White Paper

Fit-For-Purpose Biomarker Development

By Michael F Murphy, MD, PhD; Jasna Klicic Badoux, PhD; Tom Zhang, PhD

A Biomarker-Driven Approach To Developing Targeted Therapies

During a drug discovery and development process, a drug candidate is first characterized in a preclinical setting to assess its performance characteristics. This confirms the engagement of a molecule with a pathophysiologically relevant molecular target and informs the efficacy and safety of the product once a candidate molecule is introduced into clinical development. Here, we highlight the essential framework of a “fit-for-purpose” biomarker development strategy, emphasizing strategic and transactional engagements with clinical research organizations.

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