Food and Drug Administration

Center for Biologics Evaluation and Research

Cellular, Tissue and Gene Therapies Advisory Committee

Meeting #38

March 3-4

Quality Suites, Rockville, MD

DRAFT AGENDA

March 3, 2005

Open Committee Discussion

Cellular Therapies for Repair and Regeneration of Joint Surfaces

8:00 a.m. Welcoming Remarks

Conflict of Interest Statement

Introduction of Members

Recognition of Member Committee Service

8:30 FDA Introduction

8:40 Guest Presentation: Evaluating Methods of Restoring Cartilaginous Articular Surfaces

9:10 Guest Presentation: The Biology of the Joint Surface

9:50 Break

10:00 FDA Perspective on Development of Cartilage Repair Products –Preclinical

10:20 Guest Presentation: Preclinical Models

11:00 Open Public Hearing

11:30 Committee Discussion of Preclinical Questions

12:30 p.m. Lunch

1:30 Committee Discussion of Preclinical Questions (cont’d)

2:30 FDA Perspective on Development of Cartilage Repair Products–Clinical

2:50 Guest Presentations: Clinical Issues

4:10 Break

4:25 FDA Introduction to Clinical Questions

4:30 Committee Discussion of Clinical Questions

6:00 p.m. Adjourn

Cellular, Tissue and Gene Therapies Advisory Committee

Meeting #38

March 3-4, 2005

DRAFT AGENDA

March 4, 2005

Open Committee Discussion

Topic I - Cellular Therapies for Repair and Regeneration of Joint Surfaces

8:00 a.m. Welcome and Administrative Remarks

8:05 Committee Discussion of Clinical Questions (Continued from March 3)

8:30 FDA Perspective on Development of Cartilage Repair Products – Manufacturing

8:50 Committee Discussion of Manufacturing Questions

11:00 a.m. Adjourn