BLOOD PRODUCTS ADVISORY COMMITTEE

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

MARCH 17-18, 2005

ACTING EXECUTIVE SECRETARY COMMITTEE MANAGEMENT SPECIALIST

Freas, William, Ph.D. Muckelvene, Pearline K.

Center for Biologics Evaluation Center for Biologics Evaluation

and Research and Research

1401 Rockville Pike (HFM-71) 1401 Rockville Pike (HFM-71)

Food and Drug Administration Food and Drug Administration

Rockville, MD 20852-1448 Rockville, MD 20852-1448

TEL: (301) 827-1295 TEL: (301) 827-1281

FAX: (301) 827-0294 FAX: (301) 827-0294

E-MAIL: freas@cber.fda.gov E-MAIL: Muckelvene@cber.fda.gov

CHAIRMAN

Allen, James R., M.D., M.P.H.9/30/05

President and CEO

American Social Health Association

P.O. Box 13827

Research Triangle Park, NC 27709

MEMBERS

Davis, Kenneth, Jr., M.D.* 9/30/05

Professor of Surgery and Clinical Anesthesia

Vice Chairman, Dept. of Surgery

University of Cincinnati Med. Ctr.

231 Albert Sabin Way, ML 558

Cincinnati, OH 45267-0558

DiMichele, Donna M., M.D. 9/30/05

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

Doppelt, Samuel H., M.D. 9/30/05

Chief, Dept. of Orthopedic Surgery

The Cambridge Hospital

1493 Cambridge Street

Cambridge, MA 02139

Klein, Harvey G., M.D. 9/30/05

Chief, Dept. of Transfusion Med.

National Institutes of Health

Warren G. Magnuson Clinical Center

10 Center Dr., Bldg. 10, Rm. 1C711

Bethesda, MD 20892

Kuehnert, Matthew J., M.D. 9/30/07

CDR, U.S. Public Health Service

Assistant Director for Blood Safety

Division of Viral and Rickettsial Diseases

Centers for Disease Control and

Prevention (CDC)

1600 Clifton Road, Mailstop A-30

Atlanta, GA 30333

Laal, Suman, Ph.D.* 9/30/05

Assistant Professor

Department of Pathology

New York University School of Med.

423 East 23^rd Street, Rm. 18124N

VA Medical Center

New York, NY 10010

Lew, Judy F., M.D. 9/30/05

Asst. Prof. of Pediatrics

Univ. of Florida

Dept. of Pediatric Immunology and

Infectious Diseases

P.O. Box 100296

Gainesville, FL 32610

Manno, Catherine S., M.D. 9/30/07

Professor of Pediatrics

The Children’s Hospital of Philadelphia

University of Pennsylvania School of Medicine

9^th Floor, Main Hospital

34^th Street and Civic Center Boulevard

Philadelphia, PA 19104

Quirolo, Keith C., M.D. 9/30/07

Hemoglobinopathy Pediatrician

Department of Hematology

Children’s Hospital and Research Center at Oakland

747 52^nd Street

Oakland, CA 94609-1809

Schreiber, George B., Sc.D. 9/30/07

Associate Director for Health Studies

Westat

1650 Research Blvd., WB272

Rockville, MD 20850

Whittaker, Donna S., Ph.D. 9/30/07

Director

Robertson Blood Center (MCXI-BBC)

3600 Darnall Loop, Box #7

Fort Hood, Texas 76544

TEMPORARY VOTING REPRESENTATIVES

Baker, Judith R., M.H.S.A. **

Regional Coordinator

Federal Hemophilia Treatment Centers/Region IX

Childrens Hospital Los Angeles

4650 Sunset Boulevard, Box 54

Los Angeles, California 90028

Harvath, Liana, Ph.D.

Deputy Director

Division of Blood Diseases

and Resources

NHLBI, NIH

6701 Rockledge Drive

Bethesda, MD 20817

Hudson, Leonard P., M.D.

Professor of Medicine

University of Washington

Harborview Medical Center

325 Ninth Avenue, 10EH-25

Seattle, WA 98104

CONSULTANT (NON-VOTING)

Leitman, Susan F., M.D.

Chief, Blood Services Section

Department of Transfusion Medicine

National Institute of Health

10 Center Drive, MSC 1184

Bethesda, MD 20892-1184

ACTING NON-VOTING INDUSTRY REPRESENTATIVE

Katz, Louis M. M.D.

Executive Vice President, Medical Affairs

Mississippi Valley Regional Blood Center

5500 Lake View Parkway

Davenport, Iowa 52807

GUEST SPEAKERS

Bassett, Mary Beth, MS, MT(ASCP)SBB

Vice President, Quality Management

and Regulatory Affairs

Blood Systems, Inc.

6210 E. Oak Street

Scottsdale, AZ 85257

Finfer, Simon, M.D.

Senior Staff Specialist in Intensive Care

Clinical Associate Professor (Intensive Care)

Faculty of Medicine university of Sydney

Intensive Therapy Unit

Level 6, Main Block,

Royal North Shore Hospital,

Pacific Highway

St. Leonards, NSW 2065

Australia

Hebert, Paul, MD

Vice Chair of Research

Department of Medicine, University of Ottawa

Chair in Transfusion and Critical Care Research

Ottawa Health Research Institute

Professor of Medicine, University of Ottawa

Box 201

501 Smyth Road

Ottawa, Ontario K1H8L6

Holmberg, Jerry A., Ph.D.

Senior Advisor for Blood Policy and Executive Secretary

Advisory Committee on Blood Safety and Availability

Office of the Secretary, Office of Public Health and Science

1101 Wooton Parkway, Suite 250

Rockville, MD 20852

Kessler, Debra RN, MS
Director, Regional Services
New York Blood Center
310 East 67 St.
New York, NY  10021

Szymanski, Irma O., MD

Professor of Pathology Emerita

University of Massachusetts Medical School

Worcester, MA

55 Lake Avenue, North

Worcester, MA 01655

*Will not attend

**Acting Consumer Representative