2011 Anniversary Yearbook - EUFEPS today and history
2011 Anniversary Yearbook - EUFEPS today and history
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 />
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<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 />
Fax:(+33) 01.77.72.27.59<br />
269 S. Beverly Drive,<br />
E-mail:<br />
Suite 630<br />
Email :contact@osc-edition.c<br />
E-mail: contact@osc-edition.com<br />
Beverly Hills, California 90212<br />
Web:<br />
U.S.A.<br />
Web :www.osc-edition.com<br />
Web: www.osc-edition.com<br />
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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