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Post-Genomic Biomarkers: Revolutionizing Drug Development and Diagnostics 2nd edition

Published by: Drug and Market Development Publishing

Published: Mar. 1, 2005 - 211 Pages


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




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® Technology

Exhibit 5.4 High Throughput Genomics Multiplexed Gene Expression Detection Technology

Exhibit 5.5 Ciphergen ProteinChip® 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

Abstract

Since the publication of the first edition, pharmaceutical and biotechnology companies have broadened from a primary focus on biomarker discovery to greater emphasis on assay development and implementation of biomarker applications. Drug developers have also demonstrated increased interest in imaging-based based biomarkers. The second edition, Post-Genomic Biomarkers: From Discovery to Implementation covers these and other new developments.



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