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Huijuan Li, PhD
Head, Analytical Development at Moderna Therapeutics

Profile

Dr. Huijuan Li is currently the Head of Analytical Development at Moderna Therapeutics. Her responsibilities are to develop science-driven, phase appropriate and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture. She oversees analytical method development, transfer, qualification and validation characterization and applications to process and product development from discovery through to regulatory filing of mRNA therapeutics. She also leads CMC and development teams to work closely with discovery, preclinical and clinical teams for the development mRNA vaccines and therapeutics. Prior to join Moderna, Dr. Huijuan Li was the director of analytical development within Biologics Discovery (GlycoFi site) and later in Bioprocess Development, Merck Research Laboratory. Dr. Huijuan Li oversaw method development, characterization and applications to cell line, process and product development from early discovery through to regulatory filing for all biologics modalities. Huijuan led CMC and development teams to work closely with discovery, preclinical and clinical teams for the development of biologics at all stages, including post approval technical, strategic support and life cycle management. Dr. Huijuan Li worked with physician scientists in oncology, infectious disease, diabetes, immunology and immune-oncology. Dr. Huijuan Li has contributed to commercial filings for global approvals of monoclonal antibodies (KEYTRUDA, ZINPLAVA) and biosimilars (insulin glargine). Huijuan received her PhD from University of Melbourne, Australia in 1998. From there she pursued her postdoctoral studies at Biology Department, McGill University, Montreal, Canada.

Agenda Sessions

  • Characterization of Critical Quality Attributes of mRNA, A Novel Modality for Therapeutic Antibody Engineering

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