1st Edition

Innovation, Commercialization, and Start-Ups in Life Sciences

By James F. Jordan Copyright 2015
    256 Pages 29 B/W Illustrations
    by CRC Press

    Innovation is the translation of a new method, idea, or product into reality and profit. It is a process of connected steps that accumulates into your brand or reputation. However, there can be many pitfalls and wrong turns on the road to realizing this goal. Innovation, Commercialization, and Start-Ups in Life Sciences details the methodologies necessary to create a successful life sciences start-up from initiation to exit. You will gain an appreciation for the necessary data, partnership, and skills to be acquired and the constituencies that must be satisfied along the way.

    The book examines how life sciences start-ups can create an exit for their investors by recognizing that a liquidity event is not consummated without due diligence. Due diligence is bigger than validating accounting transactions. It ensures the company is solving an important customer problem, demonstrating sales access, and making sure that intellectual property is impervious to competitive advancement. The due diligence process supports the telling of a compelling story to customers, investors, regulators, and acquirers.

    Written by an expert who has worked with more than 200 life sciences start-ups during the past decade, the book discusses specific processes and investor milestones that must be navigated to align customer, funder, and acquirer needs. It examines these processes from the perspective of marketing value through a focus on the needs of individual constituents—investors, regulators, customers, and exit candidates. The book presents data and analytical processes articulating the fundable milestones for angel and venture capital. It gives you the tools needed to create branding for public investors and more.

    Innovation Is a Process of Connected Steps
    Investment Uses a Translation Process to Deliver Innovation

    Investment Is Critical to a Nation’s Prosperity

    The Journey of Innovation Begins with Investment

    The United States Helps Small Companies Conduct R&D

    Commercialization Is Primarily Executed through Two Organization Types

    Investment Must Be Connected to Exit
    Angels and Venture Capitalists Invest in Commercialization
    The Stages of Start-Up Financing
    The Players in Start-Up Financing

    Create Liquidity for Your Investors

    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

    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

    Align with the Industry Norms
    Find the Industry Norms

    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

    Demonstrate the Ability to Access the Sales Channel

    Gather Domain-Experienced Personnel to Reduce Risk
    Channel Partners
    Domain-Experienced Personnel
    Capital Providers
    Suppliers and Contractors
    The Management Team
    A Thoughtful Gathering of Experience Reduces Risk

    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

    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)

    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?

    A Start-Up Must Tell a Compelling Story
    A ddress Your Story to the Needs of All Constituencies
    The Customer’s Story
    The Acquirer’s Story
    The Funder’s Story

    Deliver to Your Plan
    Mission Statement
    Executive Summary
    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

    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

    Continuously Improve Your Message with the Plan-Do-Check-Act Cycle


    Jim Jordan, a Distinguished Service Professor of Healthcare & Biotechnology Management and Senior Director of Healthcare and Biotechnology Programs at Carnegie Mellon University’s Heinz College, serves as the Chief Investment Officer of the Pittsburgh Life Sciences Greenhouse, a public-private economic and venture fund owned by Carnegie Mellon University and the University of Pittsburgh.

    As an accomplished Fortune 20-level executive with companies such as Boston Scientific, Johnson & Johnson and McKesson, Jim has leveraged his experience in several startup ventures and is active on multiple Boards of Directors. Through the Pittsburgh Life Sciences Greenhouse, he has applied his 25 years of experience in industry, consulting and academia to work with over 400 life science startup companies, with direct investment in 75 of them.

    "So how do you get more new innovative technology to market? Well, you take risks for sure, but you have to have a process for churning the evolution of technology and turning concepts in the minds of researchers and entrepreneurs into commercialized products in the market. The contents of this book will not only do that for the reader, but the book will also show the pitfalls to avoid along the way. Not every good idea is able to get to market. … And what causes innovators to fail? The answers to these and other important questions are addressed in the book."
    —From the Foreword by John W. Manzetti, President and CEO, Pittsburgh Life Sciences Greenhouse, Founder, Managing Director, PLSG Accelerator Fund

    "This book, and the approach the author describes in it, is based in extensive real-life experience. The author gives the reader the theory behind innovation and commercialization, but then adds the application details only an experienced professional can deliver. ... I like the fact that the book is driven from the perspective of the investor versus the technologist or policy analyst. ... I think the author has written a very useful guide that is clear and compelling."
    —William Donaldson, Christopher Newport University, Newport News, Virginia, USA