我国医药创新环境SWOT分析及战略选择

目的为我国医药产业选择创新战略提供参考。方法参阅国内、外文献,采用SWOT分析法对我国医药产业的实际情况进行研究、分析。结果与结论提高自主创新能力应是我国医药产业中长期科技发展规划战略研究中的一个关键议题,我国医药产业应从体系、金融、法律、人才、文化等几个方面来构建适应我国实际情况的创新战略。     

药物创新与经济发展

医药产业一直在画民经济占有特殊地位，近几年来，医药产业随着医改方案的推行．药品市场规范化的运行，一直呈现蓬勃发展的态势。医疗支出在国民生产总值的比重越来越大，医药进出口也对我国对外贸易的增长起到了推动作用。推动医药产业发展的源动力在于新药新技术的创新．而使创新成果产业化的关键则在于风险基金的适宜介入。这样，医药产业才能为经济发展带来新的热点和活力。     

加快打造陕西医药产业升级版的探讨

目的对打造陕西医药产业升级版提供建议与对策。方法分析全球及我国医药产业发展现状与趋势,与企业家和有关专家进行座谈,梳理和重新认识陕西医药产业。结果与讨论对打造陕西医药产业升级版提出以下建议:建立医药产业集群;实施大物流战略;加快特色健康服务产业发展;优化创新战略;加快培育产业人才;加大产业支持力度;为产业升级营造良好的市场环境;充分发挥行业协会作用等。     

FDA创新性药品审批管理动力性政策研究与分析

创新是医药产业存在和发展的基础。其中，药品创新是医药产业创新的主要内容。     

第三篇：蕴育突破——第五章创新优势蓄势等发

生物工程和新医药产业是北京重点发展的高新技术产业之一，是北京现代制造业的重要组成部分。北京将以提高整体竞争力为目标，以体制创新和知识创新为动力，以招商引资和经济结构调整为主线，实现生物工程和新医药产业的经济总量的跨越式增长和产业水平的大幅度提高。     

论医药产业区域创新系统的构建

国家创新系统理论研究已取得了重大进展,它强调一个国家范围的创新活动,往往忽视了次一级经济区域的特殊性,因而不能满足区域经济发展的需要.尽管区域创新系统理论试图描述一定经济区域的创新活动特点与机制,并涵盖多个产业的创新活动过程,但它仍然忽视了特定产业创新活动的特殊性.医药产业的高技术、高投入、高收益与高风险的特征决定创新活动对医药产业发展的重要性,对医药产业的管理与协调机制以及医药行业人才的培养等多方面的状况也同时决定了医药产业的创新活动和能力.本文试图利用区域创新理论的框架,针对医药行业创新活动的特殊性,建立医药产业区域创新系统模型,为指导区域医药产业创新与发展奠定基础.     

中外创新药物研发能力比较分析——基于医药技术创新评价体系的实证研究

 创新药物研发能力是一个国家医药产业发展能力的航标。在建设自主创新型国家的背景下,我国医药产业也将走过从“仿制为主—模仿创新—自主创新”的转变历程。文中通过构建创新药物研发能力评价指标体系,将我国与美国、欧盟、印度创新药物研发能力进行量化分析,评价我国创新药物研发的比较优势和比较劣势,并分析其深层次政策原因。并建议政府适时调整与完善药品专利、药品规制、财政与人才政策,更好地激励医药企业加大创新投入,以提升我国创新药物研发的总体水平。     

信息快递

药业动态南京市加快发展医药产业“争取用3~5年的时间,把南京药谷建设成医药产业新产品新技术的孕育地、资金人才的会聚地、生产加工的制造地,形成在全国具有较大影响的医药产业基地。”《南京市加快发展医药产业打造南京药谷的实施意见》日前正式出台。据了解,南京药谷的建设重点是“两园一中心”:即在新港开发区和浦口开发区分别打造南京医药产业工业园;在鼓楼区依托重点优势医药企业、高等院校国家级实验室和大型医院,建立南京医药产业创新中心。新港开发区和浦口经济开发区内医药工业园的建设,以大企业为主体,以旗舰型大项目为龙头,吸引…     

中美医药产业创新体系对比分析

目的 为完善我国医药产业创新体系,促进我国新药研发提供参考。方法 在阐述了产业创新体系理论的基础上,对比分析了政府、企业、大学和科研院所在中关医药产业创新体系中发挥的不同作用,提出了建立和完善我国医药产业创新体系的建议。结果与结论 我国政府要加大对医药产业的支持力度,企业要加强自主创新,大学和科研院所要深化科研体制改革,建立和完善我国的医药产业创新体系。     

对国内医药代表培养模式的探讨

近年来，我国医药产业发展迅速，前景广阔，成为我国国民经济中的朝阳产业，但与发达国家医药企业相比有较大差距，问题不仅在于研发水平落后，还在于缺乏有效的营销手段和高素质的营销人才。因此，探索适合中国国情的营销人才培养，对促进我国医药产业的健康快速发展有着十分重要的意义。     

Pharmacogenomics and drug development

It is generally anticipated that pharmacogenomic information will have a large impact on drug development and will facilitate individualized drug treatment. However, there has been relatively little quantitative modeling to assess how pharmacogenomic information could be best utilized in clinical practice. Using a quantitative model, this review demonstrates that efficacy is increased and toxicity is reduced when a genetically-guided dose adjustment strategy is utilized in a clinical trial. However, there is limited information available regarding the genetic variables affecting the disposition or mechanism of action of most commonly used medications. These genetic factors must be identified to enable pharmacogenomic testing to be routinely used in the clinic. A recently described murine haplotype-based computational genetic analysis method provides one strategy for identifying genetic factors regulating the pharmacokinetics and pharmacodynamics of commonly used medications.     

Nanotechnology and vaccine development

Despite the progress of conventional vaccines, improvements are clearly required due to concerns about the weak immunogenicity of these vaccines, intrinsic instability in vivo, toxicity, and the need for multiple administrations. To overcome such problems, nanotechnology platforms have recently been incorporated into vaccine development. Nanocarrier-based delivery systems offer an opportunity to enhance the humoral and cellular immune responses. This advantage is attributable to the nanoscale particle size, which facilitates uptake by phagocytic cells, the gut-associated lymphoid tissue, and the mucosa-associated lymphoid tissue, leading to efficient antigen recognition and presentation. Modifying the surfaces of nanocarriers with a variety of targeting moieties permits the delivery of antigens to specific cell surface receptors, thereby stimulating specific and selective immune responses. In this review, we introduce recent advances in nanocarrier-based vaccine delivery systems, with a focus on the types of carriers, including liposomes, emulsions, polymer-based particles, and carbon-based nanomaterials. We describe the remaining challenges and possible breakthroughs, including the development of needle-free nanotechnologies and a fundamental understanding of the in vivo behavior and stability of the nanocarriers in nanotechnology-based delivery systems.     

Drug development and immunotoxicity

Immunotoxicity of drugs has to be evaluated same as other kinds of toxicities,since the functions of the immune system are vital to human survival,consisting of the protection of the body from invading pathogens and to provide immune surveillance against arising tumor cells.A given drug‘s effect on the immune system can be classified as (1)immuno-suppression/activation.(2)antigenicity and hypersensitivity,(3)autoimmunity.The guidance of immumotoxicity has highlighted on immuno-suppression in Harmonizing Congress among EC,USA and Japan.In this paper,the strategy and methods to evaluate immunotoxicity,mainly immuno-suppression,of the drugs will be show.complexity and variety of immuno-systems make assessment of immumotoxicity complex.The testing in rats to assess immune function is thought to be the first choice for immunotoxicity evaluation in a drug development,and then other suitable testing should be added depending on the mature of drugs.     

Ubiquitylation and cancer development

Ubiquitylation is an essential cellular process, and yet many cancer cells appear to be more reliant upon it than normal cells as they are surprisingly sensitive to proteasome inhibitors (PI) and proteasome inhibitor drugs are well tolerated in vivo. Several reviews have suggested that specific protein targets account for PI induced cell death, but fail to adequately explain why cancer cells are more sensitive than normal cells to PIs. We review the evidence for these models, focusing primarily on inducers of cell death including p53 and the pro-apoptotic Bcl-2 Homology proteins (BH3 proteins) and propose an additional hypothesis; that a tumour cell's abnormal physiology makes it particularly reliant upon the proteasome. This hypothesis is well supported in the case of Multiple Myelomas, that may produce large amounts of antibodies and are therefore under considerable ER strain and in turn particularly reliant upon the proteasome to clear the large numbers of misfolded proteins. We propose that other cell types, tumor or non tumour, that are already under ER stress, or its equivalent, maybe particularly susceptible to proteasome inhibitors.     

Consensus development methods: Considerations for national and global frameworks and policy development

Backgroundkey decisions have to be made in healthcare systems and policies often under uncertain conditions or without complete objective evidence. Decisions made on the health system and policy levels affect national and global population, which requires transparency and accountability to ensure the best impact to population's health. Consensus development methods assist complex process of the decision making combining existing evidence and expert opinions. Variety of challenges affect the selection, application and use of the consensus development methods, which requires careful consideration to keep rigour, validity and transparency.ObjectiveTo identify and review studies which have used consensus development methods in order to develop national or international policy or framework in health field.MethodsA literature review was conducted searching the databases PubMed, EMBASE and PsycINFO. Studies using a consensus development approach to develop tools or frameworks for health system and policy enhancement were eligible for the review. Key elements of consensus development process were extracted and reported using content analysis and narrative synthesis.ResultsThe review included 26 studies in total either in national or international settings. Over 60% of studies extracted did not apply typical consensus development methods; however, stated as consensus meetings instead. Delphi technique was the most used method from the consensus development methods, which often combined with some face-to-face meeting features.ConclusionsThis review summarised the use of consensus development methods in health system and policy development. The review identified a wide range of variations in the selection, use and application of the methods in studies. For better utilisation and application of the consensus development methods in the field, some standardisation of the methods and reporting would be warranted.     

药物经济学研究与药物开发

本文是药物经济学讲座系列文章的第二篇。重点介绍了在药物开发阶段开展药物经济学研究的必要性，分析了产生这种要求的主要原因，讨论了新药开发不同临床中以运行的经济学评价，以及药物经济学研究对广义药物开的启迪作用，最后，针对药物经济学研究结果应用中可能出现的偏向，提出了应当注意的几个问题。