Prof. Lu serves as a new drug evaluation expert of the National Medical Products Administration (NMPA), Executive Deputy Director of the Safety Pharmacology Professional Committee of the Chinese Pharmacological Society, Deputy Director of the Drug Toxicology Professional Committee of the Chinese Pharmacological Society, Council Member of the Chinese Society of Toxicology, and Deputy Director of the Pharmacodynamics Professional Committee of the Shanghai Pharmacological Society, among other positions.

Previously, he served as Director of the Center for Drug Safety Evaluation at the Second Military Medical University, Head of the Department of Health Toxicology, Director of the Key Laboratory of Military Specialty Drug Research and Safety Evaluation, GLP inspection expert of the NMPA, Deputy Director of the Drug Toxicology and Safety Evaluation Professional Committee of the Chinese Society of Toxicology, Deputy Director of the Toxicology History Professional Committee of the Chinese Society of Toxicology, Deputy Director of the Toxicology Professional Committee of the Shanghai Pharmacological Society, and Vice President of the Jiangsu Society of Toxicology.

His main research focus is the preclinical safety evaluation of new drugs. He has been responsible for or led teams in completing preclinical safety evaluations for over 400 new drugs. Among these, more than 120 new drugs have received clinical trial approvals/permits or new drug certificates from the NMPA, and over 10 evaluated new drugs have obtained clinical trial permits from the FDA.

He has published over 130 articles, including 70 original research papers (32 published in SCI-indexed journals). He has supervised more than 20 graduate students. He is the editor-in-chief or deputy editor-in-chief of 6 monographs. He has led or co-led projects funded by the National Major Scientific and Technological Special Project for "Significant New Drug Development" of the Ministry of Science and Technology, the National Development and Reform Commission’s Special Program for Supporting Innovation and Entrepreneurship (Biotechnology and Information Technology Integration Application Engineering Project), the National Natural Science Foundation of China, and the Shanghai Key Discipline Construction Program for Public Health, among others.

He holds 16 authorized patents, including 3 invention patents.

Prof. Li graduated from the Department of Pharmacy of the former Tongji Medical University. He is the former Dean of the School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology. He has served as a member of the 9th, 10th, and 11th Chinese Pharmacopoeia Commission, a national expert in new drug evaluation, an honorary director of the Chinese Pharmacological Society, and a senior member of the Pharmaceutics Committee of the Chinese Pharmaceutical Association. He has conducted visiting research for three years at the Institute of Human Pharmacology, University of Tübingen, Germany; the Dr. Margarete Fischer‑Bosch Institute of Clinical Pharmacology, Stuttgart, Germany; and the Department of Pharmaceutics and Biopharmaceutics, University of Heidelberg, Germany.

Prof. Li’s research focuses on "biopharmaceutics and pharmacokinetics of innovative drugs and their formulations," "correlation between pharmacokinetics and pharmacodynamics," and "bioequivalence of drugs." He has presided over four projects funded by the National Natural Science Foundation of China, three major projects including the National New Drug Creation Program of the Ministry of Science and Technology, five major projects including the Technological Innovation Major Project of Hubei Province, and two projects of the Wuhan Science and Technology Innovation Fund. He has successfully collaborated with enterprises in the development of new drugs, resulting in multiple INDs and NDAs, and has been granted two authorized invention patents for new drugs. He has published over 180 papers in international and domestic academic journals. He has received one Second Prize of Hubei Provincial Scientific and Technological Progress Award and one First Prize of Hubei Provincial Teaching Achievement Award. He has supervised more than 100 master’s and doctoral students and has been honored with the Outstanding Graduate Supervisor Award of Hubei Province. 

Distinguished Professor of the Yangtze River Scholar Program of the Ministry of Education, recipient of the National Science Fund for Distinguished Young Scholars, selected as a leading talent of the National High‑Level Talents Special Support Plan (“Ten Thousand Talent Plan”), and National Teaching Master. She also serves as Vice Chair of the International Association of Pathophysiology, member of the Biology and Medicine Division of the 6th Science and Technology Committee of the Ministry of Education, head of the Ministry of Education Innovative Team on Neurodegenerative Diseases and the “985” Innovation Platform for Neurological Disorders, director of the Key Laboratory of Major Neurological Diseases of the Ministry of Education, and deputy director of the 6th Academic Committee of Huazhong University of Science and Technology.

Prof. Wang has been engaged in research on the pathogenesis, early diagnosis, and protective strategies of Alzheimer’s disease for nearly 30 years. She has proposed unique theoretical insights into the causes and mechanisms of chronic neurodegeneration in Alzheimer’s disease. Her research findings have been published in over 200 SCI‑indexed papers, which have been widely and positively cited by international journals. From 2014 to 2020, she was consecutively listed as a Highly Cited Chinese Researcher by Elsevier. In 2020, she was included in the World’s Top 2% Scientists list for both “career‑long impact” and “annual impact.” As the lead recipient, she has won one Second Prize of the National Natural Science Award and four First Prizes of Provincial/Ministerial Natural Science Awards.

Chair of the 8th Reproductive Toxicology Professional Committee of the Chinese Society of Toxicology (CSOT); Chair of the Experimental Animal and Toxicology Professional Committee of the Chinese Association for Laboratory Animal Sciences; Secretary-General of the 9th Reproductive Toxicology Professional Committee of CSOT; Executive Council Member of CSOT; Council Member of the Chinese Association for Laboratory Animal Sciences; Executive Council Member of the Biotechnology Drug Toxicology and Safety Evaluation Professional Committee of CSOT; Deputy Chair of the Mutagenesis Professional Committee of the Chinese Environmental Mutagen Society; Executive Council Member of the Safety Pharmacology Professional Committee of the Chinese Pharmacological Society; Council Member of the Applied Pharmacology Professional Committee of the Chinese Pharmaceutical Association; GLP Certification Expert of the Center for Inspection and Certification of the National Medical Products Administration (NMPA); Expert of the Center for Drug Evaluation, NMPA; GLP Inspection Expert of the China National Accreditation Service for Conformity Assessment (CNAS), among others.

Publications and Research Projects:

Prof. Zhou has published 7 monographs as editor-in-chief and co-authored 5 others. She has led or been responsible for the non‑clinical safety evaluation and regulatory submission of more than 600 new drugs. Among these, over 120 new drugs have received clinical trial approvals/permits or new drug certificates from the NMPA, 20 evaluated new drugs have obtained FDA clinical trial permits, and 1 evaluated new drug has received TGA approval. She has led or participated in 10 national or ministerial‑level research projects. As Project Leader, she directs the Shanghai Professional Technical Service Platform for Non‑clinical Evaluation of Maternal and Child Drugs. As Deputy Leader and Sub‑task Leader, she has led the Establishment and Application of Key Technologies for Non‑clinical Reproductive and Developmental Toxicology under the “Major New Drug Development” Mega‑Project of the 13th Five‑Year Plan, as well as the sub‑project Establishment of a Preclinical Safety Evaluation Technology Platform Compliant with International New Drug Research Standards under the 12th Five‑Year Plan “Major Innovative Drug Development” Program.

EMBA of China Europe International Business School (CEIBS). Standing Committee Member of the Experimental Animal and Toxicology Professional Committee of the Chinese Association for Laboratory Animal Sciences, Youth Committee Member of the Chinese Society of Toxicology (CSOT), and Member of the Reproductive Toxicology Professional Committee of CSOT.

She has completed the evaluation of more than 400 new drugs, including over 50 projects submitted to both NMPA and FDA, of which 10 have received FDA clinical trial permits. She has led or co-led nearly 10 research projects, including the Shanghai Natural Science Foundation, the National Natural Science Foundation of China, the Shanghai Key Discipline Construction Program, Major Project Special Funds, and the Key Project of the National Natural Science Foundation of China.

Ph.D. in Medicine from Peking University; Postdoctoral Fellow at Oregon Health & Science University, USA; Member of the International Society of Toxicological Pathologists; Certified Pathologist of the Veterinary Pathologist Subdivision of the Chinese Veterinary Medical Association; Recipient of the Haimen "Dongzhou Elite" Introduction Program.

He currently serves as an NMPA GLP Inspection Expert and New Drug Evaluation Expert, a member of the NMPA ICH S1(R1) Expert Working Group, a CNAS Technical Expert and Inspection Expert for Good Laboratory Practice, a Council Member of the Asian Federation of Toxicological Pathology, and a Council Member of the Chinese Pharmaceutical Association, among other positions.

He has received more than 10 awards, including from the American SCBA and various Chinese provincial/ministerial levels. He has published over 150 articles, including more than 30 in SCI-indexed journals. He has served as editor-in-chief or contributing author for more than 20 monographs on toxicological pathology. He has filed 9 patents, of which 7 have been granted.

With over 20 years of experience in GLP quality assurance, Ms. Chen has participated in numerous inspections by domestic and international GLP regulatory authorities, including those of Belgium, the UK MHRA, the US FDA, the EMA, and China's NMPA. She is one of the earliest QA professionals in China to obtain the Registered Quality Assurance Professional–GLP (RQAP‑GLP) certification from the US Society of Quality Assurance (SQA). Ms. Chen has extensive experience in team management, personnel development and training, establishment of standard operating procedures (SOPs), and quality assurance.

Dr. Tian received his Ph.D. from the Wuhan Institute of Virology, Chinese Academy of Sciences, and has been selected for the “Wuhan Talents” Program. His major professional appointments include: Member of the Traditional Chinese Medicine Committee of the Chinese Society of Toxicology (CSOT), Youth Committee Member of CSOT, Youth Committee Member of the China Association of Chinese Medicine, Executive Council Member of the Hubei Society of Toxicology, Council Member of the Hubei Pharmacological Society, Council Member of the Hubei Laboratory Animal Society, Evaluation Expert of the Hubei Provincial Department of Science and Technology Expert Database, and Youth Editorial Board Member of the journal Drug Evaluation Research published by the Chinese Herbal Medicines Editorial Office, among over 10 academic society positions.

He has been engaged in non‑clinical pharmacological and toxicological research of new drugs for more than 10 years, completing preclinical pharmacology and toxicology studies for over 200 drugs. These include traditional Chinese medicines (pediatric drugs, classical formulas, empirical formulas, innovative TCMs, etc.), chemical drugs (Class 1 new chemical drugs, generics), and biologics (antibody drugs, ADCs, vaccines, cell therapy products, etc.). Several Class 1 new drugs he has worked on have obtained clinical trial approvals from NMPA and FDA. As a core member, he has participated multiple times in the National Major New Drug Creation Program and the National Key Research and Development Program. He has filed 2 patents, contributed as a co‑author to the “13th Five‑Year Plan” national key book Non‑clinical Safety Studies of Pediatric Drugs, and published over 10 papers in core journals. He has received numerous awards at provincial, national, and international industry conferences.