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The third Biomedical Imaging Research Opportunities Workshop (BIROW III) was held on March 11-12, 2005, in Bethesda, MD. The workshop addressed four areas of imaging that present opportunities for research and development: Multimodality Image-Guided Therapy, Imaging Informatics, Imaging Cell Trafficking, and Technology Improvement and Commercialization. The first three areas were individually addressed in their own plenary sessions, followed by audience discussions that explored research opportunities and challenges. This paper synthesizes these discussions into a strategy for future research directions in biomedical imaging.

Biotechnology and small pharma companies must recognize the opportunity presented by FDA Breakthrough Therapy Designation (BTD) to expedite drug development for serious conditions. This paper evaluates BTD economic and developmental impacts on such companies. Analysis of 29 BTD events from 2017 to 2022 revealed immediate share price boosts and improved drug approval rates, alongside faster development times. Yet, long-term share prices underperformed relative to the broader market, underscoring the persistent risks in pharma investments. Although offering new insights, the limited sample size calls for further investigation., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

With the rapid development of synthetic biology, lots of synthetic biology technology achievements in various application fields have been commercialized, generating broad market prospects. The commercialization of products employing synthetic biology technology (hereinafter referred as synthetic biology products) has brought benefits to human beings, but it has also produced potential safety risks. At present, relevant laws and standards for regulation of biotechnology or genetically modified organisms have been adopted to regulate the safety risks of commercialization of synthetic biology products (CSBP). However, due to the complexity and uncertainty of synthetic biology, the safety risks of CSBP cannot be comprehensively regulated by these laws and standards. Therefore, it is of great significance to formulate specific supervision and management measures for regulating the safety risks of CSBP. This paper summarized the situation of CSBP in the fields of food, medical care, agriculture, environment, energy and materials, analyzed the safety risks existing in the CSBP, and sorted out current supervision situation of its safety risks in European countries, United States, as well as in China. We further proposed suggestions on the safety supervision and management measures on the safety risks of CSBP, including classified examination and approval, classified identification of products, and strict screening and approval of market entities before entering the market, and strengthening safety supervision and emergency treatment as well as accident responsibility investigation after entering the market. This whole-process safety regulation might provide support for the safety of CSBP and promote the healthy and long-term development of synthetic biology industry.

This article reports that ending months of uncertainty, the U.S. National Institutes of Health (NIH) Director Elias Zerhouni last week unveiled a policy aimed at making the results of research it funds more freely available. But the announcement has injected a new element of controversy into an already bitter debate. That language has stirred worries that NIH is putting authors on the spot by asking them to challenge publishers' own release dates. NIH argued that this would increase public access to research and help it manage research programs. Norka Ruiz Bravo, NIH deputy director for extramural research, expects that researchers will negotiate the timing with the publisher rather than relying on the publisher's policy for when articles can be posted.

The article reports that the Council for Agricultural Science and Technology (CAST) is now offering free issue papers to help broaden distribution of important agricultural research in the U.S. The latest of 38 CAST Issue Papers is "Vaccine Development Using Recombinant DNA Technology," seventh in a nine-part series on "Animal Agriculture's Future through Biotechnology."

The article reports on the release of a white paper by Environmental Health & Engineering Inc. (EH&E) to help biotechnology firms improve compliance with Safety, Health & Environmental (SH&E) regulations in the U.S. According to EH&E's Jack McCarthy, all biotechnology firms are required to meet complex regulatory compliance requirement. The compliance areas of white paper include environmental, employee training, and occupational safety and health. Moreover, the white paper introduces examples of the most common violations encountered during routine audits and offers recommendations for maintaining a continual high level of compliance using limited manpower.

At a time when agri-food biotechnologies are receiving a surge of investment, innovation, and public interest in the United States, it is common to hear both supporters and critics call for open and inclusive dialogue on the topic. Social scientists have a potentially important role to play in these discursive engagements, but the legacy of the intractable genetically modified (GM) food debate calls for some reflection regarding the best ways to shape the norms of that conversation. This commentary argues that agri-food scholars interested in promoting a more constructive agri-food biotechnology discussion could do so by blending key insights, as well as guarding against key shortcomings, from the fields of science communication and science and technology studies (STS). Science communication's collaborative and translational approach to the public understanding of science has proven pragmatically valuable to scientists in academia, government, and private industry, but it has too often remained wedded to deficit model approaches and struggled to explore deeper questions of public values and corporate power. STS's critical approach has highlighted the need for multi-stakeholder power-sharing and the integration of diverse knowledge systems into public engagement, but it has done little to grapple with the prevalence of misinformation in movements against GM foods and other agri-food biotechnologies. Ultimately, a better agri-food biotechnology conversation will require a strong foundation in scientific literacy as well as conceptual grounding in the social studies of science. The paper concludes by describing how, with attention to the structure, content, and style of public engagement in the agri-food biotechnology debates, social scientists can play a productive conversational role across a variety of academic, institutional, community-level, and mediated contexts. [ABSTRACT FROM AUTHOR]

Copyright of Review of Policy Research is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This study looks at the United States biotechnology industry as a community of practice caught between two evolutionary logics by which valuable scientific knowledge and valuable innovations are selected. We analyze the publications and patents of 116 biotechnology firms during the period 1988-1995. In models that link scientific capabilities to patent citations, we show that scientific ideas are not simply inputs into inventions; important scientific ideas and influential patents follow different and conflicting selection logics. Publication, collaboration, and science intensity are associated with patented innovations; however, important scientific papers are negatively associated with high-impact innovations. These results point to conflicting logics between science and innovation, and scientists must contribute to both while inhabiting a single epistemic community. We identify individuals listed on patents and scientific papers and find they effectively integrate science with innovation, leading to more successful innovations. Our findings suggest that the role of the small, research-intensive firm is to create a repository of knowledge; to act as an organizational mechanism to combine the capabilities of versatile scientists within and outside the boundaries of the firm; and to manage the selection of scientific ideas to produce valuable technical innovations. [ABSTRACT FROM AUTHOR]

Background: Immersive virtual reality (VR) is increasingly used in organizational training interventions. However, few studies have systematically investigated VR compared to standard training methods in actual organizational contexts. Objectives: The focus of this study was to evaluate the effectiveness of a VR simulation for training professionals in the biotech industry. Aligning training needs to unique media affordances, the study designed an immersive story‐based VR simulation for training customer‐facing employees on a new product and tested it in an international biotech company. Methods: The system was evaluated by comparing its effectiveness to a traditional video presentation with the same content in a randomized between subjects experiment. The sample consisted of 95 employees across three locations: Brazil, Denmark, and USA. Results: The VR simulation group performed better than the video presentation group on the outcomes of conceptual knowledge (d = 0.41) spatial knowledge (d = 0.61), transfer intentions (d = 0.57), enjoyment (d = 1.74), self‐efficacy (d = 0.68), perceived learning (d = 0.89), personal value (d = 0.83), and organizational value (d = 0.82), but no significant difference was found for factual knowledge (d = −0.10). Implications: Results suggest that VR simulations can be effective across cultures in organizational training interventions. VR is specifically effective when the goals of the training are to increase conceptual and spatial understanding as well as enjoyment, and self‐efficacy, but not factual knowledge. Furthermore, employees report higher levels of perceived learning, personal and organizational value and transfer intentions after VR training compared to standard video‐based training. Lay Description: What is currently known about the subject matter: Immersive virtual reality (VR) is increasingly used in organizational training interventions. This interest has especially surged amid recent global challenges, and the sudden need for companies and employees to adapt to the new remote working conditions.However, few studies have systematically investigated VR compared to standard training methods in actual organizational contexts that include a real‐world scenario and a representative testing sample.Applied research that assesses the outcomes of VR based training in realistic learning and training settings is needed. What their paper adds: We propose and test an interdisciplinary approach that links unique features of VR with training needs and multidimensional outcome measures in an organizational training context within the biotech industry in Brazil, Denmark and USA.The findings suggest that a specifically designed VR tool is superior to a comparable video presentation for the outcomes of spatial and conceptual knowledge acquisition and transfer intentions, but not factual knowledge acquisition.The VR group also reported significantly higher personal value, organizational value, self‐efficacy, perceived learning, and enjoyment compared to the video group. Implications of study findings for practitioners: The results support the value of using VR simulations in organizational training, specifically related to affective outcomes as well as spatial and conceptual knowledge and transfer intentions.The study suggests that it is not the medium of VR, but rather the alignment between the training goals with the instructional methods and the unique affordances of VR that will contribute to better or worse learning outcomes.The article describes how to evaluate the effectiveness of VR tools in applied contexts, suggesting that we have to evaluate the effectiveness of tested content with respect to different outcome variables, which coincide with the training outcomes of a particular organizational context.The project as a whole, can be used as a blueprint for future applied research efforts, exemplifying how to bridge gaps between small‐medium‐enterprises, international corporate companies and academic institutions. [ABSTRACT FROM AUTHOR]

This paper tests the hypothesis that country-specific advantage embedded in firms of a particular nationality is a motivation for international interfirm cooperation. A sample of domestic and international cooperative relationships formed by Japanese firms in the commercialization of biotechnology is used to identify factors which differentiate domestic from foreign partners. The findings support our hypothesis that country-specific advantage is a significant variable in explaining differences between cooperative relationships with partners of different countries. The results of this study indicate that interfirm cooperation has implications for the international competitiveness of both firms and nations in high technology industries. [ABSTRACT FROM AUTHOR]

Oligonucleotides (ONs) are gaining increasing importance as a promising novel class of biopharmaceuticals. Thanks to their fundamental role in gene regulation, they can be used to develop custom-made drugs (also called N-to-1) able to act on the gene expression at pre-translational level. With recent approvals of ON-based therapeutics by the Food and Drug Administration (FDA), a growing demand for high-quality chemically modified ONs is emerging and their market is expected to impressively prosper in the near future. To satisfy this growing market demand, a scalable and economically sustainable ON production is needed. In this paper, the state of the art of the whole ON production process is illustrated with the aim of highlighting the most promising routes toward the auspicated market-size production. In particular, the most recent advancements in both the upstream stage, mainly based on solid-phase synthesis and recombinant technology, and the downstream one, focusing on chromatographic techniques, are reviewed. Since ON production is projected to expand to the large scale, automatized multicolumn countercurrent technologies will reasonably be required soon to replace the current ones based on batch single-column operations. This consideration is supported by a recent cutting-edge application of continuous chromatography for the ON purification., (© 2020 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Human activities, such as research, innovation and industry, concentrate disproportionately in large cities. The ten most innovative cities in the United States account for 23% of the national population, but for 48% of its patents and 33% of its gross domestic product. But why has human activity become increasingly concentrated? Here we use data on scientific papers, patents, employment and gross domestic product, for 353 metropolitan areas in the United States, to show that the spatial concentration of productive activities increases with their complexity. Complex economic activities, such as biotechnology, neurobiology and semiconductors, concentrate disproportionately in a few large cities compared to less--complex activities, such as apparel or paper manufacturing. We use multiple proxies to measure the complexity of activities, finding that complexity explains from 40% to 80% of the variance in urban concentration of occupations, industries, scientific fields and technologies. Using historical patent data, we show that the spatial concentration of cutting-edge technologies has increased since 1850, suggesting a reinforcing cycle between the increase in the complexity of activities and urbanization. These findings suggest that the growth of spatial inequality may be connected to the increasing complexity of the economy.

This paper reviews the creation and the development of biotechnology start-ups in Japan known as "bioventures". In the early 1990s, the Japanese government began to introduce new policies to promote the development of bioventures. Within the span of a decade, the number of bioventures grew five times. However, majority of them continued to operate at the seed or start-up stage. This paper seeks to explore the underdeveloped state of bioventures in Japan, based on the case study method which includes the use of interviews and reviews of several policies and regulations. This paper also compares the development of Japanese biotechnology industry with the biotechnology industry in the US and Europe. This paper concludes that the lack of a sustainable system of funding is the real issue hindering the development of bioventures in Japan. [ABSTRACT FROM AUTHOR]

Pharmacogenomics is the use of genomic science to study human variability in drug response. Proponents of pharmacogenomics suggest that it will lead to a new era of personalized medicine through a fundamental transformation in the drug discovery and development process. Uncertainty about the regulatory standards and processes for this emergent technology have been widely cited as an obstacle to more widespread and rapid adoption of pharmacogenomics. Pharmacogenomics thus presents an ideal case study of the role of regulators in the co-production of new biomedical technologies. This paper describes the attempt to create a new transnational regulatory regime for pharmacogenomics through the creation of novel regulatory experiments by a transnational network encompassing regulatory agencies, academic scientists and industry. This process has been marked by the creation of new socio-technical spaces in the regulatory regimes for pharmaceuticals – a pre-regulatory space for the sharing of data outside the regulatory decision-making process and a pre-competitive space for the sharing of data between companies. It is marked also by the expansion of a transnational regulatory space for sharing data and setting standards across jurisdictional boundaries. [ABSTRACT FROM AUTHOR]

Following an 8-year-long dispute over cotton subsidies, Brazil and the US signed a Memorandum of Understanding on 21 April 2010, effectively paving the way for settling the dispute. This paper argues that cotton subsidies are just the tip of the iceberg while a number of other, perhaps more important, issues require attention and, indeed, political will. Chief among them is the persistent divergence between cotton prices and the prices of other agricultural commodities which reflects, for the most part, the large supply response by China and India, a direct consequence of conversion to biotech cotton varieties in these (and other) countries. Such a response - which kept cotton prices low, compared to other commodities - imposes a competitive disadvantage to nonusers of biotech cotton. The paper also highlights two additional constraints faced by the cotton-producing countries of West and Central Africa, namely the structural inefficiencies of their primary processing industries (also known as ginning) and the appreciation of the CFAf against the US dollar. Without downplaying the importance of subsidy elimination, this paper concludes that these impediments should receive high priority in the policy agenda. [ABSTRACT FROM AUTHOR]

This paper reviews the paper by Kuzma, Najmaie, and Larson that looks at what can be learned from the experience with genetically engineered organisms for oversight of emerging technologies more generally. That paper identifies key attributes of a good oversight system: promoting innovation, ensuring safety, identifying benefits, assessing costs, and doing so all while building public confidence. In commenting on that analysis, this paper suggests that looking at “oversight” in three phases — research and development, regulatory review, and market acceptance — can help to determine when certain of these attributes should take precedence over others and how to structure remedies when an error occurs. The result is an approach that is precautionary with respect to research and development, prudent and open to public input in the regulatory review stage, and purposefully persuasive once market acceptability is at stake, with remedies that are risk-containing in the first phase, risk-managing in the second, and risk-assuaging in the third. Combining the key attributes with the idea of three phases can help attune oversight to society's needs. [ABSTRACT FROM AUTHOR]

The article focuses on the recent advances in biotechnology. It cites that the advances in the biotechnology have changed the key nature of biological researches. It relates that scientists in the past used paper notebooks or simple spreadsheets to document their experiments, but at present, scientists use various new tools such as gene chips or measuring gene expression or sequence variation that brought changes and has altered their works and reveals potential associations and interactions with a variety of genes and other biological entities. It also mentions that the advances in biotechnology brought a massive increase in the scientific knowledge of scientists. The establishment of the Text Retrieval Conference in the U.S. is also discussed.

Diagnostic methods have been gaining medical recognition and social importance as innovations that can be useful to provide individuals with a diagnosis, a prognosis or a prediction with regard to a condition that they currently have or that they are in risk of developing. Despite the great amount of resources deployed to produce these health technologies and their potential benefits for healthcare systems and patients or prospective patients alike, their exclusive protection in the united States has recently faced resistance from patent examiners and courts on the basis that diagnostics constitute a dubious innovation. Inconsistent arguments used for the refusal of patent protection led to a labyrinth where innovators in the diagnostics sector could not reasonably expect their patent application would be allowed or after the patent was issued. This paper aims to convey the doctrine of subject matter eligibility as applied to diagnostic methods by the relevant administrative guidances and case law. In doing so, it aims to depict the pitfalls resulting from the general application of a non-patentability rule to diagnostics, and to suggest opportunities still available for innovators to overcome uncertainty by filing compliant applications while maximizing the likeliness of enjoying protection once the patent is awarded. [ABSTRACT FROM AUTHOR]

This paper examines the American legal system's reliance upon the unity of science through a close study of the testimony presented in a biotech patent trial, explicated through the context of the legal practice of patent drafting and the history of the American biotechnology industry. In order to decide whether a key patent related to the polymerase chain reaction (PCR) was invalid, the court needed to decide whether the inventing scientists had made intentional misrepresentations in the process of drafting and prosecuting the patent. I analyze the various images of science presented to the court by scientists testifying about how scientists report their experimental results in scientific publications. By setting this testimony about scientific authorship in the context of the legal understanding of patent authorship, I explain why the court was prepared to accept a universal notion of science and of the scientist that rendered unimportant any distinctions between papers and patents, or between professors and biotech scientists. This image of universal science was opposed at trial by local and specific images of sciences which have been institutionalized in industrial science throughout the 20th century, and which I argue were adopted and adapted by the American biotech industry of the 19705 to the 1990s in ways that contributed both to the trial court's finding against the patent, and to the instability of that ruling. [ABSTRACT FROM AUTHOR]

In 2004, Europe took the lead among regulated markets in creating a legal framework and a regulatory route for biogenerics. The EU has consequently established a competitive advantage over the USA and Japan in this sector. This paper covers the process of drafting and adopting the legal framework for biogenerics in the enlarged EU through the review process of the European pharmaceutical legislation and in parallel with the publication of the new Annex I of Directive 2001/83/EC, which delineates instructions for the presentation and content of the different types of application dossier in Europe. This paper describes the precise chronological order of the development of the legal framework, as well as the main actors in the process, and describes the background to the adoption of the final terminology used to designate biogenerics - that is, 'similar biological medicinal products'. [ABSTRACT FROM AUTHOR]

In commercial applications of biotechnology, there is no international convergence. On many critical dimensions, the United States is pulling ahead vis-à-vis most other developed or emerging countries, in spite of the efforts made by the potential catching-up nations. The article argues that the explanation lies in the institutional fabric that fosters commercial biotechnology: this institutional structure is too complex and costly, it exists mainly in the United States, and the followers either do not understand it, or are trapped with more inefficient institutions. The paper builds on biotechnology in order to theorize about institutions and their evolution in sectoral innovation systems. It also applies concepts and models from complex system theory. [ABSTRACT FROM PUBLISHER]

Bulk commodity row crop production in the United States is frequently subject to narrow profit margins, often complicated by weather, supply chains, trade, and other factors. Farmers seeking to increase profits and hedge against market volatility often seek to diversify their operations, including producing more lucrative or productive crop varieties. Recombinant plants producing animal or other non-native proteins (commonly referred to as plant molecular farming) present a value-added opportunity for row crop farmers. However, these crops must be produced under robust identity preserved systems to prevent comingling with bulk commodities to maintain the value for farmers, mitigate against market disruptions, and minimize any potential food, feed, or environmental risks. [ABSTRACT FROM AUTHOR]

This study investigates the relationship between media framing and public opinion on the issue of biofuels-transportation fuels made from plants, animal products, or organic waste. First, the paper investigates how media framing of biofuels has changed since the issue regained national prominence in the early 2000s. Through a detailed content analysis of newspaper coverage, the paper documents an increase in negative frames between 1999 and 2008, especially frames focusing on the negative economic effects of biofuels on consumers. Second, using data from a 2010 Internet survey of a random sample of the U. S. public, the paper analyzes the relative influence of these new media frames on public attitudes toward biofuels compared with other common predictors of public opinion, such as party ID, regional economic interests, and personal identity as an environmentalist. In general, the results confirm that public attitudes toward biofuels appear to be shaped by these new media frames, especially among those who indicate a high degree of attention to the media, suggesting the relative importance of framing effects on policy attitudes for environmental and energy policies in general. [ABSTRACT FROM AUTHOR]

Lecocq C., Leten B., Kusters J. and van Looy B. Do firms benefit from being present in multiple technology clusters? An assessment of the technological performance of biopharmaceutical firms, Regional Studies. Firms active in knowledge-intensive fields are increasingly organizing their research and development activities on an international scale. This paper investigates whether firms active in biotechnology can improve their technological performance by developing research and development activities in multiple technology clusters. Regions in Europe, Japan and the United States, characterized by a critical mass in terms of technological activity within biotechnology, are identified as clusters. Fixed-effect panel data analyses with fifty-nine biopharmaceutical firms (for the period 1995–2002) provide evidence for a positive, albeit diminishing (inverted ‘U’-shape) relationship between the number of technology clusters in which a firm is present and its overall technological performance. This effect is distinct from a mere multi-location effect. Lecocq C., Leten B., Kusters J. and van Looy B. 公司是否从其所参与的多技术集群中受益？对于生物制药公司技术性业绩的评价，区域研究。 知识密集型产业中的公司正试图在国际尺度上组织其研究与发展活动。本研究考察了生物制药产业公司能否通过在多重技术集群中发展研究与开发活动而提高其业绩。本研究将欧洲、日本以及美国地区内生物科技产业活动积聚的部分定义为集群。对59家生物制药公司进行的固定效应面板数据分析（时间跨度1995－2002）表明，公司业绩与其所在的技术集群数量之间存在着倒U形关系。这一结果与单纯的多区位效应有所不同。 集群 创新 生物科技 Lecocq C., Leten B., Kusters J. et van Looy B. Les entreprises, tirent-elles profit de leur présence au sein de multiples clusters à technologies? Une évaluation de la performance technologique des entreprises biopharmaceutiques, Regional Studies. Les entreprises qui travaillent dans les secteurs à la pointe de la technologie organisent de plus en plus leurs activités de recherche et de développement au niveau international. Cet article examine si les entreprises actives dans le secteur de la biotechnologie sont capables d'améliorer leurs performances technologiques en développant des activités de recherche et de développement au sein de multiples clusters à technologies. Sont considérées comme clusters, les régions situées en Europe, au Japon et aux Etats-Unis qui secaractérisent par une masse critique en termes d'activité technologique au sein de la biotechnologie. Des analyses (effects fixes) à base de données de cinquante-neuf entreprises biopharmaceutiques (de 1995 à 2002) fournissent des preuves d'un rapport positif, bien qu'en baisse (à savoir, courbe en U inversée), entre le nombre des clusters technologiques au sein desquels une entreprise est présente et sa performance technologique globale. Cet effet se distingue d'un simple effet d'emplacements multiples. Cluster Innovation Biotechnologie Lecocq C., Leten B., Kusters J. und van Looy B. Profitieren Unternehmen von einer Präsenz in mehreren Technologie-Clustern? Eine Bewertung der technologischen Leistung von biopharmazeutischen Unternehmen, Regional Studies. Firmen, die in wissensintensiven Gebieten aktiv sind, organisieren ihre Forschungs- und Entwicklungsarbeit zunehmend auf internationaler Ebene. In diesem Beitrag wird untersucht, ob Firmen im Bereich der Biotechnologie ihre technologische Leistung durch den Ausbau ihrer Forschungs- und Entwicklungsarbeit in mehreren technologischen Clustern verbessern können. Als Cluster werden Regionen in Europa, Japan und den USA identifiziert, die sich durch eine kritische Masse an technologischer Aktivität im Bereich der Biotechnologie auszeichnen. Die (Fix Effekt) analyses der panel daten von 59 biopharmazeutischen Unternehmen (im Zeitraum von 1995 bis 2002) liefern Anhaltspunkte für eine positive, wenn auch nachlassende (Form eines umgekehrten U) Beziehung zwischen der Anzahl der Technologie-Cluster, in denen ein Unternehmen vertreten ist, und der generellen technologischen Leistung dieses Unternehmens. Dieser Effekt unterscheidet sich von einem einfachen Mehrfachstandort-Effekt. Cluster Innovation Biotechnologie Lecocq C., Leten B., Kusters J. y van Looy B. ¿Se benefician las empresas de estar presentes en varias aglomeraciones de tecnología? Una valoración del rendimiento tecnológico de empresas biofarmacéuticas, Regional Studies. Las empresas que son activas en campos que requieren un alto nivel de conocimientos específicos organizan sus actividades de investigación y desarrollo cada vez más a nivel internacional. En este artículo investigamos si las empresas activas en biotecnología pueden mejorar su rendimiento tecnológico al fomentar actividades de investigación y desarrollo en varias aglomeraciones de tecnología. Identificamos como aglomeraciones las regiones en Europa, Japón y los Estados Unidos que se caracterizan por una masa crítica en términos de actividad tecnológica en biotecnología. Los análisis (efecto fijo) de los datos de un panel de 59 empresas biofarmacéuticas (para el periodo de 1995 a 2002) demuestran una relación positiva, aunque decreciente (en forma de ‘U’ invertida) entre el número de aglomeraciones tecnológicas en las que una empresa está presente y su rendimiento tecnológico general. Este efecto es distinto al de un simple efecto de varias ubicaciones. Aglomeración Innovación Biotecnología [ABSTRACT FROM AUTHOR]

Embryonic stem cell research and cloning are among the most controversial and ethically-loaded scientific advances of the past few decades. This paper argues that, in the context of recent theoretical developments in anthropology and cognitive psychology, Thorstein Veblen's work on the place of science in modern societies can provide a theoretical framework to study public misgiving toward embryology in the United States. It is argued that combining insights regarding human cognitive predisposition toward ritualization offered by Veblen with evolutionary theory on hazard-precaution systems and religious cognition may shed some light on the "peculiarity" of the initial public responses to embryology. Ultimately, this paper contends that understanding that initial reactions to embryology may follow a cognitive path of least resistance signifies that assessing the legitimacy of embryology will necessitate a deliberate effort toward instrumental thinking that may go against human cognitive predispositions. [ABSTRACT FROM AUTHOR]

For the biotechnology executive looking to cut a deal with a pharmaceutical company, it is not the type of new molecule that matters, but the quality of the records and data that back up the new biotechnology drug's efficacy that matters. Executives unprepared for pharma's due diligence weaken their own negotiating hand. This paper presents three key aspects to research data quality that any prospective pharma due diligence will examine. Recommendations within the paper stress the elements of a biotechnology preparation strategy that will not only serve to prove the biotechnology's scientific quality, but will also give the biotechnology company an edge over others competing for a slice of the pharma pie.Journal of Commercial Biotechnology (2009) 15, 16–20. doi:10.1057/jcb.2008.48; published online 4 November 2008 [ABSTRACT FROM AUTHOR]

This paper details how patent law purifies “the” inventing subject of big science while simultaneously disqualifying others from patent eligibility for practicing a similar form of collective authorship. The author begins by detailing what is known as the romantic author trope - the assumption within (Western) patent law that invention is the product of one (versus many). The romantic author trope, however, runs counter to the (collective) inventive process in developing countries. Yet this raises the question: are not the inventions of global capital collective in nature? To understand how the collective nature of invention becomes masked by patent law I introduce the idea of corporate authorship. The paper concludes by making visible the inventive assemblages that make the patentable artifacts of big science possible. [ABSTRACT FROM AUTHOR]

Copyright of Praxis (16618157) is the property of Aerzteverlag medinfo AG and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This paper draws a comparison between Chinese and US technology policies aimed at generating clustering in biotechnology. It compares characteristics of biotechnology companies and patents that have been created on the east coast of China since the mid-1990s with early US biotechnology clusters. It highlights Chinese policies aimed at returning scientists and directive locational policies. Policy deficiencies include: difficulty in shifting away from government-led responsiveness to funding programmes; failure to set in place governance structures that promote interaction between the domestic science base and domestic firms; and shortcomings in policies towards returnees and the financing of small and medium-sized enterprises (SMEs). [ABSTRACT FROM AUTHOR]

During the formative years of biotechnology, ‘star’ bioscientists possessed intellectual capital of extraordinary scientific and pecuniary value. In America and Japan, 35 percent of star bioscientists became involved with firms in commercialising their discoveries (a crucial determinant of success) versus 7 percent in Europe. Did star involvement come at expense of scientific progress? No, the publication rate of these ‘involved stars’ increased very significantly whilst actively involved with firms. Furthermore, citations per article were unchanged or significantly increased; so quality was maintained. Top academic scientists and firms working together led to faster commercial and scientific progress – a truly virtuous circle. Durante los años formativos de la biotecnología, los bioinvestigadores “estrella” acumulaban un capital intelectual de extraordinario valor científico y pecuniario. En América y Japón, el 35 por ciento de bioinvestigadores “estrella” se involucraron con empresas en la comercialización de sus descubrimientos (determinante crucial del éxito) comparado con un 7 por ciento en Europa. ¿Fue este involucramiento a costa del progreso científico? No, la tasa de publicación de estos investigadores estrella aumentó muy significativamente mientras que estaban activamente involucrados con dichas empresas. Es más, el número de citas de sus artículos no cambiaron o aumentaron significativamente, y por tanto la calidad se ha mantenido. Los investigadores más eminentes y las empresas punteras trabajando juntos nos llevan más rápidamente al progreso comercial y científico – un círculo virtuoso verdadero. [ABSTRACT FROM AUTHOR]

After a long-lasting period of economic growth and catching-up efforts with the US technological leadership, in the 90th major European economies entered a trend of slow growth, and patchy technological progress. Studies by Acemoglu, Aghion, Zilibotti, 2003; Aghion and Howitt, 2005 identify the source of this trend in the failure to shift from an investment-based model of growth to an innovation-based one's, deemed mostly appropriate when economic performance takes place close to the technological frontier. This failure may occur because policies fostering catching-up investment-based strategies bring about market rigidities and relatively less competitive environment, which in turn hinder the transition to innovation-based strategies. The upshot brings to a vicious circle, called the 'trap of the follower'. Against this background, the paper investigates what caused European economies falling 'trapped', and what made them unable to cross the frontier. A major paper's argument argues that the failure occurred not so much because they were unsuccessful to get into an innovation-based growth pattern, as some of them get into. When assessing their innovation regime, the paper shows that the failure lies in the adoption of a pattern of incremental instead of radical innovations, as it shows in the technological leader. The case in point is the biotechnology sector in the US and Germany. The paper finds that the different models of economic organization in the two countries affected deeply their respective innovation regimes. In the final section, the paper analyzes some aspects of the European competitiveness deficit, and points to more risky and dynamic systems of innovation, as the way out of the European low growth potential. [ABSTRACT FROM AUTHOR]

Over the years industry clusters have been touted to have economic and strategic advantages and have been used to develop embryonic industries. Cluster development process and methodology have generally taken two distinct approaches, “laissez-faire,” which is economic system driven vs. “planned/sponsored,” which is driven by government policy and intent. This paper looks at two biotech clusters that are representative of each of these methodologies, the SF Bay Area (California, U.S.) cluster and the Hsinchu (Taiwan) cluster to identify the evolution and success of these two methodologies. [ABSTRACT FROM PUBLISHER]

This paper considers the current performance and future prospects of the UK biotech industry, particularly the biomedical sector. The central argument is that the performance of the UK biotech industry cannot be understood in isolation from the European system of regulation and, increasingly, the international regulatory environment, and from what is happening elsewhere in the regulation of science– particularly in the U.S. To develop this argument, it adopts as its conceptual framework Kim and von Tunzelmann's network alignment approach following Radosevic. It explores the link between regulatory policies and the biotechnology production system– networks between academic research, biotech firms, and large pharmaceutical companies. [ABSTRACT FROM AUTHOR]

This paper develops a theoretical frame for analysing social movements in/and biomedicine. Drawing from work in social movement theory and science and technology studies, the paper describes the field of biotechnology as the material/imagined space of contemporary biopolitics in the contemporary United States. Interviews with activists from four social movements, websites and written material are examined, and two processes of knowledge construction were found to be central in constituting the field of biotechnology. These processes open up multiple sites for citizen participation in the construction of scientific knowledge. [ABSTRACT FROM AUTHOR]

This paper reviews the public and scientific debates over the risks and benefits of aquaculture and aquatic biotechnology worldwide, and in the United States in particular. The basic argument is that business tends to respond to uncertainty with innovation in management and technology. Technological evolution in the fish business is therefore interpreted as a continuous response to new environmental and socioeconomic uncertainties and subsequent regulation. The use of aquatic biotechnology in fish breeding is just the latest techno-logical response, but also the most controversial. Growth-enhanced transgenic salmon may become the first bioengineered animal product approved for use as food in the United States. The fish may boost future salmon harvests, contribute to productivity increases in aquaculture and lower consumer prices for salmon. But it also faces public opposition, reluctant investors and scientific skepticism due to mainly environmental concerns. The paper argues that even though the regulatory framework in the United States is well-elaborated, it may not be able to re- assure public opposition once transgenic salmon should be approved as a `new animal drug'. Analogous to genetically modified food crops, the consumer market rather than regulation will determine the ultimate fate of transgenic fish. [ABSTRACT FROM AUTHOR]

Gene therapies hold great promise for treatment of diseases but so far their market authorisation has been limited. This paper describes the development of patented gene therapies in the sector of life sciences and health. It was found that the annual number of patented gene therapies increased significantly till the year 2005. A cluster analysis of gene therapies patented in 1995 shows that: a) more than eighty percent has been renewed for more than fifteen years (fifty three per cent till the maximum patent term) and b) fifty per cent of the patents have been licensed. There is a statistically significant correlation between the numbers of citations in future patent applications by third parties and the number of years of patent renewals. A case study of the patent EP 0833934 of biotechnology start-up Crucell demonstrates that the number of citations by third companies to this patent even predicts the companies' market capitalization. This research yielded evidence that the number of patent citations can be used as indicator to determine the value of gene therapies. Such information is of relevance for both the patentee and investors. [ABSTRACT FROM AUTHOR]

Given the absence of progress toward a multilateral agreement on trade liberalization in the WTO's Doha Round, countries are attempting to gain the perceived gains from trade through the negotiation of preferential trade agreements. One of the most ambitious attempts to negotiate a preferential agreement is the Trans Pacific Partnership (TPP) which encompasses 12 countries across the Pacific including both the US and Japan. The TPP members account for approximately 40 % of global GDP. One of the most difficult issues in current international trade policy is the regulation of trade in the products of modern agricultural biotechnology. This question was on the negotiating agenda of the TPP. The objective of this paper is to lay out the major issues in the trade of products of modern agricultural biotechnology and examines the regulatory regimes for biotechnology in the 12 TPP countries. It finds that there is a significant divergence in the approaches to regulating genetically modified organisms (GMOs) across the TPP countries. As a result, the development of a harmonized regulatory regime to govern trade in GMOs was impossible directly in the TPP. A forum where the development of a harmonized system could potentially be undertaken was, however, agreed in the TPP. [ABSTRACT FROM AUTHOR]

Until recently, the patentability of stem cells was well established within the judicial and statutory framework in the United States. However, the shifting landscape of patent law, particularly with regard to patent-eligible subject matter under 35 U.S.C. §101, presents new challenges to the patentability of stem cells. In this paper, we discuss the legal precedent that paved the way for stem cell patents, including Diamond v. Chakrabarty and In re Bergy. Additionally, we review recent Supreme Court cases and recent guidance issued by the U.S. Patent and Trademark Office that impose new limitations on patent-eligible subject matter and thereby threaten the patentability of stem cells in the United States., (Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.)