AstraZeneca

个人简介:Dr. Zhuang has over 20 years’ experience in the pharmaceutical and biotech industry with expertise in bioanalytical science. He received his Ph.D. degree in biochemistry from University of Illinois at Urbana-Champaign, followed by a postdoc training at Glaxo-Wellcome (now GSK). After a tenure at Promega Corporation and Millennium Pharmaceuticals, he joined Amgen where he led teams for large molecule bioanalysis particularly in the immunogenicity field employing cell-based assays for neutralizing antibodies. As an immunogenicity lead, he directly contributed to the approvals of IND filings and market applications for several biologics including marketing approvals for Repatha (evolocumab), Amjevita (Humira biosimilar), and Aimovig (erenumab). Leaving Amgen as a Principle Scientist, he joined Ultragenyx as an Associate Director providing immunogenicity strategies and support for three gene therapy programs at various development stages. Currently he is a director at AstraZeneca leading a team for immunogenicity assessment of novel modality therapeutics. Dr. Zhuang is a member of AAPS and some subcommittees. He also has ample experience interacting with regulatory agencies concerning immunogenicity testing, including scientific and compliance matters as well as providing feedback for regulatory guidance documents. 查看更多