Tuesday, June 20 • 10:30am - 11:45am
#224: Success in Early CNS Drug Development: Getting Proof-of-Principle by Stacking the Deck with Biomarkers

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-553-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Identify how biomarkers can be used to help de-risk CNS drug development programs.


Bruce Morimoto, PhD


Public / Private Partnerships in Alzheimer’s Biomarkers
Keith Fargo, PhD

Small Clinical Trials: Alternative Design and Analysis
Michael Gold, MD

avatar for Nita Ichhpurani

Nita Ichhpurani

Senior Director, Global Clinical Development, Celerion
24 yrs of pharma experience. At Pharmacia, Nita was a Chemist and PM in Clinical Pharmacology in oncology and CNS research. At MDS, she managed Global Central lab teams and later become the Latin American Lab Manager. At Celerion, she managed drug development programs from discovery... Read More →

avatar for Keith Fargo

Keith Fargo

Director of Medical and Scientific Relations, Alzheimer's Association
At the Alzheimer's Association, Dr. Fargo is responsible for coordinating the scientific programming for the Alzheimer's Association International Conference (AAIC), the largest scientific dementia conference in the world. In addition, Dr. Fargo oversees the International Society... Read More →

Michael Gold

Head of Neuroscience, AbbVie, Inc.
Dr. Gold obtained his BS, MS and MD degrees from the University of Miami. He completed a residency in Neurology at the Albert Einstein College of Medicine in NYC and a fellowship in Behavioral Neurology at the University of Florida. Dr. Gold has nearly 20 years of industry experience... Read More →
avatar for Bruce Morimoto

Bruce Morimoto

Vice President, Scientific Affairs, Celerion
Bruce is the Vice President, Scientific Affairs, a key leadership position at Celerion and is directly responsible for developing and deploying scientific, regulatory and medical expertise and advice to various biotech and emerging pharmaceutical companies. Prior to joining Celerion... Read More →

Tuesday June 20, 2017 10:30am - 11:45am CDT
S504abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  07: SpecialPops, Session