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.
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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.
Mentioned in This Spectrum Report
Companies and Organizations
- Abbott
- Aegerion Pharmaceuticals
- Affymetrix
- Amgen
- AstraZeneca
- Aureus Pharma
- Bayer
- BG Medicine
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Budapest University of Technology and
- Economics
- Cambridge Antibody Technology
- ChemAxon
- Ciphergen
- Clinical Data
- Consortium for Metabonomic Toxicology
- C-Path Institute
- Drug-Induced Liver Injury Network
- Eli Lilly
- Environmental Science Institute
- Enzon Pharmaceuticals
- Eureka
- Food and Drug Administration
- GeneLogic
- GlaxoSmithKline
- Iconic Biosciences
- Icoria
- Imperial College, London
- International Life Science Institute
- Isis Pharmaceuticals
- Johnson & Johnson
- Liver Toxicology Biomarker Study
- Merck
- Metabometrix
- Micromet
- Mitsubishi Pharmaceuticals
- National Institutes of Health
- Novartis
- Pfi zer
- Pharmacia
- Predictive Safety Testing Consortium
- Roche
- RxGen
- Sanofi -Aventis
- Schering-Plough
- University of Pennsylvania
- Warner-Lambert
- Waters
- Wyeth-Ayerst
- Technologies
- Bioinformatics
- DrugMatrix database
- Gas chromatography
- Gene expression profi ling
- Genesis Enterprise System
- Genotyping
- KnowTox
- Liquid chromatography
- Mass spectrometry
- Metabolic profi ling (metabolomics,
- metabonomics)
- Nuclear magnetic resonance spectroscopy
- Open Array platform
- PrimaTox
- Proteomics
- SNP assay
- Systems toxicology
- ToxExpress
- ToxFX Analysis
- ToxShield
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
- α-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 17
- 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
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