Bridging the gap between invention and innovation: Increasing success rates in publicly and industry-funded clinical trials

While basic research in the natural sciences can generate discoveries with great promise to improve human health, advancing these discoveries from bench to bedside through clinical trials is a major challenge requiring individuals to possess a specific set of skills and prior experience. The ability to translate—especially between basic and applied research—and to bridge these two areas is likely to be key. We call skills that encompass both basic and applied research horizontal skills; experience in diverse fields, such as both cancer and diabetes, is termed vertical experience. We develop a framework to define and differentiate between horizontal skills and vertical experience and discuss how they separately and jointly impact the success of turning discoveries into products. Drawing on data from 3,889 clinical trials, we find that both qualities matter for publicly funded and industry-funded trials but with nuanced differences. Our results suggest that the likelihood of success increases when the investigators who lead trials have a balanced set of skills in both basic and applied science independent of the funding source. In both types of trials, investigators who possess vertical experience were found to reduce the success probability of clinical trials. However, investigators in industry-funded trials are able to alleviate this effect if they possess basic research skills or horizontal skills. Our paper uncovers context specificities in terms of how horizontal skills and experience in multiple fields, as well as their interplay, relate to translational success.     

知识经济背景下的产品创新流程再造

通过借鉴第六代创新模型特征,对原有的产品创新流程的缺陷进行分析,并对其进行相关的改造。在进行产品创新流程再造的过程中应该对以下若干问题进行关注:组织结构、内部激励、创新文化、人力资源的结构、信息技术的应用、企业知识流失管理。     

Understanding regional innovation cultures: Narratives,directionality, and conservative innovation in Bavaria

In recent years, innovation policy has increasingly embraced “situated” perspectives to better account for both how culture matters for innovation in diverse settings and how to deal with growing socio-economic inequalities and conflicts in the global innovation landscape. In this paper, we develop the framework of “regional innovation cultures” to put these perspectives on more solid theoretical footing. Regional innovation cultures refer to unique ways in which regional innovation initiatives and technology developments (their goals, meanings, material organization, and actor constellations) are being brought into alignment with local identities, socio-economic legacies, and unique political cultures. Our framework foregrounds five analytic dimensions: imagined social orders, representations, political cultures, relationship to national and global initiatives, and local controversies. We apply this framework to one in-depth regional case study of the German state of Bavaria, focusing on innovation policy in three sectors: space, agriculture, and automotive. We show how Bavaria enacts what we call a “conservative innovation culture”, where innovation is framed as a way to preserve socio-economic orders rather than disrupt them, and where political and economic incumbents forcefully shape and absorb emerging niche activities. Innovation in Bavaria is performed through a political culture of small state-like corporatism that emphasizes strong coordination of all major actors, grants state bureaucracies a key role in defining directions for innovation in the form of a quasi-technonationalism, and tends to sideline alternative visions and voices for innovation. Across all three sectors, culture serves as a framing device to legitimize innovation primarily as an extension of existing social orders; conversely, innovation serves as a vehicle to reinforce dominant ideas of the public good. Through the lens of culture, innovation ceases to be primarily a source of social change and disruption, but can be understood as a mode of socio-cultural reproduction subject to tentative, constrained experimentation. Innovation initiatives cannot break too radically with existing social norms and orders without risking public support or legitimacy, thus creating a trade-off between proposing novelty and ensuring continuity. Our analysis lends further support for constructivist approaches to innovation studies, emphasizing plural and socially grounded perspectives on the rationalization, implementation, and evaluation of innovation.     

The era of incremental change in the technology innovation life cycle: An analysis of the automotive emission control industry

According to the life cycle model of technological evolution, after the emergence of a dominant design, technological product industries undergo an “era of incremental change.” This era of incremental change is not well understood in the existing literature. Although the period is typically characterized in terms of stability and minimal innovation, we find that the era of incremental change can be actually quite dynamic. Through our research into the period of time following the emergence of a dominant design in automotive emission control systems, we find that the overall product innovation in the industry did not decline immediately following the dominant design, and increased throughout the era of incremental change. Further, we find that firms maintain their attention on the same core components that they innovated upon before the dominant design, but that these components make up less of the overall proportion of total innovation throughout the era of incremental change. Finally, we found that the concentration of innovating firms in the industry increases immediately following the dominant design, and this concentration decreases over time throughout the era of incremental change. Findings imply a pattern of contraction and expansion in the era of incremental change that extends previous work on the technological product life cycles and helps to characterize the era of incremental change in a novel way.     

The fog of innovation: Innovativeness and deviance in developing new clinical testing equipment

Even when innovators know they are working with a potential breakthrough innovation, they face formidable difficulties in assessing the exact ways it will be innovative as well as deviant in regard to extant systems, business and practices. This finding emerges from our case study that spans the 40-year history of an ongoing and by now potentially radical innovation in automated and miniaturized liquid processing. We analyze the changes in the system-to-be and its relationship to its future contexts throughout this period and show how the developers were able to reliably predict technical compatibility, the outcome, the interface points and effects towards the intended environment only some distance ahead. This ‘fog of innovation’ presents a management challenge not duly met by instruments available in innovation literature.     

Emergent innovation systems and the delivery of clinical services: The case of intra-ocular lenses

This paper is an exploration of the dynamics of technical change in medicine. We argue that innovation in medicine is a process that is distributed across time, space and epistemic and institutional domains; that it entails the entrepreneurial effort of creative individuals as well as the emergence of correlated understanding among heterogeneous agents whose rules of interaction are contingently instituted in socio-economic systems along unfolding scientific and technological trajectories. We illustrate our arguments through an in-depth analysis of a major ophthalmologic innovation - the intra-ocular lens - that has literally transformed the treatment of cataract in the developed world and has the potential to do so in many developing countries. We investigate the advancement of clinical knowledge about the disease, the development of effective technological capabilities and the co-evolution of the supply capacity and demand of a micro-innovation system emerged along a specific sequence of interrelated problems, and associated solutions, which engaged scientists, technicians, practitioners, regulators and patients alike over a period of around three decades.     

虚拟创新:未来技术创新的主导模式

本文探讨了信息化时代技术创新的新模式 :虚拟创新 ,及其特征、理论依据、运作模式 ,和虚拟创新应注意的关键因素 ,并对应用前景作了展望     

Public bioethics and publics: consensus, boundaries, and participation in biomedical science policy

Public bioethics bodies are used internationally as institutions with the declared aims of facilitating societal debate and providing policy advice in certain areas of scientific inquiry raising questions of values and legitimate science. In the United States, bioethical experts in these institutions use the language of consensus building to justify and define the outcome of the enterprise. However, the implications of public bioethics at science-policy boundaries are underexamined. Political interest in such bodies continues while their influence on societal consensus, public debate, and science policy remains ambiguous. This article presents a theoretical discussion of public bioethics bodies as boundary organizations and examines them in terms of relationship to the moral and cognitive authority of science and other forms of expertise, mechanisms for public participation in controversial science policy, and the deployment of consensus models. The theoretical discussion is examined in the case of the U.S. Human Embryo Research Panel.     

Visions of a cure. Visualization, clinical trials, and controversies in cardiac therapeutics, 1968-1998

In the early 1970s physicians engaged in fierce debates over the most appropriate method of evaluating the efficacy of coronary artery bypass grafting (CABG). With millions of patients and billions of dollars at stake, CABG sparked fierce controversy. Skeptics demanded that randomized controlled trials (RCTs) be performed, while enthusiasts argued that they already had visual proof of CABG's efficacy. When RCTs appeared, they did not settle the controversy. Participants simply reasserted their preconceptions, defending a trial's strengths or exploiting its flaws. The debate centered on standards of knowledge for the evaluation of therapeutic efficacy. Specifically, cardiologists and cardiac surgeons struggled to assess the relevance of different measures of therapeutic success: physiological or clinical, visual or statistical. Many factors contributed to participants' decisions, including disciplinary affiliation, traditions of research, personal experience with angiography, and assessments of the history of cardiac therapeutics. Physicians had to decide whether angiography provided a meaningful representation of the disease and its treatment or whether demonstrations of therapeutic success could come only from long-term statistical evaluation of mortality data.     

Murky waters: thoughts on desire, utility, and the sea of modem science

Historians of science in modern China have tried to challenge misconceptions that late nineteenth- and early twentieth-century Chinese were slow to master science or, worse, that they missed the point of science altogether. In so doing, we have often put aside basic questions-like why Chinese were interested in modern science in the first place or how they found modern science useful for their own purposes-in order to demonstrate the quality and advancement of scientific work in China. But overlooking these underlying issues not only strengthens the myth of science as an obvious and inevitable step in development; it also limits the relevance of the Chinese case to the history of science more broadly. If, instead, the spread of science is reconceptualized as a problem of desire and utility, the Chinese example may suggest interesting new avenues for the study of cultural innovation across geographic and disciplinary frameworks.     

Public bioethics and publics: consensus, boundaries, and participation in biomedical science policy.

Public bioethics bodies are used internationally as institutions with the declared aims of facilitating societal debate and providing policy advice in certain areas of scientific inquiry raising questions of values and legitimate science. In the United States, bioethical experts in these institutions use the language of consensus building to justify and define the outcome of the enterprise. However, the implications of public bioethics at science-policy boundaries are underexamined. Political interest in such bodies continues while their influence on societal consensus, public debate, and science policy remains ambiguous. This article presents a theoretical discussion of public bioethics bodies as boundary organizations and examines them in terms of relationship to the moral and cognitive authority of science and other forms of expertise, mechanisms for public participation in controversial science policy, and the deployment of consensus models. The theoretical discussion is examined in the case of the U.S. Human Embryo Research Panel.     

我国生物技术与新医药产业专利保护:现状、问题与可持续创新战略

生物技术和新医药是本世纪最具发展潜力的领域之一,许多国家特剐是发达国家都把发展生物技术及其产业作为提高本国科技和经济竞争力的重要手段。我国必须在生物技术领域拥有自己的知识产权．这是生物技术与新医药产业可持续发展的需要。本文在对我国生物技术与新医药企业知识产权保护状况调研的基础上,分析了生物技术与新医药专利保护现状与问题,并对生物技术与新医药产业可持续创新战略提出了一些建议。     

中国企业技术和市场协同创新机制初探——基于“环境-管理-创新不确定性”的变量相关分析

通过对我国企业技术和市场协同创新过程中所表现出的联系特征进行统计分析,本文初步探究了实现我国企业技术和市场协同创新的有序发展所需建立的协同机制,指出技术和市场协同创新机制的内在本质在于“环境-管理-过程”的全面联系。本文的研究构思,是对上海宝钢ESI经验的总结及发展,并通过统计分析,对我国企业技术和市场协同创新机制给出理论建议及指导。     

Three frames for innovation policy: R&D,systems of innovation and transformative change

Science, technology and innovation (STI) policy is shaped by persistent framings that arise from historical context. Two established frames are identified as co-existing and dominant in contemporary innovation policy discussions. The first frame is identified as beginning with a Post-World War II institutionalisation of government support for science and R&D with the presumption that this would contribute to growth and address market failure in private provision of new knowledge. The second frame emerged in the 1980s globalising world and its emphasis on competitiveness which is shaped by the national systems of innovation for knowledge creation and commercialisation. STI policy focuses on building links, clusters and networks, and on stimulating learning between elements in the systems, and enabling entrepreneurship. A third frame linked to contemporary social and environmental challenges such as the Sustainable Development Goals and calling for transformative change is identified and distinguished from the two earlier frames. Transformation refers to socio-technical system change as conceptualised in the sustainability transitions literature. The nature of this third framing is examined with the aim of identifying its key features and its potential for provoking a re-examination of the earlier two frames. One key feature is its focus on experimentation, and the argument that the Global South does not need to play catch-up to follow the transformation model of the Global North. It is argued that all three frames are relevant for policymaking, but exploring options for transformative innovation policy should be a priority.     

Ownership matters: Intellectual Property, privatization and innovation

This paper discusses a conflict between private defence firms and government procurement agencies related to Intellectual Property management issues that emerged during the privatization process of the main UK defence research establishment. Our analysis questions a common argument found in studies of the defence industries: that a close confluence of interests exists between private suppliers and their public customers, so much so that the boundaries between public and private actors become blurred. Instead, we argue that the tensions between private suppliers and their government customers are jeopardizing the success of process innovations in defence procurement that rely on “partnership” and collaboration between defence and government customers and users.     

The Crisis of communication: Videotext,the internet and innovation in France and the United States

This article compares videotext in France and the United States, the two advanced industrialized countries where videotext was the most and least successful, respectively, in order to demonstrate how videotext as a techno-political project foreshadows the explosive growth of the Internet as the dominant global communications platform. It draws upon the theory of network effects, in combination with a comparative analysis of both the institutional settings for research and development and political discourse, to explain how the interaction between state, market, and culture shaped network development and policy outcomes. Data are drawn primarily from official policy documents and trade journals from the era.     

China's innovation policies: Evolution, institutional structure, and trajectory

China has transformed itself from a planning to a market-oriented economy over the past three decades and has sustained a fairly long period of rapid economic growth, to which the contributions from innovation in science and technology (S&T) have become increasingly important. Then, how have China's innovation policies evolved to reflect the changing and supposedly better understanding of innovation by China's policy makers? The paper tries to answer this question through a quantitative analysis of 287 policies issued by China's central government agencies between 1980 and 2005 and of 79 policies introduced between 2006 and 2008 to implement the Medium- and Long-Term Plan for the Development of Science and Technology (2006-2020). China has shifted its S&T and industrial policy-centered innovation strategy and has pursued a series of better coordinated, innovation-oriented economic and technology initiatives that give greater attention to a portfolio of policies that include critical financial, tax, and fiscal measures. There has been a gradual departure from the pattern in which innovation policies are formulated by one single government agency, therefore steering China to a different and probably more promising innovation trajectory.