Programs
- Biosimilars: ranibizumab and risankizumab
- Novel drugs: an EGFR/c-MET bispecific antibody, an antibody-drug conjugate (ADC), and an investigational small-molecule HDAC6 inhibitor for Charcot-Marie-Tooth disease (CMT) with FDA orphan drug designation
Submissions went to MFDS (Korea) and FDA.
Product approval and post-approval change: ranibizumab biosimilar
I built a terminology map across departments and ran pre-submission check meetings for the marketing application, which MFDS approved in October 2022. After approval, I worked on the post-approval change from vial to prefilled syringe.
IND: novel EGFR/c-MET bispecific antibody
When some data were not yet final, I set priorities for which data to lock first so the program could enter Phase 1.
FDA pre-IND: risankizumab biosimilar
One of two people on the submission. I compared CROs as part of the preparation.
Across all programs
I shared regular summaries of new regulatory guidelines with the team. Every submission I owned went in on time without being returned.