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November 28, 2001
ODAC MEMBERS
Stephen L. George, Ph.D. 6/30/05
Professor of Biostatistics
Department of Biostatistics and Bioinformatics
Box 3958
Hanes House, Room 219
Trent Drive at Erwin Road
Duke University Medical Center
Durham, NC 27710
Donna Przepiorka, MD, PhD 6/30/04
Associate Professor of Medicine
Center for Cell and Gene Therapy
Baylor College of Medicine
6565 Fannin Street, M964
Houston, Texas 77030
EXECUTIVE SECRETARY (Acting)
Kimberly L. Topper, MS
Advisors & Consultants Staff, HFD-21
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
(301) 827-7001 FAX (301) 827-6776
Topperk@cder.fda.gov
Consumer Representative
Jody L. Pelusi, F.N.P., Ph.D. 6/30/03
Phoenix Indian Medical Center
4212 North 16th Street
Phoenix, AZ 85016
AD HOC MEMBERS
CHAIRMAN
Victor M. Santana, MD
Associate Professor
Department of Hematology/Oncology
The University of Tennessee
St. Jude Children’s Research Hospital
332 North Lauderdale
Memphis, Tennessee 38101
James M. Boyett, Ph.D.
Chair, Dept. of Biostatistics & Epidemiology
St. Jude Children’s Research Hospital
332 North Lauderdale Street
Memphis, Tennessee 38105
Susan L. Cohn, MD
Associate Professor of Pediatrics
Northwestern University Medical School
Box 30, 2300 Children’s Place
Chicago, Illinois 60614
Alice Ettinger, MSN, RN, CPON, CPNP
St. Peter’s University Hospital
254 Easton Avenue
New Brunswick, New Jersey 08901
Jerry Z. Finklestein, MD
Clinical Professor of Pediatrics/UCLA
Jonathan Jacques Children’s Cancer Center
Long Beach Memorial Cancer Center
2653 Elm Avenue, Suite 200
Long Beach, California 90801
Henry S. Friedman, MD
James B. Powell, Jr. Professor of Neurosurgery
Duke University Medical Center
Trent Drive, Baker House, Room 047
Durham, North Carolina 27710
C. Patrick Reynolds, MD, PhD
Professor of Pediatrics
Division of Hematology/Oncology
Children’s Hospital of Los Angeles
4650 Sunset Boulevard
Los Angeles, California 90801
PATIENT ADVOCATES
Nancy Keene
4167 Elizabeth Lane
Annandale, Virginia 22003
Susan L.Weiner, PhD
The Children’s Cause, Inc.
1010 Wayne Avenue, Suite 505
Silver Spring, Maryland 20910
ONCOLOGIC DRUGS ADVISORY COMMITTEE PEDIATRIC SUBCOMMITTEE
November 28, 2001
Consultant (voting) Peter C. Adamson, MD Children's Hospital of Philadelphia 3516 Civic Center Blvd. Abramson Bldg, Room 907 Philadelphia, PA 19104 Guest Speakers (non-voting)
Steven Goodman, MD, MHS, Ph.D.
Associate Professor of Oncology, Pediatrics, Epidemiology and Biostatistics
Department of Oncology, Division of Biostatistics
Johns Hopkins School of Medicine
550 N. Broadway, Suite 1103
Baltimore, MD 21205
J. Steven Leeder, Pharm.D., Ph.D.
Chief, Section of Developmental Pharmacology and Experimental Therapeutics
Division of Clinical Pharmacology and Toxicology
Children's Mercy Hospital and Clinics
2401 Gillham Road
Kansas City, MO 64108
Mary V. Relling
Member, Department of Pharmaceutical Sciences
St. Jude Children's Research Hospital
332 N. Lauderdale
Memphis, TN 38101
Clinton F. Stewart, Pharm.D.
Associate Member
Department of Pharmaceutical Sciences
332 N. Lauderdale
St. Jude Children's Research Hospital
Memphis, TN 38105
Guests (non-voting)
Dr. Mark Bernstein
Hematology
St. Justine Hospital
3175 Cote St. Catherine Road
Montreal, Quebec
Canada H3T 1C5
Charles A. Coltman, Jr. M.D.
President and C.E.O
Cancer Therapy Research Center
8122 Datapoint Dr., Suite 600
San Antonio, TX 78229-3219
Edward L. Korn, Ph.D.
Head, Clinical Trial Section
Biometrics Research Branch
Executive Plaza North, Room 8128
National Cancer Institute
Bethesda, MD 20892
ONCOLOGIC DRUGS ADVISORY COMMITTEE PEDIATRIC SUBCOMMITTEE
November 28, 2001
Guests (non-voting) Cont.
Malcon Smith, M.D., Ph.D.
Rm. 741
Executive Park North
Bethesda, MD 20892
Eric Kodish, MD. Ph.D.
Director, Rainbow Center for Pediatric Ethics
Associate Professor
Pediatrics, Oncology and Biomedical Ethics
Rainbow Babies and Children's Hospital Room 340
11100 Euclid Avenue
Cleveland, OH 44106-6054
Frank Balis, MD
Mailing Address: Pediatric
National Cancer Institute , NIH
10 Center Drive, Bldg. 10/Rm. 13N240
Bethesda, MD 20892-1928
Eric Keith Rowinsky, M.D.
Director, Clinical Research
Institute for Drug Development
Cancer Therapy and Research Center
8122 Datapoint Drive, Suite 700
San Antonio, Texas 78229
INDUSTRY GUESTS (non-voting)
Wayne Rackoff, M.D.
Jansen Research Foundation
1125 Trenton-Harbourton Road
Room E-31908
Titusville, New Jersey 08560
Martine F. Bayssas, M.D.
DEBIOPHARM S.A.
17, rue des Terreaux
1000 Lausanne 9
Switzerland
FDA Presenters
Steven Hirschfeld, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Richard Pazdur, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
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