Report: Developments in Early-Stage Toxicity Prediction

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.

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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