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Toxicogenomics and Predictive Toxicology


Publication Date   December 2004
Publisher   Cambridge Healthtech Advisors
Product Type   Report
Pages   188
ISBN Number   not applicable
Product Code   CHA011
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Price £1,950.00

approximately: $3,644 | €2,473

Summary


Toxicogenomics and Predictive Toxicology: Market and Business Outlook addresses the significant need and potential for predictive toxicology in drug development. The report evaluates a number of novel approaches to toxicology research that have become available over the past five years that are raising optimism for dramatic improvements in the field. A detailed and insightful business outlook on the strategic, regulatory, and marketplace issues driving growth of toxicogenomic and predictive toxicology applications completes the analysis.

Toxicogenomics and Predictive Toxicology: Market and Business Outlook examines new predictive toxicology approaches including in vivo, in vitro, and in silico technologies such as toxicogenomics, metabolomics, new animal models, and computational methods. Predictive toxicology differs from traditional toxicology testing primarily by having a greater emphasis on low-cost, high through-put assays, anticipating toxic responses rather than measuring them after they occur; and by having a greater emphasis on understanding the underlying mechanisms of action rather than just monitoring toxic response. Predictive toxicology is still in its early stages, characterized by the use of gene expression profiles to gain a basic understanding of whether a compound has a “clean” or “messy” profile. It is still some way off from replacing traditional toxicology testing. However, the tremendous advantages of these approaches, as well as pressure from the FDA to improve toxicology testing in drug development, indicate that advancements in predictive toxicology will play an increasing and accelerating role in drug development. This report is crucial reading for companies that are exploring the potential benefits of these methods and that wish to realize a maximum return on their R&D spending.

Content


Chapter I. Introduction

Overview
Impact of Toxicology Issues in Pharmaceutical Research
Adverse Drug Reactions

Toxicology Background
Effects of Toxicants


Chapter 2. The Role of Toxicology in Drug Development

Toxicology in Drug Development
Traditional Approaches vs. Predictive Toxicology
Traditional Approaches
Animal Models
Genotoxicity Tests
Limits of Traditional Approaches
Predictive Toxicology

Potential Benefits of Predictive Toxicology
Reducing Adverse Drug Reactions
Reduce cost of Drug Development
Reduce time of Drug Development
Improved Drugs
Reduce Animal Testing
Increase Sensitivity
Improve Other Industries
Reduce Potential Lawsuits
Provide Biomarkers
Fewer Regulatory Requirements
Rescue Failed Drugs


Chapter 3. Toxicogenomics

Overview
Background
Genes and Genomics
Gene Expression
Advantages of Genomics Approaches

Measuring Gene Expression
DNA Microarrays
Companies Selling Microarray Products for Toxicology Testing
RNA Splicing

Applications of Toxicogenomics
In Vitro Applications
Predictive Versus Mechanism-Based Investigations

Toxicogenomics Data
National Center for Toxicogenomics
Standardization and Comparison of Toxicogenomics Data
Toxicogenomics Data Analysis
Proprietary Toxicogenomics Databases
Public Databases

Collaborations in Toxicogenomics Research
Toxicogenomics Research Consortium
HESI Collaborative Research Program

Case Study: Using Microarrays to Detect Kidney Toxicity

Chapter 4. Technologies for Predictive Toxicology

Metabolomics/Metabonomics
Profiling Metabolites
Detecting Metabolites
Growth of Metabonomics
Advantages of Metabonomics
The Future of Metabonomics
Selected Companies Active in Metabolomics

Toxicoproteomics
Primary Technologies for Toxicoproteomics
In-House Approaches
Selected Companies Providing Toxicoproteomic Products and Services

Pharmocogenomics
Drug Metabolism
Selected Companies in Pharmacogenomics

In Silico Predictive Toxicology
Applications and Limitations in Predictive Toxicology
In Silico Methods
Programs and Companies Active in In Silico Toxicology
Limitations and Appropriate Uses of In Silico Methods

New Animal Models
Types of Animal Toxicity Tests
Limitations of Animal Toxicity Tests
Companies Offering Approaches to Improving Current Animal Models
Zebrafish
C. elegans

Novel In Vitro Assays: “Animal on a Chip”
Applications
3D Tissue Models
Animal on a Chip ― Companies and Approaches
Stem Cells


Chapter 5. Business and Strategic Issues

Overview
Potential Applications of Predictive Toxicology
Factors Driving Adoption
Cost of the Assay Itself
Cost of Drug Failures
Primary Areas of Growth in Predictive Toxicology and Toxicogenomics

Factors Limiting Growth of New Toxicology Approaches
Regulatory Pressures that Promote Extremely Conservative Approaches to
Toxicology Testing

Drug Toxicity Research Primarily Takes Place in Pharmaceutical Companies

Key Players
Government
Pharmaceutical Industry
Biotechnology Industry
Academia
Vendors
Healthcare Providers and Patients

Regulatory Issues
United States
Global Regulations
Europe

Unmet Needs and Opportunities
Biomarkers
Data Quality and Analysis
Databases
Demonstrated Accuracy
Heart Rhythm Abnormalities

Toxicology Technology Evaluations using SWOT Analysis
Comparison of Rodent Versus Zebrafish Models
Cross-Comparison of Toxicogenomics Versus Proteomics Versus Metabolomics

Conclusions