National Institutes of Health

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[06 Dec 2001]

National Institutes of Health
Recombinant DNA Advisory Committee (RAC)
91st Meeting of the NIH RAC

Bethesda Marriott Hotel
Bethesda, Maryland
June 18-19, 2003

Webcast

Wednesday June 18 Morning before break
Wednesday June 18 Morning after break
Wednesday June 18 Afternoon after lunch
Wednesday June 18 Afternoon after break
Thursday June 19 Morning before break
Thursday June 19 Morning after break

Meeting Agenda
 

Wednesday, June 18, 2003

    • 8:30 AM Call to Order and Opening Remarks
    • Theodore Friedmann, M.D., Chair, NIH RAC
        • Tab 2295 For Your Information
        • - Notice of Meeting

          • - Conflict of Interest Guidance
           

    • 8:45 AM Minutes of the February 10, 2003 RAC Meeting
    • Tab 2296
       
    •   RAC Reviewers: Theodore Friedmann, M.D.
    •     Madison Powers, J.D., D.Phil.
       
    •   Minutes of the March 6-7, 2003 RAC Meeting
    • Tab 2297
       
    •   RAC Reviewers: Baruch Brody, Ph.D.
    •     David Sidransky, M.D
       
    • 9:00 AM Presentation of NIH Award of Merit to Dr. Theodore Friedmann and Dr. Linda Gooding
       
    • 9:30 AM Discussion of Human Gene Transfer Protocol #0301-575 entitled: A Phase I Study of NT-501, An Implant of Encapsulated Human NTC-201 Cells Releasing Ciliary Neurotrophic Factor (CNTF), in Patients With Retinitis Pigmentosa

        PI: Paul A. Sieving, M.D., Ph.D., National Institutes of Health

      •   RAC Reviewers: Neal DeLuca, Ph.D.

        • Larry Johnson, M.D.
        • Maxine Linial, Ph.D.
        •     Bernard Lo, M.D.

          •   Ad Hoc Reviewer: Jean Bennett, M.D., Ph.D.Wednesday, June 18, 2003 (continued)

            Tab 2298 Protocol

            Tab 2299 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, L. Johnson, Linial, Lo, and Bennett
        •   PI's/Sponsor's Response

          • 11:15 AM Public Comment

            The Foundation Fighting Blindness

          11:40 AM BREAK

          11:55 AM Data Management Report

        • Tab 2300 Protocol List
        •   Protocols Not Selected for RAC Public Review

          •    Discussion of Amendments to Protocol 304

          • RAC Reviewers: Baruch Brody, Ph.D.
          •     Linda Gooding, Ph.D.
          •     Larry Johnson, M.D.
          •     Robert Simari, M.D.
          •     Diane Wara, M.D.
             
    • 1:00 PM LUNCH
       
    • 2:00 PM Review of Selected American Society of Gene Therapy (ASGT) Annual Meeting Sessions Related to Retroviral Vectors
    • Theodore Friedmann, M.D., Chair, NIH RAC

      POWERPOINT SLIDES
       
        • Tab 2301 "Ethical and Policy Dilemmas in Clinical Gene Therapy Studies:     Balancing Real Benefits and Real Risks"
        • "Report from the ASGT Ad Hoc Committee on Retroviral-              mediated Gene Transfer to Hematopoietic Stem Cells"
        • "SCID-X1 Clinical Trial: Current State"
           
    • Recommendations of the United Kingdom Gene Therapy Advisory Committee (GTAC) and Committee on Safety of Medicines (CSM) Working Party on Retroviruses (April 2003)

      POWERPOINT FILES
       
    • Marina O'Reilly, Ph.D., Biotechnology Program Advisor, OBA
    • Tab 2302
       
    • 3:00 PM Public Comment
       
    • 3:10 PM BREAK
    • Wednesday, June 18, 2003 (continued)
       
    • 3:25 PM Retroviral Vectors: Topics for Future Presentations and Discussions at RAC Meetings

      POWERPOINT FILES
       
    •   Marina O'Reilly, Ph.D., Alexander Rakowsky, M.D., and Madison Powers, J.D., D.Phil.
       
    •   Retrovirus Working Group Members: Martha Bohn, Ph.D.
    •       Neal DeLuca, Ph.D.
    •       Theodore Friedmann, M.D.
    •       Larry Johnson, M.D.
    •       Maxine Linial, Ph.D.
    •       Robert Simari, M.D.
    •       Diane Wara, M.D.
       
    • 3:45 PM Public Comment
       
    • 3:55 PM Presentation of in-depth Assessment Regarding Containment-Level Requirements for Modified Vaccinia Ankara (MVA) Pox Viral Vector
    • RAC Presenter: Emmett Barkley, Ph.D.

      POWERPOINT FILES
       
    •   Tab 2303
    • Assessment Team: Mark Feinberg, M.D., Ph.D., Emory University
          • Bernard Moss, M.D., Ph.D., National Institute of Allergy
          •   and Infectious Diseases, NIH
    •     Paul Spearman, M.D., Vanderbilt University
    • 4:45 PM Public Comment
    • 5:00 PM ADJOURNMENT

    •  

      Thursday, June 19, 2003

       

      8:30 AM Call to Order and Opening Remarks

        Theodore Friedmann, M.D., Chair, NIH RAC

       

      8:35 AM Informed Consent

       

    • What Consent Forms Say and What Researchers and Subjects Expect in
    • Gene Transfer Research
    • Nancy M.P. King, J.D., and Gail Henderson, Ph.D., University of North Carolina, Chapel Hill
    • 9:35 AM Discussion
    • Thursday, June 19, 2003 (continued)

      •  

      9:50 AM BREAK

       

      10:05 AM NIH RAC Informed Consent Working Group (ICWG) Draft Guidance

        Nancy M.P. King, J.D., and Baruch Brody, Ph.D., Cochairs, ICWG

       

        Tab 2304

       

        RAC ICWG Members: James Childress, Ph.D.

          • Bernard Lo, M.D.
      • Diane Wara, M.D.
  • U.S. Department of Health and Human Services (DHHS) ICWG Members:
  •     Suzanne Goodwin, OBA

    •      Allan Shipp, OBA

         Stephen Rose, Ph.D., OBA

      • Kristina Borror, Ph.D., Office for Human Research
          • Protections, DHHS
      • Cynthia Rask, M.D., U.S. Food and Drug
          • Administration

          • 10:35 AM Discussion

             

            11:35 AM Public Comment

             

            12:00 NOON ADJOURNMENT

             

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