Delivering precision medicine: Personalization at scale

The hard way to deliver personalized medicine is always going to be to develop new medicines that suit ever more specific, molecularly determined cohorts of patients. The traditional approach is to discover a novel biomarker, clinically validate it, and then use it to segment patients into corresponding therapy response groups, design a clinical trial and approval process and put a new drug on market. This is hard for a number of reasons– first it takes a minimum of 10–15 years to put a drug on the market and costs upward of two billion dollars.[5] Second, smaller responder populations may improve the efficiency and success rate of approvals, but they will likely mean a reduced economic potential of the drug once on market. Third, having more specific patient cohorts can vastly increase the cost and complexity of patient recruitment.