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 - Workshop: Defining an Evidentiary Criteria Framework for Surrogate Endpoint Qualification

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.

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 - Inflammatory Markers for Early Detection and Subtyping of Neurodegenerative and Mood Disorders

This project will aim to standardize and validate measurement methods for inflammatory markers associated with Alzheimer’s Disease and/or Major Depressive Disorder to ultimately identify a unique biosignature of disease. The identified biosignature would greatly assist with medication development, patient diagnosing, and patient selection for clinical trials.

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.

Biomarkers Consortium - Placebo Data Analysis Project in Alzheimer’s Disease/Mild Cognitive Impairment Clinical Trials

The Biomarkers Consortium’s Placebo Data Analysis Project in Alzheimer’s Disease/Mild Cognitive Impairment Clinical Trials combined placebo data from large clinical trials provided by multiple pharmaceutical companies to create datasets of 3,000 to 5,000 subjects for Alzheimer’s disease (AD) and mild cognitive impairment (MCI) groups. The goal of the project was to develop better measures of disease progression in terms of outcome measures that have both low variability and are sensitive to change, for use in future clinical trials.

Biomarkers Consortium - Longitudinal Proteomic Changes in CSF from ADNI: Towards Better Defining the Trajectory of Prodromal and Early Alzheimer’s Disease

The Biomarkers Consortium Longitudinal CSF Proteomics Project addresses the need for tools for early diagnosis and measurement of disease progression in Alzheimer’s disease. This longitudinal study will measure the rate of change of five protein biomarkers within patients from the Alzheimer’s Disease Neuroimaging Initiative Cohort with Mild Cognitive Impairment (MCI), AD and healthy controls, utilizing a multiplexed mass spectrometry-based approach.