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Success in Early CNS Drug Development: Getting Proof-of-Principle by Stacking the Deck with Biomarkers
Session Chair(s)
Bruce Morimoto, PHD
Vice President, Drug Development
United States
Central nervous system (CNS) drug development is plagued with challenges. First, getting a CNS therapeutic to the appropriate pharmacodynamic compartment most often requires crossing the blood-brain-barrier for target engagement. Determining the appropriate dose, understanding PK-PD relationships and the use of predominantly subjective clinical outcome measures all contribute to the high attrition rate for CNS therapeutics. To get new therapeutics to market for this area of high unmet medical need, we can turn to biomarkers to establish target engagement, verify mechanism of action, and detect a signal of efficacy. This session will discuss the role of biomarkers in early clinical research to help de-risk drug development programs.
Learning Objective : Identify how biomarkers can be used to help de-risk CNS drug development programs.
Speaker(s)
Public / Private Partnerships in Alzheimer’s Biomarkers
Keith Fargo, PHD
Alzheimer's Association, United States
Director of Medical and Scientific Relations
Small Clinical Trials: Alternative Design and Analysis
Michael Gold, MD
AbbVie, Inc., United States
Head of Neuroscience