Drugs

FDA Taking on Biomarker Qualification

David McFarland

— 2 min read
Share

CDER director Janet Woodcock says that several years ago FDA became aware of a lack of an orderly process for biomarker development and set up its “qualification process.” Woodcock explains the process in a video included in the Center’s quarterly update “What’s New in Regulatory Science.” She says the agency took the position that “We see the need for a new generation of biomarkers, and we can also see the fact that they aren’t being developed. And so we can’t use them as regulators. If there’s not enough information to make decisions on, we’re not going to bet people’s health on these, so they have to be developed.”

She says the qualification process is a public process in which FDA is seeking adoption of new biomarkers by the scientific community, so that anyone who is doing a trial and wants to monitor for a particular condition doesn’t have to go through evaluating the biomarker and doing preliminary work on it but can refer to the FDA qualification data.

The quarterly report contains additional biomarker information: 

  •          The National Institutes of Health released 12/2015 its Framework for Defining Evidentiary Criteria for Biomarker Qualification. The framework defines the level of evidence needed to support qualification of biomarkers. CDER says the document was developed in partnership with FDA, the National Institutes of Health, Critical Path Institute, the Pharmaceutical Research and Manufacturers of America, and multiple drug companies, and incorporates input from nearly 200 scientific leaders in the field.
  •          A table gives examples of biomarkers that have been accepted and used as endpoints in clinical trials for drug and biologic approvals across 12 therapeutic areas. Specifically, the update says, the biomarkers were used as outcomes in developing FDA-approved new molecular entities and new biological therapeutics in different disease areas from FY 2007 to FY 2015.
  •          The FDA-National Institutes of Health Biomarker Working Group developed the Biomarkers, Endpoints, and Other Tools (BEST) resource for scientific and medical communities to use consistent terminology throughout all stages of medical product development. The update says the BEST resource is a “living document” that is updated periodically with additional definitions and examples.
  •          CDER has launched a suite of Web pages to inform stakeholders about biomarkers and the Biomarker Qualification Program. The Center says the pages have been organized for easier navigation and include expanded information on how to submit a biomarker for qualification and a new education and training section.

Read more