Deep Diving Into CMC Best Practices to Ensure Stakeholder Alliance to Optimize ADC Production & Regulatory CMC Strategy
Selecting and maintaining strong relationships with CDMO and regulator stakeholders is vital to navigate ADC manufacturing and supply chain in a timely, cost-effective and regulatory compliant manner to bring more accessible ADC therapies to patients in need.
Join this strategy-led workshop session to troubleshoot and optimize CMC stakeholder relationships to ensure ADC GMP quality and best set up regulatory submissions for success.
Workshop highlights include:
- Debating and navigating differences in opinion between industry and outsourcing partners at different stages of ADC manufacturing
- Understanding best strategies to optimize manufacturing stakeholder relationships and ensure ADC quality under GMP requirements
- Assessing best approaches for ADC regulatory submissions with discussion of science-based justifications to support alternative ADC control strategies