Oncologic Drugs Advisory Committee
8:00 Call to order and Introduction Victor M. Santana, M.D.
Welcome Richard Pazdur, M.D.
Conflict of Interest Kimberly L. Topper, MS
8:15 Charge to Committee Steven Hirschfeld, M.D.
8:20 Open public hearing
8:50 Review of ethical principles as applied to Eric Kodish, MD. Ph.D.
research in children with cancer
9:15 Committee Discussion
9:40 Review of developmental pharmacology J. Steven Leeder, Pharm.D., Ph.D.
10:20 Challenges of pharmacokinetic/ Clinton F. Stewart, Pharm.D.
pharmacodynamic assessments in
10:45 Pharmacogenomic considerations and Mary V. Relling,
opportunities in trial design
11:10 Committee Discussion
12:45 Open Public Hearing
1:15 Approaches to endpoint validation with Steven Goodman, M.D., MHS, Ph.D.
small numbers of patients-challenges, and Edward L. Korn, Ph.D.
constraints, and methods
2:00 Summary of experience with Phase II Victor M. Santana, M.D.
2:20 Committee Discussion
4:00 Summary Statements Peter C. Adamson, M.D. and
Wayne Rackoff, M.D.