ポストゲノムにおけるバイオマーカー (第2版)：創薬と診断技術の改革

Abstract

The first edition of D&MD Publications report, covering post-genomic biomarkers, was published in September 2003. Since that time, pharmaceutical and biotechnology companies have broadened from a primary focus on biomarker discovery to greater emphasis on assay development and implementation of biomarker applications. Since publication of the first edition, drug developers have also demonstrated increased interest in imaging-based biomarkers. This report, Post-Genomics Biomarkers: From Discovery to Implementation, covers these and other new developments with the following specific objectives:

• To examine the impacts of Genome Era omic technologies on the discovery and utilization of biomarkers
• To analyze the current and future impacts of post-genomic biomarkers on the pharmaceutical and diagnostics industries
• To assess the performance and viability of the industry segments that provide products and services for biomarker discovery/detection or offer biomarkers for license
• To examine the extent to which post-genomic biomarkers actually improve pharmaceutical R&D and clinical diagnostics

TABLE OF CONTENTS

Chapter 1: Executive Summary

• Technology Background
• The Industry Environment
• Technologies
• Products and Applications
• Market Dynamics
• Future Trends
• References

Chapter 2: Introduction

• Post-Genomic Biomarkers: From Discovery to Implementation
• Nature of This Report

Chapter 3: Technology Background

• References

Chapter 4: The Industry Environment

• References 4

Chapter 5: Technologies

• Pre-genomic Methods for Biomarker Discovery and Detection
• Post-genomic Methods for Biomarker Discovery and Detection
  • Transcriptomics
    • Positional DNA Microarrays
    • Encoded Bead Arrays
• Proteomics
• Metabolomics
• Imaging
  • PET and SPECT Imaging
  • Magnetic Resonance Imaging.
  • Computed Tomography Imaging
  • Optical Imaging
• References

Chapter 6: Products and Applications

• Biomarkers in Drug Discovery and Development
  • Examples of Biomarker Development
  • Biomarkers in Drug Discovery
  • Biomarkers in Lead Optimization and Preclinical Development
  • Biomarkers in Clinical Development.
  • Regulatory Perspectives on Pharmaceutical Biomarkers
• Biomarkers in Diagnostics
  • Historical Aspects of Diagnostic Biomarkers
  • Biomarkers in Cancer Diagnostics
  • Commercial Cancer Diagnosis Activity
  • Diagnostic Biomarkers for Other Diseases
• General Biomarker Products and Services
  • Transcriptomics
  • Proteomics
  • Metabolomics
• Imaging Biomarkers
  • Commercial Imaging Biomarker Offerings
• References

Chapter 7: Market Dynamics

• Conclusions from the Survey

Chapter 8: Company Profiles

• Aclara Biosciences
• Applied Biosystems
• Beyond Genomics
• BioVision AG
• Bruker Daltonics, Inc
• Caprion Pharmaceuticals, Inc
• Ciphergen Biosystems
• Compugen Ltd
• Correlogic Systems, Inc
• CTI Molecular Imaging, Inc
• Epigenomics AG
• GE Healthcare
• Health Discovery Corporation
• IBEX Technologies Inc
• Icoria, Inc. (Previously Paradigm Genetics)
• Metabolon, Inc.
• Power 3 Medical Products, Inc
• Predictive Diagnostics, Inc
• Predicant Biosciences
• Proteome Sciences plc
• SurroMed, Inc
• Synarc, Inc
• TheRyte, Ltd
• VirtualScopics LLC

Chapter 9: Future Trends

• References

Chapter 10: Interviews With Industry Experts

• Brian Edmonds, Ph.D., Manager, New Technologies, Eli Lilly
• 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 Center
• Deborah Neff, President & CEO, Predicant Biosciences.
• Peter Steiger, Ph.D., President and CEO, Synarc, Inc.
• Michael Spain, M.D., Chief Medical Officer, Rules Based Medicine.
• John Ryals, Ph.D., President and Chief Executive Officer, Metabolon
• Homer Pien, Ph.D., Managing Director, MGH-HST Center for Biomarkers in Imaging
• Mark Flocco, Business Development Manager for Clinical Proteomics, Bruker Daltonics

TABLE OF EXHIBITS

• Exhibit 3.1 Examples of Surrogate Endpoints for Drug Development
• Exhibit 3.2 The Pfizer Biomarker Classification Scheme
• Exhibit 5.1 The Affymetrix Microarray Assay Process
• Exhibit 5.2 The Affymetrix Photolithographic Array Production Process
• Exhibit 5.3 The Aclara eTagｮ Technology
• Exhibit 5.4 High Throughput Genomics Multiplexed Gene Expression Detection Technology
• Exhibit 5.5 Ciphergen ProteinChipｮ Technology
• Exhibit 5.6 Ciphergen Biomarker Discovery Technology
• Exhibit 5.7 A 2D Gel Illustrating a Typical Protein Electrophorogram
• Exhibit 6.1 Beyond Genomics Generic Correlation Diagram
• Exhibit 6.2 Cancer Diagnostic Biomarker Commercialization
• Exhibit 6.3 Selected Transcriptomic Commercial Biomarker Offerings
• Exhibit 6.4 Selected Proteomic Commercial Biomarker Offerings
• Exhibit 6.5 Selected Metabolomic Commercial Biomarker Offerings
• Exhibit 6.6 Selected Systems Biology Commercial Biomarker Offerings
• Exhibit 6.7 Selected Commercial Offerings in the Imaging Biomarker Field
• Exhibit 7.1 Business Models of Biomarker-Related Companies
• Exhibit 7.2 Business Models of Biomarker Companies by Category
• Exhibit 7.3 Selected Recent Biomarker-related Deal Activity
• Exhibit 7.4 Potential Impact of Biomarkers on Pharmaceutical R&D Costs
• Exhibit 7.5 Results from a Survey of Scientists Engaged in Biomarker Work