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National Institutes of Health
Recombinant DNA Advisory Committee (RAC)
Bethesda Marriott Hotel
Congressional Ballroom
Bethesda, Maryland
December 6, 2001

Meeting Agenda


8:00 AM Call to Order
Claudia Mickelson, Ph.D., RAC Chair
8:05 AM Opening Remarks: Appreciation for Service to the DHHS
William F. Raub, Ph.D., Deputy Assistant Secretary for Science Policy, DHHS 
8:15 AM Presentation of RAC Member Certificates
  William F. Raub, Ph.D., Deputy Assistant Secretary for Science Policy, DHHS
  Lana Skirboll, Ph.D., Director, Office of Science Policy, NIH
8:45 AM Spotlight on the RAC:  Recent Accomplishments and Future Directions
  Amy P. Patterson, M.D., Director, Office of Biotechnology Activities, NIH
 9:05 AM Perspectives From the RAC Chair
 Claudia Mickelson, Ph.D.
9:25 AM Minutes of the September 6-7, 2001, RAC Meeting
  RAC  Reviewers: Estuardo Aguilar-Cordova, Ph.D.   Sue Levi-Pearl

9:35 AM Proposed Response to Reported Appearance of Neoplasms After Vascular Growth Factor Gene Transfer Jon Gordon, M.D., Ph.D., RAC Member
10:15 AM Data Management Report
  Jay Greenblatt, Ph.D., RAC Member

10:30 AM BREAK

  TAPE 3

10:45 AM Detection of Adeno-Associated Virus Vector Sequence in Research Participant Semen: Report and Analysis  RAC Working Group: Estuardo Aguilar-Cordova, Ph.D. Xandra Breakefield, Ph.D.Theodore Friedmann, M.D. Jon Gordon, M.D., Ph.D. Nancy King, J.D.Louise Markert, M.D., Ph.D.Claudia Mickelson, Ph.D. Ad Hoc Consultants: Philip Johnson, M.D., Ohio State UniversitySimon Hall, M.D., Mount Sinai Hospital Myron Cohen, M.D., University of North Carolina Jude Samulski, Ph.D., University of North Carolina Terence Flotte, M.D., University of Florida
10:50 AM Liver-Directed Gene Transfer of rAAV for Hemophilia B: Summary of Clinical Protocol and Data (Including Summary of Semen Vector Analysis) and Statement of Problem Mark Kay, M.D., Ph.D., Stanford University Questions (15 minutes)

  TAPE 4

11:35 AM Brief Explanation of Assay Used for Semen Vector Analysis Deb Leonard, M.D., Ph.D., University of Pennsylvania  Questions (15 minutes)

  TAPE 5

12:05 PM Overview of Spermatogenesis Simon Hall, M.D., Mount Sinai Hospital  

12:35 PM LUNCH

  TAPE 6

1:35 PM Preclinical Studies of AAV-hFIX Vector Safety and Biodistribution  Kathy High, M.D., Children's Hospital of Philadelphia

  TAPE 7

2.:20 PM Summary, Position Statement, and Clinical Trial Perspective Elliot Grossbard, M.D., Avigen

  TAPE 8

2:40 PM FDA Procedures Regarding Potential Germ Line Transmission and Impact on Gene Therapy Clinical Trials  Stephanie Simek, Ph.D., Center for Biologics Evaluation and Research, FDA

     TAPE 10

3:25 PM Public Comment


3:45 PM RAC Working Group Analysis

4:15 PM Discussion


5:25 PM Closing Remarks

5:30 PM Adjournment

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