Announcements

Q&A with George H. Talbot, M.D.: Improving Antibacterial Drug Development Tools

October 2, 2018 — Bacterial infections acquired in hospitals are a major concern for healthcare providers and their patients. In particular, hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) are severe infections that cause patient deaths. As bacterial resistance to antibiotics increases, new treatments to combat these infections are desperately needed. Yet, measuring the effectiveness of new treatments continues to be a challenge due to a lack of well-defined clinical trial endpoints (outcomes measured to determine whether a therapy being studied is beneficial to patients).

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The Role of Public-Private Partnerships in the Cancer Moonshot: How PACT can Transform Cancer Immunotherapy Clinical Trials

September 21, 2018 - Today, Vice President Joe Biden and Dr. Jill Biden are hosting the national Biden Cancer Summit in Washington, D.C. This event is one of more than 350 Biden Cancer Community Summits convening across the country to bring together patients and caregivers with the scientific community to help promote new solutions for tackling cancer and share stories of the tremendous resilience and strength shown by those who have been touched by the disease and remain #CancerFIERCE. 

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FNIH Biomarkers Consortium Launches Project Seeking Regulatory Qualification of Biomarkers for Measuring Knee Osteoarthritis

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.

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FNIH Statement on the Moderate Alcohol and Cardiovascular Health Trial Working Group Report

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.

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The FNIH Earns the Highest Rating from Charity Navigator

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.”

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American Journal of Tropical Medicine and Hygiene Publishes Recommendations for Safe and Ethical Testing of Gene Drive Mosquitoes to Reduce Malaria Transmission in Africa

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.

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Q&A with Lawrence Schwartz, M.D., Columbia University Medical Center: Vol-PACT Project Expansion Initiates Analysis of Cancer Tumor Growth with Novel Measurement Technique

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.

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The FNIH Biomarkers Consortium Launches Project to Improve Diagnosis and Treatment of Neurodegenerative and Psychiatric Diseases

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).

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Driven to Cure, Inc. Donates an Additional $100,000 to the Foundation for the National Institutes of Health to Further Cutting-Edge Research on Rare Kidney Cancer

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.

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Science Translational Medicine Publishes Article on Evidence Needed for Biomarker Qualification

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.

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