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August 4-6, 2009
(August 4 pre-conference workshop*, August 6-5 main conference)
Translating Toxicity Predictions from Preclinical Models to Man
The importance of predicting compound safety in humans has never been greater for the pharmaceutical industry considering recent drug withdrawals due to adverse events and a more stringent regulatory environment. While existing in vitro, organ, animal and in silico/virtual models to predict toxicity preclinically are very difficult to translate to toxicity in man, some significant recent advances have been made. This conference has been developed to provide you with only the latest data from preclinical models to predict hepatotoxicity, cardiotoxicity and muscle toxicity that are having an impact today on decisions about whether to progress a compound or withdraw it from development. Specific examples of projects translating preclinical safety predictions to the clinic will be presented to illustrate these models.
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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