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

 

Sangtae Kim, Morgridge Institute for Research



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