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시장보고서
Developments in Early-Stage Toxicity Prediction
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Abstract
Introduction
Drug toxicity is a major cause of costly late-stage development failures and
devastating market withdrawals. To reduce these failures, researchers are
developing novel toxicity prediction technologies that can be integrated into
the early stages of drug development. Collaboration among regulatory agencies,
pharmaceutical companies, and research institutions promises to advance this
fi eld.
Get the Answers You Need to Shape Your Strategy
- Companies are seeking alternatives to low-throughput, expensive animal
studies for predicting drug toxicity. How advanced are these alternative
technologies? How can these technologies be applied during drug discovery?
- The need for toxicity prediction tools provides opportunities for
companies that can develop and exploit novel technologies. Which companies are
developing and offering novel tools and/or services? What partnerships are
these companies forming with Big Pharma? What types of technologies are
commercially available?
- Drug manufacturers are concerned about regulatory acceptance of new
toxicity assays and biomarkers. How are regulatory agencies addressing these
concerns? What programs are available to industry to encourage working with
regulatory agencies in the fi eld of toxicity prediction? What initiatives
include participation by regulatory agencies?
- To develop reliable toxicity prediction tools, researchers require access
to vast datasets of experimental and clinical information. How can researchers
develop and access this information? How can public-private initiatives
promote data-sharing among industry, government, and academia? What progress
has been achieved by these initiatives?
Scope
- Drawbacks of traditional toxicology: traditional indicators; predictive
reliability of animal models; throughput; cost.
- Emerging in vitro assays: microscale cell culture devices, toxicology
microarrays; human embryonic stem cells.
- ' Omics technologies: toxicogenomics; databases; commercial microarrays;
proteomics, metabolomic profi ling, voluntary genomic data submissions
(VGDSs); voluntary exploratory data submissions (VXDSs).
- Novel predictive tools: Computational prediction tools; reference
databases; novel animal models.
- Public-private projects and consortia: FDA; Critical Path Initiative;
Predictive Safety Testing Consortium (PSTC); Development and Application of
Biomarkers of Toxicity Technical Committee; Consortium for Metabonomic
Toxicology; Environmental Protection Agency (EPA); National Toxicology
Program; National Research Council; ToxCast.
- Company highlights: Companies involved in systems biology; bioinformatics;
computational analysis; human embryonic stem cells; cell-based assays;
toxicogenomics; reference databases; novel animal models.
Companies Mentioned in This Spectrum Report
- Abbott Laboratories
- Accelrys
- Affymetrix
- Allergan
- AstraZeneca
- Amgen
- Bayer
- Bayer Healthcare
- BG Medicine
- Biogen Idec
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Caliper Life Sciences
- Cellartis
- Cellumen
- Centocor
- ChemSilico
- ClinXus
- CompuDrug
- Eisai
- Elan Pharmaceuticals
- Eli Lilly
- Entelos
- Expression Analysis
- GeneGo
- Gene Logic
- GlaxoSmithKline
- Hoffmann-La Roche
- Iconix Biosciences
- Invitrogen
- Janssen Pharmaceutica
- Johnson & Johnson
- Lhasa
- Merck
- Merck Serono
- Mitsubishi Chemical Holdings
- Mitsubishi Pharma
- Mitsubishi Tanabe Pharma
- Multicase
- Novartis
- NovaThera
- Novo Nordisk
- Ocimum Biosolutions
- Ore Pharmaceuticals
- Orion
- Par Pharmaceutical
- Parke-Davis
- Pfi zer
- Phylonix Pharmaceuticals
- Purdue Pharma
- Quantum Pharmaceuticals
- Roche
- Sankyo
- Sanofi -Aventis
- Schering-Plough
- Servier
- SimuGen
- Solidus
- StemCells
- Symyx
- Teva Pharmaceutical
- UCB
- Valeant Pharmaceuticals
- VistaGen Therapeutics
- VivoMedica
- Warner-Lambert
- Waters
- Wyeth
- Wyeth-Ayerst
- Zygogen
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
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