Starting A Business In The Life Sciences

Innovation is a translation of a new method, idea, or product into reality and profit. It is a process of connected steps that accumulates into a brand reputation required for success. Unlike Fortune 500 companies, whose projects are self-funded, a start-up must simultaneously have a value proposition that attracts a customer (for revenue), investors (for capital), and acquirers (for a liquidity event or IPO). A high percentage of start-ups fail before attaining positive cashflow, due to a variety of reasons that are detailed in this book. Avoiding the pitfalls and wrong turns are the goals of this book. Innovation, Commercialization, and Start-Ups in Life Sciences details the methodologies necessary to create a successful life science start-up from initiation to exit. Written by an expert who has worked with more nearly 500 life science start-ups, this book discusses specific processes and investor milestones that must be navigated to align customer, funder, and acquirer needs. Successful commercialization requires attention to multiple constituents, such as investors, regulators, and customers. Investors require liquidity for their return, which is achieved through selling their stock in a public or private sale. The reader will gain an appreciation for the necessary data, partnerships, and skills needed to create a competitive and sustainable company. The author discusses such specific issues as customer problems, demonstrating sales access, and ensuring intellectual property is impervious to competitive advancement. This book is intended to be suitable for entrepreneurs, venture capitalists, and investors in both business and academic settings. These organizations have specific departments, such as R&D, operations, business development, legal, regulatory, and marketing, that would also benefit from this book. FEATURES Focuses specifically on life science start-ups Examines how to determine a company valuation and future "fundable milestones" Explores how to align regulatory and clinical strategies Discusses intellectual property derived from a university or individual through formation to exit. Reviews how start‐ups must simultaneously meet the needs of multiple constituencies at once: investors, regulators, customers and exit candidates James F. Jordan is an author, consultant, and speaker. He is a Distinguished Service Professor of Healthcare & Biotechnology Management, a former Fortune 100 executive, and a managing director of a venture fund. Access the Support Material: https://healthcaredata.center/ Cover design by Sarah Mailhott.

This practice-orientated guide provides comprehensive background knowledge for promoters of firms and all others involved in the sphere of biotechnology. Internationally acting professionals deal with subjects from business plan, financing/funding, site selection, patent portfolio, co-operations to long-term perspectives of how to prevail in the market. In a final chapter several promoters of firms report about their personal experiences. Apart from promoters of firms this book has also been written for educational organizations (universities), regulatory authorities, consulting firms, technology transfer centers, bio-science parks and financing/funding organizations or persons (banks, venture capital providers, other financiers). Book jacket.

'The processes of internationalization, innovation and venture-creation in high-technology new ventures are inextricably intertwined. This is particularly true in the uncertain and troubled waters of the life sciences industry where startups with very uncertain futures are required to face significant challenges in short windows of opportunity. Navigating these waters is not straightforward, either for those immediately involved in it, or for those trying to understand it. This book is a must-read for anyone who is serious about understanding entrepreneurship in the biotechnology industry.' Alberto Onetti, CrESIT (Research Center for Innovation and Life Science Management), Italy In this thought-provoking book, leading experts explore why international entrepreneurship is important to the life sciences industry. From multi-disciplinary and cross-national perspectives, they question why international entrepreneurship scholars might usefully invest interest in research focused on one specific industry context. The book addresses contemporary challenges of relevance to life science firms and draws on leading-edge debates in international entrepreneurship research. Topics include: the nature of the born-global firm; the development of international capabilities and competencies; the role of local and international partnerships and alliances; competitiveness, opportunity recognition and orientation; and the role of specialized complementary assets in internationalization. It concludes by proposing an agenda for future research across the underpinning fields of innovation, entrepreneurship and internationalization. This book will prove a stimulating read for academics, students and researchers with an interest in international business, management and entrepreneurship, as well as for practitioners in the health professions or life sciences academics who are, or may become, entrepreneurs.

Innovation is the translation of a new method, idea, or product into reality and profit. It is a process of connected steps that accumulates into your brand or reputation. However, there can be many pitfalls and wrong turns on the road to realizing this goal. Innovation, Commercialization, and Start-Ups in Life Sciences details the methodologies necessary to create a successful life sciences start-up from initiation to exit. You will gain an appreciation for the necessary data, partnership, and skills to be acquired and the constituencies that must be satisfied along the way. The book examines how life sciences start-ups can create an exit for their investors by recognizing that a liquidity event is not consummated without due diligence. Due diligence is bigger than validating accounting transactions. It ensures the company is solving an important customer problem, demonstrating sales access, and making sure that intellectual property is impervious to competitive advancement. The due diligence process supports the telling of a compelling story to customers, investors, regulators, and acquirers. Written by an expert who has worked with more than 200 life sciences start-ups during the past decade, the book discusses specific processes and investor milestones that must be navigated to align customer, funder, and acquirer needs. It examines these processes from the perspective of marketing value through a focus on the needs of individual constituents—investors, regulators, customers, and exit candidates. The book presents data and analytical processes articulating the fundable milestones for angel and venture capital. It gives you the tools needed to create branding for public investors and more.

My journey into this fascinating field of biotechnology started about 26 years ago at a small biotechnology company in South San Francisco called Genentech. I was very fortunate to work for the company that begat the biotech industry during its formative years. This experience established a solid foundation from which I could grow in both the science and business of biotechnology. After my fourth year of working on Oyster Point Boulevard, a close friend and colleague left Genentech to join a start-up biotechnology company. Later, he approached me to leave and join him in of all places – Oklahoma. He persisted for at least a year before I seriously considered his proposal. After listening to their plans, the opportunity suddenly became more and more intriguing. Finally, I took the plunge and joined this ent- preneurial team in cofounding and growing a start-up biotechnology company. Making that fateful decision to leave the security of a larger company was extremely difficult, but it turned out to be the beginning of an entrepreneurial career that forever changed how I viewed the biotechnology industry. Since that time, I have been fortunate to have cofounded two other biotechnology com- nies and even participated in taking one of them public. During my career in these start-ups, I held a variety of positions, from directing the science, operations, regulatory, and marketing components, to subsequently becoming CEO.

Innovation is the translation of a new method, idea, or product into reality and profit. It is a process of connected steps that accumulates into your brand or reputation. However, there can be many pitfalls and wrong turns on the road to realizing this goal. Innovation, Commercialization, and Start-Ups in Life Sciences details the methodologies ne

The process of innovation in life science is capital intensive, associated with a high risk as well as highly regulated and is therefore distinct from other types of innovation. This book closes the educational gap in life science entrepreneurship and fills a market niche. It allows you to understand, manage and successfully lead the innovation process in life science. Learn how to develop and successful market biomedical technology Increase the return of your investments in biomedical innovation Get ready for a new career in a life science start-up Discover how to transfer a bio- or medtech project from academia to industry Obtain a comprehensive overview of the innovation process in life science

Developing a business in the life sciences industry presents certain unique management challenges. The life sciences industry, which includes pharmaceuticals, biotech, biological products, imaging, medical devices, diagnostics, and drug delivery, comes with high risk and can lead to high rewards. It may take up to ten years to obtain a drug approval and the industry is subjected to government regulations. Intellectual property rights are critically important, and due to the specialized nature of the business, raising capital, hiring key executives and staff, and navigating development candidates through a rigorous development process can present unique management challenges. This conversational and accessible guide on starting, growing, and exiting a life sciences business will help you tackle these thorny issues and more. With the help of expert Jack J. Luchese, learn both business basics and industry specialization, with clear explanations for every step along the way. Anyone from budding entrepreneurs to research scientists to potential investors will find this book a useful companion. From founding the business to formulating an exit plan, this glimpse into the life cycle of a life sciences business is informative and entertaining.