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Exploratory Clinical Development World Americas 2008
23 - 25 September 2008
Conference:
Day 1
24 Sept 8am - 5:30pm
Day 2
25 Sept 8am - 5:30pm
Workshops: 23 September
Venue has changed
The Philadelphia Hilton City Avenue Hotel, Philadelphia, United States
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ITGR Biomarker Group Scientist,
Genetech, Inc
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Director and Principal Consultant CNS Services,
Parexel
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Jr. Distisnguished Lilly Scholar,
Eli Lilly & Co
Dr. Beasley’s internship was in the Department of Psychiatry, Yale University and he completed his training in psychiatry at the University of Cincinnati in 1987. He immediately joined Eli Lilly and Company in the area of clinical development of psychiatric medications. He was responsible for Prozac from the time of its US launch through 1991 working extensively on the topic of the potential for SSRI medications to induce suicidality. During this period of time he was also responsible for the development program for atomxetine as an antidepressant (program terminated) during which he developed a particular interest in placebo response and trial design. From 1991 through 2001 he was responsible for the development of Zyprexa as a treatment for schizophrenia. From 2001 through 2002 he served as Medical Director for Cialis. Since 2003 he has served as a consultant across all therapeutic areas in both experimental design and safety, initially from a position in the Neuroscience area and since 2004 in Global Patient Safety. He has particular interest in three areas of safety: suicide; hepatic dysfunction; and delay in ventricular repolarization and the design of “Trough QT Studies”.
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Associate Director, Modeling and Simulation, Global Phase I, Clinical Pharmacology,
Quintiles, Inc.
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Vice President, Early Development and Clinical Pharmacology,
Wyeth Research
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Director Oncology Biomarker Group,
Bristol Myer Squibb
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Senior Director & Head of Imaging Programmes,
Eisai Inc
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Professor, Sir Colin Dollery, Senior R&D consultant,
GSK
Sir Colin Dollery graduated from Birmingham University with honours degrees in physiology and in medicine. He spent almost all his academic career at the Royal Postgraduate Medical School at Hammersmith Hospital and established one of the world-leading departments of clinical pharmacology. His clinical interest was particularly in the treatment of hypertension both in early phase studies and in the large scale clinical trials conducted by the MRC. Later in his career he was successively Chairman of the Department of Medicine and Dean of the Medical School. He had a prominent national and international role in clinical pharmacology and pharmacology and was the first (and so far the only) clinical pharmacologist to become President of the International Union of Pharmacology. He was the managing Editor of the two volume reference book, “Therapeutic Drugs”. He is still a member of the receptor nomenclature committee of IUPHAR (NC-IUPHAR). He served on many public committees including the UK Committee on Safety of Medicines, Medical Sub-Committee of the University Grants Committee (Chairman) and the Physiological Systems Board (Chairman) of the Medical Research Council.
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Manager, Modeling and Simulation, Global Phase I, Clinical Pharmacology,
Quintiles, Inc.
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Chief Executive Officer,
Xceleron
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Associate Director, Modelling and Simulation,
Novartis Inc
Dr. Anna Georgieva is an associate director in the Department of Modeling and Simulations, part of CD&MA at Novartis Pharmaceuticals. She provides modeling support for compounds in both clinical and pre-clinical development to better understand mechanism of action and help in the discovery of markers of both efficacy and toxicity. Dr. Georgieva has worked on implementing and further developing different types of system-based models, ranging from signal transduction pathways to network inference and cardiac electrophysiology. Dr. Georgieva holds a PhD in Applied Mathematics from Duke University.
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Executive Director, Clinical Pharmacology Unit,
AstraZeneca Pharmaceuticals
Dr. Hollister earned a Ph.D. in Pharmacology and an M.D. at the University of North Carolina, trained in Internal Medicine at the University of Florida and in Clinical Pharmacology at Vanderbilt University. He served on the faculty in the Departments of Medicine and Pharmacology at Vanderbilt University and the University of Colorado for 15 years where he performed basic and clinical research in the cardiovascular area, taught Cardiovascular Pharmacology, Physiology, Clinical Pharmacology, and Medicine. His clinical specialties are hypertension and autonomic dysfunction, and he was twice elected to the “Best Doctors in America”. Dr. Hollister developed the Human Physiology Laboratories at Vanderbilt and the University of Colorado Clinical Research Centers, and organized and directed the Clinical Trials Office at the University of Colorado. In 1998 he entered industry and has worked for Bayer, Sanofi-Synthelabo, and GlaxoSmithKline prior to joining AstraZeneca in May 2006 to establish the U.S. Clinical Pharmacology Unit. Dr. Hollister has specialized in the design and execution of “Thorough QT” studies and early Phase I studies that elucidate drug action and safety.
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Associate Director, dvanced PK/PD Modelling Simulation,
Johnson & Johnson
Dr. Hui Kimko works at Johnson & Johnson Pharmaceutical Research & Development in New Jersey as a member of Advanced Pharmacokinetic/Pharmacodynamic Modeling and Simulation Department since 2002. She teaches at School of Pharmacy of Rutgers University as an adjunct professor. Before joining the company, she was a faculty at the Center for Drug Development Science of Georgetown University Medical School in Washington, D.C.
She got her PhD from the State University of New York at Buffalo on Pharmacokinetic and Pharmacodynamic Modeling of Direct and Indirect Responses under the mentorship of Dr. William Jusko. She edited the book titled Simulation for Designing Clinical Trials: A Pharmacokinetic/Pharmacodynamic Modeling Perspective (published by Marcel Dekker, Inc. 2003). The book explains how to optimize clinical trial design via pharmacokinetic-pharmacodynamic modeling and clinical trial simulation in order to enhance study success rate and, in return, help reduce the cost of conducting trials with human subjects. Optimization of clinical trial designs via modeling & simulation is her current interest.
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Director, Clinical Pharmacology and Head of Quatative Clinical Pharmacology,
Merck & Co
At Merck, he is heads the quantitative clinical pharmacology group within the department in addition to being involved in the clinical development of new molecular entities in the cardiovascular and metabolic diseases therapeutic areas. Prior to his current position at Merck, he was employed at Bristol-Myers Squibb, Inc., and at Aventis Pharmaceuticals, Inc. in the Clinical Discovery and Clinical PK/PD departments, respectively. He received his Bachelor of Pharmacy degree (University of Kerala) and a Master of Pharmacy degree (Institute of Technology, BHU) from India, a Master of Science degree in clinical pharmacy, biopharmaceutics and pharmacokinetics from the University of British Columbia, Canada, and a Doctor of Philosophy degree in advanced therapeutics/medical oncology from British Columbia Cancer Research Centre and the University of British Columbia, Canada. He is an elected Fellow of the American College of Clinical Pharmacology (ACCP) and a member of the American Society for Clinical Pharmacology and Therapeutics and the American Association of Pharmaceutical Scientists (AAPS).
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Deputy Head, GMPK Frankfurt and Head of Metabolism / In Vitro Systems,
Sanofi Aventis
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Head of Bioinformatics,
Johnson & Johnson
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Director, Modeling and Simulation, Global Phase I, Clinical Pharmacology,
Quintiles, Inc.
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Senior Associate,
RH Bouchard & Associates
Since joining the consulting firm R H Bouchard & Associates in 2005, Ms. Newbould has provided outsourcing and contract/budget negotiations for major Pharmaceutical and Biotech companies as well as CROs. Prior to joining the firm, Lynn was the Director of R&D Global Contracting at Centocor, Inc., a subsidiary of Johnson & Johnson. She has 11 years of experience with contracts and outsourcing for the pharmaceutical and biotech industry. Prior to that, Lynn spent 15 years negotiating contracts for major corporations including RJR Nabisco and Cadbury Schweppes, as well as a major Wall Street law firm, Fried Frank Harris Shriver & Jacobson. She currently lives in Malvern, Pennsylvania, with her husband and two children.
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Executive Director Medical Science,
Amgen Inc
Dr. Patterson returned to Amgen Inc., California in 2003 and is an Executive Director in the Medical Sciences function leading the Molecular Sciences department (with the Computational Biology department also reporting into him). Medical Sciences is responsible for conducting first-in-human studies through to Phase 2a for all therapeutic areas in the company, and Molecular Sciences is part of this function to enable biochemical determination of whether the targeted pathway is being interdicted, whether exposure:response relationships can be generated (to inform dose ranging), and in which patient populations the therapeutic may be more efficacious (should that be necessary). He is well known in the field of protein chemistry, and is one of the pioneers in the field of proteomics. He has published extensively and is a frequent guest lecturer. After leaving Amgen in 2000, he served as Vice President of Proteomics at the Celera Genomics Group and then as Chief Scientific Officer of Farmal Biomedicines, LLC.
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Chief Scientific Officer,
Pharmaceutical Profiles
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Chief Medical Officer,
Caridio DX, Inc
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Director, Translational Science, Global PK-PD & Bioanalysis,
Medimmune Inc.
Dr. Tabrizi has broad experience in research and development with particular interest in development of biologics and monoclonal antibodies. He has served in numerous scientific and managerial positions and the scope of his product development activities has included therapeutic areas such as oncology, and inflammatory diseases. Prior to MedImmune (a wholly owned subsidiary of AstraZeneca) and AstraZeneca Pharmaceutical LP, he held various positions at Amgen Fremont Inc. (formerly Abgenix, Inc.), Coulter Pharmaceutical Inc., and TAP holdings Inc. His work has been focused on preclinical safety studies, preclinical and clinical pharmacokinetics, GLP-compliant bioanalytics, and clinical pharmacology of therapeutic monoclonal antibodies with experience in translational sciences and integration of pharmacokinetics and pharmacodynamics in drug development strategies. Dr. Tabrizi received his bachelor’s degree in Pharmacy from University of Houston and his PhD from University at Buffalo, State University of New York (SUNY) in the area of Pharmacokinetics and Pharmaceutical Sciences. He completed postdoctoral training in pharmacology at SUNY with a focus on therapeutics. He has been an author or co-inventor on over 25 original papers, reviews, book chapters, and patents and has been an invited speaker to numerous national and international conferences.
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Managing Director,
Richmond Pharmacology Ltd
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Associate Director, Clinical Translational Medicine,
Wyeth Research
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Head of Exploratory Medicine,
Merck Serono
Before being appointed Head of Exploratory Medicine Frank was the Corporate Chief Medical Officer at Merck and Merck Serono and Head of the GCDU Fertility, Endocrinology. Before Frank held several senior management position as the Global Head of Experimental Medicine and Development Management. Prior to joining Merck, Dr. Weber worked as a Medical Director at MedNet / Münchner Rück. He has also worked for the Synthelabo Group and Lederle Pharmaceuticals in various management positions. He received his MD PhD from the Medical University of Cologne.
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Professor Sir Colin Dollery
Senior R&D Consultant
GlaxoSmithKline
Dr Alan Hollister
Executive Director, Clinical Pharmacology Unit
AstraZeneca
Dr Frank Weber
Head of Exploratory Medicine
Merck Serono
Dr Scott Patterson
Executive Director for Medical Science
Amgen
Dr Thorir Bjornsson
Vice President, Early Development and Clinical Pharmacology
Wyeth Research
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