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Emerging Safety Science: Workshop Summary (2008)

Chapter: Appendix A: Workshop Agenda

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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Emerging Safety Science: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11975.
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Emerging Safety Science: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11975.
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Page 118
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Emerging Safety Science: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11975.
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Page 119
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Emerging Safety Science: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11975.
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Page 120
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Emerging Safety Science: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11975.
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Page 121
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Emerging Safety Science: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11975.
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Page 122
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Emerging Safety Science: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11975.
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Page 123
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Emerging Safety Science: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11975.
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Page 124

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Appendix A Workshop Agenda Emerging Safety Science April 23–24, 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 8:30–8:35 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 8:35–8:45 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 System–Based Approaches to Signaling and Biology 8:45–9:40 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    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    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.    15 min. Discussion

APPENDIX A 119 Biomarkers of Toxicity in Drug Discovery and Development 9:40–12:30 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    20 min. Toxicogenomics and Assessment of Drug Pharmacology Using Microarrays Mark Cockett Vice President, Applied Genomics Bristol-Myers Squibb Company    20 min. Application of Toxicogenomics to Drug Discovery and to Preclinical Safety Assessment Don Halbert Executive Vice President of Research and Development Iconix Pharmaceuticals 10:20–10:35 Break    20 min.  Practical Application of Toxicogenomics in Early Drug Discovery Brian Spear Director, Genomic and Proteomic Technologies Abbott Laboratories    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    20 min. Integration of Preclinical, Clinical, and Postmarket Safety Data Philip MacLaughlin Senior Product Manager, Pharmaceutical Development Elsevier    20 min. Qualification of Drug-Induced Nephrotoxicity Biomarkers Jacky Vonderscher  Vice President, Head of Exploratory Development in Europe Novartis    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    15 min. Discussion 12:30–1:30 Lunch Metabolomics in Drug Safety 1:30–2:25 Moderator: Shiew-Mei Huang Deputy Director Office of Clinical Pharmacology Center for Drug Evaluation and Research U.S. Food and Drug Administration    20 min. Metabolomics as an Emerging Technology in Drug Safety Assessment Michael Milburn Chief Scientific Officer Metabolon, Inc.

APPENDIX A 121    20 min. Targeted Metabolomics in Pharmacodynamics and Toxicology Klaus M. Weinberger Chief Scientific Officer Biocrates Life Sciences    15 min. Discussion Targeted Therapy 2:25–3:20 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    30 min. ALK5: Targeted Investigations of a Targeted Therapy— Using Laser Capture Microdissection, Flow Cytometry, Immunohistochemical Approaches, and Genomics Kendall Frazier ������������������������������������������� Director of Cellular & Molecular Pathology GlaxoSmithKline, Safety Assessment    25 min. Discussion 3:20–3:35 Break Abacavir: A Working Example of PGx Investigation of Drug-Related Adverse Events 3:35–4:15 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    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    10 min. Discussion Where Is the Science Taking Us? 4:15–4:45 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 23–24, 2007 FDA White Oak Conference Center Silver Spring, MD Tuesday, April 24: Data Mining from Medical Experience Welcome and Opening Remarks 8:30–8:45 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 8:45–11:00 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    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    30 min. Statistical Issues in the Analysis of Spontaneous Report Databases William DuMouchel Chief Statistical Scientist Lincoln Technologies    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 10:15–10:30 Break    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? 11:00–11:30 Moderator: Edward Holmes    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 11:30–12:00 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

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In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients.

Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval.
Emerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop.
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