Cellular, Tissue and Gene Therapies Advisory Committee
(Formerly Biological Response Modifiers Advisory Committee)
February 27, 2003
Date and Time
The meeting will be held on February 27, 2003, 8:00 a.m. to approximately 6:00 p.m.; and February 28, 2003, 8:00 a.m. to approximately 4:30 p.m.
Location
Holiday Inn, 8777 Georgia Avenue, Silver Spring, MD, 301-589-0800
Contact Persons
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 February 27, 2003 from 8:00 a.m. to approximately 3:45 p.m. the committee will discuss efficacy data for the use of minimally manipulated hematopoietic stem cells from placental/umbilical cord blood for hematopoietic reconstitution for particular age groups. From approximately 3:45 to 5:30 p.m. the committtee will receive updates of research programs in the Division of Monoclonal Antibodies. On February 28, 2003 from 8:00 a.m. to approximately 4:30 p.m. the committee will discuss safety issues related to the use of retrovirus vectors in gene therapy clinical trials.
Oral Presentations
On February 27, 2003 from approximately 11:30 a.m. to 12:30 p.m.; and on February 28, 2003, from approximately 11:00 a.m. to 12:00 noon oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before February 20, 2003.
Closed Committee Deliberations
On February 27, 2003 from approximately 5:30 p.m. to 6:00 p.m, the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b (c)(6)).
|
