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Clinical Proteomics: Rethinking Approaches to Protein Biomarker Discovery


Description: 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 scientific 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 benefits 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?

Scope

- Proteomics technologies: 2D PAGE, mass spectrometry, antibody micro arrays, micro fluidics, label-free technologies.
- Alternatives to discovery-based approach: hypothesis-based approach, engineering better biomarkers, systems biology.
- Major players in protein biomarker discovery: Bayer, Eli Lilly, Novartis, Pfizer, Roche.
- Outlook: The path toward successful protein biomarker discovery may include multiplexing strategies, collaborations among researchers and developers, and support from regulatory bodies.


Contents: 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 Identified Proteins of the Human Plasma Proteome
2. Number of Novel Protein Analyses in FDA-Approved Diagnostic Tests, 1994-2002
3. Sensitivities and Specificities of Select FDA-Approved Protein Biomarkers
4. Alternate Approach: Suggested Technology Workflow for Developing Protein Biomarkers
5. Drug-Device Co development Process: Key Steps during Development


Companies Mentioned - Applied Biosystems - Axis Shield - Bayer Pharmaceuticals - Beyond Genomics - Biacore - Bioforce Nanoscience - Bio-Rad - Biosite - Bruker Daltonics - Cantion - Clontech - CODA Genomics - Eisai - Eli Lilly - Fujirebio - Gene News - Genedata - GeneProt - Geneva Proteomics - Genomic Solutions - Genoptics - GenTel Biosciences - Integrated Genomics - Invitrogen - Johnson & Johnson - Lumera - Matritech - Microfluidics - Millennium Pharmaceuticals - Pfizer - Phadia US - Power3 Medical Products - Predictive Diagnostics - Proteome Systems - Quadraspec - RBM - Roche - Rosetta Inpharmatics - Sareum - Shimadzu - Target Discovery


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