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Thursday 4 December 2003
Webcast
Morning before break
Morning after break
Afternoon
8:30 AM Call to Order and Opening Remarks
Theodore Friedmann, M.D., Chair, NIH RAC
8:35 AM Discussion of Human Gene Transfer Protocol #0307-589:
Powerpoint Presentation
A Phase 1 Study in Glaucoma Subjects Receiving SCH 412499 (rAd-p21) Administered as a Single Injection into the Subconjunctival Space Prior to Primary Trabeculectomy
PIs: Paul L. Kaufman, M.D.
University of Wisconsin Medical School, Madison
Robert N. Weinreb, M.D.
University of California, San Diego
RAC Reviewers: Neal DeLuca, Ph.D.
Robert Simari, M.D.
Terry Kwan, M.S.Ed.
Ad Hoc Reviewer: Donald L. Budenz, M.D.
Bascom Palmer Eye Institute, Miami, FL
Tab 2322 Protocol
Tab 2323 OBA Summary
OBA Letter to PI on Indepth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. DeLuca and Simari and Ms. Kwan
PIs'/Sponsor's Response
10:35 AM Public Comment
10:45AM BREAK
11:00 AM "NIH Guidance on Informed Consent for Gene Transfer Research"—A Web-Based Resource
Powerpoint Presentation
Presenter: Nancy M.P. King, J.D., University of North Carolina, Chapel Hill
Sue L. Levi-Pearl, Tourette's Syndrome Association, Inc., Bayside, NY
12:00 NOON LUNCH
1:00 PM Discussion of Human Gene Transfer Protocol #0307-592:
A Phase 1 Study to Determine the Safety and Immunogenicity of Vaccination With Listeria Monocytogenes Expressing Human Papillomavirus Type 16 E7 for the Treatment of Progressive, Recurrent, and
Advanced Squamous Cell Cancer of the Cervix
Powerpoint Presentation
PI: John Marshall, M.D.
Georgetown University Medical Center, Washington, DC
RAC Reviewers: Emmett Barkley, Ph.D.
Larry Johnson, M.D.
Bernard Lo, M.D.
Tab 2324 Protocol
Tab 2325 OBA Summary
OBA Letter to PI on Indepth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Barkley, L. Johnson, and Lo
PI's/Sponsor's Response
3:00 PM Public Comment
3:10 PM ADJOURNMENT
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