Food and Drug Administration

Center for Biologics Evaluation and Research

Cellular, Tissue and Gene Therapies Advisory Committee

March 4, 2005

Meeting #38

Quality Suites, Rockville, MD

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

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

8:50 Committee Discussion of Manufacturing Questions

11:00 Lunch

Topic II – Update on Retroviral Vector-Mediated Insertional Tumorigenesis

12:00 noon Open Public Hearing

12:30 p.m. FDA Introduction

Guest Presentations:

12:45 Update on Severe Adverse Event in X-SCID Gene Therapy Protocol

1:25 Report on a Myeloid Malignancy Arising in a Rhesus Macaque 6 Years Following Transplantation of Retrovirally-Transduced Cells

2:00 Update on Murine Studies with Wildtype Murine Retroviruses

2:30 Retroviral Vector-Mediated Insertional Mutagenesis: Insights from Mouse Models

2:45 Use of Retroviral Vector-Mediated Gene Transfer in ADA-SCID Clinical Trials

3:10 Committee Discussion of Questions

5:00 p.m. Adjourn