Where do we need to improve the development trend of global pharmaceutical industry?

Source: Biovalley 2016-11-04 in recent years, the R & D of new drugs has become more and more difficult, and the pace of new drugs coming out has slowed down However, the launch of each new drug means that human beings are closer to conquering a certain disease For example, the God drug of hepatitis C sofosbuvir of Gilead can almost cure hepatitis C, but from another point of view, the rising drug price also makes more people can only hope for the drug How does the cost of new drug research and development gradually rise to today's "sky high"? Why is it so difficult for new drugs to come out? Table 1: the cost of new drugs increased exponentially The data is from the PPT of the Ninth Conference of covence pharmaceuticals In Figure 1, we can clearly see that in the process of new drug research and development, both the pre human stage and the clinical stage, the cost has been increasing since 1970, especially in 1990-2000s In the early and early 2000s-2010 period, the pre clinical cost increased by 151.8%, the clinical cost increased by 140.1%, and the total cost increased by 145.0% Many new drugs are in phase III, and many people will have a misunderstanding about this: phase III research and development costs must account for the largest proportion of the whole clinical trial However, from table 1, we can see that there is no obvious difference in the cost of phase I, phase II and phase III, which means that even if the R & D of new drugs fails in phase III, the R & D personnel will suffer losses for the huge investment in the early stage Table 2: data from the PPT of covence chinaries Although new drug R & D is like a bottomless hole with great risks, the success of new drug R & D means huge market and profits Many large pharmaceutical companies and investors in the world are constantly investing money to promote more new drugs to market, even if the R & D cost of each new drug is higher and higher Table 3: research spending per new drug (1997-2011) table 3: data from ppt of covence pharmaceuticals 9 conference cost elements of new drug control Procedures, administrative staff, site monitoring costs Eric Lang believes that only 20% of the cost of clinical trials It is directly related to clinical data, for example, a large number of samples generated in clinical trials need to be stored, and a considerable part of these stored samples will not be used to measure the data; some additional retained samples will be used to re measure to avoid some uncertain results in the experiment (such as test titration results); some of the collected data are used to please the tax People and investors (measuring the quality of life of patients).. The proportion of data finally discarded in the experiment ranges from 15% to 30%, which is about 20 million to 25 million US dollars, and these are the places where we can reconsider and reduce the cost Data shows that personnel management accounts for 11% - 20% of the total new drug development process, while on-site supervision costs account for 9% - 14% Eric Lang said that the cost of on-site supervision can be further reduced through the wider use of mobile technology The centralized processing of analysis data can be used to assess the effectiveness of supervision, the correctness of electronic data capture and risk control Why does the emergence of new drugs slow down? As we all know, one of the factors that slow down the pace of new drugs is that the modern medical level cannot fully understand the physiological mechanism of human body More often, the research and development of new drugs is not the active design of drug molecules, but the search for potential new drugs in the vast ocean of biochemical molecules, and then further research and development At the same time, with the continuous progress of the times, more and more attention has been paid to drug safety Regulatory authorities have also issued more and more policies and regulations, requiring enterprises to recruit more clinical cases, do more safety tests, and submit more detailed test reports.. From 2000 to 2008 Taking the annual data as an example, the complexity of the experimental design and projects made by pharmaceutical companies is also significantly increasing Table 4: data from the PPT meeting of covence China s 9 conference In contrast, the proportion of the average time for FDA to approve new drugs in the whole R & D and marketing of new drugs is decreasing year by year Figure 5: data from the PPT conclusion of the Ninth Conference of covence pharmaceuticals: the 13th five year plan of the Chinese government strongly encourages the research and development of indigenous original and innovative drugs Wu Haidong, deputy director of the consumer Industrial Products Department of the Ministry of industry and information technology, said that "innovation and upgrading of the pharmaceutical industry has become a national strategy, and innovation has become the 13th five year plan of the pharmaceutical industry." Key words of the plan: innovation is the key to the transformation of the pharmaceutical industry from large to strong "Wang Hongguang, President of the Development Strategy Research Institute of the Ministry of science and technology, also said that during the 13th Five Year Plan period, major pharmaceutical projects will focus more on core bottleneck technologies to solve those" neck sticking "problems "By analyzing the development trend of the global pharmaceutical industry, we may bring some new ideas to our new drug R & D innovation.