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Entering its second full year of operations in 2008, The Biomarkers Consortium significantly refined its strategy for identifying and evaluating projects for execution and funding. The consortium has refocused its efforts on identifying “High- Impact Biomarker Opportunities” that address significant unmet medical needs, promise immediate practical impact on outcomes such as development of treatments and patient care, and that can be accomplished within practical limits on timeframes and cost. The new focus has allowed the consortium to internally develop priority projects within its four disease/therapeutic focus areas: cancer, immunity and inflammation, metabolic disorders and neuroscience, as well as evaluate externally generated projects more efficiently. In 2008, the consortium launched four new projects, in addition to the initial two FDG-PET lung and lymphoma projects launched in 2007, and developed a substantial pipeline of additional projects for eventual execution in 2009 and beyond.
The first new project aims to determine whether the protein adiponectin can serve as a predictive biomarker for glycemic control in Type II diabetes patients being treated with peroxisome proliferator-activated receptor agonists (PPARs). It is analyzing data pooled from randomized Phase II clinical trials provided by pharmaceutical companies Eli Lilly and Company, F. Hoffmann-La Roche, GlaxoSmithKline and Merck & Co., Inc. Project results will be disseminated to the scientific community in late 2009.
A second study looks at the reproducibility of non-invasive carotid magnetic resonance imaging (MRI) in distinguishing vulnerable from stable atherosclerotic plaque. This project is conducting an 80-patient study at a total of 15 established imaging centers in conjunction with an ongoing clinical study sponsored by the National Heart, Lung and Blood Institute at NIH. The Foundation for NIH has raised nearly $1 million for this project from Abbott Laboratories, Merck & Co., Inc. and Pfizer Inc.
A third project is bringing together resources from industry and the National Institute of Mental Health to assess the utility of two newly developed positron emission tomography (PET) radioligands in quantifying inflammation in the central nervous system and the brain. Initial testing is being done in Alzheimer’s disease and atherosclerosis. Application of this work could extend to neurodegenerative and psychiatric disease and potentially to drug delivery. The Foundation for NIH raised over $500,000 for this project from Eli Lilly and Company, Merck & Co., Inc., Merck Serono Research, Pfizer Inc and F. Hoffmann-La Roche.
The latest consortium project also focuses on Alzheimer’s disease, utilizing resources from another Foundation for NIH partnership, the Alzheimer’s Disease Neuroimaging Initiative (ADNI). It is pursuing a targeted approach to identify viable plasma-based biomarkers of Alzheimer’s disease, utilizing samples collected from the ADNI partnership. The funds needed to conduct this project are being provided through a surplus of funds raised for the greater ADNI partnership.
A fifth project, approved in late 2008 but not yet initiated, will characterize circulating tumor cells as biomarkers in metastatic prostate cancer. It joins the two cancer-related programs begun in 2007, which hope to determine the utility of FDG-PET imaging to gauge the effectiveness of conventional cytotoxic drugs against lymphoma and lung cancer.
The FDG-PET lung and lymphoma cancer projects, as well as other projects under development by the consortium’s cancer steering committee, were the topic of a well-attended “super-session” at the Biotechnology Industry Organization (BIO) 2008 International Convention in San Diego in June. Biomarkers were a strong theme throughout the conference, raising the consortium’s profile among the biopharmaceutical community. A second “super-session,” attended by more than 400 people, focused on the role of public-private partnerships in biomarker development.
Related Resources: Contributor Information The Biomarkers Consortium Report
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