Project Optimus: helping or hindering cancer drug development?

Alongside the multitude of guidance documents, recent years have seen the US Food and Drug Administration (FDA) ramp up workshops and project implementation efforts in a bid to drive innovation in drug development. Agency eyes have zeroed in on oncology, with the FDA Oncology Center of Excellence (OCE) introducing frameworks such as Project Optimus to reform the dose optimisation and dose selection paradigm in oncology drug development.