Journal of Commercial Biotechnology <h2 style="margin: 0 0 .5em; font-weight: 300;">Leading thinking on biotechnology business management</h2> <p style="margin-top: 3px;">The <em>Journal of Commercial Biotechnology</em>, in print since 1994, is the definitive international quarterly publication for life sciences business professionals. The Journal is designed specifically for those professionals who need to enhance their knowledge of business strategy and management, improve and advance their product development, or those who want to keep up-to-date with current issues and industry trends. Our focus is on the life science industries, e.g. biopharma (biotechnology &amp; pharmaceuticals, MedTech and digital health; and on food and agricultural products and services to improve organisms.</p> <p>Each issue publishes peer-reviewed, authoritative, cutting-edge articles and perspectives (“Biotechnology Industry Perspectives”; and ”Bioentrepreneurship University Insights”) written by the leading practitioners and researchers in the field. We publish both submitted and solicited articles (including special editions), addressing topics such as:</p> <ul> <li>Management, Leadership, and collaborative teams</li> <li>Commercialization, Marketing, and Innovation strategies and best practices</li> <li>Entrepreneurship, including education</li> <li>Policy</li> <li>Finance &amp; transactions associated with founding, building, partnering and exiting</li> <li>Law, Intellectual Property, Regulation, Reimbursement</li> <li>Bioethics</li> </ul> <p style="background: white;"><span style="font-size: 10.5pt; font-family: 'Arial',sans-serif;">The <em><span style="font-family: 'Arial',sans-serif;">Journal of Commercial Biotechnology</span></em> is a unique forum for all those involved in life sciences 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 and diverse field.</span></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. Abridge: A mission driven approach to machine learning for healthcare conversation <p>In this brief case study, we describe an approach to structuring and summarizing information from one of the largest untapped sources of data in healthcare delivery -- spoken conversations. Abridge’s mission is to shift agency to the people and families at the center of those spoken conversations, using bleeding-edge machine learning and human-centered design. The space of conversation understanding is largely untapped and we will discuss our scientific approaches to business challenges that map to the company’s mission of helping everyone better understand and follow through on their healthcare conversations.</p> Sandeep Konam Shivdev Rao Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb994 Foundational Tools for Building a New Bioeconomy <p>While biotechnology has been transforming the diagnosis and treatment of disease, it has also been altering everything from the production of crops to how we manufacture goods. Berkeley Lights, which sits at the nexus of biotechnology, microfluidics, and information technology, is playing a critical role in enabling the way living cells can be harnessed as microscopic factories to power the emerging bioeconomy.</p> Daniel S. Levine Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb992 Building technology enabled platform companies in Biopharma – a perspective on early-stage value creation from Millennium, Alnylam, Moderna, & Kymera <p>This paper addresses the topic of building platform-based companies in biopharma.&nbsp; We provide a short literature review on the topic, followed by a discussion of financing growth of platform companies.&nbsp; This is followed by case studies on four pioneering biopharma companies that cover the era of the mid-1990s until today.&nbsp; These companies are all well recognized pioneers and have gone thru their life cycles from founding, to building portfolios of products, to acquisition. Our mini-case studies include Millennium Pharmaceuticals (now a unit of Takeda), Alnylam, Moderna, and Kymera.) These also cover different technology bases for their respective platforms that have emerged during the last two decades since the emergence of the genomics revolution.</p> Yuanxin Rong Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb990 A Case Study - NeuBase Therapeutics, Inc. <p>NeuBase&nbsp;is accelerating the genetic revolution by developing a new class of precision genetic medicines which can be designed to increase, decrease, or change gene function, as appropriate, to resolve genetic defects that drive disease.</p> Dietrich A. Stephan Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb995 Illumina Accelerator: Next-Gen Corporate Accelerator with a Customer-Creation Focus <p>We describe the history, design and expansion of Illumina for Startups -- a case that represents a company with strong entrepreneurial capacity engaging in open innovation through a startup accelerator now expanding internationally with different models. This case highlights the strategy and tactical reasoning behind Illumina’s approach.</p> Diana Joseph Amanda Cashin Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb993 Putting Theory into Practice at BridgeBio <p>Many drug companies spring from scientific discoveries made in a laboratory. BridgeBio Pharma, though, owes its genesis to the musings of a financial theorist.</p> Daniel S. Levine Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb991 A Note on Corporate Open Innovation: Engagement with Startups <p>This Note summarizes our findings based on an exploratory and initial global research study of best practices for organizations employing open innovation business model strategies. We utilized an expert interview approach to develop a survey that was taken during the Covid-19 pandemic. It was meant to assess open innovation strategies and tactics, particularly focused on partnering with startups and emerging companies. We worked with a cohort of Corporate Accelerator Forum (CAF) members (as experts), prior to a more extensive survey of corporations concerning their engagement with startups. Our experts included key leadership from Techstars, Bayer CoLaborator, and Illumina Accelerator. We plan a broader, more extensive survey of national and international companies as a follow up.&nbsp; Our results highlight and provide commentary on current industry practices and trends during the Covid-19 pandemic, and have applicability to the biopharma, MedTech, and digital medicine/health markets.</p> Diana Joseph Arthur A Boni Dennis Abremski Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb989 Waiving COVID-19 Vaccine Patents: A Bad Idea and a Dangerous Precedent <p>The Biden Administration believes that suspending COVID-19 vaccine patents will expedite the swift development of high quality “cheap” versions of existing vaccines and hasten the pandemic’s end. This view is dangerously wrong. Vaccinating the world is essential, but<em> temporarily</em> waiving patent rights for COVID-19 vaccines (also known as “compulsory licensing”) will actually slow their availability to the developing world.</p> <p>&nbsp;</p> <p>While providing no gain, compulsory licensing promises lots of pain. Waiving patent protection discourages cutting-edge research investments, which in turn produce breakthrough treatments not just for COVID-19, but for other diseases, like cancer. Weakening these protections would be anti-patient and counterproductive.</p> <p>&nbsp;</p> <p>The reality is that, in order to save the world, we must all work together as partners. The remarkable speed with which we developed diagnostics, therapeutics, and vaccines to combat COVID-19 points to the need for more collaboration, not less. Patents are a foundational principle upon which that success rests.</p> <p>&nbsp;</p> <p>While the policy of temporarily waiving patents seems fair and humanitarian, the devil is in the details.&nbsp; Such a policy will not result in a single citizen of the developing world getting vaccinated one minute sooner. In fact, the unintended consequences are the reverse. More confusion, lower quality, less transnational cooperation. A triple play of disastrous global proportions.</p> Peter J Pitts Robert Popovian Wayne Weingarden Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb987 The Code Breaker: Jennifer Doudna, gene editing, and the future of the human race <p>In this book review and accompanying commentary and Addendum, we focus on 5 principal topics/major themes that are of interest for our readership, with a focus on framing the translation of transformative technology into a platform business model in biopharma.&nbsp; We focus on: 1) the behavioral and personal side of the story of the academic scientist, in this case the principal “code breaker” – Jennifer Doudna; 2) the innovation/technology transfer models, including team building appropriate for successfully translating technology from the academic laboratory into the private sector; 3) the IP considerations needed for broad commercialization and dissemination of pivotal, platform inventions in biopharma; and, 4) framing the issues surrounding the ethical discussion related to use in patients associated with a transformative, gene based technology like CRISPR. We also include an Addendum that covers, 5) Some pertinent, concluding comments on the importance of high–performance, diverse teams for founding, building, and growing successful biotechnology companies.</p> Arthur A Boni Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb988 Companies Recognized as Innovators for 2021 <p>Our awards are framed into the 4 models or paths to innovation as described by Boni and Joseph, and published in JCB previously in two companion articles, c. f. JCB Vol. 24, No. 4 (2020); “Aligning the Corporation for Transformative Innovation: Introducing Dashboard 2.0”, pp 14-22, &amp;“Four Models for Corporate Transformative, Open Innovation”, pp. 23-31. The 4 models that we categorized can be summarized: 1) Direct Entrepreneurship; 2) Consortia/Alliances – open innovation partnerships or alignments with Startups &amp; Emerging Companies; 3) External Accelerators; and, 4) Corporate Accelerators.</p> Arthur A Boni Dennis M. Gross Moira A Gunn Daniel S. Levine Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb986 Recognizing and Celebrating Innovation and Innovators in Biopharma <p>This introductory article summarizes our basis for recognition of innovative companies (past, present and emerging) in our industry, and summarizes the criterion that we are using to evaluate those organizations selected for contributing to innovation in the life sciences industry. We also develop and list both industry leaders, both pioneers and current, who we selected as members of the <em>JCB Innovators Hall of Fame - 2021</em>.</p> Arthur A Boni Dennis M. Gross Moira A Gunn Daniel S. Levine Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb983 Introduction, Rationale and Commentary on Recognizing and Celebrating Innovation in Our Industry <p>This article summarizes our intent and basis for recognition of innovators in our industry, including the criterion that we are using for those organizations selected. Our focus for this year is largely on the Biopharma segment, because of Covid-19 and the positive and significant impact that our industry has made in that regard. We focus on companies across the life cycle from startups ranging to the large multi-national pharma companies.</p> Arthur A Boni Dennis M. Gross Moira A Gunn Daniel S. Levine Copyright (c) 2021 Journal of Commercial Biotechnology 2021-09-02 2021-09-02 26 2 10.5912/jcb985