Draft Agenda: Monday, November 18, 2002
Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee with the Medical Imaging Drugs Advisory Committee
Food and Drug Administration
Holiday Inn, Gaithersburg, Maryland
The Role of Brain Imaging as an Outcome Measure in Phase 3 Drug Trials in Alzheimer’s Disease
8:00 Call to Order, Introductions
Claudia Kawas, M.D., Acting Chair, PCNS
Conflict of Interest Statement
Sandra Titus, Ph.D., Executive Secretary, PCNS
8:15 FDA Overview of Issues
Overview of Issues, Russell Katz, M.D., Director, Neuropharmacological Drug Products
8:30 Overview of Imaging
Charles De Carli, MD
8:45 Statistical Issues: Imaging as a surrogate Marker
9:00 Questions to the two speakers
9:15 Volumetric MRI and Related Subjects
Clifford Jack, M.D.
Nick Fox, M.D.
H. Cecil Charles, Ph.D.
Michael Grundman, M.D.
10:15 Questions to speakers
11:00 Open Public Hearing
Eric Reisman, M.D., University of Arizona and Good Samaritan Positron Emission Tomography Center
12:00 Lunch Break
1:00 MR Spectroscopy and PET
Michael Weiner, M.D.
Murali Doraiswamy, MD
William Jaqust, MD
1:45 Imaging as a surrogate Marker
Michael Hughes, Ph.D.
2:00 Questions to speakers
2:30 Discussion of questions posed by FDA
3:45 Continuation of Discussion