bluuebunny/crossref_metadata_2025 huggingface dataset:
Country-of-origin effect of VC investment in biotechnology companies
Authors: Ang Siah Hwee
Published: January 2017

Biotechnology companies can access financial and management resources through venture capitalist (VC) firms. An analysis of 1,490 VC investments shows that country-of-origin (CO) of biotech companies has an effect on the participation by VC firms in various biotech subsectors. Specifically, it is found that US biotech companies tend to have higher amount received per VC firm, greater number of VC firms investing in them and greater biotech investment experience of the investing VC firms. Asia-Pacific biotech companies have consistently less VC firms investing in them and these investing VC firms tend to have less biotech investment experience. VC firms with greater biotech investment experience are also investing in European biotech companies more than those from the Americas less US. CO also correlates with outcomes in the four of the six key biotech subsectors studied. These findings suggest a strong CO effect of VC investment in biotech companies.
Legal and regulatory update
Authors: Wilkinson John
Published: January 2017

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In defence of science-based regulation
Authors: Miller Henry
Published: January 2017

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New path to profits in biotech: Taking the acquisition exit
Authors: Behnke Nils , HÃ¼ltenschmidt Norbert
Published: January 2017

The paper aims to demonstrate that biotech start-ups increasingly are choosing trade sales to large pharma or biotech players to move their drug discoveries into the marketplace. It draws on Bain & Company analysis to show that this can provide higher return on investments than an initial public offering, or IPO, once the traditional exit for entrepreneurs and venture capitalists (VCs), but now far less common, and in a shorter time. It argues that pharma companies, VCs and biotech firms need to adapt their approaches to this shift and identifies new priorities for each of these key actors in the sector. In addition to its central thesis, the reader will take from the paper analysis of historical biotech trade sale and IPO data; analysis of pharma companies' strategies for and results from licensing and acquisition deal making; analysis of VCs' strategies for and results from biotech investments; and analysis of biotech companies' strategies for and results from crystallising the value of drug discoveries. The latter includes the recommendation of a 'parallel trade' approach that seeks maximum flexibility by preparing the company for both IPO and trade sale.
A maturing industry: Strategic patenting trends, US and academic dominance, and the global biotechnology landscape
Authors: Williams Gareth
Published: January 2017

Patent analytical data has proved itself a key enabler in measuring the commercial focus and activity taking place within highly research and development (R&D) intensive industries such as biotechnology. Marks & Clerk has assessed biotechnology patent application and grant records from a range of international patent office and proprietary databases, with a view to gauging the industry's commitment to R&D and the particular areas of biotechnology that are attracting investment. Using this research, this paper seeks to provide a snapshot as to the current 'state of play' across the biotechnology sector, looking at strategic trends, technological focus and industry dominance. It also seeks to analyse indicators as to the future commercial development of the industry.
Measuring performance of field-medical programmes: Medical science liaison metrics consensus
Authors: Chin Jane
Published: January 2017

A Medical Science Liaison (MSL) Metrics Consensus initiative aims to identify field-medical activities throughout the pharmaceutical product lifecycle, and metrics associated with those activities. Since MSL programme deployment strategies may vary from company to company, pharmaceutical executives often use retrospective benchmarking studies to assist their field-medical teams in establishing programme metrics. This Medical Science Liaison Metrics Consensus initiative is the first of its kind to identify activities that are unique to field-based MSL team capabilities. Upon identification of unique contribution of MSL teams across the product lifecycle, metrics were identified and associated with MSL activities across the product lifecycle, with an emphasis on outcomes and compliance. Organisations may use the results of this Medical Science Liaison Metrics Consensus to proactively assess and design their MSL programmes' current valuation standards.
Editorial
Authors: Henderson Neil
Published: January 2017

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Development of Cuban biotechnology
Authors: Mola Ernesto LÃ³pez , Acevedo Boris E. , Silva Ricardo , Tormo Blanca , Montero Ricardo , Herrera Luis
Published: January 2017

The emergence and expansion of biotechnology in Cuba as a new branch of the economy provide a good example of the challenges faced by a high-technology sector which deserves analysis. There are already clearly visible results in this sector such as investment in the research and production infrastructure, a qualified workforce, high-quality research and good product pipelines in the Cuban health system coupled with a growing export capacity, supporting a positive cash flow. These advances have been aided by the integration of research-production organisations, state funding, social ownership, export orientation and the comprehensive integration of the Cuban biotechnology multi-institutional system. In the forthcoming years, the future development of this sector in Cuba should produce a more evident impact on the economy and Cuban society.
Investing in new medical technologies: A decision framework
Authors: Cosh Emma , Girling Alan , Lilford Richard , McAteer Helen , Young Terry
Published: January 2017

Purchasing and reimbursement decisions in healthcare systems with finite resources are increasingly influenced by formal health economic analysis. It is therefore sensible for a company considering the development of a new medical technology to assess its potential cost effectiveness as early as possible in the development cycle. This document describes a process by which an organisation can add rigour to decisions about which technologies to pursue, as well as creating a persuasive argument for outside investment. The process consists of a series of analyses that should be conducted before substantial investments are made. The stages of the algorithm are: strategic considerations, clinical problem definition, headroom analysis, return on investment analysis and further economic analysis. This paper concentrates on the clinical problem definition and headroom analysis aspects of the process. Two worked examples of calculating headroom for theoretical products in tissue engineering of urogenital tissue are given. The health gain in urethral tissue is unlikely to be sufficient to justify the cost of a regenerative medicine solution, whereas bladder substitution after tumour resection has the potential to be cost effective providing marginal costs do not exceed Â£16,000. The framework discussed here provides a structure for investment decisions that can illuminate a situation, which may otherwise appear hard to fathom. A headroom analysis is primarily useful as a barrier to misguidedly investing in those devices, which can never be cost effective.
Innovative capabilities and strategic alliances: Who is gaining what in the pharmaceutical industry?
Authors: Ohba Marisa , Figueiredo Paulo N
Published: January 2017

There have been several respected studies, from a capability-based perspective, pointing to the emergence of a new division of innovative labour in the pharmaceutical industry over the past decades. We still, however, miss empirical evidence relative to the implications of collaborative arrangements, like strategic alliances, for the innovative capabilities of companies involved in such collaborative arrangements. Drawing on a scrutiny of specialised databases (GalÃ©, Dialog, and Business & Industry) covering the 1993â€“2003 period, this paper examines the entry and exit composition of innovative capabilities of 25 pharmaceutical companies' capabilities involved in such alliances. They are organised in three groups: (i) large pharmaceutical companies ('big-pharma'); (ii) large bio-pharmaceutical companies ('bio-pharma'); and (iii) small and research-intensive companies. The evidence shows the extent to which each of these three types companies, particularly large companies, benefit from these alliances in terms of absorption of strategic pieces of innovative capabilities. Such type of evidence is important to provide researchers, corporate managers, and policy makers with a concrete notion of some features of the nature of such division of innovative labour that occurs and the actual changes going on in the structure and organisation of innovative activities in the pharmaceutical industry.
Book Review: Global Governance of Food and Agriculture Industries
Authors: McHughen Alan
Published: January 2017

Global Governance of Food and Agriculture Industries Edited by Reba A. Carruth Edward Elgar Publishing, Cheltenham, UK ISBN 978 1 84376 196 9; 2006; 496pp;
Book Review: The International Politics of Genetically Modified Food: Diplomacy, Trade and Law
Authors: Paarlberg Robert
Published: January 2017

The International Politics of Genetically Modified Food: Diplomacy, Trade and Law Robert Falkner Palgrave Macmillan, Basingstoke, UK; ISBN 0 230 001 254; November 2006; 280 pp;
Biotechnology in India: Publicâ€“private partnerships
Authors: Konde Viren
Published: January 2017

As the purpose of this study was a survey of public sectorâ€“private industry collaborations of the biotechnology sector in India, an organisational and functional overview of this sector was needed. Therefore, rather than studying a hypothetical biotech sector in India, the focus of this work was to study the publicâ€“private partnerships (PPP) that are occurring in India in the area of modern biotechnology. The Indian Government has been playing an important role in the development of the Biotech sector from the very beginning and there are large numbers of R&D institutions (Scientific, Medical, Industrial and Agricultural) that have been set up by the Government during the past 2â€“3 decades. The Indian Biotechnology industry is advancing towards new heights in alignment with the growth and progression observed globally. The past performance of the industry indicates that it has surpassed the growth rate of many other industries. This paper also highlights the favourable national policies undertaken to strengthen the Indian biotechnology industry. It is in this context that the paper shows that these collaborations are an expression of more general trends towards a changing role of the country in economic production.
Globalising clinical development in Japan
Authors: Tabata Yorozu , Albani Chris
Published: January 2017

Most global pharmaceutical companies, no matter where they are headquartered, are struggling to effectively integrate their Japanese operations into a new global structure. In the past, companies would have worked on development plans for the whole world â€˜except Japanâ€™. But those days are quickly evaporating and companies need to set out in a new direction. Japan is taking part in the trend for globalising clinical trials. Companies are working hard to leverage global operations and are quickly taking advantage of the opportunities offered by the Japanese government. Two typical approaches have emerged to address this emerging tide of globalisation. The first of these can be called, â€˜mirror image myopiaâ€™ and the second, â€˜Japan-centred syndromeâ€™. Both of these approaches are attractive at first glance. However, the practicalities of the current environment demand that companies not try for a quick-hit, generic approach but rather a customised approach that matches their global strategy. Some practical ideas are presented to help avoid common pitfalls in globalisation relative to your Japan operations. In the end, by taking a balanced, strategic approach, companies can make the most of their global operations in Japan â€“ whether these be Japan-based or globally based organisations.
A new approach to improve technology commercialisation in university medical schools
Authors: Price Courtney , Huston Richard , Meyers Arlen D
Published: January 2017

US university-based technology transfer has grown exponentially since the passage of the Bayhâ€“Dole Act in 1980. As a result, invention disclosures and technology commercialisation initiatives have significantly increased, creating the need for a standardised, qualitative method of screening proposals that might have commercial potential. Successful academic bioscience technology commercialisation is difficult at best because of early stage bioscience inventions, faulty concepts, long lead times, high risk technologies, and working with physicians and medical researchers who frequently have little or no interest in the commercialisation process. We describe an easy-to-use, standardised, web-based technology assessment instrument that was used to better evaluate bioscience invention disclosures at the University of Kansas School of Medicine Technology Transfer Office. After implementing the new system and eliminating backlogged invention disclosures, staff reported that they migrated from very qualitative discussions taking many months to more quantitative, fact-based evaluations and discussions focusing on commercial value. Consequently, they reported making quicker and improved Go-No-go decisions investing further resources in only those technologies with the highest potential for commercialisation. In addition, they improved inventor satisfaction and strengthened their relationships with physicians, inventors, and researchers.
Valuing biotechnology companies: Does classification by technology type help?
Authors: Loh Jacqueline , Brooks Robert
Published: January 2017

This paper explores whether conventional financial ratios can be used for portfolio construction in the biotechnology sector after the companies are classified into groups based on technology platforms such as DNA, biochemistry and bioprocessing technologies. We find some success in the use of financial measures after the classification is made indicating that they do a better job when comparing like firms. Appropriate risk adjustment is, however, critical to determining if superior performance is attained. This remains a challenge due to the difficulties in finding appropriate risk measures for the sector.
Risk management for the biotechnology industry: A Canadian perspective
Authors: Vanderbyl Sandra , Kobelak Sherry
Published: January 2017

In order to break down industry barriers and decrease failure rates, biotechnology companies require a sophisticated risk management plan. Biotechnology is an industry sector where a high failure rate for companies is considered the norm. The opportunity for high-profit levels is what currently drives the industry and sustains investment even in the backdrop of the elevated risk. A recent survey of senior management of Canadian biotechnology companies identified the industry's key risk and growth factors and allowed for the development of models of the changing profiles over the product lifecycle. The model for company growth reinforces that a company's dependence on funding decreases during product development as product distribution and generated profits support company growth. The model for company risk exemplifies that risk is higher earlier in development and decreases with expanding market exposure. These models provide a framework to build an infrastructure to position companies in the knowledge-based economy. In order for biotechnology companies to mitigate risk, they need solid corporate governance with adequate resources to develop a risk management plan. Making the risk management plan part of the strategic plan and the strategic planning process improves a company's ability to manage growth and to compete in the local and global economy. This paper investigates what the industry growth and factors are from a Canadian perspective, how risk factors can be managed by developing a risk mitigation plan and how risk impacts the industry's success as a whole.
Singapore's biomedical sciences landscape
Authors: Yeoh Keat-Chuan
Published: January 2017

Singapore's vision is to be the Biopolis of Asia, a leading international biomedical sciences cluster advancing human health, through the pursuit of excellence in research and development, manufacturing and healthcare delivery. To achieve this, Singapore has built up world-class capabilities across the entire value chain from drug discovery, development and clinical research, to manufacturing and healthcare delivery. In the year 2000, Singapore's Biomedical Sciences (BMS) initiative was launched to establish a focused effort on the development of this sector as the fourth pillar of Singapore's industry cluster, alongside electronics, chemicals and engineering. The BMS initiative covers the Pharmaceutical, Biotechnology, Medical Engineering and Technology and Healthcare Services industries. An integrated strategy was adopted for the development of the BMS sector, focusing on Human Capital, Intellectual Capital and Industrial Capital, or 3 Cs in short. The first phase of the BMS initiative (2000â€“2005) put in place key building blocks by establishing core capabilities in biomedical research, and introducing important human capital and industrial capital development initiatives. For the next phase (2006â€“2010), we will build on this foundation and strengthen our capabilities in translational and clinical research to bring discoveries from the bench to the bedside and the marketplace, and ultimately improve human healthcare.
Social responsibility for the use of genes, genomes and biotechnology in biotechnology companies: A commentary from the bioethical viewpoint
Authors: Okada Yoshihiro , Watanabe Kazuo N
Published: January 2017

Corporate social responsibility (CSR) is discussed, targeting a broad range of industries. As yet, little work on CSR has focused on the specific situation of each industry. The biotechnology industry is unique in that companies use the genes and genomes of plants, animals, and humans, as well as biotechnology in their business. Public concern about genes and genomes centres on their inappropriate use or application in either research or business. This paper proposes a new CSR component for biotechnology companies: taking responsibility for the use of genes, genomes, and biotechnology (GGB) by adopting environmental ethics and bioethics. Environmental ethics is proposed as the ethical root of the environmental responsibility that companies take. The principles of environmental ethics are inductively reasoned from actual business activities, and towards the achievement of environmental responsibility. CSR for the use of GGB is deductively derived from the principles of bioethics and genetic ethics.
Maryland and Virginia unite at 2007 Mid-Atlantic Bio Conference
Authors: King Harley
Published: January 2017

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Connecting product innovation management and marketing
Authors: Pitt Leyland , McCarthy Ian
Published: January 2017

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New pharmaceutical product development: Barriers to overcome and opportunities to exploit
Authors: Terblanche Nic S
Published: January 2017

The pharmaceutical industry experienced an unprecedented rate of increase in the cost of developing new drugs while the number of new drugs that were approved and accepted in the marketplace has reached a very low level. Various factors are responsible for this state of affairs. One of the major opportunities available to the pharmaceutical industry to improve this situation is to collaborate with the biotechnology industry. The future solutions to a host of current diseases as well new strains of existing ones lie in the cooperation between these two industries. The pharmaceutical industry will, however, have to carefully manage challenges such as increased governmental control and the damaged image of the industry. There are many opportunities offered by offshoring, advanced application of information technology, climate change and a new approach to sales and marketing, all of which the pharmaceutical industry can exploit. Should the pharmaceutical industry manage to address the issues responsible for the high costs prevalent in the industry, its role as partner with the biotechnology industry could prove to be very beneficial for both these industries.
The biotechnology and marketing interface: Functional integration using mechanistic and holographic responses to environmental turbulence
Authors: Berthon Pierre , Pitt Leyland , Nel Deon , Salehi-Sangari Esmail , Engstrom Anne
Published: January 2017

This paper serves to specify and ground research into interfunctional integration in a wider theoretical context with particular reference to the interaction between technology and marketing in the biotechnology sphere. The general and specific problem areas are specified as those of interfunctional relations and the dyadic relationship between marketing and biotechnical managerial functions in particular. The contextual/organisational generative mechanisms that are likely to keep interfunctional relations at the centre of scholarly attention for some time are explored from the perspective of cybernetic theory. The law of requisite variety states that in an effective open system environmental variety is matched by internal structural variety. As organisations are faced with ever more turbulent, and complex environments, this must be matched by an increased internal complexity within the organisation. The two modes of response, namely holographic and mechanistic, both highlight the need to further our understanding of interfunctional differences. Having established the problem and its genesis, a specific research agenda is outlined as the exploration of the interfunctional differences from a decision-making perspective.
Anticipating and managing the challenges of biotechnology marketing
Authors: RajamÃ¤ki Heidi
Published: January 2017

Biotechnology companies are facing the reality that greater emphasis must be placed on delivering products to markets as companies become increasingly evaluated on their profitability. Potential risks related to markets and technologies have to be evaluated as realistically as possible to avoid mistakes. This paper discusses the features that make biotechnology marketing different from more established industries as well as the key challenges arising from those differences. This paper draws attention to issues that are distinctively important in biotechnology marketing. First, profound technological uncertainty is a key characteristic of biotechnology. Secondly, side effects emerging after the product has been in the market can cause a shutdown of an entire product line or cut down estimated market potential. Thirdly, a biotechnology product's lifecycle can also face premature death due to challenges originating from market uncertainties. A fourth issue is the threat of obsolescence that is high in a market where new innovations are introduced at a rapid rate. A fifth issue is the capability of protecting intellectual property rights. Finally, these challenges make it difficult to estimate the size of a potential market. Controlling these challenges, however, gives a solid base to make a biotechnology company a profitable business.
Using brand personality to assess whether biotechnology firms are saying the right things to their network
Authors: Papania Lisa , Campbell Colin , Opoku Robert Ankomah , Styven Maria , Berthon Jean-Paul
Published: January 2017

Through their websites, biotechnology firms communicate information about themselves and their products to other members of their networks. These networks are made up of an array of organisations with which biotechnology firms collaborate on product development projects, and on whom they rely for funding, and/or marketing and production. Therefore, it is important that the information communicated by firms' websites portrays them in the light they wish to be perceived by others. Despite its importance, biotechnology firms, however, do not prioritise branding or the development of a brand personality. By using demonstrated content analysis methodologies, our study shows that biotechnology firms are nonetheless portraying brand personalities online, even if unintentionally. We show that, by using the same methodologies, managers in biotechnology firms can monitor and manage their firms' brand personalities to ensure that the words they communicate online present an appropriate and attractive image of the firm to their communities. We extend previous research in the area of brand personality and show its application in and importance for the biotechnology industry.
Remembering Epimetheus: Biotechnologies and the market
Authors: Berthon Pierre , Pehlivan Ekin , DesAutels Philip
Published: January 2017

We all remember Prometheus (forethought, projection), but he makes little sense without his counterpart and brother Epimetheus (afterthought, reflection). Our stance towards biotechnology has all too often been compared with Frankenstein's handling of the creature he gave life to. Indeed it is no coincidence that Mary Shelley's book Frankenstein was subtitled â€˜The Modern Prometheusâ€™. Marketers, like scientists, have tended to project their vision of a technology's interaction with society and the natural world â€“ and time and time again the hiatus between vision and reality has manifest as a yawing fissure. In this paper, we take an Epimethian approach to the interaction of biotechnology and the market; specifically, we reflect upon the intentional and emergent trajectories that biotechnology can trace within the marketplace using a model developed by Berthon et al. We argue that such reflections can help scientists and marketers better understand the complex dynamics of biotechnology and the market: we remember Epimetheus to ameliorate our Promethean suffering.
Legal and regulatory update
Authors: Kamstra Gerry , Wilkinson John
Published: January 2017

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Book Review: The Regulatory Challenge of Biotechnology
Authors: Avellanet John
Published: January 2017

The Regulatory Challenge of BiotechnologyHans SomsenEdward Elgar Publishing, Cheltenham, UK;ISBN: 978 1 84542 489 3; 2007; 265pp; hardback
Book Review: Commercializing Successful Biomedical Technologies
Authors: Meyers Arlen D
Published: January 2017

Commercializing Successful Biomedical TechnologiesShreefal S. MehtaCambridge University Press, Cambridge, UK;ISBN 978 0 521 87098 6; 2008; 335pp; hardback
Genetic Glass Ceilings: Transgenics for Crop Biodiversity
Authors: Kershen Drew L
Published: January 2017

Genetic Glass Ceilings: Transgenics for Crop BiodiversityJonathan GresselJohns Hopkins Press, Baltimore;ISBN: 978 0 8018 8719 2; 2008; 488pp; hardback
Welcome to Biotech Nation
Authors: Rogers James
Published: January 2017

Welcome to Biotech NationMoira A. Gunn, PhDAMACOM, New York, NY;ISBN: 978 0814409237; 2007; 258pp; hardback
Biotechnology commercialisation: Getting past the technology-push
Authors: Friedman Yali
Published: January 2017

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NIH assistance for new therapeutic development: NIH-RAID Pilot Program
Authors: Badman David G
Published: January 2017

The National Institutes of Health (NIH) wishes to alert the biotech/medical research community to an opportunity to obtain assistance in the development of new therapeutic agents. The NIH Roadmap has established a pilot programme, the NIH-Rapid Access to Interventional Development (RAID) Pilot, to make available, on a competitive basis, critical resources needed for the development of new small-molecule or natural product-derived therapeutic agents. This programme, part of the Translational Research component of Reengineering the Clinical Research Enterprise, uses resources of NCI's Developmental Therapeutics Program. Services provided depend upon the project and strength of the preliminary data. Services potentially available include bulk supply, GMP manufacturing, formulation, assay development suitable for pharmacokinetic testing, and animal toxicology. Assistance can also be provided in the regulatory process. Currently, animal efficacy studies and synthesis of recombinant proteins, monoclonal antibodies, or reagents for gene therapy are not supported. The NIH-RAID Pilot will, however, consider requests for services to support later-stage preclinical development of monoclonal antibodies, recombinant proteins, and gene therapy agents. Additionally, the NIH-RAID Pilot will now consider requests for the manufacture of small-molecule or natural product material for any clinical study. Proposals must originate from academic or non-profit investigators, but collaboration with industry partners is encouraged.
ATMP in practice: Towards a new industry landscape in tissue engineering
Authors: BrÃ©vignon-Dodin Laure , Singh Pawanbir
Published: January 2017

Regulatory divergences and market fragmentation across member states have hampered the development of the tissue engineering industry in the EU. Addressing this situation by providing a harmonised and more predictable regulatory regime, the regulation on advanced therapy medicinal products (ATMPs) is based on a regulatory strategy that aims to consolidate the increased activity in the domain of regenerative medicine while maintaining the pace of technical development and innovation in this area. The regime draws together the professional expectations of ATMP developers by aiming for a harmonised market access and for providing legal certainty for all stakeholders and concurrently assuring safety and quality of these products to render highest standard of health protection to patients. Still a work in progress as its technical guidelines are in drafting and as it will only apply from December 2008, the ATMP Regulation, which comprises several small and medium sized enterprises (SMEs) friendly provisions, is nevertheless anticipated to have significant impacts on developers. This paper considers some of them.
The implementation of a proseminar course to lead change in the MS.MBA biotechnology programme at Johns Hopkins University
Authors: Langer Lynn Johnson
Published: January 2017

Complications arose in a new dual MS.MBA Biotechnology Programme at Johns Hopkins University when two separate schools and degree programmes joined together to create a joint degree. Students and administrators struggled to create a seamless programme that was hindered by administrative difficulties in registration, but also by students who often did not fully understand the complexities and the interrelationships between the various segments within the biotechnology industry. A new course was created and taught by a co-director of the programme. The course was intended to help alleviate some of the struggles students were experiencing regarding the technical aspects of the programme, and to introduce them to the interconnectedness of various industry components. Students were able to network with industry leaders and learn critical thinking skills necessary to become leaders in the industry.
Creating bioentrepreneurs: How graduate student organisations foster science entrepreneurship
Authors: Brown Justin T , Kant Andrew C
Published: January 2017

Despite an increase in life science technology commercialisation and venture creation, graduate schools have largely failed to provide ample opportunities for students to acquire knowledge and experience in bioentrepreneurship. Postdoctoral trainees and graduate students have recognised this educational gap, as well as a role in complementing university-run bioentrepreneurship programmes, and formed student organisations that foster bioentrepreneurship education. These groups are uniquely positioned to facilitate campus bioentrepreneurship. This paper identifies life science graduate student organisations and examines how these groups promote bioentrepreneurship in their respective communities. This report also discusses the challenges and advantages of student groups, and identifies best practices for development of bioentrepreneurship programmes. Furthermore, the authors propose a framework for identifying gaps in bioentrepreneurship education.
Creating alternatives in science
Authors: Gravagna Nicole G
Published: January 2017

Traditional scientist training at the PhD level does not prepare students to be competitive in biotechnology or other non-academic science careers. Some universities have developed biotechnology-relevant doctoral programmes, but most have not. Forming a life science career club makes a statement to university administrators that it is time to rework the curriculum to include biotechnology-relevant training. A career club can supplement traditional PhD training by introducing students to available career choices, help them develop a personal network and teach the business skills that they will need to be competitive in science outside of academia. This paper is an instructional guide designed to help students create a science career club at their own university. These suggestions are based on the experience gained in establishing such a club for the Graduate School at the University of Colorado Denver. We describe the activities that can be offered, the job descriptions for the offices required and potential challenges. With determination, a creative spirit, and the guidance of this paper, students should be able to greatly increase awareness of science career options, and begin building the skills necessary to become competitive in non-academic science.
The Bioentrepreneurship MBA: Options for mid-tier business schools
Authors: Back Susan Malone
Published: January 2017

Most successful Bioentrepreneurship MBA programmes are located in major metropolitan areas described as â€˜biotechnology clustersâ€™. The present study focuses on the demographics and characteristics of a private research university to determine the feasibility of offering such a programme and the appropriate format(s) for its delivery. Recommendations include that a school should not initiate a Bioentrepreneurship MBA until there is regional demand for graduates and sufficient university expertise in areas such as regulatory issues, technology transfer and bioenterprise ethics. A conservative approach would devote 1 year to curriculum and expertise development, during which the school could supplement its present MBA programme with elective courses aimed at current MBA students. A line extension of MBA with electives could also be offered to the emerging markets of (a) mid-level non-technology managers seeking biotechnology employment and (b) laboratory technicians wishing to develop business expertise. Thereafter, the school could launch an MBA programme aimed at its broader potential student market. Provision should be made for individuals not interested in obtaining an MBA to take selected courses and for those desiring a certificate. It is concluded that the issues unique to the subject area warrant its recognition as both a career and academic discipline.
The correlation between medical tourism and biotechnology
Authors: Vequist IV David G , Valdez Erika
Published: January 2017

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Multiyear patterns regarding the relative availability of venture capital for the US biotechnology industry
Authors: Glick J Leslie
Published: January 2017

Venture capital (VC) funding of US biotechnology companies was analysed relative to total VC investments placed in US companies from 1995 to 2007. During those years, except for a spike because of the dot-com bubble from 1999 to 2001, VC funding of US biotechnology companies grew at a faster rate percentagewise than total VC funding of US companies, with respect to annual dollars invested, number of deals closed and the mean dollar investment. Start-up and early-stage VC funding of US biotechnology companies also grew at a faster rate percentagewise, with respect to all three parameters, than total start-up and early-stage VC funding of US companies. It was further observed that long-term trends in the availability of VC for biotechnology do not appear to be affected by perturbations in the financial markets and short-term fluctuations in the availability of VC. It was concluded that the biotechnology industry should continue to attract VC over the long run particularly because of the emerging impact of personalised medicine and the coming of age of bioenergy.
Book Review: Commercialization of innovative technologies: Bringing good ideas to the marketplace
Authors: Meyers Arlen D
Published: January 2017

Commercialization of innovative technologies: Bringing good ideas to the marketplaceC Joseph Touhill, Gregory J Touhill and Thomas A O'RiordanJohn Wiley and Sons, Hoboken, New Jersey, USA, 2008, hardback, 252pp.,ISBN: 978-0470230077
Innovation and commercialisation in the stem cell industries in Australia: State strategies and other opportunities to build a competitive position in the global stem cell economy
Authors: Harvey Olivia
Published: January 2017

Recent research in the social studies of stem cell science has demonstrated that there is (a) a significant global economy emerging around stem cell science, and (b) that individual states are competing fiercely in an effort to obtain leadership in this global stem cell economy. Over the last several years, the governments of the United Kingdom, China, India, Canada, Singapore and Australia (among others), have been attempting to leverage the process of innovation in stem cell science by implementing a variety of strategies including, but not limited to: dedicated funding programmes, the introduction of specific licensing systems, the implementation of new regulations for human cell-based material, emulating US-based venture capital, and encouraging entrepreneurship and spin-off developments. What remains to be seen though, is how effective such attempts actually will be in encouraging the commercial development of nationally oriented stem cell industries. Given that the relationship between innovation and commercialisation is unique to national and regional contexts, as well as unique to specific industries, this article discusses the specific strategies adopted in developing the stem cell industries in Australia and highlights some of the pros and cons with a government interventionist approach to developing global economic advantage from national and regional innovation.
Book Review: Aging, Biotechnology, and the Future
Authors: King Harley
Published: January 2017

Aging, Biotechnology, and the FutureCatherine Y. Read, Robert C. Green and Michael A. SmyerThe Johns Hopkins University Press, Baltimore, 2008, hardback, 250pp.,ISBN: 978-0801887888
Biotechnology marketing: Insider and outsider views
Authors: Eriksson PÃ¤ivi , RajamÃ¤ki Heidi
Published: January 2017

This paper explores biotechnology marketing as defined, performed and organised in small biotechnology companies. Prior research has argued on the one hand that marketing-related deficiencies could explain the lack of commercial success in biotechnology. On the other hand, it has been suggested that biotechnology marketing could be different from what is considered marketing in other industries. This raises the question of whether there are deficiencies in biotechnology marketing or whether the meaning of biotechnology marketing remains unexplored with the survey-based research designs used in earlier studies. This paper is based on a novel qualitative methodology combining the insider and outsider views in the study of five cases of biotechnology marketing. The findings do not suggest that there is substantial lack of marketing effort and competence in biotechnology companies. Instead, the findings provide new knowledge on the specific nature of biotechnology marketing produced by a combination of the insider and outsider views.
The current M&A environment and its strategic implications for emerging biotherapeutics companies
Authors: Sowlay Mohan , Lloyd Scott
Published: January 2017

The age of the blockbuster drug may have come and gone. With dwindling pipelines and increasing generic competition, pharmaceutical companies continue to create efficiencies through mergers and acquisitions (M&A). Increasingly, the pharmaceutical industry is turning to biotechnology companies to drive new product innovations. As part of this evolving paradigm, biotechnology companies with deep therapeutic product pipelines â€“ â€˜biotherapeutics' companies â€“ protected by sound intellectual property rights are becoming ever more attractive targets for M&A. This is likely due to the facts that biotherapies command high reimbursement rates due to high efficacy and reduced toxicity, and are less vulnerable to generic competition due to technical and regulatory barriers. As a result, M&A has offered high returns to investors in recent years at a time when public markets have declined. In order to attract a purchaser, small biotherapeutics companies must develop product pipelines in a strategic manner, defining the target markets accurately and patenting technologies needed to protect shares of those markets. This article discusses the strategic considerations a biotherapeutics company should make as part of its exit strategy, as well as examples of how those considerations are represented in the current pharmaceutical M&A landscape.
Funding the dream at the Mid-Atlantic Biotech Conference
Authors: King Harley
Published: January 2017

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Book Review: Getting to Plan B: Breaking through to a better business model
Authors: Meyers Arlen D
Published: January 2017

Getting to Plan B: Breaking through to a better business modelJohn Mullins and Randy KomisarHarvard Business School Press, Boston, MA, 2009, hardback, 249pp.,ISBN: 978-1422126691
Book Review: Driving innovation â€“ Intellectual property strategies for a dynamic world
Authors: Marenberg Barry J
Published: January 2017

Driving innovation â€“ Intellectual property strategies for a dynamic worldMichael A. GollinCambridge University Press, New York, 2008, paperback, 415pp.,ISBN: 978-0521701693
Book Review: Intellectual property, medicine and health: Current debates
Authors: Kowalski Stanley P
Published: January 2017

Intellectual property, medicine and health: Current debatesJohanna GibsonAshgate, Farnham, England and Burlington, VT, USA, 2009, hardback, 223pp.,ISBN: 978-0754672180
Increasing clarity
Authors: Friedman Yali
Published: January 2017

The fates of biotechnology companies, like those in many other dynamic industries, depend on the outcome of future events, which can be difficult to predict. Seemingly late-stage issues such as regulatory uncertainty dissuade investors, stalling innovation and company growth. Accordingly, increased definition of regulatory processes and opportunities for profitable investment exit can improve the financing climate, and drive innovation. In my editorials earlier this year I have commented on the numerous uncertainties the biotechnology industry faced. What a difference a few months makes! Recent events have clarified several important issues.Although obtaining financing in biotechnology has seldom been described as easy, the situation is far better now than it was a year ago. With a large number of companies having less than a year's cash on hand, there was a strong fear that a majority of biotechnology companies would go bankrupt. This fear was not realized, and it appears that companies were able to adjust their burn rates and fundraising activities to accommodate the financial challenges. While many jobs were cut and R&D scaled back, mass-bankruptcy now seems unlikely and the industry stands well positioned for growth.The passage of the health reform bill has also had a profound impact. Important issues such as the approval pathway for generic biologics and data exclusivity for branded biologics are now better defined. The FDA has been empowered to approve follow-on biologic drugs, and biologic manufacturers have been granted 12 years of exclusivity. For more discussion on biologic exclusivity, see the two commentaries on the topic in issue 16.1.1, 2These important clarifications are offset by some important unresolved issues: The Small Business Innovation Research program, which is an important source of gap financing between academic and development-stage research for American companies, is overdue for reauthorization. While the US congress has failed to renew the program, it appears that the program will continue to be extended through annual 1-year â€˜puntsâ€™. Another pressing issue is approval time for biologic drugs. While the FDA approved 16 biologic drugs in 2009 â€“ reversing a declining trend â€“ it appears that approval times are increasing. So it appears that while development-stage funding and follow-on biologic approval are becoming better-defined, other issues may be taking their place as key issues.NETWORK ON LinkedInThe Journal of Commercial Biotechnology has a networking group on LinkedIn. You can use this forum to discuss papers, to post jobs, to announce industry events and company updates, and for general networking. The JCB networking forum is available at www.linkedin.com/groups?gid=1241807&trk=hb_side_g. See you there!References Pitts, P.J. (2010) Why data exclusivity is the new patent protection. Journal of Commercial Biotechnology 16 (1): 3â€“4.Wroblewski, M.S. and Jex, E.A. (2010) Follow-on biologic drug competition â€“ No need for new marketing exclusivities. Journal of Commercial Biotechnology 16 (1): 5â€“7.
Market access â€“ An essential investment before drug launch
Authors: McGrath Sean
Published: January 2017

Before introducing a new pharmaceutical/biopharmaceutical agent into clinical practice, local decision makers need to consider not only the costs and benefits of the product, but also the impact that it will have on local health-care priorities and on the manner in which services are delivered. Its use is likely to require updated protocols, new patient information, staff training and changes to the manner in which clinics are organised â€“ all of which can take many months to develop and implement. Hence, timely introduction of a new product relies on the delivery of advance information via a carefully planned market access strategy. Ideally, local decision makers need to receive initial notification of the likely impact of a product at least 18 months before its launch date, with follow-up communications at intervals thereafter. Failure to devise and fund a market access strategy in good time can reduce the company's return on its product. More important, patients may have to wait for access to the new product, and there is a potential for inequality of care when the introduction of a drug is delayed in some areas and not in others.
Algae and Biodiesel: Patenting energized as green goes commercial
Authors: Preiss Matthew R , Kowalski Stanley P
Published: January 2017

In the twenty-first century, predominant dependence on fossil fuels as energy resources will not be sustainable. Developing and commercializing green energy innovations will be an essential component of the transition to a more diversified energy economy. Algal biodiesel is one of the most promising green fuels because of its potential as a renewable and sustainable fuel source without displacing food crops. Algal biodiesel research and development are necessary early steps towards a transition to a green energy economy. The strategic use of strong patent portfolios will drive this by attracting investment, incentivizing innovation and accelerating commercialization. Whereas algal biodiesel research and development is largely still early stage, this will rapidly change as aggressive investments and government subsidies facilitate economically competitive algal biodiesel to enter the energy market. Algal domestication, improvement and industrial utilization for biodiesel production will therefore inevitably create value, leading to increased assertion of property rights, of which intellectual property rights in the form of patents are fundamental. This article provides a summary of representative patents and patent applications in the algal biodiesel technology space and their commercial applications.
The aftermath of Bilski
Authors: Meyers Thomas C , Schoen Adam M
Published: January 2017

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