Emerging Safety Science Workshop Summary (2008) / Chapter Skim
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Appendix A: Workshop Agenda
Appendix A: Workshop Agenda
Pages 117-124
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From page 117... ...
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)
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From page 118... ...
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.
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From page 119... ...
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.
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From page 120... ...
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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From page 121... ...
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.
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(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*
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From page 123... ...
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.
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Food and Drug Administration J Paul Seligman, U.S. Food and Drug Administration Ronald Krall, GlaxoSmithKline John Jenkins, U.S.
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