The Food and Drug Administration (FDA), the National Cancer Institute (NCI), part of the National Institutes of Health, and the Centers & Medicare and Medicaid Services (CMS) last week announced the Oncology Biomarker Qualification Initiative (OBQI). The goal of the initiative will be improving the development of cancer therapies through biomarker technology innovations and analysis, according to a release.
Biomarkers are biologic indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests, as well as tests on blood, tissue, and other biologic samples.
“This collaboration among NCI, FDA and CMS leverages the three agency’s respective scientific, regulatory, and delivery expertise, in an effort to bring targeted, more personalized cancer diagnostics, treatments, and preventions to patients more rapidly,” said Mike Leavitt, Secretary of Health and Human Services (HHS). “Tapping into the knowledge and expertise within these agencies will enhance the clinical relevance of scientific discoveries made in the lab, and get these advances to the patient’s bedside more quickly,” he added.
A central focus of the initiative will be to better understand the ways biomarkers can help our understanding of how cancer therapies are working. As an example, OBQI will address questions such as how particular biomarkers can be used to:
- Assess after one or two treatments if a patient’s tumor is responding to treatment;
- Determine more definitively if a tumor is dying;
- Identify which cancer patients are at high risk of their tumor coming back after therapy;
- Determine if a patient’s tumor is likely to respond at all to a specific treatment; and
- Efficiently evaluate whether an investigational therapy is effective for tumor treatment.
The overall goal of OBQI is to validate particular biomarkers so that they can be used to evaluate new, promising technologies. The research will be focused in four 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 to trial to another.
“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 Andrew C. von Eschenbach, MD, acting FDA Commissioner of Food and Drugs. “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,” he added.
The research will also speed up understanding of the efficacy of certain drugs as well, rather than waiting weeks or months to determine it.
“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 Anna D. Barker, PhD, NCI Deputy Director.
The first OBQI project to be implemented will serve to validate and standardize the use of fluorodeoxyglucose – positron emission tomography (FDG-PET) – scanning. In this phase, researchers will use FDG-PET in trials of patients being treated for non-Hodgkin’s lymphoma, to determine if FDG-PET is a predictor of tumor response, according to the agencies.
In line with this initiative, some vendors are simultaneously creating business units to capitalize on the evolution and increasing importance of biomarker technology.
The OBQI “is completely in line with our own [GE Healthcare’s] approach, in fact we’ve created a business called ‘Pharma Enterprise’ which is dedicated to working with pharmaceutical companies in this way. The future of healthcare is an “early health” model, when early detection enables early intervention,” said Richard Frank, vice president of medical and clinical strategy, GE Healthcare. “The next step for diagnostics is analogous to the biomarker model in drug development; early measures of treatment benefit enable refinements in the treatment regimen and better outcomes. Better outcomes will reduce healthcare costs, hence the involvement of CMS in the OBQI.