Developing Products for Personalized Medicine: Facing the Challenges of Biomarkers

Chairs: L Alphs, K Broich

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 safety, tolerability, efficacy and outcomes values for 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, workshops led by experts will give practical experience in how to incorporate biomarkers in clinical trials and establish their value. The results of these workshops will be reviewed by senior experts in the field.