Strategies to compare clinical antitherapeutic antibody data when changing assay platforms: a case study

Autor: Patricia Siguenza, An Song, Suzanne Brignoli, Valerie Quarmby, Saloumeh K Fischer, Yong Ying, Sock-Cheng Lewin-Koh, Robert Hendricks, Zhihua Julia Qiu, Daniel Coleman
Rok vydání: 2015
Předmět:
Zdroj: Bioanalysis. 7:1775-1783
ISSN: 1757-6199
1757-6180
DOI: 10.4155/bio.15.91
Popis: Zhihua Julia Qiu has over 20 years post PhD experience in academic institutes, pharmaceutical industry and biotechnology startup settings; focused on novel therapeutics discovery and development and diagnostic tools. She is currently a Scientist in the Bioanalytical Sciences department at Genentech; responsible for developing, evaluating and implementing Bioanalytical strategy to support protein therapeutics development. That includes assay development and validation to evaluate PK, antitherapeutic antibodies as well as biomarkers in both nonclinical and clinical studies for Immunology and Oncology indications. In addition, she has led the evaluation of multiple novel technology platforms and transitioning assay platform to enable continuous support for the development of protein therapeutics and antibody–drug conjugates.
Databáze: OpenAIRE