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

Speakers:

Herbert Ogutu

Senior Manager, Contract Development & Manufacturing

Amgen

Johnathan Harris

CMC Executive Director, Regulatory Affairs

Exelixis