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Appendix A Workshop Agenda Emerging Safety Science April 23â24, 2007 FDA White Oak Conference Center Silver Spring, MD Workshop Objective: Safety science is a rapidly changing field, leading to new developments in the methods and technologies used to detect and interpret safety signals. Predictive tools are needed to accurately screen out candidates, early in development, that are most likely to have seri- ous, undesired effects and identify those most likely to become safe and effective treatments. The goal of this workshop is to present and collab- oratively discuss novel, cutting-edge methodologies and techniques that are being used by academicians, researchers, drug manufacturers, and regulatory scientists. It will also explore how this new knowledge and technology may be applied for both drug development and postapproval regulatory/safety review processes. Day 1 (Emerging Safety Science: Biol- ogy of Adverse Events) will cover primarily preclinical safety issues, and Day 2 (Emerging Safety Science: Data Mining from the Medical Experi- ence) will focus on postmarket surveillance/pharmacovigilance topics. Monday, April 23: The Biology of Adverse Events Welcome and Opening Remarks 8:30â8:35 Edward Holmes, Workshop Chair Co-Chair, Forum on Drug Discovery, Development, and Translation Executive Deputy Chairman A*Star Biomedical Research Council, National University of Singapore 117
118 EMERGING SAFETY SCIENCE Meeting Objectives: Merging New Science and Drug Review 8:35â8:45 Steve Galson Member, Forum on Drug Discovery, Development, and Translation Director, Center for Drug Evaluation and Research U.S. Food and Drug Administration Janet Woodcock Member, Forum on Drug Discovery, Development, and Translation Deputy Commissioner and Chief Medical Officer U.S. Food and Drug Administration Human Cell SystemâBased Approaches to Signaling and Biology 8:45â9:40 Moderator: David Jacobson-Kram Associate Director for Pharmacology and Toxicology Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration ââ 20 min. Drug Evaluation in Human Cell-Systems: Biology- Based Models of Physiology and Disease Eugene Butcher Cofounder and Chair of the Scientific Advisory Board, Bioseek Professor, Department of Pathology Stanford University School of Medicine ââ 20 min. High-Throughput, High-Content Cellular Screening for Definition of Drug Mechanisms, Selectivity, and Safety John K. Westwick President and CSO Odyssey Thera, Inc. ââ 15 min. Discussion
APPENDIX A 119 Biomarkers of Toxicity in Drug Discovery and Development 9:40â12:30 Moderator: Federico Goodsaid Senior Staff Scientist in Genomics Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research U.S. Food and Drug Administration ââ 20 min. Toxicogenomics and Assessment of Drug Pharmacology Using Microarrays Mark Cockett Vice President, Applied Genomics Bristol-Myers Squibb Company ââ 20 min. Application of Toxicogenomics to Drug Discovery and to Preclinical Safety Assessment Don Halbert Executive Vice President of Research and Development Iconix Pharmaceuticals 10:20â10:35 Break ââ 20 min. Practical Application of Toxicogenomics in Early Drug Discovery Brian Spear Director, Genomic and Proteomic Technologies Abbott Laboratories ââ 20 min. Gene Expression Profiling in Rat Exploratory Toxicology Studies: Why and Where Is It Useful? Eric Blomme Project Leader, Cell and Molecular Toxicology Abbott Laboratories
120 EMERGING SAFETY SCIENCE ââ 20 min. Integration of Preclinical, Clinical, and Postmarket Safety Data Philip MacLaughlin Senior Product Manager, Pharmaceutical Development Elsevier ââ 20 min. Qualification of Drug-Induced Nephrotoxicity Biomarkers Jacky Vonderscher Vice President, Head of Exploratory Development in Europe Novartis ââ 20 min. The Transition from Preclinical to Clinical Application of Safety-Related Genomics Felix Frueh Associate Director for Genomics Office of Clinical Pharmacology Center for Drug Evaluation and Research U.S. Food and Drug Administration ââ 15 min. Discussion 12:30â1:30 Lunch Metabolomics in Drug Safety 1:30â2:25 Moderator: Shiew-Mei Huang Deputy Director Office of Clinical Pharmacology Center for Drug Evaluation and Research U.S. Food and Drug Administration ââ 20 min. Metabolomics as an Emerging Technology in Drug Safety Assessment Michael Milburn Chief Scientific Officer Metabolon, Inc.
APPENDIX A 121 ââ 20 min. Targeted Metabolomics in Pharmacodynamics and Toxicology Klaus M. Weinberger Chief Scientific Officer Biocrates Life Sciences ââ 15 min. Discussion Targeted Therapy 2:25â3:20 Moderator: George Rochester Lead Mathematical Statistician Quantitative Safety & Pharmacoepidemiology Group Office of Biostatistics Center for Drug Evaluation and Research U.S. Food and Drug Administration ââ 30 min. ALK5: Targeted Investigations of a Targeted Therapyâ Using Laser Capture Microdissection, Flow Cytometry, Immunohistochemical Approaches, and Genomics Kendall Frazier ������������������������������������������� Director of Cellular & Molecular Pathology GlaxoSmithKline, Safety Assessment ââ 25 min. Discussion 3:20â3:35 Break Abacavir: A Working Example of PGx Investigation of Drug-Related Adverse Events 3:35â4:15 Moderator: Kendall Marcus Medical Team Leader, Division of Antiviral Products Center for Drug Evaluation and Research U.S. Food and Drug Administration
122 EMERGING SAFETY SCIENCE ââ 30 min. Abacavir: A Working Example of PGx Investigation of Drug-Related Adverse Events Eric Lai Vice President PGx Experimental Project Coordination and Analysis GlaxoSmithKline ââ 10 min. Discussion Where Is the Science Taking Us? 4:15â4:45 Moderator: Edward Holmes Drug Forum Panel Discussion: Janet Woodcock, U.S. Food and Drug Administration Mikhail Gishizky, Entelos, Inc. Peter Corr, Pfizer, Inc. (retired) Thomas Caskey, University of Texas HSC at Houston Emerging Safety Science April 23â24, 2007 FDA White Oak Conference Center Silver Spring, MD Tuesday, April 24: Data Mining from Medical Experience Welcome and Opening Remarks 8:30â8:45 Edward Holmes, Workshop Chair Co-Chair, Forum on Drug Discovery, Development, and Translation Executive Deputy Chairman A*Star Biomedical Research Council, Singapore
APPENDIX A 123 Janet Woodcock M ember, Forum on Drug Discovery, Development, and Translation Deputy Commissioner and Chief Medical Officer U.S. Food and Drug Administration Approaches to Pharmacovigilance and Signal Detection 8:45â11:00 Moderators: Paul Seligman Associate Director for Safety Policy and Communication Center for Drug Evaluation and Research U.S. Food and Drug Administration Gerald Dal Pan Director, Office of Surveillance and Epidemiology Center for Drug Evaluation and Research U.S. Food and Drug Administration ââ 30 min. Signal Management Through the Product Life Cycle June S. Almenoff Vice President, Safety Evaluation and Risk Management Global Clinical Safety and Pharmacovigilance GlaxoSmithKline ââ 30 min. Statistical Issues in the Analysis of Spontaneous Report Databases William DuMouchel Chief Statistical Scientist Lincoln Technologies ââ 30 min. Active Surveillance for Anticipated Adverse Events: Opportunities and Challenges Richard Platt Professor and Chair Harvard Medical School and Harvard Pilgrim Health Care
124 EMERGING SAFETY SCIENCE 10:15â10:30 Break ââ 30 min. Panel Discussion June Almenoff, GlaxoSmithKline William DuMouchel, Lincoln Technologies Richard Platt, Harvard Medical School Ana Szarfman, U.S. Food and Drug Administration Judith Racoosin, U.S. Food and Drug Administration Where Is the Science Taking Us? 11:00â11:30 Moderator: Edward Holmes ââ 30 min. Summing Up: Improving Safety Science to Make Better Medicines Ronald Krall Member, Forum on Drug Discovery, Development, and Translation Senior Vice President and Chief Medical Officer GlaxoSmithKline 11:30â12:00 Panel Discussion anet Woodcock, U.S. Food and Drug Administration J Paul Seligman, U.S. Food and Drug Administration Ronald Krall, GlaxoSmithKline John Jenkins, U.S. Food and Drug Administration Mary Prince Panaccio, Merck 12:00 Adjourn