Medicilon Biomedicine's 15th Anniversary Series of Events Seminar on Innovative Drug Preclinical Research and Application-Nanjing

Medicilon will launch the 15th anniversary tour of “Hand in hand with you to help new drugs” nationwide. We invite you to witness our service capabilities in the field of new drug preclinical research and all our efforts in the development process, and to share and discuss the bits and pieces of new drug development. . On November 30th, we took Nanjing as the first stop of the touring seminar. With the theme of “Innovative Drug Preclinical Research and Application“, we will discuss with you how to strategically carry out preclinical research and registration application in the development of new drugs. How to effectively reduce the risk of new drug development and help you quickly advance drug development to the clinical stage.

Conference organizer: Shanghai Medicilon Biopharmaceutical Co., Ltd.

Conference co-organizer: “Pharmaceutical Progress” Editorial Office|China Pharmaceutical University Returned Overseas Chinese Association|Jiangsu Society of Biochemistry and Molecular Biology

Meeting time: November 30

Conference location: Jiangning District, Nanjing (specific location will be sent after successful registration)

Conference content: Covering pre-clinical one-stop service, from LEADs (lead compounds) to PCCs (preclinical candidate compounds), and then to IND (application for clinical research approval) domestic and foreign declarations

Agenda

09:00-09:15 Opening & Speech
09:15-09:45 Experience sharing of dual application for clinical research of new drugs in China and the United States
                       Speaker: Dr. Chunlin Chen
09:45-10:15 Safety evaluation strategy and technical requirements of innovative drugs

Speaker: Dr. Peng Shuangqing
10:15-10:30 Coffee break
10:30-11:00 Analysis strategies and trends of biomacromolecule drugs

Speaker: Dr. Xin Baomin
11:00-11:30 DMPK research and application strategy and key technical points

Speaker: Dr. Ma Fei
11:30-12:00 Preclinical safety experiment design and schedule of innovative drugs
                       Speaker: Dr. Zhang Xiaodong
12:00-13:30 Lunch

13:30-14:00 CAR-T preclinical safety evaluation focus

Speaker: Dr. Gu Xingchu

14:00-14:30 ADC pre-clinical research and application

Speaker: Dr. Zeng Xiancheng

14:30-15:00 Pharmacodynamic evaluation model of immuno-oncology therapeutic drugs
                        Speaker: Dr. Hu Zheyi

15:00-15:15 tea break

15:15-15:45 Evaluation of preclinical animal pharmacodynamics of therapeutic drugs for nervous system

Speaker: Dr. Dong Wenxin

15:45-16:15 High-efficiency drug discovery: the application of bioelectronic isosteres in new drug development

Speaker: Dr. Ren Feng

16:15-17:00 Questions & exchanges

Guest introduction (in order of speech)

He graduated from China Pharmaceutical University in 1986 with a master’s degree in pharmacy. He graduated from Oklahoma State University in 1994 with a doctorate in pharmacology and toxicology and an EMBA from China Europe Business School. After graduation, he has been engaged in drug pharmacology, toxicology and biochemistry research for many years, and has deep attainments in the design of cardiovascular drugs, pharmacokinetics and metabolism of new anti-AIDS and anti-cancer drugs. In early 2004, he returned to China and founded Shanghai Medicilon Biopharmaceutical Co., Ltd. He is currently the deputy chairman of the Pharmacokinetics Professional Committee of the Shanghai Pharmacological Society and the deputy chairman of the Shanghai Pudong Biomedical Association. At the same time, he is also employed as a visiting professor in the School of Life Sciences, China Pharmaceutical University.

Researcher and doctoral supervisor of the Academy of Military Medical Sciences. Served as the vice chairman of the Chinese Society of Toxicology and the executive director of the Chinese Society of Environmental Mutagens. He has long been engaged in the safety evaluation of innovative drugs and GLP management, undertook the construction of the national GLP technology platform supported by the Ministry of Science and Technology, presided over and undertook more than 40 national scientific research projects, including the 973 project, the 863 project and the national “Major new drug creation” science and technology project . Published more than 280 scientific research papers, including more than 100 SCI academic papers, and edited (participated) 12 monographs. 12 scientific and technological achievements have successively won national, provincial and ministerial achievement awards. He has won the special government allowance of the State Council, the post allowance of outstanding military talents, the honorary title of “Outstanding Scientific and Technological Worker” of the Chinese Association for Science and Technology, and the Outstanding Contribution Award of the Chinese Society of Toxicology. Guided the training of more than 90 master, doctoral and postdoctoral students. He is a new drug review expert, medical device review expert, new chemical substance review expert of the Ministry of Environmental Protection, and deputy editor-in-chief of “Environmental Toxicology and Pharmacology” of the State Food and Drug Administration.

PhD in Chemistry from Brigham Young University in the United States, with 17 years of experience in new drug research and development in foreign pharmaceutical companies. He was the chief scientist of Bristol-Myers Squibb Pharmaceuticals (BMS) and a researcher of DuPont Pharmaceuticals. Leading the team to participate in the research and development of new drugs and obtain a number of new drugs on the market. Among them, the annual sales of Eliquis, a new anti-cardio-cerebrovascular disease drug targeting fXa coagulation factor, has exceeded US$3 billion. During his PhD study, he designed a new time-of-flight mass spectrometer, which was later adopted by Sensor and developed into a commercial product (Jaguar) for sale. He used to be the executive director of WuXi AppTec’s bioanalysis department, providing GLP bioanalysis services for domestic and foreign pharmaceutical companies, passing CFDA inspections more than 20 times and passing FDA inspections with zero defects. Organized a four-and-a-half-day CFDA Phase I clinical trial biological sample analysis standardized training course for the CFDA Advanced Research Institute of the State Food and Drug Administration, teaching, providing laboratories, and training advanced bioanalytical talents with international GLP level. The current executive member of the North American CACA Society.

Master of China Pharmaceutical University, Ph.D. in Pharmacokinetics of University of Tennessee. He used to be a drug metabolism researcher at GTx in the United States, a senior scientist in drug metabolism at Seventh Wave Laboratories, and an assistant director and deputy director of the Pharmacokinetic Department of Shanghai Ruizhi Chemical. Joined Medicipua in 2016 and served as the Senior Director of the Bioanalysis Room and is currently the Executive Director of the Early Pharmacokinetics Room.

Department of Hygienic Toxicology, Department of Tropical Medicine and Public Health, Second Military Medical University, Branch Secretary, Deputy Director, Associate Professor, Master’s Supervisor, Second Military Medical University Drug Safety Evaluation Center. The person in charge of general toxicology room and clinical laboratory. A new drug review expert of the State Food and Drug Administration, a member of the Pharmaceutical Toxicology Professional Committee of the Chinese Pharmacological Society, and a member of the Drug Toxicology and Safety Evaluation Committee of the Chinese Toxicology Society.

He was the director of the Toxicology Research Office of Shanghai Pharmaceutical Industry Research Institute and the executive deputy director of the National Shanghai New Drug Safety Evaluation Research Center. His professional field is drug safety evaluation research and GLP management. As a visiting scholar, he studied pre-clinical research of drugs at Hearst Pharmaceuticals in Germany for two years, and visited and inspected GLP laboratories in the United States, Canada and Australia. He was responsible for and completed one of the 973 sub-projects of the Ministry of Science and Technology, two of the National Youth New Drug Fund projects and ten projects of the Shanghai Science Foundation. As the main researcher, he participated in three national research projects. Won the second prize of 2001 Shanghai Science and Technology Progress Award. He is a member or member of many professional societies such as the Chinese Society of Toxicology. Member of the National Food Supervision Administration’s new drug review and GLP audit expert database.

With 8 years of preclinical pharmacy and safety evaluation research experience, received 8 months of drug application and review theory and technical training in CDE, design, implementation, data comprehensive analysis and evaluation for different types of new drugs before clinical pharmacy and safety evaluation Has accumulated a wealth of experience. As the project leader, he completed 13 pre-clinical pharmacokinetics and safety evaluation studies for category 1 chemical drugs, 10 of which passed the CFDA or FDA review at one time, and the other 3 are waiting to be declared; 3 ADC drugs preclinical pharmacokinetics and safety evaluation Research, two of which have passed the CFDA or FDA review, and the other one is being reviewed by the CFDA; the pre-clinical pharmacokinetics and safety evaluation studies of two chemical drug compounds have been completed.

Master and Ph.D. in Pharmacology of China Pharmaceutical University. Joined Medicilon in 2006 and has long been engaged in the research and development of anti-tumor drugs. During his work at Medicilon, he led the research team to establish and evaluate a large number of different types of tumor animal models, and participated in more than ten anti-tumor drug research and new drug application work by domestic and foreign pharmaceutical companies.

From 1991 to 1997, he went to study at the Six Major Medical Schools in Paris and the French National Academy of Medical Sciences, and obtained a master’s degree and a doctorate degree in pharmacology. He was a researcher and doctoral supervisor of the Shanghai Institute of Pharmaceutical Industry, a director of the Shanghai Pharmaceutical Association, and a deputy of the Shanghai Committee of Pharmacology. Chairman, recipient of special allowance from the State Council. He has been engaged in pharmacological research and new drug research and development for a long time, mainly in the fields of cardiovascular system and neuropsychiatric pharmacology. Undertook a number of national and municipal major new drug innovation projects. He presided over the establishment of a systematic anti-depressant, anti-Alzheimer’s new drug pharmacological efficacy research and development technology platform domestically, and established a pharmacological efficacy research and development technology platform for new analgesic drugs, anti-anxiety new drugs, and anti-Parkinson’s disease drugs. Responsible for completing preclinical research tasks for dozens of new drugs.

In 2007, he graduated from the Department of Chemistry, Harvard University, USA. 11 years of experience in research and development of small molecule innovative drugs by a multinational pharmaceutical company (GSK). Served as the chief researcher, deputy director, director and head of the chemistry department of GlaxoSmithKline. Successfully developed several clinical candidate compounds/clinical phase I compounds for the treatment of Parkinson’s disease, multiple sclerosis, ankylosing spondylitis, and pain. In 2018, he joined Medicilon as the vice president, responsible for the R&D service business of the Chemistry Department and Biology Department.

Conference registration

1. This forum aims to build a communication platform for industry insiders. It is free and open to participants. Deadline for registration: November 28.

2. The real-name system shall prevail for this conference. Please send “Name+Company+Position+Email+Telephone” to marketing@medicilon.com.cn from the company or person who registered for the conference.

3. We will uniformly send the registration receipt information (including the meeting address) before November 29, and the registration is successful when the receipt is received.