Pharmas seeing paradigm shift in new dose-optimization guidance

If the R&D chiefs of two major pharmas are representative of the class, then FDA’s recent guidance on dose optimization is causing major ripples across the industry for cancer drug developers. While there’s agreement with the motivation behind the directive, the ideas add some risks, and the utility will depend on the target and therapy in question.

On the latest two episodes of The BioCentury Show, David Reese, EVP of R&D at  Amgen Inc. (NASDAQ:AMGN), and Shreeram Aradhye, president of global drug development and CMO at  Novartis AG (SIX:NOVN; NYSE:NVS), said the new guidance coming out of FDA’s Project Optimus is likely to cause significant changes in how companies structure their development programs in cancer...