Cellular, Tissue and Gene Therapies Advisory Committee
(Formerly Biological Response Modifiers Advisory Committee)
October 24-26, 2001 Meeting
Date and Time
The meeting will be held on October 24, 2001, 9:00 a.m.
to 3:00 p.m.; October 25, 2001, 8:00 a.m. to 6:00 p.m.; and October 26, 2001, 8:00 a.m. to 3:00 p.m.
Location
Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD, 20879, 301-948-8900
Contact Person
Gail Dapolito or Rosanna L. Harvey, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12389. Please call the Information Line for up-to-date information on this meeting.
Agenda
On October 24, 2001, the committee will meeting to discuss long-term follow-up of participants in gene transfer clinical trials. On October 25, 2001, the committee will discuss vector design, manufacture, and preclinical studies of lentivirus vectors in gene transfer clinical trials. On October 26, 2001, the committee will discuss development of a lentivirus vector gene transfer product for people with HIV.
Oral Presentations
Between approximately 10:30 and 11:00 a.m. on October 24, 2001; 2:45 and 3:00 p.m. on October 25, 2001; and 11:15 to 11:30 a.m. on October 26, 2001, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before October 18, 2001.
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