At two recent Biomarker meetings (workshop & symposium) and two on-line OSD’s, feedback and discussions suggested that many still suffer from lack of understanding of the term Context of Use (COU) and indeed how to put it into practice. Knowledge of how to use relevant information to evaluate an analytical method to meet the performance criteria required is clearly a challenge for many bioanalytical scientists who may lack relevant experience that clinical scientists use to answer such questions (and indeed have done so for many years). There is also a need to expand upon a change in thought processes for Biomarker Assay Performance assessment vs Context of Use and the many terms used in the classical assay validation paradigm according to BMV. Based on discussion of presenters after the Pharmsci360 and EBF Biomarker workshops of last year, this presentation will demonstrate how this has been routinely used historically to move from an early method development & performance characterization to a method which can support different COU’s (such as is already established in Diagnostics and CDx methods). This process effectively concludes in the regulatory acceptance of a method being suitable for its intended purpose (COU). References and case studies will be used to explain latest industry thinking of recognised KOL’s and also assist in understanding how the C-Path paper can be used to assist application in the early drug development space where the majority of Biomarker research and development is conducted – especially in the absence of suitable guidance documents for Biomarker Assay Validation in drug development.
Upon completion, participants will be able to: Ask key stakeholders the right questions to define COU and craft specific COU statements to support drug development programs at all stages
Upon completion, participants will be able to: Determine key considerations for COU-driven assay characterization and validation and evaluate existing assays for their suitability for proposed COUs
Upon completion, participants will be able to: Understand how to iterate an assay to meet evolving COUs