Session – Knowledge based CQA assessment for BLA submission Dr. Weijun Li has more than 15 years’ experience in biological research, development, and product manufacturing. He is the Director, Analytical Development and Quality Control at Allakos Inc., a bay area company that is developing antibody therapeutics.  Previously, he held various roles in analytical development and commercial QC functions at Bayer and contributed to the approval of Kovaltry® and JIVI®. He holds a Ph.D. in Chemical Technology from Chinese Academy of Sciences and completed postdoctoral training in drug and gene delivery at UCSF