Biomarkers in Drug Development
Once a proposed biomarker has been validated, it can be used to diagnose disease risk, presence of disease in an individual, or to tailor treatments for the disease in an individual (choices of drug treatment or administration regimes). In evaluating potential drug therapies, a biomarker may be used as a surrogate for a natural endpoint such as survival or irreversible morbidity. If a treatment alters the biomarker, which has a direct connection to improved health, the biomarker serves as a surrogate endpoint for evaluating clinical benefit. Some of the main areas in which molecular biomarkers are used in the drug development process are: early drug development studies, safety studies, proof of concept studies, and molecular profiling.
Molecular biomarkers are often used in early drug development studies. For instance, they are used in phase I study for establishing doses and dosing regimen for future phase II studies. PD biomarkers are commonly observed to respond (either decrease or increase) proportionally with dose. This data, in conjunction with safety data, help determine doses for phase II studies. In addition, Safety molecular biomarkers have been used for decades both in preclinical and clinical research. Since these tests have become mainstream tests, they have been fully automated for both animal and human testing. Among the most common safety tests are those of liver function (e.g., transaminases, bilirubin, alkaline phosphatase) and kidney function (e.g., serum creatinine, creatinine clearance, cystatin C). Others include markers of skeletal muscle(e.g., myoglobin) or cardiac muscle injury (e.g., CK-MB, troponin I or T), as well as bone biomarkers (e.g., bone-specific alkaline phosphatase).
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