Safety Sciences - EUFEPS

7.3 Appendix 3: List of participants (1-2)
EUFEPS Workshop II
on
Safety Sciences
July 2-3, 2007, Austrian Academy of Sciences, Vienna, Austria
“Development and implementation of European Education and Training Programmes”
List of Participants
Jeffrey Atkinson University of Nancy FRANCE
Rolf Bass GERMANY
Barbara Bennani University of Vienna AUSTRIA
Ursula Berndt University of Vienna AUSTRIA
Ole J Bjerrum University of Copenhagen DENMARK
John Caldwell University UNITED KINGDOM
Daan JA Crommelin Top Institute Pharma THE NETHERLANDS
Lennart Dencker University of Uppsala SWEDEN
Daniel R Dietrich Universität Konstanz GERMANY
Jörgen Dirach Novo Nordisk A/S DENMARK
Mehrdad Dirin University of Vienna AUSTRIA
Heidi Foth University of Halle GERMANY
Helmut Gadner Austrian Academy of Sciences AUSTRIA
Yvonne Gaspar Federal Ministry of Health AUSTRIA
Theodor W Guentert F Hoffmann-La Roche Ltd SWITZERLAND
Oskar Hoffmann University of Vienna AUSTRIA
Hannelore Kopelent University of Vienna AUSTRIA
Thekla Korodi University of Vienna AUSTRIA
Hans Kroath Austrian Research Centers GmbH AUSTRIA
Bodo Lachmann University of Vienna AUSTRIA
Rosa Lemmens-Gruber University of Vienna AUSTRIA
Hans H Lindén EUFEPS SWEDEN
Carole Moquin-Pattey European Science Foundation FRANCE
Eva-Maria Muchitsch University of Vienna AUSTRIA
Winfried Neuhaus University of Vienna AUSTRIA
Christian R Noe University of Vienna AUSTRIA
Dominique Parent Massin University of Brest FRANCE
Wolfram Parzefall Medical University of Vienna AUSTRIA
Sergio Peano Merck Serono ITALY
Friedlieb Pfannkuch F Hoffmann - La Roche SWITZERLAND
Ivo Schmerold Veterinary University of Vienna AUSTRIA
Hans J Schuitmaker Top Institute Pharma THE NETHERLANDS
Rolf Schulte-Hermann University of Vienna AUSTRIA
Inge Schuster University of Vienna AUSTRIA
Thomas Singer F Hoffmann-La Roche AG SWITZERLAND
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Per Spindler University of Copenhagen DENMARK
Helmut Sterz Pfizer FRANCE
Martina Stressl University of Vienna AUSTRIA
Polonca Trebse University of Nova Gorica SLOVENIA
Paul Trennery GlaxoSmithKline UNITED KINGDOM
Ernst Urban University of Vienna AUSTRIA
Karl-Heinz Wagner University of Vienna AUSTRIA
Bob van de Water Leiden University THE NETHERLANDS
Nico PE Vermeulen Vrije Universiteit THE NETHERLANDS
Silvio Wuschko Austrian Research Centers GmbH AUSTRIA
Kirsi Vähäkangas University of Kuopio FINLAND
Michael Zwitkovits University of Vienna AUSTRIA
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7.4 Appendix 4: Bibliographies
Biography
Jeffrey Atkinson
After gaining my BA, MA, and PhD degrees in Cambridge, England, my first post was as
assistant professor at the University of California at Davis in the physiology department. I then
went to the Mario Negri Pharmacology Institute in Milan and after that headed the pharmacology
department of the Nestlé company in Lausanne, Switzerland. From there, I moved to the Medical
Faculty of Lausanne University where I taught pharmacology and therapeutics for over 10 years.
I moved to my present position at the Pharmacy Faculty in Nancy, France in 1986. In addition to
my undergraduate teaching in pharmacology, I run a one-year postgraduate course on preclinical
drug evaluation in collaboration with the pharmaceutical industries of France, Switzerland, the
UK, Germany, Belgium and Australia.
My research is on age-related changes in vascular biology and I have published well over a
120 major papers and some 50 books, book chapters and reviews in the area. I acted and act
as consensus group member and panel evaluator for the EU framework programmes (major
diseases) of the DG “Research” of the EC. I am a member of the French drug evaluation and
pharmaco-vigilance agencies. I am external advisor for several EU and other universities and
have acted as an expert for several national research funding agencies.
I have run and been part of many EU programmes both in research (EURECA - the EU
intracellular calcium project, for example) and teaching. I ran the European School of Preclinical
Pharmacology in Pont-à-Mousson, France in the fifth EU framework.
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Biography
Rolf Bass
Rolf Bass is a native of Germany and was born in Berlin in 1941. He is married to Gisela Bass
and they have three children: Miriam Julia, Jan Christopher and Nina Charlotte, now attending
University.
Rolf Bass has been chosen by the Polish Government to lead an EU-“Twinning project”,
whereby the Polish drug regulatory authority will receive support and training to achieve
EU-Standard Performance, (i.e. the fulfillment of the acquis communautaire in the field of
pharmaceuticals for human and veterinary use). In October 2003 Rolf Bass set up office in
Warsaw at the Polish Office for Medicinal Products, Medical Devices and Biocides (URPL).
He now resides in Warsaw and executes an ambitious BfArM/PEI/BVL/”Laender” – URPL
cooperation programme; over 50 experts from Germany will come to Poland until mid 2005 to
strengthen the Polish Office and other institutions attached to the Ministry of Health in the areas
of inspection (GMP/GCP), assessment of dossiers, update of previous marketing authorizations,
pharmacovigilance, and IT – also reviewing the suitability of URPL structure to fulfill its
European tasks.
Rolf Bass qualified as physician in 1967 and holds a medical degree (Dr. med.) from the
Free University of Berlin. Following postdoctoral work for three years at The Johns Hopkins
University, School of Medicine – Dept. of Physiological Chemistry with Prof. Albert L.
Lehninger in Baltimore, Maryland, United States he did research for ten years at the Dept. of
Toxicology and Prenatal Pharmacology of the Free University with Prof. Diether Neubert, where
he received the venia legendi (Privat-Dozent) for Experimental and Clinical Pharmacology
and Toxicology in 1979 and where he was appointed Adjunct Professor (Außerplanmäßiger
Professor) in 1984. He has published more than 170 papers in journals, periodicals and
books on pharmacological, toxicological and regulatory affairs issues and regularly teaches
medical students. He has been on the editorial boards of Toxicology Letters (until 1993) and
Pharmacoepidemiology (since 1992). He was on the Board of the European Teratology Society
(1979 – 1984) and received a reward on animal protection from the Swiss Federal Technical
University (ETH) in Zürich. In 1998 Rolf Bass was awarded an honorary degree (FFPM
hon) from the Faculty of Pharmaceutical Medicine of the three Royal Colleges of Medicine
(Edinburgh, Glasgow and London) of the UK.
Professional career:
Following university career in pharmacology, toxicology and clinical pharmacology and
focussing on research in prenatal toxicology / transplacental carcinogenesis, Rolf Bass in 1979
joined the German Health Authority (BGA) as Head of the Pre-Clinical Unit at its Drug Institute.
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He became Chairman of CPMP´s Safety Working Party in 1984 where he was in charge of the
pre-clinical ICH programme; he created the tripartite ICH guideline on „Testing for Reproductive
Toxicity“. This and a full set of toxicological guidelines were developed and implemented under
his leadership. He was in charge of development of risk assessment, risk benefit procedures, and
assessment. He was responsible for the formaldehyde risk/benefit report of the BGA.
From 1995 to 2000 he was Head of the Human Medicines Evaluation Unit at the EMEA in
London. He was responsible for the development and the running of the EMEA business
concerning medicines for human use including herbal medicinal products. This comprised
both pre-approval aspects (scientific advice, regulatory affairs, CPMP Secretariat, European
Commission and ICH liaison), and post-marketing issues (pharmacovigilance, variations and
extensions, and renewals) as well as external contacts (the press, trade associations, health
professionals and patient associations, and giving support to the preparation of designated
Central and Eastern European Countries Drug Regulatory Authorities (CADREAC) for accession
of their countries to the European Union). Following his departure re-structuring activities at the
EMEA have split the human medicines business into two operational Units.
Following his return to Germany Rolf Bass was first given the task of managing the
„Nachzulassung“ (re-registration) of all „old“ medicines to be scrutinised for their adherence to
EU-standards, a procedural and scientific/technical evaluation process prompted by intervention
of the European Commission, before being appointed member to the CPMP by the German
Federal Ministry for Health. In August 2000 Rolf Bass was asked to set up the new Department
for European and International Business as part of a re-structuring exercise of the Federal
Institute for Drugs and Medical Devices (BfArM) and its re-location from Berlin to Bonn. As
Head of this Division; he served as German delegate to the CPMP at the EMEA in London until
his move to Warsaw.
Biography
Ursula Berndt
Born: 1979 in Vöcklabruck/ Upper Austria
1997: School Leaving Examination in Vöcklabruck
1997-2003: Study pharmacy at the University in Vienna
2003: Diploma Thesis at the King’s College in London: “Characterisation of Iron Chelating
Dendrimers by MALDI-TOF MS”
2004: Complete the study of pharmacy.
Since 2005: PhD at the University in Vienna (Department of Medicinal an Pharmaceutical
Chemistry) in cooperation with the Austrian Research Centres in Seibersdorf: “Synthesis and
Evaluation of a [ 18 F]Fluorobenzothiazole as potential Amyloid Imaging Agent”.
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Biography
Ole J. Bjerrum
After finishing his medical internship, Ole J. Bjerrum (MD, DMSc) became associated with the
Protein Laboratory at the Medical Faculty, University of Copenhagen as Assistant Professor
(1970-1974), and as Associate Professor (1974-1987). In the period he served five years as
director of the laboratory. Further to this Ole J. Bjerrum has 14 years of industrial experience at
Novo Nordisk, first as Director of Biolabs (a diagnostic unit), and after that as senior principal
scientist at Bioscience (working with various aspects of drug discovery, including HTS), and
lately as liaison officer between the company and academia and national and international
research organisations. In the period 1989-99 he was Adjunct professor in Immunotechnology at
the Technical University of Denmark.
From August 1, 2001, he is Professor in Pharmacology at the Danish University of
Pharmaceutical Sciences, from 2007 University of Copenhagen. Scientifically Ole J. Bjerrum
has been engaged in the analysis and characterisation of membrane receptors and transporters,
employing electrophoresis and immunotechnology tools (thesis 1977). Lately, his interest has
been in in vitro and in vivo pharmacology aspects of chronic pain conditions. His publication list
covers 3 books and more than 135 peer reviewed scientific papers. Ole J. Bjerrum is a fellow of
the Danish Academies of Technical Sciences and Natural Sciences, respectively. He served as
member of the Danish Medical Research Council and of the European Science and Technology
Assembly, as well as of the EU Commission 4 th and 5 th Framework Programme Committee on
Biotechnology and Quality of Life, respectively. In addition, he was co-founder of the Centre for
Proteome Analysis, University of Southern Denmark, where he was associated to the Centre as
Adjunct professor 1999 - 2004.
In 1998, Ole J. Bjerrum joined the EUFEPS Committee on Industrial Relations (CIR). In 1999
he became member of the Executive Committee and served from 2000 as President-elect, from
2003 as President and from 2005 as Immediate past-president. He has taken an interest the
promotion of the pharmaceutical sciences in Europe, among other initiatives through formulation
of the theme: New Safe Medicines Faster. An initiative which has had significant impact on the
EU 6 th Framework Programme for 2003-2007 and which paved the way for the Joint Technology
Initiative: Innovative Medicines in the 7 th Framework Programme.
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Biography
John Caldwell
Professor Caldwell is Dean of the Faculty of Medicine and Pro-Vice-Chancellor in the
University of Liverpool, England, where he has worked since 2002. He was educated in
London, graduating in pharmacy from Chelsea College and then obtained his Ph.D. with
Professor Tecwyn Williams at St Mary’s Hospital Medical School. He held academic positions
at St Mary’s Hospital Medical School from 1972 and was its Dean from 1995-1997. Following
merger with Imperial College, he became of Head the Division of Biomedical Sciences (1997-
2002) and Head of Undergraduate Medicine (2000-2002) in the Imperial College Faculty of
Medicine. He was President of the International Society for the Study of Xenobiotics in 1994-
95, Sterling-Winthrop Distinguished Professor at the University of Michigan Medical Center
(1995), and in 1998 was elected an Honorary Member of the Royal College of Physicians of
London. He sits on numerous national and international government and industrial advisory
committees, including the U.K. Committee on Safety of Medicines and has in the past advised
the UK government and WHO on aspects of food safety. Professor Caldwell is European Editor
and founder of the journal Chirality (1989) and a past or present member of 17 other Editorial
Boards. He is member of 20 national and international scientific societies and is a past or present
office holder in 8. Since 1971, he has authored or co-authored over 500 publications on drug
metabolism, including some 270 full papers and invited contributions and ten edited books. His
special areas of interest include pharmacogenetics, structure-metabolism relationships, metabolic
mechanisms of toxicity and the integration of drug metabolism into the drug development
process.
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Biography
Daan JA Crommelin, PhD
Prof. Daan Crommmelin is presently scientific director of the Dutch Top Institute Pharma in
Leiden. He is also professor at the Department of Pharmaceutics at Utrecht University. He is
adjunct professor at the Department of Pharmaceutics and Pharmaceutical Chemistry at the
University of Utah. Crommelin is co-founder and chair of the scientific advisory board of
OctoPlus, a Leiden based company specialized in the development of pharmaceutical product
formulations and advanced drug delivery systems. He published extensively and is on the
editorial board of 10 peer reviewed journals in the pharmaceutical sciences. He presently chairs
the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (F.I.P.) and
was chair of the organizing committee of the Pharmaceutical Sciences World Conference 2007
in Amsterdam. He is president elect of the European Federation of Pharmaceutical Sciences
(EUFEPS).
Biography
Lennart Dencker
DVM in Stockholm1970, PhD in Toxicology at Uppsala university 1976, postdoc at NIH,
Bethesda, Maryland 1979-1980.
After that, he has worked at Uppsala university, as Professor and Chairman, Dept.of Toxicology
from 1976, Chairman at the Department of Pharmaceutical Biosciences from
1993 and as a Dean at the Faculty of Pharmacy 1999-2005.
As to traning in the pharmaceutical field, he has among others served on the board of
the ULLA Consortium 1999-2005.
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Biography
Daniel R Dietrich
Date of birth July 27, 1959
Citizen of Zurich, Switzerland
Profession Registered Toxicologist (Dr. nat. sci., ETH)
Languages German, English, French, Italian & Spanish
Jan. 1996 - 2007 Professor of Toxicology, Head of the Environmental
Toxicology Research Group, University of Konstanz,
Germany. Adjunct Professor of Toxicology, Department of
Environmental and Occupational Health, Graduate
School of Public Health, University of Pittsburgh, USA
Adjunct Associate Professor, Swiss Federal Institute of
Technology (ETH), Zurich, Switzerland
May 1995 – Dec. 1995 Visiting Associate Professor at the University of Pittsburgh,
Department of Environmental and Occupational Health and
Toxicology, Graduate School of Public Health.
September 1994 Venia Legendi in Toxicology at the Swiss Federal Institute of
Technology (ETH Zurich), Switzerland: „Alpha2u-Globulin:
Species and sex specific protein synthesis and excretion and its
association with chemically induced renal toxicity and neoplasia in
the male rat, and its relevance in conjunction with human cancer
risk assessment.“
Nov. 1989 – July 1991 Post-doctoral fellow. The University of North Carolina
Department of Pathology, Program of Molecular
Carcinogenesis and Mutagenesis, Head J.A. Swenberg
D.V.M., Ph.D.
Nov. 1985 – Oct. 1988 Ph.D. – thesis and work as scientific assistant at the Institute of
Toxicology, Zurich, Switzerland.
Ph.D.-thesis: Aluminum toxicity to salmonids at low pH.“
Registered Board Member
Swiss Board of Toxicologists / EUROTOX Registered Toxicologist / Fellow of the Academy of
Toxicological Sciences
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Biography
Jörgen Dirach
Jorgen Dirach, MD, MBA (Henley), is Director at Corporate Research Affairs at Novo Nordisk
A/S in Copenhagen, Denmark. Dr. Dirach has worked as a physician at hospitals and thereafter
done clinical development project and portfolio management in the pharmaceutical industry for
20 years.
• Honorary member of the Danish Society for Good Clinical Practice, which he started in 1988
and served as Chairman for 1988 to 1996.
• Fellow of the Faculty of Pharmaceutical Physicians (UK)
• Chairman of the Section on Medicines Development under the auspices of the European
Federation of Biotechnology (EFB) www.nsmf.org.
• Member of the EUFEPS Committee for Industry Research Relations (CIRR).
• Serves at a number of committees for EFPIA, EBE and EuropaBio and is involved in the
planning of the European Technology Platform: Innovative Medicines being responsible for
the education and training part of the programme.
Dr. Dirach has authored publications and delivered lectures on clinical research methodology,
pharmacokinetics, good clinical practice (GCP), drug development, multi project management
and quality management.
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Biography
Heidi Foth
Heidi Foth, Professor Dr., Director of the Institute for Environmental Toxicology, Martin Luther
University, Halle/Saale, Germany. Professor Foth is toxicologist (Fachtoxikologe DGPT) and
European registered Toxicologist.
Her educations include Dental Medicine 1976-1981, a post-doctoral fellowship in Pharmacology
and Toxicology (1981-1985). She was research fellow in Toxicology at the Institute 1985-1991.
Achieved habilitation (venia legendi) in „Basic Pharmacology and Toxicology“(12/91), became
associate Professor 1992-1995 and full professor in environmental toxicology 1995 and Director
of the Institute.
National activities as Commissions (member) comprises Committee on Drug Safety (Federal
Institute for Drugs and Medical Devices BfArm, Commission A (drugs), Commission D
(hemeopathic drugs), expert committee drug therapy in children), advisory committee on
intoxication and chemical safety (Federal Institute for Risk Assessement BfR), German Advisory
Council on the Environment (SRU of the Federal Republic of Germany,) and advisory committee
on chemicals (BUA, GDCh). Heidi Foth is President (2004-2009) of German Society of
Toxicology, President (2005) of German Society for Experimental and Clinical Pharmacology
and Toxicology and former member of the executive committee of the European Societies of
Toxicology (1999-2005), EUROTOX (member of EC, chair of SC Education, 2004 - 2006).
Professional experience concerns metabolism of tobacco smoke constituents, kinetics of
amide type local anesthetics in lung and heart, kinetics and metabolism of cytostatics drugs
(fluorinated pyrimidines), activity and regulation of ABC transporters of the MDR and MRP
family in lung, clinical toxicology (University of Göttingen, service unit clinical toxicology
analyses and advising), environmental health (University of Halle, Universitätszentrum
Umweltwissenschaften).
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Biography
Yvonne Gaspar
Akad. Grad: Mag.pharm.
Funktion: Arzneibuchkommissionsmitglied,
National authority for Pharmacopoeia of Austria
AUSBILDUNG
1968 bis 1/1975 Studium der Pharmazie; Werbung und Marketing Teilstudium.
Während des Studiums Praxis im Arzneimittelgroßhandel (Fa. Hestag)
und in einem Galvanisierungslabor (Fa. Oxymetal
finishing)
1975 bis 1978 Tätigkeit als vertretungsberechtigte Apothekerin in öffentl. Apotheken
und Anstaltsapotheken (Wilhelminenspital, Rudolfstiftung)
1978 bis 1981 Firma Immuno (Qualitätskontrolle, Registrierung)
1981 bis 1982 Tätigkeit als vertretungsberechtigte Apothekerin in öffentl. Apotheken in
Wien
1982 bis 1996 Amtssachverständige für Arzneimittelkontrolle in Bundesanstalt für
chem.und pharm. Untersuchungen, Apothekenvisitatorin im gesamten
Bundesgebiet
1985 Ausbildung zur Strahlenschutzbeauftragten im Forschungszentrum
Seibersdorf
28. 4. 1992 Kommissionelle Anhörung nach § 4 Abs 2 Sachverständigen- u.
Dolmetschergesetz
ab 1992 (16.9.) Eintragung beim Handelsgericht Wien als allgem. beeidete gerichtl.
zertifizierte Sachverständige für pharm. Chemie
(Apothekerwaren, Kosmetika, Drogen)
1.10.1996 bis Bundesministerium für Gesundheit und Konsumentenschutz
18.5.1999 (dzt. BMSG) als stellvertretende Abteilungsleiterin in der
Suchtmittelüberwachungsstelle
1996-2000 Absolvierung des EU-Curriculums in der Bundesverwaltungsakademie
ab 19.5.1999 Bundesministerium f. Arbeit, Gesundheit u. Soziales, Tätigkeit als
Inspektorin für pharmazeutische Betriebe im gesamten Bundesgebiet
ab 1.6.2006 Arzneibuchkommissionsmitglied, National authority für Pharmacopoeia
of Austria, Vertreterin Österreichs beim EDQM (European Directorate for
the Quality of Medicines), Council of Europe, European Pharmacopoeia
Commission, ÖAB Expertengruppe (Österreichisches Arzneibuch).
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Biography
Theodor W Guentert
Prof. Dr. Theodor W. Guentert is today a member of Roche’s Global Non-clinical Drug Safety
group and is responsible here for strategies in the areas of in-licensing, early safety, safety
biomarkers. Prior to this he held the positions of Head of Non-Clinical Drug Development,
Head of Non-clinical Drug Safety – both also in the Research Department - and Associate
Clinical Pharmacology Area Head in the Clinical Research Department in the same company.
These exposures to pre-clinical and clinical development questions provided him with a broad
experience in pharmaceutical drug development.
Dr. Guentert is a pharmacist by training and received his Ph.D. in Pharmaceutical Chemistry
from the University in Basel. During a three-year post-doctoral stay with Prof. S. Riegelman
at the Medical Center in San Francisco he studied the pharmacokinetics and -dynamics of
antiarrhythmics in animal and man. He returned 1980 to the School of Pharmacy in Basel to head
a research team in analytical methodology and drug metabolism. In 1981 he joined F. Hoffmann-
La Roche Ltd. to pursue studies in pharmacokinetics/ biopharmaceutics and is today recognized
as a Scientific Expert in non-clinical and clinical pharmacokinetics. He is certified as a Clinical
Pharmacologist by the Swiss Society of Clinical Pharmacology. His special interests are PK/
PD modeling and simulations to optimize drug development programs. While holding a venia
docendi since 1981,
Dr. Guentert was appointed Associate Professor of Pharmacy at the University of Basel in 1992
and today teaches regularly at the Universities of Basel and Leiden (Holland) [Biopharmaceutics/Pharmacokinetics,
Drug Metabolism, Analytics] and at international courses in
pharmacokinetics. He is a co-author of the multi-media based teaching software RIDO, Right
Dose First Time, developed through sponsorship of the ECPM.
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Biography
Hans Kroath
Dr. Hans Kroath is Head of the Division of Life Sciences at Austrian Research Centers – ARC,
Austria`s largest non-university research institution. ARC Life Sciences comprises departments
of toxicology, chemical analytics, and molecular diagnostics. Major research topics are drug &
chemicals safety, proteomics, and diagnostic biochips.
Trained as a chemist at the University of Graz, Hans Kroath was postdoctoral fellow at the
University of Würzburg, Germany, and the Roche Institute of Molecular Biology in Nutley,
USA, and later headed biotechnology research at Chemie Linz, now part of DSM. Since 1990,
he has held senior management positions within Life Sciences and Environmental Sciences
divisions at ARC.
Hans Kroath holds several patents in biotechnology and is a former Board member of the
Austrian Society for Biotechnology. He also served as President of former ENERO (European
Network of Environmental Research Organisations).
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Biography
Rosa Lemmens-Gruber
Education:
1960-1964 Primary School in Gablitz (Lower Austria)
1972-1972 Grammar School in Vienna (Wirtschaftskundliches Realgymnasium der
Dominikannerinnen, Schloßberggasse 17, 1130 Wien)
1978-1978 Study of Pharmacy at the University of Vienna
1979.1979.1979 Master Degree (Mag. pharm.)
1981-1981 PhD student (Supervisor: o.Univ.Prof. Dr. P. Heistracher)
1981.1981.1981 PhD awarded (Dr. rer. nat.)
1.1.-31.3.1987 PostDoc at Department of Physiology of KULeuven/Belgium (Prof.
Carmeliet), funded by a fellowship of the Austrian Ministry of Science
and Research
1.9.1988-31.8.1989 PostDoc at Department of Physiology of KULeuven/Belgium (Prof.
Carmeliet), funded by an “Erwin Schrödinger Auslandsstipendium”
(JO300M) of the FWF
Profession:
Since 1.1.1979 University Assistant at the Department of Pharmacology and Toxicology at
the University of Vienna, since 1991 half position
1992 Assistant Professor
1996.1996.1996 Habilitation (Pharmacology and Toxicology, Assoc.Prof.)
1.1.2000-31.3.2003 Temporary Head of the Department
Reviewer:
Cardiovascular Research
Archives of Biochemistry and Biophysics
Chemical Research in Toxicology
British Journal of Pharmacology
Toxicology Letters
Pharmacological Research
Annals of Nutrition and Metabolism
Scientia Pharmaceutica
Grants:
FWF: JO300M
P14507-PHA
P16045-B05
P17089-B11
Hochschuljubiläumsstiftung der Stadt Wien: H-38/2000
H-630/2003
HERBA-Prize: 1990
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Biography
Hans H Lindén
Hans H. Lindén obtained his pharmaceutical degree in 1971, at the Faculty of Pharmacy
of the University of Uppsala, Sweden. During the last two years at the Faculty he was also
Assistant Lecturer as well as Assistant Secretary of the Faculty Board of Education. He joined
the Swedish Pharmaceutical Society in 1971. From 1971 to 1986 Hans H. Lindén was Head
of the Department of Educational Programmes of the Society. His responsibilities included
books, tapes, videos, courses, seminars, work-shops, conferences, congresses, symposia and
other educational and training activities in both basic and applied pharmaceutical sciences, drug
distribution and information, industrial and other drug research and development, drug control
etc., designed for pharmacists and pharmaceutical scientists, but also for physicians and nurses.
He was actively involved in Third world Training Programmes on Quality Assurance in Drug
Manufacturing, developed and/or administered by the Society, for the Swedish Government,
in the beginning of the eighties. From 1986 through 1991 Hans H. Lindén was Head of the
Department of Studies and Analysis and Deputy Managing Director of the Society. He then
was engaged in research projects on patient drug information, and on public risk perception of
medicines. Hans H. Lindén was also one of the initiators of the Drug Information Section of the
Swedish Pharmaceutical Society in 1979. From then on through 1989 he served as Secretary,
Vice President and President of the Section, respectively.
In 1980, Hans H. Lindén, parallel to his responsibilities within the Pharmaceutical Society
and the Academy of Pharmaceutical Sciences, was appointed Secretary General of the Swedish
Medicines Information & Communications Council (Läkemedelsinformationsrådet, LIR),
established the same year, a position held for 16 years. In the mid nineties, the activities of the
Council were transferred to other bodies and agencies, due to growing European collaboration in
this field.
During the last years with the Council he chaired a working party on standardisation of patient
cards and related information carriers, a role which was soon expanded into leadership of a 20 plus
members investigation committee on the use of smart cards and IT security for the public sector in
Sweden. Several reports were produced, in a few years, for the Government Top Leaders’ Forum
and the Swedish County Council. Parallel to this, Hans H. Lindén became engaged (part-time) in
the European Federation for Pharmaceutical Sciences (EUFEPS), in 1994, as Assistant Secretary-
General. A few years later, this engagement was transformed into a full-time position. In 2001,
Hans H. Lindén assumed the position as Secretary-General of EUFEPS, chairing the EUFEPS
Secretariat. In 2002, this title was exchanged for Executive Director, a position he still holds.
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Biography
Carole Moquin-Pattey
Carole Moquin-Pattey, Pharmaceutical Doctor (major in Industry) and PhD in
Pharmacochemistry, was appointed in January 2005 as Head of Unit for the European Medical
Research Councils (EMRC) at the European Science Foundation (ESF).
Until December 2004, she was the Director of the Department of Scientific Strategies and
Partnering (DAPS) at Inserm (National Institute of Health and Medical Research) in Paris
– France, for the past three years in charge of:
• partnering with pharmaceutical or biotech companies, public or private pension funds and
health insurance companies, private foundations/associations, as well as with other national
or supranational research institutes for public health, more particularly in Europe, in the
perspective of leveraging Inserm’s own resources along its key scientific strategies,
• creating a Clinical Research Unit and launching National Scientific Programs to actively
promote the transfer from basic research to public health research.
Prior to her position at Inserm, Carole Moquin-Pattey was Scientific Director of Fondation
pour la Recherche Médicale (FRM), a French private foundation, and had various assignments
in pharmaceutical and biotech companies, in France and in the USA, more specifically with
Boehringer Mannheim (Rueil-Malmaison, France), as Coordinator of Clinical Trials, and with
Enzon Inc. (New Jersey, USA) as Research Scientist in charge of FDA New Drug Applications’
filing for rare diseases. This last assignment followed a three-year post-doctoral research period
within the Department of Chemistry at Columbia University (New York, USA), and ended up
a ten-year period of living/working overseas (Australia, Indonesia, and the USA, six years).
In addition to acquiring a global vision, this experience was also geared to the research and
development of new therapeutics and diagnosis tools, while fostering both innovation and the
mastering of the various regulations in an International environment.
Carole Moquin-Pattey was until February 2007 a member of the French National Consultative
Bioethics Committee for Health and Life Science.
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Biography
Eva-Maria Muchitsch
Eva-Maria studied Veterinary Medicine at the University of Veterinary Medicine in Vienna,
Austria and started her career in a veterinary laboratory for poultry diseases.
She joined the pharmaceutical industry 1994 as laboratory supervisor at Baxter (former Immuno
AG) and became 1998 Manager of the Department of Pharmacology. Eva-Maria was promoted
as Director of Experimental Pharmacology/ Transgenic Animals in 2002 and subsequently as
Director of Pharmacology/ Toxicology/ Preclinicals including the Departments of Histology and
Pathology.
During her work at Baxter she specialized in Veterinary Pharmacology and Toxicology and was
appointed as specialist (“Fachtierärztin für Pharmakologie und Toxikologie”) in 2001 by the
Chamber of Austrian´s Veterinarians.
Since her habilitation in 2004 she is also giving lectures at the University of Veterinary Medicine
in Vienna in Pharmacology and Toxicology and was recently appointed as Visiting Professor for
Safety Science at the Department of Pharmaceutical/Medicinal Chemistry at the University of
Vienna.
Her research focus is on preclinical development of biopharmaceuticals.
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Biography
Christian R Noe
Christian R. Noe is Ordinarius (full professor) of Pharmaceutical (Medicinal) Chemistry and is
Dean (2001 – present) of the Faculty of Life Sciences of the University of Vienna. He studied
chemistry at the Vienna University of Technology (degrees of “Diplomingenieur” in 1970 and
“Doctor of Technological Sciences under the auspices of the President of the Republic” in
1972). In addition, he studied pharmacy at the University of Vienna (degree of “Magister der
Pharmazie” in 1979). He carried out his post-doctoral research with Albert Eschenmoser at the
ETH Zürich and received his “Habilitation” from the Vienna University of Technology in 1982.
He was awarded the “Ernst Späth Preis” of the Austrian Academy of Sciences in 1991. He was
appointed C4-Professor of Pharmaceutical Chemistry at the Johann Wolfgang Goethe-University
Frankfurt in 1991 and was Managing Director of the Institute of Pharmaceutical Chemistry up
to his his appointment to the University of Vienna in 1999. In addition, he had the privilege
to be Head of the “Christian Doppler Laboratory of Chemistry of Chiral Compounds” (first in
Vienna, then in Frankfurt) from 1989 - 1995. During his time in Frankfurt he was Founder and
Speaker of the DFG-Graduate School “Drugs: Design and Quality Assurance” and Dean of
the Faculty (Fachbereich) of Biochemistry, Pharmacy and Food Chemistry (1996-1997). He is
corresponding Member of the Austrian Academy of Sciences, Chairman of the Scientific Board
for Life Sciences of the Austrian Research Center (ARC Seibersdorf) and Austrian delegate to
the Pharmakopoeia Commission.
The research interests of Professor Noe include the search for new drugs acting at the central
nervous system (NMDA-receptor ligands, polyamine function, blood-brain-barrier models).
„Antisense“-oligonucleotides, siRNA and proteome analysis of human uterus and cancer cells
are elements of genome and proteome based drug research. Glycoproteins constitute the most
challenging part of analytical projects.
The consulting experience of Professor Noe includes many years of expert work for
UNIDO (United Nations Industrial Development Organization) in the fields of chemical and
pharmaceutical industry. He is also founder of the “Summer Academy for Pharmacists” of the
Austrian Chamber of Pharmacists in Pörtschach/Austria.
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Biography
Dominique Parent Massin
Dominique PARENT-MASSIN Docteur d’état es Sciences (Toxicology)
Professor of University in Food Toxicology
Head of the laboratory of Food Toxicology
Expert of the French Agency of Food Safety
Nationality French
Education Docteur d’etat es Sciences (Toxicology) 1995
PhD Cytology 1978
Maîtrise Génétique 1974
DUES Biology Chemistry 1972
DU Immunopathology 1990
Other Training DU Nutrithérapie 1992
Food toxicology postgraduate (ADITEC) 1990
DER Human Biology 1984
Membership of professionnal
societies
Employement records and
Task Assigned
Certificate of Human Pathology 1984
French society of Toxicology (General Secretary)
French society of cellular Pharmacotoxicology
Eurotox
1999-2002 Professor of Food Toxicology
University of Bretagne Occidentale (Brest)
1988-1999 Research assistant (assistant Professor)
University of Bretagne Occidentale (Brest)
1978-1988 Research assistant
University Hospital (Brest)
1975-1978 Research assistant (assistant Professor)
University Paris VI
Extra mural activities
International Committees European Food Safety Authority
Invited expert in Working group Food Additives
2003-2006
Scientific Committee of Food
Invited expert in Working group Food Additives 2001,
Rapporteur of ”Neotame” dossier
Invited expert in Working group Contaminant –2001
(fusarium toxins)
National Committees Chairman of Experts Committee for Food Additives
French Agency of Food Safety (Afssa) 2000-2003, 2003-2006
Chairman of working Group (ad hoc) ”Neotame”
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French Agency of Food Safety (Afssa) 2000
Rapporteur of ”Neotame” dossier for Afssa
Chairman of working group (ad doc) ”Risk and benefit
biological agriculture, food safety”French Agency of Food
Safety (Afssa) 2000
Superior Council for Public Health of France
Working Group Food Additives 1993-2000
Working Group Biotechnology 1997-2000
French Commission of Pesticides 1997-2002
Working Group Formulation 1997-2001
Working Group Risk for Human 2001
Accreditation European register of Toxicologist
Research interests lie within field of food toxicology and risk assessment. Specific areas
of current research include effect of xenobiotics on hematopoiesis using in vitro models,
mycotoxins toxicity, Food contaminant and organic food
Biography
Wofram Parzefall
FIELDS OF RESEARCH ACTIVITY
Effects and mechanisms of tumor promoters on organ growth and
enzyme induction in the liver. Inflammation and hepatocarcinogenesis.
Toxicological testing of chemicals for cytotoxic and carcinogenic
potential (see attached list of publications).
1967 - 1971 University education in Food Chemistry and Pharmacy
1) at the Institute of Pharmacy and Food Chemistry, Philipps University,
Marburg.
2) Practical Training at Staatlich Chemisches Untersuchungsamt in
Kassel.
3) Advanced Studies at the Institute of Pharmacy and Food Chemistry,
Philipps University, Marburg.
16.11.1971 Graduation as State Approved Food Chemist (“Staatlich geprüfter
Lebensmittelchemiker”)
03.04.1971 Marriage with Johanna Margarete Parzefall, Pharmacist
Children: Ingrid 1975, Christoph 1977, Elke 1981.
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1971-1975 Thesis at the Institute for Pharmacy and Food Chemistry, Philipps
University, Marburg. “Berechnung und Auswertung Digitaler
Potentiometrischer Titrationen” (Calculation and Evaluation of Digitized
Potentiometric Titrations)
17.12.1975 Graduation to Dr. rerum naturarum (PhD, natl. sciences). Supervisor,
Prof. Dr. Siegfried Ebel
Nov.1971 - March 1976 Scientist (assistant) at the Institute for Pharmacy and Food Chemistry,
Philipps University, Marburg.
1976 - 1979 Studies in Human Biology at Philipps University, Marburg, Medical
School
May 1976 - Nov. 1979 Scientist (assistant) at the Institute for Toxicology and Pharmacology,
University, Marburg.
Nov. 1979 - Nov. 1980 Scholarship of the German Research Foundation (DFG) for a
postdoctoral training program in Tissue Culture Techniques at the
McArdle Laboratory for Cancer Research in Madison, Wisconsin, USA.
Supervisor, Prof. Dr. H.C. Pitot.
Nov. 1980 - Oct. 1985 Scientist (assistant) at the Institute for Toxicology and Pharmacology,
University, Marburg.
Nov. 1985 - April 1988 Scientist (assistant)
April 1988: Bistowal of the Austrian citizenship
since April 1988 Assistant Professor at the Institute of Cancer Research, Uiversity Vienna
22.Oct.1992 Habilitation in Toxicology at the Med. Faculty Univ. Vienna
Since 1992 Continued Research in: Tumor cell biology, Toxicology and risk
assessment of liver tumor promoters, Growth regulation in preneoplastic
liver cells, Interaction of non-parenchymal cells in normal and neoplastic
liver growth, Involvement of reactive oxygen species (ROS) in
hepatocarcinogenesis
Application of liver tissue slices in proteomics research
(cooperation with Prof. Ch. Gerner) Detection of genotoxic and
antigenotoxic effects (cooperation with Prof. S. Knasmüller).
Broad experience in experimental models in toxicology: in vivo, rats
and mice, transgenic mouse; in vitro: primary mouse, rat and human
hepatocytes (previous cooperation with the department of surgery) Cell
lines (e.g. rat hepatoma, mouse macrophages).
Risk assessment of dioxin, pesticide mixtures, acrylamide and others.
Evaluation of Toxic Effects of Dental Materials (in cooperation with Prof
Schedle, Clinics of Dentistry, Univ Vienna and Dr. J. Dahl, Scandinavian
Inst of Dental Materials, Haslum, Norway).
Teaching of undergraduate and graduate students in toxicology;
Medical students in chemical carcinogenesis and tumor biology. Vice
director of the Toxicology Course Vienna
(Universitätslehrgang für Postgraduierte).
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Biography
Friedlieb Pfannkuch
Professor Friedlieb Pfannkuch have 20 years experience in non-clinical safety assessment for all
phases of drug development with comprehensive knowledge of experimental toxicology.
He was Head of Experimental Toxicology at Ciba-Geigy Limited in Basel, Switzerland, Head of
the Pre-Clinical Safety Section at Yamanouchi Europe B.V. in The Netherlands and responsible
for pre-clinical nutrition safety at F. Hoffmann-La Roche, Ltd. Vitamins Division. He is now in
the Global Non-Clinical Drug Safety Group at Roche’s headquarters in Basel, mainly involved
in activities of the European Federation of Pharmaceutical Industries and Associations (EFPIA)
and the European Commission’s Research Framework Programs 6 and 7.
Friedlieb Pfannkuch contributed to other international pharmaceutical consortia such as toxicity
testing of alternatives to CFCs propellants (IPACT), working groups of the International
Conference on Harmonization (ICH), the ILSI task force on Food Safety in Europe.
F. Pfannkuch is a medical doctor, with qualification in pathological anatomy. He graduated
from the Free University of Berlin and is Professor of the University of Basel. F. Pfannkuch is
engaged in professional internal and interdisciplinary, as well as in academic education. Since
2006, he is the President of the Swiss Society of Toxicology.
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Biography
Academical Career:
Ivo Schmerold
University 1970-75 Study of Veterinary Medicine, Ludwig-
Maximilians-Universität München (University of
Munich), Germany
Registration as a
veterinary surgeon
(Approbation)
Dissertation
(Dr. med. vet.)
1975 Bayerisches Staatsministerium des Innern
1978 Maximilians-Universität München (University of
Munich), Germany
Specialist 1984 Specialist for Veterinary Pharmacology and
Toxicology (appointed by the „Bayerische
Landestierärztekammer“)
Inauguration
(Habilitation)
Außerordentlicher
Universitätsprofessor
Professional
Career:
1991 Subjects: Pharmacology and Toxicology;
University of Munich, Faculty of Veterinary
Medicine
1995 Appointment as „Außerordentlicher
Universitätsprofessor für Pharmakologie“ at the
Veterinary University of Vienna, Austria
1978 - 84 Scientific assistant at the Institute of
Pharmacology, Toxicology, and Pharmacy,
Faculty of Veterinary Medicine, University of
Munich
1984 - 85 Scientific employee of the „Deutsche
Forschungsgemeinschaft“ at the Division of
Neuropathology of the Institute of Pathology,
University of Freiburg i. Br., Germany
1986 - 87 Scientific assistant at the Institute of Pathology,
Division of Neuropathology, „Universitätsspital
Zürich“, Zurich, Switzerland
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Professional
Career (cont.):
1987 - 89 Postdoctoral Research Associate at the Purdue
University, Department of Medicinal Chemistry
and Pharmacognosy, West-Lafayette, IN; U.S.A.
1990 - 91 Scientific assistant at the Institute of Pathology,
Division of Neuropathology, „Universitätsspital
Zürich“, Zurich, Switzerland
1991 - 94 Scientific employee at the Federal Health Office
(Bundesgesundheitsamt) in Berlin (Germany),
Institute of Veterinary Medicine, chief of the unit
„Toxicology“
1994 - 95 Discontinuance of the Federal Health Office;
continued employment at the Federal Institute
for Health Protection of Consumers and
Veterinary Medicine in Berlin (BgVV); chief of
the unit „Coordination of the MRL-procedures,
Toxicological Assessment“
1995 Appointment as „Außerordentlicher
Universitätsprofessor für Pharmakologie“,
Institute of Pharmacology, Veterinary University
of Vienna, Austria
since 2002 Head of Institute of Pharmacology and
Toxicology, Veterinary University of Vienna,
Austria
Memberships/
Functions: Deutsche Gesellschaft für experimentelle und klinische Pharmakologie und
Toxikologie
Austrian Pharmacological Society (APHAR)
Austrian Society of Toxicology (ASTOX)
American Association for Cancer Research, Inc. (Corresponding Member)
Delegated Member of the „Arzneibuchkommission für das Fachgebiet
Veterinärpharmakologie und -toxikologie“ (§ 6 Arzneibuchgesetz)
Member (nicht ständiges Mitglied) of the „Arzneimittelbeirat für das
Fachgebiet Veterinärpharmakologie und -toxikologie“ (§ 49 Arzneimittelgesetz)
Austrian Expert for the Safety Evaluation of Veterinary Drugs
(Nominated by EMEA).
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Biography
Hans J Schuitmaker
Hans Schuitmaker joined the Top Institute Pharma as program manager in September 2006 from
PhotoBioChem (PBC) where he was a founding scientist and Chief Scientific Officer. Prior to
PBC he held a position as Scientific Officer at Boston Clinics PDT BV a company specializing in
the development of non-oncological applications of photodynamics.
Schuitmaker holds a masters degree in Biology from the University of Groningen and has a
PhD on respiratory physiology of the University of Leiden. Obtaining tenure after a two-year
post-doctoral fellowship at the Department of Ophthalmology of the Leiden University Medical
Centre, his research focussed on the development of new photodynamic treatment modalities for
cancer.
This research was awarded with grants from a multitude of ophthalmologic foundations and a
million-plus grant from the Dutch Technology Foundation (STW) for the development of a new
photosensitising compound together with a matching laser device.
Dr. Schuitmaker is also an active reserve officer, presently holding the rank of Major of Artillery.
He is chairman of the board of the Den Haag branch of the Royal Dutch Association of Reserve
Officers (KNVRO).
Biography
Rolf Schulte-Hermann
Education and Qualification:
1958-1963 Study of Pharmacy, Staatsexamen 1963, University of
Bonn, Germany
1963-1970 Study of Medicine, Staatsexamen 1970, Universities of Bonn, Berlin,
Marburg, Germany
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1968 Ph.D. (Doctor rer. nat.), Institute of Pharmacology,
Free University Berlin, Germany
1975 Venia Legendi in Pharmacology and Toxicology,
Philipps University, Marburg, Germany
Professional Appointments:
1968-1974 Post-doctoral Fellow, Institute of Toxicology and
Pharmacology, Philipps University, Marburg
1974-1985 Professor (C2), Institute of Toxicology and
Pharmacology, Philipps University, Marburg
1985 Full Professor of Toxicology, University of Vienna
1985-2004 Director, Institute of Cancer Research, University of Vienna
1985-present Head, Division of Toxicology, now: Toxicology and Prevention, Institute
of Cancer Research, now: Clinic Internal Medicine I, Medical
University of Vienna
Honors and Awards:
1965-1968 Scholarship “Stiftung Volkswagenwerk”
1993 Austrian Academy of Sciences, corr. Member
1994 Honorary Medal, Hungarian Cancer Society
1995 “Hoechst” Award of the Medical Faculty, University of Vienna
1996 Honorary Lecture and Medal, Foundation for Promotion of Cancer
Research, Tokyo, Japan
1997 Dr. h. c., Medical University of Debrecen, Hungary
1975-present Many keynote and other invited plenary lectures at international
meetings
Activities in Scientific Societies:
1991 Foundation of the Austrian Society of Toxicology (ASTOX)
1991-present Austrian Society of Toxicology, Chairman
Numerous other Societies
Membership in many Governmental Advisory Committees
Research Interests:
• Regulation of organ growth, chemical mitogens, nutrition-mitogen-interactions,
growth factors and cytokines, endogenous growth inhibitors (TGFß family).
• Tumor initiation and promotion. Mechanisms of action of tumor promoters and of
non-genotoxic carcinogens. Role of the microenvironment. Mechanism-based risk
assessment of chemical carcinogens.
• Discovery and investigation of apoptotic cell death during organ regression, and during
carcinogenesis.
Publications:
250 papers in peer-reviewed journals
about 200 reviews and book contributions
about 200 published abstracts.
Independent quotations from 1994-2006: ca. 5000
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Member of numerous Editorial Boards
Organisation of Scientific Meetings:
Organisation of numerous scientific congresses and symposia related to
Apoptosis, Chemical Carcinogenesis, Toxicology etc. Invention (1984) and co-organisation of 8
“European Meetings on Hepatocarcinogenesis”
Teaching:
Student Lectures:
• Pharmacology (until 1985), Toxicology, Chemical Carcinogenesis
Postgraduate education:
• Foundation and organisation of a 3 years postgraduate course in Toxicology at the
University of Vienna (since 1992), Course director from 1992 - present
• Foundation and organisation of a 3 years course in Tumor Biology at the University
of Vienna (1999-2005), Course director from 1999 - 2004
• Organization of 9 “Seminars in Toxicology” in Austria
Textbook chapters:
“Tumor Promotion”in „Lehrbuch der Toxikologie”, Wissenschaftliche Verlagsgesellschaft
Stuttgart, 1 st edition 1994, 2 nd edition 2004.
“Tumor Promotion” in “Toxicology“, Academic Press, 1994
“Multistage Carcinogenesis”, “Chemical Carcinogenesis”, “Hormonal
Carcinogenesis” in the comprehensive textbook “Die Onkologie”, Springer Verlag, 1 st edition
2004, 2 nd edition in press.
Biography
Thomas Singer
Education
1978 Study of Biotechnology Science, University of Munich, Weihenstephan
1982 Dipl. Ing. agr. (M.Sc.)
1983-1988 Faculty of Veterinary Medicine, Ludwig-Maximilian University of Munich
(D.V.M.)
1989 Ph.D. thesis: Deoxyspergualin, a New Immunosuppressive Regimen in
Xenogeneic Organ Transplantation (Dr. med. vet.)
1993 Veterinary Board Certification for Toxicology (FVH, Spezialtierarzt für
Grundlagenmedizin und Toxikologie, CH)
1994 Certified Diplomate of the American Board of Toxicology, DABT
1996 Veterinary Board Certification for Pharmacology and
Toxicology (Fachtierarzt für Pharmakologie und Toxikologie)
2003 Fellow Pembroke College, Cambridge, UK
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Employment
history
2004 Global Deputy Head Non Clinical Development Roche Pharma AG (TRD
small and macro molecules)
2004 Head of the Roche Holding Biotherapeutic Workgroup.
Scope early development of biotherapeutics with regard to safety, regulatory
and API. Development of company holding wide guidelines to harmonize
protein development within the Roche Holding (Roche, Chugai, Genentech)
according to the most current regulatory standards and impacting health
authority regulations.
2003 Appointment to Senior Vice President
1999 - 2003 European Liaison Officer of the American Board of Toxicology
2002 Global Head of Non Clinical Safety at
F. Hoffmann-La Roche Ltd., Basel
2000 Chair of the Boehringer Ingelheim Safety Committee
1998 Head of Department of Nonclinical Drug Safety at
Boehringer Ingelheim Pharma KG, Biberach
1997 Scientific Deputy Head of the Department TOX/PATH Novartis AG
1996 Member of Integration Team Drug Safety Sandoz/Ciba to form Novartis
1995 Deputy Head of Toxicology, Sandoz Pharma Ltd.
1992 Head of General Toxicology, Sandoz.
Pharma Ltd., Department of Drug Safety.
1989 Sandoz Pharma Ltd., Department of Drug Safety
Biography
Per Spindler
Dr Per Spindler has a long curriculum within pharmaceutical research, preclinical development
and registration. His past affiliations include the Danish Medicines Agency,
H. Lundbeck A/S, Novo Nordisk A/S and, most recently he was Vice President of Preclinical
Development at BioImage A/S. Dr Spindler was member of the CHMP Safety Working
Party and today he maintains active in a plethora of scientific and regulatory issues related to
pharmaceutical R&D and so-called ’personalised medicines’. His present position is Director
of BioLogue, a growing premium Danish consortium consisting of stakeholders of translational
biomedical research and it is hosted by University of Copenhagen and associated with the Danish
Pharma Consortium.
Dr Spindler was given the Outstanding Services Award from the Drug Information Association
in 2002 and he is now member of the Advisory Council for Europe and chairing the Nonclinical
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Special Interest Community of this association. Dr Spindler is past council member of the
European Teratology Society, he serves on the Editorial Board of the Drug Information
Journal and he has authored numerous articles and given many invited lectures in preclinical
pharmaceutical sciences.
Dr Spindler holds a DVM from the Royal Veterinary and Agricultural University in Denmark,
an Executive MBA from the Scandinavian International Management Institute and a MSc in
Applied Toxicology from the University of Surrey. He is a EUROTOX Registered Toxicologist
and member of the Society of Toxicology, Drug Information Association and the Organisation
for Professionals in Regulatory Affairs.
Biography
Helmut Sterz
Helmut joined Pfizer in December 2001 as Head of the Amboise Safety Sciences Research
Center. Helmut has a DVM and PhD in virology from the Justus von Liebig University
in Giessen, Germany. He has been employed as Head of the Department of Reproductive
Toxicology at Boehringer Mannheim, Germany, as Head of the Toxicology Department at
Servier in Orléans, France, and from 1994 to 2001 at Hoffmann La Roche in Basel, Switzerland
where his last position was Head of Global Non-Clinical Drug Safety.
Helmut’s main interests and concerns, also in his new position, are:
a) Partnership with Discovery in the selection of molecules for clinical development,
b) Transparency of the findings from pre-clinical safety studies including the distinction
between irrelevant alerts/signals and real safety issues and
c) Consulting of project teams beginning before Lead Development such that mechanismbound
safety issues will be anticipated, regularly evaluated and an effective & tailored
de-risking strategy will be applied in a timely manner before final selection of a drug
development candidate.
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Biography
Martina Stressl
Education:
06/1999 A-level at the BG/BRG Villach Peraustrasse with distinction
2005-2005 Study of pharmacy at the Karl-Franzens University of Graz
03 – 09/2004 Diploma thesis at the Institute of Pharmaceutical Sciences at the Swiss
Federal Institute of Technology in Zurich within the framework of an
Erasmus-semester; title: Structural Characterisation of Vaccinia Virus
Thymidine Kinase
07/2005 Final examination at the KF-University of Graz with distinction
since 11/2005 PhD student at the University of Vienna in the field of nucleic acid
chemistry
04/2007 Poster presentation at the PSWC 2007 in Amsterdam: The Influence of
Bcl-2 down-regulation by Oblimersen and siRNA using a proteomic
approach
Professional experience:
2002 Perauapotheke Villach
07 – 09/2003 R&D Boehringer Ingelheim Vienna
10/03 – 02/04 R&D Boehringer Ingelheim Vienna
10/04 – 05/05 R&D Boehringer Ingelheim: cell culture; cytotoxicity tests; protein
chemistry;
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Biography
Paul Trennery
Paul Trennery is head of global non-clinical safety assessment for GlaxoSmithKline (GSK) and
has responsibility for a group of 600 scientists who support the drug discovery and development
portfolio across the US, UK and Italian research sites.
In addition he chairs the GSK pan-R&D predictive toxicology initiative. Paul joined Roche in
1983 before moving to Glaxo in 1986. In 1990 he was appointed Director of Drug Safety for
Glaxo in the USA, based in North Carolina.
He returned to the UK in 1996 as Director of International Safety Projects, before taking up his
current role in 2000. He has a PhD in Biochemical Toxicology and is a Fellow of the Royal
College of Pathologists (Toxicology).
Biography
Ernst Urban
University studies Pharmacy (1977 -1983), University of Vienna
Pharmaceutical Chemistry (1984-1987), University of Vienna
Emploiment Assistent (since 1983), Assistent Prof (since 1990)
Ao. Prof. (since 1997) at the Institute of Pharmaceutical
Chemistry, University of Vienna
Diplomata thesis Synthesis of 14-alkyl codeine derivatives
Master of Science in Pharmacy (November 22, 1983),
awarded by the University of Vienna
Thesis Synthesis of a benzodiazepine analogous sydnotriazepine
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PhD in Pharmaceutical Chemistry (November 18, 1987),
awarded by the University of Vienna
Postdoctorial education Postdoctorial fellow of Prof. G. Helmchen (in 1992)
Institute of Organic Chemistry, University of Heidelberg
Postdoctorial thesis Auxiliary protected enoates as chiral building blocks
for the EPC synthesis of antimicrobial natural products
Lectureship in Pharmaceutical Chemistry (April 30, 1997) awarded by
the Faculty of Natural Science, University of Vienna
Fields of reseach Artificial antisense oligonucleotides
Biography
Bob van de Water
Asymmetric synthesis of natural products
Synthesis and analysis of steroid hormones
Synthesis and analysis of macrolid antibiotics
Synthesis of GABA-analogous spirocycles
Professor Van de Water studied bio-pharmaceutical sciences at Leiden University where he
graduated in 1990 (specialization: toxicology). He obtained his PhD (cum laude) from the
same university in 1995. After a postdoctoral position in the USA (W Alton Jones Cell Science
Center, Lake Placid; mentor: Dr JL Stevens), he rejoined the Division of Toxicology. In 1999 he
received a fellowship from the Royal Netherlands Academy of Arts and Sciences (KNAW). In
2006 he was appointed as professor of drug safety sciences and head of the division. His research
interest is on identifying molecular mechanisms of xenobiotic-induced cytotoxicity using a
systems toxicology approach by integrating both gene expression profiling, phospho-proteomics
and functional genomics. A central theme is the control of cellular signaling by cell-matrix and
cell-cell interactions in the context of molecular mechanisms of cytotoxicity. These studies
provide fundamental insight on the consequences of cellular stress conditions on cell adhesion,
migration, differentiation and survival in context of both xenobiotic-induced acute tissue injury
and repair as well as cancer treatment.
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Biography
Nico PE Vermeulen
Education:
1975 Degree in Chemistry (M.Sc.) Catholic University of Nijmegen and University of
Amsterdam, The Netherlands
1980 Ph.D.-degree in Bio-Pharmaceutical Sciences, Subfaculty of Pharmacy, University of
Leiden (supervisor Prof. dr. D.D. Breimer)
Employment:
1975 Staff-member at the Subfaculty of Pharmacy, University of Leiden, Leiden, NL.
1985 Professor of Molecular Toxicology, Department of Pharmacochemistry, Vrije Universiteit,
Amsterdam, NL (1985 - ).
1997 Dean Faculty of Chemistry, Vrije Universiteit, Amsterdam, NL (1997-2000)
2005 Scientific Director Leiden-Amsterdam Center for Drug Research (LACDR) (2005 - )
Recognitions:
1985 Registered as Toxicologist (at SMBWO and Dutch Society of Toxicology (NVT)
2001 Work of him and his group is taken up in the ISI-list of Highly Cited Researchers in the area
‘Pharmacology’ (www.ISIHighlyCited.com)
2004 Honorary membership of ISSX (2004, lifetime)
2006 European Scientific Achievement Award 2006, ISSX Manchester, UK
Research interests:
- In general: Roles molecular and computational toxicology and drug metabolism can play in
drug discovery, development and safety assessment,
- More specifically: toxication/detoxication mechanisms involving Cytochromes P450; in silico
and in vitro prediction and screening of ADME-Tox properties, biocatalysis, xenoestrogens,
biomarkers of oxidative damage.
Various
As yet he was supervisor of 29 PhD-students and author / co-author of more than 380 publications
in the fields of (molecular) toxicology, bioanalysis and medicinal chemistry
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Biography
Silvio Wuschko
Position: Projekt and Programme Management Preclinical Development
Institution: Austrian Research Centers GmbH – ARC (Seibersdorf, Austria)
Background
Intendis GmbH (a Schering Subsidiary), Director Preclinical Development, 2005-2006
Alnylam Europe AG, Director Preclinical Development, 2002-2005
Director R&D Toxicology & Veterinary Medicine Products, Biopharm GmbH, 1997- 2001
Postgraduate Certificate as Laboratory Animal Scientist of the FELASA (Federation of European
Laboratory Animal Science Association), 1993
Head Animal Laboratories & Facilities, Biopharm GmbH, 1993- 1996
PhD, Humboldt-University of Berlin, 1992
Shemjakin-Institute of Bioorganic Chemistry at the Academy of Science Moscow, 1990
Full Time Research Assistent, Humboldt-University of Berlin, 1989 - 1992
University Degree in Biology (Diploma), Humboldt-University of Berlin , 1988
Biography
Kirsi Vähäkangas
Kirsi Vähäkangas received an MD in 1977 and PhD (pharmacology and toxicology) in 1981,
both at the University of Oulu, Finland. She visited 1982-1984 as a postdoctoral scientist and
later 1990-1991 as a visiting scientist at the National Cancer Institute, NIH USA (Laboratory
of Human Carcinogenesis at NIH, Dr. Curtis C Harris). She was appointed as a full professor
(Toxicology) at the Department of Pharmacology and Toxicology, University of Kuopio in 2000.
She is the director of the Master’s Program in Toxicology, the only existent degree program of
toxicology in Finland and is one of the founders and leaders of the new Finnish Graduate School
in Toxicology, which started 2006. Current main research areas are reproductive toxicology, and
mechanistic aspects of chemical carcinogenesis. She is also lectures and writes about biomedical
ethics and has served in several research ethics committees in Finland. She has tutored 8
completed PhD thesis and currently there are 9 under supervision. Bibliography includes over 90
original publications and over 80 other publications.
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