Five Strategies for Meeting Project Optimus

As the FDA’s Project Optimus goes into effect, developers for cancer drugs need to address the agency’s new and more rigid interpretation of evidentiary standards—or face the possibility of refuse-to-file (RTF) decisions and complete-response (CR) requests. Parexel experts outline five best practices for adapting to these new standards:

1. Conducting in-depth preclinical evaluations
2. Running data-rich early-dosing studies
3. Adding dynamic biomarkers to help identify the optimal dose
4. Understanding the toxicities that matter to patients
5. Using FDA meetings to de-risk your dose-finding strategy