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November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Agenda

Food and Drug Administration
Center for Biologics Evaluation and Research
Cellular, Tissue and Gene Therapies Advisory Committee
Meeting # 54, November 17, 2011
Hilton Hotel, Silver Spring, MD

Agenda

8:30 a.m.

Call to Order and Introduction of Committee
Steven Dubinett, M.D., Chair

Conflict of Interest Statement
Gail Dapolito, Designated Federal Officer

Open Committee Discussion
Apligraf (Oral), Organogenesis, Inc., BLA 125400, for the Treatment of Surgically Created Gingival and Alveolar Mucosal Surface Defects in Adults

8:40

FDA Introduction

Celia Witten, Ph.D., M.D.
Director
Office of Cellular, Tissue and Gene Therapies (OCTGT)
Center for Biologics Evaluation and Research (CBER), FDA

8:45

Organogenesis, Inc.

Introduction
Patrick Bilbo
Vice President, Regulatory Affairs, Organogenesis, Inc.

Conditions and Treatments
David Cochran, D.D.S., M.S., Ph.D.
Chairman, Department of Periodontics
University of Texas Health Science Center at San Antonio, TX

Clinical Efficacy and Safety
Damien Bates, M.D., Ph.D., FRACS (Plast.)
Chief Medical Officer, Organogenesis, Inc.

Benefit/Risk Summary
Michael McGuire, D.D.S.
Perio Health Professionals, Houston, TX

Conclusions
Patrick Bilbo

10:00Q&A
10:20 a.m.Break
10:30 a.m.

FDA Presentation

Product Quality
Mark H. Lee, Ph.D.
Product Reviewer, OCTGT, CBER, FDA

Overview of Periodontal Conditions and Treatments
Robert S. Betz, D.D.S., Captain (Ret), USPHS
Dental Officer, Dental Devices Branch
Center for Radiological Health and Devices, FDA

Clinical Study Design and Safety and Efficacy
Agnes Lim, M.D.
Medical Officer, OCTGT, CBER, FDA

11:30Q&A
11:45Open Public Hearing
12:45 p.m.Lunch
1:45

Committee Discussion of Questions and Vote

5:00 p.m.Adjourn