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.

Study on the Changes of Medical Income Structure in Governmentrun Hospitals of Traditional Chinese Medicine from 2012 to 2021

Objective To study the changing characteristics and trend of medical income structure in the government-run hospitals of traditional Chinese medicine(TCM),evaluate the effects of relevant reform measures,and to put forward corresponding suggestions for further optimizing their income structure.Methods The data related to the average medical income of government-run hospitals of TCM from 2012 to 2021 were sorted out.Then,descriptive analysis method was used to analyze the changes of related indicators.Besides,structural change method was applied to investigate the changes of outpatient income and inpatient income.Results and Conclusion From 2012 to 2021,the growth of medical income in government-run hospitals of TCM tended to be stable,and the proportion of medical service income increased from 22.62%(2012)to 29.38%(2021),but the average annual growth rate was only 0.68%.The main items that caused the change of outpatient income structure were medicine revenue,laboratory tests,diagnosis and treatment,and the cumulative contribution rate was 89.15%.The main items that caused the change of inpatient income structure were medicine revenue,sanitary materials,and auxiliary examinations income,with a cumulative contribution rate of 80.04%.However,the contribution rate of registration,diagnosis,treatment,surgery and nursing income reflecting the value of medical personnel’s technical labor was relatively small.The medical income structure of government-run hospitals of TCM underwent great changes and gradually became reasonable,but the medical service income increased slowly,and not all indicators achieved the expectations.To promote the sustainable development of public hospitals of TCM and enable them to provide high-quality and efficient TCM medical and health services,it is necessary to further improve the relevant policy mechanism.

Comparison of the Development Model of DTP Pharmacy between China and the United States and Its Enlightenment

Objective To systematically analyze the development status of DTP pharmacy in the United States and China,and to find out the problems in China’s DTP pharmacy and put forward some countermeasures and suggestions.Methods Relevant literature was searched and reviewed to study the history,market scale and development trend of DTP pharmacy in the United States and China.Then,the problems in China’s DTP pharmacy were found out.Results and Conclusion DTP pharmacy model in the U.S.has taken shape and is maturing.The high degree of industry concentration is an important feature of the U.S.pharmacy.In contrast,China’s DTP pharmacy started late,and the industry pattern has not yet been finalized.There are still some problems in the DTP pharmacy certification and quality management.It is recommended to promote the rapid development of DTP pharmacies in China by encouraging the outflow of prescription drugs,establishing a third-party pharmacy accreditation organization and strengthening the team of licensed pharmacists and other personnel.

Game Analysis of Regulation for Online Prescription Drugs under Customer Feedback Mechanism

Objective To study the way to better regulate the online sales of prescription drugs,and to provide reference for the adjustment of relevant policies since the online sales of prescription drugs has become an inevitable trend.Methods A game model was constructed for the strategy choice of pharmaceutical e-commerce platform,customers and government departments based on differential game theory and Nash equilibrium game model to analyze the pure strategy Nash equilibrium,Nash equilibrium dominant strategy of each subject and the mixed strategy Nash equilibrium under different conditions.Besides,Matlab was used to carry out simulation analysis.Results and Conclusion The study shows that:(1)Improving the credibility of the government and reducing the cost of government regulation can not only make the pharmaceutical e-commerce platform operate with high quality,but also give greater play to government functions;(2)The greater the influence of social evaluation on pharmaceutical e-commerce platforms,the lower the cost of high-quality operation of pharmaceutical e-commerce platform,and the greater the probability of customer choosing real evaluation strategy;(3)The greater the customers’perception of potential risk,the greater the compensation,and the lower the cost of reporting.Then,the greater the probability that government departments will choose strict regulation.Finally,the model solution and simulation analysis are combined to provide countermeasures and suggestions for the safety regulation of online sales of prescription drugs.

Analysis of Technical Intelligence of Tumor Cell Therapy Based on Patent Map

Objective To analyze the technical information in the field of tumor cell therapy in China,and to provide reference for identifying technical trends and predicting technical opportunities.Methods Based on the patent data in the field of tumor cell therapy in China,the patent map method was used to construct a scientific technical information analysis model.Then,the technical status of new drug research and development in this field was explored to identify technical opportunities.Results and Conclusion Studies have found that China’s tumor immunotherapy is in the growth stage.The technical innovation regions are mainly distributed in the east and innovative entities are enterprises.Technology hotspots are concentrated in areas such as A61P35,C12N5,and the patented technical efficacy is high.Besides,the technical research and development opportunities identified are closely related to the background in this field.To better promote the development of the industry,enterprises and research institutions should strengthen cooperation in technological innovation Meanwhile,they should pay attention to technical efficacy analysis to identify more technical opportunities,thereby effectively guiding innovation strategic decisions.

Research on the Threshold Effect of China’s Pharmaceutical Export Trade on Internal and External R&D Investment

Objective To study the threshold effect of export trade on internal and external R&D investment in China’s pharmaceutical industry,and to provide reference for some pharmaceutical enterprises to improve the investment.Methods The panel data of pharmaceutical industry in 25 provinces and cities in China from 2009 to 2019 were selected to conduct empirical analysis by establishing a threshold regression model,and a better export trade interval was obtained.Results and Conclusion There is a threshold value for the effect of new product export on both internal and external R&D expenditures,and the threshold values are 845.2788 million yuan and 318.4198 million yuan,respectively.There is a single threshold effect of export trade on both internal and external R&D investment in China’s pharmaceutical industry,and the effect of export trade on internal and external R&D investment changes from negative to positive as the export trade develops from low to high.

An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China

Objective To provide suggestions and a reference for improving the quality management system of clinical trials of therapeutic vaccines and promoting the development of therapeutic vaccines in China.Methods Literature research,case study and comparative study were used to analyze the quality management system of clinical trials of therapeutic vaccines.Results and Conclusion From the perspective of the sponsor,investigators and the thirdparty technical service company,the problems such as the low efficiency of clinical trial sample preparation and the lax implementation of the protocol by hospital departments in the quality management of clinical trials of therapeutic vaccines in China were found.Then,the optimization plan for the quality management of clinical trials of therapeutic vaccines is proposed,including optimizing the preparation process of therapeutic vaccines and strengthening the training of hospital department personnel.

An Exploration of Organizational Development in the Process of Innovation and Transformation of Pharmaceutical Enterprises-Taking X Pharmaceutical Enterprise as an Example

Objective To study how to promote the smooth innovation and transformation of enterprises and enhance the market competitiveness of enterprises from the perspective of human resources organization development.In the wave of pharmaceutical industry reform,some entrepreneurs realize the importance of innovation and technology in the future.However,domestic pharmaceutical enterprises are still in the production-oriented stage.In the process of transformative innovation,pharmaceutical enterprises should not only rely on the support of scientific and technological and economic forces,but also need a suitable organizational change and many excellent talents as the source of development.Methods Through retrieving relevant literature and combined with the organizational development practice of X pharmaceutical enterprise,the organizational development model was explored in this paper.Results and Conclusion By forming a system of strategy,organization,talent,culture and mechanism,and building an organizational development model,we can improve the organizational atmosphere and organizational efficiency in the process of enterprise innovation and transformation,so as to enhance the competitiveness of enterprises in the market.

Digital Transformation Trend of the Pharmaceutical Distribution Industry in the Context of New Infrastructure in China

Objective To study the pharmaceutical distribution industry against the background of new infrastructure construction since it is vital to the health and life of the public,and to offer some suggestions to further improve the industry quality and achieve industry upgrading.Methods The national strategies for new infrastructure as well as the underlying logic for enterprise digital transformation were analyzed to provide the outlook on the digital transformation trend of the pharmaceutical distribution industry.Results and Conclusion In the future,the pharmaceutical distribution industry shall transform the pattern,channel,management and control,and experience in the entire business chain in a digital way by focusing on connection efficiency,data efficiency and decision-making efficiency.

Comparative Study on the Policy of Multiplicity Issues in Clinical Trials at Home and Abroad

Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the similarities and differences of the guiding principles of US Food and Drug Administration(FDA),European Medicines Agency(EMA),and National Medical Products Administration(NMPA)on the multiplicity issues in clinical trials were compared one by one.Results and Conclusion In general,NMPA guidelines are based on ICH E9,but in detail,the guidelines of FDA and EMA focus differently on the multiplicity issues.Therefore,NMPA guidelines need to be detailed and comprehensive.NMPA guidelines can be refined by referring to foreign guidelines to improve the practical guiding significance for clinical research and promote the level of domestic clinical trials in line with international standards.

Analysis of Drug Medical Insurance Access Pricing Based on the Perspective of Binary Equilibrium

Objective To study the influencing factors in the process of national medical insurance negotiation and drug pricing from the dualistic equilibrium perspective,and to provide reference for the harmonious management of drug pricing in China.Methods Through the literature analysis and policy review,the pricing subject,pricing basis and price control system in the pricing process of medical-accessed medicines were analyzed from the perspective of binary equilibrium and harmonious management.Results and Conclusion It is found that four balances in the drug pricing process,two balances in pricing basis and three balances in price control system need to be considered,respectively.Drug pricing is the key content of national medical insurance access,which is also the hotspot of the policy in the pharmaceutical fields in recent years.Drug pricing not only reflects the value of drugs,but also reflects a lot of top-level designs of binary equilibriums in medical insurance policy.While the rational design of drug pricing requires the joint efforts of the government,pharmaceutical companies and relevant experts to comprehensively consider many equilibriums,so as to improve the relevant systems.

Comparative Analysis of Profit Model of Typical Pharmaceutical O2O Enterprises in China

Objective To study the profit model of Chinese pharmaceutical O2O enterprises.Methods A case study of three typical pharmaceutical O2O enterprises was conducted,and their profit models were compared.Results and Conclusion The pharmaceutical O2O enterprises in China are divided into three categories according to the profit models.It is found that the current pharmaceutical O2O enterprises have problems such as simple profit model and low corporate profits.Based on these problems,it is recommended that relevant enterprises develop various business models to increase profit channels.Besides,they should establish and improve internal cost control systems.

Research on the Status Quo and Optimization of Centralized Procurement of Coronary Stents

Objective To study the impact of the first national centralized procurement of coronary stents on patients’psychology,the economy of medical institutions,and the survival and development of the coronary stents industry,and to provide suggestions on perfecting procedures to better carry out the centralized procurement of coronary stents.Methods Literature analysis was used to investigate the results of the procurement of coronary stent in a province and a hospital.Results and Conclusion The centralized procurement of coronary stents has alleviated the economic pressure of patients,but it has many problems.Therefore,this paper proposes some suggestions,such as promoting the orderly development of the coronary stent industry,improving the evaluation link of the centralized procurement of coronary stents,adopting the accurate reporting model to ensure the quality of coronary stents and improving the standardization of clinical services.

Analysis of Patent Application Status of Scutellaria Barbata Industrial Chain Based on Patent Data

Objective To analyze patent application status of Scutellaria Barbata industrial chain and provide some suggestions for its patent application and product development.Methods Patent data were collected through IncoPat patent analysis system.Meanwhile,the patent analysis method combined with text mining method was adopted to analyze the situation and development trend of patent application in China’s Scutellaria Barbata industrial chain by using pie chart,bubble chart,trend chart and other visual charts to display the results.Results and Conclusion The patent application of Scutellaria Barbata in China mainly experienced three stages:Slow development,rapid development,and recession period.The number of patents is large,but the authorization rate is low.Individuals and enterprises are the main applicants for patent applications.Product development is involved in the whole industrial chain,but it basically focuses on its efficacy in downstream drugs,health food and other aspects.Therefore,government should enhance the awareness of patent protection,encourage collaborative innovation in industry-university-research to promote the combination of basic research and market application.Besides,it should provide theoretical support to tackle the problem of short board products,which can promote the transformation of scientific and technological achievements and contribute to the upgrading of Scutellaria Barbata industrial chain.

Research on the Status Quo and Countermeasures of Human Resource Management Outsourcing in China’s Pharmaceutical Enterprises

Objective To explore the current situation of human resource management outsourcing in China’s pharmaceutical enterprises,and to put forward some suggestions for enterprises and the government.Methods The current situation of human resource management outsourcing in China’s pharmaceutical enterprises was analyzed through the method of literature research.Results and Conclusion At present,the status of human resource management outsourcing in China’s pharmaceutical companies is that the level of human resource outsourcing companies is not high,and there are no relevant industry norms and laws.The information asymmetry between pharmaceutical enterprises and outsourcing companies results in adverse selection and moral hazard.Besides,the different culture of pharmaceutical enterprises and outsourcing companies leads to inefficient communication between enterprises and employee.To solve these problems,the government should promote and improve industry norms and laws to regulate the market.In addition,enterprises should clarify the motivation for outsourcing and make good decision on the outsourcing content.Meanwhile,enterprises should strengthen communication with employees to eliminate employees’concerns.

Identifying and Managing Technical Risks in the Process of Innovative Drugs Development in China

Objective To identify technical risks in the process of innovative drug development,and to provide reference for technical risk management so as to reduce the uncertainties and improve the efficiency of research and development.Methods The initial risk index was investigated by literature research.Then,the Likert scale was used to design a questionnaire,and the experts’opinion was used to analyze the risk factors affecting the different stages of the development of innovative drugs in China.Results and Conclusion Based on the analysis of questionnaire,31 risk indicators of five key stages in the development of innovative drugs from drug discovery to marketing authorization were established.The key risk indicators constructed in this study can provide reference for technology-related risk management in the process of innovative drug development.

Improving the Selection Model of Essential Medicines in China by Evidence-based Thinking

Objective To sort out the problems in the selection model of essential medicines in China,and to put forward some suggestions to optimize the selection model to ensure the rationality of the medicines in the essential medicines list.Methods The domestic and foreign literature on the selection of essential medicines was reviewed.Then,the opinions on the selection methods and results of essential medicines from foreign literature were investigated to make a comparison with the selection of essential medicines in China.Finally,the general and special laws of the selection process of the essential medicines were explored.Results and Conclusion It is recommended that the selection model of essential medicines in China should be further optimized,and the evidence-based thinking and methods should be utilized to enhance the scientific nature of the selection process.

Journal Introduction

AJSP has been founded jointly by Shenyang Pharmaceutical University and Hongkong Shengjing Pharmaceutical Publishing&Media Co.,Limited.The journal is published by Hongkong Shengjing Pharmaceutical Publishing&Media Co.,Limited.

Research and Enlightenment of Text Mining Applications in ADR from Social Media

Objective To discuss how to use social media data for post-marketing drug safety monitoring in China as soon as possible by systematically combing the text mining applications,and to provide new ideas and methods for pharmacovigilance.Methods Relevant domestic and foreign literature was used to explore text classification based on machine learning,text mining based on deep learning(neural networks)and adverse drug reaction(ADR)terminology.Results and Conclusion Text classification based on traditional machine learning mainly include support vector machine(SVM)algorithm,naive Bayesian(NB)classifier,decision tree,hidden Markov model(HMM)and bidirectional en-coder representations from transformers(BERT).The main neural network text mining based on deep learning are convolution neural network(CNN),recurrent neural network(RNN)and long short-term memory(LSTM).ADR terminology standardization tools mainly include“Medical Dictionary for Regulatory Activities”(MedDRA),“WHODrug”and“Systematized Nomenclature of Medicine-Clinical Terms”(SNOMED CT).

Research on Construction of Pharmacovigilance System for Marketing Authorization Holders in China

Objective To provide suggestions for helping marketing authorization holders(MAHs)to develop an effective and compliant pharmacovigilance system.Methods The construction strategies of pharmacovigilance system of the multinational pharmaceutical companies were analyzed based on the requirements of regulations and laws.Results and Conclusion There are some gaps between local and multinational pharmaceutical companies in the construction of pharmacovigilance system.We can learn from the experience of multinational pharmaceutical companies to improve the pharmacovigilance system,which includes building a sound pharmacovigilance organizational structure,establishing a series of operational system files and cultivating professional talents.MAHs of China should improve the structure of enterprise pharmacovigilance system.Besides,members of Drug Safety Committee should be department managers with higher position so that they can fulfil the responsibilities of risk assessment.If MAHs possess a large variety and quantity of products,a Drug Safety Committee should be established to ensure the timely discovery of risks.In addition,MAHs should pay attention to the implementation of related regulations and laws on pharmacovigilance and establish compliant,effective and operatable files combing with the actual operation of pharmacovigilance system.Finally,MAHs should introduce and train pharmacovigilance talents,and hire pharmacovigilance experts as consultants to solve the problem of talent shortage.