Journal of Commercial Biotechnology <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. USDA Reorganization Should Reduce Biotech Regulation and Feds’ Involvement in the Organic Industry <p>Recently the USDA proposed measures to “improve efficiencies” and help rural communities in “achieving prosperity.” The measures will not achieve such a goal. If “prosperity” is really USDA’s aim, we offer two suggestions to spur agricultural innovation and free farmers, agricultural scientists and businessmen to prosper. First, the USDA should end the unscientific regulation of molecular genetic engineering, which produces “GMOs,” and second, put an end to government officials’ involvement in misleading consumers about “organic” agriculture and food.</p> Amanda Maxham Henry I. Miller Copyright (c) 2019 Journal of Commercial Biotechnology 2019-11-20 2019-11-20 25 1 10.5912/jcb870 How Should Start-Up Biotechnology Companies Manage Learning and Generate the Necessary Knowledge to Achieve an Alliance-Based Stage of Growth <p>Ethical drugs can take hundreds of millions of dollars and over 10 years to bring to market. Start-up biotechnology companies are recognized for their unique exploration and then exploitation in the development of future drugs. However, these potential new drugs are highly unpredictable and require a broad scope of inquiry. Significant and complex knowledge along with openness to learning is required because of the unusually high risk and uncertainty of biotechnology. After initial start-up, biotechnology companies often form a strategic partnership with an established pharmaceutical company to get additional funding and incorporate needed later stage development knowledge.</p> <p>To conclude an alliance, a company needs to develop learning processes that transition the organization to the next stage of growth. These processes advance the technology sufficiently to conclude a strategic deal. Effective learning enhances exploitation of knowledge needed to generate unique insights and understandings related to the development of a new drug.</p> <p>This paper examines seven biotechnology companies and identifies key processes that should optimize “effective learning” to enhance the probability of creating the necessary new knowledge needed for a start-up to achieve an alliance stage of growth. Despite a majority of the companies successfully reaching the scaling-up stage of growth, some ultimately fail due to a lack of one or more the explored factors.</p> <p>&nbsp;</p> <p>&nbsp;</p> Christopher C Lamb Copyright (c) 2019 Journal of Commercial Biotechnology 2019-11-20 2019-11-20 25 1 10.5912/jcb878 Patents and Diagnostic Methods in the U.S.: The Subject Matter Eligibility Trap <p>Diagnostic methods have been gaining medical recognition and social importance as innovations that can be useful to provide individuals with a diagnosis, prognosis or prediction with regard to a condition that they currently have or that they are in risk of developing. Despite the great amount of resources deployed to produce these health technologies and their potential benefits for healthcare systems and patients or prospective patients alike, their exclusive protection in the United States has faced resistance from patent examiners and courts on the basis that diagnostics constitute a dubious innovation. Inconsistent arguments used for the refusal of patent protection have led to a labyrinth where innovators in the diagnostics sector cannot reasonably expect their application or their protection after the patent is in place to stand.&nbsp;</p> <p>This paper aims to convey the doctrine of subject matter eligibility as applied to diagnostic methods and the relevant guidelines and case law. In doing so, it aims to depict the pitfalls resulting from the general application of a non-patentability rule to diagnostics, and to suggest opportunities still available for innovators to overcome uncertainty by filing compliant applications while maximizing the likeliness of enjoying protection once the patent is awarded.</p> Javier Saladich Nebot Copyright (c) 2019 Journal of Commercial Biotechnology 2019-11-20 2019-11-20 25 1 10.5912/jcb876 Valuing Carryforwards for the Small Cap Biotechnology Subindustry <p>Under the 2017 tax law, carryforward rules for net operating losses (NOLs) allow corporations to apply these losses forward for up to twenty years of taxable income. Startup corporations primarily engaged in basic research or that require rapid growth to be sustainable can go a number years with no positive earnings and thus accumulate net operating losses. These losses can be used to reduce tax obligations in the future. This paper estimates the value of NOLs across firms in a specific subindustry: small cap biotechnology. A valuation method based on ARIMA estimates of future income is used to calculate the value of the NOLs that can be carried forward. The results indicate that even for a subindustry which typically has net operating losses for many years in a startup phase, the expected value of the future benefit of a reduction in taxes is actually fairly modest.&nbsp;</p> Robert Beach Copyright (c) 2019 Journal of Commercial Biotechnology 2019-11-20 2019-11-20 25 1 10.5912/jcb874 A state of the art in genetic improvement of Asparagus plants: Patent based perspective. <p>Asparagus is an important medicinal plant having multiple applications in the various treatment systems. Advances in field of biotechnology has resulted in researchers genetically manipulating medicinal plants to create desired biochemical profile. The present review explores applications of genetic engineering in wild species of <em>Asparagus</em>. The search revealed that most of the patents were targeted for yield improvement, followed by nutritional improvement and production of important biomolecules. Yield improvement, was achieved by modifications in plant hormonal levels. For nutritional improvement, popular targeted agents included β-carotene and methionine. Terms annotated for enzymes in patents are depicted using Gene Ontology based map.</p> Sujit J Patil Swapnil L Bhalke Nishad Deshpande Copyright (c) 2019 Journal of Commercial Biotechnology 2019-11-20 2019-11-20 25 1 10.5912/jcb864 Accessing Continuous Glucose Monitoring (CGM) Sensors in France and the US <p>Blood sugar monitoring is at the heart of every type one diabetic’s treatment. Because patients need make 500,000 decisions over a lifetime on average, reliability on monitoring devices is vital. Thus, the development of Continuous Glucose Monitoring (CGM) systems came as a revolution, as patients need not prick their fingers anymore and now have access to previously unavailable blood sugar trends. This note uses Abbott’s <em>FreeStyle Libre</em> (FSL) as a CGM case study comparing the patenting strategies, regulatory and pricing obstacles this biotechnology company had to face to market its product in both France and the United States.</p> Lucie Perrier Copyright (c) 2019 Journal of Commercial Biotechnology 2019-11-20 2019-11-20 25 1 10.5912/jcb873