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U.S. Department of Health and Human Services

Advisory Committees

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January 15, 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Agenda

Food and Drug Administration
Cellular, Tissue and Gene Therapies Advisory Committee
Meeting #57
January 15, 2013
National Institutes of Health, Building 29B, Conference Room C

Open Session

2:00 p.m. (EST) Welcome and Administrative Remarks
Evan Snyder, M.D., Ph.D., Chair

Roll Call and Conflict of Interest Statement
Gail Dapolito, Designated Federal Officer
Center for Drug Evaluation and Research (CDER)
2:05 Overview Research Programs
Office of Biotechnology Products (OBP), CDER
Steven Kozlowski, M.D., Director, OBP
Edward Max, M.D., Ph.D., Associate Director
for Research, Division of Therapeutic Proteins, OBP
2:25 Q&A
2:30 Division of Therapeutic Proteins (DTP)
Amy Rosenberg, M.D., Director, DTP
2:45 Q&A
Research Program Summaries
2:50 Laboratory of Immunology (LI)
Danielle Verthelyi, M.D., Ph.D., Chief, LI
3:20 Q&A
3:30 Open Public Hearing
4:30 Closed Session
5:15 p.m. Adjourn