8:00 – 8:10 am ET

14:00–14:10 CET

Welcome, objectives, and the ADC regulatory landscape in 2026

Toutounji

8:10 – 9:00 am ET

14:10–15:00 CET

What makes an ADC regulatorily distinct: antibody + linker + payload as one product

Toutounji

9:00 – 9:50 am ET

15:00–15:50 CET

CMC I — Characterization, DAR, heterogeneity, and analytical control strategy

Toutounji

9:50 – 10:00 am ET

15:50–16:00 CET

Break

—

10:00 – 10:45 am ET

16:00–16:45 CET

CMC II — Comparability, linker stability, and specifications across the lifecycle

Ruth

10:45 – 11:00 am ET

16:45–17:00 CET

Q&A

Toutounji & Ruth