【新嘉宾加入】Grace Zheng深度解析GLP-1生物制剂临床申报与BLA中美双报规范及关键点！

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Grace Zheng 再鼎医药 前大分子药学副总裁 个人介绍 Grace Zheng has more than 35 years of experience in R , Process Development, and GMP Production of Biopharmaceuticals for clinical and commercial supplies. She held various leadership roles in biotech / biopharma companies such as Glycotech, HGSI, Red Cross, Macrogenics, Teva in the US since early 1990s. In the recent decade, she led multiple biopharmaceutical projects in CMC Project Management, Process Scale-up, Pilot, Clinical and Commercial Manufacturing, GMP management and operational training with WuXi Biologics and ZaiLab in China. She has played key roles of leadership in the development and commercialization of multiple projects of monoclonal antibodies, fusion proteins, bi/tri-specific antibodies, ADCs, vaccines, and recombinant proteins in her career. She has rich experiences in Process Development, Process Scale-up, Tech Transfer, Clinical and Commercial Manufacturing, and Regulatory Documentation Writing and ………………………………