Studies On The Project Risk Management Of The R&D Of New Medicines

The research and development(R&D) of new medicines is an activity which requires high commitment, high techniques, high competition and high profits, and which needs numerous links, considerable funds, long cycle and complex systematic operation with low success rate. These features decide its high riskiness, which is the major reason why many domestic pharmaceutical enterprises flinch from the R&D of new medicines. How to avoid the high risks of the R&D of new medicines is a pressing demand and tough task. Therefore, to analyze the risk factors existing in the R&D of new medicines and to manage them effectively have theoretical and practical significance to the sustainable development of our nation's pharmaceutical industry.Though nowadays we have some relatively profound idea and have attached importance in some degree to the risks of the R&D of new medicines, on the whole, we have just enhanced the consciousness of risk management and lack the operating guidance of risk management. Moreover, most of the home research of risk managements aims at non-pharmaceutical industry, and the risk research of the R&D of new medicines focuses on a particular aspect or on the applicance of a particular method without directing at systematic research findings of risk management of R&D of new medicines. This dissertation is trying to bridge that gap.First, the dissertation makes a brief review of project management theories, risk theories and risk management theories, makes a summary and evaluation of the definition, characteristics, recognition, assessment and regulation, and points out the contribution and shortcomings of the current risk management theories. It also sums up the research of project management theories and the research of risk management of the R&D of new medicines.Second, the dissertation sums up the current situation of domestic and overseas pharmaceutical industry and the R&D of new medicines. It also points out, by briefly introducing the procedures of R&D of new medicines, the special nature of pharmeceutical industry and the high riskiness of R&D of new medicines. On the basis of above-mentioned theories and current situation research, the dissertation devises the project risk management model of the R&D of new medicines, which involves five stages: risk management plan, risk recognition, risk assessment, risk handling and risk monitoring. The model is devised on the basis of the project management theories, risk theories and risk management theories. It succeeds to and develops those theories and is the practical application of those theories to pharmaceutical industry.Then, the dissertation makes a profound study of risk management model of the R&D of new medicines. In respect of risk recognition, by summing up the existing documents, from the angle of risk sources of technical innovation, the dissertation divides the risks of the R&D of new medicines into technique risks, finance risks, manufacture risks, management risks, market risks, each of which involves different sub-factors; in respect of risk assessment, the dissertation deals with estimation matrix got from AHP by questionaries, and makes use of experts' estimating weight to determine experts' weighing and each indicator's weighing, and finally according to main factors determines which indicators can be kept and establishes the indicator system of risk assessment; by means of vague assessment, the dissertation constructs vague membership grade matrix of project risks and establishes a comprehensive assessing method of project risks of the R&D of new medicines on the basis of F-AHP; in respect of risk handling, the dissertation raises the coping strategies of risk management of the R&D of new medicines in the six aspects of techniques, finance, management, environment, manufacture and market.Finally, the dissertation makes a quantitative study of project risks of the R&D of new medicines. Through quantitative analysis of scientific and technical payoffs transformation of our nation's medicines, the dissertation shows the transformation ratio of each stage in the whole cycle of the R&D of new medicines, that is, the risk level of each stage. Thus, pharmaceutical enterprises and research institutes can enhance management, aiming at the low transformation ratio of scientific and technical payoffs, so as to reduce R&D risks of this stage.Athough the R&D of new medicines will meet with various kinds of unexpected risks and it is impossible to avoid and eliminate risks or enjoy only profits without taking on risks, we can evade risks effectively and ensure the success of the R&D of new medicines as long as we are good at taking advantage of current risk management theories and make careful investigation and research. On the other hand, the R&D of new medicines has a long cycle and involves various and complicated risks which exist interlacing in different stages, therefore dynamic risk management should be conducted during the whole process of the R&D of new medicines. All in all, effective risk management contributes to the improvement of the quality of R&D project and the sustainable development of target market; active risk management helps improve the risk consciousness and risk management standard of project group and enterprise. As a resulf, the research, promotion and appication of risk management of the R&D of new medicines are of great practical and instructive significance to new medicine project group of our nation's pharmaceutical enterprises and research institutes and academies.