Roundtable Discussion: Discussing Regulatory Strategy indications for Dose Optimisation & Expansion with Cytokine-based Drugs
Time: 10:30 am
day: Conference Day One
Details:
- Overview of the history and evolution of Project Optimus and its application to understand how to manoeuvre in the regulatory environment when developing cytokines with an FDA perspective when approaching FDA optimization
- Discussing the pros and cons of Project Optimus to advance the regulatory development plan
- Interactive discussion with the attendees about their experiences in the regulatory landscape to successfully navigate regulatory issues
