A biomarker is a characteristic of a biological process that occurs naturally or during pathogenesis, and it can serve as a function of therapeutic intervention. Biomarkers are an essential part of drug discovery, all the way from pre-clinical discovery to clinical validation and implementation, and the importance of biomarkers in decision-making continues to increase.

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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.

The most frequently used classes of biomarkers in relation to drug development include diagnostic, prognostic, monitoring, response, and predictive biomarkers.

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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.

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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.

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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.

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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.

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