I. Profile
The Department of Pharmacology and Toxicology currently has 47 researcher fellows (12 senior, 20 intermediate and 15 junior research fellows), including 4 research groups, covering multiple disciplines such as pharmacology and toxicology, reproductive pharmacology, urology pharmacology and molecular reproductive toxicology.
The Department is focused on the research of reproductive pharmacology and reproductive toxicology. It also offers pre-clinical pharmacology and safety evaluation for various new drugs especially reproductive health new drugs. In addition, the Department acts as the host institution for the Committee of Reproductive & Developmental Toxicology, Chinese Society of Toxicology; the Committee of Reproductive Pharmocology, Chinese Society of Pharmocology; and the Committee of Reproductive Pharmocology, Shanghai Society of Pharmocology. The Department is also a base for the National Evaluation Center for the Toxicology of Fertility Regulating Drugs, which was approved by Good Laboratory Practice (GLP) of the State Food and Drug Administration in January 2009.
The Department has 2 doctoral supervisors and 3 master supervisors for the School of Pharmacy/School of Public Health, Fudan University.
II. Main Research Orientations
Strengthen the construction of an international pharma-toxicology platform related to reproduction. Develop animal models related to birth control and reproductive health (e.g., contraception, tonifying Yang and premature ejaculation resistance), models relevant to prostatic diseases (e.g., BPH, PCa and prostatitis), endometriosis, etc. and pre-clinical pharmacological research systems of new drugs. Conduct mechanism studies related to reproduction and the pathogenesis of reproductive system diseases including prostatic disorders, endometriosis and primary ovarian insufficiency, etc. Develop drugs and medical devices against reproductive system diseases.
Focus on the research of pharmacodynamics (PD), pharmacokinetics (PK) and mechanism of action of medication and early drug discovery in reproductive system. We have established various experimental models of cells and animals, including antifertility, epididymis infertility, dysmenorrhea, polycystic ovary syndrome, endometriosis, uterine fibroids, and tumors of endometria and ovaries, and utilized molecular biological techniques in our research. We are experienced in the drug development for birth control, fertility protection and reproductive tumor treatment. We are capable of providing PD and PK services for novel drug development in accordance with national drug registration requirements.
Conduct research and development of novel vaginal contraceptives and microbicides. Over the years we have established the research platform for active compound screening, pharmacodynamics, pharmacology, pharmacokinetics and toxicology research. Carry out the reproductive and developmental toxicology research of environmental pollutants and explore its molecular mechanism.
III. Scientific Staff
PIs: Prof. Weihua LI, Prof. Zuyue SUN, Prof. Yan ZHU, Prof. Jianhui WU
The number of senior researchers is 12.
The number of intermediate researchers is 20.
The number of junior researchers is 15.
IV. Contact Information
Contact Person: Prof. Weihua LI
Tel.: 86-21-64437475
E-mail: iamliweihua@foxmail.com
V. Research Groups
Pharmacology and Toxicology Research Group
I. Main Research Orientations
1. Strengthen the construction of an international pharma-toxicology platform related to reproduction. Perfect and develop animal models related to birth control and reproductive health (e.g., contraception, tonifying Yang and premature ejaculation resistance), models relevant to prostatic diseases (e.g., BPH, PCa and prostatitis), female animal models associated with endometriosis, etc. and pre-clinical pharmacological research systems of new drugs.
2. Exploratory studies on deeply fundamental mechanisms related to reproduction, together with pathogenesis of reproductive system diseases including prostatic disorders, endometriosis and primary ovarian insufficiency, etc.
3. Development of drugs and medical devices against reproductive system diseases.
II. Achievements:
The Pharmacology and Toxicology Research Group, a base funded by the National Evaluation Center for the Toxicology of Fertility Regulating Drugs, is featured with the detection of various new drugs’ reproduction toxicity and genetic toxicity, and is predominated by pharma-toxicological studies on reproductive health drugs with an aim to perform pharmacological investigations and safety evaluations on diverse species of drugs. In addition, Committee of Reproductive & Developmental Toxicology, Chinese Society of Toxicology, acts as the attached institution of this Laboratory that has acquired the certification of “A Professional Technical Service Platform for Non-clinical Drug Evaluations Against Male Reproduction and Urinary Diseases in Shanghai” and “A Professional Technical Service Platform for Non-clinical Drug Evaluations on Gynecological and Pediatric Drugs”, conferred by Science and Technology Commission of Shanghai Municipality. In January 2009 and March 2014, it has been approved by GLP of the State Food and Drug Administration (SFDA) and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) respectively.
It used to win national, municipal and ministerial-level science and technology advancement awards and key research project awards for multiple times. Among them, the RU486 Research, the Long-acting Contraceptive Subdermal Implants and Pharma-toxicological Study on Drugs Against BPH and Its Application respectively win the second and the third prizes of the Science and Technology Progress Award conferred by the Ministry of Science and Technology and the second prize of the Science and Technology Progress Award of Shanghai. Over the past decade, about 500 national, provincial and ministerial-level scientific research programs have been carried out in the Laboratory, including those entrusted by enterprises. In the Laboratory, great importance has been attached to talent cultivation; and, dozens of doctors and masters have been fostered in recent years, which provides high-quality scientific and technological workers for the pharma-toxicology field at home.
III. Scientific Research Team
PI: Prof. Zuyue SUN (Tel: 021-64043044; E-mail: sunzy64@163.com)
The number of senior researchers is 6.
The number of intermediate researchers is 13.
The number of junior researchers is 10.
Reproductive Pharmacology Research Group
I. Research Orientation
The Laboratory of Reproductive Pharmacology was founded in 2008 and has been devoting to the research of pharmacodynamics (PD), pharmacokinetics (PK) and mechanism of action of medication and early drug discovery in reproductive system. After many years’ efforts, the lab is equipped advanced instruments and facilities and met the requirements of the drug research in reproductive health. We have established various experimental models of cells and animals, including antifertility, epididymis infertility, dysmenorrhea, polycystic ovary syndrome, endometriosis, uterine fibroids, and tumors of endometria and ovaries, and we are also good at utilizing molecular biological techniques to boost our research. Currently, we are experienced in the drug development of birth control, fertility protection and reproductive tumor treatment. We established unique approaches for the discovery and research of reproductive drug and are capable of offering sufficient information and suggestions for new drug development. We keep a good collaboration with the top-class domestic hospitals and enterprises and are capability of providing integrated services, including scheme design, experimental research, and data collection for novelty drug development in accordance with national drug registration requirements.
Extremely good at:
(1). R & D of birth control drugs for women: Good at PD and PK research of birth control drugs with special rout of administration, such as vagina, uterine cavity and transdermal, etc;
(2). PD evaluation and mechanism of action of drugs for gynecological diseases and tumor treatment: Especially good at the PD of Chinese medicine and chemical drugs in uterine and ovarian related diseases and tumors;
(3). R & D of male contraceptive and infertility drug: Target epididymis and focus on utilizing novel compounds and components from traditional Chinese medicine and its different components to improve male fertility;
(4). PK assay of hormone drugs: Good at PK of ultra-low-dose estrogen, progesterone and other steroidal contraceptive using HPLC-MS and radioimmunoassay and able to provide service for the assay of sex hormones and analogues.
II. Achievements
We published more than 100 papers (including more than 20 SCI papers) and obtained 6 authorized patent and compiled chapters related to reproductive disease for the book of Pharmacological Experimental Methodology (4th Edition), Pharmacological Research Methodology and Pharmacological Advance Report (2010-2011). We undertook and participated in more than twenty projects from the National Key R & D Program, including "Eleventh Five-Year", "Twelfth Five-Year" and "Thirteenth Five-Year", National Natural Science Foundation of China, Shanghai Natural Science Foundation and Shanghai Science and Technology Innovation Action Program. Based on our extensive experience, we offer pharmaceutical companies and institutions with professional services in PK, PD and bioequivalence evaluation, and these projects were approved by the State Drug Administration and received Drug Clinical Trial Approval or Drugs Registration Approval, including levonorgestrel and ethinylestradiol contraceptive patch, gestodene patch, Jiaweimojie tablets, compound levonorgestrel tablets, etc. Two projects have won the prizes of Excellent Scientific and Technological Achievements from the National Population and Family Planning in the "Eleventh Five-Year Plan".
Currently, we take charge of the reproductive professional committee of Chinese Pharmacological Society and organize the national reproductive pharmacological seminars and participate in international academic seminars and delivery oral presentation every year.
III. Group Members
PI of Laboratory Yan ZHU PhD (zhuyan@sippr.org; zhuyan0311@163.com )
Senior Researchers: Shuwu XIE PhD (xshw78@sippr.org; xshw78@163.com ) Intermediate researcher: Jie-yun ZHOU (zjy_sans@126.com) Xiang-jie GUO (gxj2009@163.com)
Junior researchers: Rui-hua ZHONG (zrh8804@126.com) Guo-ting LI (iris8908@163.com) Wen-jie Yang (18317156289@163.com
Molecular Reproductive Toxicology Research Group
I. Main Research Orientations
1. Research and Development of novel vaginal contraceptives and microbicides.
2. Using zebrafish to study the reproductive and developmental toxicity of environmental chemicals and its mechanis.
3. Molecular reproductive toxicity research of environmental pollutants.
II. Main Research Achievements
The Research Group has undertaken more than 20 research projects, including the sub-projects of the Chinese National “11th Five Year Plan”, “12th Five Year Plan” and “13th Five Year Plan” Science and Technology Support Project, titled Development of Novel Vaginal Contraceptive Drugs and Dosage-forms, the sub-projects of Chinese National Infectious Diseases Major Programs, titled Study on Drug Carrier and Dosage-form of Microbicide, two projects supported by the National Natural Science Foundation, namely, A Fundamental Research on Local Mucosal Immune Inflammatory Responses to Vaginal drugs and A Study on Epigenetic Mechanism of Trans-generational Male Reproductive Birth Defects Caused by DBP, key projects of Shanghai Municipal Science and Technology Commission, Pujiang Talent Program, Sci-tech Morning Star Talent Program of Shanghai, Shanghai Youth Sailing Program and other projects funded by Shanghai Municipal Commission of Health and Family Planning. Up to now, more than a dozen projects have been identified as scientific research achievements of Shanghai Municipality. The Group has published more than 70 Chinese and English research papers and has applied for over 20 Chinese patents.
1. The Group has devoted itself to the research and development of vaginal drugs for more than 15 years, including novel vaginal contraceptive drugs, microbicides to prevent HIV transmission through sex, and vaginal lubricants, etc., and is one of the leading groups in this field in China. The Group has developed a series of birth-control and reproductive health products, such as Phentolamine Mesylate Capsule which acquired new drug certificates issued by SFDA and was transferred to Shanghai Livzon Pharmaceutical Co., Ltd.. Besides, the Group has obtained the clinical approval of SFDA for Benzalkonium Chloride Vaginal Contraceptive Gel and completed its phase II clinical trial. The Group has developed a vaginal acid gel lubricant through cooperation with an enterprise, and the marketing authorization has been granted.
2. The Group has established the Reproductive and Developmental Toxicity Test Laboratory, using model organism zebrafish to study the reproductive and developmental toxicity (including infertility and birth defects) of the environmental chemicals and the relevant mechanism. So far, research on zebrafish developmental toxicity of byproducts produced by cholorination of drinking water, and the investigation on epigenetic mechanism of the trans-generational reproductive toxicity of DBP have been completed.
3. The Group has been working on the reproductive toxicity of environmental endocrine disruptors and atmospheric fine particles (PM2.5). With the long-term cooperation with Nagoya University, the Group has studied the impacts of bromopropanes on the health of occupational populations for many years. Research results illustrated that 1-bromopropane can lead to reduction in tibial nerve conduction velocity, prolonged latent phase of nerve conduction, cognitive disorders and pallesthesia delay of the workers, which is consistent with former animal experiment results. It is for the first time for researchers to prove that 1-bromopropane can cause dose-dependent nerve function damage in humans. Based on the above research, the Group have proposed a reference value of lower than 10 ppm as the occupational exposure limit of 1-bromopropane. More than 10 papers regarding bromopropane research have been published in the international academic journals, such as Environmental Health Perspectives, JOEM and American Journal of Industrial Medicine.
III. Personnel of the Research Group
PI: Professor Weihua LI
Consultants: Professor Xuncheng DING; Professor Shibo JIANG; Professor Haidong KAN
The number of senior researchers is 2.
The number of assistant researchers is 4.
Urology and pharmacology research group
I. Main Research Orientations
1.To develop and improve in vivo and in vitro models of urinary diseases (prostate diseases, bladder cancer, testicular cancer, kidney cancer, etc.), and continuously explore the pathogenesis of related diseases.
2.To explore the etiology and mechanism of prostate diseases (especially prostatic hyperplasia), especially focus on the role, mechanism and intervention of estrogen-active endocrine disruptors (estrogen-active endocrine disruptors) on prostate .
3.Collaborate with pharmaceutical companies, hospitals, and drug synthesis organizations to develop treatments for urinary system diseases.
II. Research achievements
The Group is newly established.
III. Personnel composition
PI:Prof. Jianhui WU
Senior research fellow: 2
Intermediate research fellow: 1
Junior research fellow: 2