DIA 2013 49th Annual Meeting
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Advancing Alzheimer's Innovation: Clinical Development Successes and Challenges
Track : Track 08:Regulatory Affairs and Submissions
Program Code: 372
Date: Wednesday, June 26, 2013
Time: 4:00 PM to 5:30 PM  EST
Location: 254AB
CHAIR :
 Andrew Satlin, (SCHNON), Executive Vice President, Eisai Inc., United States
SPEAKER (S):
Andrew Satlin, (SPKNON), Executive Vice President, Eisai Inc., United States
 Reisa A. Sperling, MD (SPKSUP), Director; Professor, Neurology, Harvard Medical School, Brigham and Women's Hospital and Massachusetts General Hospital, United States
 Johan Luthman, (SPKNON), Senior Program Leader, Early Development Neuroscience & Opthalmology R&D, Merck & Co., Inc., United States
Description
Drug discovery is hard. In fact, approximately, only 11% of new drugs that enter clinical trials make it to the US market. For central nervous system (CNS) drugs, which includes Alzheimer's, this rate is even lower - only about 8%. The most troubling trend is the rate of failure for Alzheimer's drugs in Phase 3, the final step of the drug development process before regulatory submission.

This session will discuss innovative approaches to clinical trial design, and the use of companion diagnostic testing and biomarkers, to improve the success of clinical trials in Alzheimer's disease and mild cognitive impairment.