【摘要】：醫(yī)藥企業(yè)內(nèi)部的自主研發(fā)很難滿足其可持續(xù)發(fā)展的需求,高校和研究機構(gòu)則是創(chuàng)新藥的源頭,但他們不擅長產(chǎn)業(yè)化,所以,創(chuàng)新藥的技術(shù)轉(zhuǎn)移成了產(chǎn)業(yè)化過程中不可缺少的一個環(huán)節(jié)。創(chuàng)新藥的產(chǎn)業(yè)化幾乎是所有醫(yī)藥企業(yè)戰(zhàn)略規(guī)劃的最高目標,醫(yī)藥企業(yè)為了不斷地更新其產(chǎn)品線,因自主研發(fā)無法滿足市場需求,創(chuàng)新藥技術(shù)轉(zhuǎn)移就成了醫(yī)藥產(chǎn)業(yè)化過程中的必由之路。本文介紹了創(chuàng)新藥的研發(fā)流程和產(chǎn)業(yè)化的發(fā)展過程,解釋了其風(fēng)險高、成本高、時間長的復(fù)雜性和不確定性的特點,本文通過對醫(yī)藥產(chǎn)業(yè)的發(fā)展現(xiàn)狀和發(fā)展趨勢的介紹,展現(xiàn)出了創(chuàng)新藥研發(fā)在醫(yī)藥產(chǎn)業(yè)中的重要性和必要性。技術(shù)轉(zhuǎn)移在創(chuàng)新藥產(chǎn)業(yè)化過程中的作用也顯得尤為重要,其中,知識產(chǎn)權(quán)保護是技術(shù)轉(zhuǎn)移的核心,同時,也強調(diào)了創(chuàng)新藥的市場潛力和價值研究的重要性,以及和已上市藥品的比較優(yōu)勢,項目本身的可行性程度,還有引進項目方的產(chǎn)品線特點和設(shè)備優(yōu)勢等等。在大量文獻研究的基礎(chǔ)上,本文綜合了目前創(chuàng)新藥技術(shù)轉(zhuǎn)移的各環(huán)節(jié),還增加了一些創(chuàng)新性的研究方式和評估手段,針對技術(shù)轉(zhuǎn)移的雙方進行優(yōu)劣勢分析和項目本身的全方位評估,以降低產(chǎn)業(yè)化過程中的風(fēng)險。本文還具體分析了影響技術(shù)轉(zhuǎn)移的相關(guān)因素,通過專家論證,文獻研究,國內(nèi)外政策對比,典型實例研究,包括國外項目向國內(nèi)轉(zhuǎn)移,國外和國內(nèi)項目的內(nèi)部轉(zhuǎn)移以及國內(nèi)項目向國外轉(zhuǎn)移或授權(quán)等各種情況,通過對成功經(jīng)驗的吸取和失敗教訓(xùn)的總結(jié),闡述了這些影響因素的應(yīng)對方式和轉(zhuǎn)移過程中的應(yīng)對策略。
[Abstract]:Independent R & D within pharmaceutical enterprises is very difficult to meet their sustainable development needs. Universities and research institutions are the source of innovative drugs, but they are not good at industrialization, so, The technology transfer of innovative medicine has become an indispensable link in the process of industrialization. The industrialization of innovative drugs is the highest goal of almost all pharmaceutical enterprises in their strategic planning. In order to continuously update their product lines, pharmaceutical enterprises cannot meet the market demand through independent research and development. Innovative drug technology transfer has become the only way in the process of pharmaceutical industrialization. This paper introduces the R & D process of innovative drugs and the development process of industrialization, and explains the characteristics of high risk, high cost, long time complexity and uncertainty. It shows the importance and necessity of the research and development of innovative drugs in the pharmaceutical industry. The role of technology transfer in the industrialization of innovative drugs is particularly important, in which intellectual property protection is the core of technology transfer, and the importance of market potential and value research of innovative drugs is also emphasized. As well as the comparative advantages with the listed drugs, the feasibility of the project itself, as well as the product line characteristics and equipment advantages of the imported project side and so on. On the basis of a large number of literature studies, this paper synthesizes all aspects of the technology transfer of innovative drugs at present, and adds some innovative research methods and evaluation methods. In order to reduce the risk in the process of industrialization, the advantages and disadvantages of the two sides of technology transfer and the overall evaluation of the project itself are analyzed. This paper also analyzes the relevant factors affecting technology transfer, through expert demonstration, literature research, domestic and foreign policy comparison, typical case studies, including the transfer of foreign projects to the domestic. The internal transfer of foreign and domestic projects and the transfer or authorization of domestic projects to foreign countries are discussed in this paper. By summing up the successful experiences and the lessons learned from failures, the coping methods of these influencing factors and the coping strategies in the transfer process are expounded.
【學(xué)位授予單位】：華中科技大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：F426.72

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