Journal of Commercial Biotechnology 2019-09-11T20:05:02+00:00 Art Boni Open Journal Systems <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> Transforming Technology Into High-Value Solutions for Compelling Biomedical Needs: Bio Entrepreneurship Bootcamp 2.0 2019-09-10T20:04:57+00:00 Arthur Boni <p>Startups are an important source of innovation for any industry, particularly for disruptive or transformative innovations enabled by technology. Therefore, it is no surprise that the startup community has been and continues to be an essential component at the “front end” of the evolving ecosystem for biopharma, MedTech and digital medicine. Challenges exist for the startups, the evolving community of accelerators, and their commercializing partners who form alliances with the startup community to achieve and accelerate transformative innovation.</p> 2019-09-06T14:44:37+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology Evolution of the Screening Metaphor: Project, Product, or Platform? 2019-09-09T20:06:17+00:00 Arthur Boni <p>There are multiple options or paths to the market to be considered when developing the commercialization strategy for translating a technology or invention into an innovation. We present a very simple screening methodology that may be applied to facilitate a quick, but structured approach for the entrepreneur to identify which option or options may be most viable to create, deliver and capture value in potential markets. We construct the metaphors “project, product, or platform” to categorize three potential commercialization pathways to reach the market. Projects are best pursued with commercial partners via licensing arrangements. Products may be pursued using a research and development company business model. Platform is intended to signify creation and growth of a lasting, scalable organization intended to develop and bring multiple disruptive or transformative innovations to market. Which path to the marketplace is appropriate, or even possible will depend on a number of factors. These include: the magnitude of value being created for the market; the competitive set; and, the uniqueness of the solution and its sustainable, competitive advantage that can be created. It is also necessary to determine whether the value captured by the business model that may be constructed could generate sufficient profitability to balance the commercialization risks, while meeting the goals and objectives of the founders, investors and partners over an appropriate time line.</p> 2019-09-06T14:45:54+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology Aligning the Corporation for Transformative Innovation: Introducing Innovation Dashboard 2.0 2019-09-11T20:05:02+00:00 Arthur Boni Diana Joseph <p>Under pressure from mounting forces of change, corporations must engage in innovation more than ever. The transformative types of innovation required for organizations to thrive in the long-term are extremely difficult for established incumbents, in part because they have existing businesses to maintain. We focus on these transformative innovations that are difficult to achieve since they require exploitation of both technological and business model advancements. The Innovation Dashboard 2.0 that we describe herein offers a way for organizations, especially established corporates, to determine innovation activities, measure those activities, build innovation capacity, and align stakeholders across the organization around those activities.</p> 2019-09-06T00:00:00+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology Four Models for Corporate Transformative, Open Innovation 2019-09-09T20:05:55+00:00 Arthur Boni Diana Joseph <p>Four models are identified for organizations to pursue simultaneous core growth and transformative innovation leveraging open innovation principles: 1) <em>corporate accelerators —</em>engage with or create autonomous startups<em>;&nbsp;2</em>) <em>external startup platforms</em> <em>— </em>engage with startups through established third parties, 3) <em>consortia or alliances</em> — leverage resources of peers and emergent players across the innovation ecosystem; and; 4) <em>direct entrepreneurial approach --</em> work from within the organization to develop new units. We identify “innovation maturity” as the key factor to select which model is most appropriate for the organization. Additional considerations include the resources, processes and values of the organization, and the developmental status of the transformative technology. Model choice(s) are dynamic and can evolve over time as the innovation capacity of the organization matures and adapts to change.</p> 2019-09-06T14:50:41+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology IP Fundamentals – What Every CEO Should Know About IP in Biotechnology 2019-09-09T20:05:33+00:00 Kathryn Doyle <p>This chapter addresses four essential components of Intellectual Property as it relates to patents: (1) patents and the patent process, (2) developing a strategy to maximize patent protection for a product or a process, (3) due diligence, and (4) issues of inventorship and ownership. By way of an overview, there are four basic types of Intellectual Property – Patents, Trademarks, Copyrights and Trade Secrets. Patents cover ideas that are novel, non‑obvious, have utility and satisfy the enablement and written description provisions of the U.S. patent Statute. Trademarks cover identification of goods and services. Copyrights protect tangible expression, including writings, computer code, websites and the like. A Trade Secret is a form of intellectual property where secrecy is maintained over a process or an ingredient of a product over a period of time. This chapter will focus almost exclusively on patents.</p> 2019-09-06T14:51:41+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology Intellectual Property for Life Science Entrepreneurs 2019-09-09T20:05:12+00:00 Raymond Miller <p><em>This article provides an overview of the various forms of intellectual property that are available for life science entrepreneurs. These include patent, trademarks, trade secrets, and copyrights. Intellectual property strategies are suggested including portfolio development. We also cover patent terms, ownership, and exclusivity provisions. Additionally, we consider the synergies between patent strategy with regulatory strategy to enhance competitive positioning.</em></p> 2019-09-06T14:52:42+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology Intellectual Property – Solidify Your Competitive Edge 2019-09-09T20:04:52+00:00 James Jordan <p>This article notes that startup companies are temporary organizations in search of a repeatable and scalable business model that provides the organization with the ability to scale and grow while minimizing or preferably eliminating competition. This goal is achieved thru use of our Intellectual Property Pyramid<sup> TM</sup> (IPP) which is an analysis technique that accounts for both the market and the patent landscape to determine if the company’s IP (portfolio) creates a position that is “impervious to competitive advancement’s”.</p> 2019-09-06T15:11:36+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology 2018 Mostly a Sideways Market Masking a Lot of Excitement: Innovation and Science Keep the Party Rolling 2019-09-08T20:05:41+00:00 Edwin Gordon <p>Building science and technology-based organizations requires a reliable and steady stream of funding across the life cycle of the company. Along with building a good team, building a network of reliable and high value partners is essential. The financial community itself, however goes through periods of “ups and downs” and synchronizing financial strategy with reality can be challenging. Therefore, it is necessary to build and maintain a good understanding of the realities of the “state of the financial community” for access to capital and for exits such as M&amp;A and IPOs. In this paper we provide a brief overview of the “state of the market” in 2018.</p> 2019-09-07T04:41:26+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology Founding and Funding a Life Sciences Company: An Overview 2019-09-08T20:05:19+00:00 James Jordan David Smith <p>Founding and funding a company demands that the founding team and their advisors identify and articulate the myriad of challenges and risks that they will face in pursuit of their vision. These factors have implications regarding the technology, market, and team in addition to the regulatory and reimbursement challenges. This article provides the perspective of senior industry investors and legal counsel, and covers the vast array of decisions that form and guide the organization along the pathway to the market, e. g. corporate form, governance, financing, exit.</p> 2019-09-07T04:43:41+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology Strategic Planning for Financing and Growing Biotechnology Companies 2019-09-08T20:06:03+00:00 Claudine Kearney <p style="text-align: justify; text-justify: inter-ideograph; line-height: 200%;"><span style="font-family: 'Times New Roman',serif;">There are significant aspirations from both start-ups and existing biotechnology companies, as they endeavor to finance and grow their innovation. Growth demands substantial investments of time, energy and finance. Additionally, they face major risks and uncertainties in the process of growth and new product development in what is a dynamically changing environment.</span> <span style="font-family: 'Times New Roman',serif;">There is no question that the entrepreneurial spirit is core to biotechnology companies but without a congruent strategy for growth and a plan to secure the necessary finances to fund it they will most likely fail. This paper focuses on the process of strategic planning for financing and growing a biotechnology company. First, the strategic planning of biotechnology companies is discussed and a model of strategic congruence for innovation is proposed. Second, a framework for the process of financing a biotechnology innovation is presented. Third, examines the challenges of growing the biotechnology company. Following that final conclusions are drawn. </span></p> 2019-09-07T00:00:00+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology “The Good, the Bad, the Ugly”: Leadership Lessons From two Companies – Amgen and Theranos 2019-09-08T20:04:59+00:00 Arthur Boni Stephen Sammut <p>We review two books that provide perspective on leadership challenges and best practices for building successful companies. Lessons and frameworks are extracted from our reviews of recent books focused on two high-profile life science companies, Amgen and Theranos. Amgen, a pioneer in commercializing biotechnology was very successful, and along with Genentech set the standard for how to build and scale successful companies in the industry based on transformative life science technologies. Theranos, a more recent undertaking, illustrates a very high-profile company that pursued commercialization of a revolutionary diagnostic technology for blood testing with the promise of multi-purpose diagnostics obtained “from a single prick of blood”. Theranos has turned out to be anything but a success and as reported by Molly Brown at Geekwire (loc. cit.) is actually a “what not to do guide for startups”. We reprise and summarize materials previously published by one of us as a book review on Amgen (“Science Lessons: What I Learned about Management from Biotechnology”, by Gordon Binder and Phillip Bashe). Amgen serves as a role model for “the good” in building successful life science companies. Then, we provide a short review of the recent best seller on the Theranos story, titled “Bad Blood: Secrets and Lies in a Silicon Valley Startup” by John Carreyrou. In Theranos, the “bad and the ugly” are self-evident. Carreyrou’s excellent investigative reporting is highlighted in our review of that book, but as of this writing the story continues to unfold in the press and in the court system as a result of the alleged fraud from misrepresentation to investors, partners, and regulators by Theranos leadership. We use these two book reviews to highlight the 3Ps that comprise the ingredients for a successful company – the Problem (or opportunity), the People (leadership, ethics, culture) and the Processes (which are employed to validate the product/market fit incrementally prior to being able to exploit the full potential of the technology that underlies the platform and business model). The People dimension (team, leadership and culture, e. g. execution) is indeed critical to success, and we focus on that here.</p> 2019-09-07T04:49:21+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology Leading and Managing Teams in Entrepreneurial Organizations: an Experiential Perspective 2019-09-08T20:04:39+00:00 Arthur Boni <p>This article focuses on summarizing best practices for leading and managing diverse teams in entrepreneurial companies. Our approach is to build on sound academic principles, but we focus on bringing in a strong experiential perspective based on extensive discussions with active venture capital investors in the Silicon Valley/Bay Area innovation ecosystem. A sidebar article summarizes these findings. A key observation is that the most important indicator of success in entrepreneurial ventures can be attributed to lack of leadership and team performance, with business model/market factors less important and technology failures even less of a factor. We highlight best principles for building and leading diverse, inclusive, agile teams appropriate for the biopharma and technology industries.</p> 2019-09-07T04:50:53+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology Building and Managing Great Teams: An Evidence-Based Approach 2019-09-07T20:05:55+00:00 Gergana Todorova <p style="line-height: 200%;"><span style="font-size: 12.0pt; line-height: 200%; font-family: 'Times New Roman',serif;">Efforts to initiate new startups rely heavily on teams and networks. Research demonstrates that 95 percent of the individuals trying to start a business involved others in helping build the new business. This article provides an overview of the team performance literature that can be used when making managerial decisions about building and managing successful entrepreneurial teams. I integrate and review prior research in three areas that have been disconnected previously: 1) innovation networks and teams; 2) team boundary spanning and internal processes; and 3) shared ownership and team motivation. The integration and review in this article provide new insights towards an evidence-based approach on managing entrepreneurial teams,</span></p> 2019-09-07T04:51:58+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology Setting Up and Working with a Board of Directors: A Guide for Startups 2019-09-07T20:05:35+00:00 James Jordan <p>Commercializing the idea behind the next big thing is only the first step on a long road to success for a company founder. Facing a myriad of regulatory obstacles, funding challenges, and other seemingly insurmountable roadblocks, every startup needs the support and guidance of an experienced board of directors. A board of directors’ most important function is to provide a continuous give-and-take discussion with management regarding strategy, funding, and governance while representing the shareholders and stakeholders.</p> 2019-09-07T04:52:59+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology When an FDA Drug Approval Makes Mainstream News: The Announcement of Zulresso, A Media Case Study 2019-09-07T20:05:15+00:00 Moira Gunn <p>Media coverage following U.S. Food and Drug Administration (FDA) drug approvals is generally found in two sectors: bioindustry news and the financial markets. The March 19, 2019 FDA announcement of its approval of the postpartum anti-depression biopharmaceutical Zulresso from Sage Therapeutics also elicited unusually high levels of media response in the mainstream media. This case study (1) details the total media news response following the FDA approval announcement regarding Zulresso, (2) compares that media response with the mainstream media coverage for Aimovig, a Novartis and Amgen treatment, which received the most mainstream coverage in the group of 2018 FDA novel drug approvals, and (3) compares the media coverage for three recent FDA drug approvals, Mayzent, Dovato and Evenity, to demonstrate a normative media response pattern. Findings include demonstration of Zulresso coverage across all major mainstream media outlets, well in excess of its mainstream media comparator, Aimovig. The three recently-announced comparators received the anticipated media coverage in the bioindustry and financial markets segments, while the two mainstream candidates, Zulresso and Aimovig, both received more and/or more timely media coverage in the bioindustry and financial markets media sectors three recent drug approval comparators. No determination could be made as to whether the mainstream media response to Zulresso was a singular incident, or the signaling of a sea change due to the maturation of the biotechnology industry.</p> 2019-09-07T04:53:52+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology The Complexity of Pharmaceutical Prices: An Economic Analysis 2019-09-07T20:04:54+00:00 Erwin Blackstone Joseph Fuhr Jr. <p>This article examines the complexity of pharmaceutical pricing. Specifically, list prices are often considerably higher than net prices. PBMs have considerable market power to obtain substantial discounts (rebates) from pharmaceutical companies which encourages higher list prices. In general the generic market work well. At issue is how much of the discounts are passed on to other stakeholders. High prices during market exclusivity or patent protection encourages R&amp;D. Pharmaceuticals spend a large percentage of revenues on R&amp;D, earn large profits which are somewhat overstated and take substantial risk. Many firms never make a profit. Drugs provide great value and increase the quality of life of patients. Since subscribers often change insurance companies, insurers have a shorter time horizon than pharmaceutical firms, which could lead to coverage issues. Policies to mitigate high drug prices include changes to PBM rebate practices, stricter patent approvals and reduction of barriers for generics and biosimilars.</p> 2019-09-07T04:55:56+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology The R&D Marketing Interface in Biopharma and MedTech 2019-09-07T20:04:33+00:00 Thani Jambulingam <p>This article highlights the importance of building a marketing led cross-functional team that integrates the R&amp;D, and commercialization process in an early stage Biopharma and MedTech company. Marketing should play a prominent role in the cross-functional team at the earliest stages of company formation and product development to identify unmet need, design the development plan, shape the product life cycle, position the product in the competitive set, and understand all market drivers and competitive factors that are essential to ensure commercial success. In particular, in this paper, the focus is on the importance of creating an appealing target product profile (TPP) and describe the rational and methodology for creating the TPP. Drug development is a high risk, high cost, high reward undertaking, and the TPP provides a market-guided approach to development of drugs more quickly, inexpensively, and with a higher rate of success.</p> 2019-09-07T04:56:59+00:00 Copyright (c) 2019 Journal of Commercial Biotechnology