What Is the Future Role of Predictive Safety Biomarkers in Drug Development?

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Utility of Predictive Safety Biomarkers
• Predictive Safety Biomarker Types
• Positioning Biomarkers in the Drug Development Timeline
• Predictive Safety Biomarkers for Patient Stratifi cation
  • Role of EGFR in Selecting Patients for Treatment
  • Role of KRAS in Selecting Patients for Treatment
• Regulating Predictive Safety Biomarkers and Tests
  • FDA Biomarker Qualifi cation
  • Predictive Safety Biomarkers Approved by the FDA
• Maximizing Adoption Rates of Predictive Safety Biomarkers
• Predictive Safety Biomarkers as Companion Diagnostics Case Study - Selzentry and Trofi le
• Prospective Clinical Evidence
• Reimbursement Considerations
• Competitive Intelligence
• Seizing the Opportunity
• Biomarkers in a Postmarketing Setting Case Study - Warfarin Metabolism Testing
  • Nanosphere' s Verigene Warfarin Metabolism Nucleic Acid Test
  • AutoGenomics' Infi niti Warfarin XP Assay
  • ParagonDx' s Rapid Genotyping Assay
  • Osmetech Molecular Diagnostics' eSensor Warfarin Sensitivity Test
  • CLIA-Approved Warfarin Tests
  • Lessons Learned
• Evaluating the Reimbursement Environment
  • Predictive Safety Biomarkers
  • Predictive Safety Biomarker-Based Diagnostic Tests
  • Warfarin Sensitivity Tests
• Seeking Advancements in Safety Biomarker Development Through Key Partnerships
  • Predictive Safety Testing Consortium
  • Other Clinical Research Consortia
• Select Companies Developing and Marketing Emerging Biomarkers
  • Affymetrix
  • Clarient Diagnostic Services
  • Clinical Data
  • Dako
  • DxS Diagnostics Innovations
  • Genomic Health
  • Genzyme Genetics
  • Monogram Biosciences
  • Response Genetics
  • ViennaLab Diagnostics
• Future Dynamics and the Role of Predictive Safety Biomarkers
  • FDA Guidance and Communication
  • Collaboration Opportunities

Sidebars

• Establishing Clinical Superiority: Monitoring Mutations in KRAS
• Clinical Studies Evaluating Genetic Warfarin Sensitivity Tests

Tables

• 1. Select Predictive Safety Biomarkers, Related Diagnostic Tests, and Prices
• 2. Comparison of Key Predictive Biomarkers for Selecting Patients for NSCLC and CRC Treatment
• 3. FDA-Approved Predictive Safety Biomarkers and Select Diagnostic Products
• 4. Genetic Warfarin Sensitivity Tests: A Competitive Market for Safety Biomarkers
• 5. Select Emerging Predictive Safety Biomarker Products

Figures

• 1. Likely Intervention Points for Safety Biomarkers in Drug Development
• 2. Key Elements in Developing and Marketing a Predictive Safety Biomarker