BLOOD PRODUCTS ADVISORY COMMITTEE

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

November 3-4, 2005

CHAIRMAN CHAIRMAN (Topic I only) TVM

Allen, James R., M.D., M.P.H. 9/30/06 DiMichele, Donna M., M.D.

President and CEO Assoc Prof of Pediatrics & Public Health

American Social Health Administration Weill Medical College & Graduate School

P.O. Box 13827 of Medical Sciences

Research Triangle Park, NC 27709 Cornell University

525 East 68^th Street, Room P-695

New York, NY 10021

MEMBERS

Kuehnert, Matthew J., M.D. 9/30/07 Schreiber, George C., Sc.D. 9/30/07

CDR, U.S. Public Health Service Vice President, Health Studies

Assistant Director for Blood Safety Westat

Division of Viral and Rickettsial Diseases 1650 Research Blvd., WB272

Centers for Disease Control and Prevention (CDC) Rockville, MD 20850

1600 Clifton Road, Mailstop A-30

Atlanta, GA 30333

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

Director

Manno, Catherine S., M.D. 9/30/07 Robertson Blood Center (MCXI-BBC)

Professor of Pediatrics 36000 Darnall Loop, Box #7

The Children’s Hospital of Philadelphia Fort Hood, TX 76544

University of Pennsylvania School of Medicine

9^th Floor, Main Hospital

34^th Street and Civic Center Boulevard CONSUMER REPRESENTATIVE

Philadelphia, PA 19104 Baker, Judith R., M.H.S.A. 9/30/08

Regional Coordinator

Quirolo, Keith C., M.D. 9/30/07 * Federal Hemophilia Treatment Centers/

Hemoglobinopathy Pediatrician Region IX

Clinical Director, Apheresis Children’s Hospital Los Angeles

Transfusion Medical Director, Sibling 4650 Sunset Boulevard, Box 54

Donor Cord Blood Program Los Angeles, CA 90028

Department of Hematology

Children’s Hospital & Research Center at Oakland

747 52^nd Street

Oakland, CA 94609-1809

NON-VOTING INDUSTRY REP ACTING NON-VOTING INDUSTRY REP

Katz, Louis M., M.D. 9/30/08 * Duffell Jr., William H., Ph.D.

Executive Vice President, Medical Affairs Director of Government Affairs

Mississippi Valley Regional Blood Center Regulatory Affairs/Quality Systems

5500 Lake View Parkway Gambro BCT

Davenport, IA 52807 10811 West Collins Avenue

Lakewood, CO 80215

* not attending meeting

TEMPORARY VOTING MEMBERS

Cryer III, Henry M., M.D., Ph.D. Laal, Suman, Ph.D.

Chief, Trauma & Critical Care Assistant Professor

Division of General Surgery Dept of Pathology

University of California, Los Angeles New York University School of Medicine

10836 Le Conte Ave., Rm 72-178 CHS 423 East 23^rd Street, Rm. 18123N

Los Angeles, CA 90024-1602 VA Medical Center

New York, NY 10010

Di Bisceglie, Adrian M., M.D.

Professor of Medicine Nelson, Kenrad E., M.D.

Chief of Hepatology Professor, Dept of Epidemiology

Saint Louis University School of Medicine Johns Hopkins University

3635 Vista Avenue at Grand Boulevard School of Hygiene & Public Health

P.O. Box 15250 615 Wolfe, Room E-7132

St. Louis, MO 63110-0250 Baltimore, MD 21205

DiMichele, Donna M., M.D. Quinn, Thomas C., M.D.

Associate Prof of Pediatrics & Public Health Professor of Medicine & Deputy Director

Weill Medical College & Graduate School of Infectious Disease Division

Medical Sciences The Johns Hopkins University

Cornell University Ross Research Building, Room 1159

525 East 68^th Street, Room P-695 720 Rutland Avenue

New York, NY 10021 Baltimore, MD 21205

Doppelt, Samuel H., M.D. Siegal, Frederick P., M.D.

Chief, Dept of Orthopedic Surgery Med Director, Comprehensive HIV Center

The Cambridge Hospital Saint Vincent’s Catholic Medical Centers

1493 Cambridge Street Saint Vincent’s Manhattan

Cambridge, MA 02139 NR 1425

153 West 11^th Street

Klein, Harvey G., M.D. New York, NY 10011

Chief, Dept of Transfusion Medicine

National Institutes of Health Snider, Gordon L., M.D. (Topic II)

Warren G. Magnuson Clinical Center Chestnut Hill, MA 02467

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

Bethesda, MD 20892 Szymanski, Irma O.V., M.D.

Professor of Pathology, Emerita

Kulkarni, Roshni, M.D. University of Massachusetts Medical Center

Prof & Division Chief, Pediatric & Department of Pathology

Adolescent Hematology/Oncology 55 Lake Avenue North

Michigan State University Worcester, MA 01655-0212

B-220 Clinical Center

East Lansing, MI 48824

GUEST SPEAKERS

Branson, Bernard, M.D. Schwarz, Hans Peter, M.D.

Associate Director for Laboratory Diagnostics Associate Professor of Medicine

Center for Diseases Control Vice President, Global Preclinical R&D

Division of HIV/AIDS Prevention Baxter AG, Baxter Biosciences

1600 Clifton Road, Mailstop D-21 Wagramerstrasse 17-19

Atlanta, GA 30333 A-1220 Vienna, Austria

Brantly, Mark, M.D. Smith, Theresa L., M.D.

Professor of Medicine LCDR, USPHS

Molecular Genetics and Microbiology Surveillance & Epidemiology Activity

Alpha One Foundation Research Professor Arboviral Diseases Branch

University of Florida School of Medicine Division of Vector-Borne Infectious Disease

Pulmonary & Critical Care Medicine Division National Center for Infectious Diseases

JHMHC P.O. Box 100225 Centers for Disease Control & Prevention

Gainesville, FL 32610 3150 Rampart Rd.

Fort Collins, CO 80521

Holmberg, Jerry A., Ph.D

Senior Advisor for Blood Policy Sutton-Jones, Sue, M.S.

Executive Secretary Senior Vice President

Advisory Committee on Blood Safety Regulatory Affairs & Quality Assurance

and Availability OraSure Technologies, Inc

Office of the Secretary, Office of Public Health 220 East First Street

& Science Bethlehem, PA 18015-1360

1101 Wooten Parkway, Suite 200

Rockville, MD 20852

Howerton, Devery, Ph.D.

Chief, Laboratory Practice Evaluation &

Genomics Branch

Center for Diseases Control

Division of Public Health Partnerships

4770 Buford Highway, Mailstop G-23

Atlanta, GA 30341

Inungu, Joseph, M.D., D.P.H.

Professor

Central Michigan University

School of Health Sciences, HPB 2241

Mt. Pleasant, MI 48859

FDA ADMINISTRATIVE PERSONNEL

EXECUTIVE SECRETARY COMMITTEE MANAGEMENT SPECIALIST

Jehn, Donald W., M.S. Muckelvene, Pearline K.

Executive Secretary Division of Scientific Advisors & Consultants

Blood Products Advisory Committee Center for Biologics Evaluation & Research

Division of Scientific Advisors & Consultants Food & Drug Administration

Center for Biologics Evaluation & Research 1401 Rockville Pike (HFM-71)

Food & Drug Administration Rockville, MD 20852-1448

1401 Rockville Pike (HFM-71)

Rockville, MD 20852

Zullo, Susan A., Ph.D. Dawson, Rhonda

Acting Associate Director for Policy Policy Analyst

Office for Blood Research & Review Office for Blood Research & Review

Center for Biologics Evaluation & Research Center for Biologics Evaluation & Research

Food & Drug Administration Food & Drug Administration

1401 Rockville Pike (HFM-302) 1401 Rockville Pike (HFM-302)

Rockville, MD 20852 Rockville, MD 20852