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Implementing precision medicine initiatives in the clinic: a new paradigm in drug development

Purpose of review With the recent advances in genome sequencing technology, greater knowledge of cancer biology allows the identification of different molecular alterations in tumor samples from patients with advanced cancer, some of which are promising potential therapeutic targets. This review highlights the different methods for molecular screening, examines the recent success and preliminary precision medicine programs’ results. Challenges and perspectives of this approach are discussed. Recent findings The emergence of high-throughput technologies has allowed the stratification of most common diseases into rare molecular segments. The recent success of predictive biomarkers showed that molecular screening has become essential in the development of drugs in early clinical trials. Several prospective trials are ongoing worldwide with very promising results. Summary Characterization of the genomic alterations in cancer patients is now critical to better select molecular-targeted therapies and to accelerate the drug development process in phase I/II. High-throughput analysis is feasible in daily practice, and allows enrichment of phase I trials in molecularly selected patients.