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Recombinant DNA Advisory Committee (RAC)

 100 th Meeting

 Bethesda Marriott Hotel
Bethesda , Maryland

 June 16, 2005

Morning Session   (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 correct transcript will be available on the NIH web site in due course.

Meeting Agenda

(To view the Agenda in PDF format, click here.)

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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