Advancing Alzheimer’s Innovation: Clinical Development Successes and Challenges

Track:
Regulatory Affairs and Submissions

Day & Time:
June 26, 4:00PM - 5:30PM

Session Number:
372

Room Number:
254AB

Level:
Intermediate

Type:
Forum

Title:
Advancing Alzheimer’s Innovation: Clinical Development Successes and Challenges

Chair(s):
Andrew Satlin
Senior Vice President
Eisai 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.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Bayesian Adaptive Trial Design: A New Approach for Phase 2 Clinical Trials in Alzheimer’s Disease
Andrew Satlin
Senior Vice President
Eisai Inc., United States

Current Landscape of Alzheimer's Clinical Trials: Lessons From the Recent Failures in Phase 3
Reisa A. Sperling, MD
Director; Professor, Neurology, Harvard Medical School
Brigham and Women's Hospital and Massachusetts General Hospital , United States

Advancement of Diagnostics for Patient Stratification in Alzheimer's Disease Drug Trials
Johan Luthman, MD
Vice President, Neuroscience and Opthalmology R&D for Franchise Integrator
Merck & Co., Inc. , United States