To tackle the human health challenges that face the world today, the FNIH develops collaborations with top experts from government, industry, academia and the not-for-profit sector and provides a neutral environment where we can work productively toward a common goal.
The Neuroscience Steering Committee, led by the FNIH and its co-chairs Dr. Linda Brady, Dr. Hartmuth Kolb, and the emeritus co-chair Dr. Bill Potter, is bringing together experts in the field of neuroscience from industry, NIH, FDA, and academia to present progress to date, next steps, and key obstacles that need to be addressed in order to drive biomarker development in a multitude of neuroscience focus areas.
The Sports and Health Research Program (SHRP) sought to help accelerate research that enhances the health of athletes at all ages and levels, and to extend the research’s impact beyond the playing field to benefit others in the general population, including members of the military.
The FNIH Biomarkers Consortium and FDA hosted a workshop to provide a Framework for Defining the Evidentiary Criteria for Surrogate Endpoint Qualification on July 30-31, 2018. The workshop aimed to create alignment of the biomedical community and regulators on the levels of evidence required to qualify biomarkers for use in drug development, with an emphasis on surrogate endpoints and specific clinical outcome measures.
This 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.
The Biomarkers Consortium’s Kidney Safety Project aims to advance clinical regulatory qualification and broader acceptance of new translational biomarkers that outperform sCr and BUN for monitoring kidney safety to support early clinical drug development.