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Toxicity Biomarkers: Promising Tools for Accelerated Drug Development

Published by: Decision Resources

Published: Dec. 21, 2006 - 27 Pages

Price reduced due to age.

Table of Contents



Executive Summary

Strategic Considerations

Stakeholder Implications

Drug Toxicity: An Ongoing Challenge for Developers

Drawbacks of Traditional Approaches to Toxicology




Applications and Benefits of Biomarkers of Toxicity in Drug Development

What Is a Biomarker?

Why Use Biomarkers of Toxicity?




Toxicogenomics: Technologies for Identifying Biomarkers of Toxicity

Gene Expression Profiling

Proteomics

Metabolic Profiling

Genotyping




Examples of Potential Biomarkers of Toxicity

á−Glutathion S-Transferase in Hepatotoxicity

Kidney Injury Molecule-1 in Nephrotoxicity

Troponins in Cardiotoxicity

Inhibin B in Testicular Toxicity




Challenges in Integrating Biomarkers of Toxicity into Drug Development

Technical Issues

Biomarker Validation

Bioinformatics/Integration

Intellectual Property

The Critical Path Initiative and Biomarker Discovery




Industry Trends




Collaborative Agreements

Aureus Pharma, ChemAxon, Sanofi-Aventis, and Budapest University of Technology and Economics

BG Medicine

Ciphergen Biosystems

Clinical Data

Gene Logic

Iconix Biosciences

Metabometrix

RxGen

Consortia

International Life Science Institute Health and Environmental Science Institute

Predictive Safety Testing Consortium

Consortium for Metabonomic Toxicology

Drug-Induced Liver Injury Network




Outlook for Biomarkers of Toxicity




Tables

1. Select Drug Withdrawals Due to Safety Issues, 1997-2005

2. Metabolizing Enzymes Implicated in Drug-Induced Toxicity

3. Biomarker Classification

4. Profiled Companies Active in Development of Biomarkers of Toxicity

5. Profile of the Affymetrix/Iconix ToxFX Chip




Figures

1. Reasons for Termination of New Compounds

2. Applications and Benefits of Biomarkers of Toxicity in Drug Development

3. Schematic Example of Using DNA Microarray Technology in Biomarker Discovery

4. 2DGE/MS-Based Protein Analysis Scheme in Biomarker Discovery

5. Framework for Data Integration from Different Technology Platforms

Abstract

Introduction

In the wake of several notorious drug withdrawals caused by unsuspected toxicities, pharmaceutical companies are searching for ways to minimize the escalating risks and costs of drug development. Biomarkers of toxicity offer the hope of producing safer drugs while cutting costs and time to market and are inspiring some novel collaborations.

Get the Answers You Need to Shape Your Strategy

Drug development productivity is declining while costs rise. What factors contribute to this situation? How big a role does toxicity play? How can toxicity biomarkers change the equation?

The FDA is encouraging identification and validation of biomarkers. What initiatives are under way? What companies are developing toxicity biomarkers? Who are their collaborators?

A biomarker strategy is a must to succeed in today’s extremely competitive drug development environment. What challenges do companies face? What is the time frame for the realization of toxicity biomarkers? What are the technologies to watch? What is the recommended course of action for the near and long term?

Scope of This Spectrum Report
  • Uses of toxicity biomarkers: Drug development, clinical trials, aid in go/no-go decision making, identify off-targets, select lead compound, choose the best animal model, identify interspecies biomarkers of toxicity, stratify patients, adjust schedule/dose.
  • Potential biomarkers: Alpha-glutathion S-transferase, kidney injury molecule-1, troponins, inhibin B.
  • Initiatives and organizations: Critical Path initiative, C-Path Institute, International
  • Life Sciences Institute, Health and Environmental Science Institute, Predictive Safety
  • Testing Consortium, Eureka, Consortium for Metabonomic Toxicology, Drug-
  • Induced Liver Toxicity Network, Voluntary Genomics Data Submission, Biomarker
  • Qualification Pilot Process.
  • Challenges: Technical issues, biomarker validation, bioinformatics, intellectual property.


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