Eugenio Cardenal
Associate Director, CMC Regulatory Affairs Johnson & Johnson
Seminars
Monday 23rd February 2026
ADC Regulatory CMC 101: Introducing Core Principles, Guidance & Challenges Facing Bioconjugate CMC & Submissions
9:30 am
- 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
