Food and Drug Administration

Center for Biologics Evaluation and Research

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

MEETING #34, FEBRUARY 27, 2003

Holiday Inn, Silver Spring, Maryland

 

 

 

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

Daniel R. Salomon, M.D.    03/31/03                                    Jonathan S. Allan, D.V.M.            03/31/06                           

Associate Professor                                                                  Scientist

Department of Molecular and Experimental Medicine              Department of Virology and Immunology

The Scripps Research Institute                                                            Southwest Foundation for Biomedical Research

10550 N. Torrey Pines Road, MEM 55                                     7620 N.W. Loop 410 at Military Drive

La Jolla, CA  92037                                                                   San Antonio, TX  77030

   

 

Bruce R. Blazar, M.D.     03/31/05+                                              David M. Harlan, M.D.                       03/31/06                       

Professor                                                                                  Head

Division of Pediatric Bone Marrow                                       Transplantation and Autoimmunity Branch

   Transplantation/Oncology                                                          National Institute of Diabetes and Digestive

University of Minnesota                                                                 and Kidney Disease, NIH

420 Delaware Street, SE, Box 109                                          10 Center Drive, Building 10, Room 11S210

Minneapolis, MN  55455                                                            Bethesda, MD  20892

 

 

Katherine A. High, M.D.           03/31/05                                         Joanne Kurtzberg, M.D.                        03/31/04           

William H. Bennett Professor of Pediatrics                          Professor of Pediatrics

University of Pennsylvania                                                     Pediatric Bone Marrow and Stem Cell Program

Children's Hospital of Philadelphia                                           Duke University Medical Center

310 Abramson Research Center                                                           Box 3350

3615 Civic Center Boulevard                                                         2400 Pratt Street

Philadelphia, PA  19104                                                             Durham, NC  27710

 


BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #34, February 27, 2003

 

MEMBERS (Cont'd)

 

 

 

Alison F. Lawton*                     03/31/05                                    Richard C. Mulligan, Ph.D.            03/31/04

Senior Vice President                                                                Mallinckrodt Professor of Genetics

Regulatory Affairs                                                                     Harvard Medical School

Genzyme Corporation                                                                Children's Hospital                                               

One Kendall Square                                                                  Department of Molecular Medicine

Cambridge, MA  02139                                                              320 Longwood Avenue                   

                                                                                                Boston, MA  02115                                          

 

 

Mahendra S. Rao, M.D., Ph.D.       03/31/05                                    Anastasios A. Tsiatis, Ph.D.            03/31/06

Chief, Stem Cell Biology Section                                     Professor

Laboratory of Neurosciences, 4B17                                         Department of Statistics

Gerontology Research Center                                                  North Carolina State University

National Institute on Aging, NIH                                                Box 8203

5600 Nathan Shock Dr.                                                             2501 Founders Drive

Baltimore, MD  21224                                                               Raleigh, NC  27695

 

 

Alice J. Wolfson, J.D.            **             03/31/04                                    *  - Industry Representative

Bourhis, Wolfson and Schlichtmann                                         ** - Consumer Representative

1050 Battery Street                                                                   +    - Not Attending

San Francisco, CA  94111

 

TEMPORARY VOTING MEMBERS

 

 

Mary M. Horowitz, M.D.                                                 Harvey G. Klein, M.D.

Professor of Medicine                                                                       Chief

International Bone Marrow Transplant Registry                                    Department of Transfusion Medicine

Autologous Blood and Marrow Transplant                                 National Institutes of Health

    Registry                                                                                Warren G. Magnuson Clinical Center

Health Policy Institute                                                                        Building 10, Room 1C711

Medical College of Wisconsin                                                     10 Center Drive

8701 Watertown Plank Road, HRC Suite 2500                                    Bethesda, MD  20892

Milwaukee, WI  53226

 

 

Jeanne V. Linden, M.D.                                                                David F. Stroncek, M.D.

Director                                                                                    Chief, Laboratory Service Section

Blood and Tissue Resources                                                         Department of Transfusion Medicine

New York State Department of Health                                      National Institutes of Health

Wadsworth Center                                                              Warren G. Magnuson Clinical Center

Empire State Plaza                                                                Building 10, Room 1C733

Albany, NY  12201                                                               10 Center Drive

                                                                                                Bethesda, MD  20892

 

 

 

 

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #34, February 27, 2003

 

 

 

NIH REPRESENTATIVE

 

Liana Harvath, Ph.D.

Director

Blood Resources Program

Division of Blood Diseases and Resources

National Heart, Lung and Blood Institute

Rockledge II, Room 10170

6701 Rockledge Drive

Bethesda, MD  20892

 

GUEST SPEAKERS

 

 

Nelson J. Chao, M.D., M.B.A.                                       Pablo Rubinstein, M.D.

Professor                                                                      Director

Department of Medicine                                               National Cord Blood Program

Duke University Medical Center                                     New York Blood Center

Box 3961                                                                      310 E. 67th Street

Durham, NC  27710                                                   New York, NY  10021

 

 

John E. Wagner, M.D.

Associate Professor of Pediatrics

University of Minnesota School of Medicine

660C Cancer Center Research Building

Box 366 UMHC

420 Delaware Street, S.E.

Minneapolis, MN  55455

 

FDA PARTICIPANTS

 

 

Philip D. Noguchi, M.D.                                                  Ruth Solomon, M.D.

Acting Director                                                                         Acting Director

Office of Cellular, Tissue and Gene Therapies                                  Division of Human Tissues, 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-515                                                 1401 Rockville Pike, HFM-770

Rockville, MD  20852                                                               Rockville, MD  20852

 

 

Ellen F. Lazarus, M.D.                                                               Stephen D. Litwin, M.D.

Reviewing Medical Officer                                                 Medical Officer

Division of Clinical Evaluation and                                       Division of Clinical Evaluation and

    Pharmacology and Toxicology                                          Pharmacology and Toxicology

Office of Cellular, Tissue and Gene Therapies                                  Office of Cellular, Tissue and Gene Therapies

Food and Drug Administration                                                   Food and Drug Administration

1401 Rockville Pike, HFM-770                                                 1401 Rockville Pike, HFM-755

Rockville, MD  20852                                                               Rockville, MD  20852

 

 

 

 

BRMAC #34 CBER Working Group 

February 27, 2003

Dr. Philip Noguchi

Dr. Joyce Frey-Vasconcells

Dr. Ruth Solomon

Dr. Ellen Lazarus

Dr. Steve Litwin

Dr. Cynthia Rask

Dr. Martha Wells

Dr. Ellen Areman

Dr. Jean Wang