Public Workshop: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices

June 14, 2017 (All day) to June 15, 2017 (All day)

1201 Pennsylvania Avenue, NW, Washington, DC


Over the last several years, FDA as well as others in the scientific community have co-sponsored several workshops aimed at advancing the discussion around biomarker qualification. Of particular importance are the analytical factors that must be considered when assessing the robustness and reliability of a biomarker assay used to qualify a biomarker. Under the leadership of the Critical Path Institute (C-Path), the Biomarker Assay Collaborative Evidentiary Considerations Writing Group is developing a draft framework outlining key criteria and best practices for biomarker assay performance expectations and validation. On June 14-15, 2017, The Duke-Margolis Center for Health Policy will convene a two-day public workshop to serve as a forum for broader input and feedback on this framework, with the goal of creating alignment on the evidentiary considerations for the analytical validation of biomarker assays.

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