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Agenda
9:00 - AM - Call to Order and Opening Remarks
Diane Wara, M.D., Chair, NIH RAC
9:05 AM - Data Management Report
Tab 2334 Protocol List
Protocols Not Selected for RAC Public Review
RAC Reviewers:
Larry Johnson, M.D.
Robert Simari, M.D.
Diane Wara, M.D.
Overview of Investigator and Institutional M-I-C-1 Responses
Presenter: Cheryl McDonald, M.D.
NIH Office of Biotechnology Activities
Morning BREAK
10:00
AM - Discussion of Human Gene Transfer Protocol
#0401-623: A Phase I/II Dose-Escalating
Randomized Controlled Study to Assess the Safety,
Tolerability, and Efficacy of CERE-110 [Adeno-Associated
Virus (AAV)-Based, Vector-Mediated Delivery
of Beta-Nerve Growth Factor (NGF)] in Subjects
with Mild to Moderate Alzheimer's Disease
Powerpoint
Presentation ( PDF)
PI: David A. Bennett,
M.D.
Rush University Medical Center, Chicago, IL
Powerpoint
Presentation (PDF)
Raymond T. Bartus, Ph.D.
Powerpoint
Presentation ( PDF)
RAC Reviewers:
Martha Bohn, Ph.D.
Bernard Lo, M.D.
Ad Hoc Reviewers: Steven T. DeKosky, M.D.
University of Pittsburgh
Theodore Friedmann, M.D.
University of California, San Diego
Tab 2335Protocol
Tab 2336OBA Summary
OBA Letter to PI on In-Depth RAC Review and Public
Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Bohn, Lo, DeKosky, and Friedmann
PI's/Sponsor's Response
11:35 AM - Public Comment
11:45 AM - BREAK
12:00 NOON - RAC Recommendations
12:15
PM - Discussion of Human Gene Transfer Protocol
#0401-622:
Adenylyl Cyclase VI Gene Transfer for Congenital
Heart Failure
Powerpoint Presentation ( PDF)
PI: H. Kirk Hammond, M.D.
University of California, San Diego
RAC Reviewers:David DeMets, Ph.D.
Larry Johnson, M.D.
Bernard Lo, M.D.
Robert Simari, M.D.
Thursday, March 11, 2004 (continued)
Ad Hoc Reviewer:Walter J. Koch, Ph.D.
Jefferson Medical College, Philadelphia, PA
Powerpoint Presentation ( PDF)
Tab 2337 Protocol
Tab 2338OBA Summary
OBA Letter to PI on In-Depth RAC Review and Public
Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. DeMets, Johnson, Lo, Simari,
and Koch
PI's/Sponsor's Response
1:50 PM - Public Comment
2:00 PM - BREAK
2:15 PM - RAC Recommendations
2:30 PM -
ADJOURNMENT
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