Eugenio Cardenal
Associate Director, CMC Regulatory Affairs Janssen Biologics
I majored in chemistry at Tufts University, doctorate in biology from UCSD and post-doctoral fellowship at NYU School of Medicine focusing in epigenetics. I was the project leader at Orum Therapeutics for an asset that was eventually licensed-out to a big pharma and that is currently in phase 1 clinical trials.
Seminars
Thursday 11th June 2026
Regulatory Considerations for ADCs
12:30 pm
- Understanding the core principles of ADC from a regulatory CMC perspective
- Uncovering 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 legislation
