Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

ACS Building, 5630 Fishers Lane, Rockville, MD

Timing of the initiation of pediatric oncology clinical studies in a drug development program

Agenda for October 17, 2002


8:00 Call to order and Introduction Victor M. Santana, M.D., Chair

Welcome Richard Pazdur, M.D.,
Director, Division of Oncology Drug Products

Conflict of Interest Thomas H. Perez, M.P.H., Executive Secretary

8:15 Charge to Committee Steven Hirschfeld, M.D, PhD., Medical Officer
Division of Oncology Drug Products

8:20 Preclinical Models: What can they tell us Peter Houghton, Ph.D.

8:35 Applying Preclinical Data to Clinical Studies Edward Sausville, M.D.

8:45 Applying Preclinical Data to Clinical Studies Patrick C. Reynolds, M.D.

8:55 Committee Discussion

Current Practice

9:10 Children's Oncology Group Perspective Peter Adamson, M.D.

9:20 Industry Perspective Steve Weitman, M.D.

9:30 European Perspective Bruce Morland, M.D.

9:35 European Perspective Joachim Boos, M.D.

9:40 Committee Discussion

9:55 Break

Identifying & Overcoming Barriers:

10:10 Children’s Oncology Group Perspective Gregory Reaman, M.D.

10:20 National Cancer Institute Perspective Barry Anderson, M.D. Ph.D.

10:30 Children’s Hospital & Specialty Group Perspective Susan Blaney, M.D.

10:40 Industry Perspective David Emanuel, M.D.

10:50 Industry Perspective Wayne Rackoff, M.D.

10:55 Patient & Family Perspective Ruth Hoffman

11:05 Committee Discussion

12:00 Lunch

1:00 Open Public Hearing

2:00 Questions to the Panel

4:00 Adjourn