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PAPERBACK price:$21.00 add to cart Rights & Permissions Free PDF Access Sign in to download PDF book and chapters Free Resources PDF SUMMARY Display this book on your site! Related Titles The Future of Drug Safety: Promoting and Protecting the Health of the Public Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary Other Related Titles Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary (2011) Board on Health Sciences Policy (HSP) Citation Manager Export the bibliographic data for this book in your chosen format 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. Citation Manager Lebovitz, Yeonwoo, English, Rebecca, Claiborne, Anne. "Appendix A: Agenda." Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press, 2011. Please select a format: Page 57   E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore 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 Agenda Building a National Framework for the Establishment of Regulatory Science for Drug Development February 26, 2010 National Academy of Sciences Building Lecture Room 2100 C Street NW Washington, DC 8:00–8:15 OPENING REMARKS   Drug Forum Co-Chairs:   Gail Cassell, Eli Lilly and Company Jeffrey Drazen, New England Journal of Medicine 8:15–8:45 REGULATORY SCIENCE: OVERVIEW   Moderator: Jeffrey Drazen, New England Journal of Medicine   Garret FitzGerald, Institute for the Translational Medicine and Therapeutics, University of Pennsylvania 8:45–9:15 KEYNOTE SPEAKER   Congresswoman Rosa DeLauro (D-CT) 9:15–10:00 FDA INITIATIVES ON REGULATORY SCIENCE   Margaret Hamburg, FDA Commissioner 10:00–10:15 Break Page 57 Front Matter (R1-R16) 1 Introduction (1-4) 2 Defining Regulatory Science (5-12) 3 The Urgent Need for Regulatory Science (13-22) 4 Barriers to Enhanced Regulatory Science (23-30) 5 Potential Models for Building a Regulatory Science Infrastructure (31-38) 6 Challenges in Engaging the Public Policy Community (39-44) 7 Envisioning Successful Regulatory Science at FDA (45-48) 8 Considering Next Steps (49-52) References (53-56) Appendix A: Agenda (57-60) Appendix B: Participant Biographies (61-78)

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OCR for page 57
Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary Appendix A Agenda Building a National Framework for the Establishment of Regulatory Science for Drug Development February 26, 2010 National Academy of Sciences Building Lecture Room 2100 C Street NW Washington, DC 8:00–8:15 OPENING REMARKS   Drug Forum Co-Chairs:   Gail Cassell, Eli Lilly and Company Jeffrey Drazen, New England Journal of Medicine 8:15–8:45 REGULATORY SCIENCE: OVERVIEW   Moderator: Jeffrey Drazen, New England Journal of Medicine   Garret FitzGerald, Institute for the Translational Medicine and Therapeutics, University of Pennsylvania 8:45–9:15 KEYNOTE SPEAKER   Congresswoman Rosa DeLauro (D-CT) 9:15–10:00 FDA INITIATIVES ON REGULATORY SCIENCE   Margaret Hamburg, FDA Commissioner 10:00–10:15 Break

OCR for page 58
Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary 10:15–11:30 Session I: OPPORTUNITIES FOR ENHANCING REGULATORY SCIENCE   Moderator: Mark McClellan, The Brookings Institution   The IOM and FDA Science Board Recommendations   Gail Cassell, Eli Lilly and Company   Academic Perspective   Philip Pizzo, Stanford University School of Medicine, Council of Deans, Association of American Medical Colleges   A Blueprint from the Patient’s Perspective   Ellen Sigal, Friends of Cancer Research 11:30–11:45 Break and Working Lunch Guests are asked to pick up lunch and return to their seats. 11:45–1:15 Session II: OPPORTUNITIES FOR ENHANCING REGULATORY SCIENCE (cont’d)   Moderator: Barbara Alving, National Center for Research Resources, NIH   Translational Approaches to Understand and Predict Rare Adverse Reactions to Drugs   Paul Watkins, Hamner–University of North Carolina Institute for Drug Safety Sciences   A Role for Regulatory Science in Emerging Technologies: Genomics   Allen Roses, Deane Drug Discovery Institute, Duke University   Opportunities in Statistical Design, Analysis, and Modeling   Susan Ellenberg, University of Pennsylvania School of Medicine   IT Infrastructure, Informatics and Scientific Computing in Regulatory Science   Sangtae Kim, Morgridge Institute for Research

OCR for page 59
Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary 1:15–2:15 Panel I: A COMPARISON OF EXISTING AND POTENTIAL MECHANISMS FOR PROMOTING REGULATORY SCIENCE   Moderator: Peter Honig, FDA and Merck (ret.)   Panelists: Jesse Goodman, FDA Dale Nordenberg, Novasano Health and Science Judith Kramer, Clinical Trials Transformation Initiative, Duke University Margaret Anderson, FasterCures Harry Greenberg, Stanford University School of Medicine 2:15–2:30 Break 2:30–3:15 Panel II: ENERGIZING PUBLIC POLICY TO ADVANCE THE SCIENCE   Moderator: Janet Tobias,1 Ikana Media   Panelists: Steven Grossman, HSP Group and Alliance for a Stronger FDA Michael Manganiello, HCM Strategists Mary Woolley, Research! America 3:15–3:45 HHS PERSPECTIVE   Protecting the Public through Regulatory Science—A National Priority   William Corr, HHS Deputy Secretary 3:45–4:00 SUMMARY AND NEXT STEPS   Gail Cassell, Eli Lilly and Company 1 Unable to attend the workshop due to weather.

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Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary This page intentionally left blank.