8:00 – 8:50 am ET

14:00–14:50 CET

Non-clinical strategy — toxicology, PK/PD, and the payload/antibody contribution problem

Toutounji

8:50 – 9:40 am ET

14:50–15:40 CET

Clinical development & expedited pathways (Fast Track, Breakthrough, Accelerated Approval, PRIME)

Toutounji

9:40 – 9:50 am ET

15:40–15:50 CET

Break

—

9:50 – 10:40 am ET

15:50–16:40 CET

Global submissions & agency interactions (FDA, EMA, PMDA); post-marketing commitments

Toutounji & Ruth

10:40 – 11:00 am ET

16:40–17:00 CET

Case studies of recently approved ADCs + interactive Q&A

Toutounji & Ruth