Biomarker research can be influential across all phases of drug development, from drug discovery and preclinical evaluations to clinical development and post-marketing studies. Biomarkers are important tools for informed decision-making and can include everything from proteins, peptides, cells, histological data, to genetic markers, such as mRNA, SNPs, and microRNA.
The World Health Organization (WHO) in coordination with two other organizations, has defined a biomarker as “any substance, structure, or process that can be measured in the body or its products and influence or predict the incidence of outcome or disease”.