CCR Grand Rounds February 28: No Lecture due to CCR Fellows and Young Investigators Retreat, February 28-March 1. March 7: Dr. Peter Greenwald, Director, Division of Cancer Prevention, NCI. "Clinical & Lifestyle Approaches to Cancer Prevention." CCR Grand Rounds are held 8:30 to 9:30 a.m. at the NIH campus in Bethesda, Md., in the Clinical Center's Lipsett Amphitheater.

On February 14, NCI, the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS) announced the Oncology Biomarker Qualification Initiative (OBQI) - an agreement among the three agencies to collaborate on improving the development of cancer therapies and the outcomes for cancer patients through biomarker development and evaluation.

Biomarkers are biologic indicators of disease or therapeutic effects that can be measured through dynamic imaging tests, as well as by tests of blood, tissue, and other biologic samples. The OBQI is the first time these three U.S. Department of Health and Human Services (HHS) agencies have focused together on biomarkers as a way to accelerate the development and evaluation of cancer therapies.

"We are excited about this effort to speed the development and delivery of new cancer treatments for patients," said HHS Secretary Mike Leavitt. "By bringing together the scientific, regulatory, and delivery expertise of these three agencies, we can bring targeted, more personalized cancer diagnostics, treatments, and preventions to patients more rapidly."

The collaboration will develop scientific understanding of how biomarkers can be used to assess the impact of therapies and better match therapies to patients. For instance, OBQI will address questions such as how particular biomarkers can be used to:

• Assess after one or two treatments whether a patient's tumor is responding to treatment
• Determine more definitively whether a tumor is dying, even if it is not shrinking
• Identify which cancer patients are at high risk of their tumor coming back after therapy
• Determine whether a patient's tumor is likely to respond at all to a specific treatment
• Efficiently evaluate whether an investigational therapy is effective for tumor treatment

"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," commented NCI Deputy Director and Deputy Director for Advanced Technologies and Strategic Scientific Initiatives Dr. Anna Barker. "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."

FDA Acting Commissioner and NCI Director Dr. Andrew C. von Eschenbach added, "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."

The first OBQI project to be implemented will validate and standardize the use of Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) scanning. PET scans are used to characterize biochemical changes in a cancer. Over the next several months, the OBQI team will design a number of initiatives to identify and clinically qualify other cancer biomarkers.

"There are many steps between a novel scientific idea with tremendous promise and a new drug reliably benefiting patients," said CMS Administrator Dr. Mark B. McClellan. "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."