Entelos Signs Agreement with the Biomarkers Consortium Including FDA, NIH, and the Pharmaceutical Industry

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Entelos’ PHYSIOLAB® Cardiovascular Platform Will be Used to Study Biomarkers of CV Risk.

Entelos, a premier provider of in silico modeling and simulation products and consulting services, today announced the signing of a contract with the Foundation for the NIH (FNIH) for services to be provided in relation to the Biomarkers Consortium Atherosclerosis Project that aims to study biomarker prioritization in Entelos’ Cardiovascular PhysioLab® platform.

The Consortium represents a wide range of stakeholders in the medical, pharmaceutical and food sciences including several large industry corporations, the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA) and thought leaders from academia. It is projected that the collaboration will last approximately two years producing both new knowledge and advanced computerized models and tools for the future benefit of the collaborators.

Private sector participants to date include Amylin Pharmaceuticals, Eli Lilly and Company, Pfizer Inc., Takeda Global Research & Development Center, Inc. and the Dairy Research Institute ®, with additional support from Quintiles. Institutional and government partners include FDA, NIH, Harvard University, Oakland Children’s Hospital Research Institute, and Partner’s Healthcare. More collaborators are expected to join the consortium.

“This remarkable consortium of stakeholders has taken on the challenge of determining which of the many proposed biomarkers have the most direct mechanistic links to cardiovascular health,” said Shawn O’Connor, president and CEO of Entelos. “In doing so, they have asked Entelos to address these questions by performing simulations in our Cardiovascular PhysioLab platform. Our platforms reproduce underlying disease mechanisms and identify how biomarkers change in response to both disease progression and to therapeutic interventions. Importantly, we evaluate this change in a huge virtual population – guaranteeing that we are taking individual patient variability into account.”

While there is a substantial amount of biomarker data available in scientific journals and clinical trials databases, it is highly fragmented. “Most of these biomarkers have been studied one at a time, and only measure a specific aspect of atherosclerosis,” said Dr. David Fryburg, a consultant and former pharmaceutical company executive who leads the project. “Integrating these into a comprehensive computer-based disease model will allow us to identify those short-term measures which best predict long-term clinical outcomes like heart attack and stroke. Successful development of this model can facilitate more confident testing of new therapies for atherosclerosis and prevention of cardiovascular disease.”

There are more than one hundred biomarkers that have been measured in different patients with cardiovascular disease designed to determine whether a patient’s condition is improving or worsening and how fast. Pharmaceutical companies and regulators need these diagnostic tests as measures of whether pharmaceutical therapies are benefiting patients during clinical trials. However, the potential biomarkers have not been measured in multiple studies or systematically evaluated across many different patients. The project goal is to identify the most informative biomarkers of cardiovascular risk. This should streamline and unify testing protocols submitted to the FDA, and help pharmaceutical companies design more efficient trials and more effective drug candidates.

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About Entelos:
Entelos is an in silico modeling and simulation software and services company delivering advanced predictive technologies reducing the risk, time, and cost of product development for pharmaceutical, biotechnology, nutrition and consumer products customers. The Company's PhysioLab systems biology platforms generate virtual patient populations providing highly predictive analyses to assist customers develop safer and more effective drugs, foods and consumer products. Entelos’ understanding of the drivers of patient variability has significant application to the emerging field of personalized medicine. The Company is headquartered in San Mateo, California. For more information, please visit http://www.entelos.com.

About the Foundation for the NIH:
Established by the United States Congress to support the mission of the NIH – improving health through scientific discovery in the search for cure – the Foundation for the NIH is a leader in identifying and addressing complex scientific and health issues. The Foundation is a non-profit, 501(c)(3) charitable organization that raises private-sector funds for a broad portfolio of unique programs that complement and enhance the NIH priorities and activities. For additional information about the Foundation for the NIH, visit http://www.fnih.org.

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Wendy Shelton
Entelos
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