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 serious, undesired effects and identify those most likely to become safe and effective treatments. The goal of this workshop is to present and collaboratively 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: Biology of Adverse Events) will cover primarily preclinical safety issues, and Day 2 (Emerging Safety Science: Data Mining from the Medical Experience) 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



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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 Edward HolmEs, Workshop Chair 8:30–8:35 Co-Chair, Forum on Drug Discoery, Deelopment, and Translation Executive Deputy Chairman A*Star Biomedical Research Council, National University of Singapore 

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 EMERGING SAFETY SCIENCE Meeting Objectives: Merging New Science and Drug Review 8:35–8:45 stEvE Galson Member, Forum on Drug Discoery, Deelopment, and Translation Director, Center for Drug Evaluation and Research U.S. Food and Drug Administration JanEt woodcock Member, Forum on Drug Discoery, Deelopment, and Translation Deputy Commissioner and Chief Medical Officer U.S. Food and Drug Administration Human Cell System–Based Approaches to Signaling and Biology Moderator: david Jacobson-kram 8:45–9:40 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

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 APPENDIX A Biomarkers of Toxicity in Drug Discovery and Development Moderator: FEdErico Goodsaid 9:40–12:30 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

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0 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 Moderator: sHiEw-mEi HuanG 1:30–2:25 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.

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 APPENDIX A 20 min. Targeted Metabolomics in Pharmacodynamics and Toxicology klaus m. wEinbErGEr Chief Scientific Officer Biocrates Life Sciences 15 min. discussion Targeted Therapy Moderator: GEorGE rocHEstEr 2:25–3:20 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 Moderator: kEndall marcus 3:35–4:15 Medical Team Leader, Division of Antiviral Products Center for Drug Evaluation and Research U.S. Food and Drug Administration

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 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? Moderator: Edward HolmEs 4:15–4:45 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 Edward HolmEs, Workshop Chair 8:30–8:45 Co-Chair, Forum on Drug Discoery, Deelopment, and Translation Executive Deputy Chairman A*Star Biomedical Research Council, Singapore

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 APPENDIX A JanEt woodcock Member, Forum on Drug Discoery, Deelopment, and Translation Deputy Commissioner and Chief Medical Officer U.S. Food and Drug Administration Approaches to Pharmacovigilance and Signal Detection Moderators: 8:45–11:00 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

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 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? Moderator: Edward HolmEs 11:00–11:30 30 min. Summing Up: Improving Safety Science to Make Better Medicines ronald krall Member, Forum on Drug Discoery, Deelopment, and Translation Senior Vice President and Chief Medical Officer GlaxoSmithKline Panel Discussion 11:30–12:00 JanEt woodcock, U.S. Food and Drug Administration 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