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April 17, 2013 Cellular, Tissue and Gene Therapies Advisory Committee Meeting Agenda

Food and Drug Administration
Cellular, Tissue and Gene Therapies Advisory Committee
Meeting #58
April 17, 2013
Rockwall II Building, 5515 Security Lane, Rockville, MD
Conference Room 1033

Agenda

  Open Session
1:30 p.m. (EST) Welcome and Administrative Remarks
Evan Snyder, M.D., Ph.D., Chair
Roll Call/Introduction of Members

Conflict of Interest Statement
Gail Dapolito, Designated Federal Officer
Center for Drug Evaluation and Research (CDER)
1:40 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, OBP
1:55 Q&A
2:00 Division of Therapeutic Proteins (DTP)
Amy Rosenberg, M.D., Director, DTP
2:10 Q&A
2:15 Research Program Summaries
Laboratory of Chemistry (LC)
Serge Beaucage, Ph.D., Chief (Acting), LC
2:35 Q&A
2:45 Gibbes Johnson, Ph.D., Deputy Director (Acting), DTP
3:05 Q&A
3:15 Open Public Hearing
4:15 Closed Session
5:00 p.m. Adjourn