On May 15th, Suzhou Clinical Research Service Platform, together with Corinecon (Suzhou) Medical Research Co., LTD., Suzhou Rdeo Medical Technology Co., LTD., Wuxi Betas Medical Technology Co., LTD., the First Affiliated Hospital of Soochow University and the Second Affiliated Hospital of Soochow University held the "Material Balance Special Exchange Salon" in the Biomedical Industrial Park of Suzhou Industrial Park. This special salon is focused on the topic "material balance", invited a number of industry experts, clinical expert participation, discusses the issue of "human clinical research material balance" hot spots, push upstream and downstream in the field of study and communication.
At the beginning of the meeting, as a representative of the suzhou clinical research services platform, the Chinese Academy of Sciences Shanghai Sue institute a drug valley Liu Yuan teacher, first of all, this paper introduces the general situation of suzhou clinical research service platform and the main purpose of meeting the Sharon, biological medicine industry as the focus of suzhou to build the "number one industry", the development momentum in recent years, hosted the event, To deepen the discussion material balance research hot - the human body, strengthening the study of upstream and downstream in the field of communication, power enterprise development, promote industrial upgrade.
The meeting of the first issue - material balance research industry chain - regulations, tag, analysis, clinical trials, colin oerlikon (suzhou) co., LTD., vice President of medical research willow in the medium to share, around the related content, willow material balance of total for new drug clinical research design and implementation are very detailed described.
Firstly, Professor Liu introduced the development of "material balance clinical research", and then introduced it from the comparison of research status at home and abroad and the comparison of regulations and supervision. In the end, Professor Liu focused on how to carry out "material balance clinical research" from the aspects of clinical strategy, clinical trial center, trial design considerations and clinical verification concerns.
The second topic of the meeting was the current status of human radioisotope ADME research at home and abroad, shared by Dr. Zhu Mingshe, Chief scientific Officer of Suzhou Rudi Pharmaceutical Technology Co., LTD. Dr. Zhu is an expert in drug metabolism and mass spectrometry technology, with more than 20 years of international pharmaceutical company (BMS) and 5 years of CRO innovative drug development and management experience. Involved in a number of listed drug metabolism studies of new drugs (including state o pp etc, of net, Ann for Nepal, sand column for phosphorus, propofol, the doner, mooring phenol, ring, lotus antipyretic and aurelio and for their, etc.), has published more than 100 MetID and mass spectrometry technology related papers and 2 books.
Dr. Zhu focuses on why European and American pharmaceutical companies (and drug regulatory agencies also recommend) to carry out human material balance experiments before clinical phase III; Under what circumstances or what nature of small molecule new drugs do not need to carry out human body material balance experiments; Under what circumstances it is not necessary to carry out or postpone the human body material balance experiment in clinical phase III; Whether ADC should carry out human body material balance experiment and other issues are elaborated, and the current status of human radioisotope ADME research is introduced in detail.
Meeting the last Panel discussion link, Invited the first hospital affiliated to suzhou university institutions do zhang, the second affiliated hospital of suzhou university, director of the agency to handle pan, director colin oerlikon (suzhou) co., LTD., vice President of medical research, Dr Ren Ming suzhou RuiDi European pharmaceutical technology co., LTD., chief scientific officer, Dr Zhu Mingshe beta pharmaceutical technology co., LTD., wuxi President Cao Weiqiu "clinical research material balance" related topics, The timing of human body material balance experiment in clinical research, the application of radioactive technology, and the disposal of radioactive waste were discussed.
Colin, one of the organizers of this conference for oerlikon (suzhou) medical research co., LTD. Is a set of clinical operations, drug administration registration, medical strategy and writing, medical monitoring, biological statistics and data management, pharmacovigilance, call center, quality assurance, training and consulting services, market strategy to the full range of medical science and technology service provider. Company through active participation in clinical research in the field of medical and academic promotion, both at home and abroad for the pharmaceutical enterprises and authoritative research institutions, academic institutions, clinical trials provide clinical specialized services experts, doctors, etc. In the future, we will continue to promote the academic promotion and commercialization of the medical field to help the development of the No.1 industry.