The role of gene expression profiling in drug discovery

Monitoring gene expression through the dual approaches of transcriptomics (RNA profiling) and proteomics (protein profiling) has become a key component in our efforts to understand complex biological processes. From the molecular stratification of disease states and the selection of potential drug targets, to patient selection and the confirmation of engagement of pharmacology in clinical studies, we are seeing the impact of gene expression profiling across all phases of the drug discovery process. Ongoing technological advances have driven an expansion in the use of these techniques, demonstrated utility in preclinical and clinical settings and increased regulatory and clinical acceptance. As technologies continue to advance apace, gene expression profiling is likely to play an increasingly important role in the future development of drug discovery.

► Gene expression technologies have become established and clinically accepted. ► Gene expression readouts both single and multiplex have achieved regulatory approval. ► Stratification of patient populations has become more routine. ► Gene expression pharmacodynamic readouts have become standard in early phase clinical studies.