"An enhanced understanding of clinical biomarkers will help make the development of diagnostics and treatments more targeted, one of our most pressing goals under the Critical Path Initiative, FDA's program to modernize the medical product development process," said FDA Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "We believe partnerships that help us standardize the use of new technologies are essential to refining the drug development process, so we can bring personalized medicines to patients more quickly and ultimately improve outcomes."

Under the OBQI, biomarker research will be focused in four key areas: standardizing and evaluating imaging technologies to see in more detail how treatments are working, developing scientific bases for diagnostic assays to enable personalized treatments, instituting new trial designs to utilize biomarkers, and pooling data to ensure that key lessons are shared from one trial to another. By working with academic and industry scientists, as well as professional organizations, the OBQI teams can foster the development of key information on biomarkers through clinical trials.


"By identifying biomarkers for specific cancers and clinically evaluating them, researchers will have an evidence base for their use in targeted drug development and to determine which therapies are likely to work for patients before treatment selection," said NCI Deputy Director Anna D. Barker, Ph.D. "Rather than waiting weeks to months to determine if a specific drug works for a patient, biomarkers could be used to monitor real-time treatment responses."

The first OBQI project to be implemented will serve to validate and standardize the use of Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) scanning. PET scans are used to characterize biochemical changes in a cancer. Under the collaboration, researchers will use FDG-PET imaging technology in trials of patients being treated for non-Hodgkin's lymphoma, to determine if FDG-PET is a predictor of tumor response. Data resulting from this type of evidence-based study will help both FDA and CMS work with drug developers based on a common understanding of the roles of these types of assessments.

"There are many steps between a novel scientific idea with tremendous promise and a new drug reliably benefiting patients," said CMS Administrator Mark B. McClellan, M.D., Ph.D. "This collaboration will produce evidence that will help people with Medicare and Medicaid get better care more quickly, as a result of better-targeted treatment decisions for cancer patients."

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