Innovation, Commercialization, and Start-Ups in Life Sciences

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Innovation is a translation of a new method, idea, or product into reality and profit. It is a process of connected steps that accumulates into a brand reputation required for success. Unlike Fortune 500 companies, whose projects are self-funded, a start-up must simultaneously have a value proposition that attracts a customer (for revenue), investors (for capital), and acquirers (for a liquidity event or IPO). A high percentage of start-ups fail before attaining positive cashflow, due to a variety of reasons that are detailed in this book.

Avoiding the pitfalls and wrong turns are the goals of this book. Innovation, Commercialization, and Start-Ups in Life Sciences details the methodologies necessary to create a successful life science start-up from initiation to exit.

Written by an expert who has worked with more nearly 500 life science start-ups, this book discusses specific processes and investor milestones that must be navigated to align customer, funder, and acquirer needs. Successful commercialization requires attention to multiple constituents, such as investors, regulators, and customers. Investors require liquidity for their return, which is achieved through selling their stock in a public or private sale. The reader will gain an appreciation for the necessary data, partnerships, and skills needed to create a competitive and sustainable company. The author discusses such specific issues as customer problems, demonstrating sales access, and ensuring intellectual property is impervious to competitive advancement. This book is intended to be suitable for entrepreneurs, venture capitalists, and investors in both business and academic settings. These organizations have specific departments, such as R&D, operations, business development, legal, regulatory, and marketing, that would also benefit from this book.

FEATURES

  • Focuses specifically on life science start-ups
  • Examines how to determine a company valuation and future "fundable milestones"
  • Explores how to align regulatory and clinical strategies
  • Discusses intellectual property derived from a university or individual through formation to exit.
  • Reviews how startā€ups must simultaneously meet the needs of multiple constituencies at once: investors, regulators, customers and exit candidates

James F. Jordan is an author, consultant, and speaker. He is a Distinguished Service Professor of Healthcare & Biotechnology Management, a former Fortune 100 executive, and a managing director of a venture fund.

Access the Support Material: https://healthcaredata.center/

Cover design by Sarah Mailhott.

Author(s): James F. Jordan
Edition: 2
Publisher: CRC Press
Year: 2021

Language: English
Pages: 214
City: Boca Raton

Cover
Half Title
Title Page
Copyright Page
Dedication
Contents
Foreword
Acknowledgments
About the Author
Section I: Innovation Is a Process of Connected Steps
1. Investment Uses a Translation Process to Deliver Innovation
Discussion Questions:
Notes
2. Investment Is Critical to a Nation's Prosperity
Discussion Questions:
Notes
3. The Journey of Innovation Begins with Investment
Discussion Questions:
Notes
4. The United States Helps Small Companies Conduct R&D
Discussion Questions:
Notes
5. Commercialization Is Primarily Executed through Two Organization Types
Discussion Questions:
Notes
Section II: Investment Must Be Connected to Exit
6. Angels and Venture Capitalists Invest in Commercialization
The Stages of Start-Up Financing
The Players in Start-Up Financing
Discussion Questions:
Notes
7. Create Liquidity for Your Investors
Discussion Questions:
Notes
8. A Liquidity Event Is Not Consummated without Due Diligence
A Start-Up Is Designed to Be Temporary
The Reasons for Due Diligence
Risks Associated with Due Diligence
Discussion Questions:
Notes
9. Due Diligence Reputation Is a Critical Business Process
Due Diligence Reputation Is a Critical Brand Component
Do What You Say, Then They Will Trust What You Forecast
Ambiguous Processes Are a Quality Assurance Problem
The Components of a Due Diligence Business Process
Discussion Questions:
Notes
Section III: Align with the Industry Norms
10. Find the Industry Norms
Discussion Questions:
Notes
11. Solve an Important Customer Problem
The Disease State Model Identifies the Triggers to Risk and Creating Market Value
The Health Care Flow Chart Visualizes the Market's Value Chain
Discussion Questions:
Notes
12. Demonstrate the Ability to Access the Sales Channel
Discussion Questions:
13. Gather Domain-Experienced Personnel to Reduce Risk
Government
Types of Legal Entities
Patents and Trademarks
Grants
Regulators
The FDA
Centers for Medicare & Medicaid Services
CE Mark and Foreign Regulators
ISO, cGMP, and Other Process Certifications
Channel Partners
Value Chain
Law Firms
Other Firms
Customers
The Start-Up Company Perspective
The Funder's Perspective
The Acquirer's Perspective
Domain-Experienced Personnel
Acquirers
Capital Providers
Suppliers and Contractors
The Management Team
The Management Board
The Board of Directors
The Board of Advisors
A Thoughtful Gathering of Experience Reduces Risk
Discussion Questions:
Notes
14. Determine the Acquirer's Strategic Future and Purchase Triggers
Find Your Targets (Potential Acquirers)
Develop Industry Micro and Macro Maps
Analyze the Industry's Product Life Cycle
Analyze Your Acquirer's Product Life Cycle
Finalize Your Target List and Uncover the Acquirer's Purchase Triggers
Map Your Start-Up's Exit Points
Determine What They Want to Buy: It Could Be More Than IP
The Acquirer Purchase Trigger Database
Discussion Questions:
Notes
15. Align an Investor's Fundable Milestones and an Acquirer's Exit Points
Know Your Targets: Arrive Early and Cheaply
Add the Acquirer's Exit Points to Your Funding Map
Create a Funding Relationship Management System
Plot Your Funding Syndicate by Working Backward
Create Your Tactical Approach by Investment Class
Install a Management and Measurement System
Plan-Do-Check-Act (PDCA)
Discussion Questions:
Note
16. Create an IP Pyramid for Impervious Positioning
Can the Technology Create a Franchise Category?
Can the Technology Create a Product Category?
Is There a Specific Class of Patient or Clinical Situation Where the Patent Would Be the Obvious Answer?
Is There Outcomes Evidence?
How Can the Patent Be Built upon over Time to Evolve for Distance as Other Players Attempt to Enter the Market?
Discussion Questions:
Notes
Section IV: A Start-Up Must Tell a Compelling Story
17. Address Your Story to the Needs of All Constituencies
The Customer's Story
The Acquirer's Story
The Funder's Story
Discussion Questions:
Notes
18. Deliver to Your Plan
Mission Statement
Executive Summary
Overview
The Opportunity
The Market
The Competition
The Unfair Advantage
Proprietary Relationships
Proprietary Knowledge
Intellectual Property
Regulatory and Reimbursement
The Company and Management
The Commercialization Plan
Capitalization and Exit Strategy
Financial Projections and Risks
Discussion Exercise:
Notes
19. Tell a Compelling Story with the Investor Pitch
The Preview
The Venture Concept
The Market Need
The Product Offering
The Market Opportunity
The Competition
The Business Model
The Commercialization Plan
Future Milestones
The Management Team
Funding Needs
The Acquirer's Needs
Opportunity Summary
Discussion Questions:
Notes
20. Continuously Improve Your Message with the Plan-Do-Check-Act Cycle
Discussion Questions:
Index