Jianxin Guo
Director, Regulatory CMC Biotechnology Eli Lilly & Co.
Jianxin Guo is Director of Regulatory CMC Biotechnology at Eli Lilly and Company, with over 10 years of experience in the development and regulatory submission of antibody-drug conjugates and bioconjugates. She previously held roles at Pfizer for more than 13 years, where her work spanned ADCs, mAbs, vaccines, and gene therapy — giving her a uniquely broad perspective across complex biological modalities. She has authored or co-authored multiple publications on ADC-related topics and has presented at various industry conferences on ADC analytical and process development.
Seminars
Monday 12th October 2026
Elevating Confident Characterization of Increasingly Complex Conjugates
Monday 12th October 2026
Laying Out ADC CQAs & Understanding Regulatory Quality Perspectives as Complex Biologic & Small Molecule Therapies
9:30 am
- Contextualizing CQA requirements from approved and marketed ADCs
- Breaking down CQA considerations across small molecule and biologic ADC components
- Supplementing CQA expectations with regulatory CMC guidance from available Health Authority published guidelines
