Expertise and Zeal: CMC development strategy and project management; Clinical supply planning and CMO management; Quality sections for regulatory submissions; Technology transfer and process validation.
Hong Zhao is a senior pharmaceutical professional with strategic and operational expertise, 25 years of experience in the CMC, GMP manufacturing, Clinical Supplies, Quality and Regulatory aspects of drug development from early stage to late stage developments for small molecule, conjugated products, peptides, biologics.
Hong has demonstrated success in leadership, project management, contract manufacturing and CMO management with proven track record of delivering and execution. She lead the preparation of numerous Quality (CMC) sections for INDs, IMPDs in manner to meet regulatory expectations.
Before joining Cilatus, Hong served as an independent consultant and as Senior Director and leader of the CMC Development department at Elan Pharmaceutical International Inc. Hong also held other leadership and senior management positions at Elan and American Peptide Co.
Hong earned her MS degree in Physical Chemistry from Dalian Institute of Physical Chemistry, Chinese Academy of Sciences Dalian, P. R. China and her BS degree in Physics from Harbin Engineering University, P. R. China. She is fluent in English and Chinese.