About this episode

The episode discusses Project Optimus and its impact on dose optimization strategies in oncology.

Cancer treatments have changed dramatically over the past decade, but have our dose-finding strategies kept pace? In this episode, I speak with Dr. Ayon Mukherjee, who leads statistical innovation in early oncology development at Eli Lilly. Together, we explore Project Optimus, the FDA initiative that is changing how we think about dose optimization in oncology. Instead of simply finding the highest dose patients can tolerate, Project Optimus encourages us to identify the dose that provides the best balance between efficacy, safety, pharmacokinetics, pharmacodynamics, and long-term tolerability. Ayon explains why the traditional maximum tolerated dose approach worked well for chemotherapy but often falls short for targeted therapies and immunotherapies. We also discuss how statisticians can help lead this transformation by designing better dose optimization studies and collaborating more effectively with clinicians, pharmacologists, and regulators.

People in this episode

Hosts: Alexander Schacht, Benjamin Piske

Guest: Dr. Ayon Mukherjee

Topics covered

• oncology
• dose optimization
• FDA initiatives
• statistical innovation
• cancer treatments

Keywords

• Project Optimus
• dose-finding strategies
• oncology
• maximum tolerated dose
• targeted therapies
• immunotherapies
• statistical innovation

Mentioned in this episode

Organizations: Eli Lilly, FDA

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