Strategic Emphasis Will Help Improve Diagnosis and Measure Disease Progression, Guide Treatment, Accelerate Drug Development and Target Therapies to Individuals

SAN DIEGO, June 16, 2008 —The Biomarkers Consortium, a collaborative public-private partnership managed by the Foundation for the National Institutes of Health, today announced its strategic focus on addressing High-Impact Biomarker Opportunities. These High-Impact Biomarker Opportunities represent pragmatic, high-priority areas of opportunity for biomarker identification, development, and qualification that promise to expedite therapeutic development and improve patient diagnosis, care, and treatment.

The Biomarkers Consortium is creating fundamental change in how healthcare research and medical product developments are conducted by bringing together leaders from the biotechnology and pharmaceutical industries, government, academia, and non-profit organizations to work together to accelerate the identification, development, and regulatory acceptance of biomarkers in four key areas: cancer, inflammation and immunity, metabolic disorders, and neuroscience. Results from projects implemented by the consortium will be made available to researchers worldwide.

Biomarkers are objective measurements of biological processes that can substantially improve the precision with which we evaluate disease risk, diagnosis, and progression, and guide treatment. They also promise to revolutionize both the development and use of therapeutics. In some cases, they may allow for earlier “go/no go” decisions in developing treatments and help shave years and cost off the development process by providing a clearer indication of a treatment’s efficacy, dosage, or safety. Biomarkers are the foundation of evidence-based medicine, making the practice of medicine more personalized, predictive, and preemptive.

The Biomarkers Consortium comprises major stakeholders in the nation’s healthcare system, including the National Institutes of Health (NIH), the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), Pharmaceutical Research and Manufacturers of America (PhRMA), Biotechnology Industry Organization (BIO), non-profit organizations, and patient advocacy groups.

“We believe the High-Impact Biomarker Opportunities we have identified are those most critical to move forward: those which will have the greatest and most proximal impact on future diagnosis and treatment of patients and drug development, helping the medical community realize the promise of personalized medicine,” said Charles A. Sanders, M.D., chairman of the consortium’s Executive Committee and chairman of the Foundation for NIH board of directors. “Past biomarker discoveries, such as cholesterol and blood sugar measurements, have brought about significant changes in medicine. Collaborative, thorough qualification of new biomarkers by the scientific community holds the promise of delivering similarly dramatic results in evaluating and treating disease.”

The Biomarkers Consortium has developed a number of key criteria for defining High-Impact Biomarker Opportunities:

• Important — addresses a significant unmet medical or scientific need in biomarkers with a potentially considerable impact on public health;
• Translational — will result in significant improvement in the development, approval, or delivery of care to patients (i.e., diagnostics, therapeutics, clinical practice); •
• Transformational — addresses critical gaps in the biomarkers qualification/validation process and/or may otherwise transform the process of how biomarkers are developed, approved, and applied in the future;
• Feasible — an idea or program whose end goals can likely be achieved in a specific timeframe, and that has a reasonable prospect of producing the expected outcomes; ideal programs are those which could result in regulatory qualification of a biomarker in three years;
• Practical — leverages preexisting resources (e.g., intellectual capital, personnel, facilities, specimens, reagents, data) wherever possible; • Fundable — is capable of generating the required funding and stakeholder support needed for implementation; and
• Collaborative — would uniquely benefit from the multi-stakeholder composition and approach of The Biomarkers Consortium, and could be feasibly executed under its policies.

“This strategic focus will help ensure The Biomarkers Consortium is implementing the most important biomarker projects with the broadest cross-sector support,” noted Dr.Sanders. “The consortium provides the best possible mechanism for biomarker development and standardization because it provides common ground on which both the public and private sectors can integrate and leverage their scientific, intellectual, and financial resources and insights.”

Project concepts approved by The Biomarkers Consortium are developed into detailed, comprehensive project plans which are approved by the consortium’s leadership before the Foundation for NIH undertakes formal fundraising and projects are implemented.

Among the projects launched by The Biomarkers Consortium to date:

• Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) Lung and Lymphoma Projects, two studies managed by the National Cancer Institute (NCI) to assess the use of FDG-PET as a potential biomarker for clinical trials conducted in non-Hodgkin’s lymphoma and non-small cell lung cancer. These studies could have substantial impact on patient management by validating a tool that can measure response to treatment and accelerate drug development ($6.43 million provided by Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Inc., Pfizer Inc., and Wyeth, along with substantial core investment by NCI);
• Evaluate the Utility of Adiponectin as a Biomarker Predictive of Glycemic Efficacy by Pooling Existing Clinical Trial Data from Previously Conducted Studies will determine whether adiponectin, a soluble protein, has utility as a predictive biomarker of glycemic control in normal non-diabetic subjects and patients with type 2 diabetes following treatment with peroxisome proliferator-activated receptor (PPAR) agonists, and could aid in the development of new therapies. Data from Phase II clinical trials are being provided by GlaxoSmithKline, Eli Lilly and Company, Merck and Co., Inc., and F. Hoffmann-La Roche, with statistical analysis support provided by the National Institute of Diabetes and Digestive and Kidney Diseases and Quintiles Transnational Corp.
• Carotid Magnetic Resonance Imaging (MRI) Reproducibility Study via a National Heart, Lung and Blood Institute AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL-cholesterol/High Triglyceride and Impact on Global Health Outcomes) Substudy, which promises to improve patient management by validating a tool that can help identify therapeutic response and facilitate drug development through its conduct of an 80-patient reproducibility study at a total of 15 established clinical sites to determine the reproducibility of the non-invasive technique of carotid MRI, a well-known imaging biomarker ($957,000 provided by Abbott, Merck & Co., Inc., and Pfizer Inc, leveraging an existing NHLBI-sponsored study).

The Biomarkers Consortium anticipates launching at least five to six new High-Impact Biomarker projects this year, while a second wave is being developed concurrently to commence during 2009. These new High-Impact Biomarker Opportunities will be discussed during a two-part super session sponsored by the consortium at the 2008 BIO International Convention in San Diego on Thursday, June 19, 2008 (Room 29 CD):

• A 2-3:30 p.m. panel will address “Accelerating the Identification and Development of Biomarkers for Human Health Through Public-Private Partnerships.” •
• The 4-5:30 p.m. panel will assess “The Promise and Progress of The Biomarkers Consortium,” focusing specifically on the consortium’s efforts in cancer biomarker development.

Communications activities of the Foundation for the National Institutes of Health are supported in part by professional services donated by Fleishman-Hillard.

The Foundation for the National Institutes of Health was established by the United States Congress to support the mission of the National Institutes of Health – improving health through scientific discovery. The foundation identifies and develops opportunities for innovative public-private partnerships involving industry, academia, and the philanthropic community. A non-profit, 501(c)(3) corporation, the foundation raises private-sector funds for a broad portfolio of unique programs that complement and enhance NIH priorities and activities. The foundation’s Web site address is www.fnih.org.

The Biomarkers Consortium: In addition to the Foundation for NIH, founding members of The Biomarkers Consortium include the National Institutes of Health, Food and Drug Administration and the Pharmaceutical Research and Manufacturers of America. Other partners include the Centers for Medicare & Medicaid Services (CMS) and the Biotechnology Industry Organization (BIO). The 53 contributing members of the consortium are: Academy of Molecular Imaging; Advanced Medical Technology Association; Alliance for Aging Research; Althea Technologies; Alzheimer’s Association; American Association for Cancer Research; American Cancer Society; American College of Neuropsychopharmacology; American Health Assistance Foundation; American Society for Clinical Pharmacology and Therapeutics; American Society of Clinical Oncology; American Society for Therapeutic Radiology and Oncology; Association of Clinical Research Organizations; AstraZeneca; Autism Speaks; Avalon Pharmaceuticals; Battelle Memorial Institute; BG Medicine; Biotechnology Industry Organization; Boehringer-Ingelheim Pharmaceuticals, Inc.; Bristol-Myers Squibb; Digilab Biovision; EMD Serono; Federation of Clinical Immunology Societies; Michael J. Fox Foundation for Parkinson’s Research; Genstruct Inc.; GlaxoSmithKline; GVK BIOSciences; High Q Foundation; Immune Tolerance Institute; Ingenuity Systems, Inc.; Johnson & Johnson; Juvenile Diabetes Research Foundation; Kidney Cancer Association; The Leukemia & Lymphoma Society; Eli Lilly & Company; Luminex Corporation; Lundbeck; Lupus Foundation of America; Lupus Research Institute; Merck & Co., Inc.; Novartis; Novo Nordisk; Pfizer Inc; Pharmaceutical Research and Manufacturers of America; Polo Ralph Lauren Foundation; Radiological Society of North America; F. Hoffmann-La Roche; Rules Based Medicine, Inc.; Ryan Licht Sang Bipolar Foundation; Society of Nuclear Medicine; Vanderbilt University and Wyeth. Consortium Web site: www.biomarkersconsortium.org.