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Regulatory Successes
Evidentiary Considerations
A comprehensive user guide to the analysis of biomarkers in drug development. At its core, this document contains a complete description of necessary approaches that can be applied to most analytical situations that will be encountered in fluid-based biomarker qualification.
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 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 convened 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.
Workshop information, with links to white papers and slides.
On August 21, 2015, the University of Maryland CERSI, US FDA, and the Critical Path Institute co-sponsored a symposium titled “Evidentiary Considerations for Integration of Biomarkers in Drug Development” at the University of Maryland School of Pharmacy.
The objective of the symposium was to begin to define and ultimately codify the scientific and regulatory expectations for the qualification of biomarkers.
Two types of biomarkers were discussed:
– Safety biomarkers
– Biomarkers used for trial enrichment
The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), in co-sponsorship with the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, hosted this workshop on April 14 and 15, 2016.
The workshop aimed at creating alignment among scientific stakeholders including the FDA, the NIH, the biopharmaceutical industry, academic researchers, and patient groups regarding a proposed framework for determining the levels of evidence required to qualify biomarkers for use in drug development, with an emphasis on biomarkers used in determinations of drug safety assessments. The participants elaborated a general framework for biomarker qualification along with specific application to different contexts of use related to drug safety, including assessment of several specific case studies involving qualifying clinical markers of toxicity in different organ systems.
Output
Framework for Defining Evidentiary Criteria for Biomarker Qualification
On October 27, 2015, The Center for Health Policy at the Brookings Instituted hosted an expert workshop with the following objectives:
1) discuss the common lexicon developed by FDA and NIH for the field of biomarker development;
2) use case studies to explore the biomarker characteristics (including its Context of Use) that can be used to determine whether and under what circumstances a biomarker should be targeted for qualification, and
3) develop an initial set of strategies that can help to ensure better cross-sector collaboration and communication in the area of biomarker development and qualification.
