Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary (2011)
Chapter: Appendix A: Agenda
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
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8:00–8:15 |
OPENING REMARKS |
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Drug Forum Co-Chairs: |
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Gail Cassell, Eli Lilly and Company Jeffrey Drazen, New England Journal of Medicine |
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8:15–8:45 |
REGULATORY SCIENCE: OVERVIEW |
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Moderator: Jeffrey Drazen, New England Journal of Medicine |
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Garret FitzGerald, Institute for the Translational Medicine and Therapeutics, University of Pennsylvania |
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8:45–9:15 |
KEYNOTE SPEAKER |
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Congresswoman Rosa DeLauro (D-CT) |
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9:15–10:00 |
FDA INITIATIVES ON REGULATORY SCIENCE |
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Margaret Hamburg, FDA Commissioner |
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10:00–10:15 |
Break |
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10:15–11:30 |
Session I: OPPORTUNITIES FOR ENHANCING REGULATORY SCIENCE |
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Moderator: Mark McClellan, The Brookings Institution |
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The IOM and FDA Science Board Recommendations |
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Gail Cassell, Eli Lilly and Company |
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Academic Perspective |
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Philip Pizzo, Stanford University School of Medicine, Council of Deans, Association of American Medical Colleges |
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A Blueprint from the Patient’s Perspective |
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Ellen Sigal, Friends of Cancer Research |
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11:30–11:45 |
Break and Working Lunch Guests are asked to pick up lunch and return to their seats. |
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11:45–1:15 |
Session II: OPPORTUNITIES FOR ENHANCING REGULATORY SCIENCE (cont’d) |
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Moderator: Barbara Alving, National Center for Research Resources, NIH |
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Translational Approaches to Understand and Predict Rare Adverse Reactions to Drugs |
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Paul Watkins, Hamner–University of North Carolina Institute for Drug Safety Sciences |
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A Role for Regulatory Science in Emerging Technologies: Genomics |
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Allen Roses, Deane Drug Discovery Institute, Duke University |
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Opportunities in Statistical Design, Analysis, and Modeling |
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Susan Ellenberg, University of Pennsylvania School of Medicine |
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IT Infrastructure, Informatics and Scientific Computing in Regulatory Science |
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Sangtae Kim, Morgridge Institute for Research |
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1:15–2:15 |
Panel I: A COMPARISON OF EXISTING AND POTENTIAL MECHANISMS FOR PROMOTING REGULATORY SCIENCE |
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Moderator: Peter Honig, FDA and Merck (ret.) |
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Panelists:
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2:15–2:30 |
Break |
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2:30–3:15 |
Panel II: ENERGIZING PUBLIC POLICY TO ADVANCE THE SCIENCE |
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Moderator: Janet Tobias,1 Ikana Media |
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Panelists:
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3:15–3:45 |
HHS PERSPECTIVE |
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Protecting the Public through Regulatory Science—A National Priority |
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William Corr, HHS Deputy Secretary |
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3:45–4:00 |
SUMMARY AND NEXT STEPS |
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Gail Cassell, Eli Lilly and Company |
