Food and Drug Administration
Center for Biologics Evaluation and Research
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
MEETING #34, FEBRUARY 27, 2003
Holiday Inn, Silver Spring, Maryland
Executive Secretary Committee
Management Specialist
Gail Dapolito Rosanna
L. Harvey
Scientific Advisors & Consultants Staff Scientific Advisors &
Consultants Staff
Center for Biologics Evaluation and Research Center for Biologics Evaluation and Research
Food and Drug Administration (HFM-71) Food and Drug Administration (HFM-71)
1401 Rockville Pike 1401 Rockville Pike
Rockville, MD 20852-1448 Rockville, MD 20852-1448
Phone: (301)
827-1289 Phone: (301) 827-1297
Fax: (301)
827-0294 Fax: (301) 827-0294
E-mail: dapolito@cber.fda.gov E-mail: harvey@cber.fda.gov
MEMBERS
CHAIR
Daniel R. Salomon, M.D. 03/31/03 Jonathan
S. Allan, D.V.M. 03/31/06
Associate Professor Scientist
Department of Molecular and Experimental Medicine Department
of Virology and Immunology
The Scripps Research Institute Southwest
Foundation for Biomedical Research
10550 N. Torrey Pines Road, MEM 55 7620
N.W. Loop 410 at Military Drive
La Jolla, CA
92037 San
Antonio, TX 77030
Bruce R. Blazar, M.D. 03/31/05+ David M. Harlan, M.D. 03/31/06
Professor Head
Division of Pediatric Bone Marrow Transplantation and Autoimmunity
Branch
Transplantation/Oncology National
Institute of Diabetes and Digestive
University of Minnesota and Kidney Disease, NIH
420 Delaware Street, SE, Box 109 10 Center Drive, Building 10, Room 11S210
Minneapolis, MN
55455 Bethesda,
MD 20892
Katherine A. High, M.D. 03/31/05 Joanne Kurtzberg, M.D. 03/31/04
William H. Bennett Professor of Pediatrics Professor of Pediatrics
University of Pennsylvania Pediatric Bone Marrow and Stem Cell
Program
Children's Hospital of Philadelphia Duke University Medical Center
310 Abramson Research Center Box 3350
3615 Civic Center Boulevard 2400 Pratt Street
Philadelphia, PA
19104 Durham, NC 27710
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
MEMBERS (Cont'd)
Alison F. Lawton* 03/31/05 Richard C. Mulligan, Ph.D. 03/31/04
Senior Vice President Mallinckrodt
Professor of Genetics
Regulatory Affairs Harvard
Medical School
Genzyme Corporation Children's
Hospital
One Kendall Square Department
of Molecular Medicine
Cambridge, MA
02139 320
Longwood Avenue
Boston, MA 02115
Mahendra S. Rao, M.D., Ph.D. 03/31/05 Anastasios A. Tsiatis, Ph.D. 03/31/06
Chief, Stem Cell Biology Section Professor
Laboratory of Neurosciences, 4B17 Department of Statistics
Gerontology Research Center North
Carolina State University
National Institute on Aging, NIH Box 8203
5600 Nathan Shock Dr. 2501 Founders Drive
Baltimore, MD
21224 Raleigh,
NC 27695
Alice J. Wolfson, J.D. ** 03/31/04 * - Industry Representative
Bourhis, Wolfson and Schlichtmann ** - Consumer Representative
1050 Battery Street + - Not Attending
San Francisco, CA
94111
TEMPORARY VOTING MEMBERS
Mary
M. Horowitz, M.D. Harvey G. Klein, M.D.
Professor
of Medicine Chief
International
Bone Marrow Transplant Registry Department
of Transfusion Medicine
Autologous
Blood and Marrow Transplant National
Institutes of Health
Registry Warren G. Magnuson Clinical Center
Health
Policy Institute Building
10, Room 1C711
Medical
College of Wisconsin 10
Center Drive
8701
Watertown Plank Road, HRC Suite 2500 Bethesda, MD 20892
Milwaukee,
WI 53226
Jeanne
V. Linden, M.D. David F. Stroncek, M.D.
Director Chief,
Laboratory Service Section
Blood
and Tissue Resources Department
of Transfusion Medicine
New
York State Department of Health National
Institutes of Health
Wadsworth
Center Warren
G. Magnuson Clinical Center
Empire
State Plaza Building
10, Room 1C733
Albany,
NY 12201 10
Center Drive
Bethesda,
MD 20892
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
NIH
REPRESENTATIVE
Liana
Harvath, Ph.D.
Director
Blood
Resources Program
Division
of Blood Diseases and Resources
National
Heart, Lung and Blood Institute
Rockledge
II, Room 10170
6701
Rockledge Drive
Bethesda,
MD 20892
GUEST
SPEAKERS
Nelson
J. Chao, M.D., M.B.A. Pablo Rubinstein, M.D.
Professor Director
Department
of Medicine National Cord Blood Program
Duke
University Medical Center New York Blood Center
Box
3961 310 E. 67th Street
Durham,
NC 27710 New York, NY 10021
John
E. Wagner, M.D.
Associate
Professor of Pediatrics
University
of Minnesota School of Medicine
660C
Cancer Center Research Building
Box
366 UMHC
420
Delaware Street, S.E.
Minneapolis,
MN 55455
FDA PARTICIPANTS
Philip
D. Noguchi, M.D. Ruth Solomon, M.D.
Acting
Director Acting
Director
Office
of Cellular, Tissue and Gene Therapies Division
of Human Tissues, OCTGT
Center
for Biologics Evaluation and Research Center
for Biologics Evaluation and Research
Food
and Drug Administration Food and
Drug Administration
1401
Rockville Pike, HFM-515 1401
Rockville Pike, HFM-770
Rockville,
MD 20852 Rockville,
MD 20852
Ellen
F. Lazarus, M.D. Stephen D. Litwin, M.D.
Reviewing
Medical Officer Medical Officer
Division
of Clinical Evaluation and Division of Clinical Evaluation and
Pharmacology and Toxicology
Pharmacology and Toxicology
Office
of Cellular, Tissue and Gene Therapies Office
of Cellular, Tissue and Gene Therapies
Food
and Drug Administration Food and
Drug Administration
1401
Rockville Pike, HFM-770 1401
Rockville Pike, HFM-755
Rockville,
MD 20852 Rockville,
MD 20852
BRMAC
#34 CBER Working Group
February
27, 2003
Dr.
Philip Noguchi
Dr.
Joyce Frey-Vasconcells
Dr.
Ruth Solomon
Dr.
Ellen Lazarus
Dr.
Steve Litwin
Dr.
Cynthia Rask
Dr.
Martha Wells
Dr.
Ellen Areman
Dr.
Jean Wang