Chapter 1. Introduction 1.1. Scope of Report
1.2. Overview of Biomarkers
-Applications in Clinical Research
-Beneficial Impacts of Biomarkers
1.3. Biomarkers: Definitions and Taxonomy
1.4. The Role of Biomarkers in Drug Development
1.5. Risks Associated With Biomarker Usage
1.6. FDA’s Perspec tive on Biomarkers in Clinical Development
-Accelerated Approval Provisions
-FDA’s Guidelines on Pharmacogenomic Markers
-Industry’s Response to FDA’s Request for Pharmacogenomic Data

Chapter 2. From Discovery to Clinic
2.1. Technologies Used for Biomarker Discovery and Application
Pharmacogenomics
-Microarrays Predict Likelihood of Breast Cancer Metastases
-Specific Genes Predict Risk of Alzheimer’s Disease
Proteomics
-2-D PAGE
-Isotope-Coded Affinity Tags
-MALDI
-LC-MS/MS
-Imaging MS
-Free Flow Electrophoresis
-Protein Arrays
-Affinity-Based MS Techniques for the Identification of Biomarkers
--SELDI Protein Chip and Prostate Specific Membrane Antigen Marker
--SELDI and Intra-Amniotic Infection Biomarkers
-Tissue Arrays
Metabolomics
-Paradigm Genetics’ Focus on Metabolomic Biomarkers of Liver Damage
Systems Biology
Molecular Imaging
-Tomography Based Imaging Technologies
--Computed Tomography (CT)
--Magnetic Resonance Imaging (MRI)
-Emission-Based Tomography Methods
--Positron Emission Tomography (PET)
--Single-Photon Emission Computed Tomography (SPECT)
-Biophotonic Imaging

Chapter 3. Overall Approach Used by the Pharmaceutical Industry
3.1. Pfizer Global Research and Development
3.2. Roche
3.3. Bristol-Myers Squibb
3.4. Novartis
3.5. SurroMed

Chapter 4. Biomarkers: From Clinical Research to Diagnostic Tool
4.1. Imaging Technologies
4.2. Theranostics
Herceptin and DakoCytomation’s HercepTest
Gleevec and Ventana Medical Systems’ VentanaDx c-Kit Test
4.3. Iressa
4.4. Amevive and Enbrel

Chapter 5. Business Outlook and Conclusion
5.1. Biomarker Research within the Pharmaceutical Industry
5.2. Expert Interviews
Felix Frueh, FDA Center for Drug Evaluation and Research
Aaron Kantor, SurroMed
David Lester, Pfizer
Rick Ludwig, Indiana Center for Applied Protein Sciences
Robert McBurney, BG Medicine
Rudy Potenzone and Richard Chen, Ingenuity Systems
Michael T. Stocum, Personalized Medicine Partners

Company Profiles
Affymetrix
Beckman Coulter
BG Medicine
BioMarker Pharmaceuticals
Ciphergen Biosystems
Clinical MicroArrays
Gene Logic
High Throughput Genomics
MDS Pharma Services
ParAllele BioScience
SurroMed
Xenogen