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Medical Device Case Studies
It is critical for a medical device company to understand the biological impact of their device. Typically, medical devices have their origins in mechanical or engineering disciplines. Cambridge Biomedical closely works with medical device companies to apply the appropriate science to their instrumentation. Cambridge Biomedical's clinical and biological expertise and experience provides the ability to help define which bio-markers to assess.
Biomarker Development
The Client
The client is a therapeutics company specializing in metabolic disorders and inflammatory diseases. Their history is one of product innovation and developing therapeutic options for physicians and patients.
Technical Need
The client developed a therapeutic candidate to reduce inflammation in patients with osteoarthritis and had identified eighteen discreet biomarkers as potential indicators of disease progression. The challenge for the client was to identify the role of each biomarker as related to disease indication, disease progression, and disease regression, and to measure the outcome benefit of the therapeutic product. The complexity of the project was increased because each biomarker level required monitoring in both serum and synovial fluid.
Cambridge Biomedical's Service
We developed and validated assays for each of the eighteen biomarkers in both matrices and accomplished the task in less than 12 months. During the development process, it became evident that only a certain number of the subject biomarkers actually correlated to osteoarthritis. This was a very important discovery for our client. Cambridge Biomedical was then was asked to manage the patient sampling process to identify the patients whose disease profile met the needs of our client. Our client more efficiently identified the appropriate patient population for subsequent study arms.
Results
Cambridge Biomedical's efforts were valuable in providing critical data for the client's clinical development strategy. Our work also enabled the client to efficiently and effectively utilize their limited resources without needing to set up a stand-alone laboratory for this program.
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