Mastermind Session: Navigating PhaseAppropriate Analytical Development – Where Can we Set Up for Success?

Time: 3:00 pm
day: Conf Day One Bioassays PM


  • Breaking down the regulatory requirements for assays at different development stages
  • Outlining expectations for pre-IND and early phase methods – how far should industry go during early development?
  • What are the additional challenges moving to later-stage development, and preparing to the commercial environment?
  • How can industry best communicate with regulators, and benefit from public and townhall meetings?