戻る Agenda
Advancing Alzheimer’s Innovation: Clinical Development Successes and Challenges
Session Chair(s)
Andrew Satlin
Chief Medical Officer
Intra-Cellular Therapies, United States
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.
Learning Objective : Discuss what challenges have arisen from early and late clinical development; Recognize lessons learned from past trials and what changes could be made if redesigned.
Speaker(s)
Bayesian Adaptive Trial Design: A New Approach for Phase 2 Clinical Trials in Alzheimer’s Disease
Andrew Satlin
Intra-Cellular Therapies, United States
Chief Medical Officer
Current Landscape of Alzheimer's Clinical Trials: Lessons From the Recent Failures in Phase 3
Reisa A. Sperling, MD
Brigham and Women's Hospital , United States
Director, Center for ALZ Rsrch & Treatment; Prof, Neurology, Harvard Medical
Advancement of Diagnostics for Patient Stratification in Alzheimer's Disease Drug Trials
Johan Luthman
Merck & Co., Inc., United States
Senior Program Leader, Early Development Neuroscience & Opthalmology R&D