BLOOD PRODUCTS ADVISORY COMMITTEE

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

August 16, 2007

CHAIRMAN

Siegal, Frederick P., M.D. 9/30/09

Medical Director, Comprehensive HIV Center

Saint Vincent’s Catholic Medical Centers,

Saint Vincent’s Manhattan

NR 1425

153 West 11^th Street

New York, NY 10011

MEMBERS

Ballow, Mark, M.D. 9/30/08 Edwards, Willarda V., M.D., MBA 9/30/10

Chief, Division of Allergy& Immunology President & COO Sickle Cell Disease

Department of Pediatrics Association of America, Inc.

State University of NY at Buffalo 231 E. Baltimore Street

Women & Children’s Hospital of Buffalo Suite 800

219 Bryant Street Baltimore, MD 21202

Buffalo, NY 14222

Cryer III, Henry M., M.D., Ph.D. 9/30/09 Finnegan, Maureen A., M.D. 9/30/09

Chief, Trauma & Critical Care Associate Professor

Division of General Surgery Department of Orthopedic Surgery

University of California, Los Angeles U.T. Southwestern Medical Center

10833 Le Conte Ave., Rm 72-178 CHS 5323 Harry Hines Blvd.

Los Angeles, CA 90024-1602 Dallas, TX 75390-8883

Di Bisceglie, Adrian M., M.D. 9/30/09 Glynn, Simone A., M.D., MSc, M.P.H. 9/30/10

Professor of Internal Medicine Branch Chief,

Chief of Hepatology Transfusion Medicine and Therapeutics Branch

Saint Louis University School of Medicine Division of Blood Diseases and Resources

3635 Vista Ave. at Grand Blvd National Heart, Lung, and Blood Institute

P.O. Box 15250 National Institutes of Health

St. Louis, MO 63110-0250 6701 Rockledge Drive

MSC 7590

Bethesda, MD 20892-7936

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

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

Assistant Director for Blood Safety Westat

Division of Healthcare Quality Promotion 1650 Research Blvd., TB186

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

1600 Clifton Road, Mailstop A-07

Atlanta, GA 30333

Kulkarni, Roshni, M.D. 9/30/09 * Szymanski, Irma O.V., M.D. 9/30/07

Director, Division of Hereditary Blood Disorders Professor of Pathology, Emerita

Centers for Disease Control University of Massachusetts Med Center

Professor, Dept of Pediatrics & Department of Pathology

Human Development 55 Lake Avenue North

Michigan State University Worcester, MA 01655-0212

B-220 Clinical Center

East Lansing, MI 48824

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

COL, MS, USA

Chief, Department of Clinical Support Services

Manno, Catherine S., M.D. 9/30/07 * U.S. Army Medical Dept. Center & School

Professor of Pediatrics 3151 Scott Rd, Suite 1334

The Children’s Hospital of Philadelphia Fort Sam Houston, TX 78234

University of Pennsylvania School of Medicine

9^th Floor, Main Hospital

34^th Street & Civic Center Blvd.

Philadelphia, PA 19104

CONSUMER REPRESENTATIVE

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

Quinn, Thomas C., M.D. 9/30/08 * Regional Administrative Director

Professor of Medicine Federal Hemophilia Treatment Centers/ Region IX

Division of Infectious Disease University of California, Los Angeles

The Johns Hopkins University Division of Pediatric Hematology/Oncology

Ross Research Building, Room 1159 924 Westwood Ave., Suite 200

720 Rutland Avenue Los Angeles, CA 90024

Baltimore, MD 21205

NON-VOTING INDUSTRY REPRESENTATIVE

Katz, Louis M., M.D. 9/30/08

Quirolo, Keith C., M.D. 9/30/07 Executive Vice President, Medical Affairs

Hemoglobinopathy Pediatrician Mississippi Valley Regional Blood Center

Clinical Director, Apheresis Program 5500 Lake View Parkway

Department of Hematology Davenport, IA 52807

Children’s Hospital & Research Center at Oakland

747 52^nd Street

Oakland, CA 94609-1809

* not attending meeting

Temporary Voting Members

Berger, Melvin, M.D., Ph.D. ** Colvin, Richard A., M.D., Ph.D.

Professor of Pediatrics & Pathology Clinical Assistant in Medicine

Division of Immunology/Allergy Center for Immunology & Inflammatory Diseases

Case Western Reserve School of Medicine Massachusetts General Hospital East

Director, Jeffrey Modell Center for Primary CNY Building , Room 8405

Immune Deficienceies 149 13th Street

Rainbow Babies and Children’s Hospital Charlestown, MA 02129

11100 Euclid Ave., MC6008B

Cleveland, OH 44106

Non-Voting Temporary Member

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

Medical Advisor

American Social Health Association

P.O. Box 13827

Research Triangle, NC 27709

** Topic II only

*** Topic I only

GUEST SPEAKERS

Baker, Donald, Ph.D. Seward, Jane, M.B.B.S., M.P.H.

Vice President Acting Deputy Director,

Quality Management Division of Viral Diseases

Baxter BioScience National Center for Immunizations &

One Baxter Way Respiratory Diseases

Westlake Village, CA 91362 Centers for Disease Control & Prevention

1600 Clifton Rd., MS E-61

Atlanta, GA 30333

Holmberg, Jerry A., Ph.D. Simon, Toby, M.D.

Senior Advisor for Blood Policy Corporate Medical Director

Executive Secretary, Advisory Committee ZLB Plasma

on Blood Safety and Availability 5201 Congress Ave, #220

Office of the Secretary, Office of Public Health Boca Raton, FL 33487

& Science

1101 Wooton Parkway, Suite 250

Rockville, MD 20852

Moss, William, M.D., M.P.H. Zenker, Othmar, M.D.

Associate Professor Head Clinical R&D

Departments of Epidemiology, International CSL Behring AG

Health and Molecular Microbiology Wankdorstrasse 10

and Immunology 3000 Bern 22

Johns Hopkins Bloomberg School of Public Health Switzerland

615 North Wolfe Street

Baltimore, MD 21205

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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

1401 Rockville Pike, (HFM-71)

Rockville, MD 20852

Scharpf, Jennifer, M.P.H. Dawson, Rhonda

Associate Director for Policy & Communication Policy Analyst

Office of Blood Research & Review Office of Blood Research & Review

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

Food and Drug Administration Food & Drug Administration

1401 Rockville Pike 1401 Rockville Pike (HFM-302)

Suite 400 N, (HFM-302) Rockville, MD 20852

Rockville, MD 20852