Regulatory and Quality Considerations for the US filing of Monoclonal Antibody and Related Products

Webinar Playback Time:

September 16th, Saturday, 9pm-10pm, EST (Sunday, September 17th, 9 am to 10 am Beijing Time)

Live Meeting Time:  August 5th, Saturday, 9pm-10pm, EST (Sunday, August 6th, 9 am to 10 am Beijing Time)

Abstract: Monoclonal antibodies and their related products play a central role in combating human diseases; however, developing new successful antibody products presents many challenges, including labor intensive manufacturing processes, tighter regulatory controls, and increased market competition. This talk discusses the regulatory considerations and challenges for different kinds of monoclonal antibody and related products. The regulation differences between small molecule and biological product will be highlighted. The regulatory considerations for different antibody products such as traditional IgGs, ADCs and bispecific etc. will be discussed. The law, regulation, lessons learned and the examples will be provided to further the understanding of the monoclonal antibody regulation.

Speaker: Dr. Audrey Jia

Dr. Jia has 17 years of combined experience in biologic drug development and regulatory review.

Dr. Jia spent 10 years in the biopharmaceutical companies working on monoclonal antibody engineering, humanization, affinity maturation, expression, and purification. She holds several antibody humanization patents internationally. In addition, she was specialized in high antibody producing cell line generation and is well recognized for her expertise in the field.

During her time in US FDA, Dr. Jia was a full time CMC reviewer for IND/BLA review of biological products especially monoclonal antibodies including antibody fragments, fusion proteins, antibody drug conjugate, combination products, and radiolabeled antibodies. She performed numerous IND reviews, several BLAs (including post approval reviews), and several US and international cGMP pre-approval inspections (PAIs). She is specialized in both novel proteins/antibodies and biosimilar products reviews. Dr. Jia hold a Master degree in Bioscience Regulatory Affairs from Johns Hopkins University, and a Ph.D. degree in Microbiology and Molecular Genetics from Emory University. Prior to that, Dr. Jia obtained her Bachelor degree of Medicine from Peking University.

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Past Webinars

June 24th, 2017|Title: Fundamentals of therapeutic antibody discovery|Speaker: Dr. Zhijian Lu
July 15th, 2017|Title: Cell Line and Upstream Process Development for the Manufacture of Monoclonal Antibodies|Speaker: Dr. Zhong Liu