Balancing Early Development Flexibility With Regulatory Expectations for ADC Process Development
Time: 11:30 am
day: Day One
Details:
- Understanding what must be locked down before pivotal trials and BLA submissions
- Exploring what is considered acceptable early-phase deferrals and how to justify them
- Understanding what the “must-do” aspects of process development are and what can be deferred for IND approval, in order to improve costs and speed of early development
