Thursday, June 16, 2005
8:00 AM Call to Order and Opening Remarks (Real Video)
Diane Wara, M.D., Chair, NIH RAC
8:10 AM Discussion of Human Gene Transfer Protocol #0410-677:Phase I Trial of Ocular Subretinal Injection of a Recombinant Adeno-Associated Virus (rAAV-RPE65) Gene Vector in Patients with Retinal Disease Due to RPE65 Mutations (Real Video)
Presentation (PDF)
PI: Samuel G. Jacobson, M.D., Ph.D., Scheie Eye Institute, University
of Pennsylvania School of Medicine, Philadelphia, PA
Submitter: Philip J. Cross & Associates, Inc., Wilmington, DE
RAC Reviewers:
Terry Kwan, M.S.Ed.
Helen Heslop, M.D.
Richard Vile, Ph.D.
Ad Hoc Reviewer: Karl Csaky, M.D., Ph.D., National Eye Institute, National Institutes of Health
Tab 2382 Protocol
Tab 2383 OBA Summary
- OBA Letter to PI on In-Depth RAC Review and
Public Discussion
- Outcome of Initial Review by RAC members
- Reviews from Drs. Heslop, Vile, and Csaky and Ms. Kwan
- PI’s/Sponsor’s Response
9:50 AM Public Comment
10:00 PM BREAK
10:15 AM Biological Containment for Work with Noncontemporary Strains of Influenza: Harmonization of the NIH Guidelines with Other Federal Guidances
(Real Video)
Presentation (PDF)
Presentation (PDF)
Introduction: Kathryn Harris, Ph.D., Contractor, Office of Biotechnology Activities
Presenter: Jacqueline Katz, Ph.D., U.S. Centers for Disease Control and Prevention, Altanta, G
11:00 AM Discussion of Human Gene Transfer Protocol #0504-707:Dose-Finding and Safety Study of an Oncolytic Polio/Rhinovirus against Malignant Glioma
(Real Video)
Presentation (PDF)
PI: Darrell D. Bigner, M.D., Ph.D., Duke University Medical Center, Durham, NC
Submitter: Matthias Gromeier, M.D., Duke University, Durham, NC
RAC Reviewers:
Neal DeLuca, Ph.D.
Philip Johnson, M.D. (written review)
Bernard Lo, M.D.
Diane Wara, M.D.
Ad Hoc Reviewer: Ellie Ehrenfeld, Ph.D., National Institute of Allergy and Infectious Diseases, National Institutes of Health
Tab 2384 Protocol
Tab 2385 OBA Summary
- OBA Letter to PI on In-Depth RAC Review and
Public Discussion
- Outcome of Initial Review by RAC Members
- Reviews from Drs. DeLuca, Johnson, Lo, Wara, and Ehrenfeld
- PI’s/Sponsor’s Response
12:30 PM Public Comment
12:45 PM ADJOURNMENT
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