Fit-for-Purpose Biomarker Development

During a drug discovery and development process, a drug candidate is initially characterized in a preclinical setting to attest to its performance characteristics with anticipation that these characteristics will both confirm the engagement of a molecule with a pathophysiologically relevant molecular target and subsequently inform the potential efficacy and safety of the product once a candidate molecule is introduced into clinical development. Target engagement biomarkers, present early within a pathophysiological cascade, are different than disease-related biomarkers that ultimately might be linked to clinical benefit.

Download our white paper to learn more about the “fit-for-purpose” biomarker development strategy.