National Institutes of Health

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NATIONAL INSTITUTES OF HEALTH
RECOMBINANT DNA ADVISORY COMMITTEE (RAC)


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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