The identification of new biomarkers is an increasingly essential element of predictive, preventive and personalized medicine. To meet this need, The Biomarkers Consortium projects serve to develop promising biomarkers in order to help accelerate the delivery of successful new technologies, medicines and therapies for prevention, early detection, diagnosis and treatment of disease.
Working together, the members of the Biomarkers Consortium are building uniquely powerful collaborations that are increasing the development of biomarker-based technologies, medicines and therapies for the prevention, early detection, diagnosis and treatment of disease.
The AD Targeted Cerebrospinal Fluid (CSF) Proteomics Project, completed in Q2Y15, completed an initial validation of a multiplexed panel of known biomarkers, examined BACE levels and enzymatic activity, and set up the initial validation of a mass spectroscopy panel using AD cerebrospinal fluid samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI).
The Biomarkers Consortium’s Targeted Plasma-Based Biomarkers in Alzheimer’s Disease (AD), completed in July 2012, was the first part of a multi-phased effort utilizing samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) to validate multiplex panels in both plasma and cerebrospinal fluid (CSF), to diagnose patients with AD and to monitor disease progression.
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.
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.
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.
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
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.
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.
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.
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.