Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored. Thus, cancer patients often struggle to tolerate their medication doses 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 guidance 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? what steps should you take regarding your upcoming clinical trials?
During this webinar, Certara’s experts will address:
- What is Project Optimus and what are the FDA’s new expectations of early drug dose optimization in oncology
- How Project Optimus is impacting clinical trials in the oncology space
- Can potentially include: Case studies on the application of Project Optimus principles
- Should we say something to the effect of: How can you be better prepared to address the new expectations/what Certara can do to help?
Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.
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