Food and Drug Administration
Center for Drug Evaluation and Research
Pediatric Subcommittee
of the Oncologic Drugs Advisory Committee
Best Western Washington Gateway Hotel
1251West Montgomery Avenue
Rockville, Maryland
Agenda
April 24, 2001
8:00 Call to Order and Opening Remarks Victor Santana, M.D.
Chair, Pediatric Subcommittee of ODAC
Welcome Richard Pazdur, MD
Director, Division of Oncology Drug Products
Introduction of Committee
Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Executive Secretary, ODAC
8:15 Open Public Hearing ( 30 minutes allocated unless public participation does not last that long )
8:45 Charge to the Committee Steven Hirschfeld, MD, PhD
Medical Officer, DODP
8:50 Challenges in Reviewing Adult and Pediatric Leukemiasand Considerations in Linking Adult and Pediatric Leukemias
David Poplack, MD
Baylor College of Medicine
9:15 Challenges and Considerations in Linking Adult and Pediatric Lymphomasin Reviewing Adult and Pediatric Lymphomas
Sharon B. Murphy, MD
Children’s Memorial Hospital, Chicago
9:40 Discussion
10:00 Break
10:15 Perspectives on Myeloid Leukemias David Head, MD
The Vanderbilt Clinic
Irwin Bernstein, MD
10:45 Discussion
11:45 Lunch
12:30 Open Public Hearing ( 30 minutes allocated unless public participation does not last that long )
1:00 Perspectives on Lymphoid Leukemias Michael J. Borowitz, MD, PhD
Johns Hopkins University
Charles Schiffer, MD
Wayne State University School of Medicine
1:30 Discussion
2:00 Perspectives on Lymphomas Stefania Pattiluga, MD
National Cancer Institute
Robert E. Hutchison, MD
Upstate Medical University
2:30 Break
2:45 Discussion
3:40 Summary Comments Robert J. Arceci, MD, PhD
Johns Hopkins Oncology Center
4:00 Adjourn