Toxicity Biomarkers: Promising Tools for Accelerated Drug Development
Decision Resources, Inc, December 2006, Pages: 27
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.
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
a-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
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
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