Biotechnology Entrepreneurship - Edition 1 - Edited by Craig Shimasaki Elsevier Educate

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Biotechnology Entrepreneurship,

Edition 1 Starting, Managing, and Leading Biotech Companies

Edited by Craig Shimasaki

Publication Date: 28 Apr 2014

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

Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners.

It provides a ‘how-to’ for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements.

An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making.

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

About the author

Edited by Craig Shimasaki, BioSource Consulting Group, Oklahoma City, OK, USA

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

ISBN: 9780124047303

Page Count: 488

Retail Price (USD) :

Biotechnology: Academic Cell Update Edition (2011), Clark & Pazdernik, 9780123850638, 768pp, $109.95.Academia to Biotechnology (2004), Gimble, 9780122841514 , 186pp, $53.95. Biotechnology for Beginners (2007), Renneberg& Demain, 9780123735812, 360pp, $61.95. Biotechnology Organization in Action (2002), Norus, 9780444510358, 240pp, $118.

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.