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Recombinant DNA Advisory Committee (RAC)

 101st Meeting

 Bethesda Marriott Hotel
Bethesda , Maryland

September 21, 2005

Morning Session Before Break   (Real Video)

Morning Session After Break   (Real Video)

CAPTION TEXT (HTML)
NOTE: The caption text is a record of the close captioning offered to support the video. It is not a totally accurate, verbatim transcript of the meeting. It is offered here for interest and support of the video. A transcript will be available on the NIH web site in due course.

Meeting Agenda

Wednesday, September 21, 2005

8:00 AM Call to Order and Opening Remarks  (Real Video)

Diane Wara, M.D., Chair, NIH RAC

  • Tab 2386 For Your Information
  • Notice of Meeting
  • Conflict of Interest Guidance

8:10 AM   Introduction of New RAC Members

Amy Patterson, M.D., Director, Office of Biotechnology Activities,
National Institutes of Health

8:20 AM   Minutes of the June 15-16, 2005, RAC Meeting

RAC Reviewers:
Steven Albelda, M.D.
Glen Nemerow, Ph.D.

Tab 2387 Minutes of the June 15-16, 2005, RAC Meeting

8:25 AM   Gene Transfer Safety Assessment Board Report  (Real Video)

Tab 2388 Response to M-I-C-1
Protocol List
Protocols Not Selected for RAC Public Review

RAC Reviewers:
Steven Albelda, M.D.
Helen Heslop, M.D.
Diane Wara, M.D.

8:35 AM RNAi and Its Potential Application as a Therapeutic Strategy (Real Video)

Speaker: Natasha Caplen, Ph.D., National Cancer Institute,
National Institutes of Health

Presentation (PDF)

8:55 AM   Discussion

9:25 AM   BREAK

9:40 AM Discussion of Human Gene Transfer Protocol #0508-725: (Real Video)
A Phase I Pilot Study of Safety and Feasibility of Stem Cell Therapy for AIDS Lymphoma Using Stem Cells Treated with a Lentivirus Vector Encoding Multiple Anti-HIV RNAs

PI: Amrita Krishnan, M.D., City of Hope National Medical Center,
Duarte, CA

Presentation (PDF)

RAC Reviewers:
Naomi Rosenberg, Ph.D.
Diane Wara, M.D.
Madison Powers, J.D., D.Phil.

Ad Hoc Reviewer: Natasha Caplen, Ph.D., National Cancer Institute, National
Institutes of Health

Tab 2389 Protocol
Tab 2390 OBA Summary
OBA Letter to PI on In-Depth RAC Review and
Public Discussion

Outcome of Initial Review by RAC Members

Reviews from Drs. Rosenberg, Wara, Powers, and Caplen

PI’s/Sponsor’s Response

11:00 AM Public Comment

11:10 AM   A User’s Guide to FDA’s Draft Guidance: Gene Therapy Clinical Trials
Observing Participants for Delayed Adverse Events  (Real Video)

Speaker: Carolyn A. Wilson, Ph.D., U.S. Food and Drug Administration

Presentation (PDF)

Tab 2391 Draft Guidance: Gene Therapy Clinical Trials —Observing
Participants for Delayed Adverse Events

11:30 AM   Discussion

12:00 NOON ADJOURNMENT
 

 

 


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