从基础到临床,并非路漫漫

"超级细菌"的出现曾一度让社会各界如临大敌,甚至陷入恐慌.而与之恰恰相反的是,这又一次让朝阳产业--生物医药的地位得到进一步的抬升,因为攻克这些疑难病症是需要生物医药领域研发新药来解决的.显然,不管是从维护社会公共卫生安全的角度,还是从国家发展新兴产业规划的角度,把生物医药行业作为重点发展方向成为全球各国政府不得不认真思考的问题.     

陕西省生物医药产业发展现状、存在问题及对策

目的探讨陕西生物医药产业发展对策。方法采取查阅相关文献、深入企业调研及与有关专家座谈的方式,对陕西生物医药产业发展现状、存在问题及对策进行分析。结果与结论对陕西生物医药产业发展提出了如下对策:①设立专家咨询委员会及领导小组,加强对陕西生物医药产业发展的领导;②设立陕西省新药研发科技重大专项;③寻找创新突破口,实现陕西省生物医药跨越式发展;④优化产业结构,推动陕南生物医药突破性发展;⑤加速兼并重组,加快龙头企业发展。     

我国生物医药产业发展存在的问题及对策

介绍发达国家生物医药产业概况，指出我国生物医药产业发展中存在的问题，并提出发展我国生物医药产业的对策。     

黑龙江省生物医药科技与产业发展的对策研究

本文简要的介绍了黑龙江省生物医药科技与产业发展的基本情况,对黑龙江省生物医药产业存在的问题进行了认真分析,并提出了对策建议。     

江苏省生物医药产业技术创新联盟现状及优化建议

本文在对江苏省主要生物医药产业技术创新联盟分析与调研的基础上,通过探讨和分析生物医药产业技术创新的特点与问题,提出完善江苏省生物医药产业技术创新联盟运行机制的对策与建议     

广东省药物临床试验的发展现状分析与探讨

药物临床试验是药物上市的必经之路,也是生物医药行业发展的重要推动力。近年来,广东省在药物临床试验行业不断尝试创新与变革,积极推动临床试验的发展,助力省内生物医药领域的改革与创新。本研究调研了广东省近5年药物临床试验发展、政策实施等情况,剖析存在问题并探讨解决之道,以期为国内其他兄弟省市的药物临床试验发展提供借鉴和参考。     

第六届国际科技产业博览会生物医药论坛暨第七届北京生物医药产业发展论坛会讯

随着全球经济时代的来临和国际生物医药产业的快速发展 ,国内外生物医药产业的竞争日趋激烈。全方位地探讨中国乃至全球生物医药产业的发展方向 ,把握竞争态势 ,认真考虑如何在激烈竞争中占有一席之地 ,是我国生物医药产业探索发展思路的首要思考。第七届北京生物医药产业发展论坛以“融合与发展”为主题 ,从生物医药产业发展宏观环境、全球新药研发热点和趋势、新型医疗服务市场经营模式、制药行业面临的主要问题及其发展趋势等方面展开讨论。并以专题讲座、卫星会等形式开展深层次、多侧面的互动交流 ,以期为当前生物医药企业的发展提供可…     

中国生物医药产业的升级和发展

2010年是国家启动实施战略性新兴产业发展的第一年,生物医药产业正式被纳入了战略性新兴产业之列,生物医药的"十二五"规划也即将揭开神秘面纱,各地纷纷出台相关政策,制定生物医药产业发展的规划,把生物医药产业作为下一轮的经济增长点.毫无疑问,生物医药行业是"朝阳产业",未来的十年将是生物医药产业的"黄金十年".     

我国生物医药企业如何吸引风险资本

随着国外生物医药巨头的日益逼近,我国生物医药产业正面临着极其严峻的考验.近几年来我国生物医药产业虽然从总产值上看发展迅速,但是行业的高速发展却未能引起投资的热潮,处于起步阶段的我国生物医药产业在这时陷入了“资金荒”.如何寻找源头之水？纵观世界生物医药的发展史,风险资本无疑是解决目前困境的良方.     

展望2021:中国生物医药企业在不确定大环境中的创新机遇

2020年,中国生物医药行业面对挑战迸发活力,加速转型创新发展.2021年,政策改革的持续深化与全面实施对生物医药企业提出实现高质量、可持续发展的更高要求.上海市药物研发协同创新中心召开智库圆桌会议,通过多轮头脑风暴,对我国生物医药行业进行了年度展望,提出生物医药企业需在不确定大环境中切实抓住创新机遇.     

The future relationship between the media, the food industry and the consumer

The relationship between the media, the food industry and the consumer is probably at its lowest point as we start the new millennium. The frequency of food scares appears to be increasing and news reports sometimes seem both sensational and polarised. High profile issues like the development of bovine spongiform encephalopathy in the UK and the dioxin contamination of poultry products in Belgium have undermined consumer confidence in the food industry. The recent genetically modified foods' debate has served to demonstrate the gulf that has grown between the food industry, food safety experts and the public. This is a rift that has been exploited by environmental pressure groups and fuelled by the media. This paper examines some of the underlying causes of the current air of mistrust that seems to exist between the media, the food industry and the consumer. Also, by examining the projected trends in these root causes, it draws some conclusions for the future relationship between the parties involved and suggests some changes that may improve the present situation.     

Paediatric medicines research in the UK: how to move forward?

There have been numerous studies to show that many of the medicines used in children are used off-label or are unlicensed for use in children. When children are prescribed unlicensed and off-label medications, some people may see them as unknowing participants in informal and uncontrolled experiments. However, the licensing status of a drug can be seen as a by-product of the real issues: the safety, efficacy and quality of these medicines in the current licensing system. It is important to conduct research in order to provide high quality data regarding safety and efficacy to support evidence-based paediatric prescribing. Clinical trials will always be an invaluable means of acquiring vital information about a drug; but when it comes to children, we may find that these trials are not always practical for technical, ethical and financial reasons; therefore, it is important to explore other methodologies in paediatric medicines research. Pharmacoepidemiological and prospective cohort studies could provide vital safety and efficacy data on paediatric medicines; however, resources need to be invested in the methodological research. Paediatric drug formulation research is under-resourced and under-valued, and, unfortunately, fatal and serious adverse reactions due to inappropriate formulations have been reported in many instances. Paediatric medication is a complex problem; we need to use all available tools for research on safety, efficacy and formulation. The reason for lack of progress in paediatric drug research is most likely due to lack of resources and research capacity. The industry and government should work together and invest more money in paediatric drug research. Finally, regulatory authorities, healthcare professionals and academics need to rethink the research strategy in order to provide better medicines for children.     

“床位管理”在医院管理中的应用分析

随着人们医疗保健意识不断增强及现代医疗水平不断发展,医疗卫生产业投入力度不断加大,同时医疗行业人力资源与床位资源也在不断增加。床位可以说是医院管理的基本组成单位,床位管理的优劣对医院管理工作及医院整体发展有直接影响。因此,在医院管理中强化床位管理,是对医院管理方法加以创新,促使医疗安全得以保障的重要手段。     

Metabolites in safety testing

Traditionally, only circulating concentrations of parent drug have been measured in the rodent and nonrodent test species used for drug safety assessments and served as an index of systemic exposure for comparisons to human exposures. Circulating concentrations of metabolites have generally only been measured in specialized circumstances (e.g., parent compound was extensively metabolized). Measurement of only the parent compound is usually sufficient when the metabolite profile in humans is similar to that in at least one of the animal species used in the nonclinical safety assessment. However, it is possible that metabolites formed in humans might not be present in the rodent and nonrodent test species used for drug safety assessments or the metabolites are formed at disproportionately higher concentrations in humans than in the animal test species. Generally, metabolites identified only in human plasma or metabolites present at disproportionately higher concentrations in humans than in any of the animal test species should be considered for safety assessment. The Center for Drug Evaluation and Research (CDER) published a Guidance for Industry on Safety Testing of Drug Metabolites that provides current thinking within CDER on the nonclinical safety assessment of human drug metabolites derived from drug products. The CDER guidance defines human metabolites that can raise a safety concern as those formed at greater than 10% of parent drug systemic exposure at a steady state. By contrast, the more recent International Conference on Harmonization: Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3[R2]) describes the threshold as 10% of total drug-related exposure. Where they differ, the ICH guidance supersedes the CDER Guidance. The purpose of this article is to provide a perspective on the important details of these guidances from a regulatory review standpoint, as well as discuss some concerns that have arisen from the regulated industry regarding the CDER guidance. Such issues include parent drug that is extensively metabolized, metabolism by intestinal bacteria and metabolites formed by nonclinical test species but not humans.     

In silico methods for early toxicity assessment

The number of new drugs that reach the market is declining every year, and, in recent years, several drugs already on the market have been withdrawn because of safety concerns. In response to this, the pharmaceutical industry is poised to take advantage of innovative methods that will increase the efficiency of its research and development. An in silico approach to predicting safety issues could provide meaningful information early on in the drug discovery process, and representing a relatively inexpensive alternative to current methods. Recent advances in the field of in silico toxicology are reviewed herein, along with a discussion of the reasons behind this increased attention.     

Food allergy: what are the issues?

With a growing interest in the development of genetically modified crop plants there is a need for appropriate approaches to safety assessment. Among the issues that have to be addressed is consideration of whether the products of novel genes have the potential to cause allergic sensitization. Resulting from a collaboration between the International Food Biotechnology Council and the International Life Sciences Institute recommendations have been made for a step-wise approach to the assessment of allergenic potential based upon considerations of serological identity, and sequence or structural homology, with known allergens and examination of the stability of the test protein in a simulated gastric fluid. In parallel there has been interest in the development of animal models, which would permit a more direct evaluation of potential allergenic activity. Progress in these areas is reviewed briefly in the context of what is known of food allergy and some of the important issues, which must be addressed in designing safety assessment strategies identified.     

The impact of assay technology as applied to safety assessment in reducing compound attrition in drug discovery

INTRODUCTION: Attrition in the drug industry due to safety findings remains high and requires a shift in the current safety testing paradigm. Many companies are now positioning safety assessment at each stage of the drug development process, including discovery, where an early perspective on potential safety issues is sought, often at chemical scaffold level, using a variety of emerging technologies. Given the lengthy development time frames of drugs in the pharmaceutical industry, the authors believe that the impact of new technologies on attrition is best measured as a function of the quality and timeliness of candidate compounds entering development. AREAS COVERED: The authors provide an overview of in silico and in vitro models, as well as more complex approaches such as 'omics,' and where they are best positioned within the drug discovery process. EXPERT OPINION: It is important to take away that not all technologies should be applied to all projects. Technologies vary widely in their validation state, throughput and cost. A thoughtful combination of validated and emerging technologies is crucial in identifying the most promising candidates to move to proof-of-concept testing in humans. In spite of the challenges inherent in applying new technologies to drug discovery, the successes and recognition that we cannot continue to rely on safety assessment practices used for decades have led to rather dramatic strategy shifts and fostered partnerships across government agencies and industry. We are optimistic that these efforts will ultimately benefit patients by delivering effective and safe medications in a timely fashion.     

Trends in early drug safety

Successful introduction of a new drug to the market is not only an extremely costly and complicated process, but also fraught with a substantial risk of failure. The number of new drugs launched each year from 1990 to 2000 has stayed relatively constant, while the cost of pharmaceutical research and development has risen by almost 2.5-fold over the same period. What is not revealed by these figures is that the chance of success for a drug candidate passing through the various hurdles in pharmaceutical development is at best 1 in 10 and has barely changed despite advancing technology in other areas of research and development. While we expect high failure rates in drug discovery, it is of substantial concern that most candidates in development on which large investments have already been made are probably not going to make any return. A major stumbling block is the absorption, distribution, metabolism, excretion and toxicology profile of drug candidates. These issues were discussed at the Society for Medicines Research symposium held September 18, 2003, in London, United Kingdom. Recent SMR symposia have focused on the ADME and pharmacokinetic aspects of drug discovery and development. Indeed, it is now uncommon for drug discovery projects not to address these issues early in their lifetimes. Although it is less common to address drug safety early in a project, it is being utilized more frequently to help select the best clinical candidates for further development. This meeting report summarizes some of the key aspects of early drug safety issues facing the drug discoverer today. Classical approaches to toxicology, p450-mediated safety, cardiovascular safety, "omics" approaches and their impact upon clinical safety will be discussed.