Cardiovascular (CV) disease remains the leading cause of death in the United States and is still a major cause of disability in 2011 according to the CDC. The knowledge that a high level of low-density lipoprotein cholesterol (LDL-C) in the blood predicts an increased risk of future atherosclerotic (arterial) CV events has enabled the discovery and development of statins—a class of drug used to lower plasma cholesterol level—which subsequently have saved many lives. In turn, statin trials have demonstrated that short-term reductions in LDL-C are associated with reduced adverse CV events in the long term. In contrast, for interventions with mechanisms of action that do not alter LDL-C levels, there are no consensus short-term biomarkers that predict treatment-induced reduction in clinical atherosclerotic events. Although many potentially valuable atherosclerotic biomarkers have already been studied, none have been proven to be as predictive for treatment outcome as changes in LDL-C. This biomarker data exists in a fragmented state and is studied one at a time, only measuring a specific aspect of atherosclerosis, without any substantial integration.
 
The Atherosclerosis Working Group, a committee of experts from academia, the pharmaceutical industry, government, and the nonprofit sector, managed by the Foundation for the NIH Biomarkers Consortium, has designed a project to integrate these different measures into an in silico model of atherosclerosis. Through integration of diverse biomarker measurements and outcomes in silico, it is possible to improve clinical trial design as well as increase the predictive power of short-term markers for longer-term outcomes. For the current solicitation for applications from organizations with experience in developing in silico models from public and patient level data, see the Biomarkers Consortium website.
 
The commentary, authored by the project team chair, Dr. David Fryburg, and the Biomarkers Consortium Scientific Program Manager, Dr. Maria Vassileva, on behalf of the Atherosclerosis Working Group, was published in Science Translational Medicine in March 2011 (STM, Vol. 3, Issue 72, p. 72cm6). It describes the unmet medical need that the project strategy aims to address. (to read the full commentary, click here >>).