bluuebunny/crossref_metadata_2025 huggingface dataset:
Human cell- and tissue- based products: Progress, promise and regulatory issues
Authors: Brown Phil , Dombal Greg , Dornbusch Daniel , Eslami Behruz , Lawton Alison , Stewart Susan , Vasconcelles Michael , Tambuyzer Erik
Published: January 2017

The field of cell- and tissue-based products is radically changing through the use of biotechnology. The authors outline developments that are currently taking place, leading to the need for adapted regulations, for which worldwide harmonisation is important since potential safety issues have no borders and companies operate globally. Potential ethical issues need to be discussed and resolved within society in an open and transparent way.
Patient access to innovation: Biopharmaceuticals, 4th hurdles and socioeconomic issues
Authors: Rappagliosi Andrea
Published: January 2017

Biopharmaceuticals and innovative therapeutic solutions offer treatments that are increasingly tailored to patient needs. Although biotechnology has produced health benefits, biopharmaceutical products require resources that governments had not planned or budgeted for in the appropriate time frame. As a result, economics has entered the healthcare arena without taking a number of important societal concerns into account. More specifically, several governments have introduced procedures to evaluate the cost-effectiveness of newly approved medicines. Unfortunately, patient access is not an equation of public budget figures, but an equation of government priorities. Therefore, this paper describes the limits of traditional pharmacoeconomic evaluations particularly when applied to innovative biopharmaceuticals and offers solutions to the questions they pose.
Festo A patent applicant's plague
Authors: Brown Scott M , Familant Scott B
Published: January 2017

This paper highlights some of the intricacies and complexities associated with patent drafting, particularly in unpredictable sciences such as biotechnology. The paper draws on the new guidelines issued by the Patent Office regarding compliance with the 'utility' and 'written description' requirements of the Patent Statutes to illustrate some of the thorny issues applicants must thoughtfully consider during drafting as well as the pitfalls applicants will encounter when failing to do so. The paper then reviews the recent decision in Festo Corp. v Shoketsu Kinzoku Kogyo Kabushiki Co, Ltd to underscore how a lack of forethought can result in the issuance of claims that provide a compromised scope of protection.
Practical and legal preparation for young companies seeking technology transfer
Authors: Newiss Hilary , Horton Audrey
Published: January 2017

This paper looks at the basic law of intellectual property as it applies to a small biotechnology company or start-up. It focuses on the systems and attention to paperwork required so that the company can maximise its intellectual property protection.
A civic duty
Authors: Sime John M
Published: January 2017

Â Â
Emerging issues in research tool licensing
Authors: Bersin Brent , Bratic Walt , McLane Patrick
Published: January 2017

This paper presents a brief examination of the current trends and issues in the licensing of patented research tools, as well as perspectives on 'reach through' licensing of research tools.
EU Financial accounts reports
Authors: Citron David
Published: January 2017

Presents updates on the 2000 financial results of several biotechnology and pharmaceutical firms in Europe. Celltech Group Plc; ML Laboratories plc; Pharmagene plc.
Book Review: The Biotechnology Revolution in Global Agriculture: Invention, Innovation and Investment in the Canola Sector
Authors: Cook Jeremy Curnock
Published: January 2017

The Biotechnology Revolution in Global Agriculture: Invention, Innovation and Investment in the Canola SectorPeter W. B. Phillips and George G. Khachatourians (eds)
Fast track clinical development for treatments for cancer
Authors: Steiner Jan
Published: January 2017

Comments on the fast track guidance from the U.S. Food and Drug Administration on the treatment of cancer, as of January 2002. Significance of fast track applications to the treatment of cancer; Details of the guidance; Factors that contribute to the fast track approval of a drug; Pros and cons of the fast track development.
A precautionary approach to genetic modification
Authors: Lubbock Mark , Coop Andrew
Published: January 2017

Presents a study that discussed the development of a new legal regime for the deliberate release of genetically modified organisms (GMO) into the European environment, as of January 2002. Information on the Precautionary Principle requirement of the existing regime; Assessment of the possible effect of the Precautionary Principle on decisions about GMO releases; Implications for the expectations of consumers regarding genetically modified products.
Dealing with liability issues in biotechnology contracts
Authors: Smith Simon J
Published: January 2017

Presents a study that analyzed the principles built up by courts in Great Britain concerning liability issues in biotechnology contracts. Discussion on the principles behind exemption clauses; Factors that affect the limitation of liability; Strategies to avoid some pitfalls that many contracting parties encounter when dealing with liability issues.
Strategic management: A tool for growth in the biotechnology sector.
Authors: Muller Christian
Published: January 2017

Presents a study that examined the applicability of traditional tools and concepts abo
Forecasting new product revenues
Authors: McIntyre Lisa
Published: January 2017

This paper discusses real-life experiences in developing revenue forecasts for biopharmaceutical clients. The importance of forecasts based on emerging information about the product, market conditions and the competitive landscape is emphasised.
Intellectual property: The driving force for growth and funding
Authors: Schneider Judith E
Published: January 2017

For most 'bio-entrepreneurs' the science is the easy part -- leveraging that science to create a viable business becomes the real challenge. This paper provides an overview for utilising intellectual property to strengthen a business' attributes, thereby increasing the firm's likelihood of attracting funding and attaining its objectives.
Animal biotechnology: A study of opinions among stakeholder groups in the academic, pharmaceutical and agrifood sectors
Authors: McNeil Sharon , Williams Gwilym
Published: January 2017

The commercialisation of animal biotechnology for use in human medical applications and as food will require the availability of accurate market information. As witnessed in the case of genetically modified plants, a failure to assess market receptivity accurately can have significant ramifications for the biotechnology industry. This paper describes the findings of a survey of attitudes among a scientifically literate audience (predominantly the university and biopharmaceutical sectors) regarding animal biotechnology and associated parameters. As shown in previous studies, the use of transgenic technology for medical applications was found to carry a higher acceptance rating than its use in agriculture. Additionally, the phraseology and terminology used in questions were found to have a measurable effect on influencing respondent replies. The results of the survey are interpreted in the context of transgenic animal technologies currently in development.
New approaches to global health governance: The evolution to publicâ€“private partnerships
Authors: Balcius James , Novotny Thomas E
Published: January 2017

Global health issues that transcend geopolitical borders are altering the nature of global health governance. Sovereign nations are more connected than ever and increasingly exposed to trans-border health risks. Traditional global health governance may not account for involvement of multi-level global health actors such as civil-society organizations, private philanthropies and new intergovernmental alliances. In addition, private entities have engaged with governments to form new publicâ€“private partnerships to further common global health objectives. As these new partnerships evolve, new approaches to transparent and accountable global health governance are necessary to assure effective, equitable and ethical actions addressing global health challenges.
Publicâ€“private partnerships in trust-based public health social networking: Connecting organizations for regional disease surveillance (CORDS)
Authors: Greshama Louise S , Pray Leslie A , Wibulpolprasert Suwit , Trayner Beverly
Published: January 2017

We describe a new trust-based global health security initiative known as CORDS: Connecting Organizations for Regional Disease Surveillance. Initiated and managed by the Nuclear Threat Initiative with support of The Rockefeller Foundation, Fondation MÃ©rieux and the Skoll Global Threats Fund. CORDS is a non-governmental platform to transform dialogue among public health, veterinary and wildlife professionals from multi-country infectious disease surveillance networks. It also links with the World Health Organization, World Organization for Animal Health and other global partners in managing cross-border emerging infectious disease threats and building disease surveillance capacity. The publicâ€“private partnerships of CORDS create a global social fabric and continuity of disease experts based upon trust.
Global governance: Promoting biodiversity and protecting indigenous communities against biopiracy
Authors: Liang Bryan A
Published: January 2017

Many potentially useful medicines arise from developing countriesâ€™ biodiverse environments as well as from indigenous community knowledge. This bioprospecting has become an important strategy in drug discovery and development. However, global intellectual property rules have resulted in biopiracy, where public and private entities have exploited natural and ethnic resources without benefit sharing with indigenous peoples. Sovereign-based approaches have not led to adequate biodiversity management. There is tremendous opportunity for public-private partnerships to fill this void. Coupling pharmaceutical companies with indigenous peoples, civil society organizations, and country academics, long term, trust-based relationships can provide equitable benefits sharing and effective biodiversity management.
Publicâ€“private partnerships in addressing counterfeit medicines: The development of the Partnership for Safe Medicines and the Partnership for Safe Medicines-India
Authors: LaGanga Scott
Published: January 2017

The global drug supply chain has resulted in tremendous vulnerabilities. Despite individual country efforts, both developed and resource-poor countries have experienced tremendous challenges with ensuring safety of the drug supply. In this piece, the formation of a novel publicâ€“private partnership (PPP), the Partnership for Safe Medicines (PSM), is described to illustrate the issues involved in creation of a successful stakeholder-based PPP. It then expands this discussion to the unique concerns when establishing global PPPs, describing the formation of the PSM-India. The formation of these partnerships may guide future efforts to create PPPs to address other public health and patient safety issues.
Recapping Section 48D (qualifying therapeutic discovery project credit) âˆ’ Will it be extended?
Authors: Wynacht Peter
Published: January 2017

Â Â
Notes from the EU
Authors: Kamstra Gerry
Published: January 2017

Â Â
Anatomy of a Patent Case
Authors: Sullivan Michael G
Published: January 2017

Anatomy of a patent caseGeorge F. Pappas â€“ Editor-in-ChiefBNA Books, Arlington USA, 2009, paperback, 202pp., US $ 155.00,ISBN: 978-1570188572Buy this book at Amazon.com
Biotechnology commercialisation in universities of developing countries: A review of the University of Ibadan, Nigeria
Authors: Onyeka Chimdiya Julian
Published: January 2017

The British colonial administration established the University of Ibadan (UI) in 1948 as an extension of the University College London and it became Nigeria's first full-fledged and premier university in 1962. The university comprises 13 faculties and a distance learning programme. Among the university's faculties is one for Science, one for Technology and another for Agriculture and Forestry. These are in addition to the Research Centres which address specific societal needs. The institution boasts of over 20 000 students, 30 per cent of which are postgraduate.
The strength of pharmaceutical IPRs vis-Ã -vis foreign direct investment in clinical research: Preliminary findings
Authors: Pugatch Meir Perez , Chu Rachel
Published: January 2017

This article examines the effect of the intellectual property (IP) environment in developing countries on the level of foreign direct investment (FDI) and technology transfer occurring in the biopharmaceutical field in these countries. In particular, it considers the correlation between the strength of IP protection in several developing countries (using the Pharmaceutical IP Index) and the number of clinical trials taking place in these countries (as a proxy of biomedical FDI). The article finds that overall, the strength of national pharmaceutical IP environments provide a good estimate of the level of clinical trials taking place in these countries. Accordingly, countries with a more robust level of pharmaceutical IP protection tend to enjoy a greater level of clinical trial activity by multinational research-based companies. In other words, by choosing to improve their level of protection of pharmaceutical IPRs (together with other factors), developing countries may also be exposed to higher levels of biomedical FDI, not least in the field of clinical trials.
Some considerations for the implementation of disposable technology and single-use systems in biopharmaceuticals
Authors: Sandle Tim , Saghee Madhu Raju
Published: January 2017

This article, written from an industry perspective, examines the current trend towards the implementation of single-use disposable technologies in the biopharmaceutical and biotechnology sectors. Single-use technologies are generally sterile, plastic disposable items implemented to replace traditional pharmaceutical processing items that require recycling, cleaning and in-house sterilisation. The forces driving the technological change are a mix of process efficiencies (including cost reduction) and sterility assurance. This article examines the advantages of some single-use systems used for aseptic processing, although in doing so a cautionary approach is adopted, particularly with regard to the validation requirements and practical considerations when such technologies are implemented.
Transfer to Africa of the resources and rewards from biotechnology: The need for a participatory approach
Authors: Clarke Belinda R.
Published: January 2017

The low adoption rate of new technologies by rural communities in developing countries in the 1970s and 1980s revealed a need for a different approach to the setting of research agendas and technology transfer. More recent programmes have shown a shift away from 'top-down' researcher-led projects, towards a 'bottom-up' participatory approach. Here, all stakeholders are extensively consulted and local people are actively involved in development initiatives, leading to more focused and community-driven solutions to problems.Recognition of, and long-term investment in, the participatory approach is crucial for any organisation attempting to bring about change at a community level. Commitment at the institutional level is also necessary to make participatory research an integral part of programme design and management, rather than simply a 'bolt-on' to a more traditional mainstream approach.The participatory approach also presents new challenges in terms of changing the mind-sets of researchers, requiring them to consider all stakeholders as valid participants in the programme. The researcher becomes more of a facilitator, empowering the whole community (particularly its most marginalised members) to take ownership of the project.This paper aims to give a general overview of participatory research. It highlights important factors to consider when embracing the participatory approach, as well as discussing the new challenges it presents. Examples and case studies from Africa will demonstrate how greater emphasis on the process of mutual knowledge acquisition and decision making, rather than simply project outcomes, is now forming the basis of many community development projects in health and agriculture.Â
What will it take to get institutional investors interested in life sciences again?
Authors: Brooks William
Published: January 2017

With the European biotechnology market nearing a crisis state, companies must try to attract and maintain interest from institutional investors. In this article, a brief outline of who companies should be trying to appeal to and how these investors view the sector is followed by an assessment of the areas that management must focus on to attract investors. The problems that they must avoid to prevent disappointing investors are outlined.
Pharmacoeconomics and its role in the growth of the biotechnology industry
Authors: Szucs Thomas D , Schneeweiss Sebastian
Published: January 2017

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

The revised CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects supersede the previous 1993 Guidelines and consist of a statement of general ethical principles, a preamble and 21 guidelines with extensive commentaries. The Guidelines provide advice on the implementation in practice of the World Medical Association (WMA) Declaration of Helsinki and are designed to be of use, particularly to low-resource countries, in defining national policies and regulations on the ethics of biomedical research. The Guidelines are available on the CIOMS website.
Current and future prospects for the global biotechnology industry
Authors: Kermani Faiz , Bonacossa Pietro
Published: January 2017

The number of biotechnology compounds has been increasing steadily over the past 20 years, reflecting the key contribution that biotechnology is now making to healthcare. Recombinant DNA technology has been used to develop a number of therapeutic proteins, including antibodies, cytokines, hormones and vaccines for use in tackling and diagnosing a range of disorders. Worldwide there are more than 4,000 specialised biotechnology companies. The most well-known companies are located in the USA and Europe, but there are significant companies emerging in Canada, Australia, New Zealand and throughout Asia â€“ particularly in Japan. Most of these companies are small in size and limited when it comes to finances and this has had an impact on the output of the industry in terms of new drugs.
Integra: The research tool patent revival
Authors: Raubicheck Charles J , White Barry S , Kowalski Thomas J , Brown Daniel G , Leahy Amy , Fekete Pamela
Published: January 2017

There was a question as to the value of research tool patents; for instance, whether practising such patents for preclinical research would be within the research exemption of the US Patent Statute. The Federal Circuit in Integra Lifesciences I, Ltd v Merck kgaA held that the preclinical research in issue was not within the safe harbour of the research exemption, breathing life into research tool patents; but vacated the damages award because it appeared to have been influenced by hindsight knowledge that a valuable drug candidate had emerged. Integra is thus good news and bad news for owners of patents relating to discovery tools.This paper is not to be considered opinions of Frommer Lawrence & Haug LLP or any of the firm's clients; and nothing in this paper is to be considered as legal advice, a substitute for legal advice, or as positions/strategies, etc taken/employed in, or suitable for, any particular case or set of facts.
Editorial
Authors: Burke Derek
Published: January 2017

Â Â
Public-good plant breeding: What should be done next?
Authors: Dale Philip J
Published: January 2017

Plant breeding has played a major role in improving crop production during the past century. From the birth of genetics to the early 1980s plant breeding was driven in the UK mainly by objectives directed primarily to the public good. Since that time most plant breeding has been transferred to the private sector, which must define objectives more narrowly in terms of commercial success. There were significant changes in agriculture over the 20th century, including the use of production subsidies to stimulate increase in crop production. Associated with these changes was a growing public unease about the impact of agriculture on the environment and an increasing dissociation between agriculture and food supply. It is within this context that the UK has recently decided to review whether to proceed with the commercial cultivation of genetically modified (GM) crops. To aid this decision the UK Government has supported a review of the science, economics and public attitudes associated with the decision. As part of this review there has been vigorous campaigning on the topic, which has become polarised and politicised. In considering a future for plant breeding, it is important that we take stock of breeding aims that are directed primarily at meeting public-good and needs-led objectives. Various examples of public-good breeding objectives are discussed. But in meeting future public-good objectives it is important that there is greater honesty and openness in a discussion that values all constructive contributors.
Prospects and Challenges for the Commercialization of Biosimilars: Perspectives from the EU, Japan, and the US
Authors: Brougher Joanna
Published: January 2017

With many blockbuster biologic drugs coming off patent in the next couple of years, biosimilars are making significant breakthroughs in cost-effective biologic therapies. The global market for biosimilars is expected to increase nearly 30 fold from $1.3 billion in 2013 to $35 billion by 2020. To promote biosimilar development and commercialization in the U.S., the Biosimilars Act was signed into law in 2010 to establish an abbreviated pathway by which the FDA could approve biosimilar versions of previously licensed biological products. Since its enactment, two biosimilars have been approved in the U.S. This Article will discuss key aspects of the U.S., the EU and Japanese approval pathways and will explore their likely impact on the commercialization of biosimilar medicines.Â Â
Induced Pluripotent Stem Cells: Inventors turning into competitors
Authors: Devarapalli Pratap , Bhalke Swapnil Laxman , Dharmadhikari Neelam Sudhir , Mishra Vandana , Mago Neha , Deshpande Nishad , Hirwani Rajkumar
Published: January 2017

Induced Pluripotent Stem Cells (IPSCs) are a kind of adult cells that have been genetically reprogrammed to become different cell types. Differentiated cells can be reprogrammed to an embryonic-like state by transfer of nuclear contents into oocytes or by fusion with embryonic stem cells. IPSCs technology was pioneered by Shinya Yamanaka from Kyoto University. This breakthrough has inspired researchers to start working around IPSC technology. James Thomson from University of California has developed IPS cell lines derived from Human Somatic Cells. Subsequently, he also established a large scale human IPSC manufacturing company named Cellular Dynamics International. Thus, increasing interest in the commercial exploitation of IPSCs patents has lead us to look into the patent portfolios of top three patent assignees in IPSC technology. In this study, we have discussed technological patent trends and multiple factors which reflect the competitive scenario between the top assignees of IPSC technology. Our conclusions suggest that Kyoto University led by inventor Shinya Yamanaka is the leader of IPSC technology. However, patent-product linkage analysis suggests that Cellular Dynamics International led by inventor James Thomson may surpass Kyoto University in near future.
Commercial plant breeding: What is in the biotech pipeline?
Authors: Cockbum Andrew
Published: January 2017

Of all of humankind's endeavours, agriculture has led to the most pressure on land, its resources and biodiversity. Over the past 50 years, the need to increase food production has resulted in the loss of one-fifth of the world's topsoil, one-fifth of its agricultural land and one-third of its forests. To slow down, and ideally reverse, this trend in the face of a predicted population increase of 50 per cent, a water shortage and climate change, new approaches will be needed. In this context, crop biotechnology and genomics have a major contributory role to play in the sustainable improvement of crop and livestock productivity, human and animal health and the development of renewable resources such as fibres, plastics, biofuels and plant-made pharmaceuticals. Manifestly, this will require both political will and international agreement.
Marketspace: The immunotherapies markets, 2003â€“2008
Authors: Pavlou Alex K
Published: January 2017

Analysis of 170 leading and emerging therapeutic antibodies (Ab) and vaccine companies unveils two different business growth trends. The therapeutic antibodies sector will see strong revenue growth with 15 new fully human and humanised product launches and its sales growing from US$5bn in 2002 to more than US$16bn in 2008. However, the therapeutic vaccines sector, despite its highly innovative nature and newly developed personalised approach, is unlikely to be able to achieve high market penetration with 2008 sales forecast less than US$0.5bn.
Biotechnology's special forces: Field-based medical science liaisons
Authors: Chin Jane
Published: January 2017

Biotechnology companies with a product commercialisation strategy are deploying field-based medical science liaisons (MSLs) to increase awareness of a therapeutic market, support clinical trials, and educate the healthcare community on appropriate product utilisation. Attracting experienced MSLs to smaller or younger companies remains a significant challenge for MSL directors. Comprehensive MSL training programmes are also lacking at young biotechnology companies, even though directors interviewed in this paper all agreed that training is a key provision to equip MSLs for quality performance. As field-based medical programmes are expanding in the biopharmaceutical industry, small MSL teams often compete in the same market dominated by large pharmaceutical MSL forces. Small teams that are staffed with experienced MSLs, trained rigorously on both technical and non-technical competencies, and motivated toward effective teamwork are positioned for success. Medical science liaison directors who proactively communicate with senior management on the value that MSLs bring to their companies are more likely to obtain resources for training and will leverage their MSL programmes for growth.
Encouraging industry participation in the EU's Sixth Framework Programme: Issues, barriers and potential solutions
Authors: Hughes-Wilson Wills
Published: January 2017

There is around 100m annually in the Sixth Framework Programme earmarked exclusively for small and medium-sized enterprises (SMEs) in the life sciences field. That is 15 per cent of the total amount available. But most of it has yet to be allocated. Why are biopharmaceutical SMEs not applying and how can they get access to this money?The Emerging Biopharmaceutical Enterprises (EBE) group teamed up with representatives of the European Commission for the 'Life Sciences, Genomics and Biotechnology for Health' Thematic Priority to help companies understand how they can benefit from the Programme and give them an opportunity to add their ideas to it. Attendees came from 60 biopharmaceutical companies, and the programme was structured to allow companies to ask questions, but also put forward ideas to be included in upcoming Calls for the Sixth Framework Programme, as well as suggestions for improving the Seventh Framework Programme to improve industry participation. The event also gave them the chance to ask the Commission representatives specific questions on the administrative aspects of the Programme. The event was organised in conjunction with the Scientific Officers responsible for the different areas in the Programme; and the external experts who advise the Commission on the content of the future calls and the overall strategy for priority areas and activities of research were also invited. This meeting was designed to be as relaxed and open as possible and put the companies directly in contact with the people who implement the Framework Programme. The input from this session based on the feedback of the attendees has been formally forwarded to the Commission and the Thematic Priority Advisory Group.This paper discusses the aims and focus of the Sixth Framework Programme. It provides an overview of the discussion between the EBE and the representatives from the European Commission for the 'Life Sciences, Genomics and Biotechnology for Health' Thematic Priority and summarises the key problems and solutions arising therein.
Singapore's biomedical science sector development strategy: Is it sustainable?
Authors: Lim Lisa P L , Gregory Michael J
Published: January 2017

This paper outlines the strategic efforts undertaken by Singapore to establish its national capability in the biomedical science sector, reviews the commercial base as a result of these efforts and compares Singapore's approach with the UK and US development models, discusses the challenges that Singapore faces and raises some questions on the long-term sustainability of the sector.Although Singapore is a small country in terms of geographical size, its economic size is significant, with gross domestic product (GDP) and GDP per capita of US$112bn and US$25,200 respectively in 2002. For the past 40 years, the country has achieved an average annual GDP growth of 8.4 per cent by focusing on manufacturing and productivity improvements. Biotechnology has been earmarked as the next wave of technology that will sustain the country's economic growth. For almost two decades, Singapore has focused its efforts on building capabilities in the biomedical science area to exploit biotechnology and traditional chemistry-based technologies in drug discovery, development and production. The main principle of Singapore's strategy is to locate a sector targeted for growth and then to focus its efforts on building the key pillars to support the sector; identified in this case to be research, early stage funding and specialised infrastructure.
The market of therapeutic recombinant proteins to 2010
Authors: Pavlou Alex K
Published: January 2017

Datamonitor's recombinant protein analytical framework shows that the sector with 77 marketed and 104 pipeline products will reach maturity undisturbed from potential biogeneric threat. It will see its value growing from US$35.8bn in 2004 to US$53bn in 2010 with a compound annual growth rate of no higher than 7 per cent. In terms of protein class focus, erythropoietins will continue to lead sales with 2010 sales of US$11.4; almost one-fifth of the sector's value. Haematology diabetes/endocrinology and oncology will continue to be the key therapy areas with 2010 sales of US$13.4bn, US$9.5bn and US$8bn, respectively. Amgen's blockbusters Enbrel, Neulasta and Aranesp will be the sector's key leading blockbusters, with combined 2010 sales of more than US$10.8bn, capturing one-fifth of the sector's value.
Editorial: Are clinical trial authorisations truly being harmonised?
Authors: Horton Linda R
Published: January 2017

Â Â
Changes to the European Union pharmaceutical legislation: Implications of the 'Pharma Review' for biotechnology companies
Authors: Liikanen Erkki
Published: January 2017

A global revision of the European regulatory framework for medicinal products, the 'Pharma Review', has recently been adopted by the European Institutions. This is an important step for the competitiveness of the European life sciences industry, as this 'Pharma Review' has numerous and significant implications for companies involved in the field of biotechnology. Three main amendments can be highlighted in this context: (1) the strengthening of the European Agency for the Evaluation of Medicinal Products (EMEA) as a scientific advisory body, which will enable biotechnology firms to get high-quality scientific advice early in the drug development process; (2) new marketing authorisation procedures, which will provide a simpler and faster market access for 'breakthrough' medicinal products when no therapeutic alternative is available; and (3) the establishment of an EU-harmonised data protection scheme, in order to set the appropriate balance between innovation and the development of the generics industry. The objective of this paper is to explore these essential regulatory changes, which all aim at meeting one critical challenge: enabling innovative firms to get streamlined access to the enlarged European market without compromising public health.
Evaluating Polymers to Avoid Polymer‐Induced N‐Nitrosodimethylamine Formation
Authors: Cornwell David A. , Brown Richard A. , Krasner Stuart W.
Published: January 2017

Chloramines are often used instead of free chlorine as a residual disinfectant in order to limit formation of regulated halogen‐substituted disinfection by‐products that form more readily in the presence of free chlorine. However, the use of chloramines can form carcinogenic nitrosamines. Some polymers, particularly polyDADMAC, contribute nitrosamine precursors (as confirmed in this research). Alternative polymers produced from natural products evaluated in bench and pilot testing produced clarification and filtration performance as good as or better than that with polyDADMAC or other currently used polymers while contributing little or no nitrosamine precursors. However, there was indication of high biological growth in filters that were not chlorinated. Replacing readily biodegradable acetic acid with a mineral acid (e.g., hydrochloric acid) during synthesis of chitosan might reduce the potential for biological activity with this polymer. Performance variations in different source waters suggest that site‐specific determination of the best polymer type, dose, and application point should be completed before using any polymer.
Regenerating an Arsenic Removal Iron‐Based Adsorptive Media System, Part 1: The Regeneration Process
Authors: Sorg Thomas J. , Chen Abraham S.C. , Wang Lili , Kolisz Raymond
Published: January 2017

Adsorptive media technology is frequently used by small water systems to remove arsenic because of its simplicity and efficiency. Current practice is to replace the media when it no longer reduces arsenic below the maximum contaminant level of 10 µg/L that the US Environmental Protection Agency has set for drinking water. Media replacement typically accounts for approximately 80% of the total operational and maintenance costs. One potential option to reduce the cost is onsite regeneration and reuse of the media. To evaluate the regeneration option, three consecutive regeneration studies were conducted on a full‐scale adsorptive media system. This article, the first of a two‐part series, describes the regeneration process and its efficacy in stripping arsenic and other contaminants from exhausted media. Study results found that a three‐step regeneration process of media backwash, caustic regeneration, and acid neutralization conditioning proved effective for stripping arsenic and other contaminants from the exhausted media.
A Rare Cause of Mechanical Intestinal Obstruction: A Neoplastic Intra-Abdominal Testis
Authors: Ciftci Fatih , Benek Suat , Kezer Cem
Published: January 2017

The acute abdomen has many etiologies frequently encountered in emergency surgical units. Approximately 20% of surgical admissions for acute abdominal conditions are for intestinal obstruction. Clinicians often overlook rarer causes. A 43-year-old man presented to the emergency ward with the clinical findings of ileus. Computed tomography revealed a heterogeneous necrotic 168 × 100-mm mass between the sigmoid colon and urinary bladder. Physical examination revealed a palpable intra-abdominal mass that was removed via exploratory laparotomy. On histopathologic examination, the mass was identified as a seminoma. The literature contains few reports of seminoma as a cause of acute abdomen and ileus, mostly seen between the ages of 30 and 40 years. We report a patient with seminoma arising in an undescended testis that presented as a palpable painful lower abdominal mass and mechanical intestinal obstruction, despite the large diameter of the mass, as well as review relevant literature.
MULTI-CRITERIA APPROACH FOR DESIGNING SUSTAINABLE DRAINAGE IN MALANG RESIDENTIAL AREA INDONESIA
Authors: Ratih Indri HAPSARI , Yasnuar MUNTAHA , Medi EFENDI
Published: January 2017

Environmentally sound approach for sustainable urban drainage could promote infiltration and lower the risk of flooding. This study presents the framework to evaluate the drainage alternatives considering multiple aspects including water quantity, life cycle cost and amenity. This approach is verified through application at a residential area in Malang city Indonesia. Different combinations of drainage components comprising of drainage channels, infiltration wells and biopore absorption holes are assessed regarding runoff reduction, present value of life cycle cost, and willingness to pay for the convenience. The first part describes the effective designs of sustainable drainage components in the houses as well as in the public spaces of the housing. The second part of this study describes the use of analytic hierarchy process for weight assignment of sustainability criteria and multiple benefit calculation. The study recommends infiltration wells and biopore absorption holes together with drainage channels as the best management practice of sustainable drainage system based on its overall sustainability index.
Neuroendocrine Tumor‐Targeted Upconversion Nanoparticle‐Based Micelles for Simultaneous NIR‐Controlled Combination Chemotherapy and Photodynamic Therapy, and Fluorescence Imaging
Authors: Chen Guojun , Jaskula‐Sztul Renata , Esquibel Corinne R. , Lou Irene , Zheng Qifeng , Dammalapati Ajitha , Harrison April , Eliceiri Kevin W. , Tang Weiping , Chen Herbert , Gong Shaoqin
Published: January 2017

Although neuroendocrine tumors (NETs) are slow growing, they are frequently metastatic at the time of discovery and no longer amenable to curative surgery, emphasizing the need for the development of other treatments. In this study, multifunctional upconversion nanoparticle (UCNP)‐based theranostic micelles are developed for NET‐targeted and near‐infrared (NIR)‐controlled combination chemotherapy and photodynamic therapy (PDT), and bioimaging. The theranostic micelle is formed by individual UCNP functionalized with light‐sensitive amphiphilic block copolymers poly(4,5‐dimethoxy‐2‐nitrobenzyl methacrylate)‐polyethylene glycol (PNBMA‐PEG) and Rose Bengal (RB) photosensitizers. A hydrophobic anticancer drug, AB3, is loaded into the micelles. The NIR‐activated UCNPs emit multiple luminescence bands, including UV, 540 nm, and 650 nm. The UV peaks overlap with the absorption peak of photocleavable hydrophobic PNBMA segments, triggering a rapid drug release due to the NIR‐induced hydrophobic‐to‐hydrophilic transition of the micelle core and thus enabling NIR‐controlled chemotherapy. RB molecules are activated via luminescence resonance energy transfer to generate 1O2 for NIR‐induced PDT. Meanwhile, the 650 nm emission allows for efficient fluorescence imaging. KE108, a true pansomatostatin nonapeptide, as an NET‐targeting ligand, drastically increases the tumoral uptake of the micelles. Intravenously injected AB3‐loaded UCNP‐based micelles conjugated with RB and KE108—enabling NET‐targeted combination chemotherapy and PDT—induce the best antitumor efficacy.
Influence of Fullerene Acceptor on the Performance, Microstructure, and Photophysics of Low Bandgap Polymer Solar Cells
Authors: Huang Wenchao , Gann Eliot , Chandrasekaran Naresh , Prasad Shyamal K. K. , Chang Sheng‐Yung , Thomsen Lars , Kabra Dinesh , Hodgkiss Justin M. , Cheng Yi‐Bing , Yang Yang , McNeill Christopher R.
Published: January 2017

The morphology, photophysics, and device performance of solar cells based on the low bandgap polymer poly[[2,6′‐4,8‐di(5‐ethylhexylthienyl)benzo[1,2‐b;3,3‐b]dithiophene]3‐fluoro‐2[(2‐ethylhexyl)carbonyl]thieno[3,4‐b]thiophenediyl (PBDTTT‐EFT) (also known as PTB7‐Th) blended with different fullerene acceptors: Phenyl‐C61‐butyric acid methyl ester (PC61BM), phenyl‐C71 ‐butyric acid methyl ester (PC71BM), or indene‐C60 bisadduct (ICBA) are correlated. Compared to PC71 BM‐based cells – which achieve a power conversion efficiency (PCE) of 9.4% – cells using ICBA achieve a higher open‐circuit voltage (VOC) of 1.0 V albeit with a lower PCE of 7.1%. To understand the origin of this lower PCE, the morphology and photophysics have been thoroughly characterized. Hard and soft X‐ray scattering measurements reveal that the PBDTTT‐EFT:ICBA blend has a lower crystallinity, lower domain purity, and smaller domain size compared to the PBDTTT‐EFT:PC71BM blend. Incomplete photoluminescence quenching is also found in the ICBA blend with transient absorption measurements showing faster recombination dynamics at short timescales. Transient photovoltage measurements highlight further differences in recombination at longer timeframes due to the more intermixed morphology of the ICBA blend. Interestingly, a mild thermal treatment improves the performance of PBDTTT‐EFT:ICBA cells which is exploited in the fabrication of a homo PBDTTT‐EFT:ICBA tandem solar cell with PCE of 9.0% and VOC of 1.93 V.
Milk ejection patterns remain consistent during the first and second lactations
Authors: Gardner Hazel , Kent Jacqueline C. , Prime Danielle K. , Lai Ching‐Tat , Hartmann Peter E. , Geddes Donna T.
Published: January 2017

Objective

Milk ejection is a critical physiological process for successful lactation in humans and without it little milk can be removed. Individual milk ejection patterns have been shown to remain consistent between breasts at different lactation stages and using different vacuum patterns with an electric breast pump. Little is known about the milk ejection characteristics during the second lactation period in the same mother. The objective of this study was to examine milk ejection characteristics in the same woman over two lactations.

Methods

One mother took part in two pumping studies during consecutive lactations. One pumping study examined milk ejection characteristics during simultaneous breast expression during the first lactation. The second pumping study (second lactation) used two different pumping patterns. Three distinct milk ejections were measured during each pumping session.

Results

Measurements of milk flow were used to compare the duration and time taken to reach the peak of each milk ejection for two pumping sessions from each of the lactations. There were no significant differences in milk ejection characteristics between breasts, using different pumping patterns, or between lactations in this mother (P > .05).

Conclusion

Milk ejection appears to be a physiological response that is consistent across consecutive lactations within the same mother. This suggests that milk ejection characteristics are established during or prior to the first lactation. The infant appears to have little influence on the milk ejection characteristics of the mother.
A comparison of skeletal maturity assessed by radiological and ultrasonic methods
Authors: Utczas Katinka , Muzsnai Agota , Cameron Noel , Zsakai Annamaria , Bodzsar Eva B.
Published: January 2017

Objectives

The estimation of skeletal maturity is a useful tool in pediatric practice to determine the degree of delay or advancement in growth disorders and the effectiveness of treatment in conditions that influence linear growth. Skeletal maturity of children is commonly assessed using either Greulich–Pyle (GP) or Tanner–Whitehouse methods (TW2 and TW3). However, a less invasive ultrasonic method, that does not use ionizing radiation, has been suggested for use in epidemiological studies of skeletal maturity. The main purpose of the present study was to determine the accuracy of an ultrasonic method based on the GP maturity indicators compared to the standard GP radiographic method.

Methods

Skeletal maturity of 1502 healthy children, aged from 6 to 18 years, was estimated by quantitative ultrasound and compared to GP bone ages estimated from left hand and wrist radiographs of a subsample of 47 randomly selected participants.

Results

The ultrasonic bone age estimation demonstrated very strong correlations with all the radiological age estimations. The correlation coefficients ranged between 0.895 and 0.958, and the strongest correlation of ultrasonic skeletal maturity estimation was found with the Tanner–Whitehouse RUS method. The ultrasonic bone age estimation is suggested for use between the chronological ages of 8.5–16.0 years in boys and 7.5–15.0 years in girls.

Conclusions

The ultrasonic bone age estimation is suggested for use in epidemiological surveys since the sensitivity for screening for not normal bone development is appropriate, at least within the 8–15 years age interval.
Hypervalent Iodine(III)‐Mediated Oxidative Decarboxylation of β‐Keto Acids
Authors: Yuan Zhipeng , Zhao Tiantian , Yu Tianyang , Wang Junru , Wei Hao
Published: January 2017

Oxidative decarboxylation of β‐keto acids mediated by hypervalent iodine(III) reagents is described. This decarboxylative C−O bond‐forming reaction uses a combination of (diacetoxyiodo)benzene and an aliphatic carboxylic acid to give the corresponding α‐acyloxy ketones. Preliminary mechanistic studies suggest that the reaction proceeds through a ligand coupling followed by decarboxylation. This reaction offers an attractive alternative to existing methods for the exclusive synthesis of α‐acyloxy ketones.
Synthesis of novel macrocyclic Schiff's‐base and its complexes having N2O2 group of donor atoms. Characterization and anticancer screening are studied
Authors: Zayed Ehab M. , Zayed Mohamed A. , Fahim Asmaa M. , El‐Samahy Fatma A.
Published: January 2017

Novel Schiff base [N′,N′″‐(((ethane‐1,2‐diylbis(oxy))bis(2,1‐phenylene))bis(methanylylidene))di(benzohydrazide)] was formed by the condensation reaction of benzohydrazide with 2,2′‐(ethane‐1,2‐diylbis(oxy))dibenzaldehyde. Its reaction with various metal ions was studied and the structures of the new products were characterized using common analytical and spectroscopic methods. All the metal complexes have pronounced anticancer activities. The antimicrobial activities against Gram‐negative and Gram‐positive bacteria were investigated.
Synthesis, characterization and catalytic properties of tetrachlorocuprate(II) immobilized on layered double hydroxide
Authors: Amini Mojtaba , Nikkhoo Mohammad , F. Farnia S. Morteza
Published: January 2017

Readily prepared copper(II) immobilized on layered double hydroxide has been found to effectively catalyse the 1,3‐dipolar cycloaddition (CuAAC) of a variety terminal alkynes and benzyl azides generated in situ from sodium azide and benzyl halides furnishing the corresponding 1,2,3‐triazoles in excellent yields. The advantages of the protocol are short reaction time, mild reaction conditions, reusability of the catalyst and applicability to a wide range of substrates.