Yuan Ren

Company: Bristol Myers Squibb

Job title: Principal Scientist

Seminars:

Developing a Comprehensive Product Understanding & Extended Characterization for Presenting a Robust Physicochemical Data Package for BLA, IND & FIH Trial Regulatory Submissions 8:31 am

Developing a comprehensive understanding of product attributes and conducting extended physicochemical characterization are essential to ensuring that ADCs meet the stringent requirements for regulatory submissions, including BLA, IND applications, and FIH trials. Extended characterization and continuous refinement of CQAs from discovery through to late-stage development enhance product consistency, efficacy, and safety, supporting robust regulatory submissions.…Read more

day: Pre-Conference Day