Section I. Biotechnology Entrepreneurship
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
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
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
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
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
Chapter 6. Characteristics of Successful Biotechnology Leaders
- Success and Failure
- Requirements for Achieving Success: Organizational
- Six Factors for Success
- Conclusion
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
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
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
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
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
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
Chapter 13. Company Formation, Ownership Structure, and Securities Issues
- Entity Formation
- Ownership Structure
- Fundrasing
- Summary
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Chapter 30. Ethical Considerations for Biotechnology Entrepreneurs
- The Nature of Ethical Reasoning
- Key Issues and Practical Matters for Biotechnology Entrepreneurs
- Case Studies
- Summary
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
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