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									                                   Food and Drug Administration
                            Center for Biologics Evaluation and Research
                   BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
                              MEETING #35 - TELECONFERENCE
                         NIH Campus – Building 29A, Conference Room 1A09
                                            June 9, 2003

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
Mahendra S. Rao, M.D., Ph.D. 03/31/05               Jonathan Allan, D.V.M.           03/31/06
Chief, Stem Cell Biology Section                    Scientist
Laboratory of Neurosciences, 4B17                   Department of Molecular and Experimental Medicine
Gerontology Research Center                         Department of Virology and Immunology
National Institute on Aging, NIH                    Southwest Foundation for Biomedical Research
5600 Nathan Shock Dr.                               7620 N.W. Loop 410 at Military Drive
Baltimore, MD 21224                                 San Antonio, TX 77030


Bruce R. Blazar, M.D.             03/31/05          Katherine A. High, M.D.             03/31/05
Professor                                           William H. Bennett Professor of Pediatrics
Division of Pediatric Bone Marrow                   University of Pennsylvania
University of Minnesota                             Children's Hospital of Philadelphia
420 Delaware Street, SE, Box 109                    310 Abramson Research Center
Minneapolis, MN 55455                               3615 Civic Center Boulevard
                                                    Philadelphia, PA 19104


Joanne Kurtzberg, M.D.            03/31/04          Alison F. Lawton*                  03/31/05
Professor of Pediatrics                             Senior Vice President
Department of Pediatrics                            Regulatory Affairs
Duke University Medical Center                      Genzyme Corporation
Box 3350, Suite 1400 North Pavilion                 One Kendall Square
Durham, NC 27710                                    Cambridge, MA 02139


Richard C. Mulligan, Ph.D.         03/31/04         Anastasios A. Tsiatis, Ph.D.       03/31/06
Mallinckrodt Professor of Genetics                  Professor
Department of Genetics                              Department of Statistics
Harvard Medical School                              North Carolina State University
Children's Hospital                                 Box 8203
861 Enders Building                                 2501 Founders Dr.
Boston, MA 02115                                    Raleigh, NC 27695
                                  Food and Drug Administration
                           Center for Biologics Evaluation and Research
                   BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

                                               MEMBERS (cont’d)



                        **
Alice J. Wolfson, J.D.              03/31/04              David M. Harlan, M.D. 03/31/06
Wolfson and Schlichtmann                                  Head
1050 Battery Street                                       Transplantation and Autoimmunity Brach
San Francisco, CA 94111                                   National Institute of Diabetes and Digestive
                                                            and Kidney Disease, NIH
*Industry Representative (not attending)                  10 Center Drive building 10, Room 11S210
** Consumer Representative                                Bethesda, MD 20892


                                           FDA PARTICIPANTS


  Kathryn M. Carbone, M.D.                                Philip Noguchi, M.D.
  Acting Associate Director for Research                  Director
  Center for Biologics Evaluation and Research            Office of Cellular, Tissue and Gene Therapies
  Food and Drug Administration                            Center for Biologics Evaluation and Research
  1401 Rockville Pike (HFM-20)                            Food and Drug Administration
  Rockville, MD 20852                                     1401 Rockville Pike (HFM-700)
                                                          Rockville, MD 20852


  Raj K. Puri, M.D., Ph.D.                                Steven Bauer, Ph.D.
  Acting Director                                         Acting Chief
  Division of Cell and Gene Therapies                     Laboratory of Stem Cell Biology
  Office of Cellular, Tissue and Gene Therapies           Division of Cell 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-530)                           1401 Rockville Pike (HFM-521)
  Rockville, MD 20852                                     Rockville, MD 20852


  Suzanne Epstein, Ph.D.                                  Deborah Hursh
  Chief                                                   Senior Staff Fellow
  Laboratory of Immunology and                            Laboratory of Immunology and Developmental
    Developmental Biology                                   Biology
  Division of Cell and Gene Therapies, OCTGT              Division of Cell 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-521)                           1401 Rockville Pike (HFM-521)
  Rockville, MD 20852                                     Rockville, MD 20852


  Malcolm Moos, M.D., Ph.D.
  Medical Officer
  Laboratory of Immunology and Developmental Biology
  Division of Cell and Gene Therapies, OCTGT
  Center for Biologics Evaluation and Research
  Food and Drug Administration
  1401 Rockville Pike (HFM-527)
  Rockville, MD 20852

								
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