Food and Drug Administration

Center for Biologics Evaluation and Research

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #34, February 28, 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 28, 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                                                   ++ - Patient Representative  

                                   

                                                                                   

 

TEMPORARY VOTING MEMBERS

 

 

Ms. Barbara Ballard++                                                           John Coffin, Ph.D.

President                                                                      Professor of Molecular Biology

SCID Alliance                                                               Department of Molecular Biology and Microbiology

Immune Deficiency Foundation                                            Tufts University School of Medicine

Clifton, VA  20124                                                   136 Harrison Avenue

                                                                                    Boston, MA  02111

 

 

Kenneth Cornetta, M.D.                                                  John E. French, Ph.D.

Chairman and Professor                                                          Group and Discipline Leader

Department of Medical and Molecular Genetics                       Laboratory of Experimental Carcinogenesis and

Indiana University                                                             Mutagenesis

975 W. Walnut Street, Room 130                               National Institute of Environmental Health Sciences

Indianapolis, IN  46202                                                   National Institutes of Health                         

4401 T.W. Alexander Drive

                                                                                    Research Triangle Park, NC  27709

 

 

                                    BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #34, February 28, 2003

 

TEMPORARY VOTING MEMBERS (Cont’d)

 

 

 

Warren Leonard, M.D.                                                  Crystal Mackall, M.D.  

Chief                                                                            Head, Immunology Section

Laboratory of Molecular Immunology                              Pediatric Oncology Branch                                    

National Heart, Lung and Blood Institute                        National Cancer Institute           

National Institutes of Health                                      National Institutes of Health             

10 Center Drive, Room 7N252                                      10 Center Drive, Room 13N240                          

Bethesda, MD  20892                                                    Bethesda, MD  20892

 

 

Abbey S. Meyers                                                 Thomas Murray, Ph.D.                          

President and Executive Director                                    President                                            

National Organization for Rare Disorders              The Hastings Center                                   

Fairwood Professional Building                                                21 Malcolm Gordon Road                                

P.O. Box 8923                                                              Garrison, NY  10524   

New Fairfield, CT  06812

 

                                                           

Stuart H. Orkin, M.D.                                                    Bruce E. Torbett, Ph.D.  

David G. Nathan Professor of Pediatrics                          Associate Professor

Department of Pediatric Oncology                                  Department of Molecular and

 Harvard Medical School                                          Experimental Medicine, MEM 55

Dana Farber Cancer Institute                                                The Scripps Research Institute

44 Binney Street                                                   10550 North Torrey Pines Road

Boston, MA  02115                                                       La Jolla, CA  92037

 

 

Linda Wolff, Ph.D.

Chief, Leukemogenesis Section

Laboratory of Cellular Oncology

National Cancer Institute

National Institutes of Health

Building 37, Room 4124A

37 Convent Drive, MSC 4255

Bethesda, MD  20892

 

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #34, February 28, 2003

 

 

GUEST SPEAKERS

 

 

Claudio Bordignon, M.D.                                        Marina Cavazzana-Calvo, M.D., Ph.D.

Professor of Hematology                                          Professor in Hematology

Scientific Director                                                         Director, Biotherapy Department

Istituto Scientifico HS Raffaele                                               INSERM U429

Via Olgettina 58                                                            Hopital Necker-Enfants Malades

20132 Milan ITALY                                                      149 rue de Sevres

                                                                        75015 Paris FRANCE

 

 

Adrian Thrasher, M.D., Ph.D.

Professor of Paediatric Immunology

Centre for Gene Therapy of Childhood Disease

Molecular Immunology Unit

Institute of Child Health

30 Guilford Street

London WC1N EH

 

NIH REPRESENTATIVES

 

 

Amy Patterson, M.D.                                                                Stephen M. Rose, Ph.D.

Director                                                                                    Deputy Director            , Recombinant DNA Program                      

Office of Biotechnology Activities                                              Office of Biotechnology Activities

National Institutes of Health                                                  National Institutes of Health

6705 Rockledge Drive                                                               6705 Rockledge Drive

Suite 750, MSC 7985                                                                 Suite 750, MSC 7985

Bethesda, MD  20892                                                                Bethesda, MD  20892

 

 

FDA PARTICIPANTS

 

 

Philip D. Noguchi, M.D.                                                  Raj K. Puri, M.D., Ph.D.              

Acting Director                                                                         Acting Director

Office of Cellular, Tissue and Gene Therapies                                  Division of Cellular and Gene Therapies, 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-500

Rockville, MD  20852                                                                Rockville, MD  20852

 

 

Carolyn A.Wilson, Ph.D.                                                   Cynthia A. Rask                       

Senior Investigator                                                                     Acting Chief

Laboratory of Molecular Tumor Biology                                      Clinical Review Branch

DCGT/OCTGT/CBER                                                             Division of Clinical Evaluation and

Food and Drug Administration                                                       Pharmacology/Toxicology, OCTGT, CBER

1401 Rockville Pike, HFM-518                                                          1401 Rockville Pike, HFM-576

Rockville, MD 20852                                                                 Rockville, MD 20852

BRMAC #33 CBER Working Group

OCTGT

Dr. Philip Noguchi

Dr. Joyce Frey-Vasconcells

Dr. Raj Puri                             

Dr. Carolyn Wilson

Dr. Cynthia Rask

Ms. Mercedes Serabian

Dr. Stephanie Simek                 

Ms. Tina Moulton

Dr. Daniel Takefman                            

Dr. Anne Pilaro