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

This project was completed in December 2018. 

The Biomarkers Consortium’s In Silico Modeling of Biomarkers of Atherosclerosis: Estimating Risk Reduction and Residual Risk From Statin Therapy project seeked to integrate multiple biomarkers for atherosclerosis outcomes into a computer-based mechanistic model of cardiovascular risk following statin treatment. The project’s goal was 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 was a $1.7 million project launched in 2012, with two 2-year phases.


  • 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.

Results & Accomplishments:

One published paper, simulation model completed. 


Atherosclerosis Drug Development in Jeopardy: The Need for Predictive Biomarkers of a Treatment Response. Fryburg D, Vassileva M. Sci Transl. Med 3, DOI: 10.1126/scitranslmed.3002029 


Public-Sector Partners:
National Heart, Lung, and Blood Institute (NHLBI)
U.S. Food and Drug Administration (FDA)

Private-Sector Partners:
AstraZeneca Pharmaceuticals LP*
Eli Lilly and Company*
National Dairy Council*
Pfizer Inc*
Quintiles Transnational Corporation*
Takeda Pharmaceuticals International, Inc.*

Academic Partners:
Children's Hospital Oakland Research Institute
Mount Sinai
UC-San Diego
Vanderbilt University

*Provided financial or in-kind support for this program.

FNIH Contact

Helen Heymann, MMSC, Scientific Project Manager, Metabolic Disorders;