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?