Eugenio Cardenal Virgil
Associate Director Regulatory Affiars CMC Johnson & Johnson
More than 20 years of regulatory experience, primarily in CMC, with a focus on product development and new MAA/BLA submissions. My background spans generics (small molecule) and innovative (small- and large-molecule) companies and now includes ADCs.
Seminars
Monday 8th March 2027
ADC Regulatory CMC 101: Introducing Core Principles, Guidance & Challenges Facing ADC Drug CMC & Submissions
9:30 am
- What differentiates ADCs from standard SM and LM?
- What regulations apply specifically to the ADC context?
- Introducing key ADC concepts for regulatory affairs CMC and get the industry up to speed with guidances
Monday 8th March 2027
Group Discussion: Unlocking Faster ADC Development Through Smarter Regulatory CMC
2:00 pm
- Exploring how early CMC strategies can help streamline development timelines and reduce regulatory delays
- Discussing the strategies for building robust CMC packages that support faster progression into and through the clinic
- Achieving best practices for process development, analytical control strategies, and comparability planning to facilitate regulatory interactions and accelerate time to market
