Biomarkers Consortium - In Silico Modeling of Biomarkers of Atherosclerosis: Estimating Risk Reduction and Residual Risk from Statin Therapy

The Biomarkers Consortium’s In Silico Modeling of Biomarkers of Atherosclerosis: Estimating Risk Reduction and Residual Risk From Statin Therapy project seeks to integrate multiple biomarkers for atherosclerosis outcomes into a computer-based mechanistic model of cardiovascular risk following statin treatment. The project’s goal is to identify a time-dependent, dynamically-responsive panel of extant markers that change in response to Phase II intervention and predict Phase III clinical cardiovascular outcomes to build the model. This model would support cardiovascular drug development decision-making and assessment of atherosclerotic risk in the development of drugs for other indications. In addition, the project would provide a basis for future development of consortium-based mathematical models of disease. The Atherosclerosis In Silico Modeling Project is a $2 million project launched in 2012, with two 2-year phases.

Goals

  • Identify a panel of biomarkers that predicts outcomes in statin-treated patients with established atherosclerotic cardiovascular disease.
  • Determine markers of residual risk of atherosclerotic cardiovascular disease in statin-treated subjects.
  • Determine if these biomarkers are as predictive in diabetic patients with atherosclerotic cardiovascular disease as in non-diabetic patients with atherosclerotic cardiovascular disease.
  • Create the operational structure to facilitate data-sharing and common use exploitation, and expansion of the model.

Partners

AstraZeneca Pharmaceuticals LP
Children’s Hospital Oakland Research Institute
Eli Lilly and Company
Evidera
Harvard
Mount Sinai
National Heart, Lung and Blood Institute
Pfizer Inc
Quintiles Transnational Corporation
Takeda Pharmaceuticals International, Inc.
UC-San Diego
U.S. Food and Drug Administration
Vanderbilt University

Contact

Tania Kamphaus, Scientific Program Manager, Metabolic Disorders, TKamphaus@fnih.org