This presentation will be part of a symposium: TTitle: Do you know what you are measuring? Developing biomarkers that have clinical impact The bioanalytical community has developed a solid understanding of developing and validating accurate, robust, and enduring PK and ADA assays to characterize protein therapeutics in clinical studies. However, the key considerations that are essential for the development of biomarker assays differ from the well-established practices for PK and ADA assays and require an iterative fit-for-purpose approach driven by the underlying biology and the intended context of use. In the arena of biomarkers, the ultimate goal is to sufficiently develop and characterize a biomarker assay such that there is a clear understanding of “what is being measured” and thereby provide meaningful guidance on interpretation of resulting study data. An often overlooked factor critical to successfully develop any biomarker is the effective engagement of cross-functional partners to align on expectations, limitations, solutions and ultimately data interpretation, so that every stakeholder understands what is being measured. Specific case studies that illustrate strategies for developing biomarkers that transition from research studies into clinical development and the corresponding challenges will be presented.
Ask key stakeholders the right questions to define COU and craft specific COU statements to support drug development programs at all stages
Determine key considerations for COU-driven assay characterization and validation and evaluate existing assays for their suitability for proposed COUs
Understand how to iterate an assay to meet evolving COUs