August 2, 2018 — The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) has launched a project, under its Inflammation and Immunity Steering Committee, to seek regulatory qualification of new biological markers (biomarkers) that predict the change in joint damage over time from osteoarthritis (OA) in the knee. The PROGRESS OA: Clinical Evaluation and Qualification of Osteoarthritis Biomarkers project, managed by the FNIH, will submit a comprehensive report, including imaging (i.e., MRI) and biochemical (i.e., urine, serum) biomarkers, for review by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Biomarker qualification is the result of a formal regulatory process that affirms a biomarker can be relied upon to have a specific interpretation and used in the review of a potential drug. The acceptance of these biomarkers for use in drug development will pave the way for improved clinical trials and treatments for knee OA.
June 15, 2018 — Today, the Moderate Alcohol and Cardiovascular Health Trial (MACH) Working Group presented a report to the National Institutes of Health (NIH) Advisory Committee to the Director. The following is the FNIH’s response to the report.
June 12, 2018 — The Foundation for the National Institutes of Health (FNIH) has received top honors again this year from Charity Navigator by earning its coveted 4-star rating. The nation’s largest charity evaluator has recognized the FNIH with its highest rating for demonstrating strong financial health and commitment to accountability and transparency. Only 13 percent of the charities evaluated by Charity Navigator have received at least four consecutive, 4-stars, indicating the FNIH “outperforms most charities in America.”
June 7, 2018 — The American Journal of Tropical Medicine and Hygiene (AJTMH) has published an article outlining recommendations for the safe and ethical testing of gene drive technology on mosquitoes to reduce the burden of malaria transmission in Africa.
May 8, 2018 — Since 2017, the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) has been developing new methods for analyzing digital images that can help track a patient’s response to cancer therapy. Housed within the BC’s Cancer Steering Committee, the project called “Advanced metrics and modeling with Volumetric CT for Precision Analysis of Clinical Trial results” (Vol-PACT) has the potential to accelerate the creation of cancer therapies and to improve treatment options for patients.
April 26, 2018— The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium has launched a project, under its Neuroscience Steering Committee, with the potential to improve diagnosis and the development of targeted therapies for Alzheimer’s Disease (AD) and Major Depressive Disorder (MDD).
December 14, 2017 — Driven to Cure, Inc. has donated an additional $100,000 to the Foundation for the National Institutes of Health (FNIH) to further cutting-edge research on rare kidney cancer conducted by the National Cancer Institute (NCI) at the National Institutes of Health (NIH) Clinical Center.
December 7, 2017 — Science Translational Medicine has published an article by experts from the Foundation for the National Institutes of Health, the National Institutes of Health, the U.S. Food and Drug Administration (FDA), industry, academia and not-for-profit organizations that outlines a framework for the level of evidence needed to support qualification of biological markers (biomarkers) for use in drug development decision making. While biomarkers can facilitate all aspects of drug development, their use has been hampered by lack of a clear and predictable process to qualify new markers with the FDA.
November 30, 2017 — Science has published an article outlining guiding principles for sponsors and supporters of gene drive research agreed upon by 13 organizations thus far, including the Foundation for the National Institutes of Health. Considered an emerging technology still in early research, gene drive can be used to promote the preferential inheritance of a beneficial trait, thereby increasing its prevalence in a population.
October 11, 2017 — For almost a decade, the Foundation for the National Institutes of Health (FNIH), in collaboration with the National Institutes of Health’s Fogarty International Center (FIC), has managed the most comprehensive multicenter study to better understand the complicated relationships among intestinal infections, nutrition and other environmental exposures early in life on child development. “The Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development” (MAL-ED) study, supported by a grant from the Bill & Melinda Gates Foundation, captured the significant burden that such exposures have on the health, physical growth and cognitive development of children from birth to early childhood at eight sites in Africa, Asia and South America.
