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.

Age-Related Eye Disease Study 2 (AREDS2) Ancillary Study

The Age-Related Eye Disease Study 2 (AREDS2) examined the effects of vitamin and mineral supplementation on the progression of age-related macular degeneration (AMD), which is one of the leading causes of blindness in the United States. Funds raised by the FNIH support the development of a genetic repository for the study, facilitating deeper analyses of the results.

Lung-MAP: Master Protocol for Treatment of Non-Small Cell Lung Cancer

Lung-MAP is an umbrella protocol which contains a screening component and multiple independently conducted and analyzed treatment sub-studies. The overarching hypothesis is that the umbrella master protocol will establish genomic screening for a large population of previously treated Non-small cell Lung Cancer (NSCLC) patients and evaluate targeted therapies (or combinations) in biomarker-driven sub-studies and immunotherapy combinations in patients previously exposed to standard checkpoint inhibitor therapy and lead to regulatory approval of efficacious regimens.

Biomarkers Consortium - Identification and Validation of ctDNA Quality Control Materials

The ctDNA Quality Control Materials project seeks to develop a set of nationally recognized standards to enable the production of suitable quality control materials that can be submitted for FDA clearance for widespread use in ctDNA testing. Once successfully developed and disseminated, these quality control materials will provide confidence in interpretation of ctDNA biomarker assay results, paving the way for more effective clinical research, therapeutic decision-making, regulatory evaluation, and reimbursement applications.

Biomarkers Consortium – CSC Scientific Symposium

The Cancer Steering Committee (CSC) Scientific Symposium reviews advances in the field of biomarker and regulatory science that are relevant to the development of new public-private partnerships for precompetitive biomarkers. This review assists the CSC with planning future public- private partnerships in this area.

Biomarkers Consortium - Vol-PACT Phase II: Advanced metrics and modeling with Volumetric CT for Precision Analysis of Clinical Trial results

Vol-PACT is designed to analyze volumetric CT imaging trial data from completed industry phase II/III solid tumor trials to improve quantitative prediction of phase III trial results. The project seeks to develop novel imaging methods to more accurately measure cancer response and progression

Biomarkers Consortium - I-SPY TRIAL-2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and MoLecular Analysis): An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy

Phase II trial of novel investigative breast cancer agents in the neoadjuvant setting that uses biomarkers and adaptive design to accelerate the clinical trial process.