bluuebunny/crossref_metadata_2025 huggingface dataset:
Global consensus â€“ Need of the hour for genetically modified organisms (GMO) labeling
Authors: Premanandh Jagadeesan
Published: January 2017

The controversies surrounding genetically modified organism (GMO) labeling motivated to assess the legitimate concerns of different stakeholders. This article provides a brief overview on GM labeling regulations and conceptual differences in labeling policies adapted by different countries. Mandatory labeling perspectives of consumers and producers were carefully evaluated. On the basis of the evaluation, it is argued that mandatory labeling does not provide any meaningful information to the consumers. The shortfalls of detection techniques and conflicting roles of governing authorities to approve the GM products after rigorous trials and experimentation on one hand and imposing stringent regulation on the other complicates the issue further, resulting in technological hurdle. In conclusion, the regulatory authorities should at least consider avoiding mandatory labeling on approved GMOs while a unified traceability system should be considered at regional level to monitor risk management of GM products on health and environment. Policy regulations imposed on GMO on unwarranted grounds would be an obstacle for further development of the technology. Therefore, consensus among different stakeholders is crucial for benefiting technologies.
Startup America: What it includes and opportunities for innovators
Authors: Orange David B
Published: January 2017

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The growing importance of incorporating US payers into biotechnology drug development decision-making
Authors: Collins Sarah
Published: January 2017

There are numerous biotechnology agents in the research and development (R&D) pipeline. In part because of the approximately 20 per cent annual increase in biotechnology agentsâ€™ costs, US payers are already very concerned about their impact on health-care costs, and seeking to manage their utilization and total cost. Payer perspectives must be incorporated into the selection of development targets for biotechnology agents, as well as the development of payer-oriented outcomes data during the clinical trials process. Ideal times to do this are the conclusion of Phase I clinical trials, and before the commencement of Phase III clinical trials. A discussion of how the new focus on Comparative Effectiveness Research may impact biotechnology is also included. The article also discusses the very different review processes that US managed care payers employ for biotechnology agents that are in established therapeutic classes, versus truly innovative agents.
The economic potential of plant-made pharmaceuticals in the manufacture of biologic pharmaceuticals
Authors: Kaufman James , Kalaitzandonakes Nicholas
Published: January 2017

Biologic pharmaceuticals have emerged to treat a number of diseases such as cancer and immune disorders. Although these drugs provide significant benefits, they have tended to be costly to produce. Production technologies that grow biologic drugs in plants offer the potential to lower those costs. This article uses a system of simulation models to compare the economics of plant made pharmaceuticals (PMP) to incumbent productions systems. Although it is found that significant cost savings are possible, RD investment in PMPs continue to be limited, which suggests that there are a number of obstacles that limit adoption.
Chronicling the development of myozyme: The Cure and Chasing Miracles
Authors: Francis Derek J
Published: January 2017

Geeta AnandThe Cure,HarperCollins Publishers Inc, New York, 2009, paperback, 368pp.,ISBN: 978-0060734404John F CrowleyChasing Miracles,Newmarket Press, New York, 2010, hardback, 224pp.,ISBN: 978-1557049100
Turning good science into successful businesses: The technology transfer systems in the UK and Germany
Authors: Kettler Hannah , Casper Steve
Published: January 2017

In the biotechnology industries, the technology transfer process serves as a crucial bridge linking public science to commercial enterprise. This paper argues that an effective analysis of technology transfer must move beyond a description of the technology transfer offices, and examine how a nation's technology transfer system is embedded within a broader national system of innovation. With this aim the UK and German technology transfer systems are compared. Important differences exist in the maturity and pattern of subsector specialisation across the two country's biotechnology industries. Germany's relatively late entry into the industry and its new companies' tendency to focus in platform technology and diagnostics segments as opposed to therapeutics (as is the case in the UK) can be linked to the laws governing intellectual property, the incentives for professors and scientists to become entrepreneurs, and the scientific resources available for commercialisation. Given the important differences in the profit and growth profiles of these product segments, the organisation of the technology transfer system together with national factors such as the availability of high-risk finance and skilled managers have a significant impact on the competitive prospects of a country's biotechnology industry.
Technology transfer in the biomedical sciences: The Medical Research Council approach
Authors: Owen David A A
Published: January 2017

This paper describes why the UK Medical Research Council participates in exploitation (an integral part of its mission), the objectives for exploitation (primarily to serve public food through contributions to the health and wealth of the UK) and how the organisation of exploitation is structured. Finally, an indication of some achievements is presented.
US Financial accounts reports
Authors: Crocker Glenn
Published: January 2017

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Managing risk and reputation in the biotechnology industry
Authors: Moon Chris , Piper Mike
Published: January 2017

One of the most important assets any company has is its reputation -damage to a company's reputation will reduce its ability to create value. Owing partly to intense media coverage and intense public interest, and partly to market volatility and the vagaries of the clinical trials process, biotechnology companies face risks to their reputation not always faced by other industries. In this paper some of these risks are highlighted, and the best practices that can be used to manage them are discussed. Drawing upon research conducted by Andersen over a three-year period and involving 10,000 organisations, the authors provide insights into how companies in many sectors are creating value through their tangible and intangible assets. The value dynamics framework is applied to life science companies in order to demonstrate that reputation damage is a key risk that needs to be managed.
Conflict of interest in academic research
Authors: Trune Dennis R , Sherer Todd T
Published: January 2017

The potential for conflict of interest in research can occur whenever a faculty member's financial interest in an industrial sponsor is sufficient to affect his or her impartiality in interpreting the results of the sponsored project. Owing, in large part, to the role of public funding of research, the appearance of a conflict of interest can be as damaging to the reputation of the investigator and/or university as an actual conflict. Therefore, universities and governmental funding agencies have established policies to help ensure that the public welfare is upheld through unbiased research conduct and reporting. Industrial partners who sponsor such research should understand the university's need to identify and appropriately manage these conflicts. Violation of the policies that govern conflict of interest in research can compromise public trust in academic research (jeopardising public funding) and pose undue health risks, as well as damage the reputation of the researcher.
EU regulation of genetically modified organisms: Food and feed, traceability and labelling
Authors: Schofield Geraldine
Published: January 2017

The European Commission has proposed two new regulations to deal with the labelling and traceability of genetically modified organisms (GMOs). These deal with both food and animal feed. The intention is to provide information to the consumer, to ensure transparency of GM ingredients in the food chain and to encourage the unblocking of an (unofficial) moratorium on GM crops. This paper describes where the proposals are in the EU system, the issues and the problems industry will face if they are implemented in their present format.
Lessons learned
Authors: Cook Jeremy Curnock
Published: January 2017

Presents an article which narrates the experience of being an investment manager in the biotechnology industry. Challenge of sustaining and maintenance of investor confidence; Information on secure intellectual property; Recommendations for those starting out on the path of biotechnology entrepreneurship.
Biomanufacturing capacity: Current and future requirements
Authors: Sinclair Andrew
Published: January 2017

In recent years the perception has arisen that biopharmaceuticals manufacturing capacity has gone from excess to shortage. What is the cause of this change and why were the shortfalls not addressed in time? This paper looks at how the structure of the industry has influenced the current shortfall and analyses the current manufacturing sector capacity and product mix. Looking to the future, the paper discusses factors that will dictate capacity requirements over the next five to ten years.
Key indicators of the German equipment and supplies industry
Authors: Woerner Stefan , Reiss Thomas
Published: January 2017

A framework is presented to analyse the sector of equipment and supplies in biotechnology. Unlike the much-studied sectors of agro-food and biopharmaceuticals, the biotechnology equipment and supplies industry has been little involved in ethical and social controversies. It is thus interesting to see how this sector developed in absence of ethical or cultural barriers to economic development and integration. We find that the sector in Germany is rather diverse, showing a relatively high degree of commercial development. Prospects for future growth are delineated by discussing supporting and hampering factors in the demand for equipment and supplies in biotechnology.
Cell therapy: European legal and regulatory implications
Authors: Parker Scott
Published: January 2017

This paper reviews some of the legal and regulatory considerations that may arise in connection with the use in Europe of cell therapy approaches for the treatment of disease.
Legal and Regulatory Update
Authors: Wilkinson John
Published: January 2017

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Genetic testing services in Europe: Quality assurance and policy issues
Authors: Cassiman Jean-Jacques , Kent Alastair , Miller Glenn , Miny Peter , Tambuyzer Erik
Published: January 2017

The popular press is painting a picture of a future in which everyone has a detailed DNA profile of themselves drawn up. Such a vision of the future, however, is more science fiction than science practice. Predictive tests for complex diseases and cancer, eg colon cancer and breast cancer, are increasingly being used, and the related, and important, genetic counselling may become complex and comprehensive. Quality assurance in genetic testing for both cytogenetics and molecular genetic testing in Europe is also described. The quality of genetic testing in Europe could be substantially improved, and before a genetic test is accepted as a routine diagnostic or prognostic procedure it should have proven clinical utility. Pharmacogenetic testing looks at the efficacy of medicines and their side effects on patients and patient groups, and is increasingly being used to develop better targeted medicines. Genetic testing services and genetic counselling are structured in different ways in Europe, and organisation and reimbursement differ among European countries. Quality and non-directive genetic counselling must be made an integral part of quality genetic testing services, and be sufficiently reimbursed. European networking and identification of reference centres for quality-based diagnostic testing of genetic diseases should be encouraged. Reimbursement within Europe for sample forwarding should be adapted to allow samples to be tested in countries other than the country of origin of the patient.
Mergers and acquisitions: A consideration of the drivers and hurdles
Authors: McBeath Ian , Bacha Jeffrey
Published: January 2017

Mergers and acquisitions (M&A) are increasingly being included by biopharmaceutical companies within earlier stage strategies as a means of accelerating technology development and thus quickening the path to shareholder value. These drivers are generally different from those of the larger established pharmaceutical companies that are more earnings focused. The authors consider some of the drivers of and hurdles to the successful implementation of M&A from both a national and cross-border perspective. In 2000 the number of cross-border transactions increased to 41 per cent of all M&A deals; however, generally, returns from international transactions are much lower. The authors also consider the important issues of determination of the price to be paid and the use of stock as 'currency'.
US Financial accounts reports
Authors: Crocker Glenn , Smith Karen
Published: January 2017

Presents financial reports from U.S.-based biotechnology and pharmaceutical companies. Celera Genomics Groups; IDEC Pharmaceuticals Corp.
Embryo and stem cell research: Views from the USA
Authors: Wertz Dorothy C
Published: January 2017

Presents a study that examined the history, ethical debates and religious views regarding embryo and stem cell research in the U.S. Effect of the abortion debate on embryo research in the U.S.; Reason behind the reluctance of the federal government to fund therapeutic research; Role of the private sector in the development of embryo and stem cell research.
Pitfalls to avoid when starting a biotechnology company in the USA
Authors: Kapner Virginia , Chory John
Published: January 2017

This paper presents an overview of some of the principal legal issues associated with establishing a biotechnology venture in the USA. We address the basic rules surrounding the establishment of a corporation and identify policies that should be followed by every company in order to prepare it for its next stage of growth.
Enforcement efforts and partnership with industry: A needed strategy addressing counterfeit drugs
Authors: Kubic Thomas T
Published: January 2017

Despite some law enforcement successes, organizations engaged in counterfeiting continued manufacturing, distributing and selling a wide range of unsafe medicines during the past year. This article will identify some of these successes that were made possible due to a publicâ€“private partnerships, as well as some of the challenges facing patients around the world. It also outlines the activities of the Pharmaceutical Security Institute, which engages through member companies and independently in publicâ€“private efforts to combat the problem of counterfeit drugs. These efforts may serve as models for innovative publicâ€“private partnerships that may be effective in coordinated, global efforts to protect the safety of the drug supply.
Promoting online drug safety: Using publicâ€“private partnerships to deter illicit online drug sales
Authors: Mackey Timothy K , Liang Bryan A
Published: January 2017

Illicit online pharmacies selling counterfeit drugs in a global virtual marketplace remain a critical problem in global health. Yet they continue to operate with little regulation while growing numbers of consumers access the Internet for health information that may lead them to purchase dangerous drugs online. This global social problem requires immediate action to protect patient safety and public health. Publicâ€“private partnerships models represent a potentially effective way to address this issue through promoting mechanisms of collaboration and coordination of multiple stakeholders.
Innovation in R&D: Using design thinking to develop new models of inventiveness, productivity and collaboration
Authors: Simons Tad , Gupta Arvind , Buchanan Mary
Published: January 2017

By adapting insights and methodologies from design thinking, a modern scientific R&D organization may have the potential to increase the speed, inventiveness and vitality of their output and become an explosive engine of growth. Modern design consultancies face the challenge of producing original, creative work for their clients on project after project, and have thus developed several strategies and behaviors to produce innovative content repeatedly at a fast pace. The innovation strategies of design firms are different than traditional models of academic and scientific scholarship and rely on new models of radical collaboration by teams, knowledge sharing, wide-reaching cross-pollination and the habit of gaining early insights through tangible expressions of ideas in order to foster continual and rapid innovation.
The impact of pharmacogenetics and pharmacogenomics
Authors: Lindpaintner Klaus
Published: January 2017

Pharmacogenetics is widely proclaimed as about to revolutionise the face of medicine. In a more realistic assessment, the implementation of molecular genetics and biology will continue to provide, as it has done already, better ways to diagnose and treat illnesses, but it will do so at a steady and evolutionary pace based on an improved understanding of the nature of disease, allowing more specific treatments, better risk prediction, and the implementation of preventive strategies. As such, future progress in biomedicine will travel the same well-trodden paths of improved differential diagnosis and risk prediction along which it has advanced over the past decades and centuries. So, while meaningful biomedical research today depends, by and large, on the use of the newly developed tools of genetics and genomics, and the insights gained through them, it is unlikely to fundamentally change the direction of medical progress.
A new model to evaluate the market for biotechnology
Authors: McMurray Amanda , Jones Richard
Published: January 2017

There is a clear need for a tool for market analysis of biotechnology markets. There are many well-respected and well-established models for market analysis but none that meets the specific needs of biotechnology marketing. A new model is proposed here that will transform market analysis for biotechnology. The model is a tool for visualisation of a new biotechnology market through comparison with an existing market that is well understood. It combines parameters identified as specific to the needs of a specialised biotechnology market into a single marketing tool and can be customised to include specific parameters or features relevant to an organisation, its markets or its marketing needs. It has been used to analyse the potential and risks of entry into a new market by comparing it with one that is well understood. Furthermore, by drawing on specialised competitor and market knowledge, it can be used as a strategic planning tool.
Biotechnology M&A insight: Deals and strategies
Authors: Pavlou Alex K
Published: January 2017

Biotechnology mergers and acquisitions (Biotech M&A) can help the industry's fully integrated players to increase in size and market value, boost the emerging players' efforts to reach full integration or allow horizontal players to survive cyclical financial crises. Analysis of 82 key deals between 1999â€“2003 showed a dollar value of biotech M&A well over US$45bn. This activity, mainly driven by a continuous move towards industrial specialisation, also revealed a widely segmented model with seven major M&A trends. Intersector activity involved 11 key deals between the biotech, the drug delivery (Bio2DD: biotech-to-drug delivery) or pharma sectors (P2Bio: pharma-to-biotech) with a value totalling US$9.7bn, and were driven either by the pharma players' need to expand their marketed portfolios or improve innovation, or the biotech sector's intention to advance management lifecycle or business diversification. Furthermore, intrasector activity included 18 agreements between fully integrated (Fbio2Fbio: fully integrated-to fully integrated biotech players) or fully integrated and emerging players (Fbio2EBio: fully integrated-to-emerging biotech players) valued at US$30bn, which were aiming to increase market value and sustain profitability. In addition, Datamonitor analysis has identified 53 deals with a value of US$5.3bn between emerging players (EBio2EBio), emerging and horizontal players (EBio2Hor: emerging-to-horizontal players) that targeted full integration, or between horizontal players to reach a higher level of innovation or larger customer base.
Additional on-line material: Pharmacoeconomics and the growth of the biotechnology industry
Authors: Szucs Thomas D , Schneeweiss Sebastian
Published: January 2017

Assuming a constant stream of new biotechnology products in the future, three key issues are likely to influence the growth of the biotechnology industry in an increasingly competitive healthcare market: (a) biotechnology products are more expensive than comparable traditional pharmaceuticals; (b) many biotechnology products target small patient populations for which they may provide the only therapy that substantially improves their condition; (c) the physiological and pathophysiological effects of some biotechnology products are not completely understood, which may require additional resources to characterise and manage patient risks. We show how these issues can be addressed with the help of pharmacoeconomic tools and how they will probably affect the growth of the biotechnology industry.
Editorial
Authors: Sime John M
Published: January 2017

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ScanBalt BioRegion: A model case for Europe
Authors: Blank Wolfgang , Samuelsson Bo , Frank Peter
Published: January 2017

Europe takes part in a global competition for scientists, capital and knowledge â€“ major factors of importance for societal growth. In the USA, regions such as Bay Area, Massachusetts and North Carolina, in particular, have developed to a critical mass far beyond the potentials of individual regions in Europe or other parts of the world. The foundation of the ScanBalt BioRegion as a pan-European life science/biotechnology collaboration has the perspective of closing this gap. The greater Nordic-Baltic region â€“ including the Nordic countries, the Baltic countries, North Germany, Poland and the north-western part of Russia â€“ constitutes a meta-region with a great pool of knowledge, capital and resources. In recognition of these potentials, the Nordic-Baltic region has marked itself as one of the world's most proactive in terms of building cross-sector and pan-regional networks and cooperation at local, regional and meta-regional levels.As a consequence private companies, public institutions and governments are aiming to create an internationally competitive and prosperous meta-region comprising Denmark, Estonia, Finland, Iceland, Latvia, Lithuania, Norway, Poland, Sweden, north-western part of Russia and the northern part of Germany. Thereby the political visions, for years expressed by, for example, the Baltic Development Forum, are becoming a reality in the world of biotechnology and life sciences â€“ the frontier of a knowledge-based society. The emerging meta-region is named the ScanBalt BioRegion.
Do Venture Capital Firms Play as Supportive Mentors or Free-riders? Evidence from China
Authors: Yang Xi , Wang Su-Sheng
Published: January 2017

This paper aims to investigate whether Venture Capital Firms in China play as active investors, who seize to provide the funded entrepreneurial firms monitoring assistance and value-adding service for the performance enhancement, or just act as passive investors, who care little about the growth of the funded firms but the opportunity of freeriding on the IPO process to gain fast and huge economic rents. Utilizing the panel data of listed companies on the Chinese SME Board, this paper employs the PSM methodology and the panel regression models with random effect to control the sample selection bias, and disentangle VC firm’s ex-ante screening effect from the ex-post effect. The analysis reveals that Venture Capital firms are able to select the entrepreneurial firms with superior performance before the first round of VC investment, but fail to enhance the development of funded ventures after the involvement. Although the venture backed firms present the performance superiority over the non-venture backed peers overall, this difference is just attributed to VC firm’s ex-ante screening effects. VC firms do not demonstrate the ex-post value-adding effect, rather to some extent they even exert hampering effect on the performance of funded firms after the investment was made.
Bioinformatics Patents - The Challenges
Authors: Shenoy Rujita Ravindra
Published: January 2017

This paper examines the problems and complexities created by the patent regime as well as challenges posed by accommodating new technologies like bioinformatics in its traditional patent framework. It examines and analyses the standards of biotechnology and software patents followed in the US, EU and India based on judicial precedents and its implications on bioinformatics patents, analyses bioinformatics patents granted in the United States and European Union and examines theÂ  Indian Patent Manual and the patentability standards followed in India.Keywords: Bioinformatics, Patents, Information Technology, research tools, biotechnology and software patents, Intellectual Property Rights.Â
Genetically modified crops: Broader environmental issues
Authors: Gray Alan
Published: January 2017

Looking back over the five years since a similar review of the field, this paper considers some of the research designed to address those uncertainties that, in part, led to the delay in the commercial-scale release of genetically modified (GM) crops in the UK. This research has included studies of the impact of transgenes on crop biology and invasiveness, the frequency and consequences of hybridisation between crops and their wild relatives and, in two costly large-scale investigations in the USA and UK respectively, attempts to assess the environmental impact of GM crops grown on a commercial scale. The first, on the effects of Bt corn on the Monarch butterfly, has important lessons for the risk assessment process. The second, farm-scale evaluations of GM herbicide-tolerant crops, should provide a blueprint for the management of the crops within an agricultural landscape delivering both food and biodiversity.
Recent developments in the regulatory system in the UK
Authors: Bainbridge Janet M
Published: January 2017

Regulatory frameworks are the mechanisms to ensure that both genetically modified (GM) crops, which are to be released into the environment, and GM foods and feeds, which need to be approved before consumption, are evaluated from both environmental and human health viewpoints. Regulatory committees, comprising independent experts, carefully examine the detailed dossiers of information that accompany the applications and also review the current relevant scientific background information in coming to their decisions. This paper explains the work of two key GM advisory committees and describes progressive developmental regulatory changes, which have followed incremental increases in science knowledge, and have also been influenced by the needs of the society they serve. The paper does not attempt to detail the specific assessment stages of the processes â€“ these are described adequately elsewhere and for those the reader is referred to committee annual reports or websites.
The regulatory system in the EU and further afield
Authors: Kinderlerer Julian
Published: January 2017

The regulation of modern biotechnology began almost as soon as the potential benefits and risks became clear. In some countries a decision was made to use current law to address the new technologies, arguing that the changes that are able to be introduced into new products are not substantially different from those introduced by other techniques. In other jurisdictions new law was enacted to ensure that the products are at least as safe (or as some would have it, safer) than those currently on the market.New treaties that have attracted widespread support among 'consumer' countries and indifference or hostility among 'producer' countries have just come into force, requiring countries to address the regulation of biotechnology and assess the risks to biological diversity and to human health of introducing living modified organisms into their territory.Public perception of genetic engineering has led to changes in the regulatory system, which may not be justified by the risks posed by this technology. In particular, the national and international requirements that have been currently agreed require an analysis of risk only rather than a balancing of risk with the benefits that may accrue.
Seeds, food and trade wars: Public opinion and policy responses in the USA and Europe
Authors: Ten Eyck Toby A , Gaskell George , Jackson Jonathan
Published: January 2017

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.
Interview: The current and future status of GM technology
Authors: Pavlou Alex K
Published: January 2017

Interview with Dr Sandy Thomas, Director of the Nuffield Council on Bioethics
Book Review: Clinica Reports: The Complete Guide to the Diagnostics Market 2004â€“2009
Authors: Stevens Anthony
Published: January 2017

Clinica Reports: The Complete Guide to the Diagnostics Market 2004â€“2009 M Simonsen PJB Publication, Richmond; 2003; 262pp; Â£1300
2003: What lessons for European biotechnology?
Authors: Fazeli M S
Published: January 2017

The biotech sector had a sizzling year last year, raising US$19bn in cash globally. This paper looks at the performance of the biotechnology sector on both sides of the Atlantic in terms of financing activity. Financing activity in the European biotechnology industry is still a long way off from the USA, with public fundraising only reaching the level that the USA had in 1997 and venture capital financings getting close to the US levels of 1994â€“95. This suggests that at least another five to eight years is needed before there is even a chance to get near where the USA is today. However, the sheer size of the US equity capital market and its liberal attitude to fundraisings and higher-risk appetite is likely to mean that European biotechs will never catch up with the USA, even if our science (across the whole of Europe) is as good. This does not mean that Europe cannot have a thriving biotechnology industry. Indeed, the current level of activity in the venture capital and public markets suggests that Europe is only just getting serious on biotechnology.
The class of 2004: Human capital in biotechnology
Authors: Collingham David
Published: January 2017

This paper assesses growth models for biotechnology organisations, comparing the dynamics of company evolution in the previous decade with circumstances pertinent to the more recent market downturn and financial constraints. Using anecdotal evidence gained from senior executives in biotechnology companies in the USA, Australia and Europe, the author demonstrates how the utilisation of human talent has evolved over the past decade. The creative use of human capital for companies with limited financial means is discussed, in the context of the differing needs of organisations as they progress along the biotechnology life cycle.
Clinical trials in the pharmaceutical industry: The scope of the research exemption under French patent law â€“ clarification is still awaited
Authors: CoustÃ© Marina , JonquÃ¨res FranÃ§ois
Published: January 2017

This paper discusses a recent French Court decision and its impact on the judicial interpretation of the extent to which pharmaceutical clinical trials may or may not fall within the scope of the exemption provided under French law for infringement of patent rights when conducting unauthorised clinical trials aimed at securing marketing authorisation of a patented drug substance.
Biotechnology policy in European countries: An assessment
Authors: Zechendorf Bernhard
Published: January 2017

For more than 20 years, all major European governments have put biotechnology as a priority on their innovation policy agendas. How did each of the three big countries â€“ France, the UK and Germany â€“ manage their biotechnology policy, and what results have they achieved? A project funded by the European Commission tried to find out by assessing, over the period 1994â€“2001, the development of the knowledge base, patent activities, technology transfer measures, regulatory policy, industry promotion measure and public opinion. By adding data from other sources, the author presents a dynamic picture of each country's policy and development up to 2003.
EU financial accounts reports
Authors: Aaronson Colin
Published: January 2017

Acambis is a profitable and cash-generative biotechnology company that is focused on building a substantial franchise in the vaccine space. Its results for the period have benefited significantly from its contract to supply 155 million doses of its ACAM2000 smallpox vaccine to the US Centers for Disease Control and Prevention (CDC). During the year ended 31st December, 2003, Acambis generated profit before taxation (before exceptional items) of Â£46.8m on sales of Â£169.1m compared with a profit of Â£9.6m on sales of Â£79.7m for the whole of 2002. The pre-tax profit for the year was Â£39.4m, after taking account of an exceptional cost of Â£7.4m following a settlement with BTG International Limited to discharge all rights and obligations under a technology licence agreement established in 1994. The profit was earned mainly in the third quarter, with Â£22.2m earned during the three months ended 30th September, 2003, the company having earned Â£20.6m for the six months ended 30th June, 2003. Research and development expenditure increased from Â£16.5m in 2002 to Â£19.1m in 2003, the result of the progression of the company's products to the later stages of development.
Bioentrepreneurship in Japan: Institutional transformation and the growth of bioventures
Authors: Lynskey Michael J
Published: January 2017

Until recently, Japan had relatively few biotechnology start-up firms and they did not play a significant role in the commercialisation of university research results. This was surprising given the pivotal role ascribed to such firms elsewhere in the commercialisation of biotechnology. However, the system of universityâ€“industry collaboration, the management of intellectual property and the role of universities are undergoing significant transformation in Japan. These changes, and others in the financial and labour markets, are proving conducive to entrepreneurship. Consequently, there has been a dramatic increase in the number of biotechnology venture firms hoping to commercialise research results from universities.This paper gives an overview of these institutional transformations in the light of recent deregulation and legislative changes, and describes why 'bioventures' are a viable means to commercialise Japanese biotechnology discoveries. Examples are given of such bioventures, based on interviews conducted with the founders and chief scientists of these firms in Japan. Some of the salient characteristics of these firms are illustrated, including their use of university collaboration and ownership of intellectual property rights.
Vulnerability Assessment of an Aquifer using Modified GIS‐based Methods
Authors: Khodabakhshi Nastaran , Heidarzadeh Nima , Asadollahfardi Gholamreza
Published: January 2017

The primary goal of this research was to compare several computational techniques to identify a groundwater vulnerability index across the Sefid‐Dasht aquifer in Iran. A model using the aquifer characteristics (depth, net recharge, soil media, aquifer media, impact of unsaturated zone, and hydraulic conductivity), the DRASTIC model, was applied to calculate vulnerability index of the mentioned aquifer considering two aspects of the conventional and modified procedures. A fuzzy geographic information system‐based DRASTIC model was also used. The conventional DRASTIC vulnerability index map indicated that 69.5 and 30.5% of the aquifer had low and moderate vulnerability, respectively. Similar results were obtained from the modified DRASTIC method, which showed that 79.22, 20.46, and 0.31% of the aquifer has low, moderate, and high vulnerability, respectively. Because of similarity in the results and the simplicity of the modified DRASTIC, the application of the former method is recommended. In the fuzzy‐DRASTIC method, final maps indicated no major difference between this method and the conventional DRASTIC model.
The Removal of N‐Nitrosodimethylamine Formation Potential in Drinking Water Treatment Plants
Authors: Uzun Habibullah , Kim Daekyun , Karanfil Tanju
Published: January 2017

A long‐term (>18 months), systematic investigation was conducted to examine (1) the removal of N‐nitrosodimethylamine (NDMA) formation potential (FP) by different treatment processes under various operational conditions at nine water treatment plants in South Carolina, and (2) the occurrence of NDMA in their distributions systems. Average NDMA FP removal by alum clarification ranged from 12 to 30% during different seasons and weather conditions. Powdered activated carbon addition improved the removal of NDMA FP, especially at high doses (>4 mg/L). The use of oxidants (i.e., chlorine [Cl2] and chlorine dioxide [ClO2]), especially simultaneous application, enhanced the removal of NDMA FP and lowered the NDMA concentration in the distribution systems to <10 ng/L. However, simultaneous application of ClO2 and Cl2 led to the formation of elevated levels of chlorate. The average NDMA FP reduction by reverse osmosis and microfiltration was 81 and 7%, respectively. The overall NDMA FP removal efficiencies between raw and finished water ranged between 40 and 59%.
Musique contemporaine et cinéma : panorama d’un territoire sans frontières
Authors: Langlois Philippe
Published: January 2017

Musique contemporaine et images cinématographiques ont une histoire en commun qui s’est illustrée tout au long du xxe siècle par la richesse et l’inventivité qui ont résulté de leur rencontre. Dans le contexte cinématographique, la musique contemporaine ne se déploie plus seulement dans la sphère du cinéma expérimental et d’avant-garde, mais touche un plus large public du fait de son emploi de plus en plus fréquent dans le cinéma de fiction, le documentaire de création ou le cinéma d’auteur. L’influence de la musique concrète et électroacoustique après 1945, l’influence du courant minimaliste américain à partir de 1960-1970 et l’apparition du postmodernisme dans les années 1980 constituent les jalons qui ont décuplé l’étendue des possibilités de dialogue audiovisuel.
La messe de terre de Michel Chion : de la liturgie à l’autoportrait
Authors: Macé Pierre-Yves
Published: January 2017

Renommé tant pour ses essais sur le son au cinéma que pour ses compositions de musique concrète, Michel Chion (né en 1947) produit également un travail cinématographique et vidéo qui s’inscrit dans le prolongement de son écriture musicale. Oeuvre-somme d’une durée de 2 h 30 min, La messe de terre est une véritable « liturgie audio-logo-visuelle » qui associe la musique concrète à une composition très sophistiquée des images. Si l’oeuvre est dominée par la césure, le clivage entre ce que l’on voit et ce que l’on entend, sa trajectoire fait peu à peu converger l’image et le son dans la constitution commune d’une « architecture de temps ». Dans les marges du genre de la messe se laissent alors deviner les traces d’un autoportrait vidéo croisant le home movie et le journal de travail.
Prevalence and correlates of psychological distress among diabetes mellitus adults in the Jilin province in China: a cross-sectional study
Authors: Qiu Shuang , Sun Xuan Hong , Liu Wen Ya , Kanu Joseph Sam , Li Ri , Yu Qin Ya , Huang Feng Xu , Li Bo , Zhang Yang Xiang
Published: January 2017

Background

Psychological disorders are common in diabetes mellitus (DM) patients, and the aim of this study was to estimate the prevalence of psychological distress and to determine the influence factors associated with psychological distress among DM patients in the Jilin province of China.

Methods and Materials

Multistage, stratified cluster sampling was used in this cross-sectional study. The 12-item General Health Questionnaire (GHQ-12) was used to assess psychological status with the total score of ≥4 as the threshold for psychological distress.

Results

A total of 1,956 subjects with DM were included in the study. Out of this total diabetic participants, 524 (26.8%) had psychological distress. Multiple logistic regression analysis showed that low educational level, divorce or separation from one’s spouse, low family average monthly income, short sleep duration, being aware of DM status, and multiple co-morbidities are positively associated with psychological distress (all P < 0.05).

Conclusions

This study revealed a high rate of psychological distress among DM population in Jilin province. Low educational level, divorce or separation from one’s spouse, low family average monthly income, short sleep duration, awareness of DM status, and multiple co-morbidities are all associated with psychological distress among our study subjects. Interventions to control these factors are needed to address the psychological problems among diabetics in Jilin Province.
Computing the Z Score and Centiles for Cross‐sectional Analysis: A Practical Approach
Authors: DeVore Greggory R.
Published: January 2017

Although Z scores have been reported in the literature, one of the problems for the nonstatistician is understanding the systematic approach used to compute the predicted mean and standard deviation, components of the Z score equation, which may vary as the independent variable changes over time (eg, gestational age). This review focuses on a step‐by‐step analysis using linear, quadratic, and fractional polynomials to compute the mean and standard deviation as a function of a continuous independent variable. Once the mean and standard deviation are computed, the Z score and centile can be derived and Z score calculators created that enable investigators to implement the results in the laboratory and/or clinical setting.
Complications, Pain Control, and Patient Recovery After Local Versus General Anesthesia for Open Inguinal Hernia Repair in Adults—Systematic Review and Meta-analysis
Authors: Bakota Bore , Kopljar Mario , Simic Diana , Franic Miljenko , Staresinic Mario , Patrlj Leonardo
Published: January 2017

The purpose of this systematic review is to provide an “up-to-date” evidence-based guideline and clarify the possible benefits as well as drawbacks of local anesthesia (LA) and general anesthesia (GA) in open inguinal hernia surgery in adults. Study method comprised randomized controlled trials. Primary outcome measures were complications, pain control, and patient recovery. Secondary outcome measures were patient satisfaction and hernia recurrence. A total of 14 randomized controlled trials contributed to the study. A total of 1677 patients were analyzed, with 953 in the LA group and 724 in the GA group. Complications were statistically less frequent in the LA group compared with the GA group [odds ratio (OR), 0.31; 95% confidence interval (95% CI), 0.15, 0.64). Supplemental intraoperative analgesia had a statistical significance in the LA group, with an OR of 28.93 (95% CI, 7.86, 106.47). Postoperative pain was statistically significantly lower in the LA group [standardized eman difference (SMD), −1.06; 95% CI, −1.64, −0.48)]. Length of stay was shorter for patients who underwent operation under LA compared with those receiving GA (OR, −1.21; 95% CI, −2.08, −0.33]). Time to full mobility was shorter in the LA group, without statistical significance (OR, 3.04; 95% CI, 0.19, 47.90), whereas measuring in SMD showed significance in comparison with GA (SMD, −1.74; 95% CI, −2.34, −1.14). Hernia recurrence was not noted. Patient satisfaction was greater in the LA group (SMD, 0.65; 95% CI, 0.15, 1.15). Compared with GA, LA showed superiority in terms of complications, postoperative pain, length of stay, time to full mobility, and patient satisfaction. Therefore, it appears to be a more appropriate anesthetic technique for open inguinal hernia repair in adults.
Effect of Palonosetron, Dexamethasone, or Palonosetron and Dexamethasone in Postoperative Nausea and Vomiting in Highly Susceptible Thyroidectomy Patients: A Randomized Trial
Authors: Kim Min Kyoung , Kang Hyun , Choi Geun Joo , Oh Jong In , Yang So Young , Park Yong Hee , Baek Chong Wha , Jung Yong Hun
Published: January 2017

Our study aimed to compare the efficacy of dexamethasone added to palonosetron to both palonosetron and dexamethasone monotherapy for preventing postoperative nausea and vomiting in highly susceptible patients receiving opioid-based, intravenous patient-controlled analgesia after thyroidectomy. Nonsmoking women who underwent total thyroidectomy were randomly allocated to either the dexamethasone group (Group D), the palonosetron group (Group P), or to the dexamethasone plus palonosetron group (Group DP). The severity of nausea and pain, the number of episodes of vomiting, the administrations of rescue anti-emetics, and the side effects of the antiemetics were documented in the recovery room at 2, 4, 8, 12, 24, and 48 hours after surgery. The severity of nausea was lowest in Group DP, followed by Group P and Group D. But there was an overall difference only between Group D and Group DP. The overall differences in the time to the first administration of the rescue antiemetic were observed in a Kaplan-Meier analysis (P = 0.017), noting a significant difference between Group D and Group DP (P = 0.003). The combination of dexamethasone and palonosetron decreased the severity of nausea and increased the time to the first antiemetic dose compared with using dexamethasone or palonosetron alone in nausea-susceptible patients undergoing thyroidectomy.
New interactions between tumor suppressor Fhit protein and a nonhydrolyzable analog of its AP4A substrate
Authors: Krakowiak Agnieszka , Kocoń‐Rębowska Beata , Dolot Rafał , Piotrzkowska Danuta
Published: January 2017

Fragile histidine triad protein (Fhit) is a protein which primarily hydrolyses dinucleoside polyphosphates. To investigate possible interactions between the protein and a substrate, we used a nonhydrolyzable phosphorothioate analog of Ap4A, containing 5‐bromo‐2′‐deoxyuridine instead of one adenosine residue. Photocrosslinking, followed by LC‐MS experiments, determined a complex in which the probe was covalently linked to the NDSIYEELQK peptide (residues 110–119). The peptide was located within the ‘disordered’ region, which is invisible in the known crystal structures of Fhit. This invisible and flexible part seems to play a role in the stabilization of the Fhit‐substrate complex, which may be important for its tumor suppressor activity.