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.

Overview of Research and Development for Anticancer Drugs

Anticancer drugs research and development have been the largest market area in the pharmaceutical industry in terms of the number of project, clinical trials and spending. In the last 10 - 30 years, targeting therapy for cancers has been developed and achieved enormous clinical effectiveness by transforming some previously deadly malignancies into chronically manageable conditions, but cure problem still remains. This mini review outlined the current status of anticancer drugs development and hinted the opinions of how to further increase the accuracy and efficacy of discovery for cancer treatment.

Problems and Measures in Internal Control and Risk Management of Drug Research and Development Enterprises

The internal control and risk managementof drug research and development enterprises directlyaffects the survival and development of enterprises.With the development of information technologyand the integration with the global economy,pharmaceutical companies are able to achieve moreachievements in development while facing increasingcompetitive pressures. Finance is a pivotal spine of acompany’s development. If the internal control andrisk management of a company are not complete andcomprehensive, the enterprise will inevitably turn intoa crisis. Therefore, it is necessary to strengthen theanalysis of the problems in the internal control andrisk management of drug research and developmententerprises, and propose corresponding solutions.

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.

PROGRESS OF RESEARCH IN THE PREPARATION OF CHINESE TRADITIONAL AND HERBAL DRUGS WITH ANTICANCER ACTIVITY

Research into anticancer substances madefrom Chinese herbal drugs and their clinicalapplication is gaining international attention bythe medical profession of the more than 20analogues of camptothecine isolated from Camp-totheca tree in China, most exhibited anticanceractivity. Among them, 10-hydroxycamptothe-cine has a wide anticancer spectrum and is lesstoxic. In suspension, it exhibits some therapeu-tic effects on primary hepatic cancer, gastriccarcinoma, cancer of the urinary bladder andleukemia.

Risk Control Strategy in the Research and Development of Pediatric Drugs

Objective To analyze the risk control strategy in the research and development of pediatric drugs and to provide references for pharmaceutical enterprises to avoid the risks so that they can produce more and much better drugs for children in China. Methods An expert questionnaire and expert interviews were conducted to identify the specific risks and the key factors, and valuable advices were put forward. Results and Conclusion There are four risk factors in the research and development of pediatric drugs. The first is that parents are concerned and they are unwilling to allow their children to participate in drug trial. Secondly, adult drug safety data cannot support pediatric drug study. Thirdly, pediatric drugs often have adverse events. Last, regulations for pediatric drugs clinical trials are not perfect. Some valuable recommendations are provided to control these risks.

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.

ON THE POSITION AND ROLE OF BASIC RESEARCH EXEMPLIFIED BY THE DEVELOPMENT OF THE DRUG "DI'AOXINXUEKANG

Basic research features its indelible contribution to and energetic promotion of scientific cause and advancing social progress. This article explores its vital position and rewarding role in creating socio-economic benefits by reviewing the development and marketing success of a new drug, "Di’ aoxinxuekang".

Opinion on pharmacology research and new drug development from precision medicine

Since President Obama announced the Precision Medicine Initiative from a national strategy perspective in his State of the Union address,precision medicine has rapidly become a world-wide hotspot and drawn global attention in the medical field.Precision medicine aims at applying genetic information of individual diseases to guide his or her diagnosis and treatment.

Progress in the development and application of plant-based antiviral agents

Plant virus disease is one of the major causes of biological disasters in agriculture worldwide. Given the complexity of transmission media and plant disease infection mechanisms, the prevention and control of plant viral diseases is a great challenge, and an efficient green pesticide is urgently needed. For this reason, when developing candidate drug leads to regulate plant viruses, pesticide experts have focused on characteristics such as low pesticide resistance, eco-friendliness, and novel mechanism. Researchers have also theoretically investigated the molecular targets of viruses infecting agricultural crops. Antiviral screening models have been constructed based on these molecular targets, and the mechanisms of commercial drugs and high-activity compounds have been extensively investigated. After screening, some compounds have been applied in the field and found to have good commercial prospects; these drugs may be used to create new green antiviral pesticides to control plant viruses. This paper reviews the screening, mode of action, development and application of recently used plant-based antiviral agents.

Global trends in diabetic eye disease research from 2012 to 2021

Diabetic eye disease refers to a group of eye complications that occur in diabetic patients and include diabetic retinopathy, diabetic macular edema, diabetic cataracts, and diabetic glaucoma. However, the global epidemiology of these conditions has not been well characterized. In this study, we collected information on diabetic eye disease-related research grants from seven representative countries––the United States, China, Japan, the United Kingdom, Spain, Germany, and France––by searching for all global diabetic eye disease journal articles in the Web of Science and Pub Med databases, all global registered clinical trials in the Clinical Trials database, and new drugs approved by the United States, China, Japan, and EU agencies from 2012 to 2021. During this time period, diabetic retinopathy accounted for the vast majority(89.53%) of the 2288 government research grants that were funded to investigate diabetic eye disease, followed by diabetic macular edema(9.27%). The United States granted the most research funding for diabetic eye disease out of the seven countries assessed. The research objectives of grants focusing on diabetic retinopathy and diabetic macular edema differed by country. Additionally, the United States was dominant in terms of research output, publishing 17.53% of global papers about diabetic eye disease and receiving 22.58% of total citations. The United States and the United Kingdom led international collaborations in research into diabetic eye disease. Of the 415 clinical trials that we identified, diabetic macular edema was the major disease that was targeted for drug development(58.19%). Approximately half of the trials(49.13%) pertained to angiogenesis. However, few drugs were approved for ophthalmic(40 out of 1830;2.19%) and diabetic eye disease(3 out of 1830;0.02%) applications. Our findings show that basic and translational research related to diabetic eye disease in the past decade has not been highly active, and has yielded few new treatment methods and newly approved drugs.

A comprehensive review of 3D cancer models for drug screening and translational research

The 3D cancer models fill the discovery gap of 2D cancer models and play an important role in cancer research.In addition to cancer cells,a range of other factors include the stroma,density and composition of extracellular matrix,cancer-associated immune cells(e.g.,cancer-associated fibroblasts cancer cell-stroma interactions and subsequent interactions,and a number of other factors(e.g.,tumor vasculature and tumor-like microenvironment in vivo)has been widely ignored in the 2D concept of culture.Despite this knowledge,the continued use of monolayer cell culture methods has led to the failure of a series of clinical trials.This review discusses the immense importance of tumor microenvironment(TME)recapitulation in cancer research,prioritizing the individual roles of TME elements in cancer histopathology.The TME provided by the 3D model fulfills the requirements of in vivo spatiotemporal arrangement,components,and is helpful in analyzing various different aspects of drug sensitivity in preclinical and clinical trials,some of which are discussed here.Furthermore,it discusses models for the co-assembly of different TME elements in vitro and focuses on their synergistic function and responsiveness as tumors.Furthermore,this review broadly describes of a handful of recently developed 3D models whose main focus is limited to drug development and their screening and/or the impact of this approach in preclinical and translational research.

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.

新药研究与开发课程思政教学探索

在新药研究与开发课程教学中融入课程思政理念,将其与学科教学内容融合,发挥思政课程与课程思政的协同效应,是以专业技能知识为载体开展育人工作的必由之路。这一教学改革可有效推进以创新为核心的学生综合能力培养,是成功实现“健康中国”战略下复合型药学人才培养的有效途径。

医疗机构基于“三结合”中药新药研发及管理体系的构建

目的:在中药审评审批制度改革的政策背景下,围绕医疗机构,探索中医药理论、人用经验和临床试验相结合(简称“三结合”)的审评证据体系落地举措,为医疗机构中药制剂及中药新药研发提供参考。方法:根据“三结合”审评证据体系下中药新药研发的相关要求,从机构层面加强人用经验研究相关配套建设,从管理层面搭建中药研发、成果转化服务平台,从临床层面规范开展人用经验研究,构建医疗机构中药新药研发及管理体系。结果:医疗机构中药新药研发及管理体系的构建,有助于将临床诊疗数据转变为支持中药新药注册的人用经验证据,通过提高中药研发水平促进中药新药转化。结论:在医疗机构构建基于“三结合”的中药新药研发及管理体系,是“三结合”审评证据体系落地、政策引导研发实践的路径之一。

同质化教学条件下参与科研创新实践对临床药学专业本科生新药研究与开发课程成绩的影响

大学生参与科研创新实践是高校人才培养的重要环节。本文收集某高校临床药学专业本科生参与科研创新实践的信息,分析同质化教学条件下参加科研创新实践对其在新药研究与开发课程中成绩的影响。结果表明,参加科研创新实践可以有效提升临床药学专业本科生新药研究与开发课程成绩,提高其对基本概念的理解能力和科研实验设计能力。

平行药物系统:基于大语言模型和三类人的框架与方法

近年来,随着物联网、大语言模型、多模态交互等新一代人工智能技术的迅猛发展,传统的药物研发、生产加工等过程面临着智能化转型的挑战。为此,以平行智能为理念,基于ACP方法和大语言模型提出了虚实交互的平行药物系统,并将三类人(数字人、机器人和生物人)的概念引入系统中,详细阐述了该系统的理论框架与构建方法。平行药物系统涵盖医药产业的全流程,药物研发阶段考虑了药物发现、实验室研究、临床试验等过程;药物生产加工阶段考虑了制药工厂运行、系统分析预测等方面;药物医疗保健阶段考虑了个性化用药咨询、增强现实用药指导、隐私安全等内容。平行药物系统打造了一个数字化的“药物空间”,旨在建立药物系统的新范式,推动智能化药物的革命。

肠道类器官在肠疾病机制研究中的运用

肠道类器官由来自肠道的隐窝或干细胞在培养基质的三维(3D)支撑下构建形成,含有肠道的所有成熟细胞,已经成为研究肠道疾病机制全新且高效的平台。相较于二维(2D)细胞培养,肠道类器官不仅可以更加有效地模拟肠道的生理结构与功能,还可以在不同体外环境下更好地还原肠道的真实生态,因此在不同肠道疾病的发病机制研究中应用更为广泛。本文介绍了肠道类器官培养方式的新进展,综述了近年来肠道类器官在炎症性肠道疾病、结肠直肠癌和乳糜泻发病机制研究中的运用及进展,同时讨论了肠道类器官在药物研发与筛选方面的应用。

氢氧化镁阻燃剂的制备工艺研究进展与发展趋势

介绍了氢氧化镁(MH)阻燃剂的应用特点和作用机理,综述了MH阻燃剂的制备方法,包括物理粉碎法和化学合成法(固相法、气相法、液相法),着重介绍了液相法中的直接沉淀法、溶剂热及水热法、沉淀-共沸蒸馏法、超声化学法和微波辅助法。结合MH阻燃剂的工业应用特点,从微细纳米化、表面改性、多种制备工艺融合化研究、复合协同化和固体废弃物制备MH等5个方面对MH阻燃剂的未来发展趋势进行了展望。