Licensing Strategies for Accessing Biomarker Technologies

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Advantages of Biomarkers Across the Health Care Value Chain
• Accessing Biomarker Technology
  • Where Do Novel Biomarkers Come From?
  • Fitness-for-Purpose
• Biomarkers in Biopharmaceutical and Diagnostics Companies
  • Biomarker Use in Biopharmaceutical Companies
  • Biomarker Use in Diagnostics Companies
  • Biomarker Licensing Activities by IVD Companies
• Role of Smaller Companies in Biomarker Research
  • Testing Lab Companies
  • Biomarker Research Tool and Service Companies
• Tapping Research Institutions and Universities
  • Commercialization of Biomarker Technologies
    • Operations
    • Royalty Rates
    • Milestone Payments
    • Continuing Support
    • Personal Contacts
  • Importance to Emerging Diagnostics and Biotechnology Companies
• Outlook
  • Engine for New Biomarkers
  • Funding Is Critical

Sidebar

• Consortia Addressing Biomarker Usage for Drug Discovery and Development

Tables

• 1. Uses of Biomarkers in Drug Discovery and Development
• 2. Biomarker Defi nitions for Drug Discovery and Development
• 3. Key Biomarker Outlicensing Agreements Among Biopharmaceutical Companies, January 2006-October 2007
• 4. Select Outlicensing Biomarker Technology Deals by IVD Companies, July 2006-October 2007
• 5. Key Biomarker Licensing Activities Among Smaller Companies, January 2007-October 2007
• 6. New Biomarker Technology Agreements with Testing Lab Companies, July 2006-October 2007
• 7. Select Biomarker Research Service and Tools Companies
• 8. Major Considerations in Technology Transfer Deals
• 9. Select Biomarker Outlicensing Activities by Research Institutions and Universities, January 2006-October 2007

Figures

• 1. Requirements for Validation and Qualifi cation in Biomarker Discovery and Development
• 2. Number of FDA-Approved New Molecular Entities (NMEs) (1997-2006) and Total Global R&D Spending, PhRMA Members (1997-2005)