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