8:29 PM
Jan 10, 2019
 |  BC Innovations  |  Product R&D

Biomarkers’ road less traveled

Why FDA’s biomarker guidance means consortia will still be in the driver’s seat

FDA’s draft guidance on biomarker qualification provides welcome codification of the regulatory path. But the amount of data required may remain beyond the reach of most companies, strengthening the importance of consortia.

The guidance, issued Dec. 10, outlines the process for obtaining approval of a biomarker for a specific preclinical or clinical purpose, and applies to biomarkers intended for making decisions about safety or efficacy.

The document formalizes a framework driven by the Foundation for the National Institutes of Health (FNIH) that was developed with FDA, the Critical Path Institute, NIH and PhRMA and outlined in a 2016 white paper.

The guidance provides new information on the recommended components of a biomarker development program, and the type and level of evidence to support qualification. Specifically, it includes a more detailed description of acceptable data types, and suggests that in most cases prospective studies will not be needed.

The tools stand to benefit many companies, for example by creating efficiencies across an indication. But industry has had little appetite for developing biomarkers independently.

Only eight biomarkers have been qualified under the Biomarker Qualification Program run by FDA’s Center for Drug Evaluation and Research (CDER), and none of these were submitted by companies.

Three industry and non-profit researchers who spoke to BioCentury said that while the guidance could spur more interest among drug companies, the standards will require large amounts of data and many years to execute.

That’s a daunting prospect for an individual company that needs to prioritize advancing its therapies, according to John-Michael Sauer, program officer for C-Path’s Biomarker Programs and executive director of its Predictive Safety Testing Consortium.

“Drug companies really aren’t positioned to resource these biomarker qualification programs. For companion diagnostics there is an incentive for those biomarkers, but for the more general ones there’s not funding,” said Sauer. C-Path is a non-profit organization with a mandate is to develop precompetititve tools for drug development. It was responsible for three of the first eight qualified biomarkers.

“The industry’s always been interested but it’s been ill-defined and looked...

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