How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline

Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the FDA’s new guidance Project Optimus, which addresses issues relating to dose optimization in clinical trials assessing oncology drugs.

Pharmacy Times interviewed Julie Bullock, vice president, global head of clinical pharmacology and translational medicine at Certara, on the new guidance from the FDA’s Oncology Center of Excellence called Project Optimus. This new guidance addresses issues relating to dose optimization in clinical trials assessing the safety and efficacy of oncology drugs.

According to Bullock, this shift in dose optimization during drug development has caused small biotechs that develop more than 80% of novel compounds to assess next steps around what this may mean for upcoming clinical trials.

Bullock is a former FDA team lead in the oncology division and spent a decade in the regulatory agency. In 2013, Bullock had addressed within her team at the FDA the problems associated with focusing on the maximum tolerated dose during studies, and she was subsequently involved in several FDA workshops to develop the idea that led to Project Optimus.

During the discussion, Bullock addresses how Project Optimus may impact clinical trials in the oncology space, how the guidance may affect the current oncology drug pipeline, and whether it may lead to the FDA making other changes in the oncology clinical trial space.