【作者】 黄立东；

【导师】 孙利华；

【作者基本信息】 沈阳药科大学 ， 企业管理， 2007， 硕士

【摘要】 新药研发由于其高风险、高投入、长周期，以及涉及学科领域广泛、需要特别研究资质等特点，从成本和资源上考虑，需要制药企业、新药研发企业以及科研院所之间进行合作研发。但新药合作研发存在绩效风险与关系风险。为规避和减小这些风险，本文从合作的生命周期入手，分别从合作的建立、运营、终止这三个方面对风险的影响因素进行识别，并讨论了规避和减小风险的措施。经讨论本文得出以下结论：(1)合作伙伴的选择应考虑：技术实力、资源(除技术)水平、诚信水平、信息沟通水平以及相容性水平等因素。(2)在合作建立过程中，对于某阶段整体的合作，发现阶段与临床研究阶段适合非实体式合作方式，临床前研究如合作双方对合作项目预期较好计划尽快完成研发而较少考虑成本的情况下可采用实体式合作方式；对于单项研究的合作，应采用非实体式合作方式。(3)在合作运营阶段，应采取以下管理措施：①建立信任动态评价机制；②适时调整控制程度大小；③适时修订合作协议或增签补充协议；④建立激励机制；⑤合理选择控制类型、分配控制程度大小及实施激励措施。(4)对于合作研发终止因素的识别，影响绩效风险的因素有五个：①项目的科学性；②成本因素；③合作伙伴能力因素；④市场因素：⑤环境(除市场)因素。影响关系风险的因素有两个：机会主义行为产生的可能性与合作伙伴终止合作的可能性。这些影响因素一旦有一个成为终止因素后，即应终止合作项目的继续运行。更多还原

【Abstract】 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.更多还原