[on site · viewpoint] Liu Linan: choose cro, don't lose money because of "price"

Cro is a contract research organization, which is an organization or institution that provides specialized outsourcing services for pharmaceutical enterprises in the process of drug research and development through contract CRO enterprises are entrusted by pharmaceutical enterprises to carry out part of the work in new drug research Cro originated in the United States in the 1970s, is the product of specialization of drug R & D division With the increasingly strict new drug approval system and the increasingly complex new drug R & D, pharmaceutical enterprises began to outsource more and more R & D work to cro enterprises Cro began to develop rapidly in the United States, Japan and Europe in the late 1980s, and has become a key link in the pharmaceutical R & D industry chain in the 1990s After the baptism of technology bubble and economic crisis, the development of global CRO industry has eased up in recent years Compared with the development history of European and American markets, the development of cro industry in China started late, only about 20 years At the 2019 China Pharmaceutical and health industry development conference and the 4th China Pharmaceutical R & D Innovation Summit (PDI Conference), Ms Liu Linan, vice general manager of beno pharmaceutical, brought her unique views on the development and selection strategies of cro industry 1 What is the situation of domestic cro industry? China's cro industry is growing rapidly, and the number of enterprises in the industry is increasing As of the end of September 2017, there are 525 domestic enterprises involved in cro, and the overall cro industry presents a pattern of many, small and scattered At present, the mainstream cro enterprises in the market mainly provide preclinical cro and clinical research cro services: A preclinical cro services: mainly engaged in compound research services and preclinical research services; B clinical cro services: mainly for the research in the clinical trial stage In domestic cro enterprises, pre clinical cro and clinical cro account for about half each, and a few enterprises have the ability of comprehensive service outsourcing China's cro industry continues to grow at a high speed, reaching 55.9 billion in 2017, with a growth rate of more than 20% The market size is expected to increase to 67 billion yuan in 2019 China's cro market size will approach 90 billion yuan in 2020 According to wind data, 281 A-share pharmaceutical companies released R & D investment data in 2018, with a total R & D cost of 34 billion yuan, no more than 3% of the total operating revenue; the average R & D cost of large international pharmaceutical companies in 2018 reached 3.75 billion US dollars, accounting for 16.10% of the median Compared with the first-class level in the world, the absolute value and proportion of R & D expenditure of domestic pharmaceutical enterprises are still far away and have broad development space In addition, China's accession to ICH has played a positive role in the development of China The advantages of domestic resources and costs make Chinese enterprises more competitive Since 2015, the reform of the national review and approval system has greatly promoted the development of innovative drugs, which is a long-term good information for cro industry; in recent years, the application of new drugs of class A has increased year by year, and the rapid development of consistency evaluation has spawned nearly 10 billion markets But at the same time, policies such as 4 + 7 volume purchase and payment by disease also have an impact on cro industry, which requires higher and higher R & D; in addition, the impact of new policies on production enterprises also makes the price competition more and more fierce This is also the reason why the profit of cro companies is declining year by year Some cro companies are difficult to continue The cro industry is gradually showing a hierarchical competition pattern Large pharmaceutical companies will carefully split the R & D process and outsource different links to different cro companies in consideration of risk, cost control and patent protection Small pharmaceutical enterprises generally lack of professional ability and the ability to split processes, so they tend to package and outsource as a whole On the other hand, MAH will improve the concentration of cro industry and resource allocation of pharmaceutical R & D industry, and vertical integrated cro will have more competitive advantages Because R & D is at the core of the whole industrial chain, cro companies have more advantages in penetrating upstream and downstream 2 To simplify the complexity is the core competitiveness of cro industry Why should we cooperate with cro? In fact, we all know that new drug research and development has four characteristics: one is strict supervision, long cycle, high investment and low success rate In the face of the changes in the industry, the demand of pharmaceutical enterprises is undoubtedly to find ways to reduce the R & D cost, shorten the R & D time, improve the R & D quality and reduce the R & D risk So the reason for choosing to cooperate with cro is that the company cost and personnel cost of cro are 20% - 30% lower than that of large pharmaceutical enterprises In addition, there are more professional people to do professional things, and the R & D cycle is naturally reduced by 1 / 3 to 1 / 4 Through outsourcing, the complex process is segmented to reduce the complexity, improve the success rate and reduce the risk Even some enterprises will transfer some risks to cro in the form of contract, and refund in full if they don't get the document number, which is why enterprises consider cooperation with cro Now, after a period of development, the domestic cro industry has gradually formed two characteristics in the cooperation: one is the universality, the cro can be seen in almost every new drug development, the other is that the satisfaction is generally not high, almost 80% of the projects in the cooperation cases between Chinese pharmaceutical companies and cro have unpleasant experiences, many enterprises are struggling in the process of contracting and not contracting, Why is this happening? It's because many pharmaceutical companies don't visit the cro company on the spot when they choose the cro Instead, they are fascinated by the low price through bidding What you see is only the price, not the big difference behind the price support This difference also causes various risks For example, the lack of technical maturity leads to the big change cost in the later period, which is not worth the loss 。 3 With the right choice of cro enterprises, new drug R & D has succeeded in half of the factors that cro customers are most concerned about at present The first is "the success rate of R & D", and then is the product "whether it conforms to its own product pipeline", "whether the R & D progress is leading", "whether it can be delivered quickly", "the stability of the process" and so on So choose cro is the most important link, so how to choose cro company? At present, the summary can be considered from five aspects: team, management system, hardware equipment, project experience and project value 1、 As for the team, we should focus on the following four aspects: 1 Whether there are some senior experts in the team, who can timely provide some experience support when the project has problems; 2 The stability of the core personnel If the core personnel are all shareholders of the company, the stability of the core personnel is very high If not, some people leave their jobs when the project is not completed, which makes it difficult for the project to continue; 3 Organizational structure and personnel qualification, whether each person has a clear job description, whether the responsibilities are clearly divided, whether the personnel have been assessed, and whether the key personnel have been certified? 4 Does the company have a professional and exclusive project service team to serve you? Does the company have a relatively fixed counterpart to provide you with close VIP service? If there is a problem, just find a person directly to avoid the cost of communication 2、 Management system should focus on three aspects: project management system, quality management system and compliance management system 1 The project management system mainly depends on whether there is a professional management team, whether there is information-based management, and how to ensure the operation of the project and key nodes through the process For example, in terms of organizational resources, we can see what kind of organizational structure there is The necessary management is more efficient than the traditional management, and the writing is more smooth We can examine the qualification of the project manager and the project team individually Is it professional For cro companies, there are many projects, so there is usually a professional project management department to operate project level management 2 Quality management system, the key point is to see whether it passes the official quality management system, which is very important, because the official quality management system certification can help you to establish a more complete quality management system, which has corresponding control from each link, and passes the standing review, management review and the third Party's on-site review every year to ensure the continuous improvement of the quality management system State, continuous and effective operation in the appropriate state, which plays a very good role in promoting 3 In compliance management, it can be seen whether the risk points have been effectively identified and effectively controlled in the process of project management, and whether the data clear audit standards have been established for each milestone node of the project 3、 Hardware devices First, whether the production equipment and analytical instruments can meet the needs of project research and development Second, whether there is a data management system to ensure the authenticity, integrity and traceability of the project In addition, large customers also need to see whether the entrusted cro company has a complete industrial chain of pharmaceutical research, clinical research, biological testing and GMP production 4、 Project application experience Because rich application experience will help the sponsor to avoid risks in advance to ensure the timely delivery of the project and the successful application of the project 5、 The value of the project In terms of time cost, risk cost and market prospect, is there any technical barrier and how mature is the process? A good project can bring a good experience Don't only see the price of the project when talking about the contract, because the price of the contract is like an iceberg, only see the part of the sea level What's unexpected is the risk factors below the sea level, which will continue to increase your cost in the process of research and development Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.