bluuebunny/crossref_metadata_2025 huggingface dataset:
Biogeochemical constraints on the origin of methane in an alluvial aquifer: evidence for the upward migration of methane from underlying coal measures
Authors: Iverach Charlotte P. , Beckmann Sabrina , Cendón Dioni I. , Manefield Mike , Kelly Bryce F. J.
Published: January 2017

Abstract. Geochemical and microbiological indicators of methane (CH4) production, oxidation and migration processes in groundwater are important to understand when attributing sources of gas. The processes controlling the natural occurrence of CH4 in groundwater must be understood, especially when considering the potential impacts of the global expansion of coal seam gas (CSG) production on groundwater quality and quantity. We use geochemical and microbiological data, along with measurements of CH4 isotopic composition (δ13C-CH4), to determine the processes acting upon CH4 in a freshwater alluvial aquifer that directly overlies coal measures targeted for CSG production in Australia. Measurements of CH4 indicate that there is biogenic CH4 in the aquifer; however, microbial data indicate that there are no methanogenic archaea in the groundwater. In addition, geochemical data, particularly the isotopes of dissolved inorganic carbon (DIC) and dissolved organic carbon (DOC), as well as the concentration of SO42−, indicate limited potential for methanogenesis in situ. Microbial community analysis also shows that aerobic oxidation of CH4 occurs in the alluvial aquifer. The combination of microbiological and geochemical indicators suggests that the most likely source of CH4, where it was present in the freshwater aquifer, is the upward migration of CH4 from the underlying coal measures.
Coral reef origins of atmospheric dimethylsulfide at Heron Island, southern Great Barrier Reef, Australia
Authors: Swan Hilton B. , Jones Graham B. , Deschaseaux Elisabeth S. M. , Eyre Bradley D.
Published: January 2017

Abstract. Atmospheric dimethylsulfide (DMSa), continually derived from the world's oceans, is a feed gas for the tropospheric production of new sulfate particles, leading to cloud condensation nuclei that influence the formation and properties of marine clouds and ultimately the Earth's radiation budget. Previous studies on the Great Barrier Reef (GBR), Australia, have indicated coral reefs are significant sessile sources of DMSa capable of enhancing the tropospheric DMSa burden mainly derived from phytoplankton in the surface ocean; however, specific environmental evidence of coral reef DMS emissions and their characteristics is lacking. By using on-site automated continuous analysis of DMSa and meteorological parameters at Heron Island in the southern GBR, we show that the coral reef was the source of occasional spikes of DMSa identified above the oceanic DMSa background signal. In most instances, these DMSa spikes were detected at low tide under low wind speeds, indicating they originated from the lagoonal platform reef surrounding the island, although evidence of longer-range transport of DMSa from a 70 km stretch of coral reefs in the southern GBR was also observed. The most intense DMSa spike occurred in the winter dry season at low tide when convective precipitation fell onto the aerially exposed platform reef. This co-occurrence of events appeared to biologically shock the coral resulting in a seasonally aberrant extreme DMSa spike concentration of 45.9 nmol m−3 (1122 ppt). Seasonal DMS emission fluxes for the 2012 wet season and 2013 dry season campaigns at Heron Island were 5.0 and 1.4 µmol m−2 day−1, respectively, of which the coral reef was estimated to contribute 4 % during the wet season and 14 % during the dry season to the dominant oceanic flux.
Contributions of microbial activity and ash deposition to post-fire nitrogen availability in a pine savanna
Authors: Ficken Cari D. , Wright Justin P.
Published: January 2017

Abstract. Many ecosystems experience drastic changes to soil nutrient availability associated with fire, but the magnitude and duration of these changes are highly variable among vegetation and fire types. In pyrogenic pine savannas across the southeastern United States, pulses of soil inorganic nitrogen (N) occur in tandem with ecosystem-scale nutrient losses from prescribed burns. Despite the importance of this management tool for restoring and maintaining fire-dependent plant communities, the contributions of different mechanisms underlying fire-associated changes to soil N availability remain unclear. Pulses of N availability following fire have been hypothesized to occur through (1) changes to microbial cycling rates and (2) direct ash deposition. Here, we document fire-associated changes to N availability across the growing season in a longleaf pine savanna in North Carolina. To differentiate between possible mechanisms driving soil N pulses, we measured net microbial cycling rates and changes to soil δ15N before and after a burn. Our findings refute both proposed mechanisms: we found no evidence for changes in microbial activity, and limited evidence that ash deposition could account for the increase in ammonium availability to more than 5–25 times background levels. Consequently, we propose a third mechanism to explain post-fire patterns of soil N availability, namely that (3) changes to plant sink strength may contribute to ephemeral increases in soil N availability, and encourage future studies to explicitly test this mechanism.
Strong linkages between surface and deep water dissolved organic matter in the East/Japan Sea
Authors: Kim Tae-Hoon , Kim Guebuem , Shen Yuan , Benner Ronald
Published: January 2017

Abstract. Vertical and horizontal distributions of total hydrolysable amino acids (THAA), dissolved organic carbon (DOC), and dissolved organic nitrogen (DON) were measured in the East/Japan Sea (EJS). The euphotic zone of this sea is N-limited, and the N : P ratio is ~ 13 below 200 m depth. Elevated THAA concentrations (137 ± 34 nM) and DOC-normalized yields (0.8 ± 0.2 % of DOC) were observed in deep waters (≥ 1000 m) of the EJS compared with those in the deep North Pacific Ocean. Significantly high THAA concentrations and yields were observed in a region of deep-water formation, indicating the convection of margin-derived bioavailable dissolved organic matter (DOM) to deep waters. Declining THAA concentrations (36 ± 12 %) and yields (33 ± 13 %) were observed between 1000–3000 m throughout the EJS, indicating the utilization of bioavailable DOM in deep waters. Concentrations of the D-enantiomers of amino acids (Ala, Glx, Asx, and Ser) were relatively high in deep waters of the EJS, indicating substantial bacterial contributions to DOM from surface and upper mesopelagic waters. These observations suggest that the transport of bioavailable DOM to microbial food webs in deep waters of the EJS is sensitive to changes in deep-water renewal rates.
Coupled Climate–Economy–Biosphere (CoCEB) model – Part 1: Abatement efficacy of low-carbon technologies
Authors: Ogutu Keroboto B. Z. , D'Andrea Fabio , Ghil Michael , Nyandwi Charles
Published: January 2017

Abstract. In the present Part 1 of a two-part paper, we formulate and study a simple Coupled Climate–Economy–Biosphere (CoCEB) model. This highly idealized model constitutes the basis of our integrated assessment approach to understanding the various feedbacks involved in the system. CoCEB is composed of a physical climate module, based on Earth's energy balance, and an economy module that uses endogenous economic growth with physical and human capital accumulation. We concentrate on the interactions between the two subsystems: the effect of climate on the economy, via damage functions, and the effect of the economy on climate, via control of greenhouse gas emissions. Simple functional forms of the relation between the two subsystems permit simple interpretations of the coupled effects. The CoCEB model is used to evaluate hypotheses on the long-term effect of investment in emission abatement, and on the comparative efficacy of different approaches to abatement. In this paper, we consider investments in low-carbon technologies. Carbon capture and storage (CCS), along with deforestation reduction, will be dealt with in Part 2. The CoCEB model is highly flexible and transparent; as such, it allows one to easily formulate and compare different functional representations of climate change mitigation policies. Using different mitigation measures and their cost estimates, as found in the literature, one is able to compare these measures in a coherent way. While many studies in the climate–economic literature treat abatement costs merely as an unproductive loss of income, this paper shows that mitigation costs do slow down economic growth over the next few decades, but only up to the mid-21st century or even earlier; growth reduction is compensated later on by having avoided negative impacts of climate change on the economy.
Drones for justice: inclusive technology and river-related action research along the Kapuas
Authors: Radjawali Irendra , Pye Oliver
Published: January 2017

Abstract. This article discusses the potential of using drones for community-based counter-mapping. Drawing on action research conducted along the Kapuas River in West Kalimantan, Indonesia, we describe how drones were used for political interventions against land grabs by palm oil and mining companies. We share our experience of how to use drones to generate high-resolution aerial photographs that can be stitched together to create GPS-referenced maps that can support local communities' land rights. We argue that do-it-yourself drones can reduce the costs of and expertise hitherto associated with counter-mapping. While this creates the potential for a more inclusive technology, the question of who controls the technology and to what end is a political one. We conclude by comparing two interventions and discuss why the drone technology could be appropriated by local activists in one case but not in the other.
Influence of snow surface processes on soil moisture dynamics and
streamflow generation in alpine catchments
Authors: Wever Nander , Comola Francesco , Bavay Mathias , Lehning Michael
Published: January 2017

Abstract. The assessment of flood risks in alpine, snow covered catchments requires an understanding of the linkage between the snow cover, soil and discharge in the stream network. Here, we apply the comprehensive, distributed model Alpine3D to investigate the role of soil moisture in the predisposition of a catchment to high flows from rainfall and snow melt for the Dischma catchment in East Switzerland. The recently updated soil module of the physics based, multi-layer snow cover model SNOWPACK, which solves the surface energy and mass balance in Alpine3D, is verified against soil moisture measurements at seven sites and various depths inside and in close proximity of the Dischma catchment. Measurements and simulations in such terrain are difficult and consequently, soil moisture was simulated with varying degrees of success. Differences between simulated and measured soil moisture mainly arises from an overestimation of soil freezing and an absence of a ground water description in the model. Both were found to have an influence in the soil moisture measurements. Streamflow simulations performed with a spatially-explicit hydrological model using a travel time distribution approach coupled to Alpine3D provided a closer agreement with observed streamflow at the outlet of the Dischma catchment when including 30 cm of soil layers. Performance decreased when including 2 cm or 60 cm of soil layers. This demonstrates that the role of soil moisture is important to take into account when understanding the relationship between both snowpack runoff and rainfall and catchment discharge in high alpine terrain. Runoff coefficients (i.e., ratio of rainfall over discharge) based on measurements for high rainfall and snowmelt events were found to be dependent on the simulated initial soil moisture state at the onset of an event, further illustrating the important role of soil moisture for the hydrological processes in the catchment. The runoff coefficients using simulated discharge were found to reproduce this dependency and this shows that the Alpine3D model framework can be successfully applied to assess the predisposition of the catchment to flood risks from both snowmelt and rainfall events.
Introduction to the Journal of Onco-Nephrology
Authors: Launay-Vacher Vincent , Porta Camillo , Cosmai Laura
Published: January 2017

Renal insufficiency is highly prevalent among cancer patients, which negatively impacts on their survival. Furthermore, many oncological treatments may severely impair kidney function or exasperate preexisting renal diseases.

Thus, the relationship between cancer and the kidney could be regarded as “circular” and warrants specific competencies and expertise for its management.

This is why onco-nephrology, as a subspecialty of both oncology and nephrology, has begun to gain importance over the past few years.

The complex issues of the management of cancer patients in dialysis, of candidates for kidney transplantation who have had a previous malignancy, and of transplant recipients who subsequently develop a malignancy, also fall into the field of onco-nephrology.
Cancer Screening in Patients with End-Stage Renal Disease: An Individualized Approach
Authors: Rosner Mitchell H.
Published: January 2017

Cancer screening guidelines exist for the general population with the expectation that screening will improve health outcomes. However, such recommendations are not easily or appropriately generalized to the end-stage renal disease (ESRD) population where mortality is high and life expectancy is often less than 5 years. Furthermore, the operational characteristics of screening tests in the ESRD population are not the same as in the general population, which changes their predictive value. Thus, an individualized approach to cancer screening is warranted in patients with ESRD, which balances the life expectancy and the potential benefits from screening versus potential costs and harm.
Renal Consults from the Oncology Floor
Authors: Perazella Mark A.
Published: January 2017

Onco-nephrology is a rapidly growing subspecialty area, which was born of the unique kidney disease and cancer connection that exists. In reality, this area of subspecialization combines the knowledge and skills of a number of specialty groups that includes nephrologists, oncologists, urologists, intensivists, pharmacologists, and palliative care specialists. In this inaugural issue of the Journal of Onco-Nephrology, a series of papers addressing the various forms of kidney disease that develop in patients admitted to the oncology floor is presented as part of the Onco-Nephrology Highlights section. These papers are based on a session at the American Society of Nephrology Kidney Week 2015 in San Diego, CA, USA, entitled “Renal Consults from the Oncology Floor.” The editors hope you find these 4 papers educational and practical in your care of patients with cancer and kidney disease.
Electrolyte Disorders Associated with Cancer
Authors: Bowman Brendan T.
Published: January 2017

Cancer patients frequently suffer electrolyte abnormalities that complicate the management of their condition. The most commonly occurring derangement is hyponatremia, while hypercalcemia, hypokalemia, and hypophosphatemia are also encountered. The etiology of these abnormalities is often identifiable, and early diagnosis and management can prevent delays in necessary anti-cancer therapies.
Immune Checkpoint Inhibitors in the Cancer Patient with An Organ Transplant
Authors: Wanchoo Rimda , Riella Leonardo V. , Uppal Nupur N. , Lopez Carlos A. , Nair Vinay , Devoe Craig , Jhaveri Kenar D.
Published: January 2017

The use of immune checkpoint inhibitors (ICI) in several cancers is expanding; however, their use in patients with cancer and an organ transplant is very limited. In this review, we summarize the literature and the experience of anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and anti-programmed cell death protein 1 (PD-1) inhibitors in the organ transplant patient. The immunology of CTLA-4 and PD-1 inhibitors and their role in tolerance breakdown is also reviewed. While CTLA-4 inhibitors have been successfully used in kidney, liver, and heart transplant patients without rejection, the uses of PD-1 inhibitors and the combination therapy of CTLA-4 and PD-1 inhibitors have been associated with cellular- and antibody-mediated rejection. While immunosuppression minimization is needed for ICI to provide the best response when managing transplant patients who develop malignancy, this can lead to rejection episodes. Prevention strategies, such as the use of ongoing steroids and sirolimus, could prevent rejection while sustaining tumor response. As the experience grows with these agents, we will learn more about tolerance and the use of ICI in the organ transplant patient. Therefore, the use of an immune checkpoint blockade in transplantation is extremely difficult, and future research should focus on finding the right balance between unleashing the immune system to provide an anti-tumor effect but at the same time sustaining tolerance so that rejection is suppressed. Also, the ability to identify biomarkers that may predict rejection early and allow for the fine tuning of doses and frequencies of drug administration would be very helpful.
Evaluation of Pre and Post Demerger-Merger Performance: Using ABN AMRO Bank as an Example
Authors: Bao Han
Published: January 2017

This study attempts to measure the impact of simultaneously demerger and merger over the financial performance of ABN AMRO Bank for the period 2007-2013 by using the DuPont system of financial analysis. ABN AMRO Bank N.V. is a Dutch state-owned bank with headquarters in Amsterdam. The bank demerged from Royal Bank of Scotland Group (RBS) in the first quarter of 2010 and merged with Fortis Bank Nederland from July 1, 2010. Two statistical techniques are used in this study; first the analysis of pre and post Demerger-Merger financial ratios is drawn and second paired sample t-test is used. Based on the analysis of 3 years pre and post Demerger-Merger financial ratios and data of ABN AMRO Bank, the result shows that the event of merger-demerger has no significant influence on the bank’s Net profit margin, Total asset turnover, Return on equity and Equity multiplier. This research fills the gap of Demerger-Merger analysis in the bank industry by using DuPont system of financial analysis.
‘Elk nadeel heb z’n voordeel’: (bewijslast)problematiek rondom het passing-on verweer in kartelschadezaken
Authors: Meijer Rogier , Zippro Erik-Jan
Published: January 2017

‘Elk nadeel heb z’n voordeel’: (bewijslast)problematiek rondom het passing-on verweer in kartelschadezaken

In deze bijdrage wordt aan de hand van het arrest TenneT/ABB, de Richtlijn en de Implementatiewet ingegaan op de manier waarop wordt omgegaan met het bewijs in kartelschadezaken, in het bijzonder bij het passing-on verweer.
Lundbeck – uitstel van executie
Authors: Raedts Elske
Published: January 2017

Lundbeck - uitstel van executie

In 2002 sloot Lundbeck overeenkomsten met een aantal generieke producenten op grond waarvan zij de marktintroductie van generieke varianten van Lundbeck’s antidepressivum Citalopram zouden uitstellen in ruil voor een betaling. Op 8 september 2016 oordeelde het Gerecht dat deze zogenoemde Pay-for-Delay overeenkomsten tot doel hadden de mededinging te beperken. Het Gerecht laat zich in deze uitspraak onder meer uit over de werkingssfeer van het mededingingsrecht in octrooizaken, over het concept van potentiële concurrentie en over de vraag wanneer schikkingsovereenkomsten als strekkingsbeperking kunnen kwalificeren. Lundbeck heeft op 18 november 2016 tegen deze uitspraak beroep ingesteld bij het Hof van Justitie.
Autonomy of law in Indonesia
Authors: Bedner Adriaan
Published: January 2017

Autonomy of law in Indonesia

This article seeks to answer how useful the theoretical approaches developed in Europe and the United States are for explaining or understanding the autonomy of law in Indonesia – a nation that is on the verge of becoming a lower-middle-income country and whose legal system presents many of the features found in other developing countries’ legal systems. The article first sketches three lines of theoretical thought that have dominated the inquiry into autonomy of law in (Western) sociology and then assesses to what extent they are represented in the socio-legal studies of Indonesian law. The conclusion is that although socio-legal scholars studying developing countries need supplementary concepts and theories, they can use the Western ones as their point of departure in understanding the functioning of law in a setting that is very different from the one in which these theories were developed.
Opinio juris as epistème: A constructivist approach to the use of contested concepts in legal doctrine
Authors: Tans Olaf
Published: January 2017

Opinio juris as epistème: A constructivist approach to the use of contested concepts in legal doctrine

Seeing that the role of opinio juris in the identification of customary international law is essentially contested, this contribution seeks to explain how this concept plays a fruitful role in legal doctrine despite of, or perhaps even due to, this essential contestedness. To that effect the paper adopts a constructivist perspective, primarily drawing from Bourdieu’s theory of practice and Berger & Luckmann’s ideas about institutionalization. In this perspective, contested concepts such as opinio juris are conceived of as multifaceted tools of knowledge production in the hands of members of epistemic communities.
The precaution controversy: an analysis through the lens of Ulrich Beck and Michel Foucault
Authors: Arnoldussen Tobias
Published: January 2017

The precaution controversy: an analysis through the lens of Ulrich Beck and Michel Foucault

According to the precautionary principle lack of scientific evidence for the existence of a certain (environmental) risk should not be a reason not to take preventative policy measures. The precautionary principle had a stormy career in International environmental law and made its mark on many treaties, including the Treaty on the Functioning of the European Union (TFEU). However it remains controversial. Proponents see it as the necessary legal curb to keep the dangerous tendencies of industrial production and technology in check. Opponents regard it with suspicion. They fear it will lead to a decrease in freedom and fear the powers to intervene that it grants the state. In this article the principle is reviewed from the perspectives of Ulrich Beck’s ‘reflexive modernisation’ and Michel Foucault’s notion of governmentality. It is argued that from Beck’s perspective the precautionary principle is the result of a learning process in which mankind gradually comes to adopt a reflexive attitude to the risks modernity has given rise to. It represents the wish to devise more inclusive and democratic policies on risks and environmental hazards. From the perspective of Michel Foucault however, the principle is part and parcel of neo-liberal tendencies of responsibilisation. Risk management and prudency are devolved to the public in an attempt to minimise risk taking, while at the same time optimising production. Moreover, it grants legitimacy to state intervention if the public does not live up to the responsibilities foisted on it. Both perspectives are at odds, but represent different sides of the same coin and might learn from each other concerns.
“The production of law”: Law in action in the everyday and the juridical consequences of juridification
Authors: Chevalier Danielle
Published: January 2017

“The production of law”: Law in action in the everyday and the juridical consequences of juridification

In an increasingly diversifying society, public space is the quintessential social realm Lofland 1998. where members of that diverse society meet each other. Thus space is shared, whilst norms regarding that space are not always shared. Of rivalling norms, some are codified into formal law, in a process Habermas called juridification. Early Habermas regarded juridification a negative process, ‘colonizing the lifeworld’. Later Habermas argued juridification a viable pillar for conviviality in diversity. The shift in Habermas’ perspective invites the question how law works in action. In this article a frame is offered to scrutinize the working of law in action in public space, by applying the conceptual triad of spatial thinker Lefebvre to understand how law is “produced”. It argues that how law is perceived in action is pivotal to understanding how law works in action. Moreover, it discusses the possible ramifications of the perception of law in action for how the legal system as a whole is perceived.
A brave new Europe with the introduction of the EU Clinical Trials Directive: Impact upon the pharma industry and academic research with special emphasis on pharmacovigilance
Authors: Ladds Graeme
Published: January 2017

1st May, 2004, saw the national implementation of the EU Clinical Trials Directive (2001/20 EEC). Additionally, Europe changed from 15 to 25 member states, all implementing the Directive nationally at the same time and all being affected by the many and varied aspects covered in the Directive. The paper looks at the new changes to European clinical trials and what this will mean for the pharmaceutical industry and research academia alike, especially in relation to safety reporting and risk/benefit assessments.
Regulatory data protection for medicines
Authors: Wilkinson John , Dorey Frederick J
Published: January 2017

Pending the coming into force in November 2005 of the changes to the regulatory data protection regime under European Medicines Legislation to be effected under the 'Future Medicines Legislation', the European Court of Justice (ECJ) continues to deal with cases referred to it concerning the existing law of regulatory data protection. Thus it gave Judgment on 29th April, 2004, in The Queen (on the application of Novartis Pharmaceuticals UK Ltd) v The Licensing Authority established under the Medicines Act 1968 (acting by the Medicines Control Agency), and the Advocate General gave his Opinion on 8th July, 2004, in Approved Prescription Services v The Licensing Authority (acting by the Medicines Control Agency).
Editorial: Biomarkers â€“ The kiss of death
Authors: Krueger Todd
Published: January 2017

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New Technology Transfer Block Exemption and Guidelines: A challenge for biotechnology
Authors: Gunn Tim
Published: January 2017

This paper focuses on the potential impact of the new Technology Transfer Block Exemption (TTBE) on biotechnology firms, particularly with regards to small and medium-size enterprises, and assesses the challenges faced when implementing the new rules. It discusses EU competition law, in particular article 81(1) and 81(3) of the European Community Treaty, and outlines the pro-competitive criteria that undertakings are required to meet in their agreements. It outlines key concepts of the TTBE, including a brief comparison with the 1996 TTBE, and details of how biotechnology licences fit within the scope of the new TTBE. Reference is made to the Commission's Guidelines and the effects of competition on the biotechnology market. The paper also discusses the difficulties faced in gaining exemption and compares those faced by competitors and non-competitors, the importance of market share and provides a list of 'hardcore' and 'excluded' restrictions. Furthermore, the paper contains details of the guidance provided by the Commission on carrying out an individual assessment for parties whose agreements fall outside the block exemption.
Book Review: The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution
Authors: Burke Derek
Published: January 2017

The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution Henry I Miller, Gregory Conko Praeger Publishers, Westport CT; ISBN 0 275 97879 6; 2004; 296 pp
Plant biotechnology, the regulator and the consumer
Authors: Bainbridge Janet
Published: January 2017

The use of genetic modification (GM) technologies to modify food crops provides one of the most hotly debated and often discussed applications of science. As the science develops, new generations of GM crops will be produced and current consumer views might change. This brief paper discusses mechanisms by which the complexity of decision-making at the regulatory level might be better understood by the public and hence provide tools for individuals to inform their own views and purchasing choices.
Distribution of data and unique material resources made with NIH funding
Authors: Rohrbaugh Mark L
Published: January 2017

The research community, particularly in academic and public sector institutions, recognises that scientists have an obligation to publish the results of their research and otherwise make available data or unique materials that are necessary for others to replicate or advance their research. Over the past 15 years, the US National Institutes of Health (NIH) has developed policies to make such obligations a requirement for recipients of NIH funding. The view of the NIH and a number of other institutions is that the public is best served as the ultimate beneficiary of public research funding when barriers are reduced for sharing unique research resources. At the same time, recipients of funding have an obligation to facilitate the commercialisation of new technologies by transferring such technologies to the private sector, sometimes on an exclusive commercial basis. These various policies are meant to provide a framework in which publicly funded research institutions may strike an appropriate balance between these goals and obligations. In practice, this balance most often is realised. However, when that is not possible, the public sector has an obligation to place public benefit above its own or its corporate partners' financial gain.
How academics can make (extra) money out of their science
Authors: Bains William
Published: January 2017

This paper analyses how UK academics can make money from their expertise, other than through earning their salary. Using statistics from the success rate and likely remuneration from recent examples, four options are discussed: licensing their intellectual property through their institution's technology transfer office, owning shares in a 'spin-out' company, personal consulting and writing books. The case of the 'average' academic who does not actively pursue any of these goals, the 'active' academic who pursues any one of them, and the top tier academic who is in the top 10 per cent of their profession worldwide are examined. In all cases, consulting is the most economically rewarding option. For the 'average' academic, being involved in a venture-funded start-up is the worst.
Downstream and into deep biology: Evolving business models in 'top tier' genomics companies
Authors: Rothman Harry , Kraft Alison
Published: January 2017

Genomics companies are changing their business models and some have moved beyond drug discovery into drug development. The authors' analysis of genomics companies' business models yields further insights into the widening role of genomics firms within drug innovation and on the evolving dynamics between the genomics sector and the wider pharmaceutical industry. Business models within the sector have included that of the FIPCO (Fully Integrated Pharmaceutical Company), technology and information platforms, and, more recently, a new 'dual' business model that combines established platform capabilities with drug development. The study identifies a cohort of 22 leading genomics companies and takes as its focus those companies following the dual and platform business strategies. The paper describes how, over the past five years, leading genomics companies have, typically, refocused their interests downstream within drug innovation, a move that brings new commercial opportunities but also threats. New and evolving business models are enabling these companies to leverage their commercial positions and capture value in the later stages of drug development. These shifts are characterised and the possibility that this 'downstream' trend could exert a major effect on the future relations between genomics companies and pharma/large biotechnology firms, and on drug innovation, is explored.
The convergence of biotechnology and nanotechnology: Why here, why now?
Authors: Thomas Tom C , AcuÃ±a-Narvaez Rachelle
Published: January 2017

Nanotechnology offers a promise to revolutionise the life sciences because it equips biologists with tools and materials that can interact directly with the biomolecules that they study on a daily basis. Both biotechnology and nanotechnology have matured to the point that their convergence offers opportunities for novel solutions to unmet needs in biology. This paper explores the developments that have led to this convergence.
Pitfalls of valuation in biotech
Authors: Villiger Ralph , Bogdan Boris
Published: January 2017

Biotech companies face the need for valuation at various stages: fund raising, licence contracts, initial public offerings and mergers and acquisitions. The authors explain why common discounted cash flow methods are not suitable for drug development projects, sketch how real options valuation works, and address the most important misunderstandings.
The SEC's enforcement programme on biotechnology's communications with the investment community
Authors: Gabinet Arthur S
Published: January 2017

The proliferation of biotechnology start-up companies has led to increased scrutiny by the regulators of the securities markets. The author, a former head of a field office of the United States Securities and Exchange Commission, examines the growing cooperation among regulatory agencies in the U.S. and the basic structure of the disclosure and anti-fraud provisions of the U.S. securities laws. The author articulates the approaches that the SEC division of enforcement has taken to investigating and prosecuting violations of the securities laws by biotechnology companies and provides useful guidance for dealing with news that may impact the securities markets.
Alternative approaches to IP management: One-stop technology platform licensing
Authors: Horn Larry
Published: January 2017

As a pioneering, one-stop technology platform licensing enterprise, MPEG LA is presented as a template for patent pooling. By providing the marketplace with fair, reasonable, non-discriminatory access to a portfolio of worldwide essential patents under a single licence, this example of a one-stop technology platform licensing programme enables widespread implementation, interoperability and use of fundamental broad-based technologies covered by many patents owned by many patent owners. This paper will: (1) present observations from MPEG LA's unique experience and perspective including a description of the necessary elements and principles on which such efforts are based, what works and why; and (2) describe efforts to apply this innovative licensing model to the biotechnology and pharmaceutical industries within the larger context of historical patent pooling as a solution to biotechnology bottlenecks.
Strategies for attracting angel investors
Authors: Holaday John W. , Meltzer Steven L. , McCormick James T.
Published: January 2017

In the early stages of corporate growth, biotechnology entrepreneurs can attract funding from a particular category of investor: the 'angel' investor. This paper describes different types of angel investors and discusses the role angel investors play in providing funding, advice and contacts to early-stage biotechnology companies. Further, some of the qualities angel investors seek in the companies in which they invest are reviewed, and techniques that biotechnology entrepreneurs can employ to increase the likelihood of obtaining funding from angel investors are discussed.
Critical success factors for biotechnology industry in Canada
Authors: Vanderbyl Sandra , Kobelak Sherry
Published: January 2017

Critical success factors and performance indicators provide the biotechnology industry with a foundation on which to grow and manage risks. In a recent survey of 247 biotechnology companies across Canada, elements critical for sustainability in the industry were investigated. The industry's dependence on intellectual property (IP) protection and strategic product development were significant findings with the top five critical factors being entrepreneurial environment, product distribution to target market, product focus, policies to protect IP and value of the firm's knowledge assets. When the data set was segregated based on stage of company development, there was a shift in what was considered a priority. Earlier stage companies, not yet self-sustaining, are more focused on funding with a dependence on external factors such as government support. The later stage companies, having access to product-derived funds, are more able to build internal resources with programmes directed at retaining and educating employees. Even with divergent interests, regardless of stage of company, IP and knowledge assets are key elements for success in this research and development rich industry. By understanding critical factors and changing priorities during business development, the industry will service an unmet need, facilitating modification of current marketing and business structure models. The results will promote sustainability in the industry as a whole.
When should you fire the founder?
Authors: Bains William
Published: January 2017

This paper examines the effect of founder team removal on the success of a set of 77 UK venture-backed biotechnology companies. Five measurements of success of these (predominantly private) companies are used: achieving liquidity for its shareholders, attracting further investment and further investors, company size, and how many products it managed to take into clinical trials. For all measures, early removal of the founding New Venture Team is correlated with poorer performance than retaining the founding team's skills. The best time to remove the founding team for this set of companies is after IPO. This suggests that venture capital investors' tendency to routinely remove founders and change CEOs on investment is damaging to their own interests as well as those of the founders concerned, and that alternative, more cooperative ways should be sought to retain founders and early executives in meaningful, effective roles in their companies to continue to harness the value that they are observed to add.
Science Business: The Promise, the Reality and the Future of Biotech
Authors: Li Weijun
Published: January 2017

Science Business: The Promise, the Reality and the Future of Biotech Gary P. Pisano Harvard Business School Press, Boston, MA; ISBN 13: 978 1591398400; November 2006; 237pp
The ability to pick biotech talent: Being a better interviewer moves â€˜youâ€™ up the ladder
Authors: Jensen David G
Published: January 2017

Do you know someone who has this unique skill? That person generally is respected throughout the company for his or her ability to interview well, and to spot those few who have the â€˜right stuff.â€™ Although there is far more to the process of selecting talent than just preliminary interviews, it is indeed interviewing skills that represent the major distinction between managers. Some people can do this so well it is second nature; others feel as much discomfort in the interviewing process as the applicant does.
How the UN's anti-biotech policies worsen global warming
Authors: Miller Henry I
Published: January 2017

Numerous United Nations policies and programmes inhibit the development and use of important tools that could help both to reduce carbon dioxide emissions and to conserve water, especially in poorer regions of the world. A prime example is the UN's unscientific, anti-innovative approach to regulating recombinant DNA-modified (or gene-spliced, or â€˜genetically modified (GM)â€™) plants that could both lessen agriculture's â€˜carbon footprintâ€™ and help farmers adapt to droughts and water shortages (a predicted outcome of warming). Like much of what transpires within UN agencies and programmes, the regulation of GM organisms and food derived from them defies scientific consensus and common sense. The result is vastly inflated research and development costs, less innovation, and diminished exploitation of superior techniques and products that could promote adaptation to environmental and public health challenges.
Cloning an industry: Strategy typologies of Shanghai biotechnology companies
Authors: Malone Ken , Hales Brent , Chan Justin , Love Monica , Rayner Jeremiah
Published: January 2017

Insight into the development of the medicinal biotechnology sector of China is provided through interviews of 19 Shanghai-based companies. Two commonly accepted strategy typologies are used to provide a predictive frame towards understanding their potential in the market. Most of the companies interviewed use the Miles & Snow Analyser Strategy. Two companies were clearly Prospectors, with founders of both discovering their technologies in laboratories of developed countries. The Porter Generic Strategy typology indicated that most are using Cost Leadership strategies. The strategic choice of these companies is problematic given the dynamics of the global market in which they could participate but are more sensible within the context of a protected market. For example, it appears that government-sponsored monopoly policies are driving low-cost strategies rather than innovation-based differentiation strategies.
Monoclonal antibody therapeutics: Leading companies to maximise sales and market share
Authors: Ziegelbauer Karl , Light David R
Published: January 2017

A close look at the biology and pharmacology of monoclonal antibodies reveals both their continuing promise as therapeutic agents to address unmet medical needs, as well as a number of challenges to the future discovery and development of this unique class of biologics. A remarkably consistent experience of reliable clinical efficacy and safety ensures that Biotech and Pharma have strong incentives to accelerate the antibody drug discovery process. Their attractive commercial potential invites consideration of potential challenges to the future expansion of the monoclonal antibody drug market. Four challenges arise from scientific and technical aspects of the antibody drug format: drug target limitations, biodistribution limitations, species specificity issues, and limitations to the route of administration and four challenges are based in the commercial and clinical use of antibody drugs: cost of goods, product differentiation within the antibody market, competition from small molecule drugs, and price sensitivity of clinical acceptance. Despite these challenges and recent setbacks, such as the withdrawal and subsequent relaunch of Tysabri and the TGN1412 Phase I disaster, the prevailing opinion is that monoclonal antibodies will continue to be safe and effective medicines that are worthy of commercialisation.
A comparison of R&D indicators for the Vancouver biotechnology cluster
Authors: Salazar Monica , Bliemel Martin J , Holbrook J Adam
Published: January 2017

The basis of this paper is to go beyond abstract definitions of what a cluster is, and look at a variety of measurable indicators, to see which can demonstrate the presence of a cluster. The example presented is based on the biotechnology industry in Vancouver, Canada. Biotechnology differs from conventional industries, in that there are few tangible goods or services traded, but rather the basis of value creation is primarily the sale or licensing of intangible intellectual property or the (usually pre-revenue) firms themselves. The two main questions we aim to test are (i) is there a biotechnology cluster in Vancouver, and (ii) what are its inputs, outcomes, and impact on the region? We use data provided from local and federal agencies such as LifeSciences British Columbia and Statistics Canada to compare biotechnology R&D activity across regions, and within the local economy. Our findings indicate that there is significant activity around biotechnology R&D and commercialisation in Vancouver, but no guarantee of the longevity of the innovation system.
Continuing education in biotechnology
Authors: Friedman Yali
Published: January 2017

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Book Review: Intellectual Property and Biotechnology: Biological Inventions
Authors: Miller Stefan M
Published: January 2017

Intellectual Property and Biotechnology: Biological InventionsMatthew RimmerEdward Elgar Publishing Limited, Cheltenham, UK and Northampton, MA, USA;ISBN 978 1845429478; 2008; 392pp; hardback
Book Review: Enterprise for Life Scientists: Developing Innovation and Entrepreneurship in the Biosciences
Authors: Meyers Arlen D
Published: January 2017

Enterprise for Life Scientists: Developing Innovation and Entrepreneurship in the BiosciencesDavid Adams and John Sparrow (eds.)Scion Publishing Ltd, Bloxham, UK;ISBN 978 1904842361; November 2007; 250pp; paperback
Book Review: Essentials of pharmacoeconomics
Authors: King Harley
Published: January 2017

Essentials of pharmacoeconomicsKaren L. RascatiLippincott Williams & Wilkins, Baltimore, 2008, paperback, 250pp.,ISBN: 978-0781765442
Best practices for developing university bioentrepreneurship education programmes
Authors: Crispeels Thomas , Uecke Oliver , Goldchstein Marc , Schefczyk Michael
Published: January 2017

The objective of this paper is to present a comprehensive overview on the bioentrepreneurship education programme organised within the framework of the project â€˜Technological Entrepreneurship at the Free University of Brussels (Vrije Universiteit Brussel, VUB)â€™. The main motivations for implementing this high-technology entrepreneurship education programme are the threats posed by the low entrepreneurial activity in Belgium and by the European innovation paradox. The biotechnology programme was implemented to stimulate and teach bioentrepreneurship among master students in business and bio-engineering at the university. The theoretical background of the paper focuses on entrepreneurship education in an academic environment and relating success factors to discover possible solutions. Following this, the paper presents a case study on the bioentrepreneurship programme implemented at the VUB. The main objective of the project is to develop and implement a set of integrated, interdisciplinary courses, organised by different faculties and attended by students in business and in bio-engineering. By presenting this solution and showing that it is possible to implement an interdisciplinary educational programme on bioentrepreneurship in a university environment, the authors suggest increasing the number of such programmes across European universities.
Biotechnology business models: An Indian perspective
Authors: Konde Viren
Published: January 2017

A typical business model consists of three components â€“ value proposition, value-chain structure and revenue generation. These components are used to give a general description of a business. The biotechnology industry is not really characterised by specific business models and neither is there one single model for success. The sector is not only characterised by an enormous diversity, but is also driven by innovations, which makes the prediction of future development rather difficult. The enormous flexibility of biotechnology companies is a strength that has helped them survive in times of economic difficulties. In years of crisis, companies have managed to reorient themselves, change their business plans or even switch markets. Several Indian firms have focused their businesses on the development, manufacturing and marketing of biopharmaceuticals and providing services. The Indian companies appear well positioned to leverage their cost-effective manufacturing capabilities to corner some of the market share and compete on a global scale. This paper discusses the various business models and strategies adopted by the biotechnology companies that directed the growth of the biotechnology industry in the country based on the techno-economic dynamics and the key challenges faced by these firms.