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Recombinant DNA Advisory Committee
Bethesda Marriott Hotel
Bethesda, Maryland
Thursday 7 March - Friday 8 March
Thursday 7 March 2002
8:10 AM Office of Biotechnology Activities Updates
Roundtable Introductions of New RAC Members
Video of 8am to 9am session OBA Updates
Final Action on Adverse Event Reporting
Amy Patterson, M.D. OBA Director
Powerpoint slides
Clinical Gene Transfer Database
Kelly Fennington, Project Officer OBA
Powerpoint slides
IBCs in a Changing Research Landscape: A Policy Conference - Debriefing
Allan Shipp, Director of Outreach, OBA
Powerpoint slides
9:00 AM Discussion of Human Gene Transfer Protocol #0201-513
Charles Lu M.D. University of Texas, Anderson Cancer Center
Video file
Powerpoint slides
10:45 AM Informed Consent Issues of Human Gene Transfer Research
Nancy King, J.D. RAC Member
Baruch Brody, Ph.D RAC Member
Video file
Powerpoint slides
1:15 PM Detection of Adeno-Associated Virus Vector Sequence in Research Participant Semen
Mark Kay M.D.
Kathy High M.D
Video File
Powerpoint slides
3:15 PM Discussion of Human Gene Transfer Protocol #0201-514
Transduction of the Upper and Lower Airway Epithelium in Healthy Subjects
by an AAV2 Vector That Encodes Human Placental Alkaline Phosphatase
Moira Aitken M.D. Fred Hutchinson Cancer Research Center, University of Washington
A. Dusty Miller Ph.D Fred Hutchinson Cancer Research
Center, University of Washington
Video File
Powerpont slides - first set
Powerpoint slides
Friday 8 March 2002
8:30 AM Call to Order
Theodore Friedmann, M.D., RAC Chair
Video File (the sound takes a few seconds to start)
8:35 AM Opening Remarks, Induction of New RAC Members
Ruth Kirschstein, M.D Acting Director, NIH
Video File (the sound takes a few seconds to start)
8:50 AM Discussion of Human Gene Transfer Protocol #0112-512 entitled: Phase I Study of Huamn Growth Hormone-Realeasing Hormone Expressed by a Plasmid DNA Myogenic Vector in Patients With Cancer Cachexia.
Malcolm K. Brenner; M.D., Ph.D., Baylor College of Medicine
Uday Popat, M.D. Baylor College of Medicine
Video File
Powerpoint slides
RAC Reviewers:
Nancy King J.D.
Robert Simari M.D.
Philip Johnson M.D.
Ad hoc Reviewers
Thomas Gelebrer, M.D. University of Michigan
Thomas Ziegler m.D. Emory University
Richard Vile, Ph.D. Mayo Clinic
Video File
Powerpoint slides of Ad hoc review
11.00 AM Data Management Report
1:30 PM Discussion of Human Gene Transfer Protocol #0201-515: Gene Therapy of Progressive Glioblastoma Multiforme Using a Replication-Defective HSV Multigene Vector NUREL-C2: Phase 1 Clinical Trail to Determine
the Maximum Tolerable Dose of Vector in Combination With Ganiciolovir and Radiosurgery.
PIs L. Dade Lunsford, M.D. University of Pittsburgh School of Medicine
Joseph c. Glorioso, Ph.D. University of Pittsburgh School of Medicine
RAC Reviewers: Xandra Breakefield Ph.D.
Diane Wara M.D.
Maxine Linial Ph.D
James Childress Ph.D
Ad Hoc Reviewer Richard Vile Ph.D Mayo Clinic
Video File (this link may not be active until Wednesday 13th)
technical help questions
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