bluuebunny/crossref_metadata_2025 huggingface dataset:
An overview of trends in multilateral environmental agreements with an impact on biotechnology and research in Asia and the Pacific
Authors: Keller Frankie , Macer Darryl R J
Published: January 2017

The international community has responded to the call for increased management of biotechnology which may harm the environment through participation in multilateral environmental agreements (MEAs). Some of these agreements contain specific provisions which are at the heart of the foundation, both implicitly and explicitly, for international regulation of biotechnology. The implications of these agreements for biotechnology research are discussed. The membership of countries in the Asia and Pacific region to specific MEAs is discussed in the context of selected economic, political, geographical and agricultural indicators.
A retrospective prospective perspective on agricultural biotechnology ten years on
Authors: McGloughlin Martina Newell
Published: January 2017

Since the first biotech crop was commercialised in 1996, these crops have enjoyed a rapid adoption and are now grown commercially by 8.5 million farmers in 21 countries, an 11 per cent increase from 8.25 million in 17 countries in 2004. Research and development is being conducted in another 45. The billionth cumulative acre of biotech crops was grown in 2005. Notably, last year Iran grew its first crop of biotech rice, the first biotech planting of this important food crop globally. The Czech Republic planted biotech maize for the first time, bringing the total number of European Union (EU) countries growing biotech crops to five with Spain, Germany and the Czech Republic being joined by France and Portugal, which resumed planting biotech maize after four and five-year gaps, respectively. This could signal an important trend in the EU. Although North America leads in the research, more than half of the 63 countries engaged in biotech research, development and production are developing countries. The first generation of such crops focused largely on input agronomic traits, the next generation will focus more on value-added output traits. In the next decade, some studies estimate the global value of biotech crops will increase nearly five-fold to $210bn.
In defence of gene patents
Authors: Toumi Emma
Published: January 2017

For two years the Nuffield Council of Bioethics has scrutinised the pros and cons of gene patenting in the healthcare industry. The Council recently published its findings, saying that too many patents have been granted on gene sequences and, in future, gene patents 'should be the exception rather than the rule'. The Council's recommendations even go as far as to propose the discontinuance of monopoly rights on existing gene patents for certain applications such as diagnostic tools. The consequences of curtailing patent rights could have a deleterious effect on the healthcare industry where patents are essential for recovering the investment made in drug discovery. Furthermore, it could lead to a 'dark age' where the human gene sequences responsible for disease are kept secret by a minority of the industry players. In its defence, the patent system is a very sophisticated, self-correcting system with safeguards to protect society from unwarranted monopolies. Its purpose is to put every scientific advance into the public domain with the trade-off of a time-limited monopoly awarded to the proprietor.
Is anyone listening?
Authors: Ireland David C , Cormick Craig , Hine Damian
Published: January 2017

Emerging industries such as the life sciences, animal health, agricultural biotechnology and environmental products offer both a potential for economic growth and improvements in quality of life, crop and stock yield, the environment, and industrial productivity. The growth and success of these industries depends on a combination of good science and good business. Biotechnology, for instance, is one emerging industry that has promised much, yet the delivery still seems to be some way off. Difficulties convincing well-informed investors of the virtues of biotechnology may be indicative of a wider communication failure. Despite numerous initiatives to popularize and sell science, it seems the attitudes and understanding of society towards science and scientists and the importance scientists place on communicating with society remains depressingly low. One-way late-stage communication models have proven ineffective and have only further alienated the very audiences they meant to attract. Solving these problems requires the involvement of both the scientific community and wider society, where appropriate information is presented in a non-guarded and accessible language, and is received by open and willing ears, setting the scene for interactive, educated debates that can progress rather than hinder the science. This paper explores the various scienceâ€“society interactions and identifies a need for early-stage two-way communication models.
ApaTech: A biomaterials success story
Authors: Cartmell Simon
Published: January 2017

ApaTech is an excellent example of how innovative technology from a British university can be developed and commercialised on a global scale. Its leading product, Actifuse, competes in the crowded bone graft substitute market. Its competitors include autograft, allograft, recombinant proteins and other synthetic materials based on similar calcium phosphate technology. Discoveries regarding the role of ionic species within normal bone lead to the development of greater insights into the subtle interactions of graft structure, graft chemistry and the biology of bone formation. Financing from 3i and MTI allied to the intellectual property residing in the IRC in Biomedical Materials, Queen Mary University London plus strong commercially oriented management has resulted in ApaTech establishing itself as a major force in the bone graft substitute market. ApaTech has successfully differentiated its products and technology from that of established major orthopaedic company offerings and is capturing significant market share, particularly in the UK and USA where ApaTech has established a direct presence.
Innovation and Entrepreneurship in Biotechnology, an International Perspective: Concepts, Theories and Cases
Authors: Shohet Simon
Published: January 2017

Innovation and Entrepreneurship in Biotechnology, an International Perspective: Concepts, Theories and Cases Damian Hine and John Kapeleris Edward Elgar Publishing, Cheltenham, UK; ISBN 0 851 199 056 8; April 2006; 272 pp
The commercialisation of bioinformatics and the threat of open-source software
Authors: Greco Joseph F
Published: January 2017

This study investigates the commercialisation process of a select group of bioinformatics companies and the impact of open-source software. Using the researchâ€“developmentâ€“application translation model provides a framework for managers as an iterative mechanism. A Value Creation Pipeline is then introduced with five phases of the commercialisation process that provide specific financial benchmarks that can guide the firm through to successful commercialisation. Using trend and financial ratio analyses relative to returns, profitability and liquidity, the study finds that the surge in open-source licenses between 2003 and 2005 limited the sales for some firms. As for the claim that open-source software negatively impacts the success of bioinformatics commercialisation, there was little evidence to suggest a direct cause-and-effect relationship. Losses in returns, profitability and liquidity were just as common before the rise of open source as after its emergence. When firms report an overall record over a nine-year period of poor return on investment, assets and equity, there is little to attract potential investors. The lesson that can be drawn is that the innovation process and financial tracking must be integrated to ensure efficient and profitable use of investor funds.
Fostering the process of adoption of personalised medicine: A matter of communication or a matter of cost?
Authors: Lara Pedro Reinares , De Mesa Emma Gutierrez
Published: January 2017

Pharmacogenetics, along with its derived products, diagnostic tests and customised medicines, has been introduced to the market with high commercial expectations (derived from its obvious science-based benefits). Nevertheless, its commercial success is far below that is expected. Although the favourable arguments for its development are sufficiently documented in the literature, the reality of the market forces the consideration of a scenario with less optimistic elements. This work synthesises the different barriers limiting their development including the crucial factors acting on the demand side. In order to support this argument, an exploratory study was carried out. The research leads to interesting operative conclusions to be taken into account by the diagnostic industry in order to improve its further adoption by the market.
Changing hopes and concerns about gene therapy in Japan
Authors: Macer Darryl , Okada Yoshihiro , Nakagawa Makoto , Ng MaryAnn Chen , Inaba Masakazu
Published: January 2017

The attitudes that the public in Japan have to gene therapy were surveyed through the use of opinion surveys in 1991, 1993, 1995, 2000 and 2003. This paper presents the results of these surveys on different groups, and in particular examines the open comments that people made in response to being asked whether they would personally use gene therapy if they were suffering from a fatal disease. The optimism towards gene therapy among the public in Japan is similar in 2003 as it was in 1991, with over half agreeing to use gene therapy upon themselves if tests showed that they were likely to get a serious or fatal genetic disease later in life. The level of enthusiasm was also similar in national random surveys of natural scientists in 1991 and in 2000. The major reasons for this support were to save their own life, and a variety of other reasons are described. There is also a presentation of the titles and content analysis of articles on gene therapy published in Asahi Shimbun newspaper over the same period. The attitudes, policy and regulation are discussed.
The roles and responsibilities of the EU qualified person for pharmacovigilance under Volume IXa March 2007
Authors: Ladds Graeme
Published: January 2017

The role of drug safety both in drug development and post-marketing surveillance has increased enormously over recent years. For the EU, this has culminated in a designated individual, the qualified person for pharmacovigilance (PV), who has responsibility for the overall procedures that exist in a company for safety management. This role has evolved since it was first introduced in the late 1990s to a critical role in the company both in terms of managing risks with products while either still in the clinical phase or the post-marketing phase. Such a role demands that the person who takes on the mantle has to be knowledgeable in PV legislation. The new Eudralex Volume IXa issued in both January and then revised in March 2007 has again emphasised and clarified this role. All licence holders in the EU must have this person in place, and the scope of this role is discussed below.
Industrial enzymes in bioindustrial sector development: An Indian perspective
Authors: Chandel Anuj Kumar , Rudravaram Ravinder , Rao Linga Venkateswar , Ravindra Pogaku , Narasu Mangamoori Lakshmi
Published: January 2017

The bioindustrial and information technology sectors have been the two most-decisive factors for the rising Indian economy over the last 15 years. India is the second fastest growing economy in the world, with a gross domestic product (GDP) of 9.2 per cent in 2006â€“2007. Industrial enzymes production and marketing predominantly cover the developments incurred in the bioindustrial sector. In 2006â€“2007, the bioindustrial sector made an impressive turnover of Rs. 3950m, with a growth rate of 5.33 per cent. India imports about 70 per cent of the total enzyme consumption. Pharmaceutical enzymes are the representatives of industrial enzymes' demand in India and cover almost 50 per cent of the total enzyme demand, followed by detergent enzymes (20 per cent) and textile enzymes (20 per cent). The global market for enzymes was estimated to be about $ 2bn in 2004 in tune with an average annual growth rate of 3.3 per cent. This article touches upon the importance of major industrial enzymes in the development of the bioindustrial sector in India. Also, applications of enzymes, manufacturing industries and major suppliers or distributors of enzymes have been discussed.
How biotechnology companies respond to bioethical issues
Authors: Kato Makina , Macer Darryl
Published: January 2017

This paper presents the main findings of a research project that investigated how biotechnology companies in different countries address bioethical issues. The study comprised a questionnaire survey and a series of interviews with international organisations and academics in Japan, Europe and North America. While the research clearly indicated that a number of companies expected to have to address bioethical issues in the future, the results also demonstrated that there was a hesitance to admit that bioethical issues had caused problems in the past. The findings also established that companies responded to bioethical issues in different ways and some of the larger organisations were found to set up ethics committees and educate their employees more effectively on bioethical issues. The respondents were also concerned by the biased or distorted view provided by the media and felt it was important that objective information on this area was provided to the public.
Editorial
Authors: Friedman Yali
Published: January 2017

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Building a conducive environment for life science-based entrepreneurship and industry clusters
Authors: Ahn Mark J , Meeks Michael
Published: January 2017

The global biopharmaceutical industry, with over $70bn in revenues and 700 publicly listed firms posting double-digit growth in North America, Europe, and Asia-Pacific in 2006, represents an attractive and promising high-growth industry of the future. Broad scientific advances and commercial successes have captured the attention and aspirations of policy makers, business people, and investors alike in spurring sector growth. An understanding of the fundamental forces that shape the industry, including the challenges faced by entrepreneurs, as well as many promising industry trends, offer several implications for investors and policy makers. This study explores industry dynamics affecting growth patterns, biotech industry cluster evolution in an era of increasing globalisation, and enabling factors which support entrepreneurship activity, productivity, and sustainability. Governments and investors seeking to create and enhance biotech entrepreneurship face several enabling trends including increasing numbers of science graduates worldwide, accelerating pace of scientific advancement, dominating role of globalisation enabling greater collaboration, democratising forces of the internet, and the relentless competitive pressure to innovate. As such, policy agendas should focus on increasing factor conditions to enhance start-up formation, alliances, and skilled employment, rather than attempt to select specific winners and losers among specific sub-sectors or individual firms.
Book Review: Stem cell wars: Inside stories from the Frontlines
Authors: Skrepnek Grant H
Published: January 2017

Stem cell wars: Inside stories from the Frontlines Eve Herold. foreword by Dr George Q. Daley Palgrave Macmillan, New York; ISBN 978 1403974990; 2006; 238pp; Hardback
Networks of dedicated biotechnology and service firms in Vancouver
Authors: Bliemel Martin J , McCarthy Ian P
Published: January 2017

Survival and growth of firms depends on their relationships to other organisations, including key suppliers, customers, supporters and competitors. This study compares geographic aspects of the networks of biotechnology firms (DBFs) and contract research organisations and service firms (CROs) in Vancouver, Canada. We find that for DBFs the key actors (organisations and individuals) that they network with are globally located (ie not local), despite the DBFs having originated from a local university. In contrast, CROs are more likely to network with local actors, and with actors on the same continent. Of the DBFs providing performance data, the distribution of their performance is consistent with recent developments in structural embeddedness theory (ie network coupling theory). This suggests that their performance may be inhibited if they are under- or over-embedded in their network, with the greatest opportunity for success in a medium range of coupling.
Open content textbooks: Educating the next generation of bioentrepreneurs in developing economies
Authors: Meyers Arlen D , McCubbrey Donald J , Watson Richard T
Published: January 2017

Bioclusters, formal and informal networks devoted to the commercial development of life science invention and discoveries, are growing throughout the world, including many developing economies. As these clusters evolve, there will be an increasing need for scientific and leadership talent. Bioentrepreneurship educational programmes require access to high quality, relevant textbook and case materials at a reasonable cost. In addition, since biobusinesses are affected by globalisation like other industries and since life sciences businesses are often â€˜born globalâ€™, future bioentrepreneurs and knowledge workers need an international perspective. We describe an open content textbook project that includes a textbook of bioentrepreneurship. The textbook site provides materials that are intended to be free, easily accessible and updated on a regular basis by content experts, students and practitioners. Bioentrepreneurship education around the world is still unstructured and developing. Instructional materials are difficult or impossible to obtain in some regions of the world. The Global Text Project provides materials to faculty and students anywhere in the world for free.
Got value? Determine it. Demonstrate it. Communicate it. Realise it
Authors: DeKoven Mitch , Hazard Elisabeth H , Goldberg Erica , Pokras Shibani
Published: January 2017

Many healthcare systems are in crisis due to rising costs, rising demand and inadequate funding. Consequently, healthcare decision makers are increasingly demanding that costs for new health technologies be justified with scientifically rigorous evidence. This is particularly true for biotechnology products, which tend to be more expensive, require more handling and have more uses/indications beyond that which is experienced for traditional pharmaceutical products. Given today's demands for demonstrating value in medicine, health economics and outcomes research (HEOR) techniques are now in focus, and increasingly linked to brand strategy. To facilitate this process, a Value Development Plan (VDP)â„¢ is warranted; a process by which to identify, demonstrate, communicate and realise the value of a product; similar and running parallel to a clinical development plan. There are four key steps in building a VDP. Briefly, these include the following:Value determinationâ€“ benchmarks available alternatives in a therapy area based on clinical/economic value.Value demonstrationâ€“ identifies tactical outcomes research and economic model projects to demonstrate the clinical and economic elements, respectively, of the target value proposition.Value communicationâ€“ helps to inform and define the value communication strategy and tactics for relevant audiences.Value realisationâ€“ defines price ranges for products based on demonstrated value and addresses reimbursement and seamless market access.
Value-driven project and portfolio management in the pharmaceutical industry: Drug discovery versus drug development â€“ Commonalities and differences in portfolio management practice
Authors: Bode-Greuel Kerstin M , Nickisch Klaus J
Published: January 2017

The concept of portfolio management has been widely used in the pharmaceutical industry. It is used to evaluate the commercial value and the risk structure of development projects. The final goal is to select a portfolio of projects that addresses the strategic objectives of the organisation optimally and that leads to the highest overall portfolio value. Companies now start to apply the portfolio management concept on their research portfolios. Although the basic principle remains the same, the methodology applied has to be adapted to the greater uncertainty that early research projects carry. Commonalities and differences of the portfolio management process in research and development are described and recommendations are given how to harmonise the two different approaches.
Teaming in biotechnology commercialisation: The diversity-performance connection and how university programmes can make a difference
Authors: York Anne S , McCarthy Kim A , Darnold Todd C
Published: January 2017

Collaboration across disciplines in the sciences is on the rise. Yet, practitioner papers abound that describe a range of dysfunctional team experiences, especially in contexts where science and business intersect. A critical issue currently preventing successful bioscience commercialisation is management's lack of â€˜soft skills,â€™ such as the ability to direct complex and functionally diverse teams to achieve productive outcomes. Our paper first reviews the diversity and teaming literature from several disciplinary perspectives in order to better understand how different types of diversity affect team outcomes and processes, as well as how to create higher functioning teams to engage in bioscience technology commercialisation. Research suggests that the â€˜surface-levelâ€™ diversity issues associated with demographic and disciplinary differences may diminish over time, as team members move beyond initial stereotypes and gain more knowledge about their fellow group members. However, problems stemming from â€˜deep-levelâ€™ diversity such as personality and values differences are more difficult to overcome and require a high degree of interaction frequency among team members, as well as strong communication skills. Going beyond the literature review, we demonstrate how these â€˜lessons learnedâ€™ can be addressed through bioscience entrepreneurship education, using a case study of a Midwestern university programme funded by an NSF Partnerships for Innovation grant.
Book Review: Science lessons: What biotech taught me about management
Authors: Boni Arthur A
Published: January 2017

Science lessons: What biotech taught me about managementGordon Binder and Philip BasheHarvard Business School Press, Boston, MA, 2008, hardback, 288pp.ISBN: 978-1591398615
Integrating virtual internships into online classrooms
Authors: Conroy Richard , Khan Rana
Published: January 2017

With the rapid increase in the number of online enrollments, educators are faced with the challenge of ensuring on-campus experiences are available to distant students, which meet quality and accessibility expectations. One of the biggest challenges with online courses is constructing meaningful group projects for part-time students who can be in disparate time zones. As part of our Master's biotechnology programme, offered completely online, we have developed a capstone course for students approaching graduation, which integrates a semester-long project working with a small biotechnology company in the DC metro area into the course curriculum. The experience and results from these projects have been well received by the participating students and companies. We describe some of the challenges we have faced, strategies we have developed, and ongoing modifications to the programme to integrate projects with small biotechnology businesses into the online classroom.
Team-based learning in Keck Graduate Institute's professional Master of Bioscience programme
Authors: Tirrell Jane G , Dewey Thomas Gregory
Published: January 2017

Keck Graduate Institute of Applied Life Sciences (KGI) offers a 2-year professional masters degree programme designed to educate scientists and engineers for leadership positions in the pharmaceutical, biotechnology and medical device industries. Inquiry through team-based projects is a central feature throughout the Master of Bioscience (MBS) curriculum. This paper presents KGI's team-based pedagogy through examples of specific team projects in the MBS curriculum. The projects described begin with the initial projects given to entering students during orientation week and culminate with the Team Masters Projects, the capstone experience of the MBS curriculum. The rationale for KGI's use of team-based learning and the effectiveness of a team-based approach are discussed. The pedagogy described may serve as a useful model for other professional or applied science programmes.
Bottom line compliance for biotechnology: Six secrets
Authors: Avellanet John
Published: January 2017

Biotechnology executives frequently short-shrift one of the key indicators of return on investment when negotiating pharmaceutical partnerships, support or licensing: a compliance and quality system. Given the increasingly tight financial markets biotechnology executives must operate within, can a good quality system be established for less than the cost of an average car?
Maturation of the biotechnology industry changes job opportunities for scientists
Authors: Liu Helen , Schmid Molly B
Published: January 2017

The biotechnology industry has historically had a strong focus on innovation and research. As the industry has matured, companies have become intensely focused on commercialising their products. This study assesses the current functional composition of the pharmaceutical and biotechnology workforce, and compares differences in workforce needs among companies of different sizes, ages and product commercialisation maturities. Sample sets of the largest pharmaceutical and biotechnology companies were selected, as were a set of smaller and younger companies. Job openings posted on the websites of these companies were categorised. Five functional categories of job openings were created â€“ Laboratory, Manufacturing, General & Administrative, Regulatory/Clinical Affairs and Sales/Marketing â€“ and each open position was placed into one of these five categories. Companies with products on the market had an average of 17 per cent of job openings in the laboratory category, and 83 per cent of openings in the remaining non-laboratory categories. Smaller companies without products on the market had a higher percentage of jobs categorised as laboratory. This study identifies the need for individuals with a blend of science and business skills, and makes clear the importance of educating scientifically trained individuals for scientifically oriented, but non-laboratory positions.
Book Review: Spin-outs: Creating businesses from university intellectual property
Authors: Meyers Arlen D
Published: January 2017

Spin-outs: Creating businesses from university intellectual propertyGraham Richards (ed.)Harriman House, Petersfield, UK, hardback, 184pp.,ISBN: 978-1905641987
Book Review: Venture capital and the European biotechnology industry
Authors: Lerer Leonard
Published: January 2017

Venture capital and the European biotechnology industryWilliam BainsPalgrave Macmillan, Basingstoke, 2008, hardback, 232pp.,ISBN: 978-0230217195
Reputation management in the biotechnology industry
Authors: Grupp Robert W , Gaines-Ross Leslie
Published: January 2017

As biotechnology companies mature, the focus of their activities shifts from a research-and-development orientation to a business model based on marketed products that deliver revenue and earnings. Companies are thus striving to occupy key positions at every stage of the industry's evolving value chain, covering each step from gene identification to patient care. The management of corporate reputation must therefore be based on the new biotechnology business model, which takes into account the shifting industry value chain. The authors discuss how the function of corporate communications in biotechnology is changing along with the industry itself, as well as the key components of a biotechnology company's reputation in the current environment. Additionally, a case study of Cephalon, Inc., is presented to illustrate how positive and negative events can affect corporate reputation in the biotechnology industry. The authors conclude with some observations on tactical solutions for building and managing corporate reputation in today's biotechnology industry.
The VC manifesto: Special pleading for a damaged cause: Commentary on Simon Witney interview
Authors: Bains William
Published: January 2017

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Valuation of complex license contracts
Authors: Villiger Ralph , Bogdan Boris
Published: January 2017

Licensing is an important business model within the drug development industry. Recently license contracts have become extremely complex, including sublicensing, co-development, or profit sharing. Traditional rules of thumb are not sufficient anymore as guidelines in negotiations of deal terms. The authors explain an easy-to-understand model that enables business developers to negotiate financial terms that are fair for both parties.
How can pharmaceutical and biotechnology companies maintain a high profitability?
Authors: Nickisch Klaus J , Greuel Joachim M , Bode-Greuel Kerstin M
Published: January 2017

Biotechnology investors are increasingly concerned about taking the risk of investing in the development of innovative drugs, and pharmaceutical companies are worried about maintaining their high profitability in the future. The question is how to build a portfolio of research and development (R&D) projects that fulfils the financial expectations of investors and shareholders. State-of-the-art net present value algorithms are applied to different types of projects at entry into development in order to evaluate their financial attractiveness and their ability to generate adequate returns. Based on the currently applied cost of capital for pharmaceutical and biotechnology companies the attractiveness of the so-called blockbuster model is clearly supported. The increasingly favoured specialty model, however, will only provide sufficient returns to biotechnology investors if significant sales volumes are reached. Complementing a company's development portfolio with risk-reduced projects could be an attractive way to ensure sustained growth for both biotechnology and pharmaceutical companies.
Building biotechnology teams: Personality does matter
Authors: York Anne S , McCarthy Kim A , Darnold Todd C
Published: January 2017

Our study describes a naturally occurring experiment exploring linkages between interdisciplinary team outcomes and personality dimensions, general mental ability, and communication type and frequency. This research took place within the context of an NSF-sponsored bioscience entrepreneurship program that engaged science, health science, law and business students working in cross-disciplinary project teams in the technology commercialization process. Our results are consistent with research findings from the management literature. Deep-level diversity seems to increase conflict in teams and is quite difficult to overcome even over time; thus, finding ways to structure teams to minimize this type of diversity from the outset is desirable.
Legal and Regulatory Update
Authors: Kamstra Gerry , Wilkinson John
Published: January 2017

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Book Review: Biotech funding trends: Insights from entrepreneurs and investors
Authors: Glick J Leslie
Published: January 2017

Biotech funding trends: Insights from entrepreneurs and investorsAlexandra Carina GruberWILEY-VCH Verlag GmbH & Co. KGaA, Weinheim, 2009, hardback, 210pp.,ISBN 978-3527324354
Why data exclusivity is the new patent protection
Authors: Pitts Peter J
Published: January 2017

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Follow-on biologic drug competition â€“ No need for new marketing exclusivities
Authors: Wroblewski Michael S , Jex Elizabeth A
Published: January 2017

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Pharmaceutical royalties in licensing deals: No place for the 25 per cent rule of thumb
Authors: Borshell Nigel , Dawkes Adrian
Published: January 2017

The 25 per cent rule of thumb is often quoted in the context of licensing royalty rates and, in particular, when deriving an appropriate rate of income due to a licensor for an individual asset. We have set out to conduct an in-depth analysis of historic market data from the pharmaceutical industry going back over 10 years to check on the validity of this concept and found little if any evidence of its use, appropriateness or relevance. An abundance of anecdotal references and attempts can be found to make deal making data fit this incongruous notion, and which does not have a sufficiently robust foundation to make its utility appropriate in the pharmaceutical and biotechnology sector. In this paper we review available data and present the case that the use of the 25 per cent rule is at best problematic and at worst inappropriate and misleading to the pharmaceutical and biotechnology industry. We look at the basic principles of value as they apply to the industry's intellectual property. Our conclusion shows that this rule has no suitable place in the arsenal of the thinking licensing executive.
Using IP audits to optimize IP assets
Authors: Cullem James G
Published: January 2017

Obtaining, maintaining and leveraging intellectual property (IP) rights on important or critical technologies requires a significant investment of both money and time. In the current challenging economic times, it is more important than ever for owners of IP assets to ensure those assets are yielding sufficient return-on-investment (ROI). This is true whether the owning entity is a corporation, an academic institution, an individual or a non-profit. In a typical organization, however, there is often a substantial percentage of underperforming IP assets in the portfolio. Conducting routine IP asset audits is one of the best management tools for regularly reviewing an IP portfolio and ensuring that individual IP assets within it are not idle and are yielding sufficient ROI.
Book Review: Health-care investing: Profiting from the new world of pharma, biotech and health-care services
Authors: LaSaracina Frank
Published: January 2017

Health-care investing: Profiting from the new world of pharma, biotech and health-care servicesLes FuntleyderMcGraw-Hill Professional, New York, 2009, hardback, 304pp.,ISBN: 978-0071597487
From carbon to carbohydrates: Corporate strategies for biopolymer technology development
Authors: Chadha Avrath
Published: January 2017

Since a few years the worldwide demand for biopolymers is increasing significantly. Many firms are trying to avoid the price spiral of fossil fuels by utilising renewable resources and simultaneously aim to contribute to the fight against climate change. Although market reports on biopolymer technology propose that with technological progress, economies of scale in manufacturing and hence lower costs the potential to substitute petrobased polymers by biopolymers will grow in the coming years, the extent of corporate strategies for industry-wide development of biopolymer technology are not well understood. This article evaluates the chances and risks of biopolymers by presenting results of a case study conducted with 10 German and Swiss firms active in the polymer industry. On the one hand the article demonstrates which importance biopolymers have gained meanwhile in the industry. On the other hand it also shows the different strategies firms apply in order to develop biopolymer technology successfully.
Made in India: Are you ready for outsourced contract manufacturing?
Authors: Lees Andrew , Khatri Sheila
Published: January 2017

Within the biotechnology industry, the number of USâ€“India collaborations is on the rise. However, there are several reoccurring problems many US firms identify in their collaborations, including smaller than expected cost savings, excessive time spent on managing relationships, production delays and missed deadlines. Oftentimes, these problems arise when there are cross-cultural disconnects in the style of doing business. A deep understanding of the cultural disconnects that are frequently at the root of problems in USâ€“India collaborations is generally not well appreciated by either side. This article seeks to shed light on cross-cultural issues that are typically not addressed in the biotechnology industry but based upon the authorsâ€™ personal experiences, and are an important component of a successful USâ€“India collaborative relationship.
Gene patent considered by English Court of Appeal
Authors: Webber Philip
Published: January 2017

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Book Review: Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry
Authors: Harber James
Published: January 2017

Biotechnology: A Comprehensive Training Guide for the Biotechnology IndustrySyed Imtiaz Haider and Anika AshtokCRC Press, 2009, paperback, 868pp.,ISBN: 978-1420084481
Key drivers influencing the commercialization of ethanol-based biorefineries
Authors: Chandel Anuj K , Singh Om V , Chandrasekhar Gajula , Rao Linga Venkateswar , Narasu Mangamoori Lakshmi
Published: January 2017

The imposition of ethanol derived from biomass for blending in gasoline would make countries less dependent on current petroleum sources, which would save foreign exchange reserves, improve rural economies and provide job opportunities in a clean and safe environment. The key drivers for successful commercial ethanol production are cheap raw materials, economic pretreatment technologies, in-house cellulase production with high and efficient titers, high ethanol fermentation rates, downstream recovery of ethanol and maximum by-products utilization. Furthermore, recent developments in engineering of biomass for increased biomass, down-regulation of lignin synthesis, improved cellulase titers and re-engineering of cellulases, and process integration of the steps involved have increased the possibility of cheap bioethanol production that competes with the price of petroleum. Recently, many companies have come forward globally for bioethanol production on a large scale. It is very clear now that bioethanol will be available at the price of fossil fuels by 2010. This article intends to provide insight and perspectives on the important recent developments in bioethanol research, the commercialization status of bioethanol production, the step-wise cost incurred in the process involved, and the possible innovations that can be utilized to reduce the cost of ethanol production.
Federal bureaucrats slip on oil spill
Authors: Miller Henry I
Published: January 2017

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Book Review: Biodesign: The process of innovating medical technologies
Authors: Tagg Randall , Bravo Catalina
Published: January 2017

Biodesign: The process of innovating medical technologiesStefanos Zenios, Josh Makower, Paul Yock, Todd J. Brinton, Uday N. Kumar, Lyn Denend, Thomas M. Krummel and Christine Kurihara (eds.)Cambridge University Press, Cambridge, UK, 2009, hardback, 778pp.,ISBN: 978-0521517423
Applying design thinking to biotechnology
Authors: Friedman Yali
Published: January 2017

I was recently invited to assemble a panel on applying design thinking to biotechnology for the conference, â€˜A Better World by Designâ€™, hosted by Brown University and the Rhode Island School of Design. This event was highly educational for me (and hopefully the other participants as well).Although many have been claiming that the business models used by biotechnology companies are flawed, and that the very structure of the biotechnology industry is likewise dysfunctional, there is a dearth of practical solutions. I am intrigued by the potential of applying design thinking to biotechnology, because it represents the introduction of a structured framework with a record of success in diverse areas. As a potential improvement to the often-narrow solutions directed by focused industry insiders, design-based solutions are often based on broad analysis and use a wide variety of interventions.Design thinking is a problem-solving protocol that emphasizes a deep definition of problems and open process to find and refine solutions. The basic elements of the design process are a thorough investigation of the problem (for example, the Toyota system of asking â€˜whyâ€™ five times to find the roots of an observed problem) followed by the creation of many possible options. These options are then refined and potentially reiteratively reconsidered until potential solutions emerge. This process is an alternative to a simple focus on addressing observed bottlenecks (for example, funding gaps or clinical trial transitions).Design thinking has been used to improve the design of many consumer goods, and in scientific disciplines it has been applied to improve the ergonomics of research tools, and even the bottles containing cell culture media.1, 2 However, my primary interest is the application to non-engineering areas such as the methodologies of discovery-stage research (for example, can design thinking improve on the scientific method?), development-stage activities such as lead optimization and clinical trials, and commercial-stage activities such as reimbursement and regulatory compliance.This issue of the Journal of Commercial Biotechnology presents brief commentaries from two panelists at the design conference, Patrick Nef from the Malaria Medicines Venture and Art Boni from Carnegie Mellon University, who describe the use of design thinking in their own work. I have also begun soliciting papers from groups with extensive expertise in the application of design thinking to biotechnology, and look forward to sharing their perspectives in future issues.References REFERENCES AND NOTESLife Technologies Corporation. (2010) Invitrogen earns AmeriStar award for GIBCO cell culture bottle design, http://www.lifetechnologies.com/news-gallery/press-releases/2009/invitrogen-earns-ameristar-award-gibco-cell-culture-bottle-design.html, accessed October 2010.Life Technologies Corporation. (2010) The new GIBCOÂ® bottle, http://www.invitrogen.com/site/us/en/home/Products-and-Services/Applications/Cell-Culture/CC-Misc/gibcoevolution.html, accessed October 2010.
Revitalizing portfolio decision-making at Merck Serono S.A. â€“ Geneva
Authors: Aurentz Vincent , Kirschbaum Bernhard , Thunecke Markus
Published: January 2017

Comprehensive, metric-based portfolio management yields well-known benefits such as increased transparency and the potential for greater objectivity in decision-making. However, the research and development (R&D)-driven characteristics of the pharma and biotech space call for further refinement of general techniques now in use. Because of the years-long timeline for the R&D of products and treatments, and because of similar horizons for testing and for securing regulatory approval, the growth, stability, and even survival of companies in this space are especially sensitive to the quality of portfolio management. In this article, we (1) briefly describe the history of portfolio management and the uneven results of its application in the R&D-centric pharma and biotech space; (2) identify eight factors which can limit the impact and quality of portfolio management in the space; (3) document a four-step process for portfolio management that directly addresses these factors; and (4) document the results of the implementation of this process in the post-merger period at Merck Serono S.A. â€“ Geneva.
The developments in the business models of biotechnology in the Central and Eastern European countries: The example of Estonia
Authors: Suurna Margit
Published: January 2017

In light of the current debate on the validation of the prevalent business models and trends taking place in the field of biotechnology in developed countries (see here in particular Pisano versus Glick), it is relevant to explore whether, and if so in which form and circumstances, the set arguments hold up and could be complemented by the context prevalent in transition countries. As one of the main concerns for the long-term development in the area relies on Pisano's argument that the sector is moving towards greater fragmentation, the deep analysis of that becomes particularly important in an environment where the very same problems are somewhat rooted in the local policymaking context and business environment. A specific example can be drawn here from the Central and Eastern European countries (CEE). Derived from this, the aim of the current article is to trace the trends in biotechnology business models in one of the rather well-performing CEE countries: Estonia. The article argues that the developments in the business models in Estonia are led by two rather contrary directions, where on the one hand increasing specialization and fragmentation and on the other hand movements towards geographical and institutional convergence can be detected.
Developing graduate skills for the United Kingdom's commercial life science sector: Experiences from the ORBIS internship programme
Authors: Gazzard James
Published: January 2017

The United Kingdom's commercial life science sector is dependent on a pipeline of skilled professionals to retain a leading position in a globally competitive sector. Work placements are one of a range of approaches available to support the development of the required graduate-level knowledge, skills and attitudes. This article describes the design, implementation and outcomes of the ORBIS (Overcome Recession: Bioscience Investment in Skills) Bioscience Graduate Internship Programme. ORBIS provided a paid 26-week programme of work-based learning for 60 recent graduates and postgraduates, mentoring partnerships and a series of training days for interns and their line managers focused on known sector skills deficits. The programme was found to positively impact on the skills development and employability of interns, and was broadly welcomed by industry. The programme's outcomes emphasised that work placements must be thoughtfully developed to meet the specific demands of participants and the critical need to provide an adequate quantity of high-quality work placements in order to support the development of key scientific and commercial skills. The findings are of broad relevance to training providers in industry and academia, and educational policy makers.
Anticipating opportunities in industrial biotechnology: Sizing the market and growth scenarios
Authors: Nieuwenhuizen Peter J , Lyon David
Published: January 2017

Bio-based chemicals are being touted as the next big thing for the chemical industry and its customers. In particular they can offer significant opportunity for the chemical industry and its customers through cost reduction, delivering unique functionality and/or marketing benefits. This article undertakes to better characterize the make-up of the bio-based chemical industry, in terms of technology platforms employed and sales, as well as to develop scenarios for the growth of the bio-based chemical market. As can be shown, the market for bio-based chemicals is comparatively small, 50â€“75 Bn EUR or 3â€“4% of global chemical industry sales. Future growth is strongly determined by a number of high-uncertainty developments including technology breakthroughs and government policy. It can nevertheless be concluded that bio-based chemicals sales will continue to grow and outpace general chemical industry growth. In particular, the dedicated production of chemicals through biocatalysis and fermentation is expected to exhibit strong growth in all scenarios. However, a wholesale transformation of the industry is not expected, with bio-based chemicals constituting another option in the chemical industry toolkit, causing a more or less gradual shift from a petroleum-based industry towards one with additional feedstock options.
EU Legal and Regulatory Update
Authors: Kamstra Gerry
Published: January 2017

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Technology Transfer
Authors: Leung Karling Alice
Published: January 2017

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