Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored in the dose decision making process. Thus, cancer patients often struggle to tolerate their medication long-term, requiring dose modifications including dose reductions and holidays. What’s more, for many oncology drugs, their dosing or schedules have been modified to address safety or tolerability issues after regulatory approval.
These challenges spurred the FDA’s Oncology Center of Excellence to develop a new initiative called “Project Optimus” to addresses issues relating to dose optimization in clinical trials assessing the safety and efficacy of oncology drugs.
What does this shift in dose optimization during drug development mean for the small biotechs that develop more than 80% of novel compounds? And what steps should they take regarding their upcoming clinical trials?
Julie Bullock, Ph.D.
Julie Bullock is currently a Senior Vice President in the Integrated Drug Development group at Certara. Dr. 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. Dr. Bullock 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.