Dr. Lu, professor and doctoral tutor, is the President of Hubei Topgene Biotechnology Co., Ltd. and the Executive Director of Hubei Topgene Xinsheng Biotechnology Co., Ltd.. He also serves as a new drug evaluation expert and the GLP certified expert of the National Medical Products Administration(NMPA). He is the Vice Chairman of Pharmaceutical Toxicology Professional Committee of Chinese Pharmacological Society, the Vice Chairman of the Professional Committee of Drug Toxicology and Safety Evaluation of the Chinese Society of Toxicology. He was the director of the Center for Drug Safety Evaluation, the director of the Teaching and Research Department of Health Toxicology of the Second Military Medical University, and the director of the Key Laboratory for Research and Safety Evaluation of Special Needed Drugs for PLA. He has hosted or co-hosted more than 400 projects of new drugs’ pre-clinical safety evaluation and application,,and more than 120 of those have passed the NMPA review and thus obtained clinical approval/clinical license or new drug certificates ,and nearly 10 of those evaluated new drugs have obtained FDA clinical license. He presided over 5 funds such as "AI-based Innovative Drug Research and Development Service platform" of the National Development and Reform Commission. He is the author of more than 130 articles, of which 32 are published on SCI journals. He is the editor or deputy editor of six monographs, and has been granted 16 patents, including 3 invention patents.
Gao Li, Level-2 professor /Doctoral supervisor,enjoys special government allowances from the State Council. He was the former dean of the School of Pharmacy,Tongji Medical College of Huazhong University of Science and Technology.He has successively served as a member of the Ninth, Tenth, and Eleventh National Pharmacopoeia Committees, a national new drug evaluation expert, an honorary director of the Chinese Pharmacological Society, and a senior member of the Pharmaceutical Preparation Professional Committee of the Chinese Pharmaceutical Association.
He was a visiting scholar of the Institute of Human Pharmacology at the University of Tubingen, the Clinical Pharmacology Research Institute of Dr. Margarete Fischer-Bosch in Stuttgart, and the Institute of Pharmacy and Biopharmaceutics at the University of Heidelberg in Germany for three years respectively.
Prof.Li specializes in the fields of "Biopharmaceutics and pharmacokinetics of innovative drugs and their formulations", "Pharmacokinetics and pharmacodynamic correlation",and "Bioequivalence of drugs". He has presided over 4 projects of the National Natural Science Foundation, 3 major projects of the National Ministry of Science and Technology on New drug Development, 5 major projects of Hubei Province Technological Innovation, and 2 projects of Wuhan Science and Technology Innovation Fund. He has successfully develop new drugs with enterprises and obtained a number of IND and NDA, inlcuding 2 new drug authorized invention patents.
He has published more than 180 papers in international/domestic academic journals. He has won the second prize of Hubei Province Science and Technology Progress Award and the first prize of Hubei Province Teaching Research Achievement Award. He has trained more than 100 doctoral and master’s students and won the Excellent Graduate Supervisor Award of Hubei Province, China.
M.D. Wang is a Changjiang Distinguished Professor of the Ministry of Education of China, winner of the National Science Fund for Distinguished Young Scholars, Leading talents of the National Special Support Program for High-level Talents (the Ten Thousand Talents Program), National Distinguished Teachers, director of the Key Laboratory of Major Neurological Diseases of the Ministry of Education, and vice chairman of the International Society of Pathophysiology. Dr. Wang has been engaged in Alzheimer's disease research for nearly 30 years and has published more than 200 SCI papers. From 2014 to 2020, she was continuously listed as a highly cited scholar in China by Elsevier. In 2020, she was included in the list of “Career-long Impact” and “Single-year Impact” of World’s Top 2% Scientists, and besides, she was listed in “Top 100000 Scientists in the world” in 2022. Her scientific research achievements include a second prize of the National Natural Science Award, four first prizes of the provincial and ministerial Natural Science Award and Chinese Medical Science and Technology Award.
Researcher. Executive Vice President of Hubei Topgene Biotechnology Co., Ltd., General Manager of Wuhan Branch, Head of Hubei Engineering Research Center for Preclinical Research and Safety Evaluation of Drugs. She mainly engages in the area of non-clinical safety evaluation of new drugs.
She has more than 20 academic positions, including a Chairman of Committee of Reproductive & Developmental Toxicology, CST, an Executive Director of Chinese Society of Toxicology, a Member of the Standing Committee of Specialty Committee of Toxicology Safety Evaluation of Biotechnological Drugs, CST, a GLP Certified Expert of the Center for Food and Drug Inspection of NMPA and a GLP Inspection Expert for CNAS and etc.
She has presided over or was responsible for the non-clinical safety evaluation projects and applications of over 300 new drugs: 70 of them have obtained clinical approval/clinical license or new drug certificate through NMPA review; 7 evaluated new drugs have obtained FDA clinical approval and 1 evaluated new drug has been approved by TGA. She has hosted or participated in 10 national and ministerial-level research projects. Moreover, she chaired the "Shanghai Professional and Technical Service Platform for Non-clinical Evaluation of Maternal and Child Drugs" as the project leader, and hosted the “Major New Drug Creation of Major Scientific and Technological Projects” and “Establishment and Application of Key Technologies of Drug Non-clinical Reproduction and Developmental Toxicology” in “13th Five-Year Plan”, and the “Establishment of Technical Platform for Preclinical Safety Evaluation in Line with International Norms For New Drug Research”, the “Major Innovative Drug Creation” special project of the “12th Five-Year Plan”as the deputy team leader and sub-task leader.
She has edited and published seven monographs, including Non-Clinical Safety Study on Pediatric Medicines, Atlas of Common Malformations in Laboratory Rabbit and Rat, Drug Reproductive and Developmental Toxicology, Drug Reproductive and Developmental Toxicology, and Prostate Pharmacology etc.
M.D. Zong is the Deputy Secretary General of the Drug Safety Evaluation Professional Committee of the Chinese Society of Toxicology, the Executive Committee Member and Deputy Secretary General of the Safety Pharmacology Professional Committee of the Chinese Pharmacological Society, a member of the Natural Medicine Professional Committee of the Chinese Society of Toxicology, a member of the Professional Committee on Experimental Animals and Toxicology of the Society of Experimental Zoology, a member of the Reproductive Professional Committee of the Chinese Society of Toxicology, a member of the Genetic Toxicology Professional Committee of the Chinese Society of Toxicology. She has completed more than 400 new drug evaluation projects with more than 50 of them jointly declared by NMPA and FDA, of which 10 of them have obtained clinical trial licenses from FDA. She has hosted or co-hosted nearly 10 projects, including the Shanghai Natural Science Foundation, National Natural Science Foundation, Shanghai Key Discipline Construction, Major Military Projects, and Key Projects of National Natural Science Foundation. She has published 34 papers, including 18 SCI articles, and she has co-authored 3 monographs, applied for 17 patents, and obtained 15 authorizations.
Ms. Chen is an expert in GLP regulatory compliance with over 20 year experience in GLP QA, and she has participated in GLP inspections by various regulatory agencies around the world, including Belgian GLP authority, MHRA, US FDA, EMA and NMPA. She was one of the earliest QA professionals in China who registered as RQAP-GLP at SQA in the States. She was Head of QAU (Senior Director) at Pharmaron TSP Site before joining in Topgene Xinsheng. In a word, she has extensive experience in team building and training, establishment of SOPs and Quality Assuance.
Mr. Tian is a member of Wuhan Talents Program. He held academic positions in more than 10 societies, including a member of Committee of Toxicology on Traditional Chinese Medicine & Natural Medicine of CST, a member of Youth Committee of CST, a member of China Association of Chinese Medicine, an executive director of Hubei Province Toxicology Society, a director of Hubei Province Pharmacological Society, a director of Hubei Association for Laboratory Animal Sciences, a reviewing expert of Expert Database of Department of Science and Technology of Hubei Province, a member of Youth Editor of Drug Evaluation Research, Chinese Traditional and Herbal Drugs. He has been engaged in non-clinical safety evaluation of new drugs for more than 10 years, and has completed more than 200 non-clinical research studies, covering traditional Chinese medicines (pediatric drugs, classic prescriptions, empirical prescriptions, innovative Chinese medicines, etc.), chemical drugs (Class 1 chemical and generic drugs) and biological products (antibody drugs, ADC drugs, vaccines, cell therapy products, etc.), and a number of Class 1 new drugs undertaken by him have been approved by NMPA and FDA for clinical trials. He is also a main participant in“Major New Drug Creation”, “National Major Research and Development Program” for many times, and he has participated in the compilation of the national key book named Non-clinical Safety Study on Pediatric Medicines during the 13th Five Year Plan period. He has applied for 2 patents and has published more than 10 papers in core journals and won awards in provincial, national and international industry associations for many times.