Table of Contents

• Table of Contents
• THE ENTREPRENEUR'S GUIDE TO A BIOTECH STARTUP
• ACKNOWLEDGEMENTS
• AUTHOR'S NOTE
  • ORIGIN OF THE GUIDE
  • THE PURPOSE OF THE GUIDE
  • RECOMMMENDED READING
• THE BIG PICTURE
  • BIOTECH PAST
  • DEFINING BUSINESS SUCCESS
  • BIOTECH FUTURE
• EVALUATING THE IDEA
  • FIVE BASICS
  • THE STARTING LINE
  • INTELLECTUAL PROPERTY
  • BUSINESS MODEL
  • MARKET
  • MANAGEMENT
• THE BUSINESS PLAN
  • Section 1: SUMMARY/MISSION STATEMENTS
  • Section 2: THE OPPORTUNITY
  • Section 3: THE TECHNOLOGY
  • Section 4: THE BUSINESS MODEL
  • Section 5: THE COMPETITION
  • Section 6: INTELLECTUAL PROPERTY
  • Section 7: EXIT STRATEGY & COMPARABLES
  • Section 8: PEOPLE
  • Section 9: FINANCIALS
  • Saved For Last: THE EXECUTIVE SUMMARY
• PEOPLE
  • FOUNDERS
  • MANAGEMENT TEAM
  • SCIENTIFIC ADVISORY BOARD
  • BOARD OF DIRECTORS
• PATENTS
  • PATENTS IN ACTION
  • CRITERIA FOR PATENT ISSUANCE
  • CLAIMS
  • PRIOR ART
  • COSTS AND TIMING
  • INTERNATIONAL PATENTS
  • FREEDOM-TO-OPERATE
  • TRADE SECRETS, TRADEMARKS, & COPYRIGHTS
  • LICENSING FROM UNIVERSITIES
• ATTORNEYS
  • CORPORATE ATTORNEY
  • PATENT ATTORNEY
• LEGAL ISSUES
  • INCORPORATION
  • INTELLECTUAL PROPERTY
  • TRANSACTIONAL DOCUMENTS
  • STOCK OPTION PLAN
  • COMPLIANCE WITH FEDERAL AND STATE SECURITIES LAWS
• ACCOUNTING & FINANCE
  • FORMS OF ENTITIES
  • FINANCIAL SOFTWARE
  • INSURANCE
  • DEBT FUNDING
• REAL ESTATE
  • REAL ESTATE CYCLES
  • ROLE OF LANDLORDS
  • LOCATION
  • NEXT GENERATION SPACE
  • FINISHED VS. SHELL SPACE
  • ESTIMATING COSTS
  • BUILD-OUT
  • OTHER STARTUP OPTIONS
• RISK MANAGEMENT & INSURANCE
• MEDIA & PUBLIC RELATIONS
• PHARMACEUTICAL BUSINESS DEVELOPMENT
  • DEFINING A PROGRAM
  • TELLING THE STORY
  • DEAL STRUCTURES
  • NEGOTIATING AN AGREEMENT
• DEVICE, DIAGNOSTIC, & INSTRUMENT MODELS
  • MEDICAL DEVICES
  • DIAGNOSTICS
  • INSTRUMENTS
• DRUG PRICING PRINCIPLES
  • GENERAL PRINCIPLES
  • US PRICING AND DISTRIBUTION
  • MARKET SEGMENTS
• CLINICAL DRUG DEVELOPMENT
  • GETTING FROM THE LAB TO IND
  • A STRATEGIC APPROACH TO CLINICAL DRUG DEVELOPMENT
  • CLINICAL DEVELOPMENT TEAM
  • THE MAJOR TASKS OF EACH PHASE OF CLINICAL DEVELOPMENT
  • PRACTICAL CONSIDERATIONS
  • FDA TAKES ACTION
• MEDICAL DEVICE APPROVAL
  • REGISTRATION, LISTING AND LABELING
  • THE PREMARKET APPROVAL APPLICATION (PMA) -- FDC ACT §515
  • SUBSTANTIAL EQUIVALENCE - PREMARKET NOTIFICATION, 510(K)
  • COSTS
• EQUITY
  • SHARES AND OPTIONS
  • EQUITY DISTRIBUTION
• RAISING MONEY
  • ANGELS
  • VENTURE CAPITAL
  • KEY ISSUES
  • BOOT-STRAPPING
  • INCUBATORS
  • LOANS AND VENTURE LEASING
• GOVERNMENT GRANTS
  • SUMMARY OF GOVERNMENT PROGRAMS
  • TIPS ON GRANT WRITING
  • GETTING OUTSIDE HELP
• IPO: GOING PUBLIC
  • HISTORY OF BIOTECH IPOS
• NETWORKING