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.
The National Institutes of Health has partnered with London-based Wellcome Trust to launch a global science competition for new products or services to advance “open science,” a movement to make scientific research data broadly accessible to the public. Up to six teams of technology experts and researchers stand to win $80,000 each to develop their ideas into a prototype or to advance an existing early stage prototype. The prototype judged to have the greatest potential to further open science will receive $230,000.