Bioanalytics – Biomolecular
2019 PharmSci 360
There are different considerations when developing and validating a biomarker assay depending on the final use of the data and it is important to also be prepared for the potential the data may have to guide program decision making. As a biomarker progresses from exploratory analysis or perhaps supports a pharmacodynamic endpoint a fit-for-purpose approach to validation and sample analysis is required. Even further, if the biomarker is a companion diagnostic (CDx, data used for patient selection/stratification) there are even more complexities to consider for development/validation and sample analysis. This talk will provide an overview of the CDx development framework to help ensure program success.