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PAPERBACK list:$36.00 Web:$32.40 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters Display this book on your site! Related Titles The Future of Drug Safety: Promoting and Protecting the Health of the Public Challenges for the FDA: The Future of Drug Safety, Workshop Summary Other Related Titles Emerging Safety Science: Workshop Summary (2008) Board on Health Sciences Policy (HSP) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 117   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. 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 Page 117 Front Matter (R1-R16) 1 Introduction (1-4) 2 Investigative Toxicology: The State of the Art (5-12) 3 Screening Technologies I: Human Cell–Based Approaches (13-27) 4 Screening Technologies II: Toxicogenomics (28-49) 5 Screening Technologies III: Metabolomics (50-58) 6 Screening Technologies IV: Pharmacogenetics (59-64) 7 Qualifying Biomarkers (65-73) 8 Pharmacovigilance (74-92) 9 Integration (93-105) 10 The Future of Safety Science (106-114) References (115-116) Appendix A: Workshop Agenda (117-124) Appendix B: Speaker Biographies (125-134)

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OCR for page 117
Emerging Safety Science: Workshop Summary 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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Emerging Safety Science: Workshop Summary 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

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Emerging Safety Science: Workshop Summary 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

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Emerging Safety Science: Workshop Summary 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.

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Emerging Safety Science: Workshop Summary 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

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Emerging Safety Science: Workshop Summary 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

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Emerging Safety Science: Workshop Summary JANET WOODCOCK Member, 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

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Emerging Safety Science: Workshop Summary 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 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