Food and Drug Administration

Center for Biologics Evaluation and Research

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #33, October 10, 2002

Hilton Hotel, Gaithersburg, MD

 

 

Draft Agenda

 

Topic I:            Retroviral Gene Therapies for the Treatment of Patients with Severe Combined Immunodeficiency – Safety Issues

 

8:00 a.m.                     Welcome and Introductions

                                                Dr. Daniel Salomon, Chair

                                                The Scripps Research Institute

 

8:10                             Conflict of Interest Statement

                                                Ms. Gail Dapolito, Executive Secretary

                                                Center for Biologics Evaluation and Research

 

8:15                             FDA Introduction to the Topic

                                                Dr. Philip Noguchi

                                                Center for Biologics Evaluation and Research, FDA

 

                                    Guest Presentations

                                   

8:20                                         Dr. Alain Fischer (audioconference)

Hospital Necker, France

 

                                                Dr. Christof Kalle

                                                University of Cincinnati School of Medicine

9:20                                          Q&A

 

9:35                                         Dr. Rebecca Buckley

                                                Duke University Medical Center

9:50                                         Q&A

 

10:00                                       Dr. Linda Wolff

                                                National Cancer Institute

10:30                                       Q&A

 

10:45                           Break

 

11:00                                       Dr. Christopher Baum

                                                Hannover Medical School, Germany

11:20                                       Q&A

 

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #33, October 10, 2002

 

 

Agenda (Cont’d)

11:30 a.m.                               Dr. Stuart Orkin

                                                Harvard Medical School

11:50                                       Q&A

 

12:00 noon                  Lunch

 

12:45 p.m.                               Dr. Donald Kohn

                                                U.S.C. Keck School of Medicine

 

1:15                                         Dr. Brian Sorrentino

                                                Dr. John Cunningham

                                                St. Jude Children’s Research Hospital

 

1:30                                         Dr. Harry Malech

                                                National Institute for Allergy and Infectious Diseases

1:45                                         Q&A

 

2:00                             Open Public Hearing

 

3:00                             Committee Discussion of Questions

 

5:00                             Break

 

Topic II:            Update – Research Programs, Division of Cell and Gene Therapies, Division of Therapeutic Proteins, CBER

 

5:10                                         Dr. Raj Puri

                                                Chief, Laboratory of Molecular Tumor Biology

 

5:20                                         Dr. David Essayan

                                                Laboratory of Molecular Tumor Biology

 

5:25                                         Dr. Michael Norcross

                                                Laboratory of Gene Regulation

 

5:35                 Closed Session

 

6:00 p.m.             Adjourn