Pharmaceutical R & D, policy led "chain fission"

Source: medical geography 2016-03-16 this spring's "flat thunder", or the comprehensive promotion of Sanming mode, or the sudden end of electronic supervision code From the perspective of the author, the announcement on the work plan for the reform of registration and classification of chemical drugs (No 51 in 2016) (hereinafter referred to as "No 51 document") just published is undoubtedly one of the policies that have far-reaching impact on the pharmaceutical industry At the micro level, the "product R & D line" that pharmaceutical enterprises spend a lot of money to lay out or lose ground in this regard, and the executives in charge of R & D have to stop many R & D projects that have been approved; at the macro level, the overall professional subdivision field or strategic direction of pharmaceutical enterprises will be adjusted accordingly From the consistency evaluation, priority review and approval channels of generic drugs to the listing Licensor system, the national R & D policy portfolio is "in place" If the policy is implemented, it is expected that the backlog of new drug applications will be basically cleared within 2-3 years Under such a policy tide, the pharmaceutical R & D group will become a rising new force, and the pharmaceutical R & D link will leverage the innovative level of the pharmaceutical industry with the power of innovation Old class 3 is "blown", new class 2 is on It has to be said that No 51 document is a sweeping cut in the direction of the whole R & D application The old three categories have become generic drugs, and the new drug certificate and monitoring period have disappeared, and the once famous class 3.1 new drugs have also declined The status of the old four categories and the old five categories has increased significantly, while the new two categories have risen As far as No 51 document is concerned, there are still many technical points to be discussed, such as specific evaluation indexes and standards with clinical value advantages As a whole, the focus of research and development has shifted from preclinical research to clinical research, and clinical data has become the focus of attention Combined with the clearing up of "strict inspection of data fraud" in the previous period, this part of regulatory issues has been straightened out From the perspective of enterprises, clinical research and development has become the focus of attention Research and development ideas come from clinical and experimental data come from clinical, which can ultimately ensure the production of new drugs Therefore, enterprises need to communicate with clinical experts in-depth from the R & D link, rather than just tracking the expiration of foreign patents As mentioned above, clinical trials become the focus, professional cro companies will devote more energy to clinical research and development, and enterprises need to fully consider the clinical capabilities of partners R & D professionals have become a new rising force in the industry In my opinion, pharmaceutical research and development will gradually move towards independence and platform in the future In combination with the listing Licensor system and the decrease of financing cost, there will be a large number of "R & D makers" in the future, and the "voice" of R & D institutions or individuals in the pharmaceutical industry will be significantly improved After all, there are a few pharmaceutical enterprises with strong R & D capabilities How to achieve small input and high output is the focus of pharmaceutical enterprises The author summarizes the current R & D mode of pharmaceutical industry, including opportunity cooperation mode, R & D management mode and venture capital mode In terms of R & D, enterprises need to combine applications in various ways according to their own R & D level, R & D investment amount, external management ability and other factors Under the premise of limited internal resources, the author suggests that the R & D Department of an enterprise must realize the role transformation, from the original participant to the manager, from the original role of providing resources to the role of integrating resources Figure 1 in the final analysis, the R & D model of the pharmaceutical industry is still the market or the product In the future, only after the development objectives and enterprise positioning are clear, can the strategies of functional departments such as R & D, marketing, M & A and production be determined When enterprises have experienced growth bottleneck and performance decline, the problem of R & D should be caused by mistakes at least five years ago Therefore, it is basically impossible for enterprises to rely on research and development to "fight the fire" Therefore, it is particularly important to plan the product strategy in advance Only by clarifying which products contribute to the current profits, which products will be the future strategic products, scale products and profit products, and by classifying and sorting them out, can we make clear what the future R & D layout is, rather than what opportunities will be seized Now that the R & D policies are gradually clear, the R & D ideas and Strategies of pharmaceutical enterprises should be market-oriented and clinical oriented, and the "review and approval" strategy should be used as a competitive strategy after the market strategy and sales strategy At this point, Zhengda Tianqing's research and development ideas are worth realizing For example, after developing entecavir for the first time, it went on to entecavir maleate, and participated in the bidding with exclusive varieties, enjoying double market competition benefits.