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论文编号：	11134
作者编号：	2220160891
上传时间：	2019/12/7 15:06:27
中文题目：	YMAK公司抗肿瘤免疫治疗药物项目风险管理研究
英文题目：	Risk Management of The Anti-tumor Immunotherapy Project in ImmuneOnco Biopharma
指导老师：	戚安邦
中文关键字：	抗肿瘤免疫治疗；项目管理；风险控制
英文关键字：	Tumor Immunotherapy；Project management；Risk control
中文摘要：	癌症仍是威胁人类生命的严重疾病。但是，近十年来随着越来越多的靶向抗肿瘤药物陆续问世，癌症的治疗效果得到了大幅度提高，大大延长了患者的寿命。然而，由于癌细胞生长迅速且容易发生突变，这些靶向药物的药效往往不能持久，相当多的患者在经过一段时间（一般是半年到一年）的靶向治疗以后均会出现耐药。 这些现象促进了癌症免疫治疗产品的研发及问世。2011年第一个免疫治疗抗体易普利姆玛（Ipilimumab）获批上市，在随后的七年时间又陆续有六个新的免疫治疗抗体获批上市。从此开启了癌症免疫治疗时代的到来。2015年8月美国前总统卡特宣布自己患了黑色素瘤，在经过半年的免疫治疗抗体“派姆单抗（Keytruda）”治疗以后，体内已完全检测不到癌细胞。后来随着越来越多的患者从该类药物的治疗中获益。大量的事例已经证明，癌症的免疫治疗将会是未来最有可能治愈癌症的一种治疗手段。 任何一种新药的研究开发，都离不开巨大的资金投入及漫长的时间成本，平均而言，一个新药从立项到上市，需要耗资8-10亿美元、耗时8-10年的时间。在研发过程中的每一个环节都会出现失败的风险，而且越到后期，失败率越高。已经有为数不少的新药在临床三期阶段以失败而告终，为此给公司带来了巨大的经济损失，甚至导致公司的破产。所以为了确保药物研发的成功率，在整个药物开发的过程中加强风险管理势在必行。 本文将以YMAK公司免疫治疗药物项目为对象展开研究。研究内容将包括项目概况、研发阶段介绍、不同研发阶段的风险分类及评价、风险管理措施的实施等。研究成果，将对YMAK公司项目的顺利执行提供保障，有利于提升YMAK公司的竞争优势，从而取得更大的公司价值的提升。
英文摘要：	Cancer is still a life-threatening disease. However following successive approval of more and more targeted therapeutic products in the past decade, therapeutic efficacy for patients with cancer got dramatically improved, and the survival time got significantly prolonged. However, since cancer cells grow rapidly and prone to mutation, targeted therapy is still unsustainable. Substantial number of patients developed resistance to the therapy after treatment for over a period of time (from six to twevel months). Thus more effective and sustainable therapeutic drugs were needed. Following the approval of the first immunotherapeutic antibody (Ipilimumab) in 2011, six more this type of antibody drugs were approved thus far, marking the arrival of the era of tumor immunotherapy. In August of 2015, the former United States President Jimmy Carter announced that he had advanced cancer and would undergo treatment using Ketruda, an immunotherapeutic antibody targeting immune checkpoint PD-1. After treatment for about six months, the cancer cells were undetectable. Since then, more and more patients benefit from the same treatment. Accumulated cases confirmed that tumor immunotherapy will most likely be the promise for cure of cancer. Research and development of a new drug is time consuming and needs large amount of capital investment. On average, it usually costs ten years and 1 billion of dollars for successful development of a new drug. It can be failed at any stage of the development, and the odds of success are slim following the advancement of developmental stage. A significant number of clinical trials failed at the late stage, thus brought great financial loss and even bankrupt for some companies. Therefore, risk management is indispensible and necessary for mitigating the risk of drug development. This thesis will illustrate the research on the risk management for a new drug development at different stage in ImmuneOnco Biopharma Company. The contents of the research will include overview of the project, introduction of development stage, category and evaluation of the risk at different stages, and implement of the measure for risk management. The results of the research will guranttee the smooth implementation for the drug development and will help to make the company more competitive and substantially increase the value of company.
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