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Preclinical Models: Innovative solutions to accelerate drug discovery and development

Published by: Business Insights

Published: Feb. 10, 2010 - 131 Pages


Table of Contents


Preclinical models
Executive summary
Preclinical models in drug discovery and development
In vivo models in preclinical research
In vitro models in preclinical research
In silico models in preclinical research
Systems biology models in drug discovery
Chapter 1 Preclinical models in drug discovery and development
Summary
Introduction: importance of preclinical models for toxicity screening in drug development
Preclinical ADMET testing systems
The challenge: reducing drug attrition rates in preclinical screening
Importance of ADMET screening
Applying of ADMET to the drug discovery and development process
Importance of in vivo models
Established in vivo and in vitro ADMET tools to screen compounds
Toxicity and genotoxicity screening
Predicting toxicity with paracellular markers
In vitro ADMET screening in preclinical drug development
Advantages and disadvantages of conventional ADME screening tools in preclinical drug development
Oral absorption prediction
Metabolism prediction
In vivo ADMET animal models
Established ADMET study methods in animal models
Radiolabels
Cassette dosing
Semi-simultaneous dosing
Conclusion
Limitations of traditional in vitro and in vivo ADMET screening methods
New approaches to predict ADMET in preclinical development
Metabolomics
Advantages of metabolomics in drug discovery and development
Lead prioritization using metabolomics
Metabolomics and ADMET studies
Strengths and limitations of metabolomics for preclinical research
Metabolomics and “systems biology” - a unified approach to preclinical
ADMET screening
Company focus: Merrimack Pharmaceuticals
Other emergent technologies used in preclinical drug discovery and development
Nanotechnologies in preclinical studies
Novel imaging systems
Preclinical research and recent multinational pharmaceutical company activities
Bayer AG and Nimbus Biotechnology
Pfizer/Johnson and Johnson and WuXi Pharma Tech
Roche
Sanofi-Aventis
UCB Pharma
Chapter 2 In vivo models in preclinical research
Summary
Vertebrate animal models in preclinical discovery and development
Assessment of predictive value of animal models
Rodent models
The need for improved small animal models
Humanized rodent models
Advantages and disadvantages of zebrafish models in preclinical research
Recent progress with vertebrate models
ADMET screens and zebrafish models: company developments and technologies
Discovery Genomics
Evotec AG
Phylonix
Summit
ZF Biolabs
Zygogen
ADMET screens in rodent models: selected company developments and technologies
Lexicon Pharmaceuticals
Taconic
Xenogen’s (now part of Caliper)
Sigma-Aldrich
Invertebrate animal models in preclinical discovery and development
Drosophila melanogaster (fruit fly)
Aktogen
En Vivo Pharmaceuticals
Exelixis
Medros Pharmaceuticals
Caenorhadbitis elegans (nematode)
Novel in vivo/ex-vivo focus: Locusta migratoria (locust)
Chapter 3 In vitro models in preclinical research
Summary
Importance of in vitro models in preclinical toxicity testing
In vitro technologies for drug discovery and development
Recent company developments
Affymetrix
Beckman Coulter
Covance
Gene Logic
HemoGenix
Recent developments in drug transport and metabolism
Qualyst
Xenobiotic Laboratories
Progress in cell-based in vitro assays
Use of cultured cells for ADMET studies in preclinical research
In vitro distribution
In vitro solubility
In vitro ADMET assays and cell-type selection
Recent developments in cell-based platforms for preclinical drug screening
Cell-based assays and liver toxicity
Stem cells in drug discovery and development
Stem cells and ADMET in drug discovery and development
Novel in vitro technologies in preclinical research
Nanotechnologies and ADMET in drug discovery and development
Chapter 4 In silico models in preclinical research
Summary
In silico models in drug discovery and development
Molecular modeling in silico
Computer models to predict ADMET
Methodological approaches to in silico models
Recent commercial developments and activities
Accelrys
Advanced Chemistry Development
Aureus Pharma
Chemical Computing Group
Entelos
Gene Network Sciences
Leadscope
Life Technologies Corporation
Molecular Discovery
Molecular Networks
Noray Bioinformatics
Schrödinger
Simcyp
Simulations Plus
TerraBase
Tripos
Chapter 5 Systems biology models in drug discovery
Summary
Systems biology: integrative science for drug discovery
Predictive biosimulation platforms to aid preclinical research
Virtual organs and patients
Pathway biology systems: recent commercial developments and activities
Ariadne Genomics
GeneGo
Genomatix
Genstruct
Ingenuity Systems
Merrimack Pharmaceuticals
Physiomics
Considerations for preclinical models in drug discovery and development
Key points and recommendations
Appendix
Abbreviations and acronyms
Primary research methodology
References
Other sources
Index
List of Figures
Figure 1.1: Established preclinical ADMET systems and models for drug discovery and development
Figure 1.2: Common reasons for a drug candidate’s failure
Figure 1.3: Key advantages & disadvantages of animal models in preclinical drug development
Figure 1.4: Animal models (%) used in preclinical ADMET studies
Figure 2.5: Advantages and disadvantages of zebrafish for preclinical ADMET screening in drug discovery and development
Figure 2.6: Preclinical ADMET screen types offered by Evotec AG
Figure 2.7: Rationale for use of Drosophila as preclinical model for neurobiological disease
Figure 4.8: Factors limiting the use of in silico ADMET models
Figure 5.9: Drivers of systems biology in pharmaceutical R&D
List of Tables
Table 1.1: Routine screens to assess ADME of drug candidates in discovery
Table 2.2: Key advantages of Drosophila in preclinical drug discovery and development
Table 3.3: Commonly used cultured cells for in-vitro permeability assays

Abstract

Preclinical models are developed to test lead compounds for toxicity and efficacy. They are valuable tools to minimize development costs and reduce failures prior to commencement of human trials. Problems with traditional animal models such as cost, ethics, and suitability has prompted researchers to develop new models and systems to overcome such disadvantages. Alternative approaches include new vertebrate, nonvertebrate, computer-based and imaging models that offer new perspectives and utility to aid the drug discovery and development process. ‘Preclinical Models’ is a new report published by Business Insights that explores novel preclinical models that show promise to expedite and improve the target validation and lead optimization timeline and discusses the various advantages and disadvantages of ADMET screening technologies to provide insight on which models or systems may enhance the R&D function of pharmaceutical and biotechnology organisations. Additionally, this report provides an outlook for preclinical testing over the next decade and how pharmaceutical companies may need to adjust to new systems and models to improve their efficiencies. It uniquely focuses on more than 60 companies that are involved in using or developing ADMET technologies to advance preclinical research and provides an update on recent company activities and developments where new models and systems are employed to accelerate the discovery and development process.

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