Table of Contents
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 Rol e of Biomarkers in Drug Development
- 1.5. Risks Associated With Biomarker Usage
- 1.6. FDAs Perspective on Biomarkers in Clinical Development
- -Accelerated Approval Provisions
- -FDAs Guidelines on Pharmacogenomic Markers
- -Industrys Response to FDAs 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 Alzheimers 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 DakoCytomations 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
- 5.3. 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
Tables and Figures
- Figure 1.1: Phases of the Drug Development Process That Are Impacted by Biomarkers
- Figure 1.2: Effective Profitability of Approved and Released Pharmaceuticals
- Figure 1.3: Value Proposition of Biomarkers Throughout the Therapeutic Development and Application Phases
- Figure 1.4: Reasons Cited for Compound Failure
- Figure 1.5: The Biomarker Research and Development Process
- Figure 2.1: Linkage of a Basic Systems Biology Research Cycle with Drug Discovery and Treatment
- Figure 2.2: How Technologies Can Better Connect Discovery and Clinical Research
- Table 1.1: Biomarker/Surrogate Endpoints That Have Aided Drug Development
- Table 1.2: Classification of Biomarkers as Described by the FDA
- Table 2.1: Comparative Throughput of Biomarker Technologies
- Table 2.2: Gene Expression as a Prognostic Tool in Breast Cancer
- Table 2.3: Genes for Early-Onset Alzheimer?fs Disease
- Table 2.4: Genes for Late-Onset Alzheimer?fs Disease
- Table 2.5: Comparison of Proteomic Technologies Used for Biomarker Discovery
- Table 2.6: Comparison of Advantages and Disadvantages of Selected Molecular Imaging Technologies
- Table 4.1: Pharmacological MRI Studies Involving Psychiatric and Neurological Conditions
- Table 5.1: Selected Pharmaceutical Company Partnerships h
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