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PARTNERSHIPS New drug development takes place in a highly competitive environment, where pharmaceutical companies expend ever-increasing resources to bring promising new compounds through the U.S. Food and Drug Administration’s (FDA’s) new drug approval process. Similarly, the medical device industry is faced with ever-increasing costs for pre-clinical and clinical trials. Appropriately validated and applied imaging biomarkers hold the promise of more efficient and accurate medical product evaluation, decreasing both the time and cost involved in successfully bringing new products to market. The need for such increased efficiency is undeniable. In the early 1990’s, taking a new drug from initial discovery to regulatory approval was estimated to take 12 years and cost approximately $500 million. Despite efforts to improve this efficiency, including the Food and Drug Administration Modernization Act of 1997 (FDAMA), these figures are now thought to have risen to 15 years and nearly a billion dollars. Adding further pressure are breakthroughs in genomics, proteomics, and high throughput screening, which together are adding a significant number of new target molecules for evaluation as potential new drugs. Only one in approximately every 5000 of these targets will ultimately be approved as a new drug, and only extensive, potentially costly testing can identify that promising compound. Biomarkers in imaging, appropriately and knowledgeably applied, offer the potential of increased efficiency throughout the research and development spectrum. In pre-clinical and early clinical test, imaging biomarkers have delineated compounds that perform as anticipated and others that are clear failures, allowing resources to be directed to the most promising applications far earlier than would otherwise be possible. Leading pharmaceutical concerns, such as Pfizer, Inc., have publicly acknowledged using imaging biomarkers in this manner. Imaging biomarkers are tremendously useful in Phase 2 and Phase 3 clinical trials as well. Tumor volume as measured by CT scan was used in the approval of Herceptin for metastatic breast cancer, while lesion volume by MRI was employed in the successful application of Betaseron, a treatment for multiple sclerosis. In the device arena, luminal diameter by angiography has been used as a secondary endpoint in the evaluation of cardiac stents, with FDA officials recently indicating their willingness to consider this imaging biomarker as a primary endpoint. In all these cases, imaging biomarkers almost certainly made possible considerable savings in both time and resources. The use of biomarkers in imaging need not be restricted to explicit study endpoints in order to enhance the efficiency of clinical trials. For example, Novartis recently employed tumor uptake of 18F-FDG by PET scanning as an internal decision-making tool in its evaluation of Gleevec for the treatment of gastrointestinal stromal tumors, noting the close correlation between this uptake and a formal study endpoint, tumor regression by CT or MRI scanning. The Center for Biomarkers in Imaging, as an access point to the extensive imaging and research resources of the Massachusetts General Hospital Department of Radiology, has the experience necessary to identify, validate and apply imaging-related biomarkers at all stages of drug and medical device development. As the nation’s leading recipient of NIH funding and other competitive grants to diagnostic radiology departments (over $45 million in extramural research funding awarded in 2002), the Department maintains one of the largest imaging research infrastructures in the world. The Department’s experience is practical as well, having worked with over 35 companies and over 30 discrete biomarkers in pre-clinical and clinical trials for both the drug and device industries. Together, this research and industrial experience make it possible for CBI to achieve the full potential of biomarkers in imaging, benefiting industry, government, and the broader academic community. SERVICES The Center for Biomarkers in Imaging (CBI) offers the following services to government, industry, and other interested parties. Please feel free to contact us for additional information or to arrange an initial consultation (info@biomarkers.org). CONSULTATION AND EDUCATION SCIENTIFIC VALIDATION IMAGE INTERPRETATION CONSULTATION AND EDUCATION
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