Chief Executive Officer
- Rutgers University, Ph.D. in Biostatistics
- Tsinghua University, BS in Electrical Engineering and Industrial Engineering
- 19 years of industry experience, worked at Pfizer and Roche
- 2003-2010 Founded a statistical consulting firm in the US
- 2010-2016 Head of the K&L data and statistics division
- 2013-2016 COO and CEO of Fountain Medical Development
- Led and completed more than 25 statistical and analysis projects in FDA/EMA NDA applications.
Chief Strategy Officer
- Army Medical University, PhD in Medicine
- Seven years of clinical surgeon experience. Senior Research Fellow and Project Team Leader, US Naval Medical Research Institute. Associate professor and professor of surgery, US Uniformed Services University of the Health Sciences and Duke University. Director of NIH/Cancer Research Program and Senior Statistician. Senior FDA epidemiologist, review leader, medical device clinical research and post-market inspector.
- China State Council Special Allowance Recipient
- China National Science and Technology Progress First Prize and Second Prize Winner
- China Military Science and Technology Progress First Price Winner
- Received the US FDA Team Leadership Award in 2016
- Published more than 130 papers and books
Chief Medical Officer
- National Taiwan University, Bachelor Clinical Medicine
- National Taiwan University, Internal medicine resident
- Vanderbilt University, Clinical Pharmacology, Researcher Fellow
- Vanderbilt University, Clinical Medicine Cardiovascular, Clinical Fellow
- Vanderbilt University, Cardiac electrophysiology, Clinical Fellow
- Arkansas Heart Hospital, Cardiovascular and Cardiac Electrophysiology, Senior Cardiologist,
- Engaged in the clinical diagnosis and treatment of cardiovascular and cardiac electrophysiology. since 1994
- As a lead investigator, completed and participated in a number of clinical studies for FDA submissions since 1988
Vice President, Regulatory Affairs
- Jiamusi Medical College, Bachelor of Pharmacy
- 27 years of industry experience, 18 years of regulatory registration experience and 9 years of preclinical research and development experience
- Deputy Director, Director and Senior Director of Fountain Medical Pharmaceuticals Registration Department
- Successfully filed IND and NDA applications for dozens of chemical and biological products as well as imported drugs. Participated in early clinical development for dozens of innovative drugs as a strategic advisor.
- Registered hundreds of pharmaceutical products
- Successfully completed US-China dual registration for multiple products
Senior Director, Clinical Operation
- Peking University School of Medicine, EMBA
- Beijing Military Medical College, Bachelor of Clinical Pharmacy
- 13 years of clinical operations. Served as CRA, PM, PMD and Operations Director in Novartis, Bayer, George Clinical, Fountain Medical. Served as the clinical project director of oncology and innovative drugs at Fountain Medical, responsible for more than 30 clinical trials of Phase I-III innovative drugs. Extensive experience in Phase I-IV clinical trials, leading clinical operations in cardiovascular, metabolic, neoplastic, neurological, liver, and kidney disease areas.
Chief of Bio-Analytical Center
- Peking University School of Medicine, Pharm.D.
- 11 years of pharmacokinetics research, regulatory experience and bioanalytical management experience, including ADME screening platform, IND DMPK filing, and regulatory bioanalysis to support GLP toxicology and clinical research
- Vice President, DMPK and Regulatory Bioanalysis, Pharmaron
- Head of Clinical Bioanalytical Testing Laboratory, Pharmaron, with extensive experience in the fields of biotransformation, ADME, and drug-drug interaction
- Familiar with pre-clinical and clinical registration of innovative drugs with NMPA and FDA submissions
Senior Director, Statistics
- Xi'an Jiaotong University, Master of Bioengineering, Genetic Statistics
- Xi'an Jiaotong University, Bachelor of Bioengineering
- Over 10 years of biostatistics and programming experience. Pharmaceutical Biostatistics Manager, Senior Manager and Director in MacroStat, Fountain Medical Development. Responsible for statistics and programming of multiple Phase I to IV international and domestic projects (involving different therapeutic areas), 2 US NDA submissions and multiple Chinese NDA submissions.
Senior Director, Statistics
- North Carolina State University, Ph.D. in Biostatistics
- National Chengchi University, MBA in Statistics
- National Taiwan University, Bachelor of Mathematics
- Over 18 years of experience in biostatistics industry
- Senior Statistician, Deputy Director of Statistics, Director and Senior Director in Merck, FMD K&L. Participated in multiple FDA NDA submissions across various therapeutic areas.