ICON today announced it has received a contract award from the Foundation for the National Institutes of Health (FNIH) to provide clinical support for the Biomarkers Consortium study entitled Characterization of the Variability of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Healthy Subjects.
ICON's dedicated metabolic research team will support the clinical execution of this project, including subject recruitment and testing in ICON's Clinical Pharmacology Unit, located in San Antonio, Texas.
The Biomarkers Consortium study aims to develop biomarkers that predict long-term beta cell function, particularly in response to an intervention or a new therapy for diabetes. Currently there is no accepted gold standard testing regimen for estimating beta cell function and many accepted regimens are technically complex, making them unsuitable for large, multi-centre clinical studies. The study is one of a series of clinical studies that aims to provide a foundation for the effective and confident use of selected methodologies in long-term, multi-centre clinical trials.
“We’re honored to have been selected following a thorough peer review process by such a distinguished group of experts. Their focus to rapidly identify and qualify biomarkers that allow a better understanding of physiologic variability is an essential, early step in the development of tailored therapies to treat diabetes,” commented Dr. Mario Rocci, President, ICON Development Solutions.
About the Biomarkers Consortium
The Biomarkers Consortium, managed by the Foundation for the National Institute of Health (FNIH), is a major public-private biomedical research partnership that endeavors to discover, develop, and qualify potential high impact biomarkers to support new drug development, preventive medicine, and medical diagnostics. The Consortium has broad participation from a variety of stakeholders, including government, industry, academia, patient advocacy and other non-profit private sector organisations. Founding members of the consortium include the FNIH, the National Institutes of Health (NIH), the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA).
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 cures—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 NIH priorities and activities.
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