The Food and Drug Administration (FDA), in co-sponsorship with the Foundation for the National Institutes of Health Biomarkers Consortium (FNIH BC), is announcing a public workshop entitled “Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop.” The purpose of the workshop is to discuss the evidentiary standards needed to support biomarker qualification with a particular emphasis on drug safety markers.

This public workshop aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for Traumatic Brain Injury (TBI). By convening the relevant stakeholders, the goal is to obtain input on the scientific, clinical, patient and regulatory considerations associated with TBI biomarker development to improve diagnosis and clinical utility for TBI.

The TRACK-TBI/TED Joint Investigators Meeting brought together lead study site investigators, senior leadership from the NINDS and Department of Defense funders, private industry partners, philanthropy, and FDA regulatory personnel. Conference presentations and activities included progress updates for the two initiatives, followed by working sessions devoted to refining strategies to achieve research and regulatory aims.

As of February 1, 2016, TRACK-TBI has now enrolled 1,300 patients in the study. These patients have been enrolled in 11 study sites across the U.S. For a list of study sites, click here.