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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AEI Participants

 

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

 

Tomas J.
Philipson
  • Tomas J. Philipson is a visiting scholar at AEI and the Daniel Levin Chair in the Irving B. Harris Graduate School of Public Policy as well as an associate member of the department of economics at the University of Chicago. He was a senior health care adviser to the 2008 presidential campaign of John McCain and served in the Bush administration as the senior economic adviser to the commissioner of the Food and Drug Administration from 2003 to 2004 and subsequently as the senior economic adviser to the administrator of the Centers for Medicare & Medicaid Services from 2004 to 2005. Mr. Philipson is an editor of Forum for Health Economics & Policy and is on the editorial board of Health Economics and The European Journal of Health Economics. He has twice been the recipient of the highest honor of his field, the Kenneth Arrow Award from the International Health Economics Association, in 2000 and 2006.  Mr. Philipson is the cofounder of Precision Health Economics, is an adviser to the Gerson Lehrman Group, and is a consultant for Compass-Lexecon and Analysis Group.
  • Email: t-philipson@uchicago.edu
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