Oncology Drug Development: Rethinking FDA Oversight
Day Two
About This Event

While controversy has raged over the Food and Drug Administration’s (FDA) handling of drug safety, a lower-profile but equally important debate has centered on the FDA’s role in the development and commercialization of the most innovative kinds of new drug treatments for cancer and other conditions that have long defied researchers. The celebrated new tools of molecular biology, matched with new thinking about clinical trials and statistical analysis, have opened the door to faster development, testing, and approval of cancer drugs. But moving innovative new cancer drugs from laboratory to bedside has taken longer than almost anyone expected, especially for such dramatic innovations as the harnessing of the immune system to fight cancer.

At this conference, experts from academia, the National Institutes of Health, and the pharmaceutical research industry will be joined by current and former FDA officials, including former commissioners David Kessler and Mark B. McClellan. Participants will address some of the thorniest issues in cancer drug development, including clinical trial design, statistical analysis of trial results, and the feedback from FDA decisions to the drug development process.

This event is cosponsored by AEI and the University of Chicago Law School.

Agenda
March 13
8:15 a.m.
Registration and Breakfast
8:30 a.m.
Welcome:
John E. Calfee, AEI
Scott Gottlieb, M.D., AEI
8:45 a.m.
Panel I: FDA Regulation and the R&D Environment
Panelists:
Richard A. Epstein, University of Chicago Law School
Richard Miller, M.D., Pharmacyclics
Moderator:
Tomas Philipson, AEI and University of Chicago
10:15 a.m.
Panel II: Clinical Trial Design
Panelists:
David Alberts, M.D., Arizona Cancer Center
James Doroshow, M.D., National Cancer Institute
Gwen Fyfe, M.D., Genentech
Moderator:
Bruce Cheson, M.D., Georgetown University Hospital
12:15 p.m.
Luncheon
Keynote Speaker:
Andrew C. von Eschenbach, M.D., Food and Drug Administration
1:30 p.m.
Panel III: Statistical Issues in Analyzing Clinical Trial Data
Panelists:
Anup Malani, University of Chicago Law School
Richard Simon, National Institutes of Health
Mark van der Laan, University of California, Berkeley
Moderator:
John E. Calfee, AEI
3:30 p.m.
Panel IV: Puzzles in FDA Standards for Oncology Drug Approval
Panelists:
John E. Calfee, AEI
Ken Carson, M.D., Feinberg School of Medicine, Northwestern University
Robert Ward, George Washington University School of Medicine
Moderator:
Richard Miller, M.D., Pharmacyclics
5:00 p.m.
Adjournment and Reception
March 14
9:00 a.m.
Panel V: FDA Past, Present, and Future
Panelists:
Nancy L. Buc, Buc and Beardsley
Scott Gottlieb, M.D., AEI
David Kessler, M.D., University of California, San Francisco, School of Medicine
Mark B. McClellan, M.D., AEI and Brookings Institution
Douglas Throckmorton, M.D., Food and Drug Administration
Moderator:
Richard A. Epstein, University of Chicago Law School
11:15 a.m.
Roundtable Discussion among Speakers
Moderator:
John E. Calfee, AEI
12:30 p.m.
Adjournment
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