Food and Drug Administration

**Center for Biologics Evaluation and Research**

**BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE**

**MEETING #35 - TELECONFERENCE**

**NIH Campus -- Building 29A, Conference Room 1A09**

**June 9, 2003**

**[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

Mahendra S. Rao, M.D., Ph.D. 03/31/05 Jonathan Allan, D.V.M. 03/31/06

Chief, Stem Cell Biology Section Scientist

Laboratory of Neurosciences, 4B17 Department of Molecular and
Experimental Medicine

Gerontology Research Center Department of Virology and Immunology

National Institute on Aging, NIH Southwest Foundation for Biomedical
Research

5600 Nathan Shock Dr. 7620 N.W. Loop 410 at Military Drive

Baltimore, MD 21224 San Antonio, TX 77030

Bruce R. Blazar, M.D. 03/31/05 Katherine A. High, M.D. 03/31/05

Professor William H. Bennett Professor of Pediatrics

Division of Pediatric Bone Marrow University of Pennsylvania

University of Minnesota Children\'s Hospital of Philadelphia

420 Delaware Street, SE, Box 109 310 Abramson Research Center

Minneapolis, MN 55455 3615 Civic Center Boulevard

> Philadelphia, PA 19104

Joanne Kurtzberg, M.D. 03/31/04 Alison F. Lawton**^\*^** 03/31/05

Professor of Pediatrics Senior Vice President

Department of Pediatrics Regulatory Affairs

Duke University Medical Center Genzyme Corporation

Box 3350, Suite 1400 North Pavilion One Kendall Square

Durham, NC 27710 Cambridge, MA 02139

Richard C. Mulligan, Ph.D. 03/31/04 Anastasios A. Tsiatis, Ph.D.
03/31/06

Mallinckrodt Professor of Genetics Professor

Department of Genetics Department of Statistics

Harvard Medical School North Carolina State University

Children\'s Hospital Box 8203

861 Enders Building 2501 Founders Dr.

Boston, MA 02115 Raleigh, NC 27695

**Food and Drug Administration**

## Center for Biologics Evaluation and Research

**BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE**

**[MEMBERS]{.underline} (cont'd)**

Alice J. Wolfson, J.D. **^\*\*^** 03/31/04 David M. Harlan, M.D.
03/31/06

Wolfson and Schlichtmann Head

1050 Battery Street Transplantation and Autoimmunity Brach

San Francisco, CA 94111 National Institute of Diabetes and Digestive

and Kidney Disease, NIH

\*Industry Representative (not attending) 10 Center Drive building 10,
Room 11S210

\*\* Consumer Representative Bethesda, MD 20892

> **[FDA PARTICIPANTS]{.underline}**
>
> Kathryn M. Carbone, M.D. Philip Noguchi, M.D.
>
> Acting Associate Director for Research Director

Center for Biologics Evaluation and Research Office of Cellular, Tissue
and Gene Therapies

> Food and Drug Administration Center for Biologics Evaluation and
> Research
>
> 1401 Rockville Pike (HFM-20) Food and Drug Administration
>
> Rockville, MD 20852 1401 Rockville Pike (HFM-700)
>
> Rockville, MD 20852
>
> Raj K. Puri, M.D., Ph.D. Steven Bauer, Ph.D.
>
> Acting Director Acting Chief
>
> Division of Cell and Gene Therapies Laboratory of Stem Cell Biology
>
> Office of Cellular, Tissue and Gene Therapies Division of Cell and
> Gene Therapies, 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-530) 1401 Rockville Pike (HFM-521)
>
> Rockville, MD 20852 Rockville, MD 20852
>
> Suzanne Epstein, Ph.D. Deborah Hursh
>
> Chief Senior Staff Fellow
>
> Laboratory of Immunology and Laboratory of Immunology and
> Developmental
>
> Developmental Biology Biology
>
> Division of Cell and Gene Therapies, OCTGT Division of Cell and Gene
> Therapies, 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-521) 1401 Rockville Pike (HFM-521)
>
> Rockville, MD 20852 Rockville, MD 20852
>
> Malcolm Moos, M.D., Ph.D.
>
> Medical Officer
>
> Laboratory of Immunology and Developmental Biology
>
> Division of Cell and Gene Therapies, OCTGT
>
> Center for Biologics Evaluation and Research
>
> Food and Drug Administration
>
> 1401 Rockville Pike (HFM-527)
>
> Rockville, MD 20852