FOOD AND DRUG ADMINISTRARION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

SUBCOMMITTEE MEETING OF THE

BLOOD PRODUCTS ADVISORY COMMITTEE

HOLIDAY INN GAITHERSBURG HOTEL

BALLROOMS

JULY 22, 2005

ADMINISTRATIVE TEAM

William Freas, Ph.D.

Division of Scientific Advisors & Consultants

Center for Biologics Evaluation and Research

Food and Drug Administration, HFM-71

1401 Rockville Pike

Rockville, MD 20852-1448

Pearline Muckelvene

Committee Management Specialist

Scientific Advisors & Consultants Staff

Center for Biologics Evaluation and Research

Food and Drug Administration, HFM-71

1401 Rockville Pike

Rockville, MD 20852-1448

Donald Jehn

Blood Products Advisory Committee

Policy and Publication Staff

Office of Blood Research and Review

Center for Biologics Evaluation and Research

Food and Drug Administration, HFM-302

1401 Rockville Pike

Rockville, MD 20852-1448

FDA PARTICIPANTS

Kathryn M. Carbone, M.D.

Associate Director for Research

Center for Biologics Evaluation and Research

Food and Drug Administration, HFM-20

1401 Rockville Pike

Rockville, MD 20852-1448

Hira L. Nakhasi, Ph.D.

Acting Associate Director for Science

Office of Blood Research and Review

Center for Biologics Evaluation and Research

Food and Drug Administration, HFM-310

8800 Rockville Pike

Bethesda, MD 20892

Jonathan C. Goldsmith, M.D.

Deputy Director

Office of Blood Research and Review

Center for Biologics Evaluation and Research

Food and Drug Administration, HFM-310

8800 Rockville Pike

Bethesda, MD 20892

Jay S. Epstein, M.D.

Director, Office of Blood Research and Review

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike

Rockville, MD 20852-1448

Alan Williams, Ph.D.

Director, Division of Blood Applications

Office of Blood Research and Review

Center for Biologics Evaluation and Research

Food and Drug Administration, HFM-310

8800 Rockville Pike

Bethesda, MD 20892

FOOD AND DRUG ADMINISTRARION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

SUBCOMMITTEE MEETING OF THE

BLOOD PRODUCTS ADVISORY COMMITTEE

HOLIDAY INN GAITHERSBURG HOTEL

BALLROOMS

JULY 22, 2005

SITE VISIT TEAM

James R. Allen, M.D., M.P.H.

Chair, Site Visit Team & BPAC

President and CEO

American Social Health Association

P.O. Box 13827

Research Triangle, NC 27709

Harvey Alter, M.D.

Chief of Infectious Diseases Section

at the Dept. of Transfusion Medicine

9000 Rockville Pike

Bldg. 10, Room 1C711

Bethesda, MD 20892-1184

Michael P. Busch, M.D., Ph.D.

Director, BSRI, VP, Research and Scientific

Affairs

Blood Systems Inc.

Professor Lab Medicine, UCSF

270 Masonic Avenue

San Francisco, CA 94118

Donna M. DiMichele, M.D., (BPAC)

Associate Prof. of Pediatrics

Weill Med. College & Graduate

School of Medical Sciences

Cornell University

525 East 68^th Street, Room P-695

New York, NY 10021

Marcos Intaglietta, Ph.D.

Professor of Applied Mechanics

And Bioengineering

Dept. of Applied Mechanics and

Engineering Science

University of California, San Diego

La Jolla, CA 92093-0412

Harvey G. Klein, M.D.(BPAC)

Chief, Dept. of Transfusion Med.

National Institutes of Health

Warren G. Magnuson Clinical Center

Bethesda, MD 20892

Suzette A. Priola, Ph.D.(TSE)

Investigator

NIH/NIAID

Rocky Mountain Laboratories

903 S. 4^th Street

Hamilton, MT 59840

George B. Schreiber, Sc.D. (BPAC)

Associate Director for Health Studies

Westat

1650 Research Blvd., WB272

Rockville, MD 20850

D. Michael Strong, Ph.D.

Executive Vice President, Operations

Puget Sound Blood Center

921 Terry Avenue

Seattle, Washington 98104

Peter Tomasulo, M.D.

Executive Vice President for Medical Affairs

Chief Medical Officer

Blood Systems, Inc.

6210 East Oak Street

Scottsdale, AZ 85257

Ching C. Wang, Ph.D.

Professor of Chemistry and Pharmaceutical

Chemistry

University of California

505 Parnassus, Room 508

San Francisco, California 94143-0446