Food and Drug Administration
Center for Biologics Evaluation and Research
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
Hilton Hotel, Gaithersburg, Maryland

May 10, 2002

 Potential for Inadvertent Germline Transmission of Gene Transfer Vectors

 DRAFT  AGENDA

 8:00-8:15 a.m.                   Welcome/administrative remarks

8:15-8:40                            FDA Introduction
                Dr. Daniel Takefman
                Division of Cellular and Gene Therapies, CBER

8:40-9:00                             Guest Presentations
                                                    Dr. Jude Samulski
                                                    University of North Carolina

9:00-9:10                              Q&A

9:10-9:40                                 Dr. Jon Gordon
   Mount Sinai School of Medicine

9:40-9:50                              Q&A

9:50-10:05                            Break

10:05-10:25                              Dr. Mark Kay
                Stanford University

10:25-10:40                              Dr. Linda Couto
                Avigen Inc.

10:40-10:55                          Q&A

10:55-11:25                             Dr. Valder Arruda
                                                    University of Pennsylvania

11:25-11:40                          Q&A  

11:40- 12:10 p.m.                Open Public Hearing

 12:10 – 1:00 p.m.                Lunch

 1:00                                        Committee discussion of questions

 3:00                                        Adjourn