CBER Briefing Document

Biological Response Modifiers Advisory Committee

July 13, 2001


1. Hutchins, B., Sajadi, N., Seaver. S., Shepard, A., Bauer, S.R., Simek, S., Carson, K., Aguilar-Cordova, E. 2000. Working toward an adenoviral vector testing standard. Molecular Therapy: 2:532-534.

2. Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy - 3/30/98. (available at: http://www.fda.gov/cber/genetherapy/gtpubs.htm)

3. Foster, C.B., Choi, E.H., and Chanock, S.J. 2000. Adenovirus and marrow transplantation in children. Ped. Path Molec Med. 19:97-114.

4. Baldwin, A., Kingman, H., Darville, M., Foot, A.B.M.,Grier, D., Cornish, J.M., Goulden, N., Oakhill A., Pamphilon, D.H., Steward, C.G., and Marks, D.I. 2000. Outcome and clinical course of 100 patients with adenovirus infection following bone marrow transplantation. Bone Marrow Transplantation 26: 1333-1338.5.

5. Flomenberg, P., Babbitt, J., Drobyski, W.R., Ash, R.C., Carrigan, D.R., Sedmak, G.V., McAuliffe. T., Camitta, B., Horowitz, M.M., Bunin, N., and Casper, J.T. 1994. Increasing Incidence of adenovirus disease in bone marrow transplant recipients. J. Infectious. Diseases 169: 775-781

6. Flomenberg, P., Gutierrez, E., Piaskowski, V., and Casper, J.T. 1997. Detection of adenovirus DNA in peripheral blood mononuclear cells by polymerase chain reaction assay. J.Med Virol. 51: 182-188.5.

7. Shirali, G.S., Ni, J., Chinnock, R.E., Johnston, J.K., Rosenthal, G.L., Bowles, N.E., and Towbin, J.A. 2001. Association of viral genome with graft loss in children after cardiac tranplantation. N. Engl. J. Med 344: 1498-1503.

8. March 6, 2000 FDA Gene Therapy Letter, http://www.fda.gov/cber/publications.htm

9. Transcripts; Biological Response Modifiers Advisory Committee Meeting, April 5, 2001, pages 145-188. http://www.fda.gov/ohrms/dockets/ac/cber01.htm#BiologicalResponse

10. Presentation Slides: Adenovirus and Bone Marrow Transplantation, Stephen J. Chanock, M.D., presented at Biological Response Modifiers Advisory Committee Meeting, April 5, 2001.