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What Oncology Drug Developers Should Expect from the FDA’s Project Optimus

February 24, 2022
On-Demand Webinar

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 for the small biotechs that develop more than 80% of novel compounds? And what steps should they take regarding their upcoming clinical trials?

During this webinar, Certara’s Dr. Julie Bullock will address:

  • How Project Optimus may impact clinical trials in the oncology space
  • How the guidance may affect the current oncology drug pipeline
  • Whether it may lead to the FDA making other changes in the oncology clinical trial space