New drug R & D technology forum held successfully

Source: China Council for the promotion of drugs 2013-10-23, October 18, 2013, golden autumn Beijing, the "2013 International Pharmaceutical Innovation Conference" and "new drug research and development technology sub forum" (hereinafter referred to as the forum) sponsored by China Council for the promotion of pharmaceutical industry research and development (hereinafter referred to as the "China Council for the promotion of drugs") were successfully held in Beijing Marriott Hotel As we all know, clinical trials are the most important and the most important part of new drug research and development How to shorten the period of clinical trials, reduce the cost of trials, and obtain real, reliable and high-quality clinical data is a common problem faced by enterprises In addition, with the increasing pressure of global medical cost reduction and the increasing difficulty of new drug research and development, the bio generic pharmaceutical market shows strong development potential, and its development trend brings new opportunities for Chinese pharmaceutical enterprises In view of these hot spots concerned by the pharmaceutical industry, the forum set up four discussion topics and invited influential experts and scholars in the pharmaceutical industry as moderators, reporters or discussion guests Among the invited guests are experts from CFDA drug review center, experts and professors from well-known enterprises and universities in the United States, and four experts in the field of new drug research and development from member enterprises of our association, Dr Wang Yinxiang, President and chief scientist of Beida Pharmaceutical Co., Ltd., and Dr Fu Daotian, executive vice president of Lizhu pharmaceutical McAb Biotechnology Co., Ltd Dr Wu Chenbing, President and chief scientific officer of Biotechnology Research Institute of Shanghai CITIC Guojian Pharmaceutical Co., Ltd and Dr He Wei, general manager and director of Zhejiang Daoming Pharmaceutical Technology Co., Ltd Dr Wang Yinxiang, President of Beida Pharmaceutical Co., Ltd., introduction expert of national thousand talents plan and responsibility expert of major new drug specialized drug group, served as the host of the first theme "clinical trial optimization design of new drugs" Professor Zhou Xianzhong, founding director of Department of Biostatistics and bioinformatics and global clinical experiment and Research Center, Duke University School of medicine, USA, made a theme report on "advantages, challenges and obstacles of adaptive design of clinical trials" From the perspective of FDA regulation, possible benefits, statistical challenges, implementation obstacles and future development prospects, the report comprehensively introduces the application advantages and disadvantages of adaptive design, which provides a useful reference for us to better carry out clinical trials with adaptive design in clinical research of new drugs in the future Dr He Wei, general manager of Zhejiang Daoming Pharmaceutical Technology Co., Ltd and expert of national thousand talents plan, and Dr Gai Wenlin, deputy director of cell engineering R & D center of Peking Union Medical University and senior director of preclinical and clinical research department of Shenzhou Cell Engineering Co., Ltd participated in the discussion of this topic as special guests We will discuss the sample distribution of global clinical trials, the FDA's requirements for the efficacy part of new drug application documents, the differences between the clinical studies of macromolecular drugs and micromolecular drugs, and the FDA The review and grasp of clinical trial drugs using adaptive design were discussed Through dialogue and discussion, we have a further understanding of the advantages of adaptive design, its application in clinical research and the review and grasp of clinical trial of adaptive design by FDA The first topic: optimized design of new drug clinical trials Dr Liu Chuan, director of Greater China development of medidata company, member of global Training Committee of Drug Information Association (DIA), and core member of clinical trial data unified standardization Steering Committee of new drug review center, served as the second topic "new drug clinical data management" The moderator of the discussion Dr Huang Qin, deputy director of Biostatistics Department of drug review center of State Food and drug administration, drafter of CFDA technical guidelines for structure and content of Clinical Research Report of chemical drugs and CDE technical guidelines for clinical trial data management, made a thematic report on "standard data management, improving data quality" The report analyzes some common problems in domestic clinical trials at present, and proposes to promote the overall data management and data quality level of national clinical trials by clarifying the responsibilities of relevant parties, strengthening training, improving the requirements of data management professionalization and standardization, and refining the review work and supervision and inspection work The report also introduces the implementation plan of CDE standard data management work, the technical specification of clinical trial data management work technical guide that has been issued, studies and establishes a unified clinical trial data standard system, and carries out a series of work referring to the CDISC standard The implementation plan of CDE standardized data management is proposed with six objectives, including the registration of clinical trials, the technical specifications of data management in the process of trials, the declaration and review of data, and the establishment of data warehouse for clinical trials, which aims to promote the overall improvement of data quality level of clinical trials in China from multiple aspects Professor Shi Yuankai, vice president of Cancer Hospital of Chinese Academy of Medical Sciences, vice director of national anti tumor drug clinical research institute, vice president of Asian Society of Clinical Oncology, Professor Li Wei, director of Statistics Center of Beijing Fuwai Hospital, visiting professor of Chinese University of Hong Kong, and Professor Han shaomei, Institute of basic medicine of Chinese Academy of Medical Sciences participated in the discussion of this topic as special guests We have a deep discussion with the guests about the relationship between clinical trial registration, supervision and inspection, on-site inspection and data quality review, as well as the role of clinical trial process supervision, how to ensure the scientific, true and accurate data collection of clinical trials, the specification of electronic data program EDC, the introduction of CDISC standard work, and the possibility of replacing clinical research by pooled analysis Through communication, we have a thorough understanding of the role of clinical experimental data management and the significance of improving the level of data operation Second topic: new drug clinical data management new drug R & D and intellectual property protection Dr Cui Guobin, director of Intellectual Property Center of Tsinghua University Law School and associate professor of Tsinghua University Law School, served as the moderator of the third topic "new drug R & D and intellectual property protection" Professor Zhang Qingkui, former director of the Pharmaceutical Invention examination department of the State Intellectual Property Office and chief senior consultant of Beijing Sanyou Intellectual Property Agency Co., Ltd., made a thematic report on "pharmaceutical technology innovation and intellectual property strategy" The report introduces the origin and development of the intellectual property protection of scientific and technological innovation, explains the existing laws and regulations of pharmaceutical intellectual property in China and the supporting policies of the state to encourage innovation, analyzes the problems existing in the pharmaceutical intellectual property strategy, and puts forward the ideas and suggestions to improve the pharmaceutical intellectual property strategy Jiang Hui, director of the General Department of the medical and biological invention examination department of the State Intellectual Property Office, Mr Michael Minney, senior director of global health access and international public affairs of celgene pharmaceutical, researcher Xue Yunli, vice president of LVYE pharmaceutical, and Tang Weijie, deputy director of the Chemical Industry Department of patent and Trademark Office of the China Council for the promotion of international trade, as special guests, participated in the discussion of this topic We discussed the current international patent law and examination of China's intellectual property rights, the scope of data disclosure in patent application and invention patent examination process, the differences between China and the United States, Europe and Japan in the implementation of technical standards for patent examination, the techniques for preventing patent application of pharmaceutical technology from being copied, the relationship between patent protection scope and data disclosure, patent litigation, etc The third topic: new drug R & D and intellectual property protection Dr Su Ling, former president of EU / dia, life science Strategic Consultant of Shengde international law firm, visiting professor of Fudan University School of medicine and Peking University Clinical Research Institute, served as the moderator of R & D technology forum and the fourth theme "EU"/ The host of the policy on biosimilars in the United States Dr Qi Maosong, head of statistics and statistical programming, Department of biosimilars, Amgen pharmaceutical company, USA, made a thematic report on "EU / US policies on biosimilars" The report introduces the EU's biosimilars policy and the approved biosimilars, the key requirements of three biosimilars product development guidelines issued by the United States in February 2012, and focuses on the "scientific considerations for verifying the biological similarity of the imitated products" This is very significant for Chinese enterprises to go to the United States or the European Union to carry out the registration of bio generic drugs Dr Fu Daotian, executive vice president of Lizhu pharmaceutical McAb Biotechnology Co., Ltd and national "thousand talents plan" Introduction expert, and Dr Wu Chenbing, President and chief scientific officer of Biotechnology Research Institute of Shanghai CITIC Guojian Pharmaceutical Co., Ltd., as special guests, participated in the discussion of this topic We have a positive discussion on the requirements for the consistency evaluation of bio generic drugs in the United States, including the requirements for comparability in the early stage, the requirements for clinical trials, patent protection related to bio generic drugs and legal challenges that bio generic companies may face The fourth topic: EU / US biosimilars related policies The atmosphere of the forum was warm The participants and representatives discussed a series of common and hot issues on new drug research and development clinical trials, intellectual property protection and international biosimilars related policies Through effective communication, the representatives have a clear understanding of the adaptive clinical trial design, a specific understanding of the national work arrangement to be implemented in the next step in clinical data management, the idea that data management should run through the whole clinical trial process has been strengthened, as well as a comprehensive understanding of the connection between China's patent and new drug management policies and the European and American biosimilars policies 。 In particular, the method of adaptive clinical trial design is very flexible, which can effectively reduce the duration of clinical trials and the sample size of research objects, which represents the development direction of clinical trials However, there is no application case in China, so we are eager to have an opportunity to hold an analysis and discussion meeting on the cases of adaptive clinical trials in foreign countries The successful holding of the new drug R & D technology forum marks a new breakthrough in providing comprehensive services for promoting industrial innovation by the China Council for the promotion of drugs It also shows that enterprises have an urgent need for high-level international technology exchange activities, which lays a solid foundation for the Council to continue to run international technology exchange activities in the future.