National Institutes of Health

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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