Established in 2006, The Biomarkers Consortium (BC) is a public-private partnership whose mission is to identify, develop and seek regulatory approval for new biological markers (biomarkers) to accelerate the detection, diagnosis and treatment of many diseases. These biomarkers support the development of new preventative medical measures, medical diagnostics and drug development.
After years of independent clinical studies, individual pharmaceutical companies, academic researchers and scientific bodies, such as the National Heart Lung and Blood Institute, have accumulated a mountain of data about biomarkers. The Biomarker Consortium pools this data to create a large dataset that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) can use to advance the availability of biomarkers as tools to evaluate drug efficacy and advance personalized medicine.
Members of the consortium include a diverse list of public and private sector entities, including:
- Foundation for the National Institutes of Health (FNIH)
- National Institutes of Health (NIH)
- Food and Drug Administration (FDA)
- Centers for Medicare & Medicaid Services (CMS)
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- Biotechnology Industry Organization (BIO)
Representatives of the public, including patient advocacy organizations, also belong to the consortium and are an important part of its function.
The Biomarkers Consortium established steering committees for four therapeutic areas of interest:
- Immunity & Inflammation
- Metabolic Disorders
The consortium develops and executes projects in other therapeutic areas as directed by its Executive Committee.
Purpose of the Biomarker Consortium
The medical community has long recognized the need to create objective, comprehensive measures of disease risk, biological processes, diagnosis and staging, prognosis and recurrence, treatment response and clinical outcomes. Despite significant advances in the understanding of disease processes and treatment outcomes, very few quality biomarkers exist for clinical use, that have been validated, i.e. accepted by the medical community.
The Biomarker Consortium was formed to facilitate the development and regulatory approval for biomarkers that use new and existing technologies, develops evidence that helps qualify biomarkers for specific applications, generates information helpful to regulatory decision-making, and makes project results broadly available to all members of the scientific community.
Some of the most widely accepted biomarkers include blood pressure, total cholesterol, HDL/LDL ratios as the markers of cardiovascular risk and treatment response. Another was HIV viral load and CD4+ T-cell counts as a way to assess severity, stage and treatment response in HIV/AIDS. These biomarkers enable research, streamline clinical care and may even speed up the development and availability of new treatments. While the need for biomarkers is clear, developers of reliable biomarkers face a variety of challenges. Developing biomarkers requires a great deal of insight into disease risk, natural history and outcomes. It also requires access to large numbers of samples from well-characterized patients and standardized data compilation, using analytical platforms that can effectively and reproducibly measure the biomarker. Researchers must also develop analytical approaches capable of assessing the usefulness of particular biomarkers as signs or predictors of the underlying biology or future outcome of a disease.
The development of such biomarkers will promote and foster discovery while facilitating translational research and clinical research.
The Biomarker Consortium Addresses a Variety of Needs
Over the past ten years the Biomarkers Consortium has helped to facilitate research and development on the discovery and utility of biomarkers. For example, the Osteoarthritis Biomarkers Project conducted a preliminary assessment of predictive validity and evaluated the responsiveness of imaging and biochemical markers for knee osteoarthritis. The AD Targeted Cerebrospinal Fluid (CSF) Proteomics Project explored the initial validation of a multiplexed panel of known biomarkers, examined BACE levels and enzymatic activity and set up initial validation of a mass spectroscopy panel using cerebrospinal fluid samples. Members of the AD/Mild Cognitive Impairment (MCI) Placebo Data Analysis Project analyzed data about placebos from about 40 large industry trials and created superior measures of disease progression and cognition. Information generated by the Sarcopenia Consensus Summit created the first evidence-based definition of sarcopenia, established specific guidelines for clinical diagnosis and regulatory evaluation of treatments.
The consortium announced availability of its project, Use of Targeted Multiplex Proteomic Strategies to Identify CSF-Based Biomarkers in Alzheimer’s disease, which qualifies biomarker panels in plasma and CSF to diagnose and monitor disease progression in patients with Alzheimer’s disease. This public domain database helps researchers explore the relationship between several physiologically important blood proteins, cerebrospinal fluid and genetic variations. Making this information available can speed up research.
The identification of new biomarkers will be increasingly important to the new era of predictive, preventive and personalized medicine. In this new era, the Biomarker Consortium will continue to help develop tools for patient stratification and assessment of efficacy to create better therapies faster.
We recently interviewed Clive Green, Director and Head of Sample Management at AstraZeneca, about the challenges in the biospecimen supply chain, from both a small molecule and biospecimen perspective. To read more, download our eBook Maximizing the Value of Biospecimens to Deliver New Therapies.