title: Personalized medicine for pathological circadian dysfunctions.
abstract: The recent approval of a therapeutic for a circadian disorder has increased interest in developing additional medicines for disorders characterized by circadian disruption. However, previous experience demonstrates that drug development for central nervous system (CNS) disorders has a high failure rate. Personalized medicine, or the approach to identifying the right treatment for the right patient, has recently become the standard for drug development in the oncology field. In addition to utilizing Companion Diagnostics (CDx) that identify specific genetic biomarkers to prescribe certain targeted therapies, patient profiling is regularly used to enrich for a responsive patient population during clinical trials, resulting in fewer patients required for statistical significance and a higher rate of success for demonstrating efficacy and hence receiving approval for the drug. This personalized medicine approach may be one mechanism that could reduce the high clinical trial failure rate in the development of CNS drugs. This review will discuss current circadian trials, the history of personalized medicine in oncology, lessons learned from a recently approved circadian therapeutic, and how personalized medicine can be tailored for use in future clinical trials for circadian disorders to ultimately lead to the approval of more therapeutics for patients suffering from circadian abnormalities.
authors.affiliation: Insight Genetics, Inc. Nashville, TN, USA.
authors.forename: Rachel L
authors.initials: RL
authors.lastname: Skelton
authors.affiliation: PhosphoSite, Cell Signaling Technology, Inc. Danvers, MA, USA.
authors.forename: Jon M
authors.initials: JM
authors.lastname: Kornhauser
authors.affiliation: Armada Therapeutics, Inc. Brooklyn, CT, USA.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Tate
keywords: circadian disorders; circadian therapeutics; companion diagnostics; patient enrollment; personalized medicine; targeted therapeutics