Although the concept of Context of Use (COU) has gained significant traction in the past 2 years, bringing this concept into day-to-day practice for implementation of biomarkers throughout all stages of drug development has been challenging, with ongoing confusion regarding what exactly constitutes a COU. This presentation will provide foundational concepts including clarification on what differentiates a biomarker category from a biomarker endpoint from the biomarker’s COU. Furthermore, since the majority of biomarkers are deployed for exploratory purposes, or to support internal decision making during early clinical development, how to craft specific COU statements to address these scenarios will be discussed. Lastly, the content will highlight how to manage situations where COU is not forthcoming, but an assay is being requested (or demanded). By providing an analytical characterization of the assay along with clear communication of assay performance characteristics and limitations, the analytical biomarker scientist can deliver an assay against which suitability for different COUs can be evaluated. This latter step will then determine whether the assay is valid for a given context or not. Examples of COUs with attendant validation considerations/requirements and/or assay characterizations and the COUs they may support (or not) will be discussed.
Understand the difference between biomarker categories, biomarker endpoints and biomarker contexts of use.
Be equipped to craft effective context of use statements and incorporate them into their assay development and validation workflows.
Develop plans to analytically characterize assays which can then be evaluated against emerging contexts of use.