2015年度中国医药市场发展蓝皮书——产业经济部分 （ Ⅰ ）

从产业经济角度,包括医药工业总产值、医药工业销售收入、医药工业盈利水平、医药流通行业销售规模、医药商业效益水平、     

Health Professionals “Make Their Choice”: Pharmaceutical Industry Leaders’ Understandings of Conflict of Interest

Conflicts of interest, stemming from relationships between health professionals and the pharmaceutical industry, remain a highly divisive and inflammatory issue in healthcare. Given that most jurisdictions rely on industry to self-regulate with respect to its interactions with health professionals, it is surprising that little research has explored industry leaders’ understandings of conflicts of interest. Drawing from in-depth interviews with ten pharmaceutical industry leaders based in Australia, we explore the normalized and structural management of conflicts of interest within pharmaceutical companies. We contrast this with participants’ unanimous belief that the antidote to conflicts of interest with health professionals were “informed consumers.” It is, thus, unlikely that a self-regulatory approach will be successful in ensuring ethical interactions with health professionals. However, the pharmaceutical industry’s routine and accepted practices for disclosing and managing employees’ conflicts of interest could, paradoxically, serve as an excellent model for healthcare.     

2015 年江苏省医药产业发展报告

江苏省作为传统医药大省,是全国医药产业发展的重要组成部分。通过资料查询,从产业规模与体系、研发创新、产业潜能、人 才队伍、科研机构和专利发明等多方位,分析江苏省医药产业发展现状,并与其他医药产业重点省份进行比较,揭示目前全省医药产业 发展中的主要问题所在,为全省医药产业健康发展建言献策。     

医药 CRO 专题报告——蓝海市场，强者恒强

随着全球制药企业研发投资成本加大、研发周期变长、研发成功率降低,作为社会分工专业化的产物,CRO 企业凭借其低成本、高效率、 多服务的特点,快速发展,且服务范畴已涵盖药物研发的整个过程,成为医药研发产业链中不可缺少的环节。报告采用文献调研、数据库检索、 数据统计与分析等定性定量研究方法,从发展概况、发展策略、竞争格局、企业布局等角度对国内外医药 CRO 领域进行多角度、多层次的 分析,旨在为相关企业确定产品研发思路、制定市场策略提供线索和参考。     

2014年江苏省医药产业发展报告

江苏省作为传统医药大省,是全国医药产业发展的重要组成部分,但仍存在诸多不足,极大地影响了其可持续发展。通过资料查询, 将江苏省与山东、河南、广东、吉林、浙江、湖北等医药产业重点省份进行比较,多方位分析江苏省医药产业发展现状,揭示眼下全省 医药产业发展中的主要问题所在,为全省医药产业健康发展建言献策     

2013 年江苏省医药产业发展报告

目前,江苏省医药产业发展位居全国前列,但仍存在诸多不足,极大地影响了其可持续发展。通过资料查询,将江苏省与山东、河南、广东、浙江等医药产业重点省份进行比较,多方位分析江苏省医药产业发展现状,揭示眼下全省医药产业发展中的主要问题所在,为全省医药产业健康发展建言献策。     

The impact of generic substitution on the activities of pharmaceutical companies - a survey from the companies' perspective one year and five years after the introduction of generic substitution in finland

Background  

Mandatory generic substitution (GS) was introduced in Finland on 1 April 2003. The aim of this study was to explore and compare the impacts of GS on the activities of pharmaceutical companies representing mainly original or generic pharmaceutical products in Finland. The self-reported impact of GS from pharmaceutical companies' perspective was explored with a focus on the number of employees, the range of sales packages on the market, the marketing activities, the research and development of new pharmaceutical products and storage of pharmaceuticals.     

生物催化反应对映选择性控制

合成光学纯的化合物在化学及生物化学的研究和发展中正变得越来越重要,尤其在制药行业中目前手性药物近占全球药品总销售额的三分之一。本文以生物还原反应为例,介绍一些控制反应对映选择性的方法。     

An Update to Returning Genetic Research Results to Individuals: Perspectives of the Industry Pharmacogenomics Working Group

The ease with which genotyping technologies generate tremendous amounts of data on research participants has been well chronicled, a feat that continues to become both faster and cheaper to perform. In parallel to these advances come additional ethical considerations and debates, one of which centers on providing individual research results and incidental findings back to research participants taking part in genetic research efforts. In 2006 the Industry Pharmacogenomics Working Group (I‐PWG) offered some ‘Points‐to‐Consider’ on this topic within the context of the drug development process from those who are affiliated to pharmaceutical companies. Today many of these points remain applicable to the discussion but will be expanded upon in this updated viewpoint from the I‐PWG. The exploratory nature of pharmacogenomic work in the pharmaceutical industry is discussed to provide context for why these results typically are not best suited for return. Operational challenges unique to this industry which cause barriers to returning this information are also explained.     

What affects the innovation performance of small and medium-sized enterprises (SMEs) in the biotechnology industry? An empirical study on Korean biotech SMEs

Research-intensive small and medium-sized enterprises (SMEs) play a crucial role in the advancement of the biotechnology industry. This paper explored the impacts of internal and contextual variables on innovative activity in Korea and compared the results of this analysis with previous studies of other countries. Our analysis of 149 Korean biotech SMEs showed that the ratio of R&D expenditure to sales, the ratio of R&D employees to total employees, CEO characteristics, governmental support and international networking are positively correlated with a firm's innovation performance. The results may help decision makers to better foster SMEs in the Korean biotechnology industry.     

The Pricing of Breakthrough Drugs: Theory and Policy Implications

Pharmaceutical sales exceed $850 billion a year, of which 84% are accounted for by brand drugs. Drug prices are the focus of an ongoing heated debate. While some argue that pharmaceutical companies exploit monopolistic power granted by patent protection to set prices that are “too high”, others claim that these prices are necessary to motivate the high R&D investments required in the pharmaceutical industry. This paper employs a recently documented utility function of health and wealth to derive the theoretically optimal pricing of monopolistic breakthrough drugs. This model provides a framework for a quantitative discussion of drug price regulation. We show that mild price regulation can substantially increase consumer surplus and the number of patients who purchase the drug, while having only a marginal effect on the revenues of the pharmaceutical company.     

Nation-building,masculinity and entrepreneurship: memories of the “liberation of Kosovo” in Switzerland

Since the end of the Kosovo War in 1999 and the “liberation” of the territory from Serbian forces, narratives about the “freedom struggle” have been crafted and defended both in Kosovo and abroad. The transmission of these memories forms part of a broader effort to create a “national” history of Kosovo and constitute an “Albanian imagined community”. This article scrutinizes the memories of the “liberation” produced by Albanian-speaking migrants who were active on behalf of their homeland in Switzerland. It explores the construction of masculinities within narratives collected via oral history interviews. In line with the literature on “nation” and gender in Kosovo, this research acknowledges the presence of two main forms of masculinity: the “heroic fighter” and the “pacifist”. However, it also demonstrates the crystallization of the “entrepreneur”, an alternative type who integrates the transnational “neoliberal” discourses and proposes a more positive image of “Albanian men” in Switzerland.     

The early history of migration and settlement of Yemenis in Cardiff, 1939–1970: religion and ethnicity as social capital

Utilizing Putnam's concept of bonding social capital, this article explores the under-researched topic of the history of migrant men's reproduction of social capital in Cardiff, Wales. Drawing upon a series of oral history interviews with a respected imam of more than fifty years, and informed by existing research on Muslim migrants, we explore both the advantages and disadvantages of community relationships between Yemeni men in relation to trust, reciprocity and interpersonal well-being. By examining these complex bonds, this article contributes to the literature on religious and ethnic social networks by challenging the assumption that migrants always benefit from social resources (Wilson 1978; Shah 2007), and offers an alternative account of religiously underpinned social capital to those of studies of majority ethnic Christians in North America (Smidt 2003). Uniquely, this article also points to the divergences between religious and ethnic capitals in the context of Yemeni migrants' social resources during 1939–1970.     

战略性微生物资源知识产权现状研究及发展对策

微生物作为全世界分布最广且拥有量最多的生物资源,其应用已涉及到诸多领域并展现出了巨大的经济价值和社会价值。因此研究微生物及其知识产权(intellectual property rights,IPR)全产业链的现状和发展,对于我们如何全新地认知微生物,如何挖掘微生物资源以及发挥微生物作为产业最重要部分的作用具有重要的意义。我国已形成了较为完备的微生物相关专利保护体系,已形成了基于微生物的全产业链生态发展闭环格局。本文通过以微生物专利构成实质技术转移、许可和质押相关大数据分析,通过挖掘利用各种微生物资源,从战略高度探索国家开放遗传资源的大数据,围绕微生物功能性活性成分、菌株(群)基因大数据,基于微生物功能代谢产物、基因组进行数据分析、预警和专利布局,做好微生物资源IPR现状研究及发展对策。最终形成以产业为依托,战略性资源作为引导,IPR助推微生物全产业链中核心技术引擎的格局,进而实现微生物战略资源产业集群发展。     

Paradigms of expected failure

This study explores the outsourcing and offshoring of clinical trials and how they interconnect with the dynamics of drug development and regulation in the United States. I focus on the activities of United States-based contract research organizations, which make up a specialized global clinical trials industry focusing on the recruitment of human subjects and investigators. Tracking this industry’s activities in eastern Europe and Latin America, two clinical trial market ‘growth regions,’ I address the strategies of evidence-making that inform clinical trial offshoring. I also show how aspects of the clinical trial model—in which failures to predict safety outcomes or a paradigm of expected failure—are being exported along with the offshored trial. The clinical trials industry is a crucial, highly mobile, and profitable arm of the global pharmaceutical industry. Where state agencies furnish limited or no health care, drug developers claim that trial expansion and experiments have become social goods in themselves. But questions remain: How is drug value and research integrity maintained? And how do the results of clinical trials strengthen or undermine the delivery of affordable and effective interventions? As this essay shows, clinical trials are not only hypothesis-testing instruments; they are operative environments redistributing resources and occasioning tense medical and social fields. In highlighting the inefficiencies and uncertainties of global drug development, this study points to problems in the operational model of drug development and in systems of human protection. It also considers new forms of accountability at the nexus of private sector science and public health.     

Antimicrobial Agents with Improved Clinical Efficacy versus Their Persistence in the Environment: Synthetic 4-Quinolone As an Example

There is increasing concern about the effects of pharmaceutical agents in the environment. The use of synthetic 4-quinolone compounds is rapidly increasing: newer and more complex analogues are being developed by the pharmaceutical industry to meet clinical and veterinary needs. This review aims at stimulating the need to consider the fate of pharmaceuticals in the environment as part of overall drug design and development. Currently, regulatory action is triggered if the predicted environmental concentration exceeds an arbitrarily set value, whereas in some countries, there are no regulations at all. By extension, from a clinical perspective, enviropharmacokinetics and enviropharmacodynamics are proposed to quantify the risk to organisms in the environment in a more realistic fashion that is reflective of concentrations at which hazardous effects are observable on such organisms. Such a new approach integrates our knowledge to address ecosystems and related health problems in a more holistic fashion, thus linking public health, environmental degradation, and ecology. Its success requires more collaboration in research and development of newer antibiotics, with their ultimate fate in the environment being central, to bolster the already existing aspirations of controlling the rapid emergence of resistance.     

Profitable gifts: a history of the Merck Mectizan donation program and its implications for international health

A unique public/private partnership situated around a pharmaceutical, Merck's Mectizan donation program stands out as an example of corporate philanthropy in the history of the pharmaceutical industry and provides insight into future public/private partnerships in public health. This paper considers the issues Merck faced in the decision to donate Mectizan (ivermectin) and in the subsequent development of the Mectizan donation program, delineating the moral and financial debates that arose within the company. Coming after almost 15 years of donation, this assessment of the program's strengths and shortcomings suggests how the pharmaceutical industry can better serve as a viable partner in improving international health.     

How Pharmaceutical Industry Employees Manage Competing Commitments in the Face of Public Criticism

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the “medical affairs” departments of pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance.