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Post-Genomic Biomarkers: Revolutionizing Drug Development and Diagnostics 2nd Edition
Drug and Market Development Publishing, March 2005, Pages: 211

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  Table of Contents  
  Summary  
    
    
   
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Chapter 1:
Executive Summary
Technology Background 1–1
The Industry Environment1–1
Technologies1–2
Products and Applications 1–2
Market Dynamics 1–4
Future Trends 1–5
References 1–6

Chapter 2:
Introduction 2–1
Post-Genomic Biomarkers: From Discovery to Implementation 2–1
Nature of This Report 2–2

Chapter 3:
Technology Background3–1
References3–5

Chapter 4:
The Industry Environment4–1
References4–4

Chapter 5: Technologies5–1
Pre-genomic Methods for Biomarker Discovery and Detection5–2
Post-genomic Methods for Biomarker Discovery and Detection 5–7
Transcriptomics5–7
Positional DNA Microarrays5–7
Encoded Bead Arrays 5–13
Proteomics 5–17
Metabolomics5–23
Imaging5–26
PET and SPECT Imaging5–27
Magnetic Resonance Imaging5–28
Computed Tomography Imaging5–28
Optical Imaging5–29
References 5–29

Chapter 6:
Products and Applications6–1
Biomarkers in Drug Discovery and Development6–2
Examples of Biomarker Development6–4
Biomarkers in Drug Discovery6–6
Biomarkers in Lead Optimization and Preclinical Development6–8
Biomarkers in Clinical Development6–11
Regulatory Perspectives on Pharmaceutical Biomarkers6–12
Biomarkers in Diagnostics6–14
Historical Aspects of Diagnostic Biomarkers6–15
Biomarkers in Cancer Diagnostics 6–19Commercial Cancer Diagnosis Activity.6–21Diagnostic Biomarkers for Other Diseases6–26
General Biomarker Products and Services6–27
Transcriptomics6–27
Proteomics 6–29
Metabolomics6–30
Imaging Biomarkers6–32
Commercial Imaging Biomarker Offerings6–35
References6–37

Chapter 7:
Market Dynamics7–1
Conclusions from the Survey 7–11

Chapter 8: Company Profiles8–1
Aclara Biosciences8–1
Applied Biosystems8–4
Beyond Genomics8–7
BioVision AG 8–9
Bruker Daltonics, Inc. 8–12
Caprion Pharmaceuticals, Inc. 8–15
Ciphergen Biosystems 8–17
Compugen Ltd. 8–20
Correlogic Systems, Inc. 8–23
CTI Molecular Imaging, Inc. 8–26
Epigenomics AG 8–28
GE Healthcare 8–31
Health Discovery Corporation 8–34
IBEX Technologies Inc.8–37I
coria, Inc. (Previously Paradigm Genetics) 8–39
Metabolon, Inc. 8–41
Power 3 Medical Products, Inc. 8–43
Predictive Diagnostics, Inc. 8–45
Predicant Biosciences 8–47
Proteome Sciences plc .8–49
SurroMed, Inc. 8–51
Synarc, Inc. .8–53
TheRyte, Ltd8–55
VirtualScopics LLC .8–57

Chapter 9: Future Trends 9–1
References 9–4

Chapter 10:

Interviews With Industry Experts 10–1
Brian Edmonds, Ph.D., Manager, New Technologies, Eli Lilly 10–1
Donald A. Berry, Ph.D., Professor of Biostatistics, Chairman, Department of Biostatistics and Applied Mathematics, Chief, Section of Biostatistics, Frank T. McGraw Memorial Chair for Cancer Research, U Texas M.D. Anderson Cancer Center10–6
Deborah Neff, President & CEO, Predicant Biosciences 10–8
Peter Steiger, Ph.D., President and CEO, Synarc, Inc. 10–14
Michael Spain, M.D., Chief Medical Officer, Rules Based Medicine 10–19
John Ryals, Ph.D., President and Chief Executive Officer, Metabolon 10–24
Homer Pien, Ph.D., Managing Director, MGH-HST Center for Biomarkers in Imaging10–29
Mark Flocco, Business Development Manager for Clinical Proteomics, Bruker Daltonics10–35

TABLE OF EXHIBITS
Exhibit 3.1 Examples of Surrogate Endpoints for Drug Development3-1
Exhibit 3.2 The Pfizer Biomarker Classification Scheme 3–4
Exhibit 5.1 The Affymetrix Microarray Assay Process 5–9
Exhibit 5.2 The Affymetrix Photolithographic Array Production Process 5–9
Exhibit 5.3 The Aclara eTag® Technology 5–16
Exhibit 5.4 High Throughput Genomics Multiplexed Gene Expression Detection Technology 5–17
Exhibit 5.5 Ciphergen ProteinChip® Technology5–18
Exhibit 5.6 Ciphergen Biomarker Discovery Technology 5–19
Exhibit 5.7 A 2D Gel Illustrating a Typical Protein Electrophorogram 5–20
Exhibit 6.1 Beyond Genomics' Generic Correlation Diagram 6–7
Exhibit 6.2 Cancer Diagnostic Biomarker Commercialization 6–25
Exhibit 6.3 Selected Transcriptomic Commercial Biomarker Offerings 6–29
Exhibit 6.4 Selected Proteomic Commercial Biomarker Offerings 6–30
Exhibit 6.5 Selected Metabolomic Commercial Biomarker Offerings6–31
Exhibit 6.6 Selected Systems Biology Commercial Biomarker Offerings 6–32
Exhibit 6.7 Selected Commercial Offerings in the Imaging Biomarker Field 6–37
Exhibit 7.1 Business Models of Biomarker-Related Companies 7–4
Exhibit 7.2 Business Models of Biomarker Companies by Category 7–5
Exhibit 7.3 Selected Recent Biomarker-related Deal Activity 7–6
Exhibit 7.4 Potential Impact of Biomarkers on Pharmaceutical R&D Costs 7–7
Exhibit 7.5 Results from a Survey of Scientists Engaged in Biomarker Work 7–9



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