ABSTRACT
Robust and validated biomarkers are needed to improve diagnosis, to monitor drug activity and therapeutic response, and to guide the development of safer and targeted therapies for different chronic diseases. Although different types of biomarkers have been impactful in the field of drug discovery and development, the process of identifying and validating disease-specific biomarkers has been quite challenging. Recent advances in multiple omics approaches (e.g., genetics, epigenetics, genomics, transcriptomics, proteomics, metabolomics, and imaging) in combination with bioinformatics and biostatistics have made it possible to accelerate the discovery and development of specific biomarkers for complex chronic diseases. Although many challenges remain to be addressed, current efforts in the discovery and development of disease-related biomarkers will assist in optimal decision making throughout the course of drug development and improve our understanding of the disease processes. Moreover, effective translation of the preclinical biomarkers into the clinic will pave the way toward the effective execution of precision therapies across complex disease areas for the benefit of patients, health care providers, and the biopharmaceutical industry. However, a consistent framework for the validation, acceptance, and qualification of biomarkers for regulatory use is still required to promote innovative research and application of biomarkers in the preclinical and clinical phases of drug development.
