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 |
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 |
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:
|
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:
|
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 |