Developments in Early-Stage Toxicity Prediction

Table of Contents

Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Drawbacks of Traditional Approaches to Toxicology
• Emerging In Vitro Toxicity Assays
  • Microscale Cell Culture Systems
  • MetaChip and DataChip
  • Human Embryonic Stem Cells
• ' Omics Technologies
• Toxicogenomics
  • Toxicogenomics Databases
  • Commercial Toxicogenomics Arrays
  • Toxicoproteomics
  • Toxicometabolomics
  • Regulatory Oversight of ' Omics Technologies
• Computational Toxicity Prediction Tools
• Zebrafi sh Models
• Government, Industry, and Academic Projects and Consortia
  • The Critical Path Initiative and the Predictive Safety Testing Consortium
  • HESI Biomarkers of Toxicity Technical Committee
  • Consortium for Metabonomic Toxicology
  • EPA Initiatives in Toxicology Prediction
• Company Highlights
  • BG Medicine
  • Cellartis
  • Cellumen
  • Gene Logic
  • Iconix Biosciences
  • Phylonix Pharmaceuticals
  • SimuGen
• Outlook for Predictive Toxicity Testing

Tables

• 1. Select Drugs Withdrawn from the Market for Safety Reasons, 1998-2008
• 2. Select Current Assays and Tools for Predicting Drug Toxicity and Metabolism
• 3. Toxicogenomics Reference Databases and Resources
• 4. Select Computational Tools for Predictive Toxicology
• 5. Industry Members of Select Public-Private Toxicology Consortia

Figures

• 1. Reasons for Termination of Drug Candidates During Development
• 2. The Toxicogenomics Approach
• 3. ToxCast: Developing Toxicity Signatures for Chemicals