Sarah Shi
Director, Global Regulatory Affairs CMC BeOne Medicines
Sarah Shi is a regulatory affairs leader with over 20 years of experience in drug development, currently serving as Director, Regulatory Affairs CMC at BeOne Medicines. She brings deep expertise across CMC regulatory strategy, regulatory submissions, and lifecycle management for synthetic chemicals, biologics and cell and gene therapy programs. Sarah has held senior regulatory CMC roles at global biopharmaceutical companies, contributing to successful development and filing activities from early clinical stages through commercialization. She is known for her collaborative, science driven approach and strong grounding in both regulatory policy and hands on regulatory CMC execution.
Seminars
Monday 12th October 2026
Evaluating Impurity Qualification Requirements for Linker-Payload Related Impurities Used to Generate ADCs
10:00 am
- Evaluating conjugatable impurities in ADC linker-payloads for potential toxicological
- Linker-payload conjugatable impurities present at ≤1.0% weight/ weight are unlikely to pose a risk to
- Contextualizing how data provides science-based justification to increase qualification limit from 0.15% to 1.0% weight/weight for linker-payload intermediates
