Study On Risk Management Of New Drug Cooperational R&D

Because of R&D of new drugs' features of high-risk, high-inputs, long-period, and involving extensive subject areas, requiring special research quality, taking into account cost and resources, pharmaceutical enterprises, new drug R&D enterprises and research institutes need cooperation on R&D of new drugs.But there are relationship risk and performance risk during the cooperation. To avoid and reduce these risks, the paper to start with the life cycle of cooperation, identifies the impact factors of risks from the establishment, operation and termination of cooperation and puts forward some measures to avoid and reduce the risk. After discussion this paper educes the following conclusions :(1) During the process of selecting partners, the trust to the ability can avoid performance risk and the trust to the goodwill can avoid relationship risk. The technical strength and resources (except the technology) of partners will influence the ability trust; while their level of integrity, information communication and compatibility will influence the goodwill trust.(2) During the process of establishing cooperation, discovery phase and clinical research stage are suitable for the non-entity cooperation. However, if the two sides have better expection to cooperation project, plan to complete R&D as soon as possible and rather than consider the cost, the entity cooperation can be used in the clinical studies. We should adopt the non-entity cooperation to the individual research.(3) In the operational phase of cooperation, we should take the following measures :①estabilish the dynamic evaluation mechanism to the trust;②according to the changes of trust size, amend the control size;③according to the research progress or environment changes, timely amend cooperation agreement or sign the complementary agreement tostrengthen result control;④establish the incentive mechanism;⑤according to the different stages of R&D and different cooperation modes, choose rational control type, control size and incentive measures.(4) Identify to the factors of cooperation termination. There are five factors affecting the performance risk :①scientific project;②cost;③partners' capacity;④market;⑤environment (except the market). There are two factors affecting relationship risk: the possibilities of opportunistic behavior occurring and partners terminating cooperation. Once one of these factors has become the termination factor, we should terminate immediately the further cooperation.