Clinical Proteomics: Rethinking Approaches to Protein Biomarker Discovery

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• The State of the Art
• Key Proteomics Technologies
  • Two-Dimensional Polyacrylamide Gel Electrophoresis
  • Mass Spectrometry
  • Antibody Microarrays
  • Microfl uidics
  • Label-Free Technologies
• The Pipeline Problem: Why Is Discovery Slowing?
  • Challenges of Discovering Protein Biomarkers
  • The Imperfect Process of Discovering Protein Biomarkers
  • From Biomarker Discovery to Diagnostic Development
• Expanding Discovery-Based Research
  • Hypothesis-Based Approach
  • Engineering Better Biomarkers
  • Systems Biology
• Major Players in Protein Biomarker Discovery
  • Bayer Pharmaceuticals
  • Eli Lilly
  • Novartis
  • Pfi zer
  • Roche
• Sidebar: Eli Lilly' s Biomarker Development Strategy for Sepsis- A Case Study
• Outlook for Protein Biomarkers
  • Rethinking Discovery-Based Research
    • Looking Beyond Pattern-Only Discovery
    • Multiplexing Leads the Way
  • Supportive Regulatory Environment: The FDA Process
  • Building Strong Collaborations

• 1. Select Commercially Available Protein-Based Diagnostics
• 2. Proteomics Business Models
• 3. Key Proteomics Technology Vendors and Service Providers
• 4. Emerging Players in Protein Biomarker Discovery
• 5. FDA Critical Path Opportunities for Biomarkers
• 6. Considerations for Choosing a Diagnostic Development Partner

• 1. The 1,175 Identifi ed Proteins of the Human Plasma Proteome
• 2. Number of Novel Protein Analytes in FDA-Approved Diagnostic Tests, 1994-2002
• 3. Sensitivities and Specifi cities of Select FDA-Approved Protein Biomarkers
• 4. Alternate Approach: Suggested Technology Workfl ow for Developing Protein Biomarkers
• 5. Drug-Device Codevelopment Process: Key Steps During Development