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



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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 5

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58 ESTABLISHMENT OF REGULATORY SCIENCE FOR DRUG DEVELOPMENT 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

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59 APPENDIX A 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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