Food
and Drug Administration
Center for Biologics Evaluation and Research
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
Hilton Hotel, Gaithersburg, Maryland
May
9, 2002
DRAFT AGENDA
8:00 a.m.
Session I - Open Session
Update Research Programs
Laboratory
of Gene Regulation, DTP, CBER
Laboratory of Immunobiology, DMA, CBER
8:45
Session II - Closed Session
9:05
Break
9:15
Session III – Open Session
Ooplasm Transfer in Assisted Reproduction
9:15-9:45
Welcome/Administrative Remarks
Presentation of Certificate of Appreciation to Dr. Edward Sausville
Jesse Goodman, M.D., CBER
Jay P. Siegel, M.D., CBER
9:35-9:45
FDA Introduction
Deborah
Hursh, Ph.D.
Division of Cellular and Gene Therapies, CBER
Guest Presentations
9:45-10:25
Susan
Lanzendorf, Ph.D., HCLD
Jones Institute
of Reproductive Medicine
10:25-10:35
Q&A
10:35-10:45
Break
10:45-11:25
Jacques
Cohen, Ph.D.
St. Barnabas Medical Center
11:25-11:35
Q&A
11:35-12:20
p.m.
Eric
Shoubridge, Ph.D.
Montreal
Neurological Institute
12:20-12:40
Q&A
12:40
–1:40 p.m.
Lunch
Guest Presentations (Cont’d)
1:40-2:25
Jonathon
VanBlerkom, Ph.D.
University of
Colorado at Boulder
2:25-2:35
Q&A
2:35-3:05
Lori P. Knowles, LL.B.,B.C.L.,M.A.,L.L.M.
The Hastings Institute
3:05-3:15
Q&A
3:15-3:45
Open public hearing
3:45-4:00
Break
4:00-6:30
Committee discussion of questions