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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
 TAPE ONE
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
TAPE TWO
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
TAPE 9
3:45 PM RAC Working Group Analysis
4:15 PM Discussion
TAPE 11
5:25 PM Closing Remarks
5:30 PM Adjournment
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