ADC Regulatory CMC 101: Introducing Core Principles, Guidance & Challenges Facing Bioconjugate CMC & Submissions

• Understanding the core principles of ADCs from a regulatory CMC perspective
• Understanding the need for ADC-specific regulatory guidance as complex biologic and small molecules
• Identifying the gaps in ADC regulatory CMC guidance and the need for further clarity and regulatory legislation

Speakers:

Eugenio Cardenal

Associate Director, CMC Regulatory Affairs

Johnson & Johnson