Laying Out ADC CQAs & Understanding Regulatory Quality Perspectives as Complex Biologic & Small Molecule Therapies

• 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 

Speakers:

Jianxin Guo

Director, Regulatory CMC Biotechnology

Eli Lilly & Co.