Regulatory Strategies to Employ When Your Study Doesn’t Qualify for Breakthrough/Prime

September 12, 2019 8:00 AM - 10:00 AM

MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

It is well understood that achieving Breakthrough or Prime Designation status provides sponsors with significant advantages in the regulatory process to achieve approval. However – not every drug candidate will qualify. This Forum will showcase best practice and real world examples of regulatory success, even without achieving coveted breakthrough status.
  • Overview of Breakthrough vs Fast Track vs Accelerated Approval, etc.
  • FDA and EMA engagement techniques to keep momentum and enthusiasm even without Breakthrough
  • Panel will share success stories and real-world examples of their strategies and FDA / EMA interactions that allowed for regulatory success
  • Equally important – what NOT TO DO examples will be shared