bluuebunny/crossref_metadata_2025 huggingface dataset:
Tracking progress: Two approaches to biotechnology development â€“ Cases from Central Europe
Authors: Mroczkowski Tomasz , Elms Heather
Published: January 2017

A number of emerging economies increasingly expend resources to improve national innovative capabilities and create knowledge economies through the development of biotechnology industries. Standard measures and ways of tracking biotechnology industry progress, such as those used by the OECD, were designed for developed economies. In this paper we review critically a recent report funded by the European Union which also assesses biotechnology industry development in the new member states of Central Europe. Going beyond the report we identify additional characteristics important for an evaluation of nascent biotechnology industries and apply them to Hungary and Poland. Our analysis reveals that the two countries are pursuing different approaches to biotechnology industry development with Hungary following a relatively well-funded national strategy of launching a biotechnology sector specialised in innovative drug discovery whereas Poland has adopted a more hands-off approach. Developing appropriate measures and tools to monitor the potential and progress of an emerging biotechnology industry can help avoid expensive and wasteful policy failures and also provide investors with more reliable information on which to base their decisions. However, those measures should take into account the differing policy objectives and national strategies pursued by different countries.
Book Review: Genomics & society: Legal, ethical and social dimensions
Authors: Clark Dominic
Published: January 2017

Genomics & society: Legal, ethical and social dimensions George Gaskell and Martin W Bauer (eds.)Earthscan Ltd, London, 2007, paperback, 280pp.,ISBN: 978-1844071142
Exploring technology agglomeration patterns for multinational pharmaceutical and biotechnology firms
Authors: Ahn Mark J , Meeks Michael , Davenport Sally , Bednarek Rebecca
Published: January 2017

This paper provides an empirical analysis of leading global multinational pharmaceutical and biotechnology firms with respect to technology agglomeration patterns, proximity to alliance partners and firm performance for the period 1996â€“2006. Our findings suggest that multinational pharmaceutical and biotechnology leaders are converging in terms of their technology agglomeration strategies; and increasingly competing over innovation from small biotechnology companies. Further, our analysis suggests that the absolute number of alliances is more than twice as important compared to proximity to partners in terms of firm performance defined as revenue, profitability and market valuation growth. Thus, for market leaders this study indicates a strategy of relentless pipeline building, with less regard to geographic proximity of alliance partners, appears to enhance relative and absolute performance of biopharmaceutical industry leaders.
Challenges and opportunities in the licensing of renewable technologies
Authors: Lloyd-Evans Meredith , Gilbert Mike , Iliev Ilian P
Published: January 2017

This paper briefly describes a new initiative dedicated to licensing of renewables, then moves on to some of the issues and challenges in the establishment and licensing of renewable technologies, an area currently of great interest from scientific, socio-political and commercial points of view. The authors expand on presentations and discussions at the Licensing Executives' Society 2008 Annual Conference in London, UK.
Ethiopia: Biotechnology for development
Authors: Sbhatu Desta Berhe
Published: January 2017

This article was written to provide compelling rationales for initiating biotechnology education, and a research and development programme in one technology institute in Ethiopia. As the author wishes to share these with a wider audience, the article is presented in the following way: it begins with a brief history of the traditional and conventional biotechnologies in Ethiopia; and reviews the national status of modern biotechnology. The potential of modern biotechnology to promote national development through its support of endeavours in agriculture, environmental management and rehabilitation, health care and industry/manufacturing is then discussed. Finally, the article lists and discusses the key topics that have to be taken into account while introducing and developing modern biotechnology in Ethiopia. Until a good national policy is produced, the topics could serve as guidelines for institutions engaged in biotechnology and life science research.
Pathways to biomedical tipping points: Vertical, horizontal or other?
Authors: Ahn Mark J , York Anne S , Rizova Polly
Published: January 2017

Breakthrough innovations in biomedical technologies such as treatments, devices and diagnostics are increasingly addressing complex medical needs and yielding significant scientific progress. The pathways to their commercial success, however, are poorly understood. In contrast to recent calls for a return to vertical integration, we suggest that relying on strong and unique horizontal relationships among biomedical organizations is more likely to shape technology convergence and increase success rates in achieving a â€˜tipping pointâ€™ or critical mass to address unmet medical needs, build new intellectual property and extend profitable growth from served markets.
Controlling costs in patent litigation
Authors: Rajwani Catherine
Published: January 2017

This article provides the top 10 ways that clients can reduce their litigation costs. The article explains the types of costs that are incurred in patent litigation and discusses the various stages and timelines for a typical patent litigation dispute. The author stresses the importance of clientsâ€™ proactively planning for litigation (before a lawsuit is commenced) and education and involvement in the litigation process.
Patenting of microorganisms: Systems and concerns
Authors: Nair Ramkumar Balachandra , Ramachandranna Pratap Chandran
Published: January 2017

The Government of India permitted patenting of microorganisms in India under the Patents (Second Amendment) Bill, 2002, which was passed by the Parliament on 14 May 2002. The Government has so far granted very few patents for microorganisms, mainly on directives from courts. With the law permitting patenting of microorganisms, several private sector pharmaceutical companies and research institutions have filed applications for patenting microorganisms including fungi, bacteria and viruses. But there is still much debate on the advisability of allowing patenting of microorganisms in India. While the existing provisions in the patents bill permit patenting of certain life forms in line with the Trade-related Intellectual Property Rights Agreement, there is still sufficient controversy regarding the term â€˜microorganismâ€™, which has not been clearly defined. This article discusses the evolution of the patenting systems in relation to microorganisms. The article also explores the feasibility of offering statutory protection to microorganisms that are genetically altered with significant human intervention on harmonized global patent systems and also elaborating on the need for a well-accepted definition of the term â€˜microorganismâ€™.
Legal and Regulatory Update
Authors: Kamstra Gerry
Published: January 2017

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Building biotechnology by design: Role of biotechnology in development
Authors: Nef Patrick
Published: January 2017

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Pricing biologics: Issues, strategic priorities and a conceptual model
Authors: Rao Sanjay K
Published: January 2017

The advent of complex and often expensive biologics raises critical commercial challenges â€“ the most important of which pertains to developing a viable pricing, distribution and reimbursement model that is intrinsically geared to the special characteristics of biologic products and the expectations of a diverse customer population. Idiosyncratic differences in health-care systems, their philosophical motivations and preferred methods of controlling access to expensive biologic treatments pose additional challenges. This article discusses key issues about pricing biologics from the primary viewpoint of biologic manufacturers and marketers, focusing on the inseparable relationship between price, distribution, access and reimbursement. Specific priorities are explicated for streamlining biologic pricing and access strategies to meet upcoming challenges. A conceptual model for developing viable biologic pricing strategy is presented. Insights from the author's work implementing key aspects of the model in the real world are discussed. The article concludes by presenting an overview of a pricing decision support system that has proven invaluable in formulating and managing biologic pricing strategies over a finite time horizon.
Repurposing of the epidermal growth factor
Authors: Mola Ernesto L , BuxadÃ³ JosÃ© A , Herrera Luis
Published: January 2017

This article deals with repurposing of the epidermal growth factor (EGF) to the treatment of diabetic foot ulcers (DFU) grades III and IV, according to the Wagner scale. The design of a repurposing commercial strategy is described in this document as a contribution to a body of knowledge with high uncertainty and lack of methodology for decision-makers. An analysis of the potential market suggested a significant impact of the product Heberprot-PÂ® on costs associated to DFU treatment. Unexpected findings, obtained from a study of the competence, are reported here. The feasibility of a repurposing strategy containing short-, medium- and long-term action plans, without mutual interferences, and adopting strategic intent, strategic assessment and strategic choice as fundamental concepts is demonstrated in this work.
Beyond investment: Advancing the biotechnology sector in the countries of the Gulf Cooperation Council (GCC)
Authors: Lerer Leonard , Bowman Brett
Published: January 2017

Despite substantial investment in healthcare, biomedical education and R&D facilities, the countries of the Gulf Cooperation Council (GCC) face challenges in building an impactful and sustainable biotechnology sector. After providing an overview of the state of the region's biotechnology sector, we assess the impact, both real and potential, of such investment against innovation proxies including patent outputs, clinical trial registrations, bibliometric footprint, knowledge economy rank and global competitiveness. Our analysis indicates that resource allocation alone, be it in physical infrastructure (biotechnology â€˜parksâ€™ or large academic institutes) or incentives (such as subsidies, prizes and bringing in international experts on a short-term basis) will not drive the sector growth required to make the GCC a truly globally competitive biotechnology player. Although significant money has been committed by governments to the development of an R&D infrastructure, supporting agencies and institutions, patent registrations remain limited, manufacturing centres sparse and the region has yet to attract world-class industry leaders and intellectual capital. The GCC faces considerable structural challenges in building the requisite human capital and appropriate environments to foster innovation. These shortcomings will continue to curtail bioscience R&D efforts and the region will remain at the tail-end of biotechnology development unless the GCC's relatively uncoordinated capital outlays are more strategically harnessed. We provide some proposals concerning best practice aimed at the development of a thriving and sustainable sector in the GCC that is more valuable than the sum of its parts.
Biotechnology commercialization: A case study from Central and Eastern Europe
Authors: Ukropcova Dana , Sturdik Ernest
Published: January 2017

A study with generalizable results was conducted on biotechnology commercialization in the region of Central and Eastern Europe. The purpose of this study was to create an understanding of the strategies that the spin-off creation implements. The existence of young innovative companies is most likely to increase the presence of venture capital in the region and, in turn, even the number of new companies.
Traditional ecological knowledge: Impact on commercial health
Authors: Khalvati Mohammadali , Michine Ikway (Yvonne Fulton) , Mukwa Wabiska (Zane Bell) , Metatawabin Mary Jane
Published: January 2017

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Licensing issues in today's bankruptcy world
Authors: Schein Michael , Fleischman Brandon J
Published: January 2017

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Limitation of gene patents to functioning DNA
Authors: Webber Philip
Published: January 2017

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The role of technology transfer in biotechnology
Authors: Wilkinson John
Published: January 2017

Technology transfer is the lifeblood of building a sustainable biotechnology industry. This paper considers the development of the technology transfer industry, and particularly its influence on the role it has played in the growth biotechnology in the UK. It identifies some of the key skills necessary to exploit intellectual property successfully and how these were effected in the case of one start-up company. It identifies some of the challenges facing the industry, including the need to retain staff, to be able to invest in technology for the longer term and to have the space and other facilities to incubate fledgling companies.
Royalty rates: Current issues and trends
Authors: Finch Sharon
Published: January 2017

One of the most intensely debated areas in a negotiation is that of the financial settlement: in particular the royalty rate, which is key, as it directly impacts on the profitability of the product long after the development work has been completed. Despite the fact that nearly all companies issue press releases announcing the successful conclusion of their technology licenses and partnerships, the detail of the royalty rates remains, in most cases, strictly confidential. In this paper, we discuss a survey undertaken by Medius Associates to investigate the current trends in pharmaceutical deal-making, including the key factors that influence the setting of royalty rates.
The consumer marketing of biotechnology
Authors: Wansink Brian , Kim Junyong
Published: January 2017

What leads to the different consumer attitudes towards biotechnology? This paper shows how consumers come to accept biotechnology applications and how marketers of biotechnology have handicapped their effectiveness by making the following incorrect assumptions: (1) the biotechnology controversy will soon be forgotten; (2) science sells and fear fails; (3) consumers buy products, not processes; (4) good medicine means good food; and (5) biotechnology education is a trade association concern. After examining these mistaken assumptions, implications for more effective consumer education and marketing are given.
Farewell Editorial
Authors: Scott-Ram Nick
Published: January 2017

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Becoming a premier partner: Measuring, managing and changing partnering capabilities at Eli Lilly and Company
Authors: Futrell David , Slugay Marlene , Stephens Carol H
Published: January 2017

When Eli Lilly and Company decided to expand its drug development by entering into strategic 'alliances' with other, usually smaller, biotechnology firms, the company committed to becoming the 'premier partner' in the pharmaceutical industry. To implement that commitment, Lilly needed a way to measure how well it performed as a partner. That seemed like a simple problem to solve. But the actual solution required Lilly to invent two new measurement instruments that it uniquely combined with an existing benchmarking instrument developed and administered by PricewaterhouseCoopers. The three tools serve complementary purposes. The PWC survey helps Lilly understand how it compares to other large pharmaceuticals as a desirable partner, Lilly's new survey provides a 'finer-grained' picture of large, individual alliances by focusing on the factors that make up many of the categories in the PWC survey. The other new tool, a focus group guide and protocol, allows Lilly to assess the health of smaller alliances and to probe areas of broad concern identified in the quantitative diagnostic surveys. Using this unique combination of tools to assess the 'health' of their alliances, Lilly and its partners are not only improving the performance of the individual alliances, they are also improving Lilly's overall capabilities as a partner.
Solid organ xenotransplantation: Progress, promise and regulatory issues
Authors: Greenstein Julia L , Schuurman Henk-Jan
Published: January 2017

Xenotransplantation, the process of transplanting live cells, tissues and organs from one species into another, is an emerging novel area in medicine. It is proposed as a treatment for human end-stage organ failure and for other applications such as, for example, the treatment of neurodegenerative and liver disorders, meeting the large demand for donor organs. The pig is considered to be the most suitable donor species. However, the rejection of a pig transplant is much more severe and multifactorial compared with that of a human graft and involves almost all branches of the human immune system. Major rejection mechanisms include complement-mediated rejection, antibody-mediated rejection and cellular rejection. Prevention of rejection requires not only improved immunosuppressive agents, but also innovative approaches including the genetic modification of the pig donor by which organs become more easily acceptable, and the modulation of the human recipient's immune system so that it tolerates the xenograft without the need of extensive immunosuppression. Regarding safety, concerns have been raised on the potential risk of transmission of infectious microorganisms by a pig transplant to a human patient, and subsequent spread of infectious microorganisms into the population by an infected individual. This in particular concerns porcine endogenous retrovirus: to date intensive research has shown no evidence that this virus is transmitted in vivo from pig to humans; also a miniature swine line has been identified which does not give detectable in vitro transmission to human cells. Based on concerns on xenotransplantation, especially the safety of porcine-to-human transplants, many countries in Europe, the USA and Canada have instituted stringent policies for the development of xenotransplantation products, which include guidelines and regulations of clinical trials and additionally include public discussions on the issues associated with xenotransplantation. Based on these initiatives of regulatory authorities, xenotransplantation could advance towards a clinical application by a closely monitored stepwise approach. It is expected that advances in preclinical research during the coming years will give a further basis for such a stepwise development from a promising tool into a new well-accepted clinical entity.
The human stem cells debate: A UK perspective
Authors: Lezemore Tor , Bull Susan
Published: January 2017

The potential use of embryonic stem cells for the treatment of common diseases raises a number of ethical concerns relating to the use of embryos in research and the possibility of human reproductive cloning. This paper assesses the debate about the moral permissibility of research using embryonic cells and outlines recent changes in UK legislation.
The European Clinical Trials Directive: What does this mean for the biopharmaceutical industry?
Authors: Bryson Simon
Published: January 2017

1st May, 2001, saw the final publication of the long-anticipated European Union Directive relating to Good clinical practice in the conduct of clinical trials on medicinal products for human use (2001/20/EC). The Directive consolidates, for the first time, aspects relating to the manufacture and provision of clinical material, clinical trial regulatory approval, and the protection of trial subjects, which encompass the conduct of clinical trials in the European Union. There are certain aspects of the directive which sow the seed of change within the pharmaceutical industry. For the first time, a qualified person will be required to perform the release of the investigational medicinal product (IMP) for use in a clinical trial. Good manufacturing practice in the manufacture of IMPs will be a legal requirement universally across the EU. This was previously dependent on member states instituting controls voluntarily. There are also changes in the pre-approval process for some biopharmaceutical products prior to trial commencement. In this paper we will explore the contents of the Directive and consider how this will impact the biopharmaceutical industry.
Strategies for improving communication between scientists and the public
Authors: Clarke Belinda R
Published: January 2017

It is believed that a scientifically literate society benefits the national economy by improving the workforce and raising consumer awareness by helping people appreciate and support scientific advancement. Traditionally, communication between scientists and the public has been viewed as unidirectional, with an 'expert' scientist bestowing information on a recipient perceived to be largely passive and unquestioning. Today, however, the white laboratory coat is no longer a symbol of credibility. Several apparent 'blunders', attributed to the misapplication of science, have led to a heightened demand for information, public consultation and transparency surrounding scientific research and policy making. The current climate of public mistrust of scientists, policy makers and commercially funded research has resulted in a stronger focus on the mechanisms by which science is communicated to and perceived by the general public. Here various strategies for communicating scientific ideas are reviewed, and how they could promote a bidirectional flow of information, thus improving trust and understanding between scientists and non-scientists, is considered. One of the major challenges ahead is to provide suitable opportunities for these exchanges to take place. The next step is to integrate these interactions (and their outcomes) into scientific policy.
Cell therapy - When will it deliver its promise?
Authors: Cubitt Iain
Published: January 2017

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New developments in China's pharmaceutical regulatory regime
Authors: Li Chiang Ling
Published: January 2017

Presents a study that discussed the regulations in the revised Pharmaceutical Administration Law in China that came into effect in December 2001. Background on the State Drug Administration of China; Details on several pharmaceutical regulations; Challenges faced by the pharmaceutical sector in China
A new season for biotechnology in Europe
Authors: Rappagliosi Andrea
Published: January 2017

Comments on the status of the biotechnology industry in Europe as of March 2002. Research system for life sciences in Europe; Changes in the European Union's (EU) policy toward biotechnology; Plans of EU for the biotechnology industry.
Employment and management trends in the biotechnolgy industry
Authors: Larbey Cynthia
Published: January 2017

This paper takes a look at the major influences on the biotechnology industry and how they are currently affecting employment and management trends. It takes a brief look at the impact of the economic environment, the pharmaceutical industry, the role of geography, the employment stages faced by the industry and the management issues. The dangers of making predictions are obvious: remember that when IBM was asked in 1947 how many computers the world would need, they thought five main frames would do it. The biotechnology industry is still in nappies. The human genome was only published in February 2001 and we do not really have any concept of where or how fast this will take our scientific knowledge. So, while buffeted by the winds of short-term political and economic agendas, there is an undercurrent of an industry that is learning and growing up.
Analyzing United States Prescribing Information to gain insight into FDA-sponsor discussions
Authors: Daizadeh Iraj
Published: January 2017

The United States Prescribing Information (USPI) is a key vehicle for communicating the benefit-risk information of a Food and Drug Administration (FDA) approved prescription drug. The USPI is typically the last step of the drug development process and requires discourse between the FDA and the sponsor for a new drug application. The USPI may also be updated after obtaining FDA approval. As a social artifact of industry and FDA discussions, it is hypothesized that an analysis of a library of USPI records may yield insight into this dialog. Here, an analysis of DailyMed â€“ a USPI data repository â€“ reveals that structural language similarities (linguistic typologies) exist across USPI. Interestingly, these typologies describe labeling language that may not be explicitly described in FDA regulatory documentation. It is proposed that the methodology herein proposed may be leveraged to potentially facilitate USPI development and FDA dialogue (and therefore expedite the drug development paradigm). Several examples are used to showcase the approach. A discussion on limitations of the methodology and opportunities for development is also presented.
Publicâ€“private partnerships in global health
Authors: Liang Bryan A
Published: January 2017

This issue of the Journal of Commercial Biotechnology includes the papers from the seventh Annual San Diego Health Policy Conference, â€˜Publicâ€“Private Partnerships in Global Healthâ€™, held on 25 March 2011. The San Diego Heath Policy Conference is sponsored by the Institute of Health Law Studies California Western School of Law, in collaboration with the San Diego Center for Patient Safety, University of California, San Diego School of Medicine and the Partnership for Safe Medicines. The event drew both national and international participants with industry representatives, health-care providers, public health officials, law enforcement personnel, attorneys, military representatives, academics and policy experts coming together to assess the role and potential of privateâ€“public partnerships in global health activities.
Trade secrets: At the crossroads of intellectual property and labor and employment law
Authors: Salins Roy
Published: January 2017

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Catalyzing capital for Canada's life sciences industry
Authors: Tucker Joseph , Chakma Justin , Fedak Paul WM , Cimini Massimo
Published: January 2017

Canada's biotech sector ranks within the top five globally, but its life sciences venture capital (VC) industry is among the worlds weakest. This makes for an interesting case study in understanding the disconnect between low levels of VC and a healthy innovation ecosystem in terms of R&D spending, skilled workforce and enterprise support. Three key provinces (Quebec, Ontario and British Columbia) that have taken significantly different approaches to attracting VC are large enough to attract as much government investment as whole emerging markets. The aim of this article is to present evidence from a Canadian natural economic experiment in order to evaluate the effectiveness of varying government policies in attracting VC investment, to illustrate how these policies need tailoring to individual sub-sectors of the life sciences sector, and to highlight potential policy mechanisms that may be applicable beyond Canada's borders. We employ VC returns on investment (ROI) and exit data as a proxy for our evaluation. Our results suggest that government biotechnology investment needs to be structured end-to-end from early to late stage in order to be successful, that prevalence of private and international VC flows is critical for generating market efficiency, and that there is an â€˜optimalâ€™ efficient amount of capital before ROI result in diminishing returns.
FDA at BIO 2011 â€“ Weighing a hefty mission: Where is the balance?
Authors: Levy Suzanne
Published: January 2017

The mission of the Food and Drug Administration (FDA) is to promote public health by ensuring the safety and quality of food and medical products sold in the United States. At this year's annual Biotechnology Industry Organization (BIO) convention, significant discussion revolved around the appropriate interpretation and execution of that mission.The BIO meeting hosted 15 646 participants from across industry, government and the nonprofit sector, focusing on the current state of the biotechnology industry, as well as its challenges in seeking to further improve public welfare. Perhaps partly because this year's meeting was held in Washington, DC â€“ the seat of the federal government and of BIO's headquarters â€“ much attention was paid to the US regulatory environment. In particular, attendees debated the quandary faced every day by the FDA: how to enable access to novel therapies quickly, but only once their safety has been certified.
Consolidation challenges in Europe's life science sector â€“ Making it happen
Authors: Stoiber Wolfgang
Published: January 2017

Even though the current market environment is tough on biotechnology companies, the number of consolidation transactions in Europe has fallen. Platform specialists have to turn themselves into product companies in order to be heard by investors. Product companies are crushed between high financing needs and their cost of capital. A full integration strategy can destroy value for founders and early investors. Thorough analysis, good strategic fit, a rigorous integration plan and retaining the talent are predictors of success in a merger situation. Engineering the future value proposition around fundamental drivers of investor return determines mid-term access to capital. Trade sales are becoming a very lucrative exit route, provided the assets meet expectations of the pharmaceutical industry.
Financial accounts reports
Authors: Citron David
Published: January 2017

Antisoma, founded in 1988, specialises in the development of novel anti-cancer drugs. Its strategy is to focus on the middle pre-clinical and clinical development stages rather than on either the relatively risky initial discovery or costly marketing stages.
Business development: A barometer of future success
Authors: Valentine Edmund L
Published: January 2017

In the pharmaceutical and biotechnology industry, an excellent barometer of potential future success is a company's ability to find and execute accreditive deals. The key factors that differentiate successful companies are: (1) visionary leadership that sets aggressive but achievable, coordinated, measurable individual business development objectives to be met by designated dates, and (2) a proactive results- versus activity-oriented corporate culture. In these companies, senior management, from the Chief Executive Officer down, are focused on business development efforts to ensure that future product line gaps are filled before they materialise. Business development is supported by systems and processes that facilitate the timely identification and execution of accreditive deals. This paper discusses how successful companies set and achieve realistic business development objectives. Failure to fill future product line gaps through in-licensing, joint ventures or acquisitions will result in many companies being downsized, acquired or merged, or going out of business.
Staking an Advantage in an AIA World: Practical Patent Tips for Biotechnology Companies
Authors: Miller Stefan Michael
Published: January 2017

With passage of the Leahy-Smith America Invents Act (AIA), new rules and procedures related to the application of prior art now apply to patenting under a â€œfirst-inventor-to-fileâ€ system. This article summarizes certain key prior art provisions that biotechnology companies should be aware of and details practical steps that can be implemented to help stake a competitive advantage under the new law including the use of patent liaisons, early provisional and patent application filings, and in certain circumstances, defensive publication of patentable subject matter.
Emerging Business Models and Strategies to Accelerate Innovation in the Biopharmaceutical Industry
Authors: Boni Arthur
Published: January 2017

We focus on assessing and addressing the current challenges faced by the companies that comprise the biopharmaceutical industry.Â  These include: improving productivity in the drug development process while managing many issues arising from partnering across the value chain more effectively; pricing of its products in the face of long, risky, and expensive development cycles; and, regaining the public trust as an industry that reliably and repeatedly delivers value to its constituencies at an affordable cost.Â  The motivation for this paper is derived from a panel organized for BIO 2016 in San Francisco, organized by the author and the leadership team of the 12th annual entrepreneurship Boot camp held there. The panel discussed â€œEmerging Issues and Trends in the Business of Biotechnology Entrepreneurshipâ€.Â  Discussion was held around three topics that are pertinent to accelerating innovation in the industry: emerging business models; applicability of the lean startup model to biopharma; and pricing.Â  The panel was led and moderated by the author, with participation of Steven Sammut, James Jordan, and Dennis Gross.Â  Their specific contributions are noted in the text, and their overall contributions to the panel and to this article are gratefully acknowledged.
Delivering biotherapeutics â€“ technical opportunities and strategic trends
Authors: Shohet Simon , Wood Gemma
Published: January 2017

As the list of biological drugs gaining regulatory approval grows, this paper examines how different technological approaches to delivering these drugs have evolved, and how business strategies have developed to meet the challenges. Companies can broadly be divided into three segments based on their technological approach: (1) developers of novel devices, (2) exploiters of new routes for drug administration and (3) reformulators of drugs. Case studies of companies in each segment are presented. The paper concludes by suggesting that further consolidation of the drug delivery sector is likely either between smaller companies or between large pharma and smaller entities. It is also argued that, as competition intensifies, drug delivery should no longer be regarded as a 'bolt-on', but integrated at an earlier stage of the product life cycle.
Audiovisual materials: A way to reinforce listening skills in primary school teacher education
Authors: González-Vera Pilar , Hornero Corisco Ana
Published: January 2017

Author/s

Pilar González-VeraAna Hornero CoriscoUniversidad de Zaragoza, Spain

 

ABSTRACT

This paper aims to show the effective use of audiovisual materials in the teaching of EFL to primary school teachers. For that purpose a representative sample of undergraduate students of the Degree in Primary Education with a pre-intermediate B1 level was selected. The students, whose ages ranged from 18 to 22, belonged to the so-called E-generation (Prensky 2001). In the first stage of the study a questionnaire was distributed in order to shed light on our students’ level of English as well as on the ways and resources they have used to learn English. It revealed that oral communication skills (listening, speaking and pronunciation) were usually underestimated. Bearing in mind these results, the present study proposed two main activities, one focused on listening comprehension and another on the improvement of pronunciation through audiovisual materials.
Discourse markers and lecture structure: their role in listening Comprehension and EMI lecturer training
Authors: Martín del Pozo María Ángeles
Published: January 2017

Author/s

María Ángeles Martín del PozoUniversidad de Valladolid, Spain

 

ABSTRACT

Listening comprehension of lectures in L2 contexts is a widely researched topic. Findings have been applied to both materials and course design. This paper focuses on findings about the facilitative role in comprehension of those discourse markers (DM) which signal lecture structure. These markers can also be of assistance in L2 contexts such as new English Medium Instruction (EMI) scenarios, where the lecturer is not a native speaker of English. A small-scale investigation about the presence of these markers in EMI lecturer discourse is presented. Findings indicate that lecturers need a more overt signalling of lecture phases and a wider stylistic variety enabling them to do so. The paper concludes by suggesting that EAP materials for training students in listening comprehension could be a good resource to provide the lecturer with a repertoire of linguistic tools to structure their lecturers and in consequence facilitate comprehension for students.
Multimodal digital tools and EFL audio-visual comprehension: Students’ attitudes towards vodcasts
Authors: Norte Fernández-Pacheco Natalia
Published: January 2017

Author/s

Natalia Norte Fernández-PachecoCESA Alicante, Spain

 

ABSTRACT

The emergence of Information and Communication Technologies (ICT) has helped in the development and application of new language teaching materials that promote a multimodal approach (Jewitt, 2009, 2013; Kress and Leeuwen, 2001). Multimodal digital tools, such as vodcasts, bring together diverse modes of communication, which may enhance students’ foreign language audio-visual comprehension. This paper discusses a study on the attitudes of 40 Spanish students at a B2 level, aged between 14 and 19, towards the use of vodcasts, in comparison with audio tracks. Questionnaires were employed to gather data on student attitudes towards two British Council vodcasts. The results showed positive attitudes towards the use of multimodal digital tools (e.g., vodcasts) rather than traditional listening activities (e.g., audio tracks). We suggest these findings point to the potential of vodcasts not only as influential multimodal tools to improve EFL students’ audio-visual comprehension but also to increase students’ enjoyment and engagement when learning English as a foreign language.
A Multimodal Analysis of Picture Books for Children: A Systemic Functional Approach
Authors: Litzler Mary Frances
Published: January 2017

Reviewed by Mary Frances LitzlerUniversidad de Alcalá, Spain

 

This book is a study of nine picture books for children ranging in age from 0 to 9 years old. The conceptual framework follows Halliday’s Systemic Functional Grammar (2004) (henceforth, SFG) and Kress and van Leeuwen’s Visual Social Semiotics (2006) (henceforth, VSS). The main objective is to “identify the verbal and visual strategies used by writers and illustrators… to convey a representation of reality, to create interaction with child-readers and to form coherent wholes of communication” (257).
Inhabiting a World of Numerical Things
Authors: Voegelin Salomé
Published: January 2017

This essay recounts a visit to Ryoji Ikeda’s inaugural exhibition at the HeK (Haus der elektronischen Künste) in Basel, Switzerland in November 2014. It aims to bring an inhabited sensibility to works made from information processes whose code is at once their material texture and conceptual legitimacy. Through the particularity of her recounting, the author critically engages with her experience of the works as environment in relation to Ikeda’s own ideas of a mathematical sublime put into contrast with Immanuel Kant’s notion of the sublime; and consider the mathematical purity Ikeda’s work pursues in relation to Quentin Meillassoux’s notion of a mind-independent world. Most particularly, the author engages in the relationship between the visualisation of data and its sonic composition, and recognises their connection as a central tension of the work into which she places Étienne Balibar’s portmanteau term “égaliberté,” the impossible reciprocity between equality and freedom.
Christian Calon’s Continental Divide: Chronography of a Continent
Authors: Harrod Ariel
Published: January 2017

Christian Calon’s film-installationContinental Divide(2013) asks the question “What is the time of a very large space?”. This paper questions the work itself to see how it tries to answer this question. By putting into resonance Calon’s discourse regarding his work, a description of the materials comprising the work and a descriptive restitution of my own experience of the work, it explores how 1) a singular composing of sound and image, 2) a specific mode of diffusion, and 3) their encounter with a listening subject can render possible the audiovisual experience of “the time of a very large space.”
The RFamide receptor DMSR-1 regulates stress-induced sleep in C. elegans
Authors: Iannacone Michael J , Beets Isabel , Lopes Lindsey E , Churgin Matthew A , Fang-Yen Christopher , Nelson Matthew D , Schoofs Liliane , Raizen David M
Published: January 2017

In response to environments that cause cellular stress, animals engage in sleep behavior that facilitates recovery from the stress. In Caenorhabditis elegans, stress-induced sleep(SIS) is regulated by cytokine activation of the ALA neuron, which releases FLP-13 neuropeptides characterized by an amidated arginine-phenylalanine (RFamide) C-terminus motif. By performing an unbiased genetic screen for mutants that impair the somnogenic effects of FLP-13 neuropeptides, we identified the gene dmsr-1, which encodes a G-protein coupled receptor similar to an insect RFamide receptor. DMSR-1 is activated by FLP-13 peptides in cell culture, is required for SIS in vivo, is expressed non-synaptically in several wake-promoting neurons, and likely couples to a Gi/o heterotrimeric G-protein. Our data expand our understanding of how a single neuroendocrine cell coordinates an organism-wide behavioral response, and suggest that similar signaling principles may function in other organisms to regulate sleep during sickness.
A comparative in-silico analysis of autophagy proteins in ciliates
Authors: Aslan Erhan , Küçükoğlu Nurçin , Arslanyolu Muhittin
Published: January 2017

Autophagy serves as a turnover mechanism for the recycling of redundant and/or damaged macromolecules present in eukaryotic cells to re-use them under starvation conditions via a double-membrane structure known as autophagosome. A set of eukaryotic genes called autophagy-related genes (ATGs) orchestrate this highly elaborative process. The existence of these genes and the role they play in different eukaryotes are well-characterized. However, little is known of their role in some eukaryotes such as ciliates. Here, we report the computational analyses of ATG genes in five ciliate genomes to understand their diversity. Our results show that Oxytricha trifallax is the sole ciliate which has a conserved Atg12 conjugation system (Atg5-Atg12-Atg16). Interestingly, Oxytricha Atg16 protein includes WD repeats in addition to its N-terminal Atg16 domain as is the case in multicellular organisms. Additionally, phylogenetic analyses revealed that E2-like conjugating protein Atg10 is only present in Tetrahymena thermophila. We fail to find critical autophagy components Atg5, Atg7 and Atg8 in the parasitic ciliate Ichthyophthirius multifiliis. Contrary to previous reports, we also find that ciliate genomes do not encode typical Atg1 since all the candidate sequences lack an Atg1-specific C-terminal domain which is essential for Atg1 complex formation. Consistent with the absence of Atg1, ciliates also lack other members of the Atg1 complex. However, the presence of Atg6 in all ciliates examined here may rise the possibility that autophagosome formation could be operated through Atg6 in ciliates, since Atg6 has been shown as an alternative autophagy inducer. In conclusion, our results highlight that Atg proteins are partially conserved in ciliates. This may provide a better understanding for the autophagic destruction of the parental macronucleus, a developmental process also known as programmed nuclear death in ciliates.
Observed warming trend in sea surface temperature at tropical cyclone genesis
Authors: Defforge Cécile L. , Merlis Timothy M.
Published: January 2017

Tropical cyclone (TC) activity is influenced by environmental factors, and it is expected to respond to anthropogenic climate change. However, there is observational uncertainty in historical changes in TC activity, and attributing observed TC changes to anthropogenic forcing is challenging in the presence of internal climate variability. The sea surface temperature (SST) is a well‐observed environmental factor that affects TC intensity and rainfall. Here we show that the SST at the time of TC genesis has a significant warming trend over the three decades of the satellite era. Though TCs are extreme events, the warming trend at TC genesis is comparable to the trend in SST during other tropical deep convection events and the trend in SST in the TC main development regions throughout the TC season. This newly documented, observed signature of climate change on TC activity is also present in high‐resolution global atmospheric model simulations that explicitly simulate TCs.
Volumetric components in the earthquake source related to fluid injection and stress state
Authors: Martínez‐Garzón Patricia , Kwiatek Grzegorz , Bohnhoff Marco , Dresen Georg
Published: January 2017

We investigate source processes of fluid‐induced seismicity from The Geysers geothermal reservoir in California to determine their relation with hydraulic operations and improve the corresponding seismic hazard estimates. Analysis of 869 well‐constrained full moment tensors (Mw 0.8–3.5) reveals significant non‐double‐couple components (>25%) for about 65% of the events. Volumetric deformation is governed by cumulative injection rates with larger non‐double‐couple components observed near the wells and during high injection periods. Source mechanisms are magnitude dependent and vary significantly between faulting regimes. Normal faulting events (Mw < 2) reveal substantial volumetric components indicating dilatancy in contrast to strike‐slip events that have a dominant double‐couple source. Volumetric components indicating closure of cracks in the source region are mostly found for reverse faulting events with Mw > 2.5. Our results imply that source processes and magnitudes of fluid‐induced seismic events are strongly affected by the hydraulic operations, the reservoir stress state, and the faulting regime.
Predictable and unpredictable ionospheric disturbances during St. Patrick's Day magnetic storms of 2013 and 2015 and on 8–9 March 2008
Authors: Dmitriev A. V. , Suvorova A. V. , Klimenko M. V. , Klimenko V. V. , Ratovsky K. G. , Rakhmatulin R. A. , Parkhomov V. A.
Published: January 2017

We present a comparative analysis of first principles Global Self‐consistent Model of the Thermosphere, Ionosphere, and Protonosphere (GSM TIP) in prediction of ionospheric disturbances during three geomagnetic storms: from moderate on 8–9 March 2008 and on 17–18 March 2013 to strong one on 17–18 March 2015, so‐called St. Patrick's Day storms. We have found that in general, the GSM TIP model gave reasonable prediction of both positive and negative ionospheric storms. Most difficulties have been found for the St. Patrick's Day storms. Namely, a strong positive storm at low latitudes above the Pacific and in the South Atlantic Anomaly region on the main and recovery phases could not be predicted by the model. The positive storm could be explained by ionization effect of energetic electron enhancements. Dynamics of negative ionospheric storms at middle latitudes was predicted by the GSM TIP model quite well though the amplitude of storms was underestimated. The latter could result from underestimation of the N2 contribution especially under unusual conditions of anomalous expansion of auroral precipitations to middle latitudes during the 2015 St. Patrick's Day storm.