June 29, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Final Meeting Agenda

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
Meeting #52, June 29, 2011
Crowne Plaza Hotel, Silver Spring, MD

AGENDA

Open Session (Lincoln Ballroom)

8:00 a.m.	Call to Order and Introduction of Members Stanton Gerson, M.D., Chair (Acting)
	Conflict of Interest Statement Gail Dapolito, Designated Federal Officer
8:10	Recognition of Committee Service Celia Witten, Ph.D., M.D. Director, Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and Research, FDA

Cellular and Gene Therapy Products for Retinal Disorders

8:25	FDA Introduction and Overview of Cellular and Gene Therapy Products for Retinal Disorders Samuel B. Barone, M.D. Medical Officer, Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and Research, FDA
8:55	Q&A Clinical Issues Related to Evaluation of Efficacy Endpoints and Safety
9:05	Albert Maguire, M.D. Associate Professor of Ophthalmology Scheie Eye Institute, University of Pennsylvania Jean Bennett, M.D., Ph.D. F.M. Kirby Professor of Ophthalmology Perelman School of Medicine at the University of Pennsylvania Curtis Scribner, M.D. Senior Vice President, Clinical and Regulatory Affairs RRD International, LLC
9:35	Q&A
9:45	Tim Stout, M.D., Ph.D., M.B.A. Professor of Ophthalmology Casey Eye Institute Oregon Health and Science University
10:15	Q&A
10:25 a.m.	Break
10:40	Clinical Issues Related to Evaluation of Efficacy Endpoints and Safety Peter A. Campochiaro, M.D. Professor of Ophthalmology The Wilmer Eye Institute The Johns Hopkins University School of Medicine
11:10	Q&A
11:20	Preclinical Issues Peter Coffey, B.Sc., D.Phil. Professor of Visual Psychophysics University College London
11:50	Q&A
12 noon	Open Public Hearing
1:00 p.m.	Lunch
2:00	Committee Discussion of Questions
5:00 p.m.	Adjourn