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. A Special Edition Focused on new Clinical and Commercial Opportunities in Digital Health Arthur A Boni Copyright (c) 2022 Journal of Commercial Biotechnology 2022-04-29 2022-04-29 27 1 10.5912/jcb1021 Building a fitness tracker for the brain: A journey from lab to consumers <p>In this paper, we discuss our journey as academic entrepreneurs, which began with the market need for objective markers for the diagnosis and assessment of mental health disorders. For most of history, mental health disorders have been chiefly defined by the subjective experiences of people with these disorders -- we know people have a depressive disorder because they feel depressed or that they have a psychotic disorder because they experience hallucinations. The lack of objective markers to track changes in mental health symptoms creates barriers to treatment. To address this, the vision of KeyWise AI is the further development and commercialization of an innovative digital phenotyping technology that turns smartphones into fitness trackers for the brain. Commercializing the generalizable knowledge derived from the ongoing citizen science BiAffect study, our brain fitness-tracking technology supports real-time passive and unobtrusive modeling and monitoring of emotional, behavioral and cognitive processes. The core technology centers around a custom-built smartphone keyboard that replaces the default keyboard, thus allowing for unobtrusive collection of anonymized keyboard dynamics and motor kinetics metadata. The second half of this paper provides general guidelines to help future academic entrepreneurs on their startup journey.&nbsp;</p> Raeanne Moore Olusola Ajilore Alex Leow Copyright (c) 2022 Journal of Commercial Biotechnology 2022-04-29 2022-04-29 27 1 10.5912/jcb1017 Technology and Competitive Assessment for a Bioneedle™ Drug Vaccine Platform <p>Most vaccines have a similar method of delivery, utilizing a needle-based system to administer vaccines. Moreover, many require the maintenance of a “cold chain” to preserve its integrity and usability. While these options are feasible in developed parts of the world, delivering these vaccines to underdeveloped areas becomes difficult. Many vaccines go to waste due to breakages in the “cold chain,” leaving many people without vaccinations. Furthermore, with the recent COVID-19 crisis, needs are emerging around strategies to deliver products that do not require extreme temperatures for storage and allow for efficient vaccine delivery on a mass scale. Many companies, including Pfizer, Moderna, and Johnson &amp; Johnson, have brought to market COVID-19 vaccines. Pfizer and Moderna have found development success and profitability from their vaccine technology, both now and potentially in the future. Still, storage, administration, and waste challenges exist with these current options, creating opportunities for alternative delivery mechanisms. With these vaccines being essential for the current global situation, other administration strategies, such as Bioneedle™, could provide a valuable alternative and help mitigate the associated cold chain and sustainability issues seen with currently available options.</p> <p>Bioneedle™ Drug Delivery B.V. (BDD), a European biotechnology company, is developing a needleless vaccine-device combination product, the Bioneedle™. This technology value proposition focuses on solving the logistics issues associated with many vaccine products.&nbsp; These include eliminating cold-chain requirements, increasing the speed of vaccination, and reducing non-recyclable, medical waste (e.g., plastic syringes). It employs a reusable delivery system that administers multiple vaccines using biodegradable mini-implants to aid mass immunization efforts. This approach could significantly reduce plastic waste from syringes, translating to a significant sustainability benefit consistent with the United Nation’s Initiatives. Accordingly, BDD seeks support from a venture, corporate, government, or foundation for developing this novel delivery platform.</p> <p>This case aims to achieve two objectives. &nbsp;First, it seeks to provide an in-depth overview of the value proposition of Bioneedle™, sparking discussion around its feasibility in a real-world setting. &nbsp;The second involves creating dialog regarding improvements to the Bioneedle™ system and other innovations that may help mitigate cold chain issues while still providing needleless delivery of vaccines.</p> <p>This case discussion highlights the potential of a new vaccine delivery system that various healthcare settings can use. This approach may pose a cost-effective solution to the loss of vaccines in the cold chain and address the growing concerns around plastic waste and the environment. In closing, this narrative allows for an open-forum discussion around the opportunity of introducing a new medical device in a thriving vaccine market. It is a learning experience that requires strategic decision-making in response to questions posed for new startups and the new vaccine technology.</p> John M. York Pooja Shah Farah Pragga Michael Toscani Copyright (c) 2022 Journal of Commercial Biotechnology 2022-05-12 2022-05-12 27 1 10.5912/jcb1009 Respiration Monitoring using a Motion Tape Chest Band and Portable Wireless Sensing Node <p>The measurement of vital signs (such as respiration rate, body temperature, pulse, and blood pressure), especially during strenuous activities, is essential for physical performance and health monitoring. A variety of wearable chest band sensors have been developed, commercialized, and widely used in consumer and healthcare settings. The plethora of technology choices also means that each unique chest band sensor may require different data acquisition hardware and software systems, and data may not be transferable between platforms. Therefore, the objective of this work was to develop a low-cost, disposable, respiration sensor that could be attached onto any elastic chest band. The approach was to spray-coat graphene nanosheet (GNS)-based thin films onto unidirectionally stretchable elastic fabric to form a piezoresistive material. Snap buttons were incorporated at the ends of the fabric so that they could be attached onto any chest band, removed at any time, and replaced for a new data collection event. The resistive nature of the nanocomposite sensor means that they can be easily interfaced (<em>e.g.</em>, using a voltage divider) with any existing data acquisition (DAQ) module while adding respiration monitoring capabilities. To facilitate testing of these nanocomposite respiration sensors, a miniature DAQ module with four sensing channels was also prototyped. Then, tests were performed with human subjects wearing a nanocomposite chest band and a reference commercial respiration monitoring chest band. Simultaneous measurements of subject respiration verified the respiration monitoring performance of these low-cost, disposable, nanocomposite fabric sensors.</p> Yun-An Lin Emerson Noble Chin-Hsiung Loh Kenneth J. Loh Copyright (c) 2022 Journal of Commercial Biotechnology 2022-04-29 2022-04-29 27 1 10.5912/jcb1026 Commercialization Challenges and Approaches for Digital Health Transformation Arthur A Boni Dennis Abremski Copyright (c) 2022 Journal of Commercial Biotechnology 2022-04-29 2022-04-29 27 1 10.5912/jcb1024 Market Selection for MyoTecSci: How to Decide “Where to Play” from Multiple Options <p>New ventures, either entrepreneurial or within an institution, face many challenges. A notable one involves the focusing of limited resources and efforts on a lead opportunity. Strategy researchers advocate the notion of choice and argue for a focused commitment (test two, choose one)<sup>1</sup>. This concept is essential since entrepreneurs face multiple alternatives they cannot pursue simultaneously and immediately<sup>1,2</sup>. Others highlight the non-linear relationship between pursuing multiple market opportunities and performance and see diminishing returns<sup>2</sup>. Firms need to consider multiple risks beyond technological uncertainty in life sciences, particularly around market demand uncertainty<sup>3-6</sup>.</p> <p>What does a life science founder do to minimize risk and focus their choice set? Enter the current case. MyoTechSci (MTS) is a South Korean biomedical startup founded by Hyeson Soo Kim, MD, Ph.D., a professor at the Korea University College of Medicine. The company is in the pre-clinical stage and focuses on sarcopenia or muscle wasting disease. It has multiple research assets (non-natural amino acids, myokines, and natural compounds) across the spectrum of muscle health. The company wishes to pursue five different market opportunities (cancer cachexia, use in the elderly population, an adjunct to exercise to help build muscle, and muscle waster with amyotrophic lateral sclerosis or Duchenne muscular dystrophy). MTS’s management team utilized the market opportunity navigator to focus its opportunities, a tool created by Marc Gruber, Ph.D., and Sharon Tal, Ph.D., to guide its choice process to cull and prioritize its multiple opportunities<sup>7</sup>. With this tool, Dr. Kim and his team prioritized their various market opportunities and ended up with a lead.</p> <p>In this case, you are part of a consulting team evaluating MTS’s analysis and choices. MTS is about to embark on the next phase of its entrepreneurial journey due to an opportunity presented by the South Korean government. Your task is to evaluate the current situation and decision, evaluate the strengths and weaknesses of MTS’s choice, suggest risks/mitigations, and offer a next step recommendation to enhance this venture’s prospect of achieving a positive commercial endpoint.</p> John M. York Vineet Pradhan Polly Luo Michael Toscani Copyright (c) 2022 Journal of Commercial Biotechnology 2022-04-29 2022-04-29 27 1 10.5912/jcb1010 Digital Health Commercialization: Considerations and Case Study <p>Digital Health companies have captured the interest of many stakeholders in the medical and technology communities, not least of which is investors. Other stakeholders include government regulators, clinicians, health care administrators, patients, and payors, all of whom have differing expectations of the digital health sector. The unconstrained term “digital health” covers a “Wild West” landscape of non-traditional solutions and services and encompasses multiple areas ranging from clinical workflow enhancement systems to digital therapeutics. With only a handful of long-term success stories in this nascent industry, the following discussion examines some considerations for the effective commercialization of a digital health product and presents a case study on a successful pioneering company, iRhythm® Technologies Inc. The reader will 1) understand how the complexity of traditional medical technology sales extends into digital health, 2) learn from a practical case study and 3) be exposed to emerging commercialization models in this new space.</p> Marga Ortigas-Wedekind Copyright (c) 2022 Journal of Commercial Biotechnology 2022-04-29 2022-04-29 27 1 10.5912/jcb1025 Developing Digital Therapeutics: The University Health Network Experience Quyhn Pham Joseph Cafazzo Copyright (c) 2022 Journal of Commercial Biotechnology 2022-04-29 2022-04-29 27 1 10.5912/jcb1023 New Clinical and Commercial Opportunities in Digital Health <p>This special issue of the Journal of Commercial Biotechnology highlights new research and commercial opportunities in the emerging field of digital health. Most of the papers included herein were contributed by authors who presented their work at a one-day webinar on Digital Health held on October 27th, 2021. The Symposium on New Clinical and Commercial Opportunities in Digital Health was hosted by the UC San Diego Institute of Engineering in Medicine (IEM), the Center for Health Innovation at UC San Diego Health (CHI), and the <em>Journal of Commercial Biotechnology (JCB)</em>. This issue also includes a few additional papers relevant to the symposium, but not presented there. These have been solicited by the Editor in Chief of JCB to emphasize the importance of employing cross industry best practices for commercialization, and the importance of pricing.&nbsp;</p> Andrew McCulloch Kevin Patrick Arthur A Boni Copyright (c) 2022 Journal of Commercial Biotechnology 2022-04-29 2022-04-29 27 1 10.5912/jcb1022 Rejuvenating American Healthcare <p>The debate over overhauling the American healthcare system is stuck on hold and plagued by soundbites. It’s time to insert substance and science into the conversation. If we learn nothing else from the COVID-19 experience, it’s that when the entire healthcare ecosystem works together to solve a seemingly unsolvable problem (in this case broader access to innovative prescription drugs) … we can. Nothing less than the future of American healthcare is at stake. During his March 2022 State of the Union Address, President Biden suggested a policy of price controls through direct Medicare negotiation to lower the costs of prescription drugs. This approach has long been discussed in the abstract. Let’s examine the details and potential consequences of such a proposition more closely.</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> Peter J Pitts Copyright (c) 2022 Journal of Commercial Biotechnology 2022-04-29 2022-04-29 27 1 10.5912/jcb1018