Food and Drug Administration
Center for Biologics Evaluation and
Research
Cellular, Tissue and Gene Therapies
Advisory Committee
Meeting, February 5, 2008
Keith Webber, Ph.D. Steven
Kozlowski, M.D.
Deputy Director Director
Office of Pharmaceutical Sciences (OPS) Office of Biotechnology Products, OPS
Center for Drug Evaluation and Research Center for Drug Evaluation and Research
Food and Drug Administration Food
and Drug Administration
Silver Spring, MD 20993 Silver Spring,
MD 20993
Kathleen Clouse, Ph.D. Amy Rosenberg,
M.D.
Director Director
Division of Monoclonal Antibodies Division
of Therapeutic Proteins
Office of Biotechnology Products Office
of Biotechnology Products
Center for Drug Evaluation and Research Center for Drug Evaluation and Research
Food and Drug Administration Food
and Drug Administration
8800 Rockville Pike, HFD-123 8800
Rockville Pike, HFD-122
Rockville, MD 20892 Rockville,
MD 20892
Emily Shacter, Ph.D. Lai Xu, Ph.D.
Chief Staff Fellow
Laboratory of Biochemistry Laboratory
of Immunology
Division of Therapeutic Proteins Division of Therapeutic Proteins
Office of Biotechnology Products, OPS Office of Biotechnology Products, OPS
Center for Drug Evaluation and Research Center for Drug Evaluation and Research
Food and Drug Administration Food and Drug Administration
8800 Rockville Pike, HFD-123 8800 Rockville Pike, HFD-122
Sean Fitzsimmon, Ph.D. Hugh McFarland,
Ph.D.
Staff Scientist Staff
Scientist
Laboratory of Molecular and Laboratory
of Immunology
Developmental Immunology Division
of Therapeutic Proteins
Division of Monoclonal Antibodies Office
of Biotechnology Products, OPS
Office of Biotechnology Products, OPS Center for Drug Evaluation and Research
Center for Drug Evaluation and Research Food and Drug Administration
Food and Drug Administration 8800 Rockville Pike,
HFD-122
8800 Rockville Pike, HFD-123 Rockville,
MD 20892
Rockville, MD 20892
Gerald Feldman, Ph.D. Mate Tolnay,
Ph.D.
Senior Investigator Senior
Staff Fellow
Laboratory of Molecular and Laboratory
of Molecular and
Developmental Immunology Developmental Immunology
Division of Monoclonal Antibodies Division
of Monoclonal Antibodies
Office of Biotechnology Products, OPS Office of Biotechnology Products, OPS
Center for Drug Evaluation and Research Center for Drug Evaluation and Research
Food and Drug Administration Food
and Drug Administration
8800 Rockville Pike, HFD-123 8800
Rockville Pike, HFD-123