Cellular, Tissue and Gene Therapies Advisory Committee
March 29 & 30, 2007 Meeting
Date and Time:
The meeting will be held on March 29, 2007 from 8 a.m. to approximately 6:30 p.m. and on March 30, 2007 from 8 a.m. to approximately 3 p.m.
Location:
Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Parkway, Gaithersburg, MD 20877, 301-977-8900.
Address:
Electronic comments should be submitted to www.fda.gov/dockets/ecomments Select Docket No. 2007N-0061 "Sipuleucel-T Dendreon" and follow prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on March 22, 2007. All comments received will be posted without change, including any personal information provided. Comments received on or before March 22, 2007, will be provided to the Committee before or at the meeting.
Contact Persons:
Gail Dapolito or Rosanna L. Harvey, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-1289, fax: 301-827-0294, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512389. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On March 29, 2007, in open session, the Committee will discuss, Sipuleucel-T, Dendreon (BLA-STN 125197) indicated for the treatment of men with asymptomatic metastatic hormone refractory prostate cancer. The Committee will also hear overviews of research programs in the Division of Cellular and Gene Therapies, Center for Biologics Evaluation and Research. On March 30, 2007, in open session, the Committee will discuss the Draft Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies. For a copy of the guidance visit: http://www.fda.gov/cber/gdlns/cordbld.pdf. The Committee will also discuss scientific issues regarding minimally manipulated, unrelated allogeneic peripheral blood stem cells.
Oral Presentations:
Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 p.m. on March 29 and between 10 a.m. and 11 a.m. on March 30. Those desiring to make formal oral presentations should notify the contact person on or before March 7, 2007.
Closed Committee Deliberations:
On March 29, 2007 at approximately 5:30 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)). The Committee will discuss a report of intramural research programs in the Division of Cellular and Gene Therapies.