TL9: Biomarker Qualification in Drug Safety
*Aloka Chakravarty, US FDA 


Biomarker Qualification is a drug development tool (DDT) that guides uniformity of usage for biomarker across all drug development portfolios. Typically, biomarker qualification is undertaken by a consortium rather than individual sponsors so that common knowledge can be shared by all in a particular context of clinical usage. In this roundtable discussion, we will discuss definition of the word "qualification" in this paradigm, scope and extent of the qualification, considerations for development of statistical analysis plans and best practices related to design, analysis and interpretation of such. We follow with participants' experiences and several regulatory case examples illustrating the concepts.