Biotechnology Entrepreneurship

1st Edition
Starting, Managing, and Leading Biotech Companies

Editors: Craig Shimasaki

eBook ISBN: 9780124047471
Hardcover ISBN: 9780124047303
Imprint: Academic Press
Published Date: 28th April 2014
Page Count: 488

Description
As an authoritative guide to biotechnology enterprise and
entrepreneurship, Biotechnology Entrepreneurship and Management supports the
international community in training the biotechnology leaders of tomorrow.

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Key Features
  Provides tested strategies and lessons in an engaging
and user-friendly style
supplemented by tailored pedagogy, training tips and overview sidebars
 Case studies are interspersed throughout each chapter to support key concepts
and best practices.
 Enhanced by use of numerous detailed graphics, tables and flow charts

Readership
For grad students studying or interested in the translation of medical / life science
research into applied products, commercialization of those technologies, and
development of early stage companies. Associated professionals interested in business
of biotech, or tangent issues of entrepreneurship and leadership.

Table of Contents
 Dedication
 Preface
 Foreword
 Acknowledgements
 Section I. Biotechnology Entrepreneurship
o Chapter 1. Unleashing the Promise of Biotechnology to Help Heal, Fuel,
and Feed the World
 Health Biotechnology: Helping to Save and Extend Lives
 Food and Agricultural Biotechnology: Helping to Feed the World
 Industrial and Environmental Biotechnology: A Better Way to Make
Things
 The Public Policy Environment for Biotech Innovation
o Chapter 2. A Biotechnology Entrepreneur’s Story: Advice to Future
Entrepreneurs
 Path to Entrepreneurship
 Risks of Joining a Biotechnology Company
 Genzyme in the Early Days
 The Importance of Understanding Business and Finance
 Raising Capital
 Managing the Uncertainty of Biotechnology
 Core Values
 Integrating the Science and Business
 The Value of a Business Background and Experience
 Driven from Within
 In Touch with Events Outside the Company
 Good Fortune and Success
 Closing Advice
o Chapter 3. The Biotechnology Industry: An Engine of Innovation
 The Birth of an Industry
 The Industry Takes Root
 The Industry Today
  The Challenge of Drug Development
 Falling R&D Productivity
 The Consistent Challenge
 Howdy Partner
 The End of the Blockbuster Era
 The Times they are a Changing
 Mapping the Human Genome
 An Evolving Vision
 Changing Economics
 A Greater Promise
 Investing in Innovation
 Partnerships of Convenience
 Promoting Technology Transfer
 Not Just About Drugs
 Everything Old is New Again
 The Challenge of Scale
 Improving Yields
 The Challenge Today
 The Moment is Now
 Value is Transient
 Value is Geographic Dependent
 Value to Payers is not a Constant
 Value is not a Function of Sales and Earnings
 The Challenge for Life Sciences Companies
o Chapter 4. What is Biotechnology Entrepreneurship?
 The Significance of the Biotechnology Entrepreneur
 The Integration of Two Distinctly Different Disciplines
 Biotechnology Entrepreneurship Versus General Entrepreneurship
 Entrepreneurship and Intrapreneurship
 The Biotechnology Entrepreneur, Manager, or Leader
 Essential Biotechnology Entrepreneurial Characteristics
 Four Backgrounds of Biotechnology Entrepreneurs
 Being the Entrepreneur for a Season
 Driving Forces Behind a Biotech Entrepreneur’s Decisions
 Learning from “Failure”
 Summary
o Chapter 5. Five Essential Elements for Growing Biotechnology Clusters
 Biotechnology Clusters are Actively Developing World-Wide
 What is a Biotechnology Cluster
 What are the Benefits of a Biotechnology Cluster?
 The Five Essential Elements Necessary to Growing a Biotechnology
Cluster
 “Growing” Biotechnology Clusters
 Five Essential Elements to Growing a Biotechnology Cluster in a
Region
 Important Considerations
 Other Enhancers of Biotechnology Cluster Development
  Maintenance Factors VS. DRIVERS
 Inhibitors of Biotechnology Cluster Growth
 The Role of Government in Developing Biotechnology Clusters
 Where to Start?
 Summary
 Section II. The Human Capital
o Chapter 6. Characteristics of Successful Biotechnology Leaders
 Success and Failure
 Requirements for Achieving Success: Organizational
 Six Factors for Success
 Conclusion
o Chapter 7. Building, Managing, and Motivating Great Teams
 Entrepreneurial Process Fundamentals Related to Teams
 Summary of “Lessons Learned” (The Experiential Perspective)
 Key Questions to Ask when Building the Team—The Academic
Perspective
 An Approach to Understand Factors that Motivate Teams
 Summary and Conclusions
 An Abridged Overview of Team Performance Literature
o Chapter 8. Building Human Relationship Networks
 Purposeful Networking is a Way to Expand Limited Resources
 Human Networks Lead to Mentoring
 Boards of Advisors and Directors can Help Accelerate Company
Success
 Personal Traits and Characteristics
 Conclusion
 Section III. The Technology
o Chapter 9. Understanding Biotechnology Product Sectors
 Biotechnology Product and Technology Sectors
 Product Development Costs Vary by Sector
 Product Development Timeframe Varies for Biotechnology Sectors
 Creating Value
 Overview of Product Sectors
 Summary
o Chapter 10. Technology Opportunities: Evaluating the Idea
 Sources of Biotechology Product Ideas
 Research to Commercialization Chasm
 Experimental Paths: Basic Research Versus Translational Research
 Technology is a Solution Seeking a Problem to Solve
 How to Determine if a Product Concept is Worth Pursuing as a
Company
 Evaluate the Underlying Science and the Technology Team
 Evaluating the Product’s Perceived Market Potential
 The People Factor
 What to do Next?
 Summary
o Chapter 11. Commercialization of Bioagricultural Products
  What is Agricultural Biotechnology?
 The Ag biotech Commercialization Process
 There is a Path!
 What’s been Achieved so Far
 Herbicide-Tolerance and Insect-Resistance Traits
 How the Landscape Changed
 Patently Important Trends
 Lessons Learned and Opportunities for a New Entrepreneur
o Chapter 12. Understanding Biotechnology Business Models and Managing
Risk
 What is a Business Model?
 The Virtual Company Business Model (A Temporary Start-Up
Model)
 Business Model Examples
 The Drug Repositioning Business Model
 Enabling Technology Business Models
 Diagnostic and Research Tools Companies
 Clinical Laboratory Service Business Model
 Subscription Business Model
 All Business Models have Transferable Component Parts or
Segments
 How Do You Determine the Best Business Model for a Technology
 Entrepreneurial Leaders are Risk Managers
 Biotechnology Company Evaluation Tool
 Summary
 Section IV. The Emerging-Stage Biotechnology Company
o Chapter 13. Company Formation, Ownership Structure, and Securities
Issues
 Entity Formation
 Ownership Structure
 Fundrasing
 Summary
o Chapter 14. Licensing the Technology: Biotechnology Commercialization
Strategies Using University and Federal Labs
 The Federal Government’s Investment in Basic Biomedical
Research
 Translation of Academic Research to Products for the Public Good
 Accessing Academic Technologies and Collaborations
 Technology Transfer Office Set-Up and Licensing from Universities
and Federal Laboratories
 Advantages for a Biotech Start-Up to Work with the Nih and
Universities
 New and Innovative Programs as We Move Towards “V2.0” Of
Technology Transfer
 Impact of Technology Transfer
o Chapter 15. Intellectual Property Protection Strategies for Biotechnology
Innovations
  The Intellectual Property Toolbox
 Patents
 Contracts Relating to Intellectual Property
 Joint Research Projects
 Trademarks
 Pharmaceutical Patents and Market Exclusivity
 Regulatory Approvals for Biologics and Biosimilars
 Diagnostics and Personalized Medicine
 Corporate IP Management
 Patent Strategies and Product Lifecycle Management
 Some Resources
 Section V. Biotechnology Market Development
o Chapter 16. Biotechnology Products and Their Customers: Developing a
Successful Market Strategy
 Identify the Patient
 Identify the Physician or Healthcare Provider
 Identify the Payers
 Develop a Marketing Strategy for Your Future Product
 What is Marketing?
 Advancement of the Marketing Concept
 Market Research and Assessment Tools
 Other Market Tools and Concepts
 Starting to Develop a Market Strategy
 Identify Your Market Development Milestones
 Biotechnology Product Adoption Curve
 Summary
o Chapter 17. Biotechnology Product Coverage, Coding, and Reimbursement
Strategies
 Understanding Reimbursement and Coding of Biotechnology
Products in the United States
 The Analytical Framework for New Technologies
 Defining the Terms of Coverage
 Positioning the Product for Favorable Reimbursement
 European Reimbursement Systems Overview
 Health Technology Assessment (HTA)
 Pricing
 Reimbursement Mechanisms
 European Pricing and Reimbursement Summary
o Chapter 18. Getting the Word Out: Using Public Relations Strategies to
Support Biotechnology Business Goals
 What is Public Relations and How can it Support Your Business
Objectives?
 Get Ready: What’s Your Story?
 Get Set: Creating YOUR Communications ToolS
 Designing and Implementing a Strategic Communications Program
 News Releases
 Media Relations—Why it Still Matters
  Working with Reporters and Editors
 Building Visibility when you Don’t Have News
 Case Study—Strategic Use of PR to Support both Financing and
Partnering
 What About Digital and Social Media?
 Summary
 Additional Resources
 Section VI. The Financial Capital
o Chapter 19. Sources of Capital and Investor Motivations
 Understanding Investor Criteria and Limitations
 Understanding Investors’ Expectations for Return on Investment
 Understand what Comes with Invested Money: Motivations and
Interests
 What are the Capital Sources Available to Biotechnology
Companies?
 Determining the Value of Development-Stage Biotechnology
Companies
 Financing Stages for a Biotechnology Company
 What is an “Exit” Strategy?
 How much Money is Raised at Each Funding Stage?
 How much of the Company is Given Up in Each Round?
 Summary
o Chapter 20. Securing Angel Capital and Understanding How Angel
Networks Operate
 What is an Angel Investor?
 Typical Background of Angel Investors
 How much does a Typical Angel Investor Invest?
 Angel Investor Motivations
 Locating Angel Networks
 Things to Know When Presenting to Angel Investors
 Understanding Angel Networks and How They are Formed
 Angel Expectations
o Chapter 21. Understanding and Securing Venture Capital
 What is Venture Capital?
 Capital is a Commodity, Whereas Experienced Investing Partners
are Not
 Venture Capital Partners are Time Constrained
 How can an Entrepreneur Improve Their Chances of Securing
Venture Capital?
 How and when to Approach a Venture Capital Firm
 Raising Capital for Biotechnology Companies
 Experienced and Seasoned Management Team with Passion
 Do not Overvalue Your Company at any Funding Stage
 The Presentation to VC Partners
 Next Steps in the Investment Commitment Process
 Summary
 o Chapter 22. Your Business Plan and Presentation: Articulating Your
Journey to Commercialization
 Pitching to Investors and Partners
 The Business Planning Process
 The Contents of the Business Plan
 Presenting the Written Business Plan
 Orally Communicating Your Business Plan
 Conclusion
 Section VII. Biotechnology Product Development
o Chapter 23. Therapeutic Drug Development and Human Clinical Trials
 Small Molecule Drugs
 Large Molecule Drugs
 Clinical Transition Studies—Investigational New Drug Approval
 Clinical Trials
 Summary
o Chapter 24. Development and Commercialization of In Vitro Diagnostics:
Applications for Companion Diagnostics
 Bringing IVD Products to Market
 Successful Adoption of IVDS
 Reimbursement of IVD Products
 Application of an IVD as a Companion Diagnostic
 Forging Diagnostic and Therapeutic Partnerships for Companion
Diagnostic Applications
 Integrating an IVD into the Drug Development Pathway as a
Companion Diagnostic
 Challenges to the Development and Commercialization of CDx
Products
 Future Applications for IVD Products
 Summary
o Chapter 25. Regulatory Approval and Compliances for Biotechnology
Products
 History of the FDA
 Regulations Related to Biomedical Product Development
 Current Regulatory Pathways
 Translational Development
 Human Clinical Testing Phases
 Biologics License Application (BLA)
 Summary
o Chapter 26. The Biomanufacturing of Biotechnology Products
 The History of Biotechnology and Biomanufacturing
 A Typical Biomanufacturing Process
 Biosimilars
 Discovery
 Process Development
 Clinical Manufacturing
 Clinical Trials
 Good Manufacturing Practices
  Facility Requirements
 The Biomanufacturing Team—TheIR Typical Roles and
Responsibilities in a Biologics Manufacturing Facility
 Material Management
 Biologics Drug Substance Manufacturing
 Manufacturing Support Functions
 Contract (CMO) Versus In-House Manufacturing
 Summary
 Section VIII. The Later-Stage Biotechnology Company
o Chapter 27. Company Growth Stages and the Value of Corporate Culture
 Corporate Development and Transition Stages
 The Start-Up Phase
 The Development Phase
 Expansion Phase
 Decline Phase
 The CEO’s Role in the Transition of Life Stages
 Management Skill Sets
 Corporate Culture and Core Values in a Biotechnology Company
 Guidance for Hiring Team Members
 Recognizing When to Let Some People go
 Summary
o Chapter 28. Biotechnology Business Development: The Art of the Deal
 Background of Biotechnology Licensing and Partnering Deals
 What is a Business Development “Deal?”
 Starting the Process
 The Deal Requires a Plan
 Closing the Deal
 A Summary of the Deal Dance
o Chapter 29. Biotech-Pharma Collaboration—A Strategic Tool: Case Study
of Centocor
 The Birth of Centocor
 The Collaborative Journey Begins
 Finance: “GRAB as Many Cookies as You Can”
 Expanding its Market Potential
 Therapeutics
 Centocor Goes it Alone
 “Centocorpse”: Centocor in Crisis
 Collaboration—A Means of Rescue
 Centocor Becomes Profitable
 Conclusion
o Chapter 30. Ethical Considerations for Biotechnology Entrepreneurs
 The Nature of Ethical Reasoning
 Key Issues and Practical Matters for Biotechnology Entrepreneurs
 Case Studies
 Summary
o Chapter 31. Career Opportunities in the Life Sciences Industry
  An Overview of the Many Different Vocational Areas in the Life
Sciences Industry
 Making a Career Transition
 Finding a Job in the Life Sciences Industry
 Networking
 Interviewing
 Careers in the Life Sciences Industry: Job Security and Volatility
 Final Comments and Conclusions
 Resources
o Chapter 32. Summary
 Biotechnology Entrepreneurship
 Biotechnology Sectors and Product Diversity
 Growing Biotechnology Clusters
 Technology Opportunities
 Intellectual Property Protection Strategies
 Company Business Models
 The Virtual Company
 Development of a Company Culture with Core Values
 Sources of Capital for Product Development
 Company Growth Stages
 Biologics Manufacturing
 Regulatory Approval for Biotechnology Products
 Biotechnology Products have Three Customers
 Business Development and Partnering
 Public Relations for Biotechnology Companies
 Ethics in Biotechnology
 Career Opportunities in the Life Sciences Industry
 Conclusions
 Index