Chairs:  Richard Keefe PhD,  Andrew C. Leon PhD

As our field moves toward an increasingly personalized approach to medical treatment, biomarkers (including genomic, proteomic, imaging, etc.) become increasingly important for informing clinicians about the relative value of CNS products. In addition, biomarkers can serve to help screen for new therapeutic agents, identify susceptible populations, provide endpoints for trials and, potentially, predict efficacy, safety and outcomes of clinical trials.  This increasing interest raises challenges for many different stakeholders regarding the structure and elements of clinical trials that are needed to establish scientific data around biomarkers. This session will bring clinicians, designers of clinical trials, regulators, statisticians and payers together to more clearly identify issues relative to the use of biomarkers to meet these needs.  It will include formal presentations from experts, and will provide examples of  how  biomarkers   have   been   used in the Alzheimer’s  field  as an exemplar of hurdles to this work and how they might be  addressed.  In  the  afternoon, session will focus on statistical methods for defining clinically meaninful effect, followed by a panel discussion on implementation.