Oncology Drug Development: Rethinking FDA Oversight
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.

For audio and video recordings from the second day of this event, please go here.

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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AEI Participants

 

John E.
Calfee
  • Economist John E. Calfee (1941-2011) studied the pharmaceutical industry and the Food and Drug Administration (FDA), along with the economics of tobacco, tort liability, and patents. He previously worked at the Federal Trade Commission's Bureau of Economics. He had also taught marketing and consumer behavior at the business schools of the University of Maryland at College Park and Boston University. While Mr. Calfee's writings are mostly on pharmaceutical markets and FDA regulation, his academic articles and opinion pieces covered a variety of topics, from patent law and tort liability to advertising and consumer information. His books include Prices, Markets, and the Pharmaceutical Revolution (AEI Press, 2000) and Biotechnology and the Patent System (AEI Press, 2007). Mr. Calfee wrote regularly for AEI's Health Policy Outlook series. He testified before Congress and federal agencies on various topics, including alcohol advertising; biodefense vaccine research; international drug prices; and FDA oversight of drug safety.

 

Richard
Epstein

 

Scott
Gottlieb
  • Scott Gottlieb, M.D., a practicing physician, has served in various capacities at the Food and Drug Administration, including senior adviser for medical technology; director of medical policy development; and, most recently, deputy commissioner for medical and scientific affairs. Dr. Gottlieb has also served as a senior policy adviser at the Centers for Medicare & Medicaid Services. 

    Click here to read Scott’s Medical Innovation blog.


    Follow Scott Gottlieb on Twitter.

  • Phone: 202.862.5885
    Email: scott.gottlieb@aei.org
  • Assistant Info

    Name: Kelly Funderburk
    Phone: 202.862.5920
    Email: Kelly.Funderburk@AEI.org
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