bluuebunny/crossref_metadata_2025 huggingface dataset:
Estimating sediment thickness by using horizontal distance to outcrop as secondary information
Authors: Kitterød Nils-Otto
Published: January 2017

Abstract. Sediment thickness (D) was estimated utilizing a publically available well database from Norway, GRANADA. General challenges associated with such databases typically involve clustering and bias of the data material due to preferential sampling. However, if information about horizontal distance to the nearest outcrop (L) is included, does the spatial estimation of D improve? This idea was tested comparing two cross-validation results: ordinary kriging (OK) where L was disregarded; and co-kriging (CK) where cross-covariance between D and L was included. The analysis resulted in only minor differences between OK and CK in terms of absolute estimation error, however CK produced more precise results than OK. All observations were declustered and transformed to standard normal probability density functions before estimation and back transformed for the cross-validation analysis. The semivariogram analysis gave correlation lengths for D and L of approx. 10 km and 6 km. These correlations reduce the estimation variance in the cross-validation analysis because more than 50 % of the data material had two or more observations within a radius of 5 km. The small-scale variance of D, however, was about 50 % of the total variance, which gave an accuracy of less than 60 % for most of the cross-validation cases. Despite of the noisy character in the data material, the analysis demonstrates that L can be used as a secondary information to reduce the estimation variance of D.
The predictability of reported drought events and impacts in the Ebro Basin using six different remote sensing data sets
Authors: Linés Clara , Werner Micha , Bastiaanssen Wim
Published: January 2017

Abstract. The implementation of drought management plans contributes to reduce the wide range of adverse impacts caused by water shortage. A crucial element of the development of drought management plans is the selection of appropriate indicators and their associated thresholds to detect drought events and monitor their evolution. Drought indicators should be able to detect emerging drought processes that will lead to impacts with sufficient anticipation to allow measures to be undertaken effectively. However, in the selection of appropriate drought indicators the connection to the final impacts is often disregarded. This paper explores the utility of remotely sensed data sets to detect early stages of drought at the river basin scale, and how much time can be gained to inform operational land and water management practices. Six different remote sensing data sets with different spectral origin and measurement frequency are considered, complemented by a group of classical in situ hydrologic indicators. Their predictive power to detect past drought events is tested in the Ebro basin. Qualitative (binary information based on media records) and quantitative (crop yields) data of drought events and impacts spanning a period of 12 years are used as a benchmark in the analysis. Results show that early signs of drought impacts can be detected up to some 6 months before impacts are reported in newspapers, with the best correlation-anticipation relationships for the Standard Precipitation Index (SPI), the Normalized Difference Vegetation Index (NDVI) and Evapotranspiration (ET). Soil Moisture (SM) and Land Surface Temperature (LST) offer also good anticipation, but with weaker correlations, while Gross Primary Production (GPP) presents moderate positive correlations only for some of the rainfed areas. Although classical hydrological information from water levels and water flows provided better anticipation than remote sensing indicators in most of the areas, correlations were found to be weaker. The indicators show a consistent behaviour with respect to the different levels of crop yield in rainfed areas among the analysed years, with SPI, NDVI and ET providing again the stronger correlations. Overall, the results confirm remote sensing products’ ability to anticipate reported drought impacts and therefore appear as a useful source of information to support drought management decisions.
Cryostratigraphy, sedimentology and the late Quaternary evolution of the Zackenberg Delta, Northeast Greenland
Authors: Gilbert Graham L. , Cable Stefanie , Thiel Christine , Christiansen Hanne H. , Elberling Bo
Published: January 2017

Abstract. The Zackenberg Delta is located in Northeast Greenland (74°30'N, 20°30'E) at the outlet of the Zackenberg Valley. The deltaic fill at the mouth of the valley consists of a series of terraces (ca. 2 km2) formed during a fall in relative sea level. The modern Zackenberg River has incised through the paleo-deltaic deposits creating exposures (up to 22 m in height) along the rivers banks. In addition, coastal processes have exposed sediments in 4 m – 20 m high coastal cliffs. In 2012, two 20 m long ice-bonded sediment cores were retrieved from within the deltaic deposits. The combination of river and coastal exposures with the analysis of ground ice in these cores permitted the reconstruction of the valley-fill succession and evaluation of the timing and nature of permafrost aggradation. Permafrost in the palaeo-deltaic deposits is predominantly epigenetic and aggraded following the subaerial exposure of the delta plain (beginning ca. 11 ka). The exposed deposits in the Zackenberg Valley provide a unique opportunity to investigate the relationship between depositional environments and processes, grain-size properties and cryostratigraphy in epigenetic lowland permafrost environments.
Post-merger Integration Approaches: Case Analysis of the One. Vip Macedonia Merger
Authors: Stevcevska Srbinoska Dusica , Smokvarski Edi
Published: January 2017

Selecting the best integration approach is a meticulous and sensitive process that can mold the completion of the merger and/or acquisition transaction. In this paper, I discuss that implementing the proper integration approach leads to mitigating or increasing impending risks when going into major company restructuring events. If proper selection and execution takes place, and all related processes and expectations of the parties involved are duly taken into account, successful post-merger integration can be concluded in the Republic of Macedonia in spite of numerous difficulties. One of the greatest risk factors certainly lies in the satisfaction or dissatisfaction of the work force which is of vital meaning for the operational excellence of every entity. Three different integration approaches - absorption, symbiosis, and preservation - are observed through literature overview and particular transactions. Additionally, I study the example of the integration approach adopted by one. Vip doo Skopje following the merger of Vip operator dooel Skopje and ONE in 2015, accentuating that multiple factors can increase or deteriorate the chances of integration success.
Pre-tenures remain survival wise: How to survive your first year in a tenure-track nursing faculty position
Authors: Newman Kristine
Published: January 2017

Objective: There are many challenges when starting a nursing tenure track position. This experience exchange paper reflects on a pre-tenured faculty member’s experience during their first year in their position in a university setting.Methods: Tips for surviving the first year of a pre-tenured faculty position using Grylls’ four survival priorities are reflected. Bear Grylls’ advice for outdoor survival adventures can be applied to academia.  The survival priorities of Protection, Rescue, Shelter and Water (Food) (or Pre-tenures Remain Survival Wise) are discussed in terms of knowledge gained, development of relationships and the pursuit of opportunities and resources available.Results: It is essential to maintain a positive attitude and learn as much as possible to launch an academic career successfully. Practical tips are explored and exchanged.Conclusions: It is important contemplate in this academic survival scenario, enacting in nursing tenure-track position, the concept of the Darwinian theory of evolution. Reminding us the continued existence of organisms that are best adapted to their environment, with the extinction of others who are not. There is a need to be flexible, resourceful and open-minded when entering academic position.
Baccalaureate nursing students’ confidence on patient safety
Authors: Raymond June M. , Medves Jennifer M. , Godfrey Christina M.
Published: January 2017

High rates of patient safety events led to media attention and litigation that sparked the patient safety movement. Gaining awareness of nursing students’ confidence levels on patient safety will reveal their perceptions of their competency. A quantitative descriptive cross-sectional method was employed. The Health Professional Education in Patient Safety Survey was used to determine how 458 baccalaureate nursing students from two nursing programs in Ontario, Canada rate their confidence levels on patient safety. Nursing students are the most confident on Clinical Safety topics and least confident on topics related to Human and Environmental Factors and Culture of Safety. Overall, they are more confident in the classroom than in the clinical settings with fourth year students expressing lower degrees of confidence on many of the areas. Education programs need to reinforce patient safety and educate students on their responsibilities to protect patients/clients. Programs need to target strategies to reduce student fears, promote error reporting, and system improvements.
Heterotopic Ossification in Acetabular Fracture Surgery
Authors: Firoozabadi Reza , Alton Timothy , Sagi Henry Claude
Published: January 2017

Heterotopic ossification (HO) is a common complication of the surgical treatment of acetabular fractures. HO is the formation of trabecular bone in soft tissues where bone does not usually occur. Over the last decade, many risk factors have been identified for HO after surgical fixation of acetabular fractures; however, prophylaxis and treatment of this condition are controversial. Potential preventive measures range from NSAIDs to external beam irradiation, but recent studies have questioned the utility of these measures. The Brooker classification system, which has been correlated with patient function and outcomes, is most commonly used to describe HO severity. Advances will assist in the diagnosis, prevention, and management of HO as well as the assessment of risk factors that could affect outcomes.
Student Attraction, Persistence and Retention in STEM Programs: Successes and Continuing Challenges
Authors: Sithole Alec , Chiyaka Edward T. , McCarthy Peter , Mupinga Davison M. , Bucklein Brian K. , Kibirige Joachim
Published: January 2017

Low student enrollment and high attrition rates in Science, Technology, Engineering, and Mathematics (STEM) education are major challenges in higher education. Many STEM entrants end-up switching their majors to non-STEM fields, perform poorly relative to their peers in other programs, and/or drop out of college without earning any academic qualification. Therefore, it is important to examine strategies for reducing attrition in STEM programs. This paper reviews the major factors impeding student interest, success, and persistence in STEM programs, and current institutional practices aimed at addressing these issues. Suggested institutional strategies to improve persistence in STEM programs and their implications that are discussed in this paper include: provision of orientation programs, adoption of early warning systems, Mathematics review sessions, creation of student learning communities, professional development of faculty, as well as collaborative and outreach programs. It is hoped that this review will encourage debate toward solving the major challenges facing STEM education.
Social Cues-Customer Behavior Relationship: The Mediating Role of Emotions and Cognition
Authors: Nusairat Nawras M. , Akhorshaideh Abdel Hakim O. , Rashid Tahir , Sahadev Sunil , Rembielak Grazyna
Published: January 2017

This paper investigates the effect of social cues in a mall’s shopping environment on customer behavior. Two competing mediation scenarios are assessed: emotion-cognition and cognition-emotion in a stimulus-organism-response (SOR)-based framework. Although the role of social cues in driving customer behavior in shopping contexts is largely addressed in the extant literature, the mechanism of the effect is still under-researched area and this study is an attempt to fill this gap.The conceptual model is validated through a questionnaire survey of 1028 shopping mall customers from three cities in Jordan. Two different conceptual models are tested. The analysis reveals that the cognition-emotion mediated model is more robust in predicting the effect of social cues than emotion-cognition mediated model. The findings indicate that a) social cues have a significant positive effect on customers’ emotion of pleasure; cognition; and behavioral response; and b) only pleasure and cognition mediate the effect of social cues on customers’ behavioral response.Theoretically, this study provides a comprehensive understanding of the mechanism by which customers’ emotions and cognition mediate the effect of social cues on customer behavior; and practically, it asserts the significance of social cues as a marketing tool.
The Impact of Stakeholders on Health Services Development: An Empirical Investigation on the Surgical Department at King Fahd General Hospital, Saudi Arabia
Authors: Ahmad Ala’Eddin Mohammad Khalaf
Published: January 2017

The current research investigates the stakeholders influencing health services development at King Fahd General Hospital KFGH in Jeddah city, Saudi Arabia. This study proposes and tests a six factors model that influences health services development. These factors include government regulations, competitors, suppliers, patients, public, and health service providers as independent variables; the dependent variable is health services development. In order to explore this issue, a quantitative method was used to collect primary data through a questionnaire, which was administered in KFGH in Jeddah city in Kingdom of Saudi Arabia. The researches targeted 141 surgeons in this research as a sample because of the small population. A purposive sample was used to choose the participants in this research. The research retrieves 130 valid questionnaires; representing 92%.The results confirm significant differences in the influence of these factors on health service development. The research concludes that there is a significant influence of governmental regulations, competitors, suppliers, patients, public, and health service providers on health services development. The research recommends enhancing the awareness of stakeholder factors by studying the effects of governmental regulations, competitors, suppliers, patients, public, and health service providers. The last is adopting and updating medical and non-medical technology to maintain health service development.
Aanbestedingsrechtelijke uitsluitingsgronden en het mededingingsrecht: wat moet een mededingingsjurist weten van de mogelijkheden tot uitsluiting in het aanbestedingsrecht?
Authors: Esssers Maurice , Fröger Robert
Published: January 2017

Aanbestedingsrechtelijke uitsluitingsgronden en het mededingingsrecht: wat moet een mededingingsjurist weten van de mogelijkheden tot uitsluiting in het aanbestedingsrecht?

Met de per 1 juli 2016 geïntroduceerde wijzigingen van de Aanbestedingswet 2012 is het kader voor aanbestedingsrechtelijke uitsluitingsgronden gewijzigd. In dit artikel staan de uitsluitingsgronden centraal die voor beoefenaars van het mededingingsrecht relevant zijn. Met name wanneer ACM boetes oplegt wegens overtreding van (sectorspecifieke) regelgeving, gaan deze uitsluitingsgronden in latere aanbestedingen een rol spelen. Aspecten van een besluit die een impact hebben op de aanbestedingsrechtelijke kansen van ondernemingen zijn onder meer: de duur van de overtreding, de aard van de overtreding, de wijze van afdoening, de rechtspersonen waaraan de overtreding wordt toegerekend, de publicatiedatum en de mate van verwijtbaarheid.
Introduction to the debate: How much regulation do we want or need?
Authors: Burke Derek
Published: January 2017

We in Britain have seen lots of headlines about over-regulation; for example, one headline reported Europe's top motor industries bosses telling the President of the European Commission that doing business in Europe meant extra costs because of 'increasingly dense, complex and often conflicting regulations'. So how much regulation do we want or need, for we also know that absence of or inadequate regulation can have serious consequences? We do not need to be reminded about what happened over thalidomide, or more recently over the presence of the red dye Sudan 1 in some foods.
The DNA/RNA market to 2010
Authors: Belsey Mark , Pavlou Alex K
Published: January 2017

The DNA/RNA market is currently at an early stage of development, with only two marketed products that together generated an estimated US$30m in 2004. The launch of Pfizer/Eyetech's ophthalmological aptamer Macugen (pegaptanib) is set to help power market growth to US$1.2bn by 2010. Of the 229 active DNA/RNA programmes identified by Datamonitor, oncology currently dominates the therapeutic focus, while antisense and gene therapies dominate the technological focus.
Financial accounts reports
Authors: Aaronson Colin
Published: January 2017

Serono International SA is one of the world's largest biotechnology companies with sales in 2004 of almost US$2.5bn made in over 90 countries. The company presently has eight biotechnology products and operates in four market areas: neurology, reproductive health, growth and metabolism, and dermatology. Serono's shares are traded on the Swiss Exchange as well as the virt-x exchange and its American depositary receipts (ADRs) are traded on the New York Stock Exchange. Its results were released on 1st February, 2005. The company has its headquarters in Geneva.
Kinik: Raising the stakes for importing products derived from US patented processes practised abroad
Authors: Familant Scott B
Published: January 2017

This paper analyses the recent ruling in Kinik Co. v. Int'l Trade Comm'n, 362 F.3d 1359 (Fed. Cir. 2004), and the impact that decision may have on proceedings before the US International Trade Commission under the Tariff Act of 1930 (19 USC Â§1337(a)) â€“ particularly those concerning the importation of products derived from practising US patented processes abroad.
Legal and regulatory update
Authors: Wilkinson John , Dorey Frederick J
Published: January 2017

The Human Tissue Act received royal assent on 15th November, 2004, but its provisions will not come into force until the Secretary of State makes relevant orders by statutory instrument, which is expected to happen after 1st April, 2006. The Act will repeal and replace the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989. Pressure to introduce new measures arose following the public scandal surrounding the retention and use of organs and tissues from children at the Bristol Royal Infirmary and the Royal Liverpool Children's Hospital, without proper consent. The purpose of the Act is to set up a framework that makes consent the foundation of all lawful activities involving whole body donation and the removal, storage and use of human organs and tissues for transplantation, anatomical examination, education, training and research. The Act does not cover gametes or embryos outside the human body, activities in relation to which are governed by the Human Fertilisation and Embryology Authority. Nor does the Act cover the removal of material from living persons, although it does cover the storage and use of such material. The current law relating to removal of material from living persons without their consent will continue to apply.
What to do when your technology is good but a licence is terminated
Authors: Cox Manon , Adams Dan
Published: January 2017

One of the biggest challenges in the biotech industry is to secure sufficient funding to support product or technology development. Partnering with companies that have cash and expertise â€“ which, for the most part are larger biotech or pharmaceutical industries â€“ may for many small biotech companies be more appealing than dealing with the financial community â€“ venture capitalists and the like. The risk to the small biotech, however, is enormous because the partner may decide to return the rights to the product. This event usually leaves the product in limbo and the technology used to develop it tainted because of uncertainty regarding the real reasons for the return and the assumption in the world at large that there is something wrong with the product/technology. Thus, the licensor is left in the dark and is faced with 'what's next?' Here our company's strategy to overcome the terminated licence disaster or alternatively to take advantage of the terminated licence opportunity is described.
Bioterrorism and bioethics: Challenges for industry, government and society
Authors: Meslin Eric M
Published: January 2017

The emerging threat of bioterrorism raises important challenges for the biotechnology industry. Not only do new ethical issues arise for companies seeking to take advantage of opportunities for product development; so too must industry continue to grapple with longstanding issues that arise from advances in human genetics and medical research. No longer will it be sufficient to focus bioethical attention only on whether the 'ethics' of a clinical trial is as good as the 'science' (an important justification for pharmaceutical and biotechnology research). The threat of bioterrorism requires that economic, political and ethical considerations be given increased attention.
Research collaboration and development of intellectual property with the University of Southampton in the field of asthma and COPD
Authors: Holgate Stephen , Edwards Sue
Published: January 2017

The University of Southampton, one of the UK's top ten research universities, has an active enterprise agenda encompassing commercial licensing, spin-out creation, commercial research collaboration, consultancy and staff development. Southampton aims to be a recognised world leader in its interactions with industry while maintaining the ethos of a leading academic centre of research and teaching excellence. This paper explores the creation of and ongoing relationship between Southampton and Synairgen plc, a spin-out from the University founded on its expertise in the field of asthma and COPD, as a case study of the benefits and balances to be found between academic, enterprise and corporate agendas.
Bioethical concerns in Japanese biotechnology companies
Authors: Kato Makina , Macer Darryl
Published: January 2017

Analysis of responses from a 2003 survey of 304 Japanese biotechnology companies found that 93 per cent responded that they had never had a bioethical problem related to biotechnology in their company but 31 per cent did expect to have some kind of problem in the future while 26 per cent already had systems in place to deal with these issues. The open responses to all these questions are presented and discussed. Specific issues raised by the companies concerned problems related to dealing with human samples, clinical trials, animal experiments and public reaction to their research/business. Concerns about future problems relating to intellectual property rights (IPRs) were not raised by any of the companies. A number of different systems were in place to deal with bioethical issues although some companies said they did not need any specific system to deal with any problems which might arise.
Spin-out fever: Spinning out a University of Oxford company and comments on the process in other universities
Authors: Savage Bruce
Published: January 2017

University spin-out companies are increasing seen as a favoured route for commercialisation of university intellectual property. There has been criticism in the Lambert Review of Businessâ€“University Collaboration in 2003, commissioned by the UK Government in 2003, that there have been too many spin-outs of low quality and that a measure of quality is the amount of external equity they attract. This has been refuted by Dr Williams of the University of Warwick technology transfer office. Oxford University has created 42 companies with no failures. The rigorous process involved in the creation of an Oxford spin-out is given in some detail. The author then goes on to discuss his experiences of other university spin-out models. Finally, some of the tax problems that caused universities across the UK to stop spinning-out companies recently are discussed. In conclusion despite the criticisms, the author believes the process of creating companies to commercialise university R & D is critical to the overall success of UK plc in the long term.
Autoimmune and inflammatory disorder biologicals will power biotech market growth through to 2010
Authors: Churchill Clare A C , Belsey Mark J
Published: January 2017

Biologicals designed to treat arthritis, immune and inflammatory disorders (AIID) are currently powering biotechnology market growth. Datamonitor's biotechnology strategic market analysis team has therefore analysed this market to identify key biological products, together with growth drivers and resistors shaping the growth of this market. The AIID market covers a wide range of indications; however, the most prevalent are rheumatoid arthritis and psoriasis, which together represent a significant healthcare burden. A range of monoclonal antibody therapeutics such as Abbott/CAT's Humira are set to drive AIID biological market growth, together with Amgen/Wyeth's fusion protein Enbrel. Owing to very strong sales of Enbrel as a result of continued label expansion, Amgen is set to record the greatest biological AIID sales from 2004 to 2010. Many of the highly efficacious AIID biologicals such as Enbrel target TNF, which is rapidly emerging as the leading cytokine target for many AIID indications. Overall, AIID biologicals generated US$5.4bn in 2004, and this is set to rise to US$14.3bn by 2010: a strong compound annual growth rate of 17.9 per cent.
Ticking time bomb: Poorly managed product safety
Authors: Meline Greg , Albani Chris
Published: January 2017

A key paradigm of the pharmaceutical industry has changed. With increased attention towards ensuring the safety of drugs and medical devices, the ability of firms to conduct risk management based on high-quality pharmacovigilance (PV) â€“ starting early on in clinical development â€“ is becoming increasingly important to the successful marketing of pharmaceutical products. Indeed, the repercussions of recent litigation regarding the Cox-II class of compounds are just an example of how safety management will continue to impact the marketability of both existing and future drugs and medical devices. Firms without satisfactory safety data handling and reporting operations in place are now vulnerable to significant business risks with potential long-term drug safety issues. While this has often been considered a necessity, a small proportion of companies have actively pursued excellence in this area. Companies are taking different approaches to address the increasing demands in this area â€“ from focusing on efficiency to driving higher levels of rigorousness in their PV practices. PRTM various has identified a number of key practices common among firms demonstrating excellence within PV. Results of a pioneering study of 23 top Western and Japanese pharmaceutical companies confirm that, overall, the industry has yet to achieve both a high-level of quality and productivity in firms' PV operations. As the burden for conducting efficient, effective PV becomes increasingly difficult, senior management will seek targeted improvement strategies in order to balance a high level of efficiency with a high level of rigorousness among their safety data handling practices. With this in mind, this article seeks to demonstrate how a company can most effectively comply with ever-changing requirements, strategically improve the thoroughness of the practices within their PV operations and achieve greater efficiency. In addressing these challenges, top management will be focusing a greater amount of attention on one more thing â€“ pharmacovigilance.
Cancer remains the dominant disease target for biotech through to 2010
Authors: Pijpers Fleur , Belsey Mark J
Published: January 2017

The two leading therapeutic areas for biological products, in terms of current sales and pipeline focus, are oncology and AIID (arthritis, immune and inflammatory disorders). Datamonitor's biotechnology strategic market analysis team recently analysed the AIID market, since this sector is currently powering biotechnology market growth, owing to high demand for biologicals to treat rheumatoid arthritis and psoriasis (Belsey, M. and Churchill, C. (2006) 'Autoimmune and inflammatory disorder biologicals will power biotech market growth through to 2010', J. Comm. Biotechnol., Vol. 12, No. 2, pp. 237â€“241). In the current paper, we have analysed the oncology market, since biologicals designed to treat cancer indications have underpinned the development of the biotechnology market since its inception in the 1980s. Biological products treat a wide variety of cancers, of which the most prevalent are the 'big four' tumour types â€“ breast cancer, lung cancer, prostate cancer and colorectal cancer. In terms of technology focus, both monoclonal antibody therapeutics and recombinant proteins are set to drive cancer biological market growth. Key growth drivers include mainly Genentech and Roche products, such as Avastin (bevacizumab), Rituxan (rituximab) and Herceptin (trastuzumab), as well as Amgen products, including the second-generation recombinant proteins Neulasta (pegfilgrastim) and Aranesp (darbepoetin alfa). Across the major pharmaceutical markets, oncology biologicals generated US$10.7bn in 2004 (based on company-reported data), which Datamonitor forecasts to rise to US$29.0bn by 2010.
When is patent infringement not patent infringement? Merck v Integra and the 'safe harbour'
Authors: Boyd Karen I
Published: January 2017

The Supreme Court recently ruled on the scope of the patent infringement 'safe harbour' of 35 U.S.C. Â§271(e)(1), which was passed by Congress in 1984 to allow generic drug manufacturers to test their drugs before the expiration of the patents that covered the drugs. The scope of the safe harbour has been interpreted by the courts to be much broader than that, and the Supreme Court confirmed the breadth of the exemption. The Supreme Court did not, however, address the application of the safe harbour to research tools, an issue of vast commercial importance. This paper traces the history of the safe harbour and the Merck v Integra decision, and explains the current state of the law and where the law may be going.
Media coverage and biotechnology IPOs: Some Australian evidence
Authors: Jens Paul , Brooks Robert , Nicoletti Gina , Russell Roslyn
Published: January 2017

This paper analyses Australian biotechnology initial public offerings and the role of media coverage during the issue period in explaining capital raising, sentiment and underpricing. This paper finds empirical support for the hypothesis that an issuing company that receives more press coverage during the listing process leaves significantly more money on the table than those who receive less coverage, a finding consistent with the presence of sentiment effects and hot issue periods.
Increased uptake of biologics in historically small molecule blockbuster-dominated therapeutic areas
Authors: Emerton Duncan A N , Belsey Mark J
Published: January 2017

The two leading therapeutic areas for biologic products, in terms of current sales and pipeline focus, are oncology and AIID (arthritis, immune and inflammatory disorders). Datamonitor has recently analysed these markets.1, 2 Biologics designed to treat cancer indications have underpinned the development of the biotechnology market since its inception in the 1980s, while AIID biologics are currently driving biotechnology market growth, due to the high demand for biologics to treat diseases such as rheumatoid arthritis and psoriasis.In this paper, we have looked outside these markets to identify whether biologic drugs are having an impact in other therapeutic markets. Many of these therapeutic markets (eg cardiovascular, central nervous system, respiratory, gastrointestinal) are dominated by small molecule blockbusters prescribed by primary care physicians. Here, we examine the cardiovascular therapeutic franchise as a case study for a market that has relied heavily on small molecule blockbusters to drive growth, and in which there is relatively low exposure to biologics.Marketed and pipeline cardiovascular biologics can largely be split into two categories: (i) early-evolution versions of drugs from mature biologic sectors (eg first-generation recombinant proteins and chimeric monoclonal antibodies), which are in the mature low-growth stages of their sales growth trajectories; and (ii) early-stage therapies based on innovative biologic technology platforms (eg gene therapies and oligonucleotides), which have the potential to help power cardiovascular franchise growth in the future. With the identification of more protein targets that play a role in specific disease aetiology, targeted therapies are set to power overall market growth. While companies operating in the oncology and AIID franchises are best equipped to use a targeted therapy strategy, franchises such as cardiovascular are beginning to awaken to the potential of a targeted therapy approach.
Decision-making associated with drug candidates in the biotechnology research and development (R&D) pipeline
Authors: Skrepnek Grant H , Sarnowski Jeff J
Published: January 2017

This research investigated the issues and methods of analysis considered by executives when managing biotechnology drug candidates within the research and development (R&D) pipeline. A mail survey was developed to assess: (1) factors considered during clinical trials; (2) sources of funding for R&D; (3) analytic tools used in decision-making; and (4) the use and application of pharmacoeconomics, and targeted primarily Chief Financial Officers (CFO) within 396 biotechnology firms in the United States (US). Consistent with prior research on CFOs, a response rate of 7.5 per cent was achieved and respondents generally represented smaller biotechnology companies valued below US$100m. Findings indicated that regulatory and capital requirements as well as investor expectations were important factors throughout clinical phase trials. Venture capital and capital/securities markets were the most commonly used sources of R&D capital. The most frequently cited decision-making techniques used included prior experience/intuition/human judgment, net present value (NPV), and internal rate of return (IRR). Pharmacoeconomic methods were utilised at every stage of R&D and applied to the management of R&D pipelines in addition to aspects of product pricing and reimbursement. Overall, these results reflect the nature of risk and uncertainty associated with pharmaceutical and biotechnology R&D. Although the use of past experience/intuition/human judgment was most common for decision-making, methods based upon discounted cash flow (DCF) approaches were also employed frequently, as was the use of pharmacoeconomics. The implications of this work should seek to catalyse the development and utilisation of robust methods to manage drug pipelines such that senior executives are afforded optimal recommendations when attempting to hedge risk and maximise return.
International Trade and Policies for Genetically Modified Products
Authors: Kowalski Thomas
Published: January 2017

International Trade and Policies for Genetically Modified Products RE Evenson and V Santaniello (Editors) CAB International Publishing, Wallingford, UK; ISBN 0 851 199 056 8; March 2006; 244 pp
Biotechnology: The underutilised tool in the fight for global health and security
Authors: Sunderland Anne
Published: January 2017

Biotechnology companies can contribute to developing new treatments for diseases of thedeveloping world without losing money or converting to charity.
Constructing a processual model of communication in new product development from a multiple case study of biotechnology SMEs
Authors: Frahm Jennifer , Ireland David C , Hine Damian
Published: January 2017

For most companies in the biotechnology industry, the core business is new product development (NPD). Indeed, there are still very few companies that have products that have reached the market. Research into NPD in biotechnology companies has largely focussed on success factors rather than the processes of NPD. One area receiving limited attention is the role of organisational communication in NPD. The authors of this study address this oversight in undertaking a multiple case study analysis of internal and external communication in NPD processes in biotechnology. The resultant framework for communication in NPD in biotechnology companies combines both structural and processual elements of communication. The authors found that the process of communication in NPD is essentially an information seeking and uncertainty reduction activity that occurs through both the internal and external environments of the firm. The framework is a hybrid of cross-functional, decision stage and network models.
Intellectual property issues in nanotechnology
Authors: Genieser Lars , Gollin Michael
Published: January 2017

Emerging nanotechnologies have the potential to impact a wide range of commercially important bioscience and medical applications. For example, researchers are developing nanoscale materials as diagnostic probes and targeted therapeutic delivery vehicles. By filing patents, companies can protect their intellectual property and leverage their developments over the marketplace in a way that is consistent with antitrust laws. Policies and doctrines of the US Patent and Trademark Office pertaining to nanotechnology continue to develop. Companies must be aware of challenges and strategies particular to nanotechnology in seeking patents in order to maximise the value of their innovations.
Bioentrepreneurship education programmes in the United States
Authors: Meyers Arlen D , Hurley Patrick
Published: January 2017

In this first paper of a new regular column, Arlen Meyers and Patrick Hurley review the different bioentrepreneurship education programmes available in the United States and suggest some of their critical success factors.
Some ethical issues in biotechnology involving animals
Authors: Morton David
Published: January 2017

Biotechnological discoveries have given rise to ethical issues, particularly concerning the welfare of animals and the protection of the environment with regard to other animal species. This paper argues that protection of animals and the environment matter most, and that if human beings have the right motivation and intention, then the right actions will follow.
Biotechnology business models work: Evidence from the pharmaceutical marketplace
Authors: Glick J Leslie
Published: January 2017

A study was undertaken that validates the business models of biotechnology companies that compete in the pharmaceutical marketplace. Strategic alliances, largely with established pharmaceutical companies, have enabled biopharmaceutical companies to obtain revenues prior to achieving their goal of manufacturing and marketing their own products. As a result, despite the generally long lead-times to commercialisation, an increasing number of biopharmaceutical companies are demonstrating financial success in the marketplace, particularly with respect to revenues, at a faster pace than occurred for both the traditional pharmaceutical and the specialty pharmaceutical companies. There were 244 biopharmaceuticals approved for 366 indications from 1982 to 2005, of which 48 per cent of the approvals for both the products and the indications occurred in the period 2001â€“2005 (representing just 21 per cent of the 24-year period). From 1990 to 2005, the ten largest US biopharmaceutical companies increased their total revenues from $1.1bn to $31.7bn and turned a combined loss of $0.3bn to net income of $6.2bn. During this time-frame the number of US biopharmaceutical companies reporting revenues in excess of $1bn increased from zero to eight.
Export compliance for life sciences
Authors: Avellanet John
Published: January 2017

Long before worrying about US Food and Drug Administration compliance, organisations that work with foreign employees, contractors, vendors or partners need to be concerned with the importation and exportation of technological knowledge â€“ the so-called â€˜deemed exportsâ€™. This is particularly apt for executives in the biopharmaceutical, biotechnology and medical device fields who outsource research and development overseas or who hire non-US citizens. US export regulations have strict guidelines on the types of knowledge that cannot be shared with non-US citizens and carry harsh penalties for non-compliance that fall equally on the organisation in question and its executives who ought to have known better. This paper presents an eight-step strategy to develop a regulatory compliance programme that meets US export compliance regulations.
Can compliance help marketing and business development?
Authors: Avellanet John
Published: January 2017

In many FDA-regulated companies, the marketing and business development departments have a quietly antagonistic relationship with their quality and regulatory affairs colleagues. While compliance is supposed to ensure that a safe, efficacious and high-quality new product reaches the marketplace, marketing and business development executives are left to grumble: how are consumers â€“ much less partners and investors â€“ supposed to learn about and get excited about a new product if their work is so constricted? This paper suggests that there is a way to turn compliance from the millstone around Marketing's neck to the whetstone that helps hone a sharper competitive edge. HydroGel Burn Products tackled that question by shifting quality and regulatory affairs further upstream in their product development process to a point where to be overly restrictive was to stop development altogether; in other words, to a point where the focus had to be on finding a way around obstacles. The results pleased investors, partners, customers and marketers alike.
Pharmaceutical patents after KSR: What is not obvious?
Authors: Lief Jason , Schuyler Peter
Published: January 2017

The Supreme Court recently revisited the question of patent validity based upon obviousness in KSR Int'l v Teleflex, Inc. The court rejected the Federal Circuit's rigid application of the â€˜Teaching, Suggestion, Motivationâ€™ test in determining the obviousness of patent claims, and reasserted its precedent regarding obviousness, beginning with the seminal 1852 HotchKiss decision. The decision arguably makes it easier to invalidate patents for obviousness. This paper analyzes the effect of KSR on the state of the law concerning the obviousness of pharmaceutical and biotechnology patents in the Federal Circuit and District Courts.
Building the future biotechnology workforce: A University of Houston model
Authors: Iyer Rupa S , Fitzgibbon William E
Published: January 2017

The field of biotechnology has become more quantitative and interdisciplinary as research in biotechnology continues to grow at a tremendous rate with broader and complex applications in medicine, agriculture, the environment and nanobiotechnology. The tremendous research in recombinant DNA technology has profoundly transformed the way biologists design, perform and analyze experiments. As biological concepts and models become more quantitative, biological research will be increasingly dependent on concepts and methods drawn from other scientific disciplines. Therefore, in order to prepare our undergraduate life science students to be future research scientists, we need to transform undergraduate education. This will require life science majors to develop and reinforce connections between biology and other scientific disciplines so that interdisciplinary thinking and work becomes second nature. With the integration of new technologies in biological research, biology will continue to become more interdisciplinary and will present a challenge for higher institutions that are training future biologists. This paper describes the development of a new undergraduate interdisciplinary research-based biotechnology degree programme offered by University of Houston College of Technology that addresses issues and challenges in biotechnology education.
China 10-Point Patent Checklist: Integrating patents into an overall business strategy for a Western manufacturing entity in China
Authors: Sun Catherine , Barner Sharon R , Wegner Harold C
Published: January 2017

The protection of intellectual property (IP) involved with manufactured goods comprises many aspects: Without even touching upon patents, these aspects include trade secrets and trademark protection, both very important in the classic protection of a pioneer manufacturer's product line and reputation. Yet it is well known that in China, Western companies have had challenges using trade secrets to safeguard IP. Trademark protection also has weaknesses, particularly as competitors often use Chinese marks that are very similar to the trademark â€“ a situation that is difficult to control with typical trademark remedies. The China 10-Point Patent Checklist (Checklist) provides only starting points or guidelines for technology-based outsourcing operations â€“ including biotechnology companies â€“ doing business in China. The Checklist does not address comprehensive enforcement strategies such as deciding where to bring an action: in the United States (or Japan, Germany or another applicable importing country) under Western laws and Western patents, in China itself or in both countries.
Bioscience enterprise: Postgraduate education at Cambridge and Auckland
Authors: Allan Linda , Kistler Joerg , Lowe Chris , Dunn Wendell , McGowan Claire , Whitcher Geoff
Published: January 2017

Leading universities around the world are addressing the demand for science-business-skilled professionals with a variety of novel programmes. The University of Cambridge (the United Kingdom) and University of Auckland (New Zealand) have each developed a Master's in Bioscience Enterprise programme providing specialist business and legal skills relevant to employment in the bio-economy. The biotechnology contexts in which these programmes were developed are significantly different and are reflected in the internship choices, thesis topics and postgraduate employment opportunities. In each case, industry feedback has been excellent to date as evidenced by the increasing engagements of companies in these programmes.
Innovate America: The Technology Innovation Program at NIST
Authors: Klein Andrew S , Chapekar Mrunal S
Published: January 2017

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