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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."

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]

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]

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]

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]

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]

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]

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]

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]

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.)

The article presents news briefs related to life sciences in the U.S. Robert Z. Callaham, has been named coordinator of the Wildland Resources Program at the University of California. The field of biotechnology education and training in the U.S. will expand during the next 20 years to accommodate an estimated increase of from 30,000 to 75,000 workers in the field of biotechnology. The University of California, Davis Extension, is offering a certificate program in hazardous materials management.

Biotechnology is viewed as an industry that combines scientific innovation, entrepreneurial management and experienced investment to drive innovation, primarily in biomedicine. This paper examines the third of these assumed preconditions. We find that the majority of investors in biotechnology companies over the last decade by number or by value have not been experienced, and that the majority of investors in biotechnology companies have invested in less than three such companies in the decade, suggesting that they have very limited experience of biotechnology. 13% of investment syndicates contain no investors who have made more than three biotechnology investments. Investor inexperience is disproportionately high in Seed and Series A rounds, but has little correlation with amount invested. Investor inexperience is found in all categories of investors and all territories, although US investors tend to have greater experience than those outside North America. The banking crisis of 2008-11 has not materially changed this. We suggest that the conventional image of biotechnology investment as the careful selection and nurturing of young companies by experienced investors is incomplete. This has implications for candidate investor selection by entrepreneurs, and for government support of biotechnology by supporting investors or investment mechanisms. [ABSTRACT FROM AUTHOR]

The article presents a discussion on issues related to scientific collaborations among researchers in the United States. The paper focuses on the agreement between biologist Paul Weldon and chemist Andrew Evans to confirm the compound content of the bovidic-acid samples, a suspected gaur's natural mosquito repellant. However, disagreement arose over who owned the samples. These consequences of failed collaboration is said to be a common conflict over biotechnology papers, publications, and data ownership. To avoid the problem, documented agreement at the start is suggested. Relevant questions to discuss before starting collaboration are also offered.

This Article unifies two areas of legal scholarship that have not historically intersected. In the fields of biotechnology and the law, it is generally understood that human remains and many body parts are not objects of legal property. This general rule has a startling exception, which heretofore has gone unnoticed in the literature and relevant case law. The bodily remains of Native Americans were, and I argue, continue to be, objects of legal property. With the passage of the Native American Graves Protection and Repatriation Act of 1990 ("NAGPRA") Native American remains are classified as familial and tribal property. In Native American legal scholarship the distinction and significance of property status under NAGPRA has been overlooked. The perpetuation of property status is surprising given that NAGPRA was passed to address the systematic disrespect for Native American burial grounds and commercialization of Native American remains. Property status is all the more striking and important because some federal circuits have also interpreted NAGPRA to apply to contemporary individuals with Native American ancestry. With the rise of genetic testing technologies, application of this property rule takes on some surprising implications. At first glance, we might condemn the property status of Native American remains as continued evidence of dehumanization. Property is traditionally associated with rights of alienability, exclusion, commensurability, and commodification. The understanding of property in Native American human remains advocated for in this paper challenges classic property constructs of wealth-maximization and an individually centered right of exclusion. Instead, after re-considering the paradigm of property, I argue that the communal property approach embodied by the Act enables Native Americans to protect their dead more effectively than any other American group. NAGPRA, therefore, represents an intriguing pathway for human biological materials regulation reform beyond Native American remains. [ABSTRACT FROM AUTHOR]

This paper argues that when the technological basis of an industry is changing, the firm's approach to technology sourcing plays a critical role in building the capabilities needed to generate new technical outputs. Using survey and archival data from the U.S. pharmaceutical industry during the period 1981-91, we find that different approaches to technology sourcing (internal R&D and external R&D) are related to different types of biotechnology-based output at the end of the period. Internal R&D was positively associated with patent output. Acquisition activity was positively related to number of biotechnology-based products. Greater use of R&D contracts and licenses was associated with stronger reputation for possessing expertise in biotechnology. These findings underscore the importance of taking a multifaceted approach to technology sourcing in order to build the absorptive capacity needed to generate new technical output. Surprisingly, we also found that involvement in joint ventures was negatively related to patent output. This raises interesting questions about the strategic use of joint ventures in a regime of encompassing technological change. [ABSTRACT FROM AUTHOR]

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This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy.

Purpose – This paper aims to focus on understanding three dimensions of international alliance formation by small to medium-sized enterprises (SMEs): the role of internal actors, planning/opportunity management, and organizational learning.Design/methodology/approach – The three dimensions form a proposed model of international alliance formation which is examined using semi-structured interviews with 16 biotechnology SMEs from Montreal (Canada) and 12 from Boston (USA).Findings – Findings deepen the understanding of the firm's internal development of international alliance strategy. Results generally support different roles of organizational actors in international alliance formation, often a combination of planning and opportunity management, and signal rather weak administrative routines to ensure organizational learning from the alliance experience. Interestingly, alliance formation strategies vary across the two cities (countries). Age of the firm, development phase, human and financial resources, and competencies may explain these differences.Research limitations/implications – Limitations include a single respondent in each firm, sample size, and single sector (biotechnology). Future longitudinal research could combine information from and about the implication of all actors and their networks during alliance formation and examine the process by alliance functions (R&D, production, marketing) and governance modes (equity, non-equity).Practical implications – Results suggest weaknesses and potential avenues to be explored by managers.Originality/value – To the authors' knowledge, this is a first attempt to model the internal dimensions of alliance strategy formation for SMEs, integrating the role of actors, planning and opportunity, as well as learning. Multiple quotations provide a rich environment for understanding practice. [ABSTRACT FROM AUTHOR]

This paper identifies groupings of co-located patents across American metropolitan areas and associates them with real wage levels and growth. Patent counts are first converted to inventive intensity location quotients. Principal component analysis uses these quotients to identify 'technology components' that are arrayed across distinctive sets of cities. Results reveal that nine 'technology components', account for almost 68 per cent of the variance in patent distribution intensities. Spatial regression analysis shows that real wage levels are higher in areas associated with electronics, mechanical, and drugs and biotechnology invention. Wage growth significantly associates with higher intensities of gadgets, drugs and biotechnology, and drilling patenting. Metropolitan size and positive wage characteristics in neighbouring areas also contribute to urban prosperity. Resumen. Este artículo identifica grupos de patentes co-localizadas dentro de áreas metropolitanas de los EE.UU. y las asocia con niveles salariales y de crecimiento reales. Los recuentos de patentes se convierten en primer lugar a cocientes de localización de la intensidad inventiva. El análisis de componentes principales utiliza estos cocientes para identificar 'componentes tecnológicos' distribuidos en conjuntos distintos de ciudades. Los resultados revelan que nueve de estos 'componentes tecnológicos' constituyen casi el 68% de la varianza de la intensidad de la distribución de patentes. Un análisis de regresión espacial muestra que los niveles salariales reales son mayores en áreas asociadas con invenciones electrónicas, mecánicas, y farmacéuticas y tecnológicas. El crecimiento salarial está fuertemente asociado con una mayor intensidad de patentes de artilugios, productos farmacéuticos y biotecnología, y perforación. El tamaño metropolitano y las características salariales positivas de las áreas vecinas contribuyen también a la prosperidad urbana. [ABSTRACT FROM AUTHOR]

Over the past few decades, a variety of groups have begun to argue that the US and European patent systems do not adequately represent the public interest in their decision making and that they need to undergo fundamental changes to their structure and orientation. These challengers have adopted similar strategies-in terms of the venues chosen and the arguments, evidence, and rhetoric used-in each context. However, they have experienced more success in Europe than in the United States. This paper begins to explain this difference by arguing that the US and European patent policy domains have different 'expertise barriers'-formal and informal rules that make it difficult for those without the knowledge that is recognized as relevant and legitimate in that domain to engage as equals. [ABSTRACT FROM AUTHOR]

Until now, philosophical debate about human embryonic stem cell (hESC) research has largely been limited to its ethical dimensions and implications. Although the importance and urgency of these ethical debates should not be underestimated, the almost undivided attention that mainstream and feminist philosophers have paid to the ethical dimensions of hESC research suggests that the only philosophically interesting questions and concerns about it are by and large ethical in nature. My argument goes some distance to challenge the assumption that ethical considerations alone must be foregrounded in philosophical discussions about hESC research by introducing a critical stance on the epistemological and ontological assumptions that underlie and condition it. A central aim of the paper is to show how Foucault's insights into knowledge-power, taken in combination with Hacking's claims about styles of reasoning, can make these assumptions evident, as well as cast light on their potentially deleterious implications for disabled people. Arguing in this way also enables me to draw out constitutive effects of research on stem cells, that is, to indicate how the discursive practices surrounding research on stem cells, as well as the technology itself, contribute to the constitution of impairment. [ABSTRACT FROM AUTHOR]

Background: The rise of authorized marijuana use in the U.S. means that many individuals are using cannabis as they concurrently engage in other forms of treatment, such as substance abuse counseling and psychotherapy. Clinical and legal decisions may be influenced by findings that suggest marijuana use during treatment serves as an obstacle to treatment success, compromises treatment integrity, or increases the prevalence or severity of relapse. In this paper, the author reviews the relationship between authorized marijuana use and substance abuse treatment utilizing data from a preliminary pilot study that, for the first time, uses a systematic methodology to collect data examining possible effects on treatment. Methods: Data from the California Outcomes Measurement System (CalOMS) were compared for medical (authorized) marijuana users and non-marijuana users who were admitted to a public substance abuse treatment program in California. Behavioral and social treatment outcomes recorded by clinical staff at discharge and reported to the California Department of Alcohol and Drug Programs were assessed for both groups, which included a sample of 18 reported medical marijuana users. Results: While the findings described here are preliminary and very limited due to the small sample size, the study demonstrates that questions about the relationship between medical marijuana use and involvement in drug treatment can be systematically evaluated. In this small sample, cannabis use did not seem to compromise substance abuse treatment amongst the medical marijuana using group, who (based on these preliminary data) fared equal to or better than non-medical marijuana users in several important outcome categories (e.g., treatment completion, criminal justice involvement, medical concerns). Conclusions: This exploratory study suggests that medical marijuana is consistent with participation in other forms of drug treatment and may not adversely affect positive treatment outcomes. These findings call for more extensive sampling in future research to allow for more rigorous research on the growing population of medical marijuana users and non-marijuana users who are engaged in substance abuse treatment. [ABSTRACT FROM AUTHOR]

Genetic engineering (GE) has been used to produce plants with desirable qualities for over two decades, and widespread, world-wide market adoption of engineered crops with pest and disease resistance characteristics has occurred. Genetically engineered organisms (GEOs), including GE crops, have been formally overseen by the U.S. government since the mid-1980s. In this article, our previous work on identifying strengths and weaknesses of the U.S. GEO oversight system is reviewed, and a new analysis of the system based on expert and stakeholder interviews is presented. Using both analyses and an examination of historical controversies surrounding GEOs, three categories of improvements to oversight are identified: democratization of oversight processes, establishing clear mechanisms for inter-agency and -organization coordination, and taking on uncertainty through upstream and fluid approaches. The paper also discusses feasibility issues and barriers associated with implementing changes in these areas, notably the overarching U.S. approach to regulation and legal authorities. [ABSTRACT FROM AUTHOR]

This paper examines relations between the state and capital in Argentina with respect to agricultural biotechnology. Argentina is one of the world's leading exporters of genetically modified (GM) crops and is a key player in the global politics of biotechnology. Whereas in other parts of the world, including other countries in Latin America, active civil societies and some governments have rejected the technology, Argentina has adopted it as a central accumulation strategy. The desirability of this strategy has been secured in material, institutional and discursive arenas of power, producing a particular expression of 'bio-hegemony'. Looking at the role of business in the political economy of agricultural biotechnology is revealing both of the extent and forms of corporate power and contributes to an understanding of hegemony in practice. [ABSTRACT FROM AUTHOR]

In this first paper of a new regular column, Arlen Meyers and Patrick Hurley review the different bioentrepreneurship education programmes available in the United States and suggest some of their critical success factors.Journal of Commercial Biotechnology (2008) 14, 2–12. doi:10.1057/palgrave.jcb.3050078; published online 27 November 2007 [ABSTRACT FROM AUTHOR]

The United States is a large country with a diversity of forage ecosystems and forage species to fill the varied management options within each ecosystem. For example, the American Seed Trade estimates seed of 5,500 varieties representing 1,500 grass and 4,000 legume species are produced annually. The economic benefits of forage improvement are both direct (seed and hay sales) and indirect (saleable animal products, nitrogen fixation and conservation uses). The benefits of improving forages through breeding are likewise important due to the current use of improved varieties to underpin these systems and their direct and indirect products. Because of the diversity of species and management systems, only a few case studies were examined in this paper to estimate these benefits. These were the alfalfa ( Medicago sativa L.) industry (economic value of US$8.1 billion per year), the forage and livestock systems of the southeastern USA (economic value estimated overall at US$11.4 billion per year), and switchgrass ( Panicum virgatum L.) and its potential use as bio-energy feedstock (economic value of needing an additional 28 million acres of production to supply the estimated future feedstock needs). The overall conclusion is that the economic benefits from forage improvement in the USA have been, and continue to be, immense. However, future resources are going to fewer crops, and these crops are the ones that have greater economic value and where biotechnology can be applied. This will favor alfalfa and penalize forage grasses. Even for crops with an identifiable path to market, this concentration of resources in fewer hands requires development of consortia where organizations can leverage their resources with others who possess complementary resources. The Consortium for Alfalfa Improvement is a good example of how this could work. [ABSTRACT FROM AUTHOR]

The sociological study of boundary-work and the political-ecomomic approach of principal-agent theory can be complementary ways of examining the relationship between society and science: boundary-work provides the empirical nuance to the principal-agent scheme, and principal-agent theory provides structure to the thick boundary description. This paper motivates this complementarity to examine domestic technology transfer in the USA from the intramural laboratories of the US National Institutes of Health (NIH). It casts US policy for technology transfer in the principal-agent framework, in which politicians attempt to manage the moral hazard of the productivity of research by providing specific incentives to the agents for engaging in measurable research-based innovation. Such incentives alter the previously negotiated boundary between politics and science. The paper identifies the crucial role of the NIH Office of Technology Transfer (OTT) as a boundary organization, which medicates the new boundary negotiations in its routine work, and stabilizes the boundary by performing successfully as an agent for both politicians and scientists. The paper hypothesizes that boundary organizations like OTT are general phenomena at the boundary between politics and science.

The political debate over genetically modified foods entered a new phase when the USA (under the Bush Administration) threatened legal actions within the World Trade Organization (WTO) against a moratorium of these products in the European Union. This paper focuses on developing a societal context in which these political disputes arose though an investigation of public opinion polls conducted in both the USA and Europe. While some differences do exist with regards to opinions toward biotechnology, any contention that the WTO case is a direct outcome of public opinion is tenuous. The special interest groups that have vested interests in supporting or opposing biotechnology are likely to be the ones fanning the transatlantic flames,and arguing that public opinion is in their favour. [ABSTRACT FROM AUTHOR]

Modern new biotechnology has the potential to provide major economic and other benefits, but at the same time it poses potential hazards for human health, the environment, the “natural” biological order, and can have adverse socio-economic consequences. The application of such technology frequently violates traditional ethical, moral and religious values. This paper, after outlining possible benefits of modern new biotechnologies, discusses the type of biosafety risks which they pose, their possible adverse consequences for the sustainability of biodiversity and agriculture and their potential impacts on socioeconomic welfare and traditional cultures. Particular concern is expressed about the possible consequences of such technologies for developing countries and the practice in some developed countries of issuing patents conferring very broad rights over the use of genetically engineered material. Because these rights are so broad, in some cases they have the potential to establish powerful multinational monopolies in the hands of private companies. Global debate about these issues suggests that more emphasis should be given globally to the socio-economic consequences of such technology than in the past. The need for this is highlighted by the North-South divide. Developing countries lag considerably in this new technological field, are placed in a dependent position and have weak institutional structures to control the application of such technology. [ABSTRACT FROM AUTHOR]

In 1961, the USA severed diplomatic relations with Cuba, and in 1962 an embargo was imposed on trade and financial relations with that country. It was not until five decades later that the USA and Cuba would reestablish relations. This opened the way for the New York State Trade Mission to Cuba in April 2015, during which Cuba's Molecular Immunology Center and Buffalo, New York's Roswell Park Cancer Institute signed a formal agreement that would set in motion biotechnology research collaboration to address one of the most important causes of death in both countries. Significant research from Cuba led to this groundbreaking collaboration. The purpose of this paper is to discuss the development of this cooperation, from the Molecular Immunology Center's initial investigations, through the opening of a phase I clinical trial at Roswell Park Cancer Institute with therapies developed at the Center. This cooperation was responsible for the first clinical trial for CIMAvax-EGF involving advanced-stage non-small cell lung cancer patients in the USA. A license was also approved by the US Department of the Treasury's Office of Foreign Assets Control authorizing a commercial partnership for development of biotechnology products, combining the cancer research efforts of both institutions. This unusual collaboration between Cuba and the USA--the US economic embargo and travel restrictions not withstanding--opens good prospects for expanded medical research between the two countries. While political and logistical challenges remain, the shared mission and dedication of these Cuban and US scientists points the way towards relationships that can lead to development, testing, approval and use of promising new therapies for cancer patients. [ABSTRACT FROM AUTHOR]

Presents news briefs relating to biology and biologists. Awards which were presented to Roger Renvelle of the University of California at San Diego and to Senator John Chafee of Rhode Island; Appointment of Anthony J. Dennis as vice president of biotechnology at Battelle in Columbus, Ohio; Presentation of the Bicentennial Medallion of Distinction from the University of Pittsburgh to Herbert Boyer of the University of California at San Francisco; Scientists who have joined the staff of the American Institute of Biological Sciences (AIBS), including Patricia Lynn Donaldson, Peter Richard Jackson, and Gillian R. Woollett.

Long before worrying about US Food and Drug Administration compliance, organisations that work with foreign employees, contractors, vendors or partners need to be concerned with the importation and exportation of technological knowledge – the so-called ‘deemed exports’. This is particularly apt for executives in the biopharmaceutical, biotechnology and medical device fields who outsource research and development overseas or who hire non-US citizens. US export regulations have strict guidelines on the types of knowledge that cannot be shared with non-US citizens and carry harsh penalties for non-compliance that fall equally on the organisation in question and its executives who ought to have known better. This paper presents an eight-step strategy to develop a regulatory compliance programme that meets US export compliance regulations.Journal of Commercial Biotechnology (2008) 14, 103–105. doi:10.1057/jcb.2008.4; published online 5 February 2008 [ABSTRACT FROM AUTHOR]

The article discusses policymaking for drugs and biologics for rare diseases or conditions, also known as orphan drugs, Orphan Drug Act (ODA) successes such as increased diversity of orphan drugs, and issues not addressed by ODA like high medication costs affecting accessibility.

This study analyses the relationship between technology innovation and basic research. Non-patent references analysis method is used and empirical analysis of China's biotechnology industry is done. Patent data are obtained from the United States Patent and Trademark Office website. The study shows that technology innovation in biotechnology relies more on basic research and it tends to be enhanced. The basic knowledge of technology innovation in biotechnology mainly comes from the papers of academic journals, among which America is the most important science source country to China. The study also shows that public science plays an important role in technology innovation in biotechnology. [ABSTRACT FROM AUTHOR]

The article provides information on the most important advances in biotechnology that were published in the 2005 to 2010 issues of "Nature Biotechnology." It says that the creation of induced pluripotent stem (iPS) cells is one of the most important discoveries, which Shinya Yamanaka of Kyoto University showed by inserting transcription factors into cultured mouse fibroblasts that could make them act like embryonic stem cells. The author adds that George Church of Harvard University in Massachusetts compared epigenomes and genomes across samples in 2009.

9 August 2007, the US Congress established the Technology Innovation Program (TIP) through the America COMPETES Act, a comprehensive strategy to keep the United States, the most innovative nation in the world, competitive by strengthening scientific education and research, improving technological enterprise, attracting the world's best and brightest workers, and providing twenty-first century job training. The new program, TIP, is located at the National Institute of Standards and Technology (NIST) in Gaithersburg, MD (www.nist.gov\tip). [ABSTRACT FROM AUTHOR]

Probably the most interesting feature of the 40-year history of biomedical biotechnology is the extent to which it has been open to - and influenced by - concerns over social values and the public's voice. Good intentions notwithstanding, however, benchmarks and best practices are woefully lacking for informing the policy-making process with public values. This is particularly true in the United States where the call for "public debate" is often heard but seldom heeded by policy-making bodies. Geneforum, an Oregon-based non-profit, has developed a practical and working model designed to encourage deliberative democratic processes for addressing the ethical and social issues raised by emerging biotechnologies. Ordinary citizens do not need to be scientists to understand the important implications of the new technological advances. When factual information and basic principles are conveyed in linguistically and culturally appropriate ways, the scene is set for a shift from monologue to dialogue, from "I-thinking" to "We-thinking," to occur. This paper describes the Geneforum model structured to intensify the democratization of policy decision-making, in general, using genomic science, in particular, as one example of its application. [ABSTRACT FROM AUTHOR]

This paper considers the importance of collaboration for commercial biotechnology research. Biotechnology is the most research-intensive economic activity in existence today. Inter-firm collaboration is a major support of research, since most biotech firms are unable to secure all the research resources they need on their own. The ecology of biotech collaboration and its importance is considered firstly, along with the various collaborative modes and their causes. A second part then addresses the question of whether inter-firm collaboration actually strengthens research intensity. Two main types of collaborative arrangements, strategic research alliances and subcontracting, are considered. Insights into the importance of inter-firm collaborative relationships for research are provided, based on extensive empirical analyses of US commercial biotech establishments. Establishing inter-firm collaborative relationships is considered to be vital as commercial biotechnology research becomes more independent from academic research. [ABSTRACT FROM AUTHOR]

This paper investigates the proposition that foreign direct investment in a high-technology industry is motivated in part by the sourcing of country-specific technological advantages embedded in foreign firms. The empirical findings show that foreign equity investment is drawn to American biotechnology firms with high levels of patent activity. We suggest that, in the biotechnology industry, foreign direct investment in the form of equity participation can be an efficient vehicle for tapping into country-specific, firm-embodied technological advantages. [ABSTRACT FROM AUTHOR]

Information about several papers discussed at a forum sponsored by the U.S. Center for Disease Control and Prevention and Georgia Bioscience Technology (Bio-tech) on the need of life science workforce training in Atlanta is presented. Topics include the need for minority participation Bio-tech training programs and scientific literacy for all citizens. The forum also mentions the significance of bio-tech training for national defense, general health and agribusiness.

Information about several papers discussed at the 2007 mid-Atlantic biotechnology conference sponsored by the Mid-Atlantic Venture Association (MAVA), Virginia Biotech Association (VaBIO) and the Tech Council of Maryland (MdBio) in the U.S. is presented. Topics include the importance of biofuels, stem cells and medical devices in the international market.

The article reports on the emergence of several new treatment options for women who face both cancer and possible treatment-related infertility in the U.S. in 2006. Technology such as the harvesting of eggs from a frozen ovarian tissue implanted in a woman's forearm or abdomen can be used to preserve fertility among female cancer patients.

We are experiencing a technical revolution in biotechnology that will change the way we live as much as any technological advance in human history.1 Advances in gene sequencing, gene editing, and gene synthesis have shifted our relationship with the building blocks of life. This new science, synthetic biology, is in its early stages but has already created distinct threats and opportunities in US national security. It promises advances in materials science, manufacturing, logistics, sensor technology, medicine, health care, and human augmentation while simultaneously increasing the possibility and severity of man-made pandemics through unintended consequences in genetic experiments or improved bioweapons. This article proposes a National Strategy for Synthetic Biology (NSSB) to defend the homeland and promote American strength by building security into synthetic biology and by making synthetic biology an investment priority. The United States can achieve greater security by regulating and controlling synthetic biology to prevent unintended consequences while investing in people and industries to maintain a security advantage in the field. [ABSTRACT FROM AUTHOR]

The article presents an interview with Harold Varmus, president of Memorial Sloan-Kettering Cancer Center in New York City. In response to query about the relationship between basic research and industry, Varmus replied that the relationship between both has been changing everywhere over the last few years. Results from basic research have been more easily brought into commercial application and the speed with which results can be applied is increasing remarkably. In addition, the biotechnology industry itself is doing very exciting work that one depends upon, so it's a two-way street in a way it wasn't before. New York is indeed notable in having a very high ratio of academic research to industrial research.