• Mingping Zhang
  • VP
  • PAREXEL Consulting

Curriculum Vitae

Education

Chem. & Env. Engineering, National University of Singapore, Singapore, M.Eng (scholarship), 2003
Chemical Engineering, Beijing University of Chemical Technology, Beijing, China, B.Eng (scholarship), 1997

Professional Experience

Vice President, Technical, PAREXEL Consulting, Beijing, China
CMC Director in BeiGene(Beijing)Co.,Ltd. (Jul 2013 – Jan 2015)
DRA CMC Manager in Beijing Novartis Pharma Co., Ltd. (Jan 2010 – Jul 2013)
Reviewer in Center for Drug Evaluation, China State Food and Drug Administration (Sept 2003 – Dec 2009)




Research Interests

regulatory & CMC

Honors & Awards

• ISPE China board member; Associate Chair of ISPE China (2017~2018);
• ISPE China board member; Chair of ISPE Regulatory & Compliance Committee (2015~2016);
• Ex-RDPAC CMC FG council member;

Publications

Abstract

Regulatory consideration of Cell Therapy development in China – CRO interpretation of CFDA requirements

Cell Therapy, especially CAT-T is an hot area which attract lot of attention from both industry and Health Authority; many of trials, which register in “Clinical trials” or not, have been done in China; and center of drug evaluation (CDE), affiliate of CFDA, putting lot of effort in regulatory science of Cell Therapy administration. And some guidance have been published. PAREXLE have involved in several projects discussion with industry and CDE. This speech will share our understanding of CDE current thinking on Cell Therapy project China development requirements.