[heavy weight] imitate the new era, gather efforts to develop the third China Pharmaceutical R & D Innovation Summit

2017 is a year of in-depth promotion of medical reform Policies of various pharmaceutical industries have been released intensively to encourage innovation, accelerate review and approval, and improve the quality of generic drugs There is a undercurrent behind the policy, and a no smoke elimination competition is on By the end of 2018, the knockout competition of 289 base drug varieties that must complete the consistency evaluation has entered the final period The announcement of technical requirements for consistency evaluation of listed chemical generic drugs (injection) (Draft for comments) widened the track of knockout competition, and new challenges are coming to enterprises On April 3, 2018, the general office of the State Council issued the opinions on reforming and improving the supply guarantee and use policy of generic drugs (hereinafter referred to as the opinions), comprehensively promoting the research and development of generic drugs and improving the quality and efficacy through improving the supporting policies In the critical period after the release of the drug catalog, not only shows the determination of the country to strengthen the generic drugs, but also undoubtedly becomes a focus for the shift upgrading and innovation of the generic companies Born in time: the third pharmaceutical industry brand conference - PDI summit arrived as scheduled In the first time after the release of the opinions, an important node to test the start effect of the consistency evaluation of generic drugs was issued on June 29-30 under the guidance of China Pharmaceutical University, Chongqing Economic and Information Commission, China Chemical Pharmaceutical Industry Association, the third China Pharmaceutical R & D · Innovation Summit and 2018 top 100 list of China's pharmaceutical R & D strength hosted by pharmaceutical intelligence network and China Pharmacy magazine Cloth comes from time to time and moves according to time It opens in Magic 3D City Chongqing Combined with the papers given by the new era, the forum is divided into two parts, one is "research and development of generic drugs in the new era" and the other is "Discussion on consistency evaluation technology of injection generic drugs" Aiming at the hottest topic at present, Dr Joerg Gruenwald, USP / Expert Committee of dietary supplements and plant drugs, and Prof Lu Tao, vice president of China Pharmaceutical University, are invited Dr Sun Liying, former FDA review leader, founder of Santai company and Beijing Santai cloud technology company, and more than 20 senior experts from domestic and foreign industries, represented by Dr Zhang natural, special vice president of China Chemical Pharmaceutical Industry Association and director of policy and regulation professional committee, came to the site to share their wisdom During the period, round table meetings, project roadshows and on-site Q & A were also interspersed The links and contents are wonderful, and the sharing mode is amazing, which has contributed a grand knowledge feast for the industry, attracting more than 400 enterprises and representatives of the industry In addition, the 2018 ranking of China's pharmaceutical R & D strength was solemnly released on the conference site, and nearly 100 enterprises represented by Zhengda Tianqing, Dongguang, Lizhu pharmaceutical, China Resources 39 and Nanjing Shenghe attended to receive the award A number of professional and mainstream media, such as China Pharmacy magazine, medicine guide, Chongqing TV station, Nan'an TV station, Chongqing Morning News, Chongqing daily, Chongqing Business News, Chongqing Evening News, Xinhua news agency, etc., are on-site tracking reports Wisdom gathered at the wonderful moment of the summit: 30 leaders of government and enterprises, experts at home and abroad gathered together to see the way ahead of the development of generic drugs The summit has a large number of big names and an extraordinary lineup Leaders of Chongqing municipal Party committee, enterprise leaders, FDA, EU, CFDA, CDE generic drug review experts, and domestic practical experts are all present At the beginning of the conference, Shi Yuanping, founder and chairman of yaozhi.com, LV Yi, vice president of Nan'an District, Chongqing, sun Qinghua, vice director of the pharmaceutical industry of Chongqing Economic and Information Commission, Dr Zhang Ran, specially invited vice president of China Chemical Pharmaceutical Industry Association and director of the professional committee of policies and regulations, and you Hongtao, executive chairman of Chongqing pharmaceutical industry association, delivered welcoming speeches to the conference, which fully affirmed the conference It will play a positive role in the development of pharmaceutical industry in Chongqing and even the whole country, and I wish the conference a smooth progress Hu Rui, deputy director of Chongqing Economic and Information Technology Commission, Zhang Yilong, honorary president of Chongqing pharmaceutical industry association, Yu Yongping, executive vice president of Xinhua Kangmei health think tank Co., Ltd and other government and enterprise leaders also attended the site to congratulate the successful convening of the conference After that, Dr Zhang Tianran, Dr Joerg Gruenwald and Prof Lu Tao officially opened the "wisdom lecture" of the summit, answering questions and solving doubts for the R & D problems of generic drugs in the new era, pointing out the way forward On May 31, 2018, the state health insurance bureau was officially established As the primary task of the health insurance bureau, medical insurance cost control was pushed to the forefront of the wave In this context, what opportunities and challenges will pharmaceutical enterprises meet? Dr Zhang Tianran gave the answer at the meeting; Dr Joerg Gruenwald and sanophyt GmbH, expert committee of USP / dietary supplements and plant drugs from Germany& With the cooperation of Ma Bin, founder of Co.KG, and focusing on the international market, Professor Lu Tao, vice president of China University of Pharmaceutical Sciences, combined with 40 years of ups and downs in the development of Chinese medicine, summed up the past and looked forward to the future The on-site experts spoke in a lively and eloquent manner The guests were attentive, listened with bated breath, and applauded from time to time At the beginning of the meeting, a solemn and warm meeting atmosphere was created for the following links Expert speech: 20 in-depth reports analyze 2 major themes and break through the R & D problems of generic drugs in multiple dimensions After the wonderful opening ceremony, the summit started from the two themes of "research and development of generic drugs in the new era" and "Discussion on the consistency evaluation technology of injection generic drugs" More than 20 in-depth reports were presented one by one, which were continuously brilliant, including new ideas, new ideas and new methods, which played the most exciting music for the conference In the main conference hall with the theme of "research and development of generic drugs in the new era", FDA, CDE review experts, enterprise practical experts, and industry senior professors stand under the national policy of consistency evaluation, and analyze the pain points, difficulties and solutions of generic drug research and development from various aspects Dr Yan Fang, a CDE evaluation expert, introduced the consistency evaluation and key points of technical evaluation from three aspects based on his own work experience; Professor Sun Liying, a former US FDA evaluation leader with 20 years of overseas pharmaceutical research and development experience, shared the evidence chain thinking of pharmaceutical research and development from the perspective of reviewers; deputy director of pharmacy department and clinical medicine of the First Affiliated Hospital of the Third Military Medical University Professor Chen Yongchuan, director of the office of the experimental institution and member of CFDA new drug evaluation expert database, provided how the sponsor effectively supervised the institution to carry out clinical trials, and conducted in-depth analysis from the aspects of be ultimate responsible person and how cro enterprises should choose If China wants to move forward from a big country of generic drugs to a powerful country of generic drugs, it is impossible to avoid "challenging patents" He was once a member of Chongqing Huabang Pharmaceutical Co., Ltd Meng Bayi, head of intellectual property, senior consultant and deputy general manager of the company, thinks that challenging patents is not a technical or legal issue, but a business strategy He also explains the business value, business strategy and legal risk of "patent challenge" He has been the executive director and general manager of Chongqing Libang Pharmaceutical Development Co., Ltd for many years in enterprise practice Zhang Tao, manager, summed up the pain points, solutions and Strategies of oral generic drug development and consistency evaluation technology innovation, and analyzed specific cases; Hou Yu, Professor of Hebei University of science and technology and President of Chongqing Kangzhou medical big data development and Application Research Institute, from risk and return, imitation and innovation, the relationship between chemical drugs and biological drugs, etc In this paper, the screening strategy of generic drug project is discussed, and two assistant tools which can be used in the screening of generic drug project are introduced In addition, Peng Haihui, a researcher of Fudan University and Pujiang scholar, he Xiaobing, CEO of Beijing Zhongxin Huakang medical research center, Chen Minhua, an expert of the national "thousand talents plan" and President of Suzhou Jingyun Pharmaceutical Technology Co., Ltd., Cao Shenghua, chief expert of Sichuan Antibiotic Industry Research Institute, an expert of the national "thousand talents plan", one of the first batch of talents of "Hongyan plan" in Chongqing, Chongqing dinali Medical Co., Ltd Meng min, CEO of Pharmaceutical Technology Co., Ltd., also gave a wonderful speech on related topics Exhibition of experts in the main venue The main venue is also interspersed with round table sessions on the topic of "rules and regulations of generic R & D vs innovation and development" Based on the current situation of China's generic R & D, experts provide referential objects, operable methods, innovative ideas, and urge people to make progress in generic R & D from conservative to innovation The project roadshow includes new drug certificate, clinical approval document, and new drug under research Projects, industrial docking, etc provide a platform for exchange and resource exchange for participating institutions and enterprises Cooperation has been continuously achieved, with full harvest On December 22, 2017, CDE released technical requirements for conformity assessment of listed chemical generic drugs (injections) (Draft for comments), which caused a sensation in the industry Another knockout competition with injection as the leading role is about to be staged How does the enterprise rebirth in this competition? In the branch venue with the theme of "Discussion on consistency evaluation technology of injection generic drugs", experts provided "reference answer" based on their own practical experience: Dr Chen Hong, vice president of Yiling Pharmaceutical Research Institute and President of chemical and biological medicine research branch, with many years of practical experience in consistency evaluation work in Yiling pharmaceutical industry, elaborated "how to develop high-quality Injection generic medicine; Li Tianquan, the co-founder of yaozhi.com and the president of Yaozhi elite club, specializes in the retrieval and utilization of medical information, and is good at interpreting industry policies and hot medical information through the mining of professional data He also analyzed the retrieval and utilization of injection consistency evaluation information combining with the database of yaozhi.com; vice Department of science and Technology Department of North China Pharmaceutical Co., Ltd Li Junde, special expert of China Pharmaceutical Quality Management Association, Zeng linggao, member of national pharmacopoeia committee and director of chemical medicine office of Chongqing Institute of food and drug inspection and testing, delivered speeches on two themes, i.e practice and case analysis of data reliability management in R & D laboratories and key points and case analysis of drug registration standard review Later, the above guests, together with CAI Rong, deputy director and technical director of Shanghai food and drug packaging materials testing institute, Yu Chunmei, Secretary General of Shandong Pharmaceutical Packaging Association, quality director of Shandong lino special glass Co., Ltd., and Wei Shifeng, co-founder and general manager of Beijing luonuqiangshi pharmaceutical technology research and development Center Co., Ltd., passed the on-site Q & a process and entered the stage with the guests After interaction, the dry goods are full and colorful Expert style of the branch venue, expert group photo of the on-site Q & a link of the branch venue, Li Tianquan, the co-founder of yaozhi.com, and the testing guests of Yinger group photo, full of achievements: 4 lists are published, and top enterprises in the industry are present to receive awards While brainstorming, the attendees also witnessed the summit time - the release of the industry-renowned "2018 top 100 pharmaceutical R & D strength in China" This is the third time that the company has released the annual corporate R & D strength list after the 2016 China Pharmaceutical R & D strength list and 2017 China Pharmaceutical R & D strength list, including the general list, chemical medicine list, traditional Chinese medicine list and biological medicine list The top four lists have appeared Compared with the 2017 and 2016 general lists, it can be seen that Hengrui, Zhengda Tianqing, Fosun, Haizheng, hausen, Qilu and Kelun are all ranked in the top ten in the three years, although the specific ranking changes slightly due to the performance of that year