What is Working in IVD: Successful Commercialization of New Products and Technologies

Table of Contents

EXECUTIVE SUMMARY

• Scope and Methodology
• Keys to Success
• INTRODUCTION
• Background
• Crucial Keys to Successful New Product Commercialization - Six Strengths Model
• Point of View

Strength Point One - STRATEGIC PLANNING

• Clinical Trial and Information Management
  • Qiagen/Digene
  • Aspen Bio AppyScore
  • AdvanDx PNA FISH test
  • Epigenomics PRESEPT
  • Genomic Health Oncotype DX
  • Hologic
• Product Development
  • PGxHealth
  • Evidenced Based Medicine
• Pricing Challenges
  • Down Economy Pricing Advice
  • Five Steps to Value Pricing
  • Pricing as an Impression
• Distribution Strategies
  • Examples of IVD Distribution Arrangements
  • Test Commercialization
• A New look at Customer Segmentation
  • Finding "Buckets Within Buckets" of Customers
• Conclusion

Strength Point Two - MANAGING INTELLECTUAL PROPERTY

• Some IP and Patent Basics
• Barriers to Patent Protection
• Gene Patents
• To Partner Or Not
• Conclusion

Strength Point Three - MANAGING THE REGULATORY PROCESS

• Overview Of Regulatory Trends
• Multiplexed and Molecular Tests
• Regulatory Process by Region/Country
  • United States
  • European Economic Union
  • Japan
  • China
  • India

Strength Point Four - ASSURING PRODUCT REIMBURSEMENT

• Reimbursement Issues and Strategies
• Governments React
• IVDs in Obama' s Healthcare World
• Wins and Disappointments
  • Genomic Health
  • Biosite/Inverness Medical Innovations
  • Digene/Qiagen
• Conclusion

Strength Point Five - MANAGING THE PRODUCT LIFE CYCLE

• PR - Tell Your Story
• Scale-UP Issues
• Building a Supportive Organizational Structure

Strength Point Six - MANAGING MARKET FORCES

• Investors
  • Venture Capital Activities in IVD
• Consumer Power
  • Steps between Evaluation of Needs and a Purchase Decision
• Scientific/Medical Community
• Payer Groups
• Conclusion