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.

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 - Chemotherapeutic Impact on the Immune MicroEnvironment

Project results will help determine the effect of chemotherapy on malignant and non-malignant cells including immune cells. New biomarkers characterizing the TME before and after chemotherapy may be discovered that reflect cell composition, cell states, and cell-cell interaction.

Biomarkers Consortium - PROGRESS OA: Clinical Evaluation and Qualification of Osteoarthritis Biomarkers

The goal of this three-year project is to validate the novel radiographic measures, MRI measures and biochemical markers from the Phase I OA Biomarkers Consortium Project, and to qualify those biomarkers via the formal regulatory qualification process with both the FDA and EMA.

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 - Workshop: Developing an Evidentiary Criteria Framework for Safety Biomarkers Qualification

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.

Biomarkers Consortium - The Performance of Novel Cardiac Biomarkers in the General U.S. Population

The Biomarkers Consortium’s Novel Cardiac Biomarkers in the General US Population (the Cardiac Troponin Project) seeks to define the reference ranges and to generate the epidemiologic basis for the use of several significant novel cardiac and related biomarkers for cardiovascular risk stratification in the general U.S. population. The program will measure a panel of biomarkers in almost 30,000 individuals in a national study. The project will provide key reference data regarding novel biomarkers for cardiovascular risk stratification and inform U.S. clinical and laboratory guidelines.

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

The project seeks to analyze volumetric CT imaging trial data from completed industry phase II solid tumor trials to improve quantitative prediction of phase III results.

Biomarkers Consortium - Treatments Against RA and Effect on FDG PET-CT (TARGET Biomarker Study)

The Biomarkers Consortium’s TARGET Biomarker Study seeks to utilize validated proteomic biomarkers of rheumatoid arthritis (RA) disease activity and inflammation to categorize baseline and disease-modifying antirheumatic drug (DMARD)-associated changes in vascular inflammation in RA patients.

Biomarkers Consortium - Sarcopenia as a Valid Biomarker for Identifying Individuals at Risk of Disability

Sarcopenia 2 seeks to establish evidence-based cut-points for muscle mass and strength and determine their predictive validity for clinically meaningful outcomes (such as mobility, fractures, hospitalization and death); evaluate relative strength as a discriminator for mobility limitation and incident disability; and explore the potential usefulness of sarcopenia as a clinical endpoint in randomized clinical trials.