Li Tianquan: tracking and screening of foreign phase Ⅱ and Ⅲ clinical drugs

At the "China (Nanjing) 2015 pharmaceutical information acquisition and utilization forum" jointly held by China Pharmaceutical University, the editorial board of pharmaceutical progress and pharmaceutical intelligence network, the general manager of the research and development center of pharmaceutical intelligence network came out, bringing a new speech "tracking and screening of foreign phase II and III clinical drugs" to the participants Li Tianquan analyzed the tracking and screening of foreign phase II and phase III clinical drugs from three aspects: the focus of new drug research and development, the effective screening of targets, and how to analyze varieties, which is of great significance to the development of the industry First of all, we need to determine the focus direction of new drug research and development First of all, we need to match with enterprise resources, such as existing product mix, sales network model, production and research conditions, market strategy, etc On the basis of matching of all parties, select the direction of focus, such as the technical categories of biological medicine, chemical medicine, Chinese medicine monoclonal antibody; the types of new drugs are original, innovative and imitated; the market includes large varieties, orphan drugs, domestic and overseas; the treatment fields include cardiovascular, psychiatric and diabetes Good at effective screening of objectives In order to effectively screen the target, an enterprise must carry out four steps: first, grasp the current situation of global R & D, and know the drugs under research and the drugs on the market as a whole; second, lock a series of potential varieties, such as treatment field, clinical stage and technical category; third, compare the varieties from patent and market to screen the varieties with advantages; finally, determine the target according to the products Project development There are so many complicated steps The global new drug R & D variety database, global clinical trial database, new drug database under development in the United States, and global new drug new dosage form database can effectively solve this problem and help enterprises to establish projects According to the data center of pharmaceutical intelligence from the global clinical trial registration center, who clinical trial registration center ICTRP, US clinical trial registration center ct.gov, EU clinical trial registration center eudract Japan Clinical Trial Registration Center - uminctr, UK Clinical Trial Registration Center - isrctrn, Australia New Zealand Registration Center - anzctr, China Clinical Trial Registration Center - ChiCTR, etc collected and tracked clinical data and specific companies in various countries, with rich and comprehensive contents In addition, information about new drugs under research can be obtained through other channels, such as literature reports, targets, similar drugs and various databases Due to the different drug review and approval systems at home and abroad, the products selected need to be effectively analyzed First, it is necessary to determine whether to review at home or abroad, slow R & D at home, slower approval, and basically expired patents when the certificates come down; while CDE review progress is accelerated, and patent protection is diverse, so it is necessary to carefully analyze patents Second, we should analyze the marketing market, the existing competitive products and the competitive products that will be faced with when applying for drug indications Finally, it is necessary to judge the efficacy of drugs and predict the success rate of clinical trials.