Tuesday, June 8, 2004
96th Meeting
Morning
- Session 1 (53
mins - Real Video)
Morning
- Session 2 (2 hrs 46 mins - Real
Video)
Afternoon
- Session 1 (1 hr 29 mins
- Real Video)
Afternoon
- Session 2 (1 hr 16 mins - Real
Video)
Meeting Agenda
8:30 AM - Call to Order and Opening Remarks
Diane Wara, M.D., Chair, NIH RAC
Tab 2339 - For Your Information
- Notice of Meeting
- Conflict of Interest Guidance
8:35 AM - Minutes of the March 9-11, 2004, RAC Meeting
RAC Reviewers: Maxine Linial, Ph.D.
David DeMets, Ph.D.
Tab 2340 - Minutes of the March 9-11, 2004, Meeting
8:45 AM - Update on Protocol 0107- 488: A Phase I, Open-Label Clinical Trial of the
Safety and Tolerability of Single Escalating Doses of Autologous CD4 T Cells Transduced with VRX496 in HIV-Positive Subjects
(In-depth review and public discussion at the September 2001 RAC meeting)
Update
on Protocol 0107- 488 (Real Video)
Presentation
- 488 (PDF)
Presenter:Boro Dropulic, Ph.D.
VIRxSYS Corporation, Gaithersburg, MD
9:45 AM - Discussion of Human Gene Transfer
Protocol #0404-642: A Phase I Trial of Gene Transfer
during VAD Support with SERCA2a
Discussion
of Human Gene Transfer Protocol #0404-642 (Real
Video)
Presentation
- 642 (PDF)
PI: Barry London, M.D., Ph.D.
University of Pittsburgh Medical Center
RAC Reviewers: Larry Johnson, M.D.
Bernard Lo, M.D.
Robert Simari, M.D.
Tab 2342OBA Summary
OBA Letter to PI on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. L. Johnson, Powers, and Simari
PI's/Sponsor's Response
11:15 AM - Public Comment
11:40 AM - Synopsis of RAC Discussion and RAC
Recommendations
11:50 AM - Introduction to Upcoming Safety Symposium:
Safety Considerations in Recombinant DNA Research
with Highly Pathogenic Viruses
Introduction
to Upcoming Safety Symposium: Safety Considerations (Real
Video)
Speakers: Kanta Subbarao, M.D., M.P.H.
Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH
Christina Cassetti, Ph.D.
Division of Microbiology and Infectious Diseases, National
Institute of Allergy and Infectious Diseases, NIH
12:30 PM - LUNCH
1:00 PM - Discussion of Human Gene Transfer Protocol #0403-633: Phase I Trial of Immunotherapy with BHT-3009 Alone or Combined with
Atorvastatin in Patients with Multiple Sclerosis
Discussion
of Human Gene Transfer Protocol #0403-633 (Real Video)
Presentation 1 - 633 (PDF)
PI: Timothy L. Vollmer, M.D.
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
Presentation 2 - 633 (PDF)
RAC Reviewers:
Martha Bohn, Ph.D.
Neal DeLuca, Ph.D.
Madison Powers, J.D., D.Phil.
Nicholas Muzyczka, Ph.D.
Ad Hoc Reviewer:Stephen D. Miller, Ph.D.
Northwestern University
(written response)
Tab 2343 Protocol
Tuesday, June 8, 2004 (continued)
Tab 2344OBA Summary
OBA Letter to PI on In-Depth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Bohn, DeLuca, Powers, and Muzyczka
PI's/Sponsor's Response
2:30 PM - Public Comment
2:55 PM - Synopsis of RAC Discussion and RAC Recommendations
3:05 PM - Discussion of Human Gene
Transfer Protocol #0404-641: A Phase I, Open-Label, Nonrandomized, Dose-Escalation, Multicenter Therapeutic Trial of the Safety, Immunogenicity and Efficacy of GI-4000, an Inactivated Recombinant Saccharomyces
cerevisiae Immunotherapeutic Expressing Three Different Mutations of the Ras Oncoprotein, in Patients with Solid Tumors Expressing Mutations in Ras
Discussion
of Human Gene Transfer Protocol #0404-641 (Real
Video)
Presentation
- 641 (PDF)
PI: Bert O'Neil, M.D.
University of North Carolina School of Medicine,
Chapel Hill, NC
Timothy C. Rodell, M.D.
GlobeImmune, Inc.
RAC Reviewers:
Emmett Barkley, Ph.D.
Neal DeLuca, Ph.D.
Terry Kwan, M.S.Ed.
Tab 2345 Protocol
Tab 2346OBA Summary
OBA Letter to PI on In-Depth RAC Review and Public
Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Barkley and DeLuca and Ms.
Kwan
PI's/Sponsor's Response
4:35 PM - Public Comment
5:05 PM - Synopsis of RAC Discussion and RAC
Recommendations
5:15 PM - Update on the RAC Gene Transfer Clinical
Trial Design Working Group
Update on the RAC Gene Transfer Clinical Trial Design
Working Group
(Real Video)
Tuesday, June 8, 2004
Presenters: David DeMets, Ph.D.
NIH RAC
Bernard Lo, M.D.
NIH RAC
Cheryl McDonald, M.D.
NIH Office of Biotechnology Activities
5:25 PM - ADJOURNMENT
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