The FDA’s “Project Optimus” and Oncology Drugs

Julie Bullock, VP, Global Head of Clinical Pharmacology and Translational Medicine at Certara discusses the FDA’s Oncology Center of Excellence’s new initiative called “Project Optimus” which addresses issues relating to dose optimization in clinical trials assessing the safety and efficacy of oncology drugs. She talks about how the initiative may affect the current oncology drug pipeline and whether it may lead to the FDA making other changes in the oncology clinical trial space. For additional information, read more here.

Julie Bullock is a trained drug development scientist with clinical pharmacology and regulatory experience focused in the therapeutic areas of oncology, hematology and coagulation. She brings her unique insight into pediatric development, oncology dose finding strategy and streamlining development for breakthrough therapies and accelerated approval. Contributed to over 14 new molecular entity approvals during her 10-year FDA career. Julie holds a doctorate in pharmacy from Drake University in Des Moines, Iowa.