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Tuesday, June 9, 2004
96th Meeting
Morning
- Session 1 (1 hr 24 mins. - Real Video)
Morning
- Session 2 (1 hr 38 mins. - Real Video)
Meeting Agenda
9:00 AM Call to Order and Opening Remarks
Diane Wara, M.D., Chair, NIH RAC
9:05 AM - Presentation of NIH Award of Merit to Dr.
Larry Johnson, Dr. James
Childress, Dr. David Sidransky, and Dr. Maxine Linial
9:35 AM Data Management Report
Tab 2347 Protocol List
Protocols Not Selected for RAC Public Review
RAC Reviewers:
Larry Johnson, M.D.
Robert Simari, M.D.
Diane Wara, M.D.
9:55 AM - Discussion of Human Gene Transfer Protocol #0404-638: Phase I Trial of Intramuscular Injection of a Recombinant Adeno-Associated Virus 1-Alpha 1-Antitrypsin
(rAAV1-CB-hAAT) Gene Vector to AAT-Deficient Adults
Discussion
of Human Gene Transfer Protocol #0404-638 ( Real Video)
Presentation - 638 (PDF)
PI: Terence R. Flotte, M.D.
University of Florida
RAC Reviewers:
James Childress, Ph.D.
Thomas Gelehrter, M.D.
Larry Johnson, M.D.
Tab 2438 Protocol
Wednesday, June 9, 2004 (continued)
Tab 2349OBA Summary
OBA Letter to PI on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Childress, Gelehrter, and Johnson
PI's/Sponsor's Response
11:35 AM - Public Comment
12:00 PM - Synopsis of RAC Discussion and RAC Recommendations
12:10 PM - LUNCH
1:15
PM - Discussion of Human Gene Transfer Protocol #0404-643: A Phase I/II Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder after Bacillus Calmette-Guerin Failure
Discussion of Human Gene Transfer
Protocol #0404-643 (Real Video)
Presentation - 643 (PDF)
PI: John Nemunaitis, M.D.
US Oncology, Inc., Dallas, TX
RAC Reviewers:Helen Heslop, M.D.
Bernard Lo, M.D.
David Sidransky, M.D.
Glen Nemerow, Ph.D.
Tab 2350 Protocol
Tab 2351OBA Summary
OBA Letter to PI on In-Depth RAC Review and Public
Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Heslop, Lo, Sidransky, and Nemerow
PI's/Sponsor's Response
2:45 PM - Public Comment
3:10 PM - Synopsis of RAC Discussion and RAC Recommendations
3:20 PM - ADJOURNMENT
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