Aligning on interpretation of regulatory expectations and maintaining beneficial communication between regulators and sponsors is crucial to set up ADC regulatory submissions for success and put forward future topics to prioritise.

Join individual table discussions moderated by ADC regulatory CMC experts to delve into pre-prepared discussion points surrounding the opportunities and setbacks of ADC regulatory CMC guidance. Make sure you come with your thoughts and questions prepared!

Discussion Highlights Include:

• Must-have versus nice-to-have: Is it clear what needs to be included in ADC data packages for regulatory submissions?
• Sharing experiences and takeaways from regulatory body interactions to maximise clarity and best action feedback on ADC programmes
• Putting forward top priorities and clarifications for ADC-specific regulatory CMC guidance
• Looking to the future: Anticipating how ADC regulatory CMC principles apply to emerging novel ADC modalities