Oncologic Drugs Advisory Committee

Pediatric Subcommittee

Agenda

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.

10:05 Break

10:20 Challenges of pharmacokinetic/ Clinton F. Stewart, Pharm.D.

pharmacodynamic assessments in

pediatric oncology

10:45 Pharmacogenomic considerations and Mary V. Relling,

opportunities in trial design

11:10 Committee Discussion

11:45 Lunch

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.

window studies

2:20 Committee Discussion

2:45 Break

3:00 Questions

4:00 Summary Statements Peter C. Adamson, M.D. and

Wayne Rackoff, M.D.

4:30 Adjourn