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