浅谈模仿创新在我国制药企业发展中的应用

目的讨论模仿创新在我国制药企业发展中的应用。方法通过对模仿创新内涵的阐释和我国制药企业现状的描述,分析目前我国制药企业发展中应用模仿创新战略的必要性,并在此基础上提出现阶段具体可行的模仿创新策略。结果及结论我国制药企业现阶段更适合模仿创新战略。在具体的应用中应着重考虑积极的跟随策略、合理的专利利用策略、资源的集中投入策略三大战略。     

浙江亚东制药实施"品种创新工程"赢得快速发展

创建不到10年就已成为国家重点高新技术企业、全国中成药生产企业50强和国内率先整厂动态通过国家GMP认证而闻名省内外的浙江亚东制药有限公司,确立科技强企的发展战略,实施观念、品种、技术和管理全面创新的创新工程。公司坚持在创新中发展,在发展中创新,并且始终依靠科技进步和品种创新,不仅使企业拥有一批临床疗效显著、市场适销对路的产品,还以其强大的市场竞争力推动市场需求,使企业的持续发展具有源源不断的动力。1品种创新是企业生存和发展之本浙江亚东制药在短短几年中实现了跳跃式发展,是全面实施品种创新工程的结果。几年来,公…     

医药第三方物流——多仓联网联动发展模式探析

当前加快我国医药第三方物流发展是流通领域必然形势。探讨医药流通企业发展创新模式问题十分迫切。笔者采用参考文献阅读分析的方法,总结当前医药第三方物流中多仓联网联动模式的发展状况,通过资料对该创新模式进行切实分析。其结论是尽管多仓联网联动模式在我国还处于尝试阶段,但发展该模式是大势所趋,有利于提高医药流通企业的配送效率及经济效率。而相关政府管理部门和企业应该引起重视并给予推助。     

基本药物制度对中国制药企业创新战略的影响研究

基本药物制度及相关配套措施的实施将会对中国制药企业创新动力及创新环境等方面产生巨大的影响。本文通过对基本药物制度相关内容的分析,揭示了基本药物制度对制药企业创新的影响,并在此基础上提出了制药企业的战略选择和建议。     

我国中小型医药经营企业的SWOT分析及发展策略

本文通过探究九洲通公司在医药商业模式中的创新,引出对中小型医药经营企业该如何生存与发展的思考。并在SWOT分析的基础上,针对我国中小型医药经营企业的现状提出了切实可行的应对方案。     

北京生物医药产业创新发展评价研究

生物医药产业是北京重点发展的战略性新兴产业之一,建立北京生物医药产业创新发展指数体系,对于分析和评价产业创新发展情况具有参考价值.本文以企业为主体,从创新环境、创新投入、创新产业、创新绩效4个维度,选取8个二级指标、20个三级指标,分析评价了2009～2012年北京生物医药产业创新发展情况.结果表明2009年以来北京生物医药产业创新能力稳步提升,在创新环境、创新投入、创新产出、创新绩效4个领域均取得了积极进展.     

疫苗研发的技术创新模式

目的:为疫苗生产企业技术创新提供参考。方法:通过比较3种技术创新模式即自主创新、模仿创新和合作创新的优缺点,提出疫苗生产企业技术创新的主要模式及选择。结果与结论:3种创新模式各有优缺点,据此总结出采用"自主创新为主导,合作创新求发展,模仿创新为辅助"的技术创新模式,并建议各企业应根据自身发展情况而进行不断的调整。     

以科技创新增强企业市场竞争力的管理

文章分析了广州白云山中药厂以科技创新增强企业竞争力的管理实施背景和成果内涵、原理,祥实地介绍了其实施过程。通过实施以科技创新增强企业市场竞争力的管理,广州白云山中药厂取得了明显的成效,一举改变了企业落后的面貌,经济效益迅速增加,综合实力大为提高。     

基于博弈论的我国制药工业创新驱动研究

目的通过对创新驱动战略的意义和我国制药工业现状进行分析,找到我国制药工业实施创新驱动战略的主要障碍,为相关部门提供政策建议。方法建立博弈模型,分析我国制药企业创新决策的现状。结果与结论医药不分是我国制药企业实施原研型创新的最大障碍,故医药分业是必要的。只有实行医药分业,制药企业才能选择原研型创新,从而有利于我国创新驱动战略的实施。     

全球化视野下：用高科技显微镜透视中国医药行业发展态势——同仁堂：依托技术创新提升企业文化和竞争品牌

一个企业的技术风格和产品风格展示的是企业文化，在高科技产业竞争的新形势下，创新企业文化和提升产品竞争力将在更大程度上取决于高科技的运用和革新。在医药行业中，同仁堂属于关乎生命健康的创新导向型企业。同仁堂的文化创新，同样需要通过技术创新特别是产品创新来展示。在科技革命的新时代下，同仁堂的文化意识和品牌理念也随之不断发展创新。同仁堂正是在科技创新的基础上围绕中医药传统中医文化：这个中心实施品牌战略来迎接激烈的竞争。对此，北京同仁堂(集团)有限责任公司总经理梅群详谈企业文化和品牌发展的创新之路——     

The comprehensive influence of firm-level factors on drug product internationalization of Chinese pharmaceutical firms

Drug product internationalization (DPI) can be affected by multiple firm-level factors. However, existing studies mainly focus on a single or several factors and the deviation generated by the factors’ effects on each other has been neglected. We aimed to study the comprehensive influences of firm-level factors on Chinese pharmaceutical firms that chose the DPI mode. Student’s t tests and Chi Square tests were used to explore the differences between firms with or without DPI modes. Then, logistic regression analysis was used to explore the comprehensive impacts of these 16 variables.Through empirical research, we found the factors influencing the DPI mode of Chinese pharmaceutical enterprises and the firm-level factors that influenced DPI mode selection. This study showed that the capacity of enterprise’s innovation and knowledge absorption were related to the mode selection. Moreover, the education of the top management team significantly contributed to the DPI mode selection of pharmaceutical firms. This study also provided theoretical and empirical evidence for pharmaceutical enterprises when choosing their DPI mode.The internationalization of Chinese pharmaceutical firms remained at the early stage. However, the internationalization of drug products from China would affect the international pharmaceutical supply in the long term.     

我国建立基本药物独立筹资机制的必要性分析

目的：探讨建立基本药物独立筹资机制的必要性。方法：从国家基本药物制度框架的全面性出发,基于整个基本药物的价值链,总结基本药物生产、使用和付费过程中存在的问题,提出建立基本药物独立筹资机制的必要性。结果与结论：国家基本药物制度运行过程中存在基本药物生产与创新能力不足、医疗卫生机构基本药物配备率低、医师基本药物处方率低以及基本药物实际补偿水平不高且存在差异等问题。建立基本药物独立筹资机制可有效补偿基本药物生产企业、医疗卫生机构与医师、患者,确保基本药物的可及性,从而进一步完善国家基本药物制度。     

The role of users in innovation in the pharmaceutical industry

Traditionally, innovation in the pharmaceutical industry is organised according to the linear model. Over the past two decades this model lost its meaning as a result of rising costs, increased competition, new scientific developments and better-informed, more demanding users. The linear model is not well equipped to involve these new actors and to include their feedback. Starting from a systemic approach, the involvement of actors in pharmaceutical innovation processes, more in particular users, is put central. It is discussed and illustrated with three cases why a systemic model may be more effective to cope with present developments and why users should be involved. To wind up, conclusions are drawn regarding the implications of a systemic approach for policymakers, researchers and firms.     

Pharmacophore-based virtual screening: a review of recent applications

The global pharmaceutical industry is described as facing an ‘innovation crisis’ following the ‘go-go-pharma’ era; in other words, the problem is one of ‘more money and fewer products’. Nevertheless, patients worldwide are awaiting innovative drugs. Therefore, the pharmaceutical industry has a duty to discover and develop novel drugs and medical technologies. Through universal coverage and reform of the patent system, the Japanese pharmaceutical industry has expanded greatly in line with the Japanese economy. However, in terms of scale and R&D investment, the Japanese pharmaceutical firms have lagged behind the foreign multinationals, which have undergone successive mergers and acquisitions. Meanwhile, it is true that several Japanese firms are playing an active role in overseas markets with their own blockbusters. This paper analyses and gives an overview of new trends in Japan’s pharmaceutical industry within the global context.     

Simulating the Impact of Price Regulation on Pharmaceutical Innovation

Background: Because pharmaceutical price controls fall outside the domain of historical experience in the US, standard retrospective statistical analyses of firm- and/or industry-level data are not appropriate for studying the long-run impact of price controls on pharmaceutical innovation. Simulation modeling, however, can be used to address this issue. Objective: To examine, through simulation experiments, the long-run impact of several hypothetical US price-control policies on pharmaceutical innovation; a computer simulation model of pharmaceutical competition and innovation was developed. Study design: Using the most current economic data available, a hypothetical pharmaceutical industry was created. This industry was formulated to reflect many of the relevant aspects of innovation and competition found in today’s global pharmaceutical industry. This industry was then simulated over a 50-year time horizon, under several different price-control scenarios, in order to better understand the quantitative implications price regulation may have on pharmaceutical innovation. Main outcome measures and results: The primary outcome of interest in this study was pharmaceutical innovative output. Because pharmaceutical firms finance their research and development (R&D) with internally generated funds (after-tax sales revenues), price controls in the model have the effect of reducing R&D investment, and therefore innovation. This was measured by two variables: annual innovative productivity (the annual number of drugs produced by the industry) and cumulative innovative productivity (the total number of drugs produced by the industry over the 50-year time horizon studied). Under a system of public-utility type, cost-based price controls, annual innovative productivity in the model fell by between 67 and 73% relative to baseline (the model without price controls); cumulative innovative output fell by between 30 and 37%. Simulation experiments were also run assuming less extreme forms of pharmaceutical price regulation. These experiments produced smaller reductions in innovative output: annual and cumulative innovative productivity fell by between 21 and 49% and 6 and 24%, respectively. Conclusion: The regulation of pharmaceutical prices in the US could have a precipitous effect on pharmaceutical innovation in the long run. Careful consideration must be given to any new policy that advocates imposing controls on pharmaceutical prices. Long run costs — in terms of forgone pharmaceutical innovation — must be weighed against any short-term benefits price regulation may impart.     

Pharmaceutical Technology Licensing: An Analysis in the Field of Cardiovascular Disease

The technological flows and licensing across institutions plays an essential role in the process of pharmaceutical innovation by integrating the competing resources of different institutions and sharing the costs and risks, especially in the current era of open innovation. This article aims to generally describe technology licensing activities on cardiovascular drugs and, based on visualizing technology flows at different stages, to further investigate the multistage leading performers and their licensing strategies. From the IMS R&D Focus, a world-leading database in the healthcare industry, the research sample comprises 632 licensing inventions for cardiovascular drugs from 1980 to 2014. Furthermore, a network-based approach is employed to visualize the technology flows by setting nodes to represent licensing institutions and edges for licensing behavior, and further to analyze institution leaders and licensing strategies through various indicators, e.g., out-degree, in-degree, and betweenness centrality. The results show that technology licensing networks gradually transformed from sparse to dense from the preclinical to marketed stages. There is obvious synergy and complementation among universities, multinational enterprises, and mid- and small-sized enterprises. R&D organizations represented by universities denote themselves as upstream in the pharmaceutical R&D chain. As a hub, multinational enterprises play an important role as technology integrators and show the most frequent technology licensing, both in technology inflows and outflows, whereas various small firms are viewed as satellite partners around multinational enterprises. This work provides valuable insights for pharmaceutical researchers, investors, policymakers, and technology brokers not only in the field of the discovery of cardiovascular drugs but also of other therapeutic drugs.     

Drug Recalls and Court Actions: A Comparison of Research-Intensive and Nonresearch-Intensive Pharmaceutical Firms

Abstract

The rate and volume of product recalls of the large, research-intensive (RI) pharmaceutical firms (23 firms that account for at least two-thirds of United States drug sales and 80% of research and development expenditures) was compared to that of the remaining, generally nonresearch-intensive (NRI) firms. Data were compiled on all drug recalls occurring between 1970 and 1978 (including over-the-counter products, Class I, II, and III recalls, and citations for failure to file NDAs) by combining the data used as the basis for three previous studies. Analysis of these data indicated that, while larger (RI) firms have a higher number of recalls per firm, the relative amount of material recalled as a percent of material produced is actually less than that of smaller (NRI) firms. When all firms are dichotomized as RI or NRI, the NRI firms had 1.5 times more of their product recalled; accounted for 86% of all recalls; had a seven-fold greater rate of involuntary recalls (22% of their total); and accounted for 97% of all FDA drug seizures and civil injunctions as well as all five FDA prosecutions for criminal violations during the period studied. the estimated dollar value of all recalls of products of NRI firms was $803 million as against $305 million in recalled products of RI firms. for an equivalent dollar amount or volume of product sold, the larger, research-intensive firms thus had a substantially lower rate of product citations by the FDA.     

A case study of lean drug discovery: from project driven research to innovation studios and process factories

At the operational level, the number of investigational new drugs or candidates for development per dollar spent in research, and the number of patents per year are highly integrated measures of productivity and, thus, difficult to influence at the individual or lab level. Hence, different metrics are needed to assess and thereby improve productivity in research at the individual and group level. This review centers on a case study, including over 70 interviews, in a research department of a global pharmaceutical company as well as over 40 interviews in contract research organizations (CROs) and 5 in small biotechnology firms. For each lab, its value adding process was plotted according to lean six sigma methods and appropriate metrics were defined. We suggest a strong focus on short feedback loops in research as an indicator for efficiency. Our results reveal two categories of activities: creativity-driven ones and process-driven ones, both discussed with respect to the methodology used. The fundamental differences in nature of these activities require different sets of metrics to assess them. On the basis of these metrics, different organizational forms can be derived to achieve a lean research structure: innovation studios and process factories, respectively.     

国内制药企业申报FDA制剂仿制药的调查与分析

目的为国内制药企业进行制剂仿制药FDA申报提供建议,促进我国制药企业的制剂国际化。方法通过对国内代表性的制药企业进行问卷和采访调查,并结合FDA仿制药申请的法规,分析影响国内制药企业申报美国制剂仿制药的主要因素。结果与结论提出促进我国制药企业申报FDA制剂仿制药的建议。