TL9: Biomarker Qualification in Drug Safety
*Aloka Chakravarty, US FDA Keywords: 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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC