8:30 AM Call to Order and Opening Remarks (Real Video)
Diane Wara, M.D., Chair, NIH RAC
8:40 AM Discussion of Human Gene Transfer Protocol #0510-739: (Real Video)
Transduction of the Upper Airway Epithelium in Humans with Cystic Fibrosis by an AAV6 Vector That Encodes Human Placental Alkaline Phosphatase
Presentation (PDF)
PI: Moira L. Aitken, M.D., University of Washington, Seattle, WA
Sponsor: Dusty Miller, Ph.D., Fred Hutchinson Cancer Research Center, Seattle, WA
RAC Reviewers: Stephen Dewhurst, Ph.D.
Terry Kwan, M.S.Ed.
Helen Heslop, M.D.
Tab 2401 Protocol
Tab 2402 OBA Summary
OBA Letter to PI on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Dewhurst and Heslop and Ms. Kwan
PI’s/Sponsor’s Response
10:10 AM Public Comment
10:25 AM BREAK
10:40 AM Discussion of Human Gene Transfer Protocol #0509-727: (Real Video)
Clinical Translation of a Mammaglobin-A DNA Vaccine for Breast Cancer Prevention and Therapy
Presentation (PDF)
PI: William E. Gillanders, M.D., Washington University School of Medicine,
St. Louis, MO
RAC Reviewers: Steven Piantadosi, M.D., Ph.D.
Madison Powers, J.D., D.Phil.
Richard Vile, Ph.D.
Tab 2403 Protocol
Tab 2404 OBA Summary
OBA Letter to PI on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Piantadosi, Powers, and Vile
PI’s/Sponsor’s Response
12:10 PM Public Comment
12:25 PM LUNCH
1:25 PM Discussion of Human Gene Transfer Protocol #0510-731: (Real Video)
Open-Label, Dose-Escalation Study Evaluating the Safety of a Single Administration of an Adenoviral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in Individuals with Irradiation-Induced Parotid Salivary Hypofunction
Presentation (PDF)
PI: Bruce J. Baum, D.M.D., Ph.D., National Institute of Dental and
Craniofacial Research, National Institutes of Health, Bethesda, MD
RAC Reviewers: Howard Federoff, M.D., Ph.D.
Terry Kwan, M.S.Ed.
Nicholas Muzyczka, Ph.D.
Ad Hoc Reviewers: Athena S. Papas, D.M.D., Ph.D., Tufts University,
Boston, MA
Scott E. Strome, M.D., University of Maryland,
Baltimore, MD
Tab 2405 Protocol
Tab 2406 OBA Summary
OBA Letter to PI on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Federoff, Muzyczka, Papas, and Strome and
Ms. Kwan
PI’s/Sponsor’s Response
3:00 PM Public Comment
3:15 PM ADJOURNMENT |
