Pharmaceutical R&D, Fission in Chain under the Guidance of Policies

发布日期:2016-07-01访问次数: 信息来源:http://www.pharmadl.com字号:[ ]


The unexpected surprise in this Spring may come from an overall promotion of the Sanming Model or an abrupt stop of the electronic drug supervision code. From the author’s point of view, the recently published Notice on the Work Plan of Reforming the Classified Registration of Chemical Drugs (No. [2016] 51) (hereinafter referred to as “Document No. 51”) is undoubtedly one of the far-reaching policies in the pharmaceutical industry. At the micro level, the “product R&D lines” set up with huge investment in pharmaceutical companies would thereby be eliminated and those senior managers in charge of R&D would have to cancel a number of R&D projects that have been approved. At the macro level, pharmaceutical companies would have their business segments or strategic direction adjusted. From generic drugs consistency evaluation, priority review channel to Marketing Authorization Holder (MAH) system, if these R&D policies promulgated by the State get implemented, the backlog of new drug applications will be basically cleared up, as expected, in 2 to 3 years. Under the influence of these policies, the pharmaceutical R&D groups will become a rising power and the pharmaceutical R&D link will boost the innovation level in the pharmaceutical industry with a force of change.

The new Category II shines as the old Category III gets blown out. We’ve got to acknowledge that Document No. 51 imposes new challenges to the routine R&D declarations as a whole, as those products under the old Category III become generic drugs and the new drug certificate and monitoring period are gone. The once popular new drugs under Category 3.1 have also declined. However, the rises always come along with the falls, as the old Categories IV and V have got their positions apparently improved and the new Category II has sprung up. Regarding Document No. 51, there are a number of technical issues open for discussion, such as the specific evaluation indicators and criteria of “having clinical value advantages”. In general, the R&D focus shall be shifted from pre-clinical research to clinical research and the clinical data will become the focus of attention. Moreover, following the campaign to crack down on “data fraud”, such issues have been straightened out at the regulatory level. At the enterprise level, clinical trials turn out to be the focus of attention as R&D ideas are clinically oriented and experiment data come from clinical trials, which will eventually guarantee the generation of new drugs. Therefore, pharmaceutical companies should start in-depth communication with clinical experts from the R&D stage, rather than just track the expiry of foreign patents. As mentioned above, clinical trials become the focus of attention and professional CRO companies will put more energy into clinical trials. When selecting a R&D partner, enterprises must take the potential partner’s clinical capability into full consideration.

R&D professionals become a rising power in the industry. In the opinion of, the author, pharmaceutical R&D in the future will gradually turn out to be independent and platform-oriented. There will be large amounts of “R&D Makers” that keep emerging thanks to the Marketing Authorization Holder (MAH) system and reduced financing costs, so that R&D organizations or individuals will enjoy a greater say. Since only a handful of pharmaceutical companies have strong R&D capabilities, how to realize high output with small investment makes the focus of attention among pharmaceutical companies. The author has summarized the existing R&D models in the pharmaceutical industry, which include such three types as opportunity cooperation model, R&D management model and venture investment model. For R&D, enterprises should combine different models based on their R&D level, R&D investment and external management capability. With limited internal resources, the author suggests that the R&D department in an enterprise must get its role shifted from a participant to a manager and from a resource provider to a resource integrator.

All in all, market and products matter. Only after the development objectives and positioning of a company is clearly defined can the R&D, Marketing, Merger & Acquisition and Production departments determine their respective strategies, which include the company scale, therapeutic areas, business layout and key products. When a company encounters growth bottlenecks and performance decline, it must be caused by something wrong in the R&D link which took place at least five years ago. So it’s impossible for the company to resolve the problems by resorting to R&D. Therefore, it is particularly important to work out the product strategy planning in advance and to identify which products are making profit contributions at present, which are strategic products in the future, which are scale products, and which are profitable products. Only by doing so can a company determine its R&D priorities and business layout in the future. Since the R&D policies are made clear now, pharmaceutical companies’ R&D ideas and strategies should be made even more market-oriented and clinically oriented, while adopting the “review” strategy as a competitive strategy in addition to the marketing and sales strategies. In this respect, Chia Tai Tianqing’s R&D idea is valuable for reference. For instance, Chia Tai Tianqing launched Entecavir Maleate Tablets following its development and marketing of the first-to-market generic drug of Entecavir. The company participates in the bidding with exclusive products and thereby enjoys double market competition benefits.

 





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