ABSTRACT
Biomarkers are critical to each phase of drug discovery and development, increasing research, approval, and treatment efficiency. As quantifiable markers, they provide valuable information on biological processes, diseases, and response to therapy, and thus become key tools in driving precision medicine and enhancing healthcare outcomes. In drug development, biomarkers play a key role in identifying disease mechanisms, selecting appropriate patient populations, and monitoring the effectiveness and safety of new drugs. They are categorized into diagnostic, prognostic, predictive, pharmacodynamics, and safety biomarkers, each serving specific purposes. Recent progress in genomics, proteomics, and artificial intelligence has facilitated biomarker discovery and application to allow faster development of drugs and implementation of personalized medicine. While validation, standardization, and ethical concerns still need to be addressed, biomarkers are changing the drug development process and developing more targeted and effective therapies.
