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Drug discovery and development is a formidable, risky, and costly endeavor owing to factors such as complex scientific and regulatory aspects. One approach to enhance our understanding of such issues has emerged in the form of biomarker development, validation, and application. Biomarkers of disease occupy an important position in medical research and have begun to assume a greater role in drug discovery and development. The 21st Century Cures Act, approved in the USA in December 2016, adopts into law the formal process of qualification of biomarkers developed by the FDA to increase the efficiency of clinical trials and encourage an era of molecular medicine. Therefore, biomarkers attract more attention from drug development and discovery researchers including Creative Biolabs, a world-leading biotech company with years of experience in the therapeutic molecular development area. Based on our mature platforms, we have gained some achievement in the development of novel drugs and we are glad to share our idea in the research of biomarkers with our peers.
Biomarkers are a kind of informational and dynamic biological molecule or results that can be objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes. Most biomarkers are disease-related molecules, while in some cases, imaging and the psychometric indicator also act as biomarkers such as loss of memory in Alzheimer’s disease.
In the drug discovery and development of the pharmaceutical industry, biomarkers are detected to confirm the surrogate endpoint of the therapy to replace clinical endpoints, while the latter are variables that can be used to measure how patients feel, function, or survive. Therefore, the application of biomarkers shortens the cycle and reduces the costs in the drugs R&D, especially towards chronic disease. For example, FDA has permitted the use of HIV viral load as surrogacy for AIDS, which simplifies the process of anti-AIDS drug evaluation.
Biomarkers must be robust and sensitive while the detection of a biomarker should be clinically relevant and provide clinical benefits to the patient. Every stage of drug development has its own specific set of biomarkers that may or may not apply to other stages. In fact, biomarkers are widely used in daily life. For example, blood pressure and heart rate measures are the most representative biomarkers. Moreover, a routine health examination contains dozens of biomarkers such as cytokines for rheumatoid arthritis or serum carcinoembryonic antigen for cancers.
Fig.1 Types of biomarkers in the multistep drug development process. (Ileana, 2018)
It is widely accepted that biomarkers are increasingly used in drug discovery and development, and are applied to personalized medicine. Based on rich experience and skilled groups, Creative Biolabs has established mature platforms in biomarker research. For more detail on glycoprotein research or our services, please click follow key words or directly contact us.
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