Research On The Risk Management Of Anti-hepatocarcinoma Drug R&D

Hepatocellular carcinoma (HCC) is the third leading cause of cancer-relatedmortality globally and the second most frequentlydiagnosed cancer in China.However, there are few drugs for treatment of liver cancer and sorafenib is the onlyone approved chemotherapy drug by FDA, which show many risks for the researchand development (R&D) of anti-liver cancer. Based on the characteristics ofhepatocellular carcinoma and the analysis of the status of the current anti-liver cancerdrug, we raised the risks of the research and development of anti-hepatoma drug. Weproposed countermeasures for different pepole and the risk factors by form ofquestionnaire. On the basis, we designed the system software for the risk of the drugR&D and conducted the preliminary risk assessment for the current research drugs.Anti-hepatocarcinoma drug R&D is a complex and dynamic process. Technologyinnovation, technology platforms, technical life, the level of production operators,drug screening decision-making, communication, finance and personnel risk showhigh-stakes with high probability and high degree in the development stage by thequestionnaires analysis. The supply of raw materials and process equipment riskspredominate in the production phase. Drug sales competitors, business operations andthe risk of adverse reactions play a decisive role in the stage of market share.In order to improve the accuracy of the analysis, the risk of drug R&D wasquantified by the weighted analysis combined with principal component analysisapproaches. The strategies for the research and development of anti-liver cancer drugwere proposed from seven apects including environmental, technical, production,decision-making, finance, management, and marketing. The risk managementprocesses for the research and development of anti-liver cancer drug was disigned bythe analysis and risk assessment of status of new drugs against liver cancer. Theresearch and development stage, technological innovation, technology servicesplatform, and drug screening decisions of innovative drug show large probability andinfluence, which are the factors to be considered for company priorities before thenew drug product R&D.In view of crucial position of the new drug R&D risk assessment, it is designedand created the innovative drug evaluation system in the study of five kinds of drugs. Researchers regularly submit text material, automaticly assess and develop a selectiveway to determine the progress of the audit varieties. The results showed that there is agood perspective in the anti-hepatoma drugs CT102and Pulsatilla saponin with itspreparation. In the future, it should be increased for their financial assistance. Anothertwo prodrugs including a prodrug of gemcitabine SL01and a class of targetedanti-tumor drug NX125progress well too. They should be further strengthen in thefurther real-time tracking. In contrast, the R&D progress of Konoha Aralias totalsaponins capsules seems lagged behind other similar topics. Through systematicassessment, it is necessary to promptly suspend this project for its further reducingrisk.