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.�
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Table of Contents
SECTION 1: UNDERSTANDING BIOTECHNOLOGY ENTREPRENEURSHIP1. What is Biotechnology Entrepreneurship?2. A Biotechnology Entrepreneur's Story Advice to Entrepreneurs: 2 Tributes to Henri A. Termeer3. A Biotechnology Entrepreneur's Story: From Start-up to International Contract Development and Manufacturing Organization4. Characteristics of Successful Biotechnology Leaders
SECTION 2: OVERVIEW OF THE BIOTECHNOLOGY INDUSTRY5. Unleashing the Promise of Biotechnology to Help Heal, Fuel and Feed the World6. Five Essential Elements for Growing Biotechnology Clusters
SECTION 3: THE HUMAN CAPITAL COMPONENT7. Building, Managing and Motivating Great Teams8. Building Human Relationship Networks9. Mentorship: Why You Need a Team of Mentors to be Successful
SECTION 4: THE INNOVATIVE TECHNOLOGY COMPONENT10. Understanding Biotechnology Product Sectors11. Technology Opportunities: Evaluating the Idea12. Understanding Biotechnology Business Models and Managing Risk13. Directing Your Technology Toward a Market Problem: What You Need to Know Before Applying the Business Model Canvas
SECTION 5: THE EMERGING BIOTECHNOLOGY ENTERPRISE14. Company Formation, Ownership Structure and Securities Issues15. Licensing the Technology: Biotechnology Commercialization Strategies Using University & Federal Labs16. Intellectual Property Protection Strategies for Biotechnology Innovations
SECTION 6: THE FINANICAL CAPITAL COMPONENT17. Sources of Capital and Investor Motivations18. How Investors Really Make Decisions: What Entrepreneurs Need to Know When Raising Money19. Securing Angel Capital and Understanding How Angel Networks Operate20. Understanding and Securing Venture Capital: an Entrepreneur's Perspective21. Financial Ramifications of Funding a Biotechnology Venture: What you Need to Know about Valuation and Term Sheets22. Your Business Plan and Presentation: Articulating Your Journey to Commercialization23. Investor Presentations: What Do You Need in an Investor Pitch Deck
SECTION 7: BIOTECHNOLOGY PRODUCT DEVELOPMENT24. Therapeutic Drug Development and Human Clinical Trials25. Integrating Diagnostic Applications into the Drug Development Workflow: Applications for Companion Diagnostics26. The Development and Commercialization of Medical Devices27. Commercialization and Applications of Agricultural Biotechnology28. Artificial Intelligence: Emerging Applications in Biotechnology and Pharma29. Regulatory Implications and Market Approval Considerations for Artificial Intelligence Products30. Regulatory Approval and Compliances for Biotechnology Products31. The Biomanufacturing of Biotechnology Products
SECTION 8: BIOTECHNOLOGY MARKET DEVELOPMENT32. Biotechnology Products and Their Customers: Developing a Successful Market Strategy33. Biotechnology Product Coverage, Coding, and Reimbursement Strategies34. Getting the Word Out: Public Relations Strategies to Support Biotechnology Business Goals
SECTION 9: THE LATTER-STAGE BIOTECHNOLOGY COMPANY35. Company Growth Stages and the Value of Corporate Culture36. Biotechnology Business Development: The Art of a Deal37. Biotech-Pharma Collaboration A Strategic Tool: Case Study of Centocor38. The Emergence and Transformation of China in Biotechnology: Partnering with China39. Ethical Considerations for Biotechnology Entrepreneurs (suggested change to "Leaders")40. Diverse Career Opportunities in the Biotechnology and Life Sciences Industry41. Common Biotech Entrepreneur Mistakes and How to Avoid them42. Summary
