Abandoning linear thinking

Drug developers are coming to believe that a major rethink of the traditional bench-to-bedside model in early drug discovery might be the best way to bring down the high rates of clinical trial failures. At an FDA meeting on improving productivity in R&D, stakeholders from industry, academia and government advocated a shift towards validating targets from the outset by incorporating new technologies, patient samples and systems pharmacology, instead of the linear process used today that's based on a series of assays far removed from clinical relevance.

Last month, the Brookings Institution's Center for Health Policy joined with FDA and the International Consortium for Innovation & Quality in Pharmaceutical Development to host a meeting that discussed interventions to improve clinical trial success at each stage of drug development from target validation to clinical outcomes. ...