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

Event

Conference

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

November 4, 2016 — 12:00AM–{12}:{00}{AM}

Partnership for Public Service Conference Center

Materials

agenda_11_4_16.pdf (514.89 KB)
particpants_11_4_16.pdf (204.9 KB)
white_paper_draft_11_4_16.pdf (591.59 KB)

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. Given the complexities associated with this process, clarity on the scientific and regulatory expectations for biomarker assay performance characteristics and validation is needed to guide biomarker qualification studies. Under the leadership of the Critical Path Institute (C-Path), the Biomarker Assay Collaborative Evidentiary Considerations Writing Group has developed a draft framework outlining key criteria and best practices for biomarker assay performance expectations and validation. 

On November 4, 2016, The Duke-Margolis Center for Health Policy convened a private expert meeting in order to review and further refine this draft framework on the analytical validation of assays used in the qualification of biomarkers in biological matrices. The day’s discussion included a detailed exchange of ideas on the optimization of pre-analytical factors, defining core assay expectations, and setting minimally acceptable assay performance criteria. The group also identified major takeaways and next steps for building agreement around this framework, in preparation for a public workshop that will take place in the spring of 2017. This public workshop will serve as a forum for broader input and feedback on this framework with the goal of creating alignment on the evidentiary guidelines for the analytical validation of assays.

Funding for this conference was made possible in part by a cooperative agreement with the Food and Drug Administration, Center for Drug Evaluation and Research. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.