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  • 1. Speakers in alphabetical order (with short biograph where available) Belorgey Chantal Bérard Frédéric Bone M Bonnefoy Jean-Yves Caplain Henri Chapuis F Chassard Didier Cortez Pierre de Zeeuw Rokus A Donazzolo Yves Franchimont N Forrat Rémy Grossmann Matthias Hinze Christian Janssens W Jones David Klingmann Ingrid Könen - Bergmann Michael Laurijssens Bart E Mant Timothy Nicolas Jean-Francois Patat Alain Paty Isabelle Pinquier Jean-Louis Ramael Steven Reh Christian Ruppert Thorsten Salles Gilles Schermann Jean-Michel Sciberras David Seifert Wolfgang Sibille Michel Sudhop Thomas Täubel Jörg Tomsen Thorben Tremblay D Voiriot Patrick Ward J Zühlsdorf Michael
  • 2. Belorgey, Chantal Head of Department of Evaluation of Clinical Trials and Special Status Medicinal Products, Afssaps, France Biography : - 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 development Currently : - 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 Commission - Co rapporteur on European Guidelines on clinical trials (mainly CTA and SUSAR reporting guideline).
  • 3. Bérard, Frédéric 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. University Degrees - 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 2004-2009 - Head of Clinical Immunology and Allergology Department, CHU Lyon-Sud 2009- - Professor of Clinical Immunology, Claude Bernard University, Lyon I 2007- Memberships - 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
  • 4. Bonnefoy, Jean-Yves 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. Training ∗ 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. Scientific Memberships ∗ American Association for the Advancement of Science ∗ American Association of Immunologists ∗ Société Française d'Immunologie ∗ Collegium Internationale Allergologicum Other Memberships 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) »
  • 5. Member of the European Society for Cancer Immunology and Immunotherapy (ESCII) 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 Strasbourg 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 Autoimmunity Cancer Immunology & Immunotherapy Cell adhesion and communication Cellular Immunology Clinical and Experimental Immunology European Journal of Dermatology Gene Immunology letters Immunology Today Journal of Allergy and Clinical Immunology Journal of Experimental Medicine Journal of Immunology Nature Science Thorax 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)
  • 6. European Expert DG12 FP5 and FP6 (EU) Member of the investment board of “INSERM Transfert Développement”
  • 7. Caplain, Henri 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- Longjumeau, France. 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- Longjumeau, France. 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
  • 8. 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 functional explorations. 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, Paris, France 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
  • 9. Since 2005 Member of the American Society of Clinical Pharmacology and Therapeutics – ASCPT Since 2003 Member of the AGAH (Association for Applied Human Pharmacology), Germany 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) – CPI Since 1995 Member of the French Society of Clinical Pharmacology and Therapeutics – SFP Since 1991 Member of the French Pharmaceutical Industry Association – AMIPS Update
  • 10. Chassard, Didier 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.
  • 11. Cortez, Pierre 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.
  • 12. 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.
  • 13. Forrat, Rémi (bitte separates pdf einfügen)
  • 14. Hinze, Christian 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 Pharmaceutical Medicine. Publications include own scientific work in CNS drugs and other indications, GCP and regulatory aspects in scientific journals and as a book editor.
  • 15. 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.
  • 16. Klingmann, Ingrid 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.
  • 17. Könen-Bergmann, Michael Education: 1984-1986: Mathematics at Fernuniversität Hagen 1986-1992: Medicine at Bonn University, 1992 at University of Michigan, Ann Arbor Professional Career: 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 Degrees: 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
  • 18. 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 neuroscience portfolio.
  • 19. Mant, Timothy 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.
  • 20. Nicolas, Jean-François 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.
  • 21. Patat, Alain 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, Rennes, France. 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).
  • 22. Pinquier, Jean-Louis 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.
  • 23. Ramael, Steven M.D. in Surgery and Obstetrics, Katholieke Universiteit Leuven, 1998 Limburgs Universitair Centrum 1991-1994 Katholieke Universiteit Leuven 1994-1998 Postgraduate Studies: 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, 1998-2000 Emergency Medicine, Inter University Course, VU Brussels, 2001-2002 PHARMED seminars 1 – 8, ULB, Brussels, Belgium, 2003-2004 Memberships: 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 Employment History: August 1998 – September 1998: University Hospitals of Leuven: Medical Resident in Anesthesiology-Reanimation 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 Anesthesiology-Reanimation 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 Pharmacology February 2007 – Present: Medical Director SGS Life Sciences Services
  • 24. Reh, Christian 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. Employment History: 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 Radiopharmaceuticals” 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 Head (acting) 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 Human Pharmacology APR 1992 – SEP 1992: L.A.B. GmbH & Co., Neu-Ulm, Germany, Senior Scientist, Regulatory Affairs 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, Clinical Pharmacology
  • 25. DEC 1988 – AUG 1989: University Hospital Eppendorf, Institute of Vegetative Physiology, Hamburg, Germany, Postdoctoral Research Fellow
  • 26. Ruppert, Thorsten 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 EFPIA.
  • 27. 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, Boston (1990-92) 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
  • 28. Scherrmann, Jean-Michel 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.
  • 29. Seifert, Wolfgang 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.
  • 30. Sibille, Michel 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).
  • 31. Thomsen, Torben 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.
  • 32. 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 (AGAH e.V.). 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.).
  • 33. Tremblay, Dominique 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 of Paris 1982 Ph D (pharmacy), University of Nantes. PROFESSIONAL EXPERIENCE 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, ROUSSEL-UCLAF, Romainville 1987-1991 Head of Department of Pharmacokinetics and Metabolism, ROUSSEL- UCLAF, Romainville 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 Documentation 1998 – 1999 Scientific Advisor, DI&A, HMR France, Romainville 1999 – 2004 Pre-retired 2004 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)
  • 34. 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 (EMEA) 28 abstracts and posters, 25 publications, 45 conferences and teaching