Table of Contents

CHAPTER 1: Introduction

Biotech in Its Infancy
The Business of Biotechnology Is Like No Other
What Exactly Is Biotechnology?
Biotechnology Clusters and the Decentralization of Biotech Hubs
Is the Biotechnology Business Model Broken?

CHAPTER 2: What makes a Biotech Entrepreneur?

A Different Breed
Four Backgrounds of Biotech Entrepreneurs
First Time Entrepreneur, First Time in Business
Essentials of a Biotech Entrepreneur

CHAPTER 3: Start with the Idea: Licensing and Protecting Core Assets

What to Consider Before Licensing
Is There a Real Market for This Product?
What Is Intellectual Property?
Technology Licensing and Negotiations

CHAPTER 4: Significance of the Right Business Model and Managing Risk

Business Model Examples
Becoming a Risk Manager

CHAPTER 5: Legally Establishing the Company

The First Step: Find a Good Attorney
Choosing a Company Name
Incorporating the New Company
Ownership: Issuing Stock
What Agreements are Needed?
Setting Up a Board of Directors
Setting Up a Scientific Advisory Board
The Virtual Company

CHAPTER 6: The Product Development Pathway: Charting the Right Course

It Is About Creating Value
Biotechnology R&D: Little R, Big D
A Sense of Urgency Down an Unfamiliar Path
Two Types of Product Development Categories
Product Development Stages
Development Stages for “Treatments”
Development Stages for “Analytics and Tools”
Product Development Milestones
Product Development Assistance
Market Development and Business and Organizational Development Paths

CHAPTER 7: Developing a Marketing Strategy

What Is Marketing?
The Evolution of the Marketing Concept
Marketing Tools
Market Research and Assessment Tools
Biotechnology Products Typically Have Three Customers
Five-Step Process to Applying Market Concepts
Example: Molecular Genetic Test for the Assessment of Breast Cancer Risk
Example: Nasal Spray Vaccine Against Influenza Virus
Biotechnology Product Adoption Curve

CHAPTER 8: Financing your Company: Part 1. Raising Money, Capital Needs and Funding Sources

Raising Money
How Much Money Does a Company Need to Raise?
How Long Does It Take to Raise Money for a Start-Up Company?
Where to Go to Raise Capital?
Investors Expectations for Return on Investment

CHAPTER 9: Financing the Company- Part 2: Funding Stages, Valuation, and Funding Tools

Financing Stages for a Life Science Company
How Much Money is Raised at Each Funding Stage?
How Is the Value of a Company Determined?
How Much Will the Founders Own?
Communicating to Your Shareholders
The Value of Public Relations in Raising Money
Exit Planning: Sooner not Later
The Tools
The Business Plan
The Presentation
Building a Web Presence: Putting Your Best Foot Forward
Final Comments About Funding

CHAPTER 10: Corporate Culture and Core Values in a Biotech Company

Why is a Company Culture Important?
Development of a Company Culture
Individuals Define the Culture and Core Values
Examples of Core Values
Company Core Values
Guiding Principles Based On Core Values
Impact of Core Values
How to go About Improving a Company Culture?
Communication in a Biotech Company
Core Values Apply to Partnerships Even Suppliers and Service Providers
A Good Corporate Culture is a Strength That Cannot be Easily Copied

CHAPTER 11: Hiring a Biotech Dream Team

For the Start-Up: Virtual is Vital
Who do You Hire First?
Employee Benefits Challenges
Key Employee Compensation
Diversity is Essential
A New Hiring Approach
The Hiring Process
How to Find These Individuals?
Management Skill Sets
Letting Some Go

CHAPTER 12: Strategic Alliances and Corporate Partnerships

What Are Alliances and Partnerships?
Why Are Partnerships Important?
What Does a Biotech Have That a Strategic Partner Would Want?
What Does the Biotech Get from a Partnership?
Can’t a Potential Partner Just Acquire the Biotech Company?
The Partnership
Making Alliances Work

CHAPTER 13: The Regulatory Process for Biotech Products

Alphabet Soup
Biotechnology Regulators: The Food and Drug Administration
What is an Institutional Review Board?
Informed Consent
Regulating Drugs and Biologics: The Drug Approval Process
Other Types of Regulatory Review Processes
Accelerated Development Review
Regulating Medical Devices, IVDs, Diagnostics and Laboratory Tests
Remember that Regulators are First People

CHAPTER 14: Company Life Stages and Changing Management Styles

Why Understand Company Development Life Stages?
Organizational Life Stages
Birth Phase
Development Phase
Expansion Phase
Other Corporate Identity Features
The CEO’s Role in the Transition of Life Stages

CHAPTER 15: When Do You Call it Quits?

How Can One Tell When It is Time?
Assuming There Are No Alternatives, What Should be Done?
When It Is Time for the Entrepreneur to Leave?

CHAPTER 16: Conclusions and Serendipity

A Biotech Company Opportunity
It Was the Best of Times, and It Was the Worst of Times
Every Success Was First Met with Challenges

CHAPTER 17: Practical Help: How to get Started?

What to Do First
Next Steps


Additional Reading