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8:30 AM Call to Order and Opening Remarks
Diane Wara, M.D., Chair, NIH RAC
Call
to Order and Opening Remarks ( Real Video)
Tab 2352 For Your Information
- Notice of Meeting
- Conflict of Interest Guidance
8:35 AM - Introduction of New RAC Members
8:50 AM - Minutes of the June 8-9, 2004, RAC Meeting
RAC Reviewers:
Helen Heslop, M.D.
Robert Simari, M.D.
Tab 2353 Minutes of the June 8-9, 2004, Meeting
9:00 AM - Update on the RAC Gene Transfer Clinical
Trial Design Working Group
Presenters: David DeMets, Ph.D.
NIH RAC
David
DeMets, Ph.D. (Real Video)
David
DeMets, Ph.D. - Presentation (PDF)
Terry Kwan, M.S.Ed.
NIH RAC
Tiffany Scharschmidt
University of California, San Francisco
Tiffany
Scharschmidt (Real Video)
Tiffany Scharschmidt - Presentation (PDF)
10:00 AM Data Management Report
Data Management
Report (Real Video)
Tab 2354 - Protocol List
Protocols Not Selected for RAC Public Review
RAC Reviewers:
Helen Heslop, M.D.
Robert Simari, M.D.
Diane Wara, M.D.
10:15 AM - Discussion of Human Gene Transfer Protocol
#0407-669:
Hippocampal NPY Gene Transfer in Subjects
with Intractable Mesial Temporal Lobe Epilepsy
Matthew
During, M.D., D.Sc. (Real Video)
Matthew During, M.D.,
D.Sc.- Presentation (PDF)
PIs: Matthew During, M.D., D.Sc.
Cornell University, New York, NY
Itzhak Fried, M.D., Ph.D.
University of California, Los Angeles (UCLA)
John Stern, M.D.
UCLA
RAC Reviewers:
Martha Bohn, Ph.D.
Stephen Dewhurst, Ph.D.
Philip Johnson, M.D.
Madison Powers, J.D., D.Phil.
Ad Hoc Reviewer: Marc A. Dichter, M.D., Ph.D.
University of Pennsylvania, Philadelphia, PA
(via teleconference)
Ad Hoc
Reviewer: Marc A. Dichter, M.D., Ph.D. (Real
Video)
Tab 2355 Protocol
Tab 2356OBA Summary
OBA Letter to PI on In-Depth RAC Review and Public
Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Bohn, Dewhurst, Johnson, Powers, and Dichter
PIs'/Sponsor's Response
12:00 NOON - Public Comment
12:15 PM - Synopsis of RAC Discussion and RAC Recommendations
12:45 PM ADJOURNMENT
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