define as central task<br />

of scientific work. “Iusti atque iniusti<br />

scientia” represents the Faculty of Law:<br />

“Scientia” means “profound knowledge”<br />

but also the “ability to differentiate” – to<br />

differentiate between right <strong>and</strong> wrong.<br />

Finally, the Faculty of Medicine is<br />

described with the words “Ars tuendae<br />

et repar<strong>and</strong>ae valetudinis”: The “art of<br />

maintaining health <strong>and</strong> restoring it”. Here<br />

“ars” st<strong>and</strong>s for the “individual capability”<br />

– the term “art” has not been rid of the<br />

“practical <strong>and</strong> purpose-related” yet. The<br />

artist does not only perform in the circus<br />

tent but also within the university.<br />

In our time of exp<strong>and</strong>ing <strong>and</strong><br />

interpretable neurobiology, the terms<br />

“Notitia”, “Investigatio”, “Scientia”<br />

<strong>and</strong> “Ars” can at the same time also be<br />

interpreted as a logical progression within<br />

the process of generating knowledge <strong>and</strong><br />

implementing knowledge. “Perceiving<br />

– examining – knowing – acting”: with<br />

this, the tasks of scientists are fully<br />

described. This was valid 250 years ago.<br />

It should also be valid <strong>today</strong>. The fresco<br />

on the ceiling of the old university in<br />

Vienna is a portrayal of science <strong>and</strong><br />

academia, which can be especially<br />

helpful to bring the terms “science” <strong>and</strong><br />

“academia” out of their current narrow<br />

constraints. Nowadays, we may be too<br />

much fascinated by <strong>and</strong> focused on the<br />

“causarum investigatio”, which defines the<br />

fundamental motive for “basic research”.<br />

However, all scientific disciplines, which<br />

are structured in a complex manner, such<br />

as the pharmaceutical sciences, suffer<br />

from a onesided equation of “causarum<br />

investigatio” with science.<br />

Pharmaceutical Science<br />

What do “divinarum rerum notitia”,<br />

“causarum investigatio”, “iusti atque<br />

inuisti scientia” <strong>and</strong> “ars tuenda et<br />

repar<strong>and</strong>ae valetudinis” really mean for<br />

“Pharmaceutical Science”? The question<br />

can be answered quite simply: the terms<br />

characterise its “scientificness”. The basic<br />

motivation of all pharmaceutical work is<br />

an ethical one, namely to take notice of the<br />

needs of people <strong>and</strong> to help them with the<br />

aid of “medicines”. This ethical dimension<br />

obliges the pharmaceutical scientist to be<br />

LIX<br />

The fresco on the ceiling of the festival<br />

hall of the old university in Vienna.<br />

aware of fundamental questions affecting<br />

mankind. The tremendous number of<br />

unsolved questions – mainly those of<br />

origins of <strong>and</strong> cures for diseases – bring<br />

the study of the causes into the focus of<br />

our experimental work. The anchoring of<br />

health <strong>and</strong> the health sector within a strict<br />

legal <strong>and</strong> regulatory framework means<br />

that profound knowledge <strong>and</strong> decisionmaking<br />

capabilities are needed with every<br />

pharmaceutical step or action that one<br />

undertakes. Discovering <strong>and</strong> developing<br />

new drugs, manufacturing these under the<br />

highest of quality st<strong>and</strong>ards <strong>and</strong> ensuring<br />

that the population is supplied with<br />

enough of these, dem<strong>and</strong>s a high level<br />

of qualified capabilities <strong>and</strong> is therefore<br />

an art in its classical definition. Mirrored<br />

within Pharmaceutical Science are all of<br />

those tasks, which are portrayed in the<br />

fresco on the ceiling of the old university<br />

<strong>and</strong> which characterise the four faculties.<br />

This manifold variety of tasks makes<br />

Pharmaceutical Science one of the most<br />

comprehensive fields in which people<br />

can scientifically work. They are not just<br />

in a peripheral field of “applied research”.<br />

However, only where science is fully<br />

lived from the perception of a problem<br />

to the competent implementation (from<br />

“notitia” to “ars”) - <strong>and</strong> not just limited<br />

to the “causarum investigatio” - can<br />

Pharmaceutical Science develop in an<br />

adequate manner.<br />

On “Structures” in Science<br />

The four faculties face each other on an<br />

equal footing when looking at the ceiling<br />

fresco of the old Viennese university.<br />

However, this “ranking” was not always<br />

so. In the university of the Middle Ages, the<br />

Philosophical Faculty as “Artists’ Faculty”<br />

provided a type of basic education that<br />

included the “Trivium” <strong>and</strong> “Quadrivium”


on which “Theology, Jurisprudence<br />

<strong>and</strong> Medicine” built as careeroriented<br />

faculties. Back then, Pharmacy was a<br />

branch of Medicine. Astronomy, as one of<br />

the four subjects of the Quadrivium, was<br />

credited with the first great success story<br />

of occidental natural science. Galileo<br />

Galilei, as a consequence, is first of all a<br />

symbol for the transition in the natural<br />

sciences from its primary research method<br />

of observing nature to the reductionistic<br />

approach of experimental research: “From<br />

astronomical observation to experiments<br />

on free fall”. The reductionistic form<br />

of experimental research takes certain<br />

specific, partial problems out of the<br />

whole context <strong>and</strong> works on these in<br />

a systematic manner under controlled<br />

conditions (“nature in a nutshell”). With its<br />

validated results, it provides a reliable <strong>and</strong><br />

authoritative way of researching causes<br />

<strong>and</strong> origins. It was this approach, which<br />

– as no other – shaped the development<br />

of occidental science <strong>and</strong> also society. It<br />

is not surprising that, at the time of the<br />

university reform of the 18th century, the<br />

Philosophical Faculty with its success<br />

stories in the “search for the causes <strong>and</strong><br />

origins”, the “causarum investigatio”, had<br />

drawn level with the other faculties when<br />

it came to the jockeying for positions.<br />

In the following 200 years, the<br />

original “Philosophical Faculty” became<br />

more <strong>and</strong> more important. The “building<br />

of sciences” was being set up <strong>and</strong> was<br />

also being split into major fields <strong>and</strong><br />

disciplines. The assurance of working<br />

“stone for stone” on this building with<br />

their own efforts gave the scientists<br />

<strong>and</strong> academics the feeling that what<br />

they were doing basically made a lot of<br />

sense. Working on the foundations of the<br />

building of knowledge was – <strong>and</strong> is, just<br />

as before – without a doubt a worthwhile<br />

undertaking. At the start of this new<br />

dynamic process, fierce disputes arose<br />

between the idealistic philosophers <strong>and</strong> the<br />

positivistic natural scientists as to “Who<br />

embodies real science <strong>and</strong> academia?”. In<br />

the end it came to a schism between the<br />

humanities/arts <strong>and</strong> the natural sciences.<br />

One example: in the year 1750 – at the<br />

time of the enlightening university reform<br />

– “Aesthetics” was founded by Gottlieb<br />

Baumgarten, as a mainly natural scientific<br />

discipline. However, shortly thereafter<br />

“Aesthetics” was seen to be a pure arts<br />

<strong>and</strong> humanities term. Nowadays, <strong>and</strong><br />

at a very slow pace, “Aisthesis” is being<br />

discovered again as a natural science<br />

discipline. Continual splitting up <strong>and</strong><br />

categorisation of the natural sciences<br />

was inherent in the process of their<br />

evolution: “Chemistry” <strong>and</strong> “Physics”<br />

were among the first important natural<br />

science disciplines that were created.<br />

Thereby, the traditional pharmaceutical<br />

experimentoriented education was an<br />

important element when it came to the<br />

foundation of Chemistry. Pharmacy itself,<br />

in the course of this change, moved from<br />

the Faculty of Medicine to the Faculty of<br />

Philosophy <strong>and</strong> to the Faculty of Natural<br />

Sciences, respectively, that had been<br />

created out of this.<br />

Pharmaceutical Disciplines<br />

Splitting up into fields <strong>and</strong> disciplines<br />

used to – <strong>and</strong> to this day still does –<br />

follow a certain pattern: an emerging<br />

scientific discipline defines itself – if it<br />

has enough critical mass – as a field of its<br />

own, including sub-fields, <strong>and</strong> – speaking<br />

in real pictures here – it will get its place<br />

in the “building of natural sciences”.<br />

Also within “Pharmacy” such splitting<br />

up into fields <strong>and</strong> disciplines took place.<br />

Pharmacognosy, the study of medicinal<br />

plants, was definitely a pharmaceutical<br />

discipline from the very start. Just the<br />

same, Pharmaceutical Chemistry under<br />

the term “Alchemy” is a rather traditional<br />

field. Pharmacology <strong>and</strong> Pharmaceutical<br />

Technology were brought in as new<br />

subjects in the second half of the 20th<br />

century. Restructuring Pharmacognosy<br />

into a comprehensive Pharmaceutical<br />

Biology <strong>and</strong> the setting up of further<br />

new subjects such as Biopharmacy,<br />

Pharmaceutical Biotechnology or Clinical<br />

Pharmacy are, for the moment, the steps<br />

within this process established most<br />

recently.<br />

The Industrial Revolution <strong>and</strong><br />

“Tradition” of Knowledge<br />

The European university, without a doubt,<br />

was <strong>and</strong> is the most important factor<br />

when it comes to scientific development<br />

in Europe. It is a quite significant pillar<br />

of the occidental civilisation as a whole.<br />

The universities exert their influence on<br />

society all the time. They are, however,<br />

also intensely shaped by society – mostly<br />

through political influence. It was the<br />

Industrial Revolution, which in the middle<br />

of the 19th century, introduced the massive<br />

changes that led to the industrialisation<br />

of society as a whole. At that time, the<br />

power of change was mostly coming<br />

from the new industrial entrepreneurs<br />

<strong>and</strong> businessmen. These events also led<br />

LX<br />

to consequences for the university sphere.<br />

What had been taught in universities<br />

since the Middle Ages was complex<br />

education which required mastering<br />

the “art of books”, the “artes liberales”.<br />

The trade <strong>and</strong> h<strong>and</strong>icraft arts, the “artes<br />

mechanicae”, were taught by apprentices<br />

<strong>and</strong> journeymen paying attention to the<br />

master <strong>and</strong> learning from him, all of<br />

this being organised into trade guilds as<br />

well. With the Industrial Revolution the<br />

“machinerelated” knowledge quickly<br />

grew. In the new situation, the traditional<br />

ways of passing on trade <strong>and</strong> h<strong>and</strong>icraft<br />

knowledge were at a severe disadvantage<br />

<strong>and</strong> could not cope. As a consequence<br />

<strong>and</strong> in reaction to the developments,<br />

“Polytechnical Institutes” were founded –<br />

these are the institutes of technology <strong>and</strong><br />

universities of technology nowadays. This<br />

means that now, after the “artes liberales”<br />

were passed on in a canonised manner, the<br />

“artes mechanicae” were also transmitted<br />

in this manner. From the h<strong>and</strong>icraft<br />

techniques, technologies were created. The<br />

new disciplines at these institutions were,<br />

amongst others: Mechanical Engineering,<br />

Electrical Engineering, Construction<br />

Engineering <strong>and</strong> Architecture. However,<br />

the subject “Industrial Pharmacy” cannot<br />

be found in the list of major new disciplines<br />

at the “Polytechnical Institutes”.<br />

Driving Forces in Pharmaceutical<br />

Science<br />

At the end of the 19th century, the<br />

Industrial Revolution led to the founding<br />

of the pharmaceutical industry in Europe,<br />

with most significant activities in the<br />

Rhine-Main region: “Germany – the<br />

pharmacy of the world”. The driving force<br />

behind this was the development of the<br />

Chemical Sciences which allowed drugs<br />

<strong>and</strong> medication to be developed not just<br />

from natural sources but to be invented<br />

these medicines through the new <strong>and</strong><br />

fascinating opportunity of “creative”<br />

synthesis. A time jump: about 100 years<br />

later – this time in California – techniques<br />

for transferring genes from one organism to<br />

another were being developed. From now<br />

on it was Biology, particularly Molecular<br />

Biology, which determined the dynamics<br />

taking place within the Pharmaceutical<br />

Science. The heavily research-oriented<br />

“Biotech Industry” was established.<br />

Pharmaceutical research nowadays takes<br />

place in globally operating pharmaceutical<br />

industry, in biotech companies, in research<br />

institutes <strong>and</strong> in universities. Significant<br />

scientific results are produced in biocentres


just as they are in medical, chemical or<br />

pharmaceutical research institutions. Due<br />

to all these developments, in the course of<br />

time “Pharmacy” at the universities also<br />

changed. However, it oriented itself, as a<br />

respectable <strong>and</strong> traditional science, first of<br />

all towards the needs of the professional<br />

pharmacists. In most places it responded<br />

to new scientific developments in a<br />

hesitant manner only. Today sub-fields<br />

of Pharmaceutical Science are being<br />

competently taught in a variety of nonpharmaceutical<br />

institutions. Nevertheless,<br />

a comprehensive pharmaceutical<br />

education is, just as before, still only being<br />

provided at pharmaceutical faculties <strong>and</strong><br />

universities. However, still too few of<br />

these institutions are prepared to meet<br />

the fascinating challenge. Many of them<br />

are still not capable of adequately dealing<br />

with the manifold pharmaceutical science<br />

in a comprehensive manner.<br />

On Europe<br />

“Europe” is a region in which nearly<br />

half-abillion people live. “Europe” is a<br />

rich region, in which most people have a<br />

comfortable life <strong>and</strong> enjoy prosperity as well<br />

as social security. “Europe” is the region<br />

whose culture <strong>and</strong> civilisation shaped the<br />

world the most. “Europe” is responsible<br />

for a lot of the things that are happening<br />

in the “globalised” world. “Europe” has<br />

the duty of taking on responsibility for<br />

a humane society, also in the future, due<br />

to its common cultural tradition. The<br />

motto so far has been: “Europe – the<br />

region which gives positive impulses to<br />

the world!” However, the research centres<br />

of the large pharmaceutical corporations<br />

are currently being moved to the United<br />

States. The production is being relocated<br />

to India <strong>and</strong> China. At the moment, a<br />

new motto is threatening to take effect:<br />

“Europe – a museum!” The chemical<br />

<strong>and</strong> pharmaceutical industry in Europe<br />

– probably even the whole European<br />

industrial society – is without a doubt<br />

in a crisis. If Europe wants to remain a<br />

leading region with regard to science<br />

<strong>and</strong> technology, then the dimension<br />

of “togetherness” must above all be<br />

strengthened. This means strengthening<br />

the common market, but also providing<br />

st<strong>and</strong>ardisation for laws <strong>and</strong> regulations. It<br />

also means setting up a much more tightly<br />

knit scientific <strong>and</strong> academic network.<br />

The Integration of the<br />

Pharmaceutical Sciences in<br />

Europe<br />

Fifteen years ago the disparate situation<br />

of the Pharmaceutical Sciences in Europe<br />

<strong>and</strong> the implication thereof for European<br />

integration was realised <strong>and</strong> acknowledged<br />

by some of the best scientific minds in<br />

Europe. Going from “Pharmaceutical<br />

Sciences in Europe” to a “European<br />

Pharmaceutical Science”: was <strong>and</strong> is the<br />

big aim. The “European Federation for<br />

Pharmaceutical Sciences”, <strong>EUFEPS</strong>, was<br />

founded.<br />

“<strong>EUFEPS</strong>” is a “learned society”.<br />

Scientific societies are – in their<br />

significance often underrated – supporting<br />

pillars, which probably best represent <strong>and</strong><br />

mirror the “scientific community” within<br />

a discipline. Europe <strong>today</strong> comprises<br />

almost 50 states. Just integrating the<br />

group of national pharmaceutical<br />

societies at a European level is a quite<br />

complex endeavour. With this, though,<br />

the problems still are not solved. In nearly<br />

every European country there are a whole<br />

LXI<br />

bunch of societies, which, at least in part,<br />

define themselves as being involved with<br />

medicines. These, as a rule, are usually<br />

not interconnected or within one network.<br />

In fact, there are hundreds of scientific<br />

societies in Europe, which could “in<br />

principle” come together to constitute a<br />

“pharmaceutical scientific community”.<br />

From the very start, <strong>EUFEPS</strong> has taken<br />

on the challenge of integrating all of these,<br />

both successfully <strong>and</strong> on an altruistic basis.<br />

The national pharmaceutical societies<br />

are nearly all integrated at this stage.<br />

Nevertheless, the self-underst<strong>and</strong>ing<br />

within the European dimension still has<br />

to be strengthened. The national societies<br />

should make even more of an effort to<br />

“go European” than before – knowing<br />

that one gets a lot more out of a European<br />

dimension than what one has to put in from<br />

the national level. In the meantime, due to<br />

the initiative of <strong>EUFEPS</strong>, the presidents of<br />

a number of European learned societies,<br />

which are related to pharmaceutical<br />

research, have come together to create<br />

a “European Leadership Forum of<br />

Pharmaceutical Sciences” <strong>and</strong> to promote<br />

the horizontal integration process. In Nice<br />

last year – coordinated by <strong>EUFEPS</strong> – the<br />

first European pharmaceutical science <strong>and</strong><br />

trade fair, the “PharmaSciFair”, was held<br />

with ringing success. In this framework<br />

a number of European scientific<br />

societies also presented themselves quite<br />

effectively. In addition, the “Innovative<br />

Medicines Initiative”, planned for the 7th<br />

Framework Programme of the European<br />

Commission, has its roots in a concept,<br />

initiated by <strong>EUFEPS</strong> <strong>and</strong> supported by<br />

<strong>EUFEPS</strong> through all stages.


<strong>EUFEPS</strong> Newsletter, 2007, vol. 16, issue 2<br />

Pharmaceutical<br />

Science in Europe<br />

Part 2: “Where to go”<br />

Christian Noe, Professor<br />

<strong>EUFEPS</strong> President, Vienna, Austria<br />

Underst<strong>and</strong>ing Pharmaceutical Research<br />

On a European level, “New Safe<br />

Medicines Faster” was the initiative, with<br />

which <strong>EUFEPS</strong> was successfully able to<br />

make known that “drug discovery” is<br />

pharmaceutical research, which should<br />

be supported <strong>and</strong> promoted, but also that<br />

“drug development” deserves the same<br />

recognition <strong>and</strong> funding as research. The<br />

success story of the “New Safe Medicines<br />

Faster” initiative signified a growing<br />

public awareness of a comprehensive<br />

definition of science from “notitia” all<br />

the way to “ars” – from perception to the<br />

well managed realisation.<br />

Redefining Fields of<br />

Pharmaceutical Research<br />

The setting up of subjects or individual<br />

disciplines in science has already been<br />

discussed. The cumbersomeness, which<br />

has come about due to this division – all<br />

the way to the much quoted ‘ivory tower’<br />

syndrome – has been implied as well.<br />

Ab<strong>and</strong>oning the classical division of<br />

disciplines seems to be necessary to live<br />

up to the new requirements <strong>and</strong> to pave the<br />

way for a new dynamism within science<br />

as a whole. Also in the Pharmaceutical<br />

Sciences, a coherent new definition of<br />

the research fields is urgently needed.<br />

The fields should orient themselves<br />

primarily – but not exclusively – on the<br />

pharmaceutical discovery, development<br />

<strong>and</strong> drug utilization pathways <strong>and</strong> will<br />

be all encompassing. <strong>EUFEPS</strong> will<br />

discuss with the best researchers within<br />

the individual fields <strong>and</strong> will try to get<br />

their advice <strong>and</strong> input. These experts will<br />

include trained pharmacists, in addition to<br />

biologists, chemists, medical doctors <strong>and</strong><br />

health professionals, as well as scientists<br />

from other disciplines. The “scientific<br />

community” of the Pharmaceutical<br />

Sciences should be open to all those<br />

who’s professional life are principally<br />

dedicated to the task of helping people<br />

through the use of medicines <strong>and</strong> drugs.<br />

The commitment to the complexity of<br />

this science <strong>and</strong> the need, as well as the<br />

obligation, to constantly further educate<br />

oneself is quite clear from the start for<br />

these scientists <strong>and</strong> academics. It should<br />

be clear to the trained pharmacists, who<br />

have the privilege of being placed right<br />

in the centre of this science, that only the<br />

dedication to be the best will consolidate<br />

their position in the future.<br />

The Integration of Sectors<br />

In the end, the integration of Pharmaceutical<br />

Science also means bringing together<br />

researchers that work in industry with<br />

those that work in academia <strong>and</strong> with<br />

those scientists that work in regulatory<br />

authorities. It is just this bringing together<br />

of the three important professional fields<br />

within Pharmaceutical Science – academia,<br />

industry, regulatory – where <strong>EUFEPS</strong> is so<br />

successful at a European level. The formula<br />

for success is high-quality workshops,<br />

symposia <strong>and</strong> conferences that are also<br />

up-to-date. Only in this manner can one<br />

interest scientists in industry – who are<br />

under a lot of time pressure as well as<br />

pressure to succeed – to meet creative<br />

“underfunded” university researchers, as<br />

well as the more reserved experts from the<br />

regulatory authorities so that they all enter<br />

into a scientific discourse.<br />

Main Topics in Pharmaceutical<br />

Science – Systems Biology<br />

As examples of up-<strong>and</strong>-coming topics, which<br />

were recognised early on by <strong>EUFEPS</strong> as<br />

being significant <strong>and</strong> which were the subjects<br />

of conferences <strong>and</strong> workshops organized by<br />

<strong>EUFEPS</strong>, one can name “Safety Sciences”,<br />

LXII<br />

“Biomarkers” <strong>and</strong> “Systems Biology”.<br />

Due to its fundamental importance, the<br />

term “Systems Biology” will be explained<br />

here in more detail. “Systems Biology”<br />

defines – after decades of over-deterministic<br />

orientation in research – a nearly<br />

“liberating” new approach within “Life<br />

Science” research, by which the genotypes<br />

<strong>and</strong> phenotypes within a biological system<br />

are examined in an interlinked <strong>and</strong> jointly<br />

correlated manner. Genome, proteome,<br />

metabolome: these are the levels which<br />

are being examined to the same degree<br />

<strong>and</strong> in the same manner. Applying the<br />

new approach, we can draw from an evergrowing,<br />

gigantic wealth of data, which can<br />

only be h<strong>and</strong>led <strong>and</strong> interpreted with the<br />

help of “in silico” methods (Bioinformatics).<br />

“Systems Biology” is almost tailor-made for<br />

pharmaceutical research. Pharmacists have<br />

for a long time been working with biological<br />

systems <strong>and</strong> examine these at various levels.<br />

The range goes from biochemical systems,<br />

e.g. the arachidonic acid cascade, all the way<br />

to physiological systems, e.g. the nervous<br />

system. For pharmaceutical research as<br />

a whole, “Systems Biology” nowadays<br />

provides a refreshing challenge to examine<br />

<strong>and</strong> work on problems comprehensively.<br />

“Block a receptor with an antagonist<br />

or prevent its expression”; that is the<br />

therapeutic alternative in the era of Systems<br />

Biology. However, with the deactivation of<br />

the receptor one has not reached one’s goal.<br />

The rebuilding of the homeostasis of the cell,<br />

of the tissue <strong>and</strong>, finally, of the organism –<br />

i.e. the recovery of the human being – is<br />

the aim. To attain this, detailed knowledge<br />

of all of the processes that occur after the<br />

introduction of the drug into the system<br />

<strong>and</strong> after its interference with the system<br />

should be sought. These are exciting times<br />

for committed pharmaceutical researchers.<br />

It is also a big chance for the Pharmaceutical<br />

Sciences.<br />

The “New” Industrial Revolution<br />

For more than 40 years, researchers at<br />

universities have been constantly hearing<br />

about crises for universities <strong>and</strong> have taken<br />

part in many reforms. It seems worthwhile<br />

to reflect on the causes of such a situation.<br />

Is it all coincidence? When the present<br />

generation of professors was younger,<br />

they read books such as “Brave New<br />

World” by Aldous Huxley or “1984” by<br />

George Orwell. Many of the things, which<br />

back then we shuddered to think about,<br />

have been surpassed in the modern world<br />

by reality. Drastic changes have already<br />

taken place <strong>and</strong> we barely notice them.


The basic tools to make a real science out<br />

of History were “ricorsi” – this means:<br />

observing <strong>and</strong> analysing the recurrence<br />

of events – of course always within the<br />

framework <strong>and</strong> conditions of a new era.<br />

This is how Giambattista Vico, the founder<br />

of historical research, did it. It is most<br />

notable that we are not taking note of such<br />

a recurrence, which is taking place in our<br />

time. We are in the middle of an Industrial<br />

Revolution in which human labour is being<br />

replaced by machines, just as in the middle<br />

of the 19th century. However, this time<br />

around it is not the mechanical work of<br />

mankind which is being replaced; rather, it<br />

is the mental work which is being taken on<br />

by “thinking machines”. This is a challenge.<br />

But, of course, one should not just point out<br />

the negative effects of this development.<br />

On Knowledge Coding <strong>and</strong><br />

“Tradition” of Knowledge<br />

We are delighted about computers just as<br />

we are about cars. However, the human<br />

mind is something very special. Being<br />

human has to do with biological evolution<br />

only in a limited manner, in particular<br />

if we have a look at our intellectual <strong>and</strong><br />

cultural achievements. It is not the DNAcoded<br />

tradition, which promotes this<br />

development. Rather, it is a 60,000 year old<br />

tradition, which has led to the word, then the<br />

picture, then to spoken language, to music<br />

<strong>and</strong> poetry, on to written language, to the<br />

book roll, the codex, to the printed book<br />

<strong>and</strong> finally to electronic communication.<br />

This development is now ready <strong>and</strong> poised<br />

for a type of “quantum leap” with the help<br />

of “in silico” knowledge generation.<br />

In reality, every insight made for the<br />

first time by man anatomically manifests<br />

itself within the human brain as a new,<br />

synaptic link. This link has so far not existed<br />

in any other human brain. “An exit is found<br />

out of a labyrinth” or “Long processes of<br />

thought are shortened” is what one could<br />

say, metaphorically speaking. Even the<br />

neuronal architecture of an intelligent<br />

human being takes on the most fantastic<br />

forms in the space of his or her lifetime.<br />

It is not genetically pre-programmed <strong>and</strong><br />

therefore lost in the short or long term,<br />

unless the knowledge is transmitted i.e.<br />

shared. The most important basis for this<br />

transmission is human language. It is coded<br />

as written language. Only through the<br />

progressively more efficient transmission of<br />

knowledge from one generation to the next<br />

was it possible to create the quite complex<br />

knowledge <strong>and</strong> cultural society of mankind<br />

that we have nowadays.<br />

On the Evolution of Machine<br />

Knowledge<br />

The amount of generated data<br />

(“knowledge”), effectively supported by<br />

Information Science, i.e. in Bioinformatics,<br />

is overwhelming. New algorithms are<br />

being developed continually, not only<br />

to collect <strong>and</strong> record the everincreasing<br />

data wealth, but also to be able to answer<br />

questions <strong>and</strong> problems posed in a more<br />

efficient <strong>and</strong> relevant manner. Maybe,<br />

in the near future, to also conceive new<br />

questions. New insights <strong>and</strong> findings are<br />

not cropping up for the first time in human<br />

brains as new synaptic links; rather they<br />

are being generated in a machine <strong>and</strong><br />

emerge as the “output” of this machine.<br />

Even the evolution of the method to<br />

generate new knowledge is disconnecting<br />

itself more <strong>and</strong> more from mankind <strong>and</strong><br />

is being geared towards machines <strong>and</strong><br />

their machine language. Here we have a<br />

paradoxical situation. The universities,<br />

which are teaching institutions using book<br />

knowledge <strong>and</strong> which should feel just as<br />

challenged nowadays by this development,<br />

just as the trade guilds were at the time<br />

of the first Industrial Revolution, do not<br />

perceive or take note of this fundamental<br />

“questioning” of their functions. They<br />

more or less indulge in half-hearted, quite<br />

irrelevant, reforms – maybe due to a type of<br />

unconscious unease. However, in the light<br />

of the new developments, it is obvious, if<br />

there is going to be a “European Institute<br />

of Technology” then – in the “historical<br />

recurrence” of the polytechnical teaching<br />

institutions – it should be a “European<br />

Institute of “in silico” Technology”!<br />

Pharmaceutical Sciences “in silico”<br />

Ever since the evolution of the “Rational<br />

Drug Design”, for about the last 30 years,<br />

“in silico” has become a regular topic<br />

<strong>and</strong> working field within Pharmaceutical<br />

Science. <strong>EUFEPS</strong> as well is – knowing the<br />

significance of the “in silico” revolution/<br />

evolution for the Pharmaceutical Sciences<br />

– intensively working on this topic. It<br />

is evident that “in silico knowledge<br />

generation” <strong>and</strong> “in silico science<br />

communication”, i.e. machine generation<br />

<strong>and</strong> transmission of knowledge, are big<br />

topics <strong>and</strong> they must be dealt with in a<br />

detailed manner. However, one should<br />

not forget that a parallel evolution of<br />

knowledge, which is taking place outside<br />

the human brain, also has significant<br />

ethical consequences. “Humans should<br />

determine the machine <strong>and</strong> not vice<br />

versa!” Therefore the fundamental topic<br />

LXIII<br />

of “Ethics <strong>and</strong> in silico sciences” should<br />

not be forgotten within the “in silico”<br />

Pharmaceutical Sciences.<br />

The New Pharmaceutical Scientist<br />

When entire encyclopaedias can be stored<br />

on a small “chip”, what is the knowledge<br />

that is stored in a human brain worth?<br />

Should students, in the manner of ancient<br />

Egyptian scribes, take down all the notes<br />

whilst sitting in a lecture <strong>and</strong> listening to a<br />

professor so that they can take home with<br />

them as much knowledge as possible?<br />

The answer is crystal clear. If a lecture is<br />

not an “event” in which the lecturer will<br />

adequately present himself or herself, as<br />

well as his or her interpretation of a certain<br />

topic, if the lecture is not a “happening” in<br />

which the student fully participates, then<br />

this lecture actually does not have a claim<br />

of validity anymore. Those who still sit in<br />

the old “ivory tower” do not automatically<br />

have the privilege of knowledge. The<br />

knowledge in the “ivory tower” can also<br />

be found on a chip. Knowledge – even<br />

when it is of the highest level – is easily<br />

accessible <strong>and</strong> available nowadays. In<br />

the future, the researchers at universities<br />

will not be able to limit themselves just to<br />

generating new knowledge <strong>and</strong> passing<br />

this on. Rather, going from generation to<br />

generation, they must redefine the canon<br />

of knowledge that deserves to be put into<br />

the minds of people for them to work<br />

with <strong>and</strong> ponder on. This is a huge task,<br />

mainly for politicians dealing with science<br />

as well as for universities. The European<br />

Federation for Pharmaceutical Sciences<br />

will do its utmost in contributing here.<br />

In the long run, the tasks of scientists<br />

<strong>and</strong> academics will have to do with being<br />

able to deal with available knowledge <strong>and</strong><br />

with ensuring that the human dimension is<br />

not lost. Scientific questions <strong>and</strong> academic<br />

queries have to orientate themselves much<br />

more towards the needs of society as a whole.<br />

Food <strong>and</strong> nutrition, health, the environment –<br />

these are all fully relevant themes. However,<br />

one should also not forget that a meaningful<br />

life experience <strong>and</strong> the freedom to shape<br />

one’s life are fundamental human rights.<br />

Only appropriate <strong>and</strong> relevant scientific<br />

work can ensure that there is a chance in<br />

reaching these goals. The fundamental<br />

ethical commitment of the pharmaceutical<br />

profession <strong>and</strong> the width <strong>and</strong> scope of the<br />

requirements posed by this discipline should<br />

mean that Pharmaceutical Science is capable<br />

of bringing forth its next generation of young<br />

scientists, researchers <strong>and</strong> academics, who<br />

conform to this new picture.


<strong>EUFEPS</strong> Newsletter, 2007, vol. 16, issue 4<br />

“Changing of the Guard”<br />

– <strong>EUFEPS</strong>’ New<br />

President <strong>and</strong> Past<br />

President Share Views<br />

Christian R. Noe, Professor, <strong>EUFEPS</strong> Past-President, Vienna, Austria<br />

Daan J. A. Crommelin, Professor, <strong>EUFEPS</strong> President, Leiden/Utrecht, The<br />

Netherl<strong>and</strong>s<br />

In this contribution the <strong>EUFEPS</strong> Past-<br />

President, Christian R. Noe, <strong>and</strong> the new<br />

President, Daan J.A. Crommelin, look<br />

over their shoulder into the past <strong>and</strong> then<br />

forward into the future. What has been<br />

achieved? What are the challenges that<br />

<strong>EUFEPS</strong> faces? What are the targets<br />

for new activities? What forces can be<br />

mobilised to fulfil the mission, alone or<br />

with allies in Europe <strong>and</strong> outside this<br />

region?<br />

On the Organisation<br />

Science is not “up in the sky”. Science<br />

should not be kept in an “ivory tower”.<br />

Science is the systematic application of<br />

logical thinking <strong>and</strong> logical action for the<br />

benefit of humankind. At the same time,<br />

as a kind of art, it is an intrinsic element<br />

of human culture. Scientific organisations<br />

should provide a bridge between their<br />

member scientists <strong>and</strong> society. Therefore,<br />

such organisations are subject to an<br />

obligation far beyond the activities of<br />

cultural <strong>and</strong> social clubs.<br />

At the time of its foundation, <strong>EUFEPS</strong><br />

was very aware of this obligation. The best<br />

pharmaceutical scientists of Europe joined<br />

forces to tackle the European challenge,<br />

to generate a strong <strong>and</strong> committed<br />

pharmaceutical scientific community in<br />

Europe. Amazingly (or not) nowadays<br />

<strong>and</strong> after a series of Presidents, this first<br />

challenge is still high on the agenda of<br />

<strong>EUFEPS</strong>. A lot has been achieved. Many<br />

of the national organisations in European<br />

countries are members <strong>and</strong> a high<br />

percentage of European pharmaceutical<br />

scientists are connected to <strong>EUFEPS</strong><br />

through their national organisations.<br />

The <strong>EUFEPS</strong> initiated PharmSciFair is<br />

the first pan-European meeting point for<br />

scientific organisations of many countries<br />

<strong>and</strong> pharmaceutical disciplines. The voice<br />

of the scientists has reached Brussels<br />

through <strong>EUFEPS</strong>. Important initiatives<br />

like the “New Safe Medicines Faster”<br />

<strong>and</strong> the “Innovative Medicines Initiative”<br />

would not be there without <strong>EUFEPS</strong>.<br />

More than one year ago, the Presidents<br />

of 10 European scientific organisations<br />

dealing with drug research had their<br />

first meeting in Vienna to discuss the<br />

formation of a “European Pharma<br />

Sciences Leadership Forum”. At that<br />

meeting, which had been organised by<br />

<strong>EUFEPS</strong>, about 200,000 pharmaceutical<br />

scientists were – through the Presidents<br />

of the organisations – virtually present<br />

at the table. In follow-up meetings, the<br />

enthusiastic atmosphere of the first meeting<br />

suffered somewhat from the attitude of<br />

some trying to “stake their claims” <strong>and</strong><br />

“divide the cake”, instead of implementing<br />

joint initiatives <strong>and</strong> planning for a coherent<br />

community of pharmaceutical scientists<br />

in Europe. Nevertheless, common ground<br />

is recognised <strong>and</strong> there is commitment to<br />

proceed. Without doubt, <strong>EUFEPS</strong> will<br />

actively contribute to further development<br />

of the Forum, fully aware that complex<br />

situations are not unusual in human society<br />

<strong>and</strong> that sorting complexity out requires<br />

patience. <strong>EUFEPS</strong> does not want to devour<br />

or suppress any other organisation, but it<br />

feels obliged to continue the initiative to<br />

bring together pharmaceutical scientific<br />

organisations in Europe <strong>and</strong> to shape the<br />

pharmaceutical scientific community of<br />

this region.<br />

While the meetings with Presidents of<br />

European sister organisations has the long<br />

term goal of broadening the community of<br />

our science as a whole, the meetings of the<br />

Presidents of our Member Societies have<br />

been installed to optimise cooperation of<br />

<strong>EUFEPS</strong> with its members <strong>and</strong> between<br />

its members. An increasing number of<br />

LXIV<br />

conferences, jointly organised by Member<br />

Societies with <strong>and</strong> without participation<br />

of <strong>EUFEPS</strong>, indicates progress in this<br />

area. Nevertheless, there is still a strong<br />

dem<strong>and</strong> by members of our Federation,<br />

including the Individual Members, who<br />

ask for more joint action. <strong>EUFEPS</strong> is<br />

committed to address these dem<strong>and</strong>s.<br />

Actions include;<br />

• use of the <strong>EUFEPS</strong> Online (website)<br />

for announcing events<br />

• a <strong>EUFEPS</strong> database for education <strong>and</strong><br />

training courses<br />

• <strong>EUFEPS</strong>-coordinated “in silico”<br />

learning programmes, as well as<br />

strengthened <strong>and</strong> harmonised national<br />

websites<br />

• increased membership of national<br />

organisations <strong>and</strong> <strong>EUFEPS</strong><br />

• inspiration of pharmacy students,<br />

young pharmacists <strong>and</strong> those with a<br />

Masters Degree in pharmaceutical<br />

sciences, to be interested in the science<br />

underlying their discipline from the<br />

beginning of their professional careers<br />

• a widened European network to<br />

improve chances for successfully<br />

receiving research grants <strong>and</strong><br />

participating in debates on ‘hot’ topics<br />

in the pharmaceutical sciences.<br />

The fact that the competence of our<br />

members in such areas ranges from very<br />

high to non-existent is a further indicator<br />

of the importance of such pan-European<br />

cooperation.<br />

For the last year, there has also been<br />

a new membership category within<br />

<strong>EUFEPS</strong> – Member Institutions. This<br />

category is open to universities <strong>and</strong><br />

research institutions <strong>and</strong>/or clusters<br />

of them. As will be discussed below,<br />

actions have started to address common


needs among academic institutions,<br />

producing science <strong>and</strong> scientists useful<br />

for the discovery, development <strong>and</strong> use of<br />

medicines. Furthermore, it was recently,<br />

suggested that <strong>EUFEPS</strong> look into how<br />

to provide useful support to Small <strong>and</strong><br />

Medium Size Enterprises (SMEs).<br />

<strong>EUFEPS</strong> does not only look around<br />

within Europe to collaborate with sister<br />

<strong>and</strong> member societies. <strong>EUFEPS</strong> has<br />

also operated <strong>and</strong> will operate on the<br />

global scene. Of course, “<strong>EUFEPS</strong> <strong>and</strong><br />

the world” means above all close <strong>and</strong><br />

loyal co-operation with the FIP Board<br />

of Pharmaceutical Sciences. Such a cooperation<br />

that will benefit from the fact<br />

that the current <strong>EUFEPS</strong> President is also<br />

Chair of the FIP Board of Pharmaceutical<br />

Sciences. Since <strong>EUFEPS</strong> is, probably,<br />

the most efficiently organised regional<br />

pharmaceutical scientific organisation in<br />

the world, it can be an efficient partner<br />

on the global scene elsewhere. Bilateral<br />

regional work (e.g. with AAPS, DUPHAT<br />

<strong>and</strong> the newly established Asian<br />

Federation for Pharmaceutical Sciences)<br />

will be continued <strong>and</strong> further co-operation<br />

may be initiated. The fundamental ethical<br />

commitment of our science does not allow<br />

us to ignore needs in other parts of the<br />

world.<br />

On Science <strong>and</strong> Scientists<br />

Pharmaceutical R&D is certainly a huge<br />

endeavour. It is a billion dollar undertaking<br />

to bring a new active compound to the<br />

market. After discovery, the development<br />

work of a specific new drug c<strong>and</strong>idate<br />

may take eight years or more before<br />

the product reaches the market. The<br />

disciplines involved range from molecular<br />

biology <strong>and</strong> genetics to economics <strong>and</strong><br />

even ethics. Certainly, the variety of<br />

different scientific languages spoken by<br />

the involved scientists has contributed to<br />

the long lasting decline in the number of<br />

new drugs (NCEs) reaching the market.<br />

The complexity of huge pharmaceutical<br />

research projects renders overall<br />

competence a desirable but very rare skill.<br />

The impossibility of solving the problems<br />

of scientific language <strong>and</strong> complexity<br />

just by interdisciplinary work is certainly<br />

one of the reasons for the massive<br />

reorientation, which nowadays takes<br />

place in all fields of sciences. Classical<br />

disciplines are more <strong>and</strong> more reduced to<br />

areas of “general scientific competence”<br />

<strong>and</strong> technical skills. Areas of importance<br />

(e.g. nutrition, health, environment,<br />

materials) connecting scientific progress<br />

directly to societal requirements are<br />

taking precedence over the classical<br />

scientific disciplines of the “academic<br />

ivory tower”. This situation offers a<br />

unique chance for the pharmaceutical<br />

sciences to develop into a core field of<br />

the natural sciences, instead of remaining<br />

a loose conglomerate of cooperating<br />

scientists from different disciplines. The<br />

goal is clear: pharmaceutical research<br />

<strong>and</strong> development is moving to cover all<br />

scientific activities aimed at curing <strong>and</strong><br />

preventing diseases through medicines.<br />

On Credibility <strong>and</strong> Competence<br />

Credibility <strong>and</strong> competence are closely<br />

connected to each other. It is easy to<br />

claim a leading role in a science, which<br />

has huge future importance. But there<br />

is no credibility of such claims without<br />

competence. Of course, over time,<br />

<strong>EUFEPS</strong> has built up significant <strong>and</strong><br />

structured competence in its Executive,<br />

Steering <strong>and</strong> Advisory Committees. This<br />

competence is truly proven; it is credible<br />

<strong>and</strong> has been the basis of both the general<br />

line of development of <strong>EUFEPS</strong> <strong>and</strong> of<br />

its specific actions, like conferences,<br />

workshops <strong>and</strong> courses. The ambitious<br />

goal to lead the European pharmaceutical<br />

sciences to as much excellence as<br />

achievable has fostered the decision to set<br />

up, in addition to the existing instruments,<br />

a body of European top experts, covering<br />

all areas of competence of pharmaceutical<br />

science. This body will be named the<br />

<strong>EUFEPS</strong> Senate <strong>and</strong> will give advice to<br />

the Executive Committee, primarily, in<br />

strategic scientific planning Hopefully,<br />

the Senate will become a think-tank to<br />

help <strong>EUFEPS</strong> reach a highly recognised<br />

position in the European scientific arena.<br />

On Relevance <strong>and</strong> Excellence<br />

However, excellence should not only be a<br />

feature limited to a few selected people,<br />

the elite, but it should be the goal that<br />

each pharmaceutical scientist should aim<br />

for. Nowadays, funding of sciences is a<br />

real problem in the academic world. It is<br />

obvious that, in times of shortage, funds<br />

will be assigned according to a number<br />

of rules, such as the relevance of the<br />

topic, <strong>and</strong> the excellence of the project,<br />

which frequently goes h<strong>and</strong> in h<strong>and</strong> with<br />

the excellence of the scientists involved.<br />

There is no doubt about the relevance of<br />

pharmaceutical research itself. It is so<br />

important that it is even frequently abused<br />

as an “ivy leaf” for research, which, in<br />

reality, has – at least in the medium term<br />

LXV<br />

– little to do with medicines. Sometimes<br />

otherwise excellent scientists, in particular<br />

molecular biologists, seem to use this<br />

“ivy leaf” approach in their fund-raising.<br />

A significant portion of public research<br />

money, earmarked for pharmaceutical<br />

research, has been channelled into<br />

projects, which may be important for<br />

other reasons, but which are of little<br />

pharmaceutical relevance. Hopefully, the<br />

EU “Innovative Medicines Initiative”<br />

will primarily support projects which are<br />

clearly oriented to develop “new safe <strong>and</strong><br />

effective medicines faster”. Achieving<br />

professional excellence is a challenge<br />

for every scientist, in particular for those<br />

responsible for academic education.<br />

The regular activities of <strong>EUFEPS</strong> with<br />

cutting-edge conferences, workshops <strong>and</strong><br />

courses help those pursuing excellence.<br />

To further promote the inter-institutional<br />

dialogue, <strong>EUFEPS</strong> has created the<br />

category of Institutional Members, which<br />

already includes several prestigious<br />

academic pharmaceutical research<br />

centres. However, support for educational<br />

<strong>and</strong> co-operational approaches will not<br />

be enough. Of course, the question of<br />

assessing quality of research is a critical<br />

one. Regular evaluation of research<br />

institutions, <strong>and</strong> ranking of papers <strong>and</strong><br />

scientists, comprises a significant element<br />

of competition for funding <strong>and</strong> thus for<br />

performing research. Parameters for fair<br />

evaluation of work are required. The<br />

different national peer reviewing systems<br />

are an important element of this qualitydriven<br />

approach. The debate on ‘best<br />

practices’ in institutional peer reviewing<br />

is high on the <strong>EUFEPS</strong> agenda.<br />

On Contents <strong>and</strong> Challenges<br />

Leadership is a prerequisite to make<br />

progress, but it is even more important<br />

to know, where to go. It is a particular<br />

ambition of <strong>EUFEPS</strong> to be a leading<br />

institution in generating new ideas <strong>and</strong><br />

taking up new lines of thinking in the<br />

drug discovery <strong>and</strong> development process,<br />

long before they become part of the<br />

mainstream ‘routine’. The <strong>EUFEPS</strong> New<br />

Safe Medicines Faster Initiative (NSMF)<br />

was a very successful “translational<br />

science” activity at a time when this<br />

term was not even coined. <strong>EUFEPS</strong><br />

can now watch, in full confidence, the<br />

development of its “baby”, the Innovative<br />

Medicines Initiative (IMI), without being<br />

concerned that it might not be sufficiently<br />

recognised <strong>and</strong> rewarded for being one<br />

of the early initiators. <strong>EUFEPS</strong> has taken


important steps towards a comprehensive<br />

implementation of “systems biology in<br />

pharmaceutical sciences”. This is at a time<br />

when the scientific community has just<br />

started to be fully aware of this paradigm<br />

shift in life sciences. Consequently, during<br />

the 2007 <strong>EUFEPS</strong> Basel Conference, a<br />

next step was taken as “biosimulation” <strong>and</strong><br />

“modelling” research were discussed in<br />

the light of systems biology. “Biomarkers”<br />

<strong>and</strong> “PAT science” describe other topics,<br />

which were brought up <strong>and</strong> h<strong>and</strong>led by<br />

<strong>EUFEPS</strong> as a pioneer. <strong>EUFEPS</strong> has<br />

proven, from the very beginning, that it<br />

has a good feeling where pharmaceutical<br />

sciences are going. It is competence, based<br />

on knowledge. Certainly, this feeling for<br />

future trends will enable <strong>EUFEPS</strong> to<br />

retain this leadership role in the future.<br />

What will be the major scientific<br />

challenges for <strong>EUFEPS</strong>, in the years to<br />

come, both within its traditional field<br />

of competence <strong>and</strong> beyond? Certainly,<br />

the translational science aspect will<br />

continue to play a significant role, because<br />

‘monodisciplinary’ <strong>and</strong> ‘silo’ thinking<br />

is perceived as a cause of the existing<br />

inefficiency in the drug discovery <strong>and</strong><br />

development process. Translational<br />

approaches in the pharmaceutical science<br />

– ‘translational pharmaceutical science’<br />

– are meant to make drug discovery<br />

<strong>and</strong> development more successful by<br />

stimulating direct interactions between<br />

the different tasks <strong>and</strong> disciplines<br />

forming the building blocks of the full<br />

process. Such science aims facilitate the<br />

translation of ideas, findings <strong>and</strong> concepts<br />

into products. Specifically, it addresses<br />

phases <strong>and</strong> steps in the drug discovery<br />

<strong>and</strong> development processes, such as<br />

the discovery-development transition<br />

or the preclinical-clinical transition.<br />

Clearly, emerging paradigms such as<br />

individualised medicines <strong>and</strong> therapies<br />

will specifically ask for translational<br />

approaches to ensure rapid introduction in<br />

the health care system.<br />

A further major task will certainly be<br />

to contribute to a harmonised integration<br />

of biotech pharma into pharmaceutical<br />

sciences. It is amazing to observe the<br />

general lack of the notion in the biotech<br />

field that a biotech product will have<br />

to be developed according to similar<br />

scientific <strong>and</strong> regulatory criteria as small<br />

molecules. On the biotech side, one can<br />

observe an insufficient knowledge of the<br />

rules <strong>and</strong> relevance of drug development,<br />

while many of the “conventional”<br />

pharmaceutical scientists forget that they<br />

must embrace new scientific fields – like<br />

molecular biology <strong>and</strong> genetics – to be<br />

able to claim full scientific competence in<br />

their own area.<br />

Concerning systems biology, it has<br />

not been too difficult for <strong>EUFEPS</strong> to<br />

generate awareness of the importance of<br />

systems approaches in a science that is<br />

intrinsically based on interference with<br />

biological systems. However, beyond this<br />

“general systems biology” awareness,<br />

LXVI<br />

“specific pharmaceutical systems<br />

biology” is a rapidly growing field of<br />

research, where genomic, proteomic <strong>and</strong><br />

metabolomic data are correlated by the<br />

use of biomathematics, bioinformatics <strong>and</strong><br />

other “in silico” methods. “Metabolomic<br />

networks based drug discovery” –<br />

together with “biosimulation” <strong>and</strong><br />

“rational drug design” – will significantly<br />

change approaches <strong>and</strong> efficiency in<br />

drug discovery. In fact, the “in silico”<br />

world has grown up over the years not<br />

only to complement almost every area of<br />

experimental pharmaceutical research,<br />

but also to provide us a tremendous wealth<br />

of scientific information via the Internet<br />

<strong>and</strong> other sources. Bearing this important<br />

development in mind, <strong>EUFEPS</strong> will<br />

strengthen its efforts to promote the use<br />

of the full scope of “in silico” methods<br />

<strong>and</strong> applications in pharmaceutical<br />

sciences both for experts <strong>and</strong> for those<br />

scientists for whom these methods will<br />

be complementary elements in their<br />

research.<br />

On the Mission to be Completed<br />

At this moment of change in Presidency,<br />

both the President <strong>and</strong> the Past President<br />

are convinced that <strong>EUFEPS</strong> is right on<br />

track to fulfil its mission. It has embarked<br />

on a spectrum of initiatives with active<br />

participation of colleagues from academia,<br />

industry <strong>and</strong> regulatory bodies to further<br />

shape the future of the pharmaceutical<br />

sciences in Europe.


<strong>EUFEPS</strong> Newsletter, 2007, vol. 16, issue 4<br />

Birth of the <strong>EUFEPS</strong><br />

BABP Network<br />

Henning Blume, Professor, Frankfurt Germany<br />

Clive Wilson, Professor, Glasgow United Kingdom<br />

The initiation of a <strong>EUFEPS</strong> Network on<br />

Bioavailability <strong>and</strong> Biopharmaceutics<br />

(BABP) appears to be a natural<br />

progression of the <strong>EUFEPS</strong> vision as<br />

biopharmaceutics forms the bedrock of<br />

many of the activities of the contributing<br />

societies. It is also an important<br />

opportunity to assist legislature in<br />

defining a harmonised approach across<br />

Europe.<br />

The proposed changes in European<br />

Guidelines for Bioavailability/<br />

Bioequivalence (BA/BE) have prompted<br />

the scientific community to engage in<br />

a more comprehensive communication<br />

with regulatory scientists <strong>and</strong> to stimulate<br />

exchange between both groups. In<br />

particular, efforts should focus on<br />

scientific questions, which arise from<br />

poorly resolved areas <strong>and</strong> on provision of<br />

a framework from which best practice can<br />

be developed.<br />

Why a BABP network?<br />

Biopharmaceutics is an encompassing<br />

discipline of pharmacology, material<br />

sciences, analysis <strong>and</strong> toxicology. Each<br />

year, many of the member organisations<br />

within <strong>EUFEPS</strong> host workshops <strong>and</strong><br />

conference sessions to hear key opinion<br />

leaders talk about their research <strong>and</strong><br />

viewpoints. It is a broad church; with so<br />

many disciplines represented, there will<br />

be a growth of knowledge <strong>and</strong> disparate<br />

st<strong>and</strong>points, which do not always mesh<br />

smoothly. Naturally, this activity provides<br />

the basis of new thoughts <strong>and</strong> debate, but<br />

being geographically dispersed, there is no<br />

tendency to self-propel towards consensus<br />

statements, <strong>and</strong> clear messages may not<br />

emanate. Regulators want to follow best<br />

practice but if different viewpoints cannot<br />

be heard <strong>and</strong> reconciled, progress towards<br />

uniformity will be painfully slow. This<br />

was appreciated by both the regulators<br />

<strong>and</strong> the scientific communities across<br />

pharmaceutics. A core group, consisting<br />

of Professor Dr Henning Blume, Dr<br />

Gerald Beurle <strong>and</strong> Dr Erich Brendel,<br />

prompted by industry <strong>and</strong> the regulators<br />

took on the task of addressing these<br />

issues. They resolved to generate a focus<br />

group or network representing regulatory,<br />

generic <strong>and</strong> traditional strongly researchbased<br />

industry assisted by academics<br />

from different countries. The outcome<br />

is a regionally balanced network <strong>and</strong><br />

steering group, which meets regularly to<br />

progress activities, including conferences<br />

<strong>and</strong> workshops within a <strong>EUFEPS</strong>-based<br />

Bioavailability <strong>and</strong> Biopharmaceutics<br />

Network.<br />

What will the BABP Network<br />

provide?<br />

The purpose of any <strong>EUFEPS</strong> network is<br />

to join scientists together. A mission of the<br />

BABP will be to provide an opportunity<br />

for <strong>EUFEPS</strong> members to get to know<br />

LXVII<br />

Most of the BABP Network Steering<br />

Committee in October 2007, at the Socratec<br />

Headquarters, Oberursel, Germany. The<br />

Steering Group include: Gerald Beurle,<br />

Henning Blume (Chair), Erich Brendel,<br />

Andrzej Dzierbicki, Hilda Köszegi-Szalai,<br />

Hans H. Linden, Henrike Potthast, Tomas<br />

Salmonson <strong>and</strong> Clive G Wilson.<br />

each other, to explore important issues<br />

in bioavailability, bioequivalence <strong>and</strong><br />

biopharmaceutics through conferences<br />

<strong>and</strong> workshops <strong>and</strong> ultimately to propagate<br />

learnings through various published<br />

media. The effect of these activities will<br />

be to help Europe to lead debate rather<br />

than work in a reactive mode, confident<br />

that resolutions are well-rehearsed <strong>and</strong><br />

strongly scientifically justified.<br />

The starting point is communication<br />

<strong>and</strong> it is hoped that the BABP Website<br />

(www.babp-network.org) will develop<br />

into the common information platform.<br />

An additional early activity will be a twoday<br />

conference on science <strong>and</strong> regulation<br />

planned for June 2008. Topics will include<br />

BCS-based waiver beyond Class 1,<br />

considering transporter-excipient interplay<br />

<strong>and</strong> the interpretation of data from acidic<br />

BCS Class II <strong>and</strong> Class III substances,<br />

for the first day. The second day will<br />

consider the design of steady state studies<br />

<strong>and</strong> ideas for testing novel drug delivery<br />

systems including orally dispersible<br />

forms. It is intended that the conference<br />

topics will provide a stimulus for debate<br />

<strong>and</strong> resolution, providing an opportunity<br />

for airing issues <strong>and</strong> looking for avenues<br />

which will facilitate consensus. A further<br />

conference is planned on publication of<br />

the guidelines at an appropriate point in<br />

the future.


<strong>EUFEPS</strong> Newsletter, 2008, vol. 17, issue 1<br />

Innovative Medicines<br />

Initiative (IMI)<br />

kick-off<br />

Ole J. Bjerrum, Professor<br />

<strong>EUFEPS</strong> Past-President<br />

The long awaited grants, specially<br />

designated for research related to drug<br />

development, are within reach. Now that<br />

the lists of topics are known, it is timely to<br />

form consortia of interested stakeholders<br />

beyond the founding EFPIA companies.<br />

Current status in a historical<br />

perspective<br />

The long endeavour to create solid<br />

European support for research, as well<br />

as education <strong>and</strong> training, related to the<br />

drug development process is almost<br />

finished. The kick-off meeting for calls<br />

for IMI grants will take place in Brussels<br />

on April 30, 2008. Table I shows some<br />

of the many events, initiatives <strong>and</strong> steps<br />

that have preceded the present Innovative<br />

Medicines Initiative Joint Undertaking<br />

(IMI-JU).<br />

Various unofficial lists of the EFPIA<br />

proposed calls have circulated in Europe<br />

since December 2007. The European<br />

Commission (EC) kept the books closed<br />

so that nobody outside really knew what<br />

the end results would be. However, at<br />

monthly telephone conferences held in<br />

the <strong>EUFEPS</strong> University Membership<br />

Network, the participants have kept each<br />

other updated as much as possible on the<br />

progress of IMI-related issues. The minutes<br />

of those conferences are published on the<br />

Network’s website. Finally, on March 3,<br />

2008 when the IMI Governing Board was<br />

founded, the list shown in Table II was<br />

released from the EC for comments at<br />

the interim Member State Contact Group.<br />

Once feedback has been incorporated, the<br />

final text will be available.<br />

Call <strong>and</strong> peer review process<br />

In short the IMI Executive Office will<br />

issue calls according to the following<br />

mechanism:<br />

TABLE I - History of the IMI-JU<br />

September 1999 Publication of New Safe Medicines Faster (NSMF) Vision<br />

Paper<br />

March 2000 First EC funded <strong>EUFEPS</strong> Workshop on NSMF, Brussels<br />

New, safer <strong>and</strong> more effective drugs” in FP6<br />

March 2002 Launching calls for “Rational <strong>and</strong> accelerated development of<br />

new, safer <strong>and</strong> more effective drugs” in FP6<br />

April 2003 Second EUREKA funded <strong>EUFEPS</strong> Workshop on NSMF,<br />

Copenhagen<br />

April 2003 Application through FP6 of a <strong>EUFEPS</strong> organised workshop<br />

“On creation of biopharmaceutical development platform”<br />

(subsequently transformed to an IMI technology platform)<br />

November 2003 First contact between EC <strong>and</strong> EFPIA<br />

May 2004 Start of official discussions between EC <strong>and</strong> EFPIA<br />

June 2004 EFPIA agreement to take leadership of the European<br />

Technology<br />

Platform for Innovative Medicines (IMI)<br />

December 2004 Publication of IMI Vision Paper<br />

April 2005 <strong>EUFEPS</strong> organised the Workshop on “How to establish a<br />

European Technology Platform for Innovative Medicines”,<br />

Barcelona<br />

August 2005 Publication of IMI Strategic Research Agenda (SRA)<br />

October 2005 Start of the pilot project InnoMed funded under FP6<br />

September 2006 IMI SRA version 2 (Including governance <strong>and</strong> IP policy)<br />

May 2007 Adoption of IMI legal package by the EC<br />

August 2007 Adoption of IMI Intellectual Property Policy<br />

November 2007 Adoption of IMI legal package by the European Competitiveness<br />

Council<br />

December 2007 Adoption of the European Parliament opinion<br />

December 2007 Approval of the establishment of IMI Joint Undertaking by the<br />

European Council<br />

December 2007 First EFPIA unofficial IMI calls for Expression of Interests<br />

March 2008 Founding of IMI Governing Board<br />

April 2008 Announcement of 1st Call for Expression of Interest<br />

June 2008? Founding of IMI Member State Contact Group<br />

June 2008? Founding of IMI Scientific Committee<br />

July 2008? Deadline for Application of Expression of Interests<br />

October 2008? Deadline for (final) project applications<br />

December 2008? Funding <strong>and</strong> contract agreements of 1st round of IMI calls<br />

LXVIII


• In a first stage, the Executive Office will<br />

present a list of topics, application forms<br />

<strong>and</strong> evaluation criteria on the IMI website<br />

(www.imi-europe.org) <strong>and</strong> in relevant<br />

scientific journals. Academics, SMEs<br />

<strong>and</strong> Patient organisations, operating in<br />

public consortia, will be invited to submit<br />

Expressions of Interest (EoI). These will<br />

be reviewed by one of the four St<strong>and</strong>ing<br />

Peer Review Committees. The first stage<br />

will be completed when the EFPIA<br />

Consortium asks that the highest ranked<br />

Expression of Interest be developed <strong>and</strong><br />

submitted as a full project proposal.<br />

In a second stage, the Public-Private<br />

Collaboration (a grouping of the Public<br />

Consortia <strong>and</strong> the EFPIA Consortium)<br />

will submit its full project proposal to the<br />

IMI Executive Office. In a second peer<br />

review round, the relevance <strong>and</strong> eligibility<br />

of the project for each topic will be<br />

addressed. Successful projects will then<br />

be invited to enter into a grant agreement<br />

with the Executive Office.<br />

The reviewing of the project follows<br />

a transparent peer review process,<br />

based on scientific excellence <strong>and</strong> the<br />

applicant’s ability to deliver. The EU’s<br />

7th Framework programme will fund<br />

academic participants in Public-Private<br />

Collaborations <strong>and</strong> support SMEs, while<br />

the EFPIA-organised companies will<br />

fund their own contributions 100%. Other<br />

TABLE II - List of titles of the individual calls, duration <strong>and</strong> allocated funds*)<br />

1. Improve Predictivity of Immunogenicity 5 yr, Euro 13 m<br />

2. Non-genotoxic carcinogenesis 2 + 3 yr, Euro 2.5 + 10 m<br />

3. Expert systems for in silico toxicity prediction 5 yr, Euro 5 m<br />

4. Improved predictivity of non-clinical safety evaluation 3 yr, Euro 10 m<br />

5. Qualification of translational safety biomarkers 5 yr, Euro 21 m<br />

6. Strengthening the monitoring of the benefit/risk of medicines 5 yr, Euro 15 m<br />

7. Islet cell research 5 yr, Euro 10 m<br />

8. Surrogate markers for vascular endpoints 5 yr, Euro 20 m<br />

9. Pain research 5 yr, Euro 7.5 m<br />

10. New tools for the development of novel therapies in psychiatric disorders 5<br />

yr, Euro 10 m<br />

11. Neurodegenerative disorders 5 yr, Euro 7.5 m<br />

12. Underst<strong>and</strong>ing severe asthma 5 yr, Euro 12.5 m<br />

13. COPD patient recorded outcomes 5 yr, Euro 10 m<br />

14. European Medicines Research Training Network 7 yr, Euro 5 m<br />

15. Safety sciences for medicines training programme 5 yr, Euro 3 m<br />

16. Pharmaceutical medicine training programme 4 yr, Euro 4 m<br />

17. Integrated medicines development training programme 5 yr, Euro 3 m<br />

18. Pharmacovigilance training programme 5 yr, Euro 3.5 m<br />

*) List as of March 3, 2008<br />

types of organisations participating in<br />

Public-Private Collaborations will be<br />

supported on a case-by case basis.<br />

<strong>EUFEPS</strong>’ role<br />

For partnering, <strong>EUFEPS</strong> may help to<br />

organise a kind of fair in connection to<br />

one of its conferences during spring 2008.<br />

Furthermore, the <strong>EUFEPS</strong> Secretariat<br />

will share information on consortia, as<br />

known, under formation with interested<br />

researchers who approach <strong>EUFEPS</strong>.<br />

Currently, <strong>EUFEPS</strong> is engaged<br />

in formation of a consortium on<br />

“Safety sciences for medicines training<br />

programme”. The Secretariat has also<br />

received information about potential<br />

research projects on biomarkers, safety<br />

<strong>and</strong> pain.<br />

How to form consortia<br />

At present no official pan-European<br />

website exists where the researchers can<br />

search for partnering. What initiatives<br />

EC will set up in this regard awaits the<br />

official calls. However, at the national<br />

<strong>and</strong> regional level many activities <strong>and</strong><br />

fora for partnering have been launched.<br />

It is beyond <strong>EUFEPS</strong> capacity to keep<br />

track on such activities. Here interested<br />

parties have to address the local nodes or<br />

agencies.<br />

LXIX<br />

Embark now<br />

The pharmaceutical sciences are all<br />

pertinent for the IMI topics. For this reason,<br />

the majority of the <strong>EUFEPS</strong> membership<br />

should get engaged. If you want to launch<br />

a consortium: better start <strong>today</strong>.


<strong>EUFEPS</strong> Newsletter, 2008, vol. 17, issue 2-3<br />

<strong>EUFEPS</strong> Today<br />

Hans H. Linden, M.Sc.<br />

Executive Director <strong>EUFEPS</strong><br />

Background<br />

<strong>EUFEPS</strong> was founded 17 years ago. Since<br />

then, its membership, activities, relations<br />

<strong>and</strong> collaborative operations have<br />

exp<strong>and</strong>ed a lot, even beyond European<br />

borders, as it has entered the global arena.<br />

The Swedish Pharmaceutical Society/<br />

Academy of Pharmaceutical Sciences<br />

(SAPS) provided substantial support<br />

during the first years, to run a professional<br />

secretariat. As this support came to an<br />

end, funding has been replaced by project<br />

grants from the European Commission,<br />

by income from congresses, conferences,<br />

workshops <strong>and</strong> courses, by more members,<br />

as well as by uncommitted support from a<br />

number of pharmaceutical companies.<br />

Nearly ten years ago, <strong>EUFEPS</strong><br />

started initiating <strong>and</strong> setting up the New<br />

Safe Medicines Faster Project (NSMF),<br />

obviously, the successful forerunner of the<br />

current Innovative Medicines Initiative<br />

(IMI Joint Undertaking). The IMI is<br />

funded <strong>and</strong> run in close collaboration by<br />

the European Commission (EC) <strong>and</strong> the<br />

European Association of Pharmaceutical<br />

Industries <strong>and</strong> Associations (EFPIA).<br />

So, what is <strong>EUFEPS</strong> <strong>today</strong>, at the<br />

beginning of the post-IMI-launch era?<br />

At the <strong>EUFEPS</strong> President’s Conference,<br />

in April this year, a set of slides were<br />

prepared for information <strong>and</strong> update. This<br />

rhapsodic article is based on them, together<br />

with some additional update material.<br />

The Central Office of <strong>EUFEPS</strong> is<br />

still located in the SAPS building in<br />

Stockholm, Sweden. Since one year ago,<br />

there has also been the Branch Office<br />

Systems <strong>and</strong> Learning, at the University<br />

of Vienna, Austria. Additional Branch<br />

Offices have been considered, but these<br />

plans did not yet materialise.<br />

Mission<br />

What is the mission of <strong>EUFEPS</strong>? You<br />

know it, but why not refer to it as a reminder<br />

of the role of <strong>EUFEPS</strong> <strong>and</strong> achievements<br />

anticipated. It reads (Strategic Plan 2006-<br />

2010):<br />

“The mission of the European<br />

Federation for Pharmaceutical Sciences<br />

(<strong>EUFEPS</strong>) is to serve <strong>and</strong> advance<br />

excellence in the pharmaceutical<br />

sciences <strong>and</strong> innovative drug research<br />

in Europe, including in training <strong>and</strong><br />

education, <strong>and</strong> to represent the interests<br />

of scientists engaged in drug research<br />

<strong>and</strong> development, drug regulation, drug<br />

utilisation, <strong>and</strong> drug policy making.”<br />

Implementation<br />

Why invest time, energy <strong>and</strong> money in an<br />

organisation like <strong>EUFEPS</strong>? There was –<br />

<strong>and</strong> there is still – a job to be done, which<br />

cannot be delivered by any other current<br />

European organisation. For example,<br />

• To underpin the only pan-European<br />

body for pharmaceutical scientists<br />

(whatever their origin, domain or<br />

discipline)<br />

• To proactively support systems<br />

approaches in European collaboration,<br />

co-operation <strong>and</strong> co-ordination for<br />

better drug research, development <strong>and</strong><br />

use<br />

• To further strengthen the European<br />

voice <strong>and</strong> platform for needs <strong>and</strong><br />

progress communication along with<br />

beneficial networking, including<br />

globally<br />

Operational platforms<br />

How to get the job done? The current<br />

structure, as it developed over the years,<br />

includes a number of “platforms of<br />

operation”, the ultimate responsibilities<br />

LXX<br />

Hans H. Linden, M.Sc.<br />

for which are shared by the Council, the<br />

Executive Committee <strong>and</strong> the Secretariat.<br />

The Executive Committee, chaired by<br />

Daan J.A. Crommelin, present President of<br />

<strong>EUFEPS</strong>, includes the Executive Director<br />

(with voice but no vote). In addition, there<br />

are steering <strong>and</strong> other committees, many<br />

scientific programme committees <strong>and</strong><br />

organising committees for meetings <strong>and</strong><br />

events, plus ad hoc project groups <strong>and</strong><br />

task forces, etc. The platforms are, in<br />

summary:<br />

• Membership Management<br />

• Networks (covering certain specific<br />

fields)<br />

• Senate<br />

• Research <strong>and</strong> Policy Initiatives<br />

• PharmSciFair<br />

• Meetings <strong>and</strong> Events<br />

• Education <strong>and</strong> Training<br />

• Communications<br />

• Finance <strong>and</strong> Funding<br />

• President’s Conference<br />

• Council <strong>and</strong> Open Forum<br />

• Central <strong>and</strong> Branch Offices<br />

Membership<br />

What constitutes the current membership<br />

of <strong>EUFEPS</strong>? It is:<br />

Member Societies<br />

- 24 in 24 European countries (including<br />

Israel <strong>and</strong> Turkey)<br />

Member Institutions<br />

- It’s a new category, at present including<br />

15 European universities <strong>and</strong> research<br />

institutions<br />

Member Individuals<br />

- Around 400, currently, including from<br />

non- European region; the number is a<br />

little lower than it has been for a number<br />

of years


There is a <strong>EUFEPS</strong> Steering Committee<br />

for Membership Development, chaired<br />

<strong>and</strong> co-chaired by Buket Aksu, Executive<br />

Committee Member, <strong>and</strong> Ole J. Bjerrum,<br />

Past-President of <strong>EUFEPS</strong>, respectively.<br />

Networks<br />

What are they <strong>and</strong> why? They are there<br />

to increase networking, of course, in <strong>and</strong><br />

between scientific domains that are both<br />

relevant <strong>and</strong> important for drug discovery,<br />

development <strong>and</strong> use, initiated <strong>and</strong> run by<br />

scientists in the field. Current <strong>EUFEPS</strong><br />

Networks include:<br />

BioAvailability <strong>and</strong> BioPharmaceutics<br />

(BA/BP)<br />

- Chaired by Henning Blume, Oberursel<br />

DE<br />

Process Analytical Technology Sciences<br />

(PAT)<br />

- Chaired by Peter York, Bradford UK<br />

(retiring; new chair needed)<br />

PharmacoGenetics <strong>and</strong> Pharmaco-<br />

Genomics Research (PGPG)<br />

- Chaired by Anke-Hilse Maitl<strong>and</strong>-van der<br />

Zee, Utrecht NL<br />

Safety Sciences<br />

- Chaired by Helmut Sterz, Paris FR<br />

(retiring; new chair needed)<br />

Additional Networks are emerging or being<br />

considered, including on “Environment<br />

<strong>and</strong> Pharmaceuticals” <strong>and</strong> on “Quality of<br />

Medicines”, respectively.<br />

For each <strong>EUFEPS</strong> Network, there<br />

is a Steering Committee, composed of<br />

members of the Network, as their time<br />

<strong>and</strong> availability allow, with support from<br />

the <strong>EUFEPS</strong> Executive Director <strong>and</strong><br />

Secretariat.<br />

Senate<br />

What is this? It is a new <strong>EUFEPS</strong>-linked<br />

institution, formed as the outcome of<br />

discussions on how to aggregate scientific<br />

opinions relevant for drug discovery,<br />

development <strong>and</strong> use. The discussions<br />

started several years ago. Now, top scientists<br />

in Europe have been identified <strong>and</strong> listed,<br />

representing the full spectrum of scientific<br />

disciplines. A first round of personal<br />

invitations has been circulated, <strong>and</strong> most of<br />

those approached have responded positively.<br />

Additional invitation rounds will follow, to<br />

arrive at as complete as possible a coverage<br />

<strong>and</strong> representation of the pharmaceutical<br />

sciences in Europe. Douwe D. Breimer,<br />

Founding Father <strong>and</strong> Past-President of<br />

<strong>EUFEPS</strong>, <strong>and</strong> Christian R. Noe, Past-<br />

President of <strong>EUFEPS</strong>, are in the lead.<br />

Research <strong>and</strong> policy initiatives<br />

Is this activity platform crucial to the<br />

further development of <strong>EUFEPS</strong>? Yes, it is.<br />

It is a conglomerate of <strong>EUFEPS</strong> activities<br />

<strong>and</strong> projects, many in collaboration with<br />

each other. It’s all there to further regional<br />

<strong>and</strong> global development of the science <strong>and</strong><br />

better serving the citizens. Significant<br />

“old”, ongoing <strong>and</strong> new efforts include:<br />

Projects in the European Arena<br />

- Several projects funded by European<br />

Research Framework Programmes, over<br />

nearly 10 years<br />

- Recent IMI JU Expressions of<br />

Interests, where <strong>EUFEPS</strong> is engaged in<br />

four out of five of the ones on education<br />

<strong>and</strong> training, one of which through the<br />

<strong>EUFEPS</strong> Network on Safety Sciences,<br />

particularly<br />

- The European Bio(Tissue)Bank Project<br />

on Adverse Drug Reactions, initiated<br />

<strong>and</strong> run by the <strong>EUFEPS</strong> Research<br />

Network on PharmacoGenetics/<br />

PharmacoGenomics<br />

Additional collaboration in the European<br />

region<br />

- Good, high-level relations with<br />

other (pan-)European institutions <strong>and</strong><br />

agencies, including the EMEA, the<br />

EDQM (European Directorate for<br />

Quality of Medicines, the European<br />

Pharmacopoeia, primarily), ISPE Europe<br />

(International Society of Pharmaceutical<br />

Engineering), ESF (European Science<br />

Foundation) <strong>and</strong> more – all having<br />

instruments to be utilised for new<br />

research initiatives<br />

- The European Pharma Sciences<br />

Leadership Forum (EuPSLF), comprising<br />

the Presidents of ten European sister<br />

federations/associations, in full operation<br />

representing the European scientific<br />

community devoted to contribute to new<br />

<strong>and</strong> better medicines<br />

Bilateral collaboration<br />

- Links forged with associations <strong>and</strong><br />

agencies in the USA (including the FDA<br />

<strong>and</strong> USP), Japan <strong>and</strong> in the United Arab<br />

Emirates<br />

Global collaboration<br />

- The FIP Board of Pharmaceutical<br />

Sciences (BPS) is seen as the only<br />

current global platform. The presence of<br />

<strong>EUFEPS</strong> is now changing from observer<br />

to full member status<br />

LXXI<br />

Industrial <strong>and</strong> academic research<br />

relations<br />

Any other? As the NSMF has developed<br />

into the IMI JU, contacts with industry<br />

have been frequent, of course. However,<br />

there is an even longer industrial research<br />

relations initiative in <strong>EUFEPS</strong>, still<br />

ongoing.<br />

It is the <strong>EUFEPS</strong> Committee on<br />

Industrial Research Relations (CIRR),<br />

established in the very first years of<br />

<strong>EUFEPS</strong>. Since 1994, it has been meeting<br />

regularly, mostly twice a year. As a very<br />

committed “think-tank” of <strong>EUFEPS</strong>, the<br />

CIRR contributed a lot to, for example, the<br />

meeting <strong>and</strong> course programme. Also, the<br />

first NSMF ideas emerged in a visionary<br />

<strong>and</strong> creative CIRR discussion.<br />

Over the years the vast majority of<br />

delegates in <strong>EUFEPS</strong> meetings have<br />

been representing industry. This is not<br />

surprising, since industry research needs<br />

<strong>and</strong> progress, including in education <strong>and</strong><br />

training, have been given a high priority.<br />

For a relatively short period, there was<br />

also a <strong>EUFEPS</strong> Committee on Academic<br />

Research Relations (CARR), producing an<br />

important report on priority needs in the<br />

field. Chances to meet were few, though,<br />

because of limited funds among its<br />

membership. As establishing a <strong>EUFEPS</strong><br />

Senate is now in progress, it is agreed that<br />

the tasks of CARR could be continued in<br />

this new group: the Senate.<br />

Awards<br />

Since it is important to recognise excellent<br />

contributions to the development of<br />

the research field, <strong>EUFEPS</strong> has an<br />

award scheme. What are the <strong>EUFEPS</strong><br />

awards? There is the (biennial) Segré<br />

Prize in PharmacoKinetics <strong>and</strong><br />

PharmacoDynamics, the (annual) NSMF<br />

Award for new approaches, <strong>and</strong> the<br />

(annual) Best Paper Award for articles<br />

published in the European Journal of<br />

Pharmaceutical Sciences.<br />

PharmSciFair<br />

How does it go? The first Pharmaceutical<br />

Sciences Fair <strong>and</strong> Exhibition ever –<br />

PharmSciFair – was successfully held<br />

in June 2005 in Nice FR, <strong>and</strong> organised<br />

by 26 Programme Providing Partners,<br />

including <strong>EUFEPS</strong>. The initiative<br />

was taken several years before within<br />

<strong>EUFEPS</strong>. The idea was then that it<br />

should be the start of a joint European<br />

networking meetings platform, or the<br />

“European Congress Week”, where all<br />

relevant disciplines should come together


<strong>and</strong> set up their “own” programme. By<br />

this, there would be a unique opportunity<br />

to learn about progress in one’s own <strong>and</strong><br />

other disciplines. All this with the intent to<br />

stimulate data <strong>and</strong> information exchange,<br />

as well as many interactions.<br />

Components of the PharmSciFair include:<br />

Opening Session<br />

Awards Ceremony<br />

- Including a prestigious European<br />

Pharmaceutical Sciences Award<br />

Invited Speaker Sessions<br />

Short Communication Sessions<br />

Discussion Sessions<br />

Poster Sessions<br />

Partner Introduction St<strong>and</strong>s<br />

Exhibition<br />

Welcome Reception<br />

Partner Receptions<br />

PharmSciFair Dinner<br />

In 2007, there was no full PharmSciFair,<br />

because this was the year of the<br />

Pharmaceutical Sciences World Congress<br />

– PSWC2007 – in Europe. To link these<br />

events, there was the PSWC2007 <strong>and</strong><br />

PharmSciFair Exhibition<br />

The 2nd PharmSciFair is scheduled<br />

for June 8-12, 2009, again in Nice FR.<br />

Programming is in progress (7-8 parallel<br />

sessions for five days, except the first<br />

afternoon for the Opening Session),<br />

coordinated by a PharmSciFair Planning<br />

Team, chaired by Pia Vuorela, President-<br />

Elect of <strong>EUFEPS</strong>. The general concept<br />

will be the same as in 2005, but it will be<br />

exp<strong>and</strong>ed with a first European Careers<br />

Forum <strong>and</strong> a Young Scientists Meeting<br />

- Pre-satellite with <strong>and</strong> for PhD Students<br />

<strong>and</strong> PostDocs.<br />

Meetings <strong>and</strong> events<br />

What about them? <strong>EUFEPS</strong>´ conferences<br />

<strong>and</strong> workshops – 4 to 8 per year, normally<br />

– are widely communicated <strong>and</strong> wellknown.<br />

They appear in three categories:<br />

<strong>EUFEPS</strong> organised ones<br />

- All responsibility, including risk <strong>and</strong><br />

revenue<br />

<strong>EUFEPS</strong> co-organised ones<br />

- Shared responsibility, including risk<br />

<strong>and</strong> revenue<br />

<strong>EUFEPS</strong> co-sponsored ones<br />

- e.g. communication support, but neither<br />

risk nor any revenue<br />

In addition, to education <strong>and</strong> training<br />

workshops, <strong>EUFEPS</strong> also set up a<br />

number of exploratory <strong>and</strong> discussion<br />

workshops, over the years, several funded<br />

by the European Commission. Important<br />

outcomes reports or articles have been<br />

published following such meetings. The<br />

number of delegates in such workshops<br />

ranged between 12 <strong>and</strong> 120. This activity<br />

should continue to ensure further<br />

contributions to the science <strong>and</strong> to policy<br />

making.<br />

To run it all, there is an <strong>EUFEPS</strong><br />

Steering Committee for Meetings <strong>and</strong><br />

Events, chaired by Pia Vuorela, President-<br />

Elect of <strong>EUFEPS</strong>.<br />

Education <strong>and</strong> training<br />

How does <strong>EUFEPS</strong> engage in education<br />

<strong>and</strong> training? Courses, workshops <strong>and</strong><br />

the Young Students Meeting (see above)<br />

are organised along similar lines as the<br />

meetings <strong>and</strong> events.<br />

After many years of discussions, the<br />

<strong>EUFEPS</strong> Course DataBase or Catalogue<br />

was launched earlier this year. The<br />

information included in it is provided<br />

in collaboration with universities <strong>and</strong><br />

research schools. A number of inclusion<br />

criteria have been defined to set the<br />

st<strong>and</strong>ard.<br />

In silico Systems <strong>and</strong> Learning<br />

is an additional new initiative. The<br />

initiative originates from Austria, where<br />

the University of Vienna is providing<br />

support for a <strong>EUFEPS</strong> Branch Office.<br />

One workshop has been held to engage<br />

more groups <strong>and</strong> exp<strong>and</strong> collaboration. A<br />

second workshop is in progress.<br />

<strong>EUFEPS</strong> organised two (exploratory)<br />

workshops in safety sciences. One of them<br />

a number of years ago (to feed into the<br />

NSMF) <strong>and</strong> an additional one, last year, to<br />

further address the needs of (integrated)<br />

research education <strong>and</strong> training in safety<br />

sciences. The primary outcome was<br />

a tentative postgraduate level training<br />

programme for safety scientists in<br />

industry. In the first half of this year, it<br />

has been further developed <strong>and</strong> refined<br />

into a one-year modular curriculum, also<br />

submitted as an IMI JU EoI (Expression<br />

of Interest) by a specific consortium.<br />

There are additional ideas, along the same<br />

lines for additional topics, which will be<br />

reported on in due course.<br />

Having assessed the needs <strong>and</strong><br />

defined the goals <strong>and</strong> objectives, places<br />

where effective <strong>and</strong> efficient education<br />

<strong>and</strong> training (including lab courses, as<br />

needed) can take place are required.<br />

To start looking into how to assess the<br />

quality of institutions, a workshop on<br />

Institutional Peer Reviewing was set up in<br />

LXXII<br />

the beginning of this year. The workshop<br />

outcomes have been presented in a recent<br />

article in this NewsLetter.<br />

Additional associations <strong>and</strong> groups<br />

for education <strong>and</strong> training liaising with<br />

<strong>EUFEPS</strong> include EAFP (European<br />

Association of Faculties of Pharmacy);<br />

EPSA (European Pharmaceutical<br />

Students’ Association); <strong>and</strong> the ULLA<br />

university consortium, running e.g. the<br />

ULLA Summer School.<br />

For many years, the Committee on<br />

Training <strong>and</strong> Education (CTE) has been<br />

the <strong>EUFEPS</strong> group to identify, initiate <strong>and</strong><br />

bring in courses to constitute the <strong>EUFEPS</strong><br />

training <strong>and</strong> education programme. It is<br />

still there, but has, recently, been given<br />

a broader role – the <strong>EUFEPS</strong> Steering<br />

Committee for Education <strong>and</strong> Training,<br />

charged to coordinate all education<br />

activities. This Committee is chaired<br />

by Ulrike Holzgrabe, Member of the<br />

Executive Committee.<br />

Communications<br />

What are the <strong>EUFEPS</strong> communication<br />

tools <strong>and</strong> channels? In preparing the slide<br />

set, referred to in the beginning this article,<br />

a surprisingly long list emerged:<br />

European Journal of Pharmaceutical<br />

Sciences (Eur J Pharm Sci or EJPS)<br />

- Official Scientific Journal of <strong>EUFEPS</strong>;<br />

the Impact Factor of which is gradually<br />

increasing<br />

<strong>EUFEPS</strong> NewsLetter<br />

- Four issues per year, since a number of<br />

years no longer printed, but available at<br />

<strong>EUFEPS</strong> Online<br />

<strong>EUFEPS</strong> Flash<br />

- Email announcements of <strong>EUFEPS</strong><br />

meetings <strong>and</strong> events, as needed<br />

<strong>EUFEPS</strong> Membership Bulletin<br />

- Email circulation to the membership<br />

<strong>EUFEPS</strong> Online www.eufeps.org<br />

- The <strong>EUFEPS</strong> central website<br />

<strong>EUFEPS</strong> Course DataBase/Catalogue<br />

www.etplatform.eu,<br />

- Linked to <strong>EUFEPS</strong> Online<br />

<strong>EUFEPS</strong> Vienna Branch Office<br />

(http://vienna.eufeps.org)<br />

- systems <strong>and</strong> learning related website<br />

PharmSciFair Website<br />

- The Pharmaceutical Sciences Fair <strong>and</strong><br />

Exhibition partnership website (www.<br />

pharmscifair.org)<br />

- Operated by <strong>EUFEPS</strong><br />

EUMAPP<br />

- EU funded microdosing <strong>and</strong> accelerated<br />

mass spectrometry investigation project<br />

(www.eumapp.com)


- Operated by <strong>EUFEPS</strong><br />

PSWC2007 Website<br />

- The last Pharmaceutical Sciences<br />

World.<br />

- Congress website, still running (www.<br />

pswc.org)<br />

- Operated by <strong>EUFEPS</strong><br />

Network on BioAvailability <strong>and</strong><br />

BioPharmaceutics<br />

- www.babp-network.org<br />

- Linked to <strong>EUFEPS</strong> Online<br />

Network on PAT Sciences<br />

- On <strong>EUFEPS</strong> Online<br />

Network on PharmacoGenetics <strong>and</strong><br />

PharmacoGenomics Research<br />

www.epr-network.org<br />

- Linked to <strong>EUFEPS</strong> Online<br />

Network on Safety Sciences<br />

- On <strong>EUFEPS</strong> Online<br />

European Pharma Sciences Leadership<br />

Forum (EuPSLF)<br />

- Agreed to be set up (www.eupslf.org)<br />

<strong>EUFEPS</strong> Ambassadors<br />

- Members, meeting delegates <strong>and</strong> liaison<br />

contacts promoting <strong>EUFEPS</strong> <strong>and</strong> its<br />

activities<br />

There is a <strong>EUFEPS</strong> Media Task<br />

Force, chaired by Hans H. Linden,<br />

Executive Director, available to discuss<br />

improvements <strong>and</strong> resolve problems.<br />

Enabling things<br />

What support is there? Any organisation is<br />

dependent on policy <strong>and</strong> decision-making<br />

bodies to succeed. As important are sound<br />

finances, h<strong>and</strong>s to get the job done <strong>and</strong><br />

facilities in <strong>and</strong> from which to operate.<br />

Such platforms include:<br />

• Finance <strong>and</strong> Funding<br />

• Membership dues<br />

• Meetings registration fees<br />

• General <strong>and</strong> specific sponsorship<br />

• Budgets <strong>and</strong> outcomes reports<br />

• President’s Conference<br />

• Update, discussion <strong>and</strong> advice between<br />

council meetings<br />

• Council <strong>and</strong> Open Forum<br />

• The membership representatives legal<br />

meeting<br />

• Strategic plans, progress <strong>and</strong> reports<br />

approval<br />

• Secretariat <strong>and</strong> contracted partners<br />

• Central (executive) office <strong>and</strong> branch<br />

office<br />

• General management <strong>and</strong><br />

administration<br />

• Project management <strong>and</strong><br />

administration<br />

LXXIII<br />

Where next?<br />

Are there reasons to be satisfied? At the<br />

forthcoming Council <strong>and</strong> Open Forum<br />

(September 20, 2008, in Ljubljana,<br />

Slovenia), there will be a Mid-term<br />

Assessment of the current Strategic Plan<br />

(2006-2010), reflecting on what happened<br />

to date <strong>and</strong> discussing how to proceed.<br />

Outcomes will be reported in this<br />

NewsLetter.


<strong>EUFEPS</strong> Newsletter, 2008, vol. 17, issue 4<br />

“Times are changing <strong>and</strong> we<br />

change with time”<br />

Reflections of the Past<br />

President <strong>and</strong> President at the<br />

turn of the year<br />

Christian R. Noe Professor,<br />

<strong>and</strong> Daan J.A. Crommelin, Professor<br />

“Tempora mutantur et nos mutamur<br />

in illis” – “Times are changing <strong>and</strong> we<br />

change with time”. “Globalisation”<br />

is a term implying rapid change. It is<br />

associated also with the present financialeconomic<br />

crisis, which demonstrates all<br />

of a sudden, that the old Latin expression<br />

is still relevant to a large extent. There<br />

is little doubt that everybody will change<br />

with time. However, with permanently<br />

<strong>and</strong> swiftly ongoing changes in the world<br />

around us, we are free to decide, when,<br />

how <strong>and</strong> to which degree we have to<br />

change our positions <strong>and</strong> ourselves.<br />

Otherwise, it will be others that will<br />

impose the changes upon us.<br />

So, what is <strong>EUFEPS</strong> <strong>today</strong>, at the<br />

beginning of the post-IMI-launch era?<br />

At the <strong>EUFEPS</strong> President’s Conference,<br />

in April this year, a set of slides were<br />

prepared for information <strong>and</strong> update. This<br />

rhapsodic article is based on them, together<br />

with some additional update material.<br />

The Central Office of <strong>EUFEPS</strong> is<br />

still located in the SAPS building in<br />

Stockholm, Sweden. Since one year ago,<br />

there has also been the Branch Office<br />

Systems <strong>and</strong> Learning, at the University<br />

of Vienna, Austria. Additional Branch<br />

Offices have been considered, but these<br />

plans did not yet materialise.<br />

Europe unified<br />

The formation of a unified Europe is<br />

another process of change, slowly going<br />

on over the years. This movement is of<br />

fundamental importance for all people<br />

living in this region. It is obvious that,<br />

within the European project, positive<br />

effects of changes are by far prevailing<br />

over negative effects. <strong>EUFEPS</strong> as a<br />

federation has been founded to support<br />

the European idea. <strong>EUFEPS</strong>, representing<br />

pharmaceutical scientists <strong>and</strong> promoting<br />

the pharmaceutical sciences, has done<br />

its best to promote a common European<br />

dimension of high quality research.<br />

<strong>EUFEPS</strong>, representing scientists, has also<br />

done its best to create a truly European<br />

community of pharmaceutical scientists.<br />

Last not least, all of <strong>EUFEPS</strong>´ activities<br />

have taken place to secure sustainability<br />

of successful pharmaceutical research in<br />

the European region.<br />

Bottom-up <strong>and</strong> top-down roles<br />

A further aspect of changes in time are<br />

those waves in politics, which favour<br />

either democratic “bottom up” approaches<br />

or feudalistic “top down” approaches.<br />

As a matter of fact, this situation occurs<br />

not only in politics, but in almost all<br />

human organisational systems. Only a<br />

harmonised relation between “parliament”<br />

<strong>and</strong> “government” can assure justice<br />

<strong>and</strong> benefit for the population. Taking<br />

<strong>EUFEPS</strong> as an example, the “Council”<br />

would st<strong>and</strong> for the “Parliament”, the<br />

“Executive Committee” would st<strong>and</strong><br />

for the “Government”. It is clear that the<br />

membership, represented by the Council,<br />

is the core of the Federation <strong>and</strong> that the<br />

Council has to act according to the wish<br />

of this membership. Being aware of this<br />

important Committee, which over the<br />

years has taken a series of measures to<br />

strengthen the role of membership, the rock<br />

on which <strong>EUFEPS</strong> st<strong>and</strong>s. This not only<br />

led to increasing the number of member<br />

organisations or introducing the category<br />

of individual members. It also meant<br />

establishing the President´s Conference, a<br />

‘twice-a-year gathering’ of the presidents<br />

of the <strong>EUFEPS</strong> member organisations.<br />

This forum should discuss initiatives <strong>and</strong><br />

needs arising across the continent in an<br />

open debate with the <strong>EUFEPS</strong> leadership.<br />

LXXIV<br />

New initiatives strengthen<br />

An even further reaching step was taken in<br />

view of the complexity of pharmaceutical<br />

research. The “European Pharmaceutical<br />

Sciences Leadership Forum” was<br />

established to create a platform, where<br />

the leadership of scientific organisations<br />

related to the pharmaceutical sciences<br />

meet to discuss problems, to share views,<br />

to identify areas of common interest <strong>and</strong><br />

to co-ordinate planning on both broad <strong>and</strong><br />

detailed levels. For <strong>EUFEPS</strong>, this forum<br />

is of particular interest, because it is the<br />

only organisation in Europe st<strong>and</strong>ing for<br />

pharmaceutical sciences in its full scope,<br />

comprising the main areas of discovery,<br />

development, production <strong>and</strong> utilisation<br />

of drugs (see scheme 1). It is <strong>EUFEPS</strong>´<br />

interest to strive for the common goal of<br />

promoting top quality pharmaceutical<br />

research in Europe jointly with the other<br />

organisations. The <strong>EUFEPS</strong> Senate,<br />

made up of the best European researchers<br />

in the field, regardless their educational<br />

background, will hopefully be a<br />

particularly effective think tank reacting<br />

quickly to changes <strong>and</strong> giving answers to<br />

the needs of the pharmaceutical scientists´<br />

community, in particular concerning the<br />

future of research. All these initiatives<br />

constitute, in principle, “top down”<br />

actions of the Executive Committee to<br />

provoke “bottom up” activities, which will<br />

strengthen the Federation <strong>and</strong> will help to<br />

reach the overall goals.<br />

IMI now operational<br />

As a matter of fact, the “daily” work at<br />

the executive level of <strong>EUFEPS</strong> is mainly<br />

focused on the implementation of the<br />

strategic plan as decided by the Council.<br />

This means a lot of specific activities <strong>and</strong><br />

actions, e.g. organisation of conferences,<br />

workshops, arranging the work of the


committees <strong>and</strong> networks, co-ordination<br />

of the PharmSciFair <strong>and</strong> many others. One<br />

of the most important projects, the support<br />

of the implementation of the Innovative<br />

Medicines Initiative (IMI) within the 7th<br />

Framework Programme of the EU has<br />

just been finished with the IMI starting<br />

to be operational from now on. Without<br />

any doubt, the IMI is a very promising,<br />

important <strong>and</strong>, due to the financial options,<br />

also effective “top down” instrument<br />

from the European Commission to<br />

promote the pharmaceutical sciences in<br />

Europe. Hopefully several of the present<br />

<strong>EUFEPS</strong> activities will be continued by<br />

IMI on a financially stronger basis. This<br />

will hopefully set free the required energy<br />

<strong>and</strong> capacity for important new <strong>EUFEPS</strong><br />

Executive Committee (ExCo) activities.<br />

One of these new tasks will be to raise<br />

awareness of the potential of the IMI <strong>and</strong><br />

to connect the instruments <strong>and</strong> activities<br />

of IMI to the <strong>EUFEPS</strong> membership.<br />

New pharmaceutical medicine<br />

There is one particularly important<br />

initiative within IMI, which will result<br />

in a significant change in the setting of<br />

organisations dealing with pharmaceutical<br />

sciences. Promotion of “pharmaceutical<br />

medicine” is one of the goals of IMI. The<br />

term “pharmaceutical medicine” was<br />

coined some time ago. In brief, it describes<br />

“pharmaceutical sciences” from the<br />

st<strong>and</strong>point of medically trained scientists,<br />

just as “medicinal chemistry” describes<br />

our science from the st<strong>and</strong>point of chemists<br />

or “pharmaceutical biotechnology” does<br />

so from the st<strong>and</strong>point of molecular <strong>and</strong><br />

cellular biologists. Of course, clinical<br />

drug development is at the core of<br />

pharmaceutical medicine, but it aims to<br />

be more <strong>and</strong> it should be more. It should<br />

comprise the best possible contributions<br />

that medical doctors with their educational<br />

<strong>and</strong> professional background can give to the<br />

pharmaceutical sciences. This is certainly<br />

not less relevant than the contributions from<br />

the other main disciplines. This awareness<br />

of the importance of pharmaceutical<br />

sciences within the medical community<br />

<strong>and</strong> the wish for new organisational<br />

<strong>and</strong> educational approaches have to be<br />

welcomed, in view of our ambition to<br />

promote the best possible science in<br />

Europe.<br />

<strong>EUFEPS</strong>’ mission st<strong>and</strong>s<br />

In a recent discussion within the<br />

miniExCo of <strong>EUFEPS</strong>, the opinion was<br />

shared that it is the duty of <strong>EUFEPS</strong> to<br />

support initiatives to develop the field of<br />

“pharmaceutical medicine”. This will<br />

speed up implementation of new findings<br />

in the drug development process, add<br />

quality <strong>and</strong> will help to avoid duplications.<br />

Thus, the overall quality of pharmaceutical<br />

research, concerning the full drug<br />

discovery <strong>and</strong> development process, not<br />

forgetting drug utilisation (scheme 1), will<br />

increase.<br />

Please contribute views<br />

Of course, involvement with<br />

“pharmaceutical medicine” means a<br />

change for <strong>EUFEPS</strong>. It is however not<br />

at all a change with respect to reaching<br />

the central goal of promoting the quality<br />

of pharmaceutical sciences in Europe.<br />

Within the Leadership Forum <strong>and</strong> the<br />

Senate, contacts have already been<br />

established <strong>and</strong> will be further established<br />

with organisations from different areas<br />

<strong>and</strong> scientists of different disciplines,<br />

including medicine. The change is much<br />

more related to the question of “who are<br />

our members?” Most of our membership<br />

organisations at present are national<br />

pharmaceutical organisations. In the heart<br />

of their scientific competence is preclinical<br />

pharmaceutical development. Of course,<br />

there is also high competence in the field of<br />

pharmacotherapy <strong>and</strong> drug utilisation, due<br />

to the professional qualification associated<br />

LXXV<br />

with pharmacy education. At present,<br />

the discovery competence is shared with<br />

chemists <strong>and</strong> molecular biologists. And<br />

without any doubt, nobody would have<br />

questioned the medical competence in<br />

clinical development. Therefore, there is<br />

no major obstacle for <strong>EUFEPS</strong> to support<br />

activities aiming at the promotion of the<br />

science side of pharmaceutical medicine.<br />

As a consequence, we propose <strong>EUFEPS</strong> to<br />

open up its membership to “pharmaceutical<br />

medicine” scientists <strong>and</strong> to actively seek<br />

collaboration with European organisations,<br />

existing or to be established, in the field of<br />

pharmaceutical medicine.<br />

Some mental change might be<br />

required. The present pharmacists <strong>and</strong><br />

pharmaceutical scientists tend to fear<br />

domination by medical doctors, <strong>and</strong><br />

discussions on “staking of claims” <strong>and</strong> on<br />

“importance of fields <strong>and</strong> pecking order”<br />

will continue. However, such discussions<br />

seldom bear fruit. It has been the mission<br />

of <strong>EUFEPS</strong> from its foundation to serve<br />

pharmaceutical scientists <strong>and</strong> to promote<br />

<strong>and</strong> foster the pharmaceutical sciences.<br />

To us, it is in line with this motto to seek<br />

an active interaction with our colleagues<br />

in pharmaceutical medicine. Your Past-<br />

President <strong>and</strong> President look into the<br />

future with great expectations <strong>and</strong> invite<br />

you, <strong>EUFEPS</strong>onians, for comments. ‘Top<br />

down’ <strong>and</strong> ‘bottom up’ – in a strong <strong>and</strong><br />

healthy organisation, there is this twoway<br />

street where the leadership invites<br />

its members to a debate on opinions <strong>and</strong><br />

strategies. Therefore, ending with the<br />

Greek philosopher´s version of the Latin<br />

expression cited at the beginning: “Panta<br />

rhei kai ouden menei”, ”everything<br />

changes <strong>and</strong> nothing remains the same”<br />

does – in mid-term perspective – apply to<br />

the “everyday life of <strong>EUFEPS</strong>”, but does<br />

not apply to the <strong>EUFEPS</strong> basic principles<br />

<strong>and</strong> tradition. The debate remains <strong>and</strong> the<br />

floor is yours…


<strong>EUFEPS</strong> Newsletter, 2009, vol. 17, issue 1<br />

The PharmSciFair<br />

is the premier European Platform for<br />

Advancing Pharmaceutical Sciences,<br />

initiated by <strong>EUFEPS</strong>. This became<br />

absolutely clear during the first<br />

PharmSciFair in 2005, where 26 National<br />

<strong>and</strong> International organisations in<br />

Pharmaceutical Sciences joined together.<br />

More than 700 scientists, coming from all<br />

pharmaceutical disciplines, contributed<br />

<strong>and</strong> set up a truly interdisciplinary meeting<br />

of the highest st<strong>and</strong>ard. The meeting<br />

was accompanied by a comprehensive<br />

exhibition.<br />

The Scientific Programme<br />

Commitments to the 2009 event include<br />

40+ organisations. An exciting programme<br />

has been set up, which promises up-to-date<br />

presentations of front line pharmaceutical<br />

research <strong>and</strong> development. In addition to<br />

6–8 parallel Invited Speaker Sessions,<br />

over 400 abstracts have been submitted<br />

<strong>and</strong> processed for Short Communications<br />

<strong>and</strong> Posters. The preliminary programme<br />

is constantly updated – <strong>and</strong> there will<br />

be a final one available soon. For all<br />

information, consult the PharmSciFair<br />

Website at: www.pharmscifair.org<br />

The Careers Forum<br />

is there to provide an opportunity<br />

for companies, institutions <strong>and</strong> other<br />

organisations to meet with c<strong>and</strong>idates,<br />

<strong>and</strong> to interview them at PharmSci Fair.<br />

These opportunities will principally be<br />

of great interest to graduate students,<br />

<strong>and</strong> to those in the early stages of their<br />

professional careers in industry. It is<br />

anticipated that there will be opportunities<br />

available within a variety of scientific<br />

disciplines, including chemistry,<br />

biology, physics <strong>and</strong> informatics. Please<br />

visit the Careers Forum Website at:<br />

www.careersforum.org for details!<br />

The Exhibition<br />

will take place over three days - on the<br />

Tuesday, Wednesday <strong>and</strong> Thursday –<br />

<strong>and</strong> will once again feature key players<br />

from the European Pharmaceutical<br />

Industry <strong>and</strong> beyond, as well as leading<br />

international companies from the supply<br />

chain. There will also be a number of<br />

PharmSciFair Programme Providing<br />

Partner St<strong>and</strong>s. Poster sessions, with new<br />

posters each day, <strong>and</strong> catering places will<br />

be in the Exhibition area. For floor-plan<br />

<strong>and</strong> rates etc., access: www.healthlinksevents.co.uk/<br />

pharmsci2009.htm<br />

LXXVI<br />

The 2009 PharmSciFair Young<br />

Scientists Meeting<br />

will be organized as a pre-satellite meeting,<br />

by <strong>and</strong> for young scientists. It is open to<br />

our next generation of pharmaceutical<br />

scientists. PhD students <strong>and</strong> postdoctoral<br />

fellows will convene in Nice to exchange<br />

ideas <strong>and</strong> discuss the latest developments<br />

in pharmaceutical sciences. For progress<br />

<strong>and</strong> programme, visit the Website at:<br />

www.apgi.org/presatellitePharmSciFair/<br />

You should be there, of course.


<strong>EUFEPS</strong> Newsletter, 2010, vol. 19, issue 1<br />

Update from the<br />

President<br />

Clive G. Wilson, Professor<br />

<strong>EUFEPS</strong> President<br />

July 2010<br />

The European Federation for Pharmaceutical<br />

Sciences represents affiliated<br />

scientific societies in Europe <strong>and</strong> provides<br />

activities that nurture information<br />

exchange, training programmes <strong>and</strong><br />

scientific events for academia, industry<br />

<strong>and</strong> regulatory bodies.<br />

Time to celebrate<br />

The organisation celebrates its twentieth<br />

anniversary in <strong>2011</strong> <strong>and</strong> we will mark this<br />

important event with a yearbook, launched<br />

at PharmSciFair. <strong>EUFEPS</strong> strives to<br />

encourage participation – from individuals<br />

<strong>and</strong> from member organisations –<br />

that strengthens the progress to better <strong>and</strong><br />

safer medicines. This is achieved by many<br />

interactions at conferences, workshops<br />

<strong>and</strong> collaborative partnerships, <strong>and</strong> the<br />

exploration of common interests with<br />

other learned societies that are relevant to<br />

membership needs. At the time of printing,<br />

<strong>EUFEPS</strong> has 24 member societies in 24<br />

countries, including Israel <strong>and</strong> Turkey,<br />

fifteen European universities <strong>and</strong> research<br />

institutes <strong>and</strong> more than four hundred<br />

individual members.<br />

Networks <strong>and</strong> events<br />

An important engine for the <strong>EUFEPS</strong><br />

is the network structure, <strong>and</strong> you will<br />

be able to find further details in the<br />

upcoming yearbook or on the <strong>EUFEPS</strong><br />

Online site. The networks gradually<br />

evolve by crystallisation of interest <strong>and</strong><br />

are led by steering groups as shown<br />

in the plan. Currently there are five<br />

established networks <strong>and</strong> two more,<br />

regulatory sciences <strong>and</strong> nanomedicine,<br />

under development. The activities of<br />

both member societies <strong>and</strong> the network<br />

structures contribute to PharmSciFair, a<br />

celebration of European pharmaceutical<br />

sciences held on a biennial basis. The event<br />

hosts activities of the member societies <strong>and</strong><br />

the networks <strong>and</strong> has a strong programme<br />

for young scientists. In addition, <strong>EUFEPS</strong><br />

plays an important role in programmes<br />

organised by FIP, <strong>and</strong> cosponsors events<br />

such as the BBBB (Balaton-Baltic-Bled-<br />

Bosporus) conference series, helping to<br />

contribute to southern, eastern <strong>and</strong> central<br />

European activities. The European Journal<br />

for Pharmaceutical Sciences publishes<br />

<strong>EUFEPS</strong> conference reports, NewsLetter<br />

<strong>and</strong> announcements, keeping members up<br />

to date with new events.<br />

Current governance<br />

Instruments of policy <strong>and</strong> training, <strong>and</strong><br />

interaction with industry are taken care<br />

of by committee structures. Other events<br />

are held within the aegis of <strong>EUFEPS</strong>,<br />

directed by members with assistance of<br />

the executive committee. The Executive<br />

Committee meets on a quarterly basis <strong>and</strong><br />

Member Societies propose c<strong>and</strong>idates for<br />

election for a two-year term.<br />

Recently, the formation of a Senate<br />

structure was initiated. The Senate serves<br />

the president in generating ideas for<br />

strategic planning, monitoring the health<br />

of the organisations <strong>and</strong> other appropriate<br />

tasks. It provides access to a larger <strong>and</strong><br />

senior network, which can assist in<br />

creative solutions about the expansion of<br />

<strong>EUFEPS</strong>.<br />

Central Office<br />

The Headquarters of the <strong>EUFEPS</strong> has<br />

moved but is still based in the Stockholm<br />

area under the direction of the present<br />

Chief Executive Officer, Hans H.<br />

Linden. The federation was previously<br />

based within the Swedish Academy of<br />

Pharmaceutical Sciences, <strong>and</strong> strong<br />

links across Sc<strong>and</strong>inavia have continued.<br />

LXXVII<br />

<strong>EUFEPS</strong> Committee <strong>and</strong> Network<br />

Structure.<br />

New offices in the Veddesta Business<br />

Centre provide central coordination <strong>and</strong><br />

support of the networks <strong>and</strong> committees,<br />

<strong>and</strong> link into important European<br />

initiatives such as Innovative Medicine<br />

Initiative platform (IMI JU) under the 7th<br />

Framework Programme for Research <strong>and</strong><br />

Technological Development through the<br />

activity of the CEO.<br />

Going Forward<br />

<strong>EUFEPS</strong> is unique in that it is the only<br />

pan-European organisation that supports<br />

pharmaceutical/drug scientists, whatever<br />

the origin, domain or discipline. It is<br />

therefore a powerful rallying point<br />

that has the ambition to develop the<br />

professional status of the pharmaceutical<br />

scientist. This has yet to occur, but it will<br />

happen <strong>and</strong> it will stretch beyond the<br />

current constraints of pharmacy, which<br />

in some countries (especially my own)<br />

is failing as a scientific discipline. The<br />

pressures for the formation of such a body<br />

are strong, as pharmaceutical sciences are<br />

represented at every level of the medicines<br />

chain, from discovery in laboratories<br />

in industry <strong>and</strong> academia through to<br />

regulation <strong>and</strong> safety sciences. The<br />

backgrounds of our participants include<br />

biochemistry, pharmacy, physics <strong>and</strong><br />

engineering graduates <strong>and</strong> many others.<br />

The contribution that we can make is<br />

significant <strong>and</strong> well recognised but a stepchange<br />

in setting st<strong>and</strong>ards long overdue.<br />

Let’s make sure that we use the experience<br />

of <strong>EUFEPS</strong> to represent the ambitions of<br />

our members <strong>and</strong> member organisations<br />

to set pan-European st<strong>and</strong>ards of the<br />

highest order.


<strong>EUFEPS</strong> Newsletter, 2010, vol. 19, issue 1<br />

Alain Cuiné,<br />

Chair Organising Committee<br />

PharmSciFair is an important event in<br />

the European meetings calendar, <strong>and</strong> we<br />

are building the next one to attract always<br />

more people <strong>and</strong> especially more industrial<br />

interest. The two first events were in Nice,<br />

France, <strong>and</strong> we have decided to move<br />

towards Eastern Europe with the objective<br />

to encourage flow of information across<br />

the member societies <strong>and</strong> professions in<br />

this fast growing part of the world. The<br />

provision of a scientific venue to new,<br />

younger scientists assisting in career<br />

development will be also vigorously<br />

addressed.<br />

The Opening Session will take place<br />

in the afternoon of Monday, June 13, <strong>2011</strong>.<br />

A prestigious group of influential leaders<br />

will contribute to a common vision of<br />

pharmaceutical sciences, in both the short<br />

<strong>and</strong> the long term.<br />

The pharmaceutical science as a<br />

multifaceted concept will be reflected in<br />

the program of this event, which will be<br />

wide ranging in terms of content, activities<br />

<strong>and</strong> participating partners. Exhibition<br />

<strong>and</strong> networking opportunities will be<br />

promoted. These are the tracks that are<br />

planned <strong>and</strong> tentative programme flow.<br />

The First Announcement including<br />

session topics, keywords <strong>and</strong> deadlines<br />

will be circulated before the summer, but<br />

we already urge you all to participate in<br />

the <strong>2011</strong> PharmSciFair <strong>and</strong> to invite your<br />

colleagues to do so as well!<br />

Prague Congress Center, June 13–17, <strong>2011</strong><br />

LXXVIII


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