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491 – Challenges in Biomarker and Surrogate Endpoint Qualification

Biomarkers Qualification: FDA Experience

Sponsor: Biopharmaceutical Section
Keywords: biomarker qualification, FDA, surrogate, drug development tool (DDT), regulatory guidance

Aloka Chakravarty

FDA/CDER

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 talk, 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 several regulatory case examples illustrating the concepts.

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