抗肝癌新药研发的风险管理研究

发布时间：2018-07-10 00:54

本文选题：肝癌 + 新药研发　；参考：《天津大学》2014年博士论文

【摘要】：肝癌是世界上第三大死亡癌症，是我国第二大发病恶性肿瘤。治疗肝癌的药物较少，近些年，FDA仅批准了索拉非尼作为肝癌治疗药物，这也说明肝癌药物研发存在众多风险。本文在肝癌特征分析及相应药物研发现状分析的基础上，提出了目前抗肝癌药物的研发风险。采用调查问卷的形式，针对不同人群及这些风险因素，提出相应对策，在此基础上设计了关于研发风险的系统软件，用以评价新药的研发风险，并对目前在研的药物进行了初步的风险评估。抗肝癌新药研发是一个复杂而动态的过程，通过调查问卷的形式，发现在研发阶段，技术创新能力、技术平台、技术寿命、生产操作人员的水平、药物筛选决策、信息沟通、融资风险和人才风险呈现发生概率大，影响程度大的趋势；在生产阶段原料供应和工艺设备风险占主要地位；在新药销售阶段市场占有率、竞争对手、商业运作和不良反应风险则起着决定作用。采用加权分析结合主成分分析的方法对新药研发的风险进行了量化分析，提高了分析的准确性。主要从环境、技术、生产、决策、财务、管理、市场七方面提出抗肝癌新药研发项目的风险应对策略。通过对抗肝癌新药研发现状的分析及风险评估等，最终设计了抗肝癌新药研发的风险管理流程。发现在创新药物的研发阶段，技术创新能力、技术服务平台、药物筛选决策等风险呈现发生概率大，影响程度大的趋势，，是企业在新药品种开发前需要优先要考虑的因素。鉴于创新药物研发阶段的风险评估在整个新药品种研发阶段中处于至关重要的地位，设计并创制了创新药研发评估系统，并对在研的5种新药，通过研发人员定期提交的文本材料，采用自动评估与领域专家选择性审核方式确定研发品种的进展情况。结果表明，抗肝癌药物CT102、中药5类抗癌新药白头翁皂苷及其制剂的研发成果优异，可在后期加大资金资助力度；SL01-一种吉西他滨前药，靶向抗肿瘤一类新药NX125两个项目进展顺利，应进一步加强实时跟踪；辽东id木叶总皂苷胶囊抗肿瘤新药项目课题的进展明显落后于其他类似课题，经过系统评估，此项目有必要及时中止，以进一步降低风险。
[Abstract]:Liver cancer is the third leading cancer in the world and the second most malignant tumor in China. There are fewer drugs to treat liver cancer, and in recent years the FDA has only approved Solafenib as a treatment for liver cancer, suggesting that there are many risks in the development of drugs for liver cancer. Based on the analysis of the characteristics of liver cancer and the current situation of drug research and development, this paper puts forward the research and development risk of antihepatoma drugs. In the form of questionnaire, the corresponding countermeasures are put forward for different population groups and these risk factors. On this basis, a systematic software on R & D risk is designed to evaluate the R & D risk of new drugs. A preliminary risk assessment of the drugs currently under study was also carried out. The research and development of new anti-liver cancer drugs is a complicated and dynamic process. Through the form of questionnaire, we find that in the research and development stage, the technological innovation ability, the technology platform, the technical life span, the level of the production operator, the drug screening decision, the information communication, Financing risk and talent risk show a trend of large occurrence probability and great influence degree; raw material supply and process equipment risk occupy the main position in the production phase; market share in the new drug sales phase, competitors, Business operations and adverse reaction risks play a decisive role. The method of weighted analysis combined with principal component analysis (PCA) was used to quantify the risk of new drug research and development, and the accuracy of the analysis was improved. This paper puts forward the risk response strategy of new drug development project of anti-liver cancer from seven aspects: environment, technology, production, decision making, finance, management and market. Based on the analysis and risk assessment of the status quo of new drug development against liver cancer, the risk management process of new drug development for anti-liver cancer was designed. It is found that in the stage of research and development of innovative drugs, technological innovation ability, technical service platform, drug screening decision and other risks present a trend of large probability and great influence, which is the first factor that enterprises should consider before the development of new drug varieties. In view of the critical position of risk assessment in the phase of research and development of innovative drugs throughout the research and development phase of new drugs, an evaluation system for the development and development of innovative drugs has been designed and created, and five new drugs under study have been designed and developed. The progress of R & D products is determined by automatic evaluation and selective audit of field experts through the regular submissions of R & D personnel. The results showed that CT102, a new anticancer drug of traditional Chinese medicine, had excellent results in the research and development of saponins and their preparations, and could increase financial support to SL01- a gemcitabine predrug in the later stage. The two projects, NX125, a new anti-tumor drug, are progressing smoothly, and real-time tracking should be further strengthened. The progress of the new anti-tumor drug project of id total saponins capsule in Liaodong is obviously lagging behind that of other similar projects, and has been systematically evaluated. It is necessary to stop the project in time to further reduce the risk.
【学位授予单位】：天津大学
【学位级别】：博士
【学位授予年份】：2014
【分类号】：R95

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