Guest Update by Dr. Anna Barker

The Biomarkers Consortium: A Unique Public-Private Partnership to Advance 21^st Century Medicine

Last week marked the launch of an unprecedented public-private research partnership called the Biomarkers Consortium. This unique partnership will design and perform clinical studies to validate biological markers that are deemed to be of value in accelerating the development and regulatory review processes for new drugs, biologics, and technologies to treat, detect, and prevent a variety of diseases, including cancer.

The Consortium was created by the Foundation for the National Institutes of Health (FNIH), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Pharmaceutical Research and Manufacturers of America, the Biotechnology Industry Organization, and several nonprofit organizations. In a rare move, an initial group of drug and biotech firms that are normally competitors have shown significant vision in donating funds and expertise to FNIH in support of this important initiative.

At a joint press conference on October 5, leaders of the agencies and organizations announced that $1.2 million has been committed to date by the Consortium's funding members, which include, in addition to those listed above: the Alzheimer's Association; AstraZeneca; Bristol-Myers Squibb; GlaxoSmithKline; the Leukemia & Lymphoma Society; Johnson & Johnson; Eli Lilly & Company; Pfizer Inc.; and F. Hoffmann-La Roche.

NCI has long been at the forefront of research and development of biomarkers for use in diagnosis and treatment for a variety of cancers. In fact, the first projects to be undertaken by the Consortium will be two clinical trials developed by NCI in collaboration with FDA and the Centers for Medicare and Medicaid Services. These projects will evaluate the use of fluorodeoxyglucose-positron emission tomography (FDG-PET) as a tool to measure treatment response in non-Hodgkin lymphoma and lung cancer. Dr. Gary Kelloff, of NCI's Cancer Imaging Program, provides a brief summary of these studies in this issue of the NCI Cancer Bulletin.

NCI will be responsible for the overall management of these studies and will oversee the national clinical research groups that will execute these projects. We will provide $1.5 million toward the lung study and approximately $2.25 million of in-kind support for the lymphoma study. The studies will also be funded by grants to FNIH totaling $7.5 million over 5 years. Thus far, $3.75 million has been raised from several private partners and others are expected to join this effort.

Although we are early in the development of imaging tools as biomarkers, this research holds the potential to be used not only in the diagnosis of cancer, but also in monitoring and potentially serving as a predicting marker for response to therapy.

In the future, the Biomarkers Consortium will pursue additional projects in several other disease states including major depression, diabetes, and cardiovascular disease. As FNIH Chairman Dr. Charles A. Sanders noted last week, "Rapid realization of the aims of the Biomarkers Consortium is beyond the capacity of any single sector of our nation's healthcare enterprise. It requires the expertise of all stakeholders - government, industry, patient groups, academia, and other private groups."