Chun Xu
Co-founder： Chun Xu, Ph.D.
Honor
• 1997, Finlayson Prize in Neuropathology
• 2008, Outstanding Overseas Chinese Talent of Science and Technology by the State
Council , Overseas Chinese Affairs Office, and Ministry of Science and Technology
• 2016, Leading Figure on biomedicine in Suzhou Industrial Park
Academic Qualification
B.S. in Medical Science from Capital Medical University
Jeanne Timmins academician, Montreal Neurological Institute, Canada
M.S. in Pathematology from McGill University, Canada
Ph.D. in Neuropathology from McGill University, Canada
Post Ph.D. in Pathogenesis of Alzheimer's disease from Montreal General Hospital, Canada
Work Experience
Dr. Xu has over 30 years of experience on clinical, medical research and new drug R&D in China, the United States and Canada. In Pfizer and other biopharmaceutical companies, first as clinical scientist, clinical medical inspector, clinical project manager, clinical director, and then vice president of medical operations, Dr. Xu has participated and successfully led various international multicenter clinical I-III trials of innovative drugs, involving in therapeutic areas of diabetes, mental and neural system, cancer, and AIDS.
Dr. Xu led the clinical R&D work of one long acting GLP-1 analogs, which became one of the major drugs for the treatment of diabetes. Till today, the long acting GLP-1 drug is still one of the major products feted by domestic and overseas pharmaceutical companies.
When worked in one medical consulting company in New Jersey, in charge of FDA IND, NDA, ANDA, GRASS filing of drug and medical device, as expert on medical science and FDA regulations, Dr. Xu was invited to provide scientific and technical support for several major medical health litigations, including
meales-mumps-rubella vaccine and infantile autism, antidepressant and suicide, mobile phones and brain cancer. Dr. Xu is an extremely few Chinese scientist, who has been formally consulted by American judiciary, and provides legal advices, in view of medical science.
Over the years, Dr. Xu has been invited to be the chairman or keynote speaker on multiple international new drug clinical R&D summits (involving in cancer, vaccines, clinical data collected and processing, and IND, NDA, ANDA).
Since 2008, appointed as vice president of clinical service, Dr. Xu joined in Frontage Laboratories Inc., took the lead on clinical business development and operation in China (including medical science, CFDA and FDA regulations, and clinical data management). Dr. Xu has completed over 100 clinical phase I trials of innovative drugs, and clinical bioequivalence studies of generic drugs (including first generic and biosimilar), for top 20 big pharmas, and top 10 domestic leading pharmaceutical companies. Among which, 10 of the ANDAs have been approved by CFDA, FDA and WHO.
During several on-site inspections to clinical phase I sites (United clinical phase I site of the First affiliated hospital of Zhengzhou University and Frontage, United clinical phase I site of the First Bethune hospital of Jilin University and Frontage) by FDA and WHO, Dr. Xu was playing an important leading role in inspection, got zero-defect, and obtained good track records, which has become unique examples of successful on-site audit and ANDA by domestic pharmaceutical companies combined with domestic hospitals. It provides a feasible way for conducting clinical trial in China and making ANDA filing to FDA.
During working in Frontage, the leading professional clinical CRO in China, Dr. Xu led the clinical R&D and application of tumor autologous cytology therapy, and an opened, randomized clinical study on subjects who already got radical treatment of hepatocellular carcinoma (PEIT, RFA or surgery) for safety and efficacy evaluation. Dr. Xu completed clinical trial design, and received unanimous approval from the third independent ethics committee. In particular, on setting evaluation standard of such tumor autologous cytology therapeutic efficacy and adverse reaction, Dr. Xu provided a valuable theoretical and practical basis for observation, evaluation and clinical application.
Since 2013, promoted by national 12th five-year plan, reassessment consistency of listed drugs was initiated. As clinical R&D expert, Dr. Xu was invited to give special training to CFDA officials and pharmaceutical professionals. Trainings mainly focused on regulations and clinical operating procedures for generic drugs.
In October 2013, appointed as senior director of clinical project management, Dr. Xu joined in Bioscikin of Simcere, responsible for strategic planning of clinical R&D wor on innovative drugs, leading clinical trial design, process and CFDA registration. Under the leadership of Dr. Xu, new advanced clinical design and operation ("adaptive", and combination of "phase 0" with pharmacokinetics model) were conducted on four innovative drugs (involved in cancer, macromolecule/ target, and antibody). The subjects were enrolled ahead of schedule. The safety and efficacy data were successfully gained. Dr. Xu also led the team, worked together with experts in LINC site and central lab, developing biomarkers for cancer drugs. With the help of effective biomarkers screening, safety of trials were improved, adverse reactions were reduced, unnecessary or excessive drug exposure were cut down, efficacy data were gained. It was a clinical R&D breakthrough for innovative cancer drugs, which helped to accelerate clinical efficacy verification on more big scale of subjects.
