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NATIONAL INSTITUTES OF HEALTH
RECOMBINANT DNA ADVISORY COMMITTEE (RAC)
Tuesday, March 9, 2004
Afternoon
Session before Break
Afternoon
Session after Break
Agenda
1:00 PM - Call to Order and Opening Remarks
Diane
Wara, M.D., Chair, NIH RAC
Tab 2324 - For Your
Information
Notice of Meeting
Conflict
of Interest Guidance
1:05 PM - Minutes of the October 17, 2003, and
December 3-4, 2003, RAC Meetings
Tab 2325
RAC
Reviewers: Terry Kwan, M.S.Ed.
Theodore Friedmann,
M.D.
1:15
PM - Discussion of Human Gene Transfer Protocol
# 0401-629:
A Phase I Dose-Escalation Trial of vvDD-CDSR
(Double-Deleted Vaccinia Virus Plus CD/SMR) Administered
by Intratumoral Injection in Patients with Superficial
Injectable Tumors
PI: David L. Bartlett, M.D.
University of
Pittsburgh Medical Center
- Powerpoint
Presentation (PDF)
RAC Reviewers: James Childress, Ph.D.David
DeMets, Ph.D.
Philip Johnson, M.D.
Ad Hoc Reviewer: Genoveffa Franchini, M.D.
National Cancer Institute, NIH
- RAC 629 Review - Powerpoint
Presentation (PDF)
PI:
David L. Bartlett, M.D. - Response
Tab 2326 Protocol
Tuesday, March 9, 2004 (continued)
Tab 2327OBA Summary
OBA Letter to PI on In-Depth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Childress, DeMets, P. Johnson, and Franchini
PI's/Sponsor's Response
2:50 PM - Public Comment
3:00 PM - BREAK
3:15 PM - RAC Recommendations
3:30
PM - Update on Protocol 0104-469: Subthalamic
GAD Gene Transfer in Parkinson's Disease Patients
Who Are Candidates for Deep-Brain Stimulation
-
Powerpoint Presentation (PDF)
Presenters:
-
Michael G. Kaplitt, M.D., Ph.D.
Weill Medical College, Cornell University, Ithaca,
NY
- Matthew J. During, M.D., Ph.D.
University of Auckland
4:30 PM - Public Comment
4:45 PM - ADJOURNMENT |
