10:15–11:30

Session I: OPPORTUNITIES FOR ENHANCING REGULATORY SCIENCE

Moderator: Mark McClellan, The Brookings Institution

The IOM and FDA Science Board Recommendations

Gail Cassell, Eli Lilly and Company

Academic Perspective

Philip Pizzo, Stanford University School of Medicine, Council of Deans, Association of American Medical Colleges

A Blueprint from the Patient’s Perspective

Ellen Sigal, Friends of Cancer Research

11:30–11:45

Break and Working Lunch

Guests are asked to pick up lunch and return to their seats.

11:45–1:15

Session II: OPPORTUNITIES FOR ENHANCING REGULATORY SCIENCE (cont’d)

Moderator: Barbara Alving, National Center for Research Resources, NIH

Translational Approaches to Understand and Predict Rare Adverse Reactions to Drugs

Paul Watkins, Hamner–University of North Carolina Institute for Drug Safety Sciences

A Role for Regulatory Science in Emerging Technologies: Genomics

Allen Roses, Deane Drug Discovery Institute, Duke University

Opportunities in Statistical Design, Analysis, and Modeling

Susan Ellenberg, University of Pennsylvania School of Medicine

IT Infrastructure, Informatics and Scientific Computing in Regulatory Science