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August 4-6, 2009
(August 4 pre-conference workshop*, August 6-5 main conference)
从人体临床前期模型到毒性预测之转译
近来制药业界，由于不利的事件以及日益严苛的法规环境使得药物中止使用，造成预测化合物安全性一事，展现出前所未见之重要性。利用试管试验、生物实验、动物实验、计算机模拟/虚拟模型实验等，对于在临床前期阶段预测转译对人体之毒性，仍是相当的困难。可是，最近已有几个重要的进步，在这个会议中将提供参加者临床前期模型之最新信息，藉以预测肝毒性，心毒性，肌毒性等，对于决定化合物继续开发或是中止带来重大之影响。转译临床前期安全预测到临床试验之特定案例将用来说明这些模型。
Why You Should Attend:
- Find out which preclinical models of toxicity are having a concrete impact on decision-making to progress or withdraw compounds and which are not
- Learn from experts in a special session on mitochondrial-mediated hepatotoxicity, cardiotoxicity and muscle toxicity
- Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
- Hear the latest on safety biomarker qualifications and current regulatory pathways
Confirmed Speakers and Sessions
(As of March 10, 2009)
Pre-Conference Workshop
Drug-Induced Mitochondrial Dysfunction
- Yvonne Will, Ph.D., Senior Principal Scientist, Compound Safety Prediction, Worldwide Medicinal Chemistry, Pfizer Global R&D
- James Dykens, Ph.D., Drug Safety R&D, Pfizer, Inc. (Invited)
- Vamsi Mootha, M.D., Associate Professor of Systems Biology and Medicine, Massachusetts General Hospital and Harvard Medical School
- Hirdesh Uppal, Ph.D., Research Scientist, Investigative Toxicology, Non-Clinical Drug Safety, Roche Pharmaceuticals Palo Alto
Main Conference
Keynote
- William B. Mattes, Ph.D., Director of Toxicology, The Critical Path Institute
Improving Hepatoxicity Models
- Eric Tien, Ph.D., Senior Scientist, Pfizer, Inc.
- Katsutoshi Yoshizato, Ph.D., Guest Professor, Osaka City University and Academic Advisor, Phoenixbio Co., Japan
- Carl L. Alden, DVM, Vice President, Drug Safety Evaluation, Millennium, The Takeda Oncology Company
Biomarker Development: Regulatory Perspectives
- Wendy R. Sanhai Ph.D., Senior Scientific Advisor, Office of the Commissioner, FDA
- George Q. Mills, M.D., Vice President, Medical Imaging Consulting, Perceptive Informatics (PAREXEL) and Former FDA Division Director, Medical Imaging and Hematology Products, Office of Oncology Drug Products, CDER, FDA
- Shawnmarie Mayrand-Chung, Ph.D., NIH Program Director, The Biomarkers Consortium Public-Private Partnership Program, National Institutes of Health
Improving Models of Cardiovascular Toxicity
- Ralf Kettenhofen, Ph.D., Senior Scientist, Axiogenesis AG, Germany
- Yasuyuki Asai, Ph.D., Chief Technology Officer, ReproCELL, Inc., Japan
- Vivek (Vic) Kadambi, Ph.D., Senior Director, Drug Safety Evaluation, Millennium, The Takeda Oncology Company
Emerging Technologies and Models to Improve Predictivity from Preclinical to Clinical
- Donna L. Mendrick, Ph.D., Director, Division of Systems Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration
- Colin D A Brown, Ph.D., Associate Professor, Institute for Cell & Molecular Biosciences, Medical School, University of Newcastle, United Kingdom
Point-Counterpoint Debate: Are Animal Models of Disease Predictive of Human Drug Safety?
- Alain Stricker-Krongrad, Ph.D., Chief Scientific Officer, Preclinical Sciences, Charles River Laboratories, Inc.
- Vivek (Vic) Kadambi, Ph.D., Senior Director, Drug Safety Evaluation, Millennium: The Takeda Oncology Company
- Colin D A Brown, Ph.D., Associate Professor, Institute for Cell & Molecular Biosciences, Medical School, University of Newcastle, United Kingdom
- Lauren E. Black, Director Charles River Laboratories
Case Studies of Translational Approaches to Assess Clinical Compound Safety: From Preclinical Models to Man
- James H. Stoltz, Director, Experimental Pathology, Boehringer Ingelheim Pharmaceuticals, Inc.
- Josef Scheiber, Ph.D., Research Investigator, Knowledge Engineering Consultant, Novartis Pharma, Switzerland
- Hugo Vargas, Ph.D., Director, Investigative Safety Pharmacology, Amgen
- Michael Gralinski, Ph.D., CEO, CorDynamics
- Eric Blomme, Ph.D., Project Leader, Cellular and Molecular Toxicology, Abbott Laboratories
- Alan G.E. Wilson, Ph.D., Vice President, Drug Metabolism, Pharmacokinetics, Toxicology and Pathology, Lexicon Pharmaceuticals
- Kathleen Meyer, Ph.D., Director of Toxicology, Xoma (Invited)
Making Better Decisions on Compound Selection and De-Selection from Preclinical Safety Data: Systems Biology, Computational and in silico Approaches
- William Kluwe, Global Head of Safety Assessment, Translational Sciences, Preclinical Safety, Novartis Institutes for Biomedical Research
- David Cook, Ph.D., Associate Director, Safety Informatics and Modeling, Global Safety Assessment, AstraZeneca, United Kingdom
- Keith O. Elliston, Ph.D., Co-Founder, President and CEO, Genstruct
- Mohammad Afshar, M.D., Ph.D., Ariana Pharma, France
Scientific Advisory Board
Vivek Kadambi, Senior Director, Drug Safety Evaluation, Millennium Pharmaceuticals, The Takeda Oncology Company
Lisa Minor, Ph.D., Principal Scientist, Johnson & Johnson Pharmaceutical R&D
Isabelle Morize, Ph.D., Head of Drug Design 1, Chemical & Analytical Sciences, Sanofi-Aventis
Alain Stricker-Krongrad, Ph.D., Chief Scientific Officer, Preclinical Sciences, Charles River Laboratories
Maryam Rafie-Koplin, Principal Scientist, Preclinical Safety, Synta Pharmaceuticals
Alan G.E. Wilson, PhD, Vice President, Drug Metabolism, Pharmacokinetics, Toxicology and Pathology, Lexicon Pharmaceuticals
Yvonne Will, Ph.D., Senior Principal Scientist, Compound Safety Prediction, Worldwide Medicinal Chemistry, Pfizer Global R&D
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