Personalized medicines shaping the way R&D is done, says Tufts CSDD

Personalized medicine development, occupying a growing role in the clinical pipelines of drug developers, is leading companies to change their R&D paradigms, including how they make go/no-go decisions, according to a recently completed study by the USA’s Tufts Center for the Study of Drug Development.

"Early indications show that development of personalized medicines is commanding more resources and fomenting more organizational change than is generally appreciated outside the industry," said Christopher-Paul Milne, associate director at Tufts CSDD and author of the study.

He noted that the scientific, regulatory, commercial and practical challenges confronting developers in creating personalized medicines are significant, and, as a result, approaches taken by individual companies in the pursuit of these new medicines vary greatly. In particular, developers are working with academic medical centers to better understand disease mechanisms and identify strata of target populations, and with diagnostics developers to augment in-house capabilities.