Research and Prospect of Quality Development of Pharmaceutical Technology in Drug Research and Development

Pharmaceutical technology is an indispensable and important link in drug research and development,which plays a key role in drug research and development quality.In the background of science and technology development,pharmaceutical technology has been greatly developed,but also to promote the quality of drug research and development,to provide more guarantee for people’s health.In the new era,how to achieve pharmaceutical technology innovation,so as to further improve the quality of drug research and development,is an important research topic in the current related industries.This paper mainly revolves around quality of pharmaceutical technology development of a series of exploration,in the traditional drug development based on a better control of drug quality,the future of smart pharmaceutical green pharmaceutical development direction,aims to further enhance the pharmaceutical technology,promote the quality of research and development to promote the comprehensive,promote the steady development of the pharmaceutical industry as a whole.

Application Research of Earned Value Management in New Drug Research and Development Projects

Objective To help investors assess and control the costs of new drug development and reduce the risks of new drug development projects.Methods Cost analysis and financial forecasting were carried out with the integrated approach of earned value management.According to the principle of earned value management deviation analysis,the basic process of the new drug research and development project was combined with the hypothesis method from the research of Tufts Drug Development Research Center.Results and Conclusion If the project progress check was carried out in the clinical trial,the project costs were found overspent,the efficiency was low,the project progress was faster,and the resource investment was ahead.It is recommended that the adjustment should be made to reduce the input of resources,and increase the efficient key personnel to take the place of some less efficient staff.

Analytic Hierarchy Process for Technological Risks in the Process of Innovative Drug Development in China

Objective To identify the critical risks in the process of innovative drug research and development,and to provide reference for improving the efficiency of innovative drug development and risk control in China.Methods Expert investigation and analytic hierarchy process were used to determine the weights of different risks.Results and Conclusion The research and analysis results showed that the risks at different stages of development had different effects on the success rate of drug development,among which the risk at the drug discovery stage influenced the most.In the drug discovery stage,inappropriate target selection had the greatest impact on the success rate of drug development.The lack of appropriate cell tissue or animal models had the greatest impact on the success rate of drug development from the discovery of a compound to the application for clinical trials.The difference in changes between nonclinical and clinical studies had the greatest impact on the success rate of drug development from early clinical studies to pivotal clinical studies.Incorrect dose selection had the greatest impact on the success rate of drug development from pivotal clinical studies to marketing authorization applications.The biggest impact from the marketing authorization application to the approval stage was inadequate communication with regulators.After investigating the weight of risk factors in the process of innovative drug development based on scientific methods,a new perspective for the risk control of new drug development and improving the research and development efficiency is provided.

A Review on the Research of Precision Medicine for Cancer Based on the Integration of Traditional Chinese and Western Medicine

Objective:To summarize and expound the general situation of precision medicine for cancer according to the current international research hot spots and treatment frontiers of cancer.Methods:This article makes an inventory from five aspects of treatment methods,detection technology,new drug research and development,information data and traditional Chinese medicine,"from point to surface","from outside to inside"and"integration of Chinese and Western medicine",to explore the whole picture of tumor treatment and research.Results:With the rapid development of tumor precision medicine in recent years,the tumor treatment methods have been developed from single to multiple.The research technology has been changed from macro to micro.The therapeutic drugs have been changed from systemic chemotherapy to targeted therapy,immunotherapy and other technologies.The treatment concept has been changed from local to overall.And the integrated treatment methods of traditional Chinese and Western medicine have brought a new chapter to tumor treatment.Conclusion:Through a series of new technologies,new methods and new concepts,tumor precision medicine promotes the treatment of tumors with integrated Chinese and Western medicine into a new chapter.

Analysis of Strategy for Extending Patent Protection of Rucaparib

As a knowledge-intensive and promising strategic emerging industry, the biomedical industry has high entry thresholds, large R&D investment, long cycle, high risk and high return. In all technical fields, the biomedical industry has the highest dependence on intellectual property rights, and the protection of pharmaceutical intellectual property rights by domestic and foreign biomedical enterprises also runs through the whole process of drug research and development. Extending the patent protection period of drugs as well as forming and strengthening patent fortresses requires a patent network that surrounds drugs to maximize the value of intellectual property protection, which is also the focus of every pharmaceutical company with patent rights. By analyzing the patent portfolio of Clovis Oncology Company in the United States on Rucaparib and the patent portfolio of other companies or applicants on Rucaparib, we can have a clearer understanding of the strategy of extending the patent protection period of a new drug product.

ETCM v2.0:An update with comprehensive resource and rich annotations for traditional Chinese medicine

Existing traditional Chinese medicine(TCM)-related databases are still insufficient in data standardization,integrity and precision,and need to be updated urgently.Herein,an Encyclopedia of Traditional Chinese Medicine version 2.0(ETCM v2.0,http://www.tcmip.cn/ETCM2/front/#/)was constructed as the latest curated database hosting 48,442 TCM formulas recorded by ancient Chinese medical books,9872 Chinese patent drugs,2079 Chinese medicinal materials and 38,298 ingredients.To facilitate the mechanistic research and new drug discovery,we improved the target identification method based on a two-dimensional ligand similarity search module,which provides the confirmed and/or potential targets of each ingredient,as well as their binding activities.Importantly,five TCM formulas/Chinese patent drugs/herbs/ingredients with the highest Jaccard similarity scores to the submitted drugs are offered in ETCM v2.0,which may be of significance to identify prescriptions/herbs/ingredients with similar clinical efficacy,to summarize the rules of prescription use,and to find alternative drugs for endangered Chinese medicinal materials.Moreover,ETCM v2.0 provides an enhanced Java Script-based network visualization tool for creating,modifying and exploring multi-scale biological networks.ETCM v2.0 may be a major data warehouse for the quality marker identification of TCMs,the TCM-derived drug discovery and repurposing,and the pharmacological mechanism investigation of TCMs against various human diseases.