Understanding Project Optimus

The FDA’s Oncology Center of Excellence has launched an initiative to reform the dose optimization and dose selection paradigm in oncology drug development. Known as Project Optimus, this initiative recommends a core change in how doses are selected during oncology clinical trials and post-approval studies.

Sirj Goswami, PhD, CEO, co-founder of InsightRX and Jason Rizzo, MBA, VP Global Biopharma Strategy discuss this topic in more detail in an article published by Applied Clinical Trials*.