bluuebunny/crossref_metadata_2025 huggingface dataset:
Re-Operationalizing ‘Open-Country'
Authors: Porter Jeremy , Capellan Joel , Howell Frank
Published: January 2017

The proper operationalization of urban and rural is extremely important to our understanding of the impacts of specific ecological context on human behavior. However, even with the ever-improving definitional advancements, our understanding of these community-level concepts, in regards to a comprehensive geographic space, is still somewhat unsatisfying. This article aims to contribute to this issue through the introduction of a ‘place' based geography using current Census geographies in the creation of a unified geographic landscape of the contiguous United States. The new place-level geography is superior to previous operational approaches to identifying urban and rural communities in that it allows for the examination of both without the additional variation inherent in larger geographies and providing a more comprehensive coverage than smaller geographies. Furthermore, this approach allows for the development of a unique, but phenomenologically meaningful, sub-county geography that substantively holds meaning in conceptualizing rural and urban ecological context.
Emotions in Motion
Authors: Pappas Ilias O. , Kourouthanassis Panos E. , Papavlasopoulou Sofia , Chrissikopoulos Vassilios
Published: January 2017

This research examines the combined effect of positive and negative emotions on online shopping behaviour when customers use personalised services. Data from 421 customers, experiences with personalised online shopping, were used to empirically validate the effect of the level of emotions of different valence and intensity on their intention to purchase online. The findings suggest that as the intensity of positive emotions increases, shoppers are more willing to purchase from the online store. Nevertheless, this association is statistically significant only in those cases that the sample exhibits low intensity of negative emotions. Moreover, an increase on the intensity of negative emotions tends to reduce shoppers' intentions to purchase. Results show that online vendors should aim to induce positive emotions since they are more important that negative ones. This paper offers a first step in evaluating the multidimensional role of emotions in personalised e-commerce.
Embodiment and Gameplay in Networked Publics
Authors: Hansson Karin , Ekenberg Love
Published: January 2017

Decision-making in self-organized information systems such as online collaborative data production systems can be understood as an autonomous system beyond centralized power of nation-states and their various institutions, mediated by social media tools where crowd feedbacks are aggregated in a variety of reputation mechanisms. These more informal sources are however not without problems. Group biases easily appear and assumed credible sources do not necessarily provide more accurate information, in particular when it comes to more complex problems and when a diversity of perspectives or certain expertise is required. To this adds the practical problem that there is a lack of efficient technology design to support equal representation and analysis of representativeness. This article focuses on the representativeness issue and, while providing an overview over principles and some tools for crowd sourced data production, suggests a framework for making patterns of bias in collaborative information production online more transparent.
The Adoption Drivers of Web-Based B2B Systems
Authors: Al-Omoush Khaled Saleh
Published: January 2017

The purpose of this research is to examine the drivers of Web-based B2B systems adoption from an institutional perspective by means of comparison between durable and nondurable goods-producing industries. A questionnaire survey was developed to collect data from manufacturing firms. Structural Equation Modeling using EQS was conducted to analyze the data. Results revealed that the durability characteristic of goods produced plays a moderating role in the impact of institutional pressures on the top management support of Web-based B2B systems adoption. Results also indicated that top management support, and B2B relationship quality have a direct impact on the extent of adoption and use of Web-based B2B systems. The present study contributes to the continuing discussion about why organizations respond differently to institutional pressures and vary in the level of use of Web-based B2B applications.
Plant Lectins Activate the NLRP3 Inflammasome To Promote Inflammatory Disorders
Authors: Gong Tao , Wang Xiaqiong , Yang Yanqing , Yan Yiqing , Yu Chenggong , Zhou Rongbin , Jiang Wei
Published: January 2017

Plant-derived dietary lectins have been reported to be involved in the pathogenesis of several inflammatory diseases, including inflammatory bowel disease, diabetes, rheumatoid arthritis, and celiac disease, but little is known about the molecular mechanisms underlying lectin-induced inflammation. In this study, we showed that plant lectins can induce caspase-1 activation and IL-1β secretion via the NLRP3 inflammasome. Lectins were internalized and subsequently escaped from the lysosome and then translocated to the endoplasmic reticulum. Endoplasmic reticulum–loaded plant lectins then triggered Ca2+ release and mitochondrial damage, and inhibition of Ca2+ release and mitochondrial reactive oxygen species by chemical inhibitors significantly suppressed NLRP3 inflammasome activation. In vivo, plant lectin–induced inflammation and tissue damage also depended on the NLRP3 inflammasome. Our findings indicate that plant lectins can act as an exogenous “danger signal” that can activate the NLRP3 inflammasome and suggest that dietary lectins might promote inflammatory diseases via the NLRP3 inflammasome.
The Role of the p38–MNK–eIF4E Signaling Axis in TNF Production Downstream of the NOD1 Receptor
Authors: Pashenkov Mikhail V. , Balyasova Lyudmila S. , Dagil Yulia A. , Pinegin Boris V.
Published: January 2017

Activation of nucleotide-binding oligomerization domain (NOD) 1 and NOD2 by muropeptides triggers a complex transcriptional program in innate immune cells. However, little is known about posttranscriptional regulation of NOD1- and NOD2-dependent responses. When stimulated with a prototypic NOD1 agonist, N-acetylglucosaminyl–N-acetylmuramyl–l-alanyl-d-isoglutamyl-meso-diaminopimelic acid (GM-triDAP), human monocyte-derived macrophages (MDM) produced an order of magnitude more TNF, IL-6, and pro–IL-1β than did monocyte-derived dendritic cells (MDDC), despite similar NOD1 expression, similar cytokine mRNA kinetics, and comparable responses to LPS. TNF production by GM-triDAP–activated MDM was independent of autocrine IL-1. However, GM-triDAP–activated MDM translated TNF mRNA more efficiently than did MDDC. As an underlying mechanism, NOD1 triggering in MDM caused a more potent and long-lasting activation of the signaling axis involving p38 MAPK, MAPK-interacting kinase (MNK), and eukaryotic translation initiation factor 4E, which is a critical regulator of translation. Furthermore, MNK controlled TNF mRNA abundance in MDDC and MDM upon NOD1 triggering. NOD1-dependent responses were more sensitive to MNK inhibition than were TLR4-dependent responses. These results demonstrate the importance of the p38–MNK–eukaryotic translation initiation factor 4E axis in TNF production downstream of NOD1.
Convergence of Monotone Schemes for Conservation Laws with Zero-Flux Boundary Conditions
Authors: Karlsen K. H. , Towers J. D.
Published: January 2017

We consider a scalar conservation law with zero-flux boundary conditions imposed on the boundary of a rectangular multidimensional domain. We study monotone schemes applied to this problem. For the Godunov version of the scheme, we simply set the boundary flux equal to zero. For other monotone schemes, we additionally apply a simple modification to the numerical flux. We show that the approximate solutions produced by these schemes converge to the unique entropy solution, in the sense of [7], of the conservation law. Our convergence result relies on a BV bound on the approximate numerical solution. In addition, we show that a certain functional that is closely related to the total variation is nonincreasing from one time level to the next. We extend our scheme to handle degenerate convection-diffusion equations and for the one-dimensional case we prove convergence to the unique entropy solution.
Numerical Investigation of the Coherent Structures and Sound Properties in Sonic Coaxial Jets
Authors: Shi Haitao , Chen Dawei , Wang Pei , Liu Nansheng , Lu Xiyun
Published: January 2017

Numerical investigation of the underexpanded sonic coaxial jets is carried out using large eddy simulation for three typical inner nozzle lip-thicknesses. Various fundamental mechanisms dictating the flow phenomena including shock structure, shear layer evolution and sound production are investigated. It is found that the inner nozzle lip induces a recirculation zone between inner and outer jets, which significantly influences the behaviors of shock structures and shear layers. The sound properties of the coaxial jets are further analyzed in detail. As the inner lip-thickness increases, the helical screech mode switches to an axisymmetric one and high-frequency screech also occurs with an oscillation frequency of recirculation zone. Based on the temporal Fourier transform and correlation analysis, the primary sources of low- and high-frequency screeches are associated with the downstream shock cells in the jet column and the secondary shock structures in the outer annular jet, respectively. The proper orthogonal decomposition analysis reveals that the dominant structures constructed by the most energetic modes shift from the downstream shock cells region to the upstream secondary shock region as the lip-thickness increases. The results obtained in this study provide physical insight into the understanding of the mechanisms relevant to the coherent structures and sound properties in sonic coaxial jets.
An alternative derivation of the Dirac operator generating intrinsic Lagrangian local gauge invariance
Authors: Wolk Brian Jonathan
Published: January 2017

This paper introduces an alternative formalism for deriving the Dirac operator and equation. The use of this formalism concomitantly generates a separate operator coupled to the Dirac operator. When operating on a Clifford field, this coupled operator produces field components which are formally equivalent to the field components of Maxwell's electromagnetic field tensor. Consequently, the Lagrangian of the associated coupled field exhibits internal local gauge symmetry. The coupled field Lagrangian is seen to be equivalent to the Lagrangian of Quantum Electrodynamics.
Received: 8 November 2016,  Accepted: 4 January 2017; Edited by: D. Gomez Dumm; DOI: http://dx.doi.org/10.4279/PIP.090002
Cite as: B J Wolk, Papers in Physics 9, 090002 (2017)
This paper, by B J Wolk, is licensed under the Creative Commons Attribution License 3.0.
An Exploration of Learning Styles Preferences of Higher Education Students in Pakistan
Authors: Yasmin Fakhra , Akbar Ahsan , Yan Zhang
Published: January 2017

Every individual adopts a unique way to obtain knowledge and this way of acquiring knowledge is known as learning style. These learning approaches of the students can significantly influence their learning outcomes. The aim of this study was to examine the learning styles of Master level students enrolled in Education programs of the public sector universities in southern Punjab region of Pakistan. The study findings reveal that students majoring in Education practice multiple learning styles to accomplish their academic goals endeavors. Moreover, assimilating was the most practiced learning style by the sampled students. The results of ANOVA posits that there are significant differences in learning styles adopted by the students of different universities. The findings of this study provide useful information about the learning style preferences of the social science students and postulate that the choice of university significantly influences the learning style adaptation of students.
Radium-223 in a Community Setting for Castration Resistant Prostate Cancer
Authors: Vaghefi Houman , Agarwal Sachin , Liu Fang , Xiong Bide , Garber Elizabeth , Wheeler James
Published: January 2017

Purpose: To evaluate the toxicity, palliative benefit, and survival benefit of Radium-223 (Ra-223) in a community setting.Introduction: The ALSYMCA (Alpharadin in Symptomatic Prostate Cancer) trial demonstrated improved survival for men with painful bone metastasis from castration resistant prostate cancer who were treated with Ra-223. The median survival was 14.9 months for the Ra-223 patients compared to 11.3 months for patients treated with a placebo.Methods: We identified through the nuclear medicine records 11 patients who started Ra-223 between March 15, 2013 and December 10, 2015. The Wilcoxon signed rank test was used to compare the published results of the ALSYMPCA patients with those from our institution.Results: The Hodges-Lehman estimate of the median survival of our patients from the date of the first Ra-223 infusion was 7.8 months. The 95% confidence interval (CI) was (2.8, 14.7; p=0.0122) indicating our patients had a significantly shorter survival than the Ra-223 ALSYMPCA patients.Our patients did not have a statistically significant worse rate of anemia, neutropenia, or thrombocytopenia. We used 3 measures of treatment effectiveness: 1) reduction in the pain scores, 2) reduction in the serum PSA, and 3) reduction in the alkaline phosphatase from baseline, but the reductions were not statistically significant.Conclusions: This small study is not meant to challenge the results of the ALSYMPCA international trial. It is intended only as a caution that prior lines of therapy, especially with newer agents such as abiraterone and enzalutamide, may attenuate the benefit from this treatment, particularly in elderly patients.Radium-223 in a Community Setting for Castration Resistant Prostate Cancer
Development of Spectrophotometric Method for the Determination of Atenolol in Normoten Drug
Authors: Elgailani Isam Eldin Hussein , Alghamdi Tofeeg Haseen
Published: January 2017

This research aimed to develop inexpensive, safe, rapid, efficent spectrophotometric method for the assay of atenolol in some antihypertensive drugs namely Normoten in its pharmaceutical formulation. The studied method is depend on the reaction of the drug with phenol red in acidic medium, at pH 3.0. The analytical parameters have been investigated. The maximum absorbance was obtained at 429 nm and the molar absorptivity of 0.054 L mol-1 cm-1. Beer’s law is linear in the concentration range of 0.5-100 μg/mL for atenolol in Normoten. The detection and quantification limits were found to be 0.038 and 0.113μg/mL for the atenolol in Normoten respectively, and with a linear regression correlation coefficient of 0.997. The recovery was found to be 98.94 to 100.31%. The studied method is can be applied for the determination of atenolol (active ingredient) of the antihypertensive drugs in their pharmaceutical formulations.
Children, Gender and School Curricula in Saudi Arabia
Authors: Ghalib Thikra Kaed
Published: January 2017

The present study investigates the effect of gender representation in Saudi Arabian school curricula on children’s value systems and social character. In particular, the study examines gender distribution in first-grade school textbooks in Saudi Arabia where schooling, and education at large, is single-sex throughout. The data for the study is constituted by six textbooks prescribed for the first school semester at boys’ and girls’ schools. The study attempts a content analysis of the texts and illustrations in these textbooks in order to examine the representation, indeed construction, for the children of society and the stereotypical social roles of its members. Analysis reveals a gendered representation. Women suffer low visual and verbal visibility, and are almost completely denied occupations. Moreover, social activity is segregated by gender, with women appearing mostly in indoor activities and men in outdoor activities. The paper concludes by revisiting these findings against the backcloth of the idiosyncratic religious and cultural character of the Saudi society in which gender differences are normalized.
Comparison between the Characteristics of Inflectional Systems in Arabic and English Languages
Authors: Abdulmughni Saleh Ahmed Saif
Published: January 2017

The study has contributed to compare the characteristics of the inflectional system of nouns in Arabic and English Language for pedagogical orientation. The main objective was to develop an overview of the two languages system for evaluating the pedagogical significance in Arabic and English. A qualitative research design has been implemented to introduce the nature of two languages and the anticipated difficulties that have been encountered by the learners of the Arabic and English languages. The classification of the nouns and the inflectional system of the two languages have been contrasted through the analysis. It has been observed that the Arab learners of English delete some letters while writing but have proper pronunciation because they have the habit of pronouncing two elements represented in one grapheme.
De responsabilisering van burgers van verzorgingsstaat tot participatiesamenleving
Authors: Brok Ermy
Published: January 2017

The making-responsible of citizens from welfare state to participation society. Discourse analysis of Dutch speeches from the throne and government statements since the 1960s.

Central concern of this article is tracing back how the making-responsible of citizens takes shape within Dutch speeches from the throne, government statements and reports of the Dutch Social and Cultural Research Institute (SCP) ever since the 1960s. The Dutch participation society, a term much discussed ever since mentioned in the 2013 speech of the throne, is often associated with a withdrawing government and a coming to end of the welfare state. At the same time, according to several authors, the notion of a withdrawing government that operates within a network of multiple equal actors has brought along the need for a widening of the government’s repertoire of action. This has been characterized as making-responsible citizens on conditions of the state. It has raised doubts about true government-withdrawal and authors have related it to the dominance of neo-liberal thinking ever since the 1990s. Applying an analysis framework derived from discourse analysis, it is made tangible in this article how within political discourse beginnings of the making-responsible of citizens can be traced to the 1960s, more than thirty years earlier than expected. It is argued that this longer history makes a plea for encouraging the political dimension of citizenship all the more important.
Reflectie & debat
Authors: Timmer Jaap
Published: January 2017

R&D

Reflection and debate initiates academically inspired discussions on issues that are on the current policy agenda.
Aanpassingsstoornis
Authors: Noordhof Arjen
Published: January 2017

De Blinde Vlek

The most relevant part of a discussion is not what is discussed but what cannot be spoken of. The real taboos are those for which it is taboo to call them taboos. The status quo defines itself as non-ideological while denouncing any challenge to itself as radical. Therefore the column ‘De Blinde Vlek’ frames the framers, politicizes the status quo and articulates what is not heard of.
Bemiddeling door de politie bij eergerelateerd geweld
Authors: Janssen Janine , Sanberg Ruth
Published: January 2017

Mediation by the police in case of honour related violence

Tackling honour related violence is part of the Dutch policy on domestic violence. On the police level a centre of expertise was installed, the LEC EGG. Next to strategies with regard to detection, the LEC EGG has put forward instructions with regard to the application of police mediation in cases of honour related violence. These rules, the ‘7 golden W’s’, are presented and discussed, paying attention to the institutional role of the police.
Acesso às consultas médicas nos serviços públicos de saúde
Authors: Dias Orlene Veloso , Araújo Flávia Ferreira , Oliveira Rayana Meireles de , Chagas Rosângela Barbosa , Costa Simone de Melo
Published: January 2017

Objetivo: Avaliar o acesso às consultas médicas em serviços públicos de saúde. Métodos: Pesquisa transversal, analítica de base populacional, em município de porte médio, no estado de Minas Gerais, Brasil. Os dados foram coletados a partir de questionário semiestruturado a uma amostra representativa do município, de 2150 indivíduos. O tratamento estatístico considerou o nível de significância p<0,05. Resultados: Dos entrevistados, 19,4% afirmaram ter procurado um profissional/serviço público de saúde nos 15 dias anteriores à entrevista. Entre esses, 75,6% foram na Atenção Primária à Saúde (APS). A maior procura foi por parte do sexo feminino (p<0,001) e os sem plano de saúde (p<0,001). A maioria (77,2%) foi atendida na primeira vez que procurou o serviço de saúde pública. Pode-se destacar uma maior prevalência ao não acesso quando a procura foi na APS e para tratamento/reabilitação (p<0,05). A utilização de consultas médicas no ano foi observada para 54,4%, com maiores médias para mulheres, adultos e sem plano (p<0,05). Conclusão: Necessita-se repensar a gestão de saúde pública e as práticas dos profissionais para efetivar o acesso às consultas médicas. Assim, sugere-se adotar medidas de acolhimento e educação permanente junto aos profissionais da saúde da família.
Editorial: The future of plant biotechnology
Authors: Katzek Jens A
Published: January 2017

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Key financial trends that shape biotech business growth
Authors: Pavlou Alex , Belsey Mark
Published: January 2017

Datamonitor analysis has identified two key company categories currently shaping the biotech industry: the leading biotherapeutics players and the emerging biotherapeutics players. Analysis of financial trends of companies in these categories from 2001â€“2003 has revealed that, despite strong revenue growth recorded by the leading biotherapeutics players, highly variable cost bases strongly affected net profits. Conversely, the emerging biotherapeutics players saw a decline in revenue growth, due to a reduction in collaboration or licensing revenue. Both leading and emerging biotherapeutics players strongly increased R&D spend over this period. Future growth of the leading and emerging biotherapeutics sectors will be driven primarily by M&A/licensing agreements, and in-house pipeline development driven by continued strong R&D spend.
Editorial: Is the UK NHS a good place to do clinical trials?
Authors: Steiner Jan
Published: January 2017

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The quest for generic biotechnology pharmaceuticals in the USA
Authors: Kowalski Thomas J , Fekete Pamela , Yvon Nne-Marie C
Published: January 2017

As patent protection expires on the first generation of biotechnology products, such as human growth hormone and erythropoietin, there is an impetus for the development and marketing of generic equivalents. Currently there is no statutory or regulatory framework governing generic biotechnology products. This paper explores the potential solutions that have been suggested by members of the pharmaceutical industry and government, both in the USA and internationally.
The role of research institutions in the formation of the biotech cluster in Massachusetts: The MIT experience
Authors: Nelsen Lita L
Published: January 2017

Based on the MIT experience and that of other US universities, the formation and sustained existence of biotechnology company clusters are discussed. A cluster's origin and continued health are dependent upon government funding of state-of-the-art science in universities and institutions. Effective technology transfer is also necessary with a formal legal infrastructure for university participation and sufficient funds to file patents. The formation of new companies requires a business infrastructure in the community and talented people: researchers; technology transfer professionals; entrepreneurial company founders; scientists and managers to staff the companies; and knowledgeable investors. Finding people gets easier as clusters grow. It takes a whole community to build a biotechnology cluster â€“ but once built, the cluster can achieve a sustaining life that strengthens itself.
Editorial: A new era of networking
Authors: Lloyd Wayne
Published: January 2017

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Human Tissue Act 2004: The age of consent arrives in the UK
Authors: Johnson Gillian , Wilson Alex
Published: January 2017

The organ collection scandals of Alder Hey and Bristol Royal Infirmary in the UK were the driving force for a comprehensive overhaul of the legislation and regulation of the handling and use of human tissues in the UK. The Human Tissue Act 2004 is due to come into force in April 2006 and will resolve a number of uncertainties for researchers. The adopted regulatory approach is not dissimilar to that adopted for the use of embryos in the UK. The legislation provides the framework but a body established under the Act â€“ the Human Tissue Authority (HTA) â€“ will be responsible for granting licences, determining what constitutes 'appropriate consent' and providing detailed guidance and regulations. The advantage of this approach is that it will allow the board of the HTA, whose members include experienced professionals in the medical and research communities, to adapt the system to keep up with scientific developments and possibly changes in public opinion more rapidly than would have been possible where guidance is set out within the legislation. Even before the HTA issues its first guidance, researchers can be clear that certain activities, such as those relating to cell lines, are not covered by the Act. Other processes, such as the anonymising and de-linking of patient data could be subject to additional regulation by the HTA although any guidelines must also conform with the provisions of the Data Protection Act 1998. This paper discusses the new regulatory framework and identifies the challenges for researchers in complying with an Act, which provides for criminal sanctions for breach.
Valuing biotechnology companies using the price earnings ratio
Authors: Loh Jacqueline , Brooks Robert
Published: January 2017

The biotechnology and life sciences sectors are a source of major source of growth in the economy. However the valuation of companies in the sector is problematic owing to the long lead times and uncertainty associated with product development. This paper explores the use of the price earnings ratio as a tool for portfolio construction and valuation. Our results suggest this is a poor tool, although this may be due to being constructed over a time horizon that is too short.
What you give is what you get: Investment in European biotechnology
Authors: Bains William
Published: January 2017

The European biotechnology industry receives less funding, and less funding per company, than the North American industry, especially at the sensitive early stages of company development, and the European industry is substantially smaller in terms of employment, products and capitalisation than the US industry. The cause and effect of this relationship are explored in this paper. It is shown that if the European industry is immature it is because its growth has been slower, most probably because of low investment levels, and that the relatively lower value of biotech companies at initial public offering (IPO) is a result of the lower amount of investment they receive, not a reason for. This suggests that poor investment levels are a primary cause of the small size of European biotech companies and the European industry as a whole, not an effect of it. Investor mistrust and investment mechanisms are plausible reasons for this under-investment.
Using intellectual property to map the organisational evolution of firms: Tracing a biotechnology company from startup to bureaucracy to a multidivisional firm
Authors: Daizadeh Iraj
Published: January 2017

The concomitant rise in the number of technology firms, US issued patents, and patent communications has forced researchers to investigate how such publicly known information can reveal characteristics and/or verify predictive models to describe the R&D-intensive firm. Here, we propose viewing the Boisot Information Space model through the lens of intellectual property as a means to describe and trace the organisational evolution of a technology firm. We map the model's dimensions â€“ viz., codification, abstraction, and dissemination â€“ onto publicly available forms of tangible (eg, patents, publications) and intangible (eg, trade secrets) knowledge assets to show that the model may accurately describe the social dynamics of a biotechnology company as it evolved from a 17-person startup to a >500 person multinational drug development company. This result relates to the firm's abilities to manage both tacit and explicit knowledge. A discussion of the limitations of the proposed model is described.
Dyslipidaemia: Focus shifts from LDL-C to HDL-C
Authors: Emerton Duncan
Published: January 2017

In this current analysis of the antidyslipidaemics market, a shift in focus from low-density lipoprotein cholesterol (LDL-C)-targeted therapies to drugs that elevate high-density lipoprotein cholesterol (HDL-C) is described. Key reasons for this evolution are several-fold, but mainly focus on significant generic erosion of LDL-C-targeted therapies, particularly the statins, and loss of revenues therein. Additionally, with LDL-C-lowering efficacy unlikely to improve without sacrificing patient safety, elevating HDL-C has emerged as a therapeutic option in the long-running battle against coronary heart disease.
Festo: The plague continues
Authors: Familant Scott B.
Published: January 2017

This paper reviews the law on the doctrine of equivalence and prosecution history estoppel and explores how it has been reshaped by the Federal Circuit's and Supreme Court's decisions in Festo Corp. v Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd. The paper also assesses the likely impact those decisions will have on patent prosecution, licensing and enforcement activities.
Book Review: The Economics of Biotechnology: Volumes I and II
Authors: Daizadeh Iraj
Published: January 2017

The Economics of Biotechnology: Volumes I and II Maureen McKelvey and Luigi Orsenigo Edward Elgar Publishing Limited, Cheltenham, UK; ISBN 978 1 87376 776 3; 2006; 968pp
Biogenerics 2007: How far have we come?
Authors: Tucker John , Yakatan Seth , Yakatan Stan
Published: January 2017

The recent approval of a follow-on version of Pfizer's Genotropin (recombinant human growth hormone) signalled the beginning of the end of an era in which biopharmaceuticals enjoyed immunity from competition even after expiration of their patent protection. This paper describes many of the key scientific challenges facing the nascent â€˜biogenericsâ€™ industry and the evolving regulatory framework that will shape its competition with innovator companies. We describe key differences between the biogeneric and traditional generic drug business models and the M&A activity that been undertaken in pursuit of the expertise and resources needed to be competitive in this commercial space. We conclude with a discussion of the commercial opportunity presented by recent and upcoming European patent expirations and the challenges presented by competition from second-generation innovator products.
Money for nothing? Risks in biopharmaceutical companies from the perspective of public financiers
Authors: Heinonen Laura , Sandberg Birgitta
Published: January 2017

The risks faced by biopharmaceutical companies during the process of drug development are multifaceted and complicated. Furthermore, resource intensiveness and the long time perspective force them to rely on external finance. This study describes the risks in the industry along the biopharmaceutical development process and evaluates how public investors take these risks into account in their investment decisions. The empirical study focuses on Finnish public investors. The data consists of both interviews and secondary sources. Biopharmaceutical development is divided into three stages (discovery, development and commercialisation), and the main risks at each stage are identified. The results show that the risk the investors are willing to take is reflected in the stage of the product development process they invest in. Finnish public investors tend to avoid taking commercial risks and thus invest in the early stages of development where there are mainly technical risks involved. They are increasingly emphasising risk management, and they are also keener to emphasise the importance of commercialisation. Paradoxically, however, commercialisation efforts are generally not supported financially.
Best Practices in Biotechnology Business Development
Authors: Lydecker Hans-Erik Hamid
Published: January 2017

Best Practices in Biotechnology Business DevelopmentYali FriedmanLogos Press, Washington, DC;ISBN: 978 0 9734676 0 4; 2008; 186pp
Biotechnology and the Law
Authors: Korwek Edward L
Published: January 2017

Biotechnology and the LawHugh B. Wellons, Eileen Smith Ewing, Robert F. Copple, William N. Wofford and Erika King Lietzan (eds)ABA Publishing, Chicago, IL;ISBN: 978 1 59031 761 7; 2007; 957pp; paperback
Record integrity and licensing your intellectual property
Authors: Avellanet John
Published: January 2017

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.
Thailand biotech business: Product of the national policy
Authors: Chanvarasuth Nataporn , Indaraprasirt Ramjitti
Published: January 2017

Thailand's National Biotechnology Policy Framework 2004â€“2009 acts as a catalyst to enhance industrial productivity and sustainability. Six goals are identified in the national policy framework, of which two are given priority: â€˜Kitchen of the Worldâ€™ and â€˜Healthcare Centre of Asiaâ€™. The Board of Investment of Thailand (BOI) is creating a positive environment for local and international industries. BOI provides maximum benefit privileges to biotechnology-related investments. Currently, there are 50 new emerging biotechnology companies in Thailand. More than 80 existing businesses have incorporated biotechnology R&D in their work processes. Government agencies and universities provide supporting services to stimulate biotechnology businesses. R&D infrastructures such as Biopark in the expansion phase of Thailand Science Park will be operational in 2010. The National Science and Technology Development Agency, the National Center for Genetic Engineering and Biotechnology, the Thailand Center of Excellence for Life Sciences, and the BOI under the direction of the Ministry of Industry are major agencies committed to strengthening Thailand's competitiveness in biotechnology.
Editorial
Authors: Meyers Arlen
Published: January 2017

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Umbilical cord blood banks: Modern day alchemy
Authors: Smith Helen
Published: January 2017

Stem cells are at the forefront of hopes for developing treatments for a range of serious diseases. The sources of those stem cells can be controversial, particularly for embryonic stem cell lines. Increasingly parents are opting to collect umbilical cord blood shortly after delivery of the baby, some to satisfy a current treatment need for stem cells and others to â€˜future-proofâ€™ their families and themselves against possible disease and preserving for themselves a potentially potent resource for future regenerative treatments. The author reviews recent and forthcoming changes in regulation of this area, potential legal problems and the implications of compliance for biotech companies within the field or who have current treatments which may benefit from collaboration with those who are in the field. The paper looks at, in particular, the legal position in the UK, and issues relating to, for example, ownership of cord blood deposits and anonymity of deposits.
Intellectual property landscape and patenting opportunity in biofuels
Authors: Mannan Ramasamy
Published: January 2017

The oil embargo of the 1970s forced a realisation that our fossil fuel resources are finite and fast dwindling. Three decades later, this realisation is once again hitting us hard. The good news is that this time around there is a high degree of scientific confidence that a commercially viable, renewable transportation energy resource, competitive with fossil fuel in terms of cost, may be realised within the next 10 to 20 years. Much of this is the result of the recent scientific breakthroughs in genomics and bioengineering. In recent years, a significant number of start-up biofuel companies have emerged and are offering novel biofuel technologies that promise to move these emerging technologies past the research and development stage and into commercialisation. These companies are well advised to develop a viable intellectual property (IP) strategy and a strong patent portfolio to attract investment. This paper is intended to introduce the reader to the emerging biofuel IP landscape and to identify patenting opportunity.
Personalized medicine and oncology: A commentary and key questions
Authors: Freeman Robert
Published: January 2017

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Rethinking commercial strategy â€“ A patient-centered commercial model
Authors: Rao Sanjay K
Published: January 2017

That the bio/pharmaceutical industry faces daunting challenges is common knowledge and the subject of debate for some time now. In reaction, leading bio/pharmaceutical firms have re-thought their business models. This article presents the framework, rationale and innards of a new model for commercializing outputs of the industry, given the realities of the difficult marketplace. Growing out of the axiomatic belief that patients are why the industry exists, the model defines a health-care ecosystem, re-specifying and clarifying the roles of seemingly disparate stakeholders in the service of patients. Four interlinked propositions on which the new commercial model thrives are outlined and supported with insights from real case studies and published evidence. Specific examples of tactical programs that exemplify the new model in practice are provided. The new, patient-centered commercial model is far from seeing widespread reality in practice; however, when in play, elements of the new model have consistently delivered the promise of bio/pharmaceuticals.
Biotechnology industry-physician interaction and OIG guidelines: Evidence from the stock market
Authors: Jambulingam Thani , Ghani WaQar , Sharma Rajneesh
Published: January 2017

Our article investigates the stock market reaction of the issuance of guidelines by the Office of Inspector General (OIG) to prod biotechnology manufacturers to strengthen self-regulation so as â€˜to efficiently monitor adherence to applicable statutes, regulations and program requirementsâ€™ in their marketing to physicians. Our empirical results, using standard event study methodology, show significant effect on shareholdersâ€™ wealth of 10 large biotechnology firms around various OIG-associated events leading up to the issuance of final guidance. The release of high-level government policy initiative requires the biotechnology industry to review its marketing practices that might be questionable. We provide evidence that suggests that when a public policy initiative significantly affects shareholder wealth, that in turn can impact and alter firm-level behavior without the necessity of adopting a regulation which can be hugely expensive.
Building biotechnology by design: An entrepreneur's perspective
Authors: Boni Arthur A
Published: January 2017

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Founding angels as early stage investment model to foster biotechnology start-ups
Authors: Festel Gunter
Published: January 2017

As a rule, in biotechnology and other technologies, a gap exists between innovations coming from academic research and the commercialisation of the results, which is a serious barrier for innovation processes. This article investigates the role of founding angels as an early stage investment model, which has been applied in North America for a number of years and is now also being established in Europe. Focus is the commercialisation of pre-seed and seed stage technologies developed at universities and research institutions. Founding angels close the gap by actively founding and building up biotechnology start-up companies, together with scientists, typically before the engagement of business angels and venture capital. For providing business expertise and day-to-day operational support they are not compensated monetarily, but with an equity share of the new company. This article analyses the approach and investment strategy of founding angels and contains case studies from Germany and Switzerland showing how this business model is realised.
Impact of recent IP caselaw on biomarkers and personalized medicine
Authors: Gass David A
Published: January 2017

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AMRAD: Pioneer of Australian biotechnology
Authors: Caples Amanda , Grace John
Published: January 2017

AMRAD is a biotechnology company in the human healthcare sector. Its drug discovery projects are focused on novel cytokine therapies and small molecule anti-viral treatments. The company has a portfolio of early- and late-stage projects and its strategy is to enter into collaborative arrangements with international development partners upon generating proof-of-concept data in clinical trials. AMRAD differs from the typical 'biotech model' insofar as it was initially established as a private technology transfer organisation to serve the commercialisation needs of the publicly funded founding medical research institutes. In return for shares in the company the Member Institutes gave AMRAD a first right of invitation to their research activities. Although the Member Institute arrangement remains an important asset in feeding AMRAD's R&D pipeline, AMRAD's business model has evolved from essentially a service provision role to being actively involved in the progress of new medicines through human clinical trials.
The legal and ethical considerations relating to the supply and use of human tissue for biomedical research: A UK perpective
Authors: Wilkinson John , Coleman Bob
Published: January 2017

Alder Hey Children's Hospital supplied parts of the thymus gland removed from young children during heart surgery to a pharmaceutical company. The circumstances raised a number of very serious issues to the medical research community and have led to a consideration of the legal and ethical framework in which human tissue is used for medical research. The use of human tissue has become an increasingly common feature of the drug discovery and preclinical research process in the last decade. This is because, as the understanding of human biochemistry increases, it is important to study the biochemistry of drugs in the tissue in which they are intended to act. The use of animals is currently the subject of much debate, but if the need for animal experiments is to be reduced more reliance will have to be placed on experiments based on the use of human tissue. Several problems have been encountered in this area over the last few years. These include the retention of organs by Bristol Royal Infirmary and the Alder Hey Hospital but also the more bizarre case of Anthony-Noel Kelly, an artist who had acquired body parts for use in his sculptures. This has been an area of some debate for several years and the historical precept that the body of a deceased person could not be owned has been considered in relation to the use of the human tissue in research. The debate about the ownership of human remains as such is not reviewed, but the current case law is applied to the use of human tissue both in the context of treatment and in research.
The Cartagena (Biosafety) Protocol
Authors: Kirsop Brian
Published: January 2017

Presents a study on the development and content of the Cartagena Protocol and the progress being made in its implementation, as of November 2001. Information on the Convention on Biological Diversity established in December 1993; Reasons behind the decision to develop a biosafety protocol; Terms of the protocol; Significance of the protocol to the international distribution of genetically modified organisms.
US Financial accounts reports
Authors: Crocker Glenn , Smith Karen , Clare Hedley
Published: January 2017

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Practical experiences in starting up life science companies in the academic sector
Authors: Rodgers Paul , Catton David , Duncan Gavin Scott
Published: January 2017

The authors discuss their experiences in starting up life science companies in the academic sector as a means of identifying the key issues and highlighting ways of addressing these issues. Sheffield University Enterprises Ltd has led the formation of over 30 companies at Sheffield University in the past three years, many of which are in the biotechnology sector. Ithaka Life Sciences Ltd specialises in supporting the formation and growth of life science businesses by providing specialist expertise to assist the founders; it works with a number of universities and emerging companies around the UK. The paper focuses on the technical, commercial, intellectual property, financial and, above all, practical aspects of working with academic scientists to found biotechnology companies.
Security issues for systems used for collecting, storing and interpreting human biological data
Authors: Harrison David
Published: January 2017

Over recent years there has been a substantial increase in the number of computerised systems used within the healthcare industry. The system's operation and the data produced are vital in ensuring the safety and efficacy of pharmaceutical products. At the same time the healthcare industry has been battling to keep ahead of the increasing regulatory demands of computerised system validation, one integrated component of which is system security. This paper looks at the regulatory requirements for system security and considers the impact of 21 CFR Part 11 on system security methods and practices.
Strategies for attracting healthcare venture capital.
Authors: Silverstein Beth , Osborne Carl
Published: January 2017

Scientists or entrepreneurs in the area of biotechnology seeking to convert their discoveries into commercially viable products can find the effort daunting given that it combines the well-recognised challenges inherent in any start-up company, the complex and changing regulatory requirements for marketing approval, and the uncertainty of biology. Significant capital is required at each step from discovery to manufacture to preclinical and clinical testing, and venture capital investors are an important source of this funding. This paper provides some basic guidance to early stage companies on how to attract venture capital funding.
Regional biotechnology â€“ The EU biocluster study
Authors: Zechendorf Bernhard
Published: January 2017

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Academic entrepreneurship, entrepreneurial universities and biotechnology
Authors: Meyers Arlen D , Pruthi Sarika
Published: January 2017

There are various definitions of an entrepreneurial university, yet there is a lack of agreement about its core components. This article defines the five key characteristics of an entrepreneurial university based on examples of successful bio-clusters in the United States and Europe, and suggests an agenda for stakeholders.