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. Building and leveraging the innovation ecosystem and clusters: universities, startups, accelerators, alliances, and partnerships <p>This article focuses on the concepts of ecosystems and clusters, with an emphasis on their importance for building vibrant a vibrant and life science/biopharma industry. We illustrate the underlying principles through work published in academic articles and in the popular press. These are highlighted in brief overviews of several mature and emerging ecosystems in the United States, Europe and Australia. The US perspective is based on our own professional life experiences in Boston, Silicon Valley, San Diego, and Pittsburgh, and, with a shorter preview of Philadelphia where we’ve both done business and have close colleagues.&nbsp; The article ends with a look to the future in a concluding section titled “What’s Coming Next”.&nbsp; It is our attempt to look at the future of digitally enhanced collaborative innovation.&nbsp; This is based on our observations during the first 9 months of the Covid-19 pandemic, social distancing, and working from a distance. We ask, what is the potential impact of these emerging digital technologies on work and advancement of the agenda in the life sciences industries? Will the pandemic transform or disrupt the borders and mode of collaboration of traditional definitions of ecosystems and clusters as we define them today?</p> Arthur Boni Moira Gunn Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb963 The Impact of the COVID-19 Pandemic on the Content and Logistics of this Special Edition on Building and Leveraging Ecosystems and Clusters <p>On March 11, 2020, the World Health Organization (WHO) Director General Dr. Tedros Adhanom Ghebreyesus addressed the global media: “WHO has been assessing this outbreak around the clock and we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction. We have therefore made the assessment that COVID-19 can be characterized as a <em>pandemic</em>.”<sup>1</sup> While the existence, transmissibility, treatment, and potential impact of severe acute respiratory coronavirus SARS-CoV-2 were real questions since the virus was first recognized in December, 2019,<sup>2</sup> much of the media coverage was driven by global public health concerns and international/national political posturing. However, it was a different date that catalyzed commercial biotechnology.</p> Arthur Boni Moira Gunn Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb964 California Tool Works: Assessing the Impact of Life Science Incubators and Accelerators <p>With the proliferation of types and business models in incubation and acceleration, a landscape survey commenced nearly a decade ago with innovation professionals running accelerators, incubators, corporate innovation teams, venture studios, and maker spaces. The benchmarking continues under the auspices of the California Business Incubation Alliance. For this paper, a selected set of findings specific to biotechnology have been detailed, including best practices, success measures, outcomes, and economic impact. The perspective of entrepreneurs, innovation executives, investors, and the public sector have been taken into account throughout this exercise.</p> Matt Gardner Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb977 Global Alliances to Accelerate Innovation at Plug and Play Technology Center <p>The Plug and Play (PnP) accelerator model is differentiated vs. traditional accelerators in many ways, especially by encouraging cross industry collaboration globally. PnP has developed a global network spanning the value chain from universities to startup companies, to financial partners, to global industry leaders in multiple industries, including life sciences, med tech and digital technologies. Networking&nbsp; activities across the value chain and cross industry encourage associate thinking and collaboration and differentiates PnP vs. other accelerators.</p> Alireza Masrour Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb976 What Corporates Can Do to Help an Innovation Ecosystem Thrive -- and Why They Should Do It <p>Given the pace of change in nearly every aspect of society, transformative innovation is imperative. At the same time transformation is very difficult for large established companies. Open innovation – collaboration with outside entities such as startups -- is a powerful tool for exploring both business model and technological innovation. A thriving ecosystem provides a healthy environment in which dramatically different types of entities can find each other and the resources they need to explore and ultimately engage in transformative innovation. Given these benefits, corporates can and should play a role in the creation and growth of thriving ecosystems. We describe the work done to create the life sciences ecosystem in Boston/Cambridge through the eyes of Author 2 who was a central leader in that effort. And we describe in detail both the benefits corporates can enjoy, and the role corporates can play in developing a thriving ecosystem.</p> Diana Joseph Sue Windham-Bannister Mikel Mangold Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb975 Thought Leader Insights on Innovation Ecosystems and Clusters <p>This article provides short, “book reviews” and selected comments on recent, popular books that focused on ecosystems and clusters.&nbsp; They include: <em>AnnaLee Saxenian</em> (reflections and lessons from “Regional Advantage”; <em>Leslie Berlin</em> (the building of Silicon Valley from “Troublemakers”); <em>Richard Florida</em> (reflections and extensions of “The Creative Class”); and, Greg Horowitt (lessons from “Rainforest”).</p> Moira Gunn Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb965 Creating Communities of Life Science Innovation in the US: History of Critical Factors That Helped the BioHealth Capital Region Emerge <p>Advancements in biotechnology are recognized as one of the most important scientific achievements of the 20<sup>th</sup> Century.&nbsp; The emergence of biotechnology profoundly impacted the health of the world, and the economic vitality of regions where bio clusters and bioresearch parks grew. &nbsp;This article explores some of the historical and policy implications undergirding this development in the United States and the importance of alignment of life science research activity, public policies, and leadership to build place-based communities of biotechnology innovation.</p> Brian Darmody Richard Bendis Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb966 A Tale in Three Parts: The Success of California’s Life Science Clusters <p>With the seventh largest GDP in the world, California has the economic heft of a country. One of the largest drivers of economic growth in California is the life science industry. In fact, it is a cornerstone of California’s innovation ecosystem, and is characterized by three distinct geographical clusters. There’s San Diego’s entrepreneurial energy, Los Angeles’ emerging incubators and the Bay Area’s unique tech influence. All of these clusters drive growth and distinct opportunities for institutes, universities, businesses and entrepreneurs.</p> <p>This article focuses on: how did California become a life science powerhouse, and what do each of these regions have to offer to the industry?</p> Joe Panetta Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb967 Philadelphia and the Delaware Valley: A Geographically Distributed and Expanding Life Science Ecosystem <p>Philadelphia has been considered by many to be the birthplace of the modern US pharmaceutical industry with Merck &amp; Co. Inc.’s research division Merck Research Labs [originally called MSDRL] based in West Point and GSK’s primary US labs [originally SKF] now based in Collegeville. The City of Philadelphia is also home to two of the oldest medical schools in the US: Perelman School of Medicine at the University of Pennsylvania founded in 1765 and the Sydney Kimmel Medical College [formerly Jefferson Medical College] founded in 1824. The conjunction of those two touchpoints along with the other big pharma players<em>, e.g</em>., Johnson &amp; Johnson/Janssen and emerging biotech entities in the wider Delaware Valley region is significant. Also noteworthy is the presence of other research intensive universities such as Drexel University, Temple University, Jefferson University and research institutes such as the Wistar Institute, Fox Chase Cancer Center [associated with Temple University School of Medicine], Lankenau Institute, Monell Chemical Senses Center and the Coriell Institute in Southern New Jersey.</p> Dennis Gross Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb968 Transforming Pittsburgh’s Economic Ecosystem and Clusters <p>The Pittsburgh region’s recovery and transformation from an economy dominated by heavy industry to a balanced and diversified economy throughout the region has been documented by many publications during the past decade. Pittsburgh is rightfully viewed as a model for post-industrial transformation and is positioned to provide sustainable careers and a high standard of living for its people. This article will not attempt to tell that broad economic recovery story again, but instead will focus on one important aspect of the story: the rise of Life Sciences/Biotech as one of the key clusters driving the Pittsburgh story. I had the privilege of being at the table for much of the planning and execution that went into the development of this cluster.&nbsp; In this article, I hope to provide a unique view of the key elements of the plan for Life Sciences in the Pittsburgh Region.<br><br><br></p> Dennis Yablonsky Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb969 Australian Biotechnology: Promissory Expectations and Ecosystem Performance far From the Global Superclusters <p>Australia is an interesting case study of biotechnology ecosystem development. Despite its distance from the US biotechnology superclusters, the country has had high expectations for its potential development into a biotechnology superpower. These expectations have not been met over the last two decades. Despite generous R&amp;D tax incentives and a robust network of public research organizations (PROs), the local biotechnology industry has remained small and weak, without a single ‘big biotech’ emerging. Cluster analysis over 11 years of all private and public DBFs indicated that the PRO network output failed to translate to the development by the local biotech industry of drug candidates that could attract Big Pharma deals. Analysis of the investor returns over 15 years from all public drug development biotech firms (DDBs) showed that not a single firm produced attractive long-term investor returns and the sector overall generated negative returns for investors. Despite high promissory expectations, favorable government policies and an inflated view of the quality of the country’s science output, Australia has failed to create a sustainable biotechnology ecosystem. Some of the reasons are identified and suggestions are offered for changes in government policy that could improve value creation by the local biotech sector.&nbsp;&nbsp;</p> Peter Molloy Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb970 A New Vision for Europe’s Bioeconomy in a Post-COVID World <p>In response to the COVID-19 global pandemic, the European Commission (EC) provided inclusive leadership, working as a team including EU member (national) officials, biopharmaceutical industry, NGOs, academic researchers and frontline health care personnel – acting with unprecedented collaboration and cohesion.&nbsp; The emergence in early 2020 of the greatest public health threat in a century required new approaches and new collaborations. While the United States failed to provide leadership, the EU did not disappoint.</p> Susan Finston Nigel Thompson Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb971 The U.S. National Institutes of Health – Founding A National Biomedical “Innovation Ecosystem” <p>With its unique system of intramural and extramural research programs, funding for academic and corporate product development, along with its supporting foundations, the National Institutes of Health (NIH) has created a vibrant public “innovation ecosystem” that has changed not only the face of healthcare, but has also led to the creation of the biotech industry in the U.S.&nbsp;&nbsp; Whether your interest in the overall healthcare environment is scientific, medical, educational or commercial, there is something here for you.</p> Steven M. Ferguson Lynn Johnson Langer Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb972 Multi-Disciplined Ecosystem-Centric Bioentrepreneurship Education: Case Study – University of San Francisco (USF) <p>Bioentrepreneurship education has evolved into at least three different types, all of which co-exist: Education 1.0 - In Service of Biotechnology Startups, Education 2.0 – In Service of Biotechnology Innovation Ecosystems, and Education 3.0 – In Collaboration with Biotechnology Innovation Ecosystems. Examples are given at all levels, along with a Case Study of the Bioentrepreneurship (BioE) program at the University of San Francisco (USF). The USF program draws from twelve expertise disciplines described by the Bioenterprise Innovation Expertise Model (BIEM 2.0), those essential disciplines bioenterprise requires to bridge the science/technology discovery/invention through to viable commercial product life cycle. As a result, the USF program reaches graduate students across the university. The utilization of the BIEM 2.0 model throughout the BioE courses is discussed, as well as the incorporation into the curriculum of <em>BioTech Nation</em> interviews with biotechnology industry executives and scientists. Due to the COVID-19 Pandemic and the requirement to move the BioE courses to a remote modality, future plans include the development of a fully online Bioentrepreneurship (BioE) certificate, primarily targeting the California state biotechnology corridor of San Francisco, Los Angeles, Orange County, and San Diego Biotechnology Innovation Ecosystems. Additional new BioE courseware will address the growing sector of Digital Health.</p> Moira Gunn Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb973 UC San Diego, The Military and Building a Unique, Diversified Economic Growth Ecosystem <p>San Diego’s economy, fueled by its innovation ecosystem, has experienced meteoric growth over the past several decades, with the region now ranked amongst the top life sciences clusters in the world. This growth has been inextricably linked to the military presence over the decades and the region has benefited from the symbiotic presence of both the military and private and public sector innovation partners, creating an ecosystem that may be unique in the nation. This unique combination of market forces is turbo-charging the creation of “multi-use” technologies and startups, through regional collaborations and associated programs that align the research discoveries and capabilities of universities, with the strategic needs of the government, while feeding the growth of commercial industry partners and the economy as a whole.&nbsp; One key to the continued competitiveness and success of San Diego will be to strengthen this virtuous cycle, to drive productivity and propagate the impact of the engagement across multiple innovation sectors or clusters.</p> Dennis Abremski Paul Roben Copyright (c) 2021 Journal of Commercial Biotechnology 2021-03-16 2021-03-16 26 1 10.5912/jcb974