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Biotechnology and law are inextricable. Patent, regulatory, and contract law profoundly shape the biotech industry, and each of these practice areas is deeply intertwined with the science it governs. Yet many in this industry lack even a basic grasp of these laws, jeopardizing their business success as a result.This book is an essential introduction to biotechnology law for scientists, startup founders, regulatory specialists, patent liaisons, investors, academics, students, and other nonattorneys with biotech backgrounds. It covers core topics such as patentability, patent prosecution and infringement, patent opinions, the development and FDA approval of small-molecule and biologic drugs, regulatory exclusivity, generic drugs and ANDA litigation, biosimilars and the patent dance, patent licenses, and collaboration agreements. Written with scientists in mind, Biotechnology Law is a clear, concise, and entirely practical primer on the topic, replete with straightforward, real-world examples to illustrate each key concept. Understanding the legal machinery through which science becomes business is not a luxury—it is a crucial part of a scientist’s training. Alan J. Morrison’s expert treatment embraces this new reality.
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This second edition of Biotechnology Entrepreneurship: Leading, Managing, and Commercializing Innovative Technologies is an authoritative, easy-to-read guide covering biotechnology entrepreneurship and the process of commercializing innovative biotechnology products. This best practice resource is for professional training programs, individuals starting a biotech venture, and for managers and experienced practitioners leading biotech enterprises. It is a valuable resource for those working at any level in the biotech industry, and for professionals who support and provide essential resources and services to the biotech industry. This practical, “how-to” book is written by seasoned veterans experienced in each of the operational functions essential for starting, managing, and leading a successful biotech company.Biotechnology Entrepreneurship explains the biotech business components and underlying strategies, interspersed with practical lessons from successful biotech entrepreneurs, educators, and experienced practitioners. These veteran contributors share their insights on how to be successful in this challenging but exciting industry. Subjects range from technology licensing and translating an idea into a viable business, forming your legal company entity, securing angel and venture capital, navigating product development, FDA regulatory approval, and biomanufacturing.This book is a user-friendly guide to decision-making and overall strategy written as a hands-on management tool for leaders and managers of these dynamic biotechnology ventures. If you are contemplating starting a biotech company, are a manager at any level, a seasoned veteran, or service provider in the biotech industry, this book is a “must read.”
Firms and enterprises --- E-books --- Biotechnology industries. --- Entrepreneurship.
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Marketing --- Strategic planning. --- Biotechnology industries. --- Evaluation. --- Success in business --- Management.
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Biotechnology industries. --- Entrepreneurship. --- Entrepreneur --- Intrapreneur --- Capitalism --- Business incubators --- Biomedical industries --- High technology industries --- E-books
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Market segmentation. --- Strategic planning. --- Biotechnology industries. --- Distribution. --- Internet marketing. --- Marketing --- Pricing. --- Management.
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Marketing research --- Strategic planning. --- Data processing. --- Biotechnology industries --- Marketing --- Performance --- Marketing. --- Strategy. --- Measurement.
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Medical care --- Medical technology --- Life sciences --- Marketing. --- Economic aspects. --- Biotechnology industries --- Computer service industry. --- Marketing
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Patent laws and legislation --- Patent licenses --- Biotechnology --- Biotechnology industries --- Patent laws and legislation --- Antitrust law --- Law and legislation
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Marketing --- Performance --- Biotechnology industries --- Mathematical models. --- Measurement. --- Marketing. --- Break-even analysis. --- Internet marketing. --- Marketing research. --- Medical technology --- Statistics.
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This case study demonstrates the use of the TAM-SAM-SOM model by applying it to MedLung, illustrating the principle of calculating market size and forecasted growth when performing a situation analysis.
Medical technology. --- Biotechnology industries --- Marketing --- Medical instruments and apparatus industry. --- Medical instruments and apparatus --- Medical technology --- Management --- Marketing.
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