Biomarker Development in Targeting Cancer Epigenetic

Abstract Biomarkers are at the cornerstone of modern medicine and are crucial tools in drug development from the preclinical stages to their clinical implementation as pharmacodynamic, pharmacokinetic, monitoring, and predictive indicators. The development of novel biomarkers remains challenging, with a high dropout rate that compares to the development of new drugs. This review focuses on introducing target engagement and predictive biomarkers and their challenges in terms of methods and clinical validation, from the key concept of fit-for-purpose methodologies to the specific challenges of epigenetics for biomarker development.