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11:10 AM A User’s Guide to FDA’s Draft Guidance: Gene Therapy Clinical Trials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Tab 2391 Draft Guidance: Gene Therapy Clinical Trials —Observing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 |