{"id":1803,"date":"2025-01-30T12:14:55","date_gmt":"2025-01-30T12:14:55","guid":{"rendered":"https:\/\/www.nordicbioscience.com\/?page_id=1803"},"modified":"2025-06-06T08:47:58","modified_gmt":"2025-06-06T08:47:58","slug":"why-biomarkers","status":"publish","type":"page","link":"https:\/\/www.nordicbioscience.com\/why-biomarkers\/","title":{"rendered":"Why Biomarkers?"},"content":{"rendered":"
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Why Biomarkers?<\/h1>\n

Learn more about what biomarkers are, their classifications based on FDA guidelines, their clinical value, and how they can be integrated into clinical trials.<\/p>\n

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What is a biomarker?<\/h2>\n \n\n <\/div>\n
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Biomarkers are measurable indicators of biological processes, both normal and pathological, and are increasingly central to modern drug development and clinical decision-making. They enable objective assessments of disease presence, progression, and therapeutic response. From early preclinical studies to late-stage clinical trials, biomarkers improve the precision of drug development by guiding dose selection, predicting efficacy, monitoring on- and off-target effects, and identifying suitable patient populations.<\/p>\n

This section outlines the clinical utility of biomarkers and underscores their strategic value in developing treatments that target not just symptoms, but the underlying mechanisms of organ dysfunction.<\/p>\n <\/div>\n <\/div>\n

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BEST Biomarker Guidelines (FDA Supported)<\/h2>\n \n\n <\/div>\n
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BEST is developed to accurately distinguish between different biomarker properties, in the context of biomedical research, clinical practice, drug development and regulatory considerations and use.<\/p>\n

The most frequently used classes of biomarkers in relation to drug development include\u00a0diagnostic, prognostic, monitoring, response, and predictive<\/em>\u00a0biomarkers.<\/p>\n <\/div>\n <\/div>\n

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From biomarker discovery to clinical use<\/h2>\n \n\n <\/div>\n
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Biomarkers have the potential to serve as valuable tools throughout the entire drug development process, but the utility ultimately depends on the refinement, implementation, and qualification of the biomarker. Before reaching a stage where they can provide value, biomarkers must first undergo rigorous testing and validation.<\/p>\n <\/div>\n <\/div>\n

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Clinical value of biomarkers<\/h2>\n \n\n <\/div>\n
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Implementing biomarkers on all levels of drug development has been proven to facilitate better and faster drug development, and improve the outcomes of clinical trials. Biomarkers are important for all stakeholders involved in drug development; patients, payers, regulators, and drug developers all alike, as the right biomarkers can lead to cost-effective trial design.<\/p>\n <\/div>\n <\/div>\n

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ECM biomarkers in the BEST framework<\/h2>\n \n\n <\/div>\n
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Extracellular matrix (ECM) turnover and homeostasis are becoming increasingly acknowledged as a pathological factor affected by fibro-inflammatory diseases. This process is involved in multiple different disease indications, including those affecting the liver, kidneys, heart, and lungs. Because of this increasingly clear association to many different pathologies, biomarkers reflecting tissue destruction and fibrosis can be implemented across disease indications to help guide drug development and clinical trial evaluation.<\/p>\n <\/div>\n <\/div>\n

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Regulatory considerations<\/h2>\n \n\n <\/div>\n
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A biomarker intended for general use in drug development can be granted qualification by the Center for Drug Evaluation and Research (CDER) through the Biomarker Qualification Program, leading to the establishment of a drug development tool that holds applicability within a specific COU during the drug development process.<\/p>\n <\/div>\n <\/div>\n

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Get in touch<\/h2>\n \n\n <\/div>\n
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