**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]{.underline} [Committee Management
Specialist]{.underline}**

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]{.underline}**

**[CHAIR]{.underline}**

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**

## Meeting #34, February 27, 2003

**[MEMBERS]{.underline} (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]{.underline}**

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**

## Meeting #34, February 27, 2003

**[NIH REPRESENTATIVE]{.underline}**

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]{.underline}**

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. 67^th^ 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]{.underline}**

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]{.underline}**

**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