Conducting Early Phase Oncology Studies - Successfully moving through to proof of concept and beyond

This one-hour webinar focuses on strategic considerations for the molecule, including a brief review of the dynamic research landscape of oncology drug development, patient recruitment and product development aspects.

• What is on the horizon in oncology drug development
• Clinical development strategy and tactics
• Clinical design and consideration:
  • Early V Late Phase
  • Regulatory considerations
  • Clinical aspects  – cure or control
  • Patient centricity – practical considerations
  • Trial design – early phase  3+3, Rolling 6 and other designs
  • Protocol development – clear unambiguous protocols, sense checking with KOL’s and subject matter experts. The importance of understanding how to ‘operationalize’ the protocol with thorough feasibility
• Proof of concept – how do you confirm for MAA?