Speakers in alphabetical order
(with short biograph where available)
de Zeeuw Rokus A
Könen - Bergmann Michael
Laurijssens Bart E
Head of Department of Evaluation of Clinical Trials and Special Status Medicinal
Products, Afssaps, France
- Medical doctor
- Master degree in pharmacology
- Many years in Afssaps, France, involved in the assessment of clinical trials,
pharmacovigilance and compassionate use of drugs ;
- Many years in the pharmaceutical industry in charge of pharmacovigilance and
- Head of the Clinical Trials Department of the Afssaps, France.
- Co Chair of the Clinical Trials Facilitation Group (CTFG)
- France’s representative at the ad-hoc CT experts group of the European
- Co rapporteur on European Guidelines on clinical trials (mainly CTA and SUSAR
1982-1989 Medical School. Faculté de Médecine Lyon Nord,
Claude Bernard University, Lyon I.
1989-1995 Resident, Hospices Civils de Lyon
1996-1998 Assistant-Professor, Dermatology Department
(Pr. Henri Perrot) Hospices Civils de Lyon.
Ph.D programme, Claude Bernard University, Lyon I
1998-2000 Post-Doctoral Fellowship, Baylor Institute for Immunology Research
(Dr. Jacques Banchereau), Dallas, Texas, USA.
- M.D Degree, Lyon Nord Medical School 1995
- Dermatology Degree Hospices Civils de Lyon 1995
- Ph.D Degree (Immunology) Claude Bernard University, Lyon I 2002
- Cancerology Degree Claude Bernard University, Lyon I 2002
- HDR (research director) 2003
Hospital Degrees and Positions
- Residency 1989-1995
- Assistant Professorship (Dermatology Department, Pr H. Perrot) 1996-1998
- Dermatology consultant
- Dermatology Department, Hôpital Antiquaille, Lyon 2000-2002
- Clinical Immunology Consultant
- Anti Cancer Center (Centre Leon Berard), Lyon 2001-2004
- Clinical Immunology and Allergology, CHU Lyon-Sud 2002-2004
- Clinical Immunology and Allergology Department, unit director, CHU Lyon-Sud
- Head of Clinical Immunology and Allergology Department, CHU Lyon-Sud 2009-
- Professor of Clinical Immunology, Claude Bernard University, Lyon I 2007-
- French Society of Clinical Dermatology 1998 -
- French Society of Investigative Dermatology 1996 -
- Club Francophone des Cellules Dendritiques 2001 -
- French Society of Immunology 2002 -
- European Society for Dermatology Research 2004 -
- Comité scientifique Ligue Nationale contre le Cancer (Grand Ouest) 2005 -2007
Since 2005 Vice-President, Research & Development TRANSGENE S.A.,
Strasbourg, France; therapeutic axis: cancer & infectious diseases
2002-2004 Managing Director, CANCEROPOLE Lyon Rhône-Alpes
1997-2002 Managing Director, Centre d’Immunologie Pierre FABRE, bioMérieux-
Pierre Fabre Group, St Julien en Genevois, France
1988 – 1997 Head of the Immunology Department, Senior Scientist and Project
Leader at GLAXO WELLCOME, Geneva Biomedical Research Institute, Geneva,
Switzerland. Therapeutic axis: Allergy, Inflammation and Autoimmunity.
1984 – 1987 Research Scientist at the Immunological Research Center UNICET,
Dardilly (France), subsidiary company of SCHERING PLOUGH (USA). Visiting
scientist at DNAX California and Primate Center, Washington University, USA.
Therapeutic axis: Allergy and Inflammation
1982 – 1984 DEA and Thesis training in Biochemistry in the Research laboratory of
Dermatology and Immunology CNRS 788 - Unit INSERM 209. Pavilion R, Pr. J.
THIVOLET, Lyon, France.
∗ Senior Management Programme, London Business School. Centre for
Management Development, Programme Director Pr. J. Hunt.
∗ Staff and Project Management Glaxo Courses.
∗ Principled negotiations. Centre for Professional Development, Inc.
1987 Doctorate thesis speciality : Immunology presented on December 14th, 1987.
1985 Thesis in Biochemistry « 3ème cycle » presented on January 11th, 1985.
∗ American Association for the Advancement of Science
∗ American Association of Immunologists
∗ Société Française d'Immunologie
∗ Collegium Internationale Allergologicum
Member of the Mérieux Foundation
Member of the investment board of “INSERM Transfert Développement”
Member of the « INSERM Comité d'orientation stratégique et de suivi des essais
cliniques (Cossec) »
Member of the European Society for Cancer Immunology and Immunotherapy
Member of the Scientific Council of the Centre d’Investigation Clinique de Biothérapie
at Hôpital Necker - H.E.P.G. – COCHIN
Member of the Comité National de Biochimie de l’Académie des Sciences
Expert European Commission
Board member of Ecole Doctorale des Sciences de la Vie et de la Santé de
Board member of the Alsace BioValley association
Board member of the Journal of Immunology
Board member of European Journal of Immunology
Reviewer for scientific articles
Cancer Immunology & Immunotherapy
Cell adhesion and communication
Clinical and Experimental Immunology
European Journal of Dermatology
Journal of Allergy and Clinical Immunology
Journal of Experimental Medicine
Journal of Immunology
Ad hoc reviewer for grants
Swiss National Foundation
Heart and Lung Foundation
The Wellcome Trust
European Expert (INSERM)
Royal Society Research Grants
Swiss Institute for Experimental Cancer Research (ISREC)
European Expert DG12 FP5 and FP6 (EU)
Member of the investment board of “INSERM Transfert Développement”
Senior Physician specialized in the management of the development and the safety
evaluation of new drug entities in man
Since Sept 2008 SANOFI-AVENTIS RESEARCH & DEVELOPMENT, Chilly-
Associate Vice-President, Global Pharmacology & Epidemiology, Deputy-Head
Global Risk Management Plan Unit.
In charge of the implementation of the Development Risk Management Plan process
for all our drugs in development. Responsible to elaborate with product Project
Teams risk management strategy and champion this strategy within the Company;
follow the product risk and make any necessary changes to the original strategy;
prepare and validate risk management documents updates for the competent
Authorities; serve as risk management expert.
2005 to Sept 2008 SANOFI-AVENTIS RESEARCH & DEVELOPMENT, Chilly-
Associate Vice-President, International Clinical Investigations, Deputy-Head Global
Clinical and Experimental Pharmacology.
Responsible for 50 Clinical Pharmacologists worldwide with high graduate degrees.
In charge of the Clinical Pharmacology part of the development of all the drugs
developed by the Company in various therapeutic fields, of all first in man and of
biomarkers development. Involved in the Clinical Development strategy and
championed this strategy for the Clinical Pharmacology Department.
2002 to 2004 SANOFI-SYNTHELABO RESEARCH, Chilly-Longjumeau, France.
Started as Deputy Head and Clinical Research Director in Clinical and Experimental
Pharmacology (02/2002 to 01/2003), responsible of 6 Clinical Pharmacologist and
directly in charge of 3 new drug entities. Promoted as Head of the Clinical and
Exploratory Pharmacology with a direct reporting to the International Clinical
Development Head in 02/2003, I managed and developed the Department, involved
during all the development phases (Pre-clinical to Life Cycle Management) in various
therapeutic fields, in charge of up to 20 Clinical Pharmacologists.
1987 to 2002 ASTER-CEPHAC, Paris, France, Contract Research Organization
offering a full package service in Phase I/II development of new drug entities
Clinical studies realization as Clinical Monitor from 1985 to 1988. Promoted as
Clinical Unit Manager from 1989 to 1995, I managed and developed the Clinical Unit
to increase its capabilities from 10 to 100 beds. I directed more than 100 employees
and reported directly to the CEO. I achieved this growth in 1994. Since 1995, I was
Clinical Research Director. In compliance with international requirement and
guidelines, I was in charge of negotiations, staffing, reporting and control of Phase I/II
studies on new medications in different therapeutics areas with implementation of
specialized tests. In 1997, I was also in charge of the Medical Writing Department to
reorganize and improve the performance of an under-motivated team. I increased by
three the turnover in one year. I recruited and trained new English mother tongue
medical writers and set up new procedures.
For the last two years, I was also Chief and Scientific Officer, in charge of the
development of new methods, scientific evaluation of projects, and in relation with the
Marketing department, of the scientific and technical image of the Company. In 1989,
I obtained the status of Investigator and in 1994, the qualification of Clinical
Pharmacologist. As Co-investigator and Investigator, I completed more than 1200
studies in Phase I/II. I was involved in the development of more than 150 new drug
entities in various therapeutic fields.
1987-1990 INTERCOMMUNAL HOSPITAL, Créteil, France, Specialist
echocardiographist founded and developed a new laboratory of cardiovascular
1984-1987 GENERAL HOSPITALS, Créteil, France, Resident Physician
1979 Undergraduate Degree in Human Biology (Sciences Degree), Paris, France
1987 Postgraduate Degree in Cardiac Ultrasonography, Paris, France
1988 Medicine Doctorate (M.D.), Paris, France
1989 Postgraduate Degree in Clinical Pharmacology: methodology applied to clinical
trials, Paris, France
1990 Master’s Degree in Biological and Medical Sciences: methods in pharmacology,
1989 Postgraduate Degree in Statistics: statistics methodology and statistics applied
to clinical trials, Paris, France
1994 Master’s Degree in Biological and Medical Sciences (M.Sc.): general
pharmacology, Paris, France
2002 Planning Organization, Artemis International
2004 Management of managers, M2M, Sanofi-Synthelabo Research Internal training
Since 2005 Member of the American Society of Clinical Pharmacology and
Therapeutics – ASCPT
Since 2003 Member of the AGAH (Association for Applied Human Pharmacology),
Since 1999 Member of the New York Academy of Sciences – NYAS
Since 1998 One of the founders, secretary, then president, and now honorary
president of the Club Phase I (French association of people involved in Phase I) –
Since 1995 Member of the French Society of Clinical Pharmacology and
Therapeutics – SFP
Since 1991 Member of the French Pharmaceutical Industry Association – AMIPS
Dr. Chassard studied medicine in Paris and after having earned his PhD in 1987
continued his education up to a Master in Computer Science, Clinical Pharmacology
and Pharmacology. Following several clinical assignments he joined SGS Aster,
Paris where held several positions including Phase I Principal Investigator and
Associate Director before heading the Phase I clinical operations from 2001 to 2008.
He is now Associate Medical and Scientific Director of the Biotrial Drug Evaluation
and Pharmacology Research Centres in Rennes and Paris.
Head of the Bioanalysis Group for Biologics/Biomarkers in the Global Metabolism
and Pharmacokinetic department at sanofi-aventis, Montpellier, France. He joined
sanofi-aventis in 2005 where he is in charge of the laboratory dedicated to
Bioanalytical (PK / immunogenicity / Biomarkers) assays development and validation
in support of preclinical and clinical studies. Prior to joining sanofi-aventis, he worked
for 6 years at Cytheris, a biotech company based at Issy les Moulineaux , France.
While at Cytheris, he supervised a team in charge of recombinant protein purification
process, the analytical controls and the development of assays for the
immunogenicity monitoring in support of the Interleukin 7 development. Pierre Cortez
received his diploma of engineer specialization in Biochemistry and Biotechnology in
1995 at Institut National des Sciences Appliquées of Lyon, France.
de Zeeuw , Rokus A.
Rokus de Zeeuw (1939) studied pharmacy and biochemistry at the University of
Groningen, The Netherlands and obtained his Ph.D. from the same university in
1968. He continued in various research and teaching positions in The Netherlands
and the USA before returning to Groningen in 1974 where he became Professor of
Toxicology and Bioanalysis, with a focus an early drug development. He retired from
academia in 2002, but is still active as a consultant.
In 1984 he was co-founder of the Foundation for the Evaluation of Ethics in
Biomedical Research (Dutch acronym BEBO) and was chairman of its Review Ethics
Committee until 1994, to become chairman of the Board of BEBO. He is a member of
the Dutch National Visitation Committee for REC’s since 2003.
After graduating from the Berlin Free University (FUB) medical school, he went on
training in anaesthesiology and intensive care in France and in Germany up to a
specialist degree. In 1984 he joined the pharmaceutical industry as director of the
Merrell Dow Clinical Pharmacology Unit (later Marion Merrell Dow) in Kehl, Germany
until the merger with Hoechst in 1993.
In 1994 he started a career as a free-lance consultant resulting 1998 in the creation
of medcom drug development services GmbH, of which he is the Director. The
company as a niche CRO is specialized in the supervision and conduct of Phase I to
IV clinical trials, GCP and regulatory aspects and medical writing.
He is also a founding member of AGAH, the German Association for Applied Human
Pharmacology, and chairman of the south-western chapter of DGPharMed, the
German Association of Pharmaceutical Medicine, and Fellow of the Faculty of
Publications include own scientific work in CNS drugs and other indications, GCP
and regulatory aspects in scientific journals and as a book editor.
Jones, David R
After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the
Pharmaceutical Industry, I currently work as an Expert Pharmaco-Toxicologist within
the Licensing Division of the Medicines and Healthcare products Regulatory Agency
(MHRA) in London.
My current role principally involves assessing nonclinical data for Clinical Trial
Applications, both non-biological and biological. A further aspect of my job is to offer
regulatory advice to companies on behalf of the MHRA or the EU’s Committee for
Human Medicinal Products (CHMP). I am one of the UK’s accredited preclinical
experts to support the CHMP and am the UK representative on the Safety Working
Party (SWP). I represent the EU in the ICH revision of the M3 Guideline.
I am also a guest lecturer at the University of Surrey and the University of Wales and
a frequent presenter at conferences around the world.
Dr. Klingmann studied medicine in Germany and specialized in General Medicine,
Clinical Pharmacology and Pharmaceutical Medicine.
After having joined pharmaceutical industry as medical advisor, she held senior
management positions in different international contract research organizations and
was responsible for operational, scientific, regulatory and business aspects of
international clinical research projects from Phase I to Phase IV. Since January 2003
she has her own pharmaceutical development and site management support
consulting company. From January 2004 to July 2007 she was also CEO of two
investigative sites in London, UK, performing clinical trials in acute and chronic pain
as well as musculo-skeletal diseases.
Dr. Klingmann is a founding member, Member of the Board and Conference Officer
of the European Forum for Good Clinical Practice (EFGCP) as well as Co-Chair of
the EFGCP Ethics Working Party and the EGAN/EFGCP Working Party “Patients’
Roadmap to Treatment”. She is a founding member and member of the Board of the
Association for Applied Human Pharmacology (AGAH) in Germany where she also
established and chaired the Ethics Working Party of this organisation dealing with
ethics and GCP issues in Human Pharmacology in Germany; today she is chairing
AGAH’s regulatory affairs working party and is President-Elect. In the Drug
Information Association (DIA) she was a member of the Steering Committee Europe
(now Advisory Council Europe), a former chair person of the SCE, a Member of the
Board, a Member of the Foundation Board, Co-Chair of the EuroMeeting 2005 in
Lisbon and speaker, session chair and programme committee member for numerous
conferences of the DIA. Dr. Klingmann chairs the clinical research module of the
Master in Regulatory Affairs course at the University of Bonn, Germany.
1984-1986: Mathematics at Fernuniversität Hagen
1986-1992: Medicine at Bonn University, 1992 at University of Michigan, Ann Arbor
1992-1993: Department of Physiology, University of Bonn
1993-1999: Department of Anaesthesiology, University of Bonn
Anaesthesiology, Critical Care, Emergency Medicine, Pain Medicine;
Research in Clinical Pharmacology of Anaesthetic Drugs
1999 to date: Clinical Research at Boehringer Ingelheim
Physician since 1992
Medical Doctor since 1993
Board-certified in Anaesthesiology 1999
European Diploma in Anaesthesiology and Critical Care Medicine1999
Board-certified in Clinical Pharmacology 2004
Laurijssens, Bart E.
In 1987 Bart E. Laurijssens obtained his Propaedeutic Degree (BSc equivalent) in
Chemistry, and in 1992 his Doctoraal Degree (MSc equivalent) in Bio-Pharmaceutical
Sciences at the University of Leiden, Netherlands. A postgraduate student from 1993
to 2000 at the Dept. of Pharmacology and Experimental Therapeutics, he was
awarded a PhD in Pharmacology and Experimental Therapeutics (Mentor:
D.J.Greenblatt) from Tufts University School of Medicine, Boston, USA and since
2000 has been an Adjunct Instructor there.
Joining Glaxo Welcome in 2000, now GlaxoSmithKline R&D, Greenford, UK working
in clinical pharmacology / modelling and simulation, he is now chiefly supporting the
Having completed an Honours degree in Pharmacology and graduating in medicine
from Guy’s Hospital in 1979 Tim Mant trained at various hospitals in London in
internal medicine, Clinical Pharmacology and Human Toxicology. His major activity
at Guy’s Drug Research Unit is as Principal Investigator for the investigation of new
chemical entities in man. In addition to research he maintains teaching and clinical
activities. He was a member of a Local Research Ethics Committee for
approximately 10 years. Professor Mant has published over 50 articles relating to
Clinical Pharmacology and Human Toxicology. He has co-authored the three most
recent editions of: “A Textbook of Clinical Pharmacology and Therapeutics” (Ritter,
Lewis & Mant) and the accompanying “Questions for Self Assessment” (Mant, Lewis
& Ritter). He was appointed Visiting Professor at King’s College London School of
Medicine at Guy’s, King’s and St Thomas’ Hospitals, London in January 2008
Professor Mant is Honorary Consultant Physician at Guy’s & St Thomas’ Hospital
NHS Foundation Trust. He is an examiner for the Diploma in Pharmaceutical
Medicine, an MBBS examiner, lectures on MSc courses at the Universities of
Cranfield, London and Surrey. Professor Mant also lectures for KCL (MBBS Course
and KCL toxicology BSc Course). He has been on the interview panel for prospective
medical students at KCL, and has been a student tutor for many years.
Dr. Nicolas is dermatologist and Head of the Division of Allergology and Clinical
Immunology in Lyon University Hospital. He is also professor of Immunology and
director of an INSERM research team working on the pathophysiology of
inflammatory skin diseases. The research activities concern the skin immune system
and especially the study of cellular and molecular signals that lead to immune
responses or tolerance to cutaneous antigens and allergens. Applications comprise
inflammatory skin diseases in humans (eczemas, psoriasis and drug allergy) as well
as in pre-clinical mouse models of these diseases and studies of different cutaneous
routes of vaccination to improve the overall efficacy of vaccines.
Dr. Nicolas received his M.D. degree from Lyon University Medical School in 1983.
His dermatology specialty degree was obtained through specific training in
immunodermatology (Pr Jean Thivolet). He obtained his Ph.D degree in 1990 after a
training at Scripps Clinic and University of California San-Diego (Dr Jacques Chiller)
and after being a recipient of INSERM young investigator award. He occupied the
position of research director at INSERM from 1990 to 1998.
Dr. Nicolas has authored and/or coauthored more than 150 research papers and
book chapters. In addition, he is Editor-in-Chief of European Journal of Dermatology.
Alain Patat had various positions in the pharmaceutical industry, as well as in CROs,
during the past 20 years. He worked as a clinical pharmacology investigator and as a
clinical pharmacology worldwide project leader.
His first position was in Roussel Uclaf (Hoechst Roussel). Then he moved to
Synthelabo as CNS therapeutic area Head in Clinical Pharmacology and Head of
Pharmacodynamics, promoting use of biomarkers in early development. He was then
Medical Director and Head of Clinical Pharmacology of Biotrial, a French CRO
located in Brittany, within Rennes University Hospital. Then he was Senior Director
within Wyeth Research Translational Development Department, where he is
responsible for the implementation of clinical pharmacology studies in Europe as well
as for the clinical pharmacology worldwide development of various compounds.
His current position is Vice President, Medical and Scientific Affairs at Biotrial,
He is a member of various clinical pharmacology associations (American Society for
Clinical Pharmacology and Therapeutics, American College of Clinical
Pharmacology, British Pharmacological Society, French Pharmacological Society,
EUFEPS) as well as associations involved in the CNS field (British Association of
Psychopharmacology, CINP, ECNP).
Dr. Jean-Louis Pinquier is currently Deputy Global Head of Clinical and Exploratory
Pharmacology Department at Sanofi-Aventis R&D. He received his MD at the
University of Paris V in 1986. He is board certified in Rheumatology, Internal
Medicine and Clinical Pharmacology. From 1986 to 1993, he was Associate
Professor in the Department of Internal Medicine at Cochin University Hospital and
Medical School, Paris while he was Medical Director of the Clinical Pharmacology
Unit at the Therapeutics Research Institute in the same University until he joined
Synthelabo Research in 1993.
From 1993 to 2002 he was head of Clinical Operation and Deputy head of
Synthelabo and Sanofi-Synthelabo Clinical Pharmacology Department. He joined
Aventis in 2002 as head of Clinical Discovery and Human Pharmacology France and
Europe from 2004.
Dr Pinquier has been involved in the development of a number of drugs as Clinical
Pharmacologist, in various areas. His current research interests is focused on the
optimization of early clinical development by using innovative methodology including
biomarkers, Pharmacodynamic model and Imaging technology for pharmacological
or/and therapeutics activities of new drugs (NCE and Biological), with a special
interest in the field of CNS, metabolism and inflammation.
M.D. in Surgery and Obstetrics, Katholieke Universiteit Leuven, 1998
Limburgs Universitair Centrum 1991-1994
Katholieke Universiteit Leuven 1994-1998
Methodology in Research and Clinic (I), Limburgs Universitair Centrum, 1993-1994
ECG for General Practitioners, Katholieke Universiteit Leuven, 1997-1998
Inter University Course Anesthesiology and Reanimation, Rijksuniversiteit Gent,
Emergency Medicine, Inter University Course, VU Brussels, 2001-2002
PHARMED seminars 1 – 8, ULB, Brussels, Belgium, 2003-2004
Member of BeAPP (Belgian Association Pharmaceutical Physicians) since 2002
Member of ACRP (Association of Clinical Research Professionals) since 2001
Member of DIA (Drug Information Association) since 2005
Member of the BAPU (Belgian Association of Phase I Units) since 2005
August 1998 – September 1998: University Hospitals of Leuven: Medical Resident in
October 1998 – February 1999: University Hospitals Saint Luc, Brussels: Medical
Resident in Anesthesiology-Reanimation
February 1999 –March 2001: University Hospitals of Leuven: Medical Resident in
July 2001 – June 2006: SGS Life Sciences Services:
Clinical Research Physician/Investigator (over 60 clinical studies)
July 2006 – February 2007: Johnson&Johnson: Associate Director Clinical
February 2007 – Present: Medical Director SGS Life Sciences Services
M.D., PhD., Johannes-Gutenberg-University, Mainz, Germany
20 years of early drug development experience in the pharmaceutical and CRO
industry. Held several positions as project manager, investigator, scientific director,
Chief Scientific Officer and Chief Medical Officer at several major Clinical
Pharmacology units in Europe. Gained international management experience
working in the UK for several years. Performed approximately 500 Early Phase trials.
Brought about 45 drugs first into man and about 20 drugs first into patient.
NOV 2007 – present: PRA International, Berlin, Germany, Vice President, Clinical
Affairs, Early Development Services (EDS)
SEP 2003 – OCT 2007: Pharmacon Research GmbH, Berlin, Germany. Chief
Medical & Scientific Officer
SEP 2002 – AUG 2003: Schering AG, Berlin, Germany, Head Study Operations and
Study Management for SBU “Gynecology and Andrology” and SBU “Diagnostics and
JUL 2000 – AUG 2002: Pharmacon Research GmbH, Berlin, Germany . Senior
Director Medicine & Research
JAN 1998 – JUN 2000: Quintiles (UK) Ltd., Bracknell, UK, Director Business
Development, Worldwide Phase I Services
SEP 1998 – MAY 1999: Quintiles GmbH, Freiburg, Clinical Pharmacology Unit, Unit
JUN 1997 – DEC 1997: PAREXEL GmbH, Berlin, Germany, Director Client Relations
Phase I Services
OCT 1992 – MAR 1997: L.A.B. GmbH & Co., Neu-Ulm, Germany, Scientific Director
APR 1992 – SEP 1992: L.A.B. GmbH & Co., Neu-Ulm, Germany, Senior Scientist,
JAN 1991 – MAR 1992: Spitzner Arzneimittelfabrik GmbH, Ettlingen, Germany,
Scientist, Clinical Research
SEP 1989 – DEC 1990: L.A.B. GmbH & Co., Neu-Ulm, Germany. Project Manager,
DEC 1988 – AUG 1989: University Hospital Eppendorf, Institute of Vegetative
Physiology, Hamburg, Germany, Postdoctoral Research Fellow
Having earned his Master Degree in Inorganic Chemistry at the Freie Universität
Berlin (FUB), he then continued his education as a PhD student in Biochemistry,
which he received from the FUB in 2000. Fom 2000 to 2003 he then worked for
Noxxon Pharma AG, Berlin in business development as Manager Scientific
Marketing, Customers and Communications. Since 2003 Dr. Ruppert is Consultant
Strategic Issues Research/Development and Innovation for the Verband forschender
Arzneimittelhersteller, VFA (German Association of research-based Pharmaceutical
Companies), covering a wide range of topics, such as GCP, GMP, clinical trials
regulatory issues, communications and external relations e.g. with the JPMA and
Salles, Gilles André Dominique
M.D degree, Université Claude Bernard Lyon-1 (1989)
Board specialization in Internal Medicine (1989),
Board specialization in Oncology (1992),
Ph.D. (Immunology) , Université Claude Bernard Lyon-1 (1994)
Resident in Lyon University hospitals (1984- 1989)
Research Fellow at the Dana Farber Cancer Institute, Harvard Medical School,
Assistant Professor at University Claude Bernard Lyon-1 (1992-95)
Professor of Hematology, University Claude Bernard Lyon-1 (1996)
Present Functions and Responsibilities :
Professeur des Universités - Praticien hospitalier
Department of Hematology (Chair : Professor Bertrand COIFFIER)
Centre Hospitalier Lyon-Sud - Faculté Lyon-Nord, Université Lyon-1
Head of the Research Group “Pathologie des Cellules Lymphoïdes” affiliated with the
Laboratoire de Biologie Moléculaire de la Cellule (UMR CNRS/UCB/ENS/INRA 5239)
Past-president of the Scientific Committee and presently Treasurer of the GELA
(Groupe d’Etude des Lymphomes de l’Adulte)
President of the Research Scientific Committee of the Hospices Civils de Lyon
Active Member of the American Society of Hematology (ASH), American Society of
Clinical Oncology (ASCO), European Hematology Association (EHA), Société
Française d’Hématologie (SFH).
Co-Chair of the Lunenburg Lymphoma Biomarker Committee
Jean-Michel Scherrmann, Pharm. D., Ph. D. is professor and chair, department of
Clinical Pharmacy and Pharmacokinetics, Faculty of Pharmacy, the University of
Paris Descartes. He received his Pharm.D. and Ph. D. in analytical radiochemistry
from the University René Descartes at Paris. Currently he leads the
Neuropsychopharmacology Unit at the French Institute of Health and Medical
Research (INSERM) and the National Center of Scientific Research (CNRS).
He has been recently promoted Vice-Dean of the Faculty of Pharmacy at University
Paris Descartes and nominated Professor at the National Institute of Nuclear
Sciences and Techniques. He currently served as a scientific advisor for the Head of
the National Institute of Technologies for Health.
Pr Scherrmann has made major contributions in the development of drug
radioimmunoassay, drug detoxification by immunotherapy and drug redistribution
concepts in pharmacokinetics. He pionneered the first clinical application of
colchicine immunotherapy in acute colchicine overdoses and is now focusing his
research on the role of drug transporters in neuropharmacokinetics and on drug
delivery strategies to the brain.
His work has resulted in two patents, 290 scientific articles, 35 books chapters and
more than 250 presentations. He has served on the editorial boards of several
journals in the analytical and pharmaceutical sciences.
He has mentored over 30 postgraduate and 44 doctoral students. Pr Scherrmann
has been a recipient of the 1992 Americal Academy of Clinical Toxicology Award and
the 1999 French National Academy of Medicine Achievement Award. He is a Fellow
of the American Association of Pharmaceutical Scientists and a member of the
French National Academy of Pharmacy. He has been visiting Professor of Tohoku
University (Japan) Graduate School of Pharmaceutical Sciences in 2008.
Clinical Pharmacologist, Project Management Professional. After the studies of
medicine, in 1981 he took on the task to set up a clinical pharmacology unit at
Schering AG, Berlin and later became Head of Institute for Clinical Pharmacology. In
1998, he was appointed manager of a global reorganization program of Schering´s
drug safety units.
He is one of the founding members of Association for Applied Human Pharmacology
and former president. He is now serving as a Regent with two main areas of
competence and interest: Performance analyses of drug development and therapy
and coaching, esp. in the area of prevention and treatment of burnout syndrome.
He has run a practice for behavioral therapy and coaching in Berlin since 2007.
From 1980 to 2008 Michel SIBILLE MD, PhD was Senior Director at the Lyon based
Clinical Pharmacology Department of Rhone Poulenc Rorer, then Aventis, then
Sanofi-Aventis focussing on safety and methodology, early development plans, and
practical issues of first-entry-into-man studies. He also was Director of the
Association de Recherche Thérapeutique (ART) a clinical pharmacology unit
specialised in first- -into-man studies from 1988-2008.
Since 2003, he is in charge of the French Club Phase I Register of Serious Adverse
Events in Phase I trials. His publications comprise phase I screening methods,
healthy subject selection, adverse events in phase I, lab abnormalities in first -into-
man studies, assessment of the maximum tolerated dose.
Current activities on behalf of the university-hospital of Lyon (Hospices Civils de
Lyon) and of Lyon Biopôle: Creation of a new structure dedicated to infectious
diseases, immunology and vaccine area to support interface in-between research
(start-ups or academy/INSERM/CNRS) and hospital (early development
implementation of new biologic entities).
Dr. Torben Thomsen was born in 1954 in Prisdorf, Schleswig-Holstein, Germany and
began his academic training with his study of human medicine at the University of
Cologne. He obtained his MD with a thesis on the effects of eicosanoids on
myocardial infarction at the Pharmacological Institute of the University, under
Professor Karsten Schrör, MD. Between 1984 and 1987 he worked in the
pharmaceutical industry for the British firm Beecham-Wülfing GmbH & Co. KG in
Neuss. The main emphasis of his activities was human pharmacology in Phase-I.
In 1987, Dr. Thomsen moved to the Benjamin Franklin University Medical Center in
Steglitz, Berlin, to train as a clinical pharmacologist at the Institute for Clinical
Pharmacology, Klinikum Steglitz, where he obtained qualification as Specíalist for
Clinical Pharmacology under Professor Helmut Kewitz, MD (Prof. Dr. med. emer.).
In November 1991, Dr. Thomsen returned to the pharmaceutical industry to become
Director of the CNS Working Group for the Anglo-American company SmithKline
Beecham Pharma GmbH in Neuss, Germany.
After the management buy-out of the SKB Research Institute, Dr. Thomsen began
his self-employed career as owner and General Manager of the company Pharm
PlanNet Contract Research GmbH in Mönchengladbach, Germany, in May 1992.
Since then, he has performed hundreds of clinical trials as responsible Investigator.
Since February 1998, Dr. Thomsen was nominated as a Member of the Board of
Examiners in Clinical Pharmacology at the Medical Chamber, North Rhine,
Düsseldorf and he was confirmed in 2002 and 2006.
In February 2000, he was elected as a Regent by the Convocation of Members of the
Working Association for Applied Human Pharmacology (AGAH e.V.) and in
December 2000, he received the authorisation to train medical specialists in clinical
pharmacology from the Medical Chamber, North Rhine, Düsseldorf.
Dr. Thomsen is an active Officer in the German Naval Reserve, and has held the
rank of Commander senior grade (Medical Corps; "Flottillenarzt") following several
special training courses and exercises since December 2001.
In February 2004, he was confirmed by the Annual Convocation as a Regent of the
AGAH e.V. and since April 2004, he has additionally taken part in a
postgraduate Master Qualification Course for Applied Ethics at the Faculty of
Philosophy at the Wilhelm Westphalian University in Münster, Germany. He
completed this course after a final examination in February 2006 as a Master of
Advanced Studies in Applied Ethics (MAE). During the AGAH/ACCP Annual Meeting
2006 in February 19-21, he was elected by the Annual Convocation of members as
the President Elect of the German Association for Applied Human Pharmacology
Since July 01, 2006, Dr. Thomsen is also responsible as Managing Partner and
Spokesman of the Board of Directors of CRS Clinical Research Services
Andernach GmbH and as Managing Director of "CRS-Mönchengladbach", of "CRS-
Mannheim GmbH" as well as "CRS-Kiel GmbH". Dr. Thomsen acts as President and
CEO for the CRS-Andernach Group.
Since April 17, 2008 Dr. Thomsen is President of the German Association for Applied
Human Pharmacology (AGAH e.V.).
1967 Pharmacist, University of Paris
1969 Certificate of General and Human Biochemistry, University of Paris
1979 Certificate of Statistics applied to Medical Biology, University of Paris
1981 Certificate of Clinical Pharmacology and Pharmacokinetics, University
1982 Ph D (pharmacy), University of Nantes.
1967-1970 Intern in Hospitals of Paris
1971-1982 Head of Biochemistry-Pharmacokinetics Laboratory, Laboratoires
UPSA, Rueil Malmaison
1982-1985 International Coordinator of Clinical Pharmacology and Pharmacokinetic
Studies, ROUSSEL-UCLAF, Romainville
1985-1987 Deputy Head of Department of Pharmacokinetics and Metabolism,
1987-1991 Head of Department of Pharmacokinetics and Metabolism, ROUSSEL-
1991.1998 Director of Preclinical Health Development, ROUSSEL-UCLAF then
HMR France, Romainville, including the following Departments:
Toxicology, Pharmacokinetics (preclinical and clinical), Analytics,
Pharmaceutics, Quality Assurance, Scientific Coordination and
1998 – 1999 Scientific Advisor, DI&A, HMR France, Romainville
1999 – 2004 Pre-retired
ACTIVITIES FOLLOWING Pre-RETIREMENT/RETIREMENT
1999 External Expert : Toxicology, Toxicokinetics, Pharmacokinetics, Clinical
Pharmacology at the Agence Française de Sécurité Sanitaire des
Produits de Santé (AFSSaPS)
2000 Member of the Marketing Committee Authorisation (AFSSaPS)
Co-Chairman of the PreClinical Working Party (AFSSaPS)
Member of the Safety Working Party at the European Medical
Evaluation Agency (EMEA)
2003 Chairman of the PreClinical Working Party (AFSSaPS)
2004 Member of Drug Biomedical Research Working Party (AFSSaPS)
2008 Alternate Member of Scientific Advice Working Party Working Group
28 abstracts and posters, 25 publications, 45 conferences and teaching