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February 25-26, 2014: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Agenda- February 26, 2014

Food and Drug Administration
Cellular, Tissue and Gene Therapies Advisory Committee
Meeting #59
February 25-26, 2014

Agenda: Wednesday, February 26, 2014
8:00 a.m. Opening Remarks
Evan Snyder, M.D., Ph.D., Chair

Conflict of Interest Statement
Gail Dapolito, Designated Federal Officer

Introduction of Members
Topic I: Oocyte Modification in Assisted Reproduction for the Prevention of Transmission of Mitochondrial disease or treatment of Infertility
8:15 Committee Discussion of Questions (cont’d)
Topic II – Update of Guidance Documents Issued by Office of Cellular, Tissue and Gene Therapies, CBER, FDA
11:15 a.m. FDA Guidance Update
Rachael Anatol, Ph.D.
Office of Cellular, Tissue and Gene Therapies
11:30 Q&A
11:35 Recognition of Committee Service
Karen Midthun, M.D.
Center for Biologics Evaluation and Research, FDA
11:55 a.m. Adjourn Session
Topic III – Draft Guidance for Industry:  Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
12:55 p.m. FDA Introduction
Celia Witten, Ph.D., M.D.
Office of Cellular, Tissue and Gene Therapies
1:10 FDA Presentation
John Hyde, M.D., Ph.D.
Office of Cellular, Tissue and Gene Therapies
1:40 Q&A
1:50 Open Public Hearing
2:20 Break
2:35 Committee Discussion of Questions
5:00 p.m. Adjourn Meeting