Journal of Commercial Biotechnology https://commercialbiotechnology.com/index.php/jcb <h2 style="margin: 0 0 .5em; font-weight: 300;">Leading thinking on biotechnology business management</h2> <p><img src="/public/site/images/dna2z/jcb_cover_small.jpg"></p> <p style="margin-top: 3px;">The <em>Journal of Commercial Biotechnology</em>, in print since 1994, is the definitive international quarterly publication for bioscience business professionals. The Journal is designed specifically for those professionals who need to enhance their knowledge of biotechnology business strategy and management, improve and advance their product development or want to keep up-to-date with current issues and industry trends.</p> <p>Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:</p> <ul> <li class="show">Management</li> <li class="show">Policy</li> <li class="show">Finance</li> <li class="show">Law</li> <li class="show">Regulation</li> <li class="show">Bioethics</li> </ul> <p>The <em>Journal of Commercial Biotechnology</em> is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.</p> thinkBiotech LLC en-US Journal of Commercial Biotechnology 1462-8732 <p>Unless specified by prior arrangement, the author agrees to the following terms and assurances:</p><ol><li>For myself and on behalf of the other authors listed on this work, I assign to thinkBiotech LLC the copyright* in the contribution for the full term throughout the world.</li><li>I/we further give to the following assurances<ol><li>I am the sole author of the contribution, or, if not, I have the written authority of the other authors to transfer the copyright* to thinkBiotech LLC and give these warranties;</li><li>I and (where appropriate) the other authors are entitled to transfer the copyright to thinkBiotech LLC and no one else would be entitled to prevent us from publishing the contribution;</li><li>To the best of my/our knowledge, all the facts in the contribution are true and accurate;</li><li>The content of the contribution is entirely original to me (and where appropriate to the other authors) or, if not, the written permission of the owner of the copyright in any material copied from elsewhere has been obtained for all media (all such permissions to be attached to the contribution as supplementary files);</li><li>Nothing in the contribution is obscene or libellous;</li><li>Nothing in the contribution infringes any duty of confidentiality which I/or the other authors may owe to anyone else.</li><li>I and/or the other authors have obtained the appropriate clearances from my/our employer(s) or other concerned institution(s).</li></ol></li></ol>* Works by US government employees prepared as part of official duties are in the public domain and the authors are therefore exempt from copyright assignment. Effective Leadership through Bioentrepreneurship and Bioinnovation https://commercialbiotechnology.com/index.php/jcb/article/view/843 <p>For biotechnology firms need leaders that can lead scientists beyond the science and turn new discoveries into commercially viable products. Bioentrepreneurial leaders are continuous learners; they are adaptable to change and flexible, they are not afraid to take risks, and they challenge existing assumptions with the objective of generating greater value through novel bioinnovative discoveries. Without bioentrepreneurial leadership, many discoveries will not make it to the marketplace. Biotechnology scientists, by nature, tend to work for the greater good and hope that their discoveries will benefit mankind. Yet it is often the hyper focus on addressing the scientific and technical aspects of a problem that leads to difficulties. Scientists do not generally have the necessary skills or mindsets required to meet commercial or monetary milestones to successfully commercialize products. Therefore, bioentrepreneurial leaders must themselves be willing to continuously learn and adapt to a dynamic industry and at the same time they must inspire and motivate employees at all levels of biotechnology firm to also learn and adapt. Creativity and innovative thinking are required at all stages, and across all disciplines in the organization. Only when this happen will the firm succeed with new innovations through product development and commercialization.</p> Claudine Kearney Lynn Johnson Langer ##submission.copyrightStatement## 2018-08-27 2018-08-27 24 2 10.5912/jcb843 Patients Suffer While the Science Establishment Resists Innovative Therapies https://commercialbiotechnology.com/index.php/jcb/article/view/846 <p>Human gene therapy has been up to now of a type that affects only the patient being treated; it has not modified sperm or eggs cells or embryos in a way that would constitute “germ line gene therapy” (GLGT) by creating a heritable change and affecting future generations.  Preclinical research has progressed almost to the point where GLGT interventions will be possible with a reasonable likelihood of success, but such clinical trials are currently prohibited: NIH's Recombinant DNA Advisory Committee is not permitted even to consider such proposals, and the FDA cannot use appropriated funds to review such trials.  Such absolute prohibitions are bad for patients and bad public policy.  </p> Henry I. Miller ##submission.copyrightStatement## 2018-08-27 2018-08-27 24 2 10.5912/jcb846 Turbulence in the Biotechnology Sub-sector of the Western Cape Regional Innovation System https://commercialbiotechnology.com/index.php/jcb/article/view/803 <p>The research was initially designed to complete the study with an investigation of the growth stories of the biotechnology spin-offs from the universities in the study. When it became evident that several of the firms targeted for this in-depth story, were no longer in existence, a more important question became ‘why did they fail?’ In the search for answers to this question, a tale of turbulence in the sector, and particularly in the environment in which they were to innovate and grow, emerged. This research is novel in that it shows with the aid of the case studies, how a complex series of internal (to the firms) and external factors (in the national and regional innovation systems) combined to lead to the failure of the biotechnology spin-offs. The paper yielded important insights on the unintended consequences of institutional changes. Further, funding for seed and start-up capital remains an obstacle to growth in biotechnology in South Africa. These insights may assist policy makers, technology transfer officers and entrepreneurs in designing and implementing strategies to enhance the development of the biotechnology sector and spin-off creation in general. </p> Ramazan Uctu Rachel CC Jafta ##submission.copyrightStatement## 2018-08-27 2018-08-27 24 2 10.5912/jcb803 Evaluation on National Biotechnology Policy (NBP) 2005: Towards Achieving 20 Global Companies In NBP Phase III https://commercialbiotechnology.com/index.php/jcb/article/view/818 <p>The purpose of this paper is to discuss on the latest progress of the NBP 2005 through selecting significant performance indicators towards the end of policy tenure, which is nurturing 20 global status companies. The research was carried out through qualitative method using verbatim analysis from Focus Group Discussion (FGD) with lead implementing agencies, Bioeconomy Corporation and also supported by desktop research from the statistics provided and literature review. Through this research, general performances in NBP Phase II were examined, as they will influence the strategies execution in the Phase III. Hence, researcher was exploring the global companies in the context of NBP in term of definition, grooming programs, potential and existing companies, characteristics, niches, and other relevant information related. The findings of this research indicated that NBP Phase II showed significant achievements while general information on the global companies been obtained, mostly in 3 main biotechnology sectors the namely agriculture, healthcare and industrial biotechnology due to non- disclosure agreement with the companies. Therefore, this research is very useful, it could possibly benefit policy makers in the future on policy planning, and intervention in science, technology, and innovation related policy. Finally, originality value from this research will unlock possibility for future study to conduct quantitative survey on the respective companies and also other international benchmarking indicators. However, the study was only based on the FGD session, documents analysis, and information given from ministries and agencies officers.</p> Shadiya Baqutayan Husni Alhan Md Salimun ##submission.copyrightStatement## 2018-08-27 2018-08-27 24 2 10.5912/jcb818 The Marketing of Genetically Modified Food With Direct and Indirect Consumer Benefits: An Analysis of Willingness to Pay https://commercialbiotechnology.com/index.php/jcb/article/view/838 <span>Genetically modified foods have traditionally been marketed as having direct industry benefits.  Whereas, consumer benefits of genetically modified foods have been largely indirect, through price reduction.  This study explores the marginal effects of differing value propositions on consumers’ acceptance and willingness to pay for genetically modified foods among Canadians.  Consumers’ exposure to genetically food advertisements with industry-oriented benefits lowered both purchase intention and willingness to pay for genetically modified food.  Consumers’ exposure to non-genetically modified food advertisements with direct consumer benefits increased both purchase intention and willingness to pay.  Most noteworthy, consumers’ exposure to genetically modified food advertisements with both direct consumer benefits and industry-oriented benefits increased their willingness to pay.  These findings provide insight into the future of successful genetically modified food marketing.  </span> Grant Alexander Wilson David Di Zhang ##submission.copyrightStatement## 2018-08-27 2018-08-27 24 2 10.5912/jcb838 Study on the Detection of Total Colony in Medical and Health Environment Based on ATP Bioluminescence https://commercialbiotechnology.com/index.php/jcb/article/view/839 <p><em>In this paper, the application of ATP fluorescence in the detection of colonies in the health environment of hospitals</em><em> was studied</em><em>.</em><em> </em><em>F</em><em>irstly, </em><em>the principle of ATP bioluminescence method </em><em>wa</em><em>s described.</em><em> </em><em>T</em><em>hen, </em><em>ATP bioluminescence and plate count method were used to test the density of the surface of the objects in selected area</em><em>, taking the time points </em><em>2 hours after disinfection</em><em> as the time nodes</em><em>.</em><em> </em><em>T</em><em>he results showed that the</em><em> difference between the qualified rate of ATP bioluminescence assay and the plate count method was statistically significant {P&lt;0.01}.</em><em> </em><em>Therefore, ATP bioluminescence method </em><em>wa</em><em>s highly correlated with bacterial culture method.</em><em> </em><em>The correlation coefficient of pass rate </em><em>of</em><em> the two methods was 0.782, which indicated that there was a positive correlation between the two test results.</em><em> </em><em>B</em><em>esides, the </em><em>detection results show</em><em>ed</em><em> that ATP bioluminescence method ha</em><em>d</em><em> higher sensitivity than plate counting method. Therefore, ATP bioluminescence method </em><em>wa</em><em>s more suitable for the rapid detection of the colony of hospital health environment, and helps the hospital to better manage </em><em>its </em><em>environmental hygiene</em><em> conditions</em><em>. </em><em></em></p> Zhe Li ##submission.copyrightStatement## 2018-08-27 2018-08-27 24 2 10.5912/jcb839 Strategy First, Execution Second: Why Life Science Entrepreneurs Should Adopt a Top-Down Mindset Early https://commercialbiotechnology.com/index.php/jcb/article/view/848 <p>Despite the dedication of the management team and board to a company’s success, an often  overlooked component is the dynamics of the segment in which the company operates. In an effort to demonstrate the importance of the external view and how segment dynamics are likely to significantly impact the reality of companies, we analyzed recent data in the three-year period between 2015 and 2017 pertaining to financing events, M&amp;A transactions and initial public offerings (IPO) in three separate sectors: therapeutic devices, oncology therapeutics and antibiotics. The analysis presented will provide management with a good estimation as to the required capital to achieve value-add milestones as well as the anticipated return on investment. These examples demonstrate the fundamentally different dynamics of three sectors, which will impact the most probable path to liquidity of companies in those sectors. Therapeutic devices have to often get regulatory approval prior to an exit where exits happen earlier in clinical development for the oncology therapeutics sector. Despite the high unmet need, there have been limited exits in the antibiotics sector. In all cases, return on investment is greater when the company’s exit included being acquired versus an IPO. This data demonstrates that exit opportunities are largely sector-dependent and suggests substituting external formal thinking, market-driven evaluation and analysis for inward-looking and biased judgment will being beneficial crafting a mature business case as well increasing the probability of success.</p> Echoe Bouta Oded Ben-Joseph ##submission.copyrightStatement## 2018-08-27 2018-08-27 24 2 10.5912/jcb848 Patenting Therapeutic Methods: Statutes and Strategies https://commercialbiotechnology.com/index.php/jcb/article/view/845 <p>Patenting medical therapeutic methods has become one of the toughest tasks for inventors and scientists in some jurisdictions where these methods are excluded from patentable subject matter. There are recent amendments by different countries in relation to patentability aspects of Therapeutic methods. In this scenario, analysis of these recent amendments would provide a path for researchers in the field to identify whether their inventions are considered as patentable subject matter. Our analysis sheds some light on different statutes and regulations of major jurisdictions on the patentable subject matter and patentability aspects of therapeutic methods. Furthermore, we have identified that most of the jurisdictions restrict inventors in patenting therapeutic methods. However, some countries such as United States and Australia allow patents related to therapeutic methods. We think adapting different strategies that are provided in this article would help researchers, inventors and patent attorneys in patenting the inventions related to therapeutic methods. Moreover, while applying the provided strategies, it is suggested that inventors should draft the patent claims by keeping a note of different statutes and regulations of countries in which they are interested to file the patent applications.</p> Seema Soni Pratap Devarapalli ##submission.copyrightStatement## 2018-08-27 2018-08-27 24 2 10.5912/jcb845 Patenting Bioinformatic Inventions: Global Perspective https://commercialbiotechnology.com/index.php/jcb/article/view/831 Patenting bioinformatic inventions has become a ride on the rail to the scientists and inventors. Specifically in bioinformatics, drafting an invention in bounds of patentability criteria is one the most critical task for an inventor to protect his invention. As bioinformatics is a budding field of science, patentable subject matter in bioinformatics was not specifically defined by most of the patent offices in the world. In this regard, we have tried to explain patentable subject matter in bioinformatics by classifying bioinformatics into different subject fields. Additionally, we have tried to trace out patentable subject matter for bioinformatic inventions based on country-specific patentability standards and granted bioinformatic patents of US, Europe, India, Canada and Australia. Pratap Devarapalli Nishad Deshpande Rajkumar Hirwani ##submission.copyrightStatement## 2018-08-27 2018-08-27 24 2 10.5912/jcb831