Clinical Proteomics: Rethinking Approaches to Protein Biomarker Discovery : Market Research Report

Clinical Proteomics: Rethinking Approaches to Protein Biomarker Discovery

Published: May. 31, 2007 - 26 Pages

Executive Summary: Strategic Considerations; Stakeholder Implications
The State of the Art
Key Proteomics Technologies: Two-Dimensional Polyacrylamide Gel Electrophoresis; Mass Spectrometry; Antibody Microarrays; Microfluidics; 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; Pfizer; 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
Tables: 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
Figures: 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

Abstract

Protein biomarkers are appealing to drug developers because they can be used early in the drug research pipeline, which allows early elimination of ineffective or toxic compounds. Although the promise of these biomarkers is clear, the path to successful implementation of protein biomarkers is not. Perhaps the discovery-based approach is not the best way to tap the potential of protein biomarkers.

Get the Answers You Need to Shape Your Strategy
Despite scientifi c advancements, protein biomarker discovery is slowing. What are the challenges facing companies and researchers that are hindering the discovery process?

Researchers are rethinking the discovery-based approach. What other options and innovations are available? What companies are leading the way?

The future of protein biomarkers is extremely promising for a multitude of businesses. What benefi ts are available for technology vendors, Big Pharma companies, researchers, and regulatory agencies? Can collaboration between any or all of these stakeholders ensure the success of protein biomarkers?

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Clinical Proteomics: Rethinking Approaches to Protein Biomarker Discovery

Table of Contents

Abstract