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 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

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 (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

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