ASH/FDA Workshop on Clinical Endpoints in Acute Leukemia

June 24, 2005
Washington, DC

PRESENTATIONS:

Regulatory Perspective: Acute Leukemia Clinical Endpoints
Nancy S. Scher, M.D.

Scope and Background of Panel
Frederick R. Appelbaum, M.D.

Scope of Problem/Heterogeneity Component
Frederick R. Appelbaum, M.D.

Definition of Response Component
Susan O’Brien, M.D.

Acute Lymphoblastic Leukemia: Minimal Residual Disease as a Surrogate Response Endpoint
William L. Carroll, M.D.

“A Bridge Over Troubled Waters”
Using Bridge to Transplant as Criteria for FDA Drug Approval
Stephen J. Forman, M.D.
Robert J. Arceci, M.D.

Acute leukemia: Endpoints that reflect “living better”
Philip P. Breitfeld, MD