Animal Models for Therapeutic Strategies Report Now Available on ReportsandReports
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Model organisms have long been a mainstay of basic and
applied research in the life sciences. Among model organisms, it is model
animals that have had a central place in medical research and in pharmaceutical
and biotechnology company research, including drug discovery, preclinical
studies, and toxicology. Although pharmaceutical companies have long employed
animal models based on such mammalian species as mice and rats, dogs, cats,
pigs, and primates, more recently the pharmaceutical/biotechnology industry has
also adopted several invertebrate and lower vertebrate animal models that have
emerged from academic laboratories. These animal models include the nematode
Caenorhabditis elegans, the fruit fly Drosophila, and the zebrafish. The
adoption of invertebrate and zebrafish animal models by industry has been
driven by the advent of genomics, especially the finding that not only genes,
but also pathways, tend to be conserved during evolution.
Researchers use animal models in basic research, in
developing new therapeutic strategies for treating human diseases, and in drug
discovery research (including target identification and validation, drug
screening and lead optimization, and toxicity and safety screening), as well as
in preclinical studies of drug safety and efficacy. The use of animal models in
developing novel therapeutic strategies for human diseases overlaps with basic
research that uses animal models to understand physiological and disease
pathways. But its aim is to achieve knowledge of pathways and targets in a
disease that leads to the development of new paradigms for discovery and
development of drugs or other therapeutics. It thus also overlaps with use of
animal models in drug discovery. The use of animal models in development of
novel therapeutic strategies is the main emphasis of this report.
The creation of new animal models is an important part of
animal-based therapeutic strategy research. A major reason why the
pharmaceutical/biotechnology industry needs new animal models is because poorly
predictive animal models are a major cause of drug attrition during
development. This is especially true in therapeutic areas (e.g., oncology and
central nervous system [CNS] disease) in which animal models are the most
unpredictive. Due to the poor predictivity of many animal models, some
researchers would like to work with “human models” based on induced pluripotent
stem (iPS) cells. This early stage technology may allow researchers to develop
disease models based on cells from people with such genetically determined
diseases as spinal muscular atrophy (SMA), Parkinson’s disease, Huntington’s
disease, Duchenne and Becker muscular dystrophy, amyotrophic lateral sclerosis
(ALS), Executive Summary etc., which more faithfully model the cellular basis of these
diseases than animal models. However, most human diseases involve interactions
between multiple organs and tissues. Researchers therefore need to continue to
use animal models, which are whole, living systems that model physiology—not
just cell and molecular biology. Cellular models based on iPS will be used in
screening (which may in some cases reduce the numbers of animals needed in a drug
discovery program) and to provide information on human disease pathways to
supplement information derived from studies with animal models. Information
derived from cellular models, and in some cases the cells themselves, may also
be used to design new animal models to more faithfully model human diseases.
The final section of Chapter 1 discusses the issue of
animal welfare, which is an important consideration in research involving
animals. The
However, some types of animal research, especially
research involving nonhuman primates, are particularly controversial. Moreover,
animal rights activists have had their impact on the practice of animal
research, especially in
The absolutely essential need for animal research for
progress in medical science and healthcare is well proven, and researchers and
the general public generally support animal research. However, there is an
increasing concern for animal welfare, including pressure for research
organizations to find ways to reduce the numbers of vertebrate animals used in
research. There is also the increasing need for researchers and their
organizations to foster open engagement with the public and policy-makers to
promote the value of animal research and discuss animal welfare issues.
Chapters 2 through 7 each focus on a particular type of
animal model. Chapters 2, 3, 4, and 6 focus on C. elegans, Drosophila, the
zebrafish, and the mouse, respectively. Each chapter includes case studies of
the use of each of these established animal models in developing novel
therapeutic strategies for human disease. Chapters 5 and 7 focus on emerging
animal models for use in drug discovery and development of new therapeutic
strategies, the African clawed toad Xenopus tropicalis (Chapter 5) and emerging
mammalian animal models (Chapter 7). Each of these two chapters focuses on
technological developments now in progress to develop tractable animal models
based on these organisms for use in drug discovery research. Chapter 7, in
addition to the development of model systems based on non-rodent mammals
(mainly pigs, ferrets, and marmosets), includes a discussion of the reemergence
of the laboratory rat as an animal model. The rat, despite its important uses
in physiological research, in studies involving surgery, and in other types of
studies, has been eclipsed by the mouse in the post-genomic era. However, it is
now “reemerging” as the result of new technologies (e.g., the sequencing of the
rat genome and the construction of knockout rats via various novel
gene-targeting technologies) and collaborations. Some Animal Models for
Therapeutic Strategies of these technologies are also being applied to the
development of nonrodent mammalian models.
Chapter 8 discusses the use of computer models and
translational biomarkers in helping researchers to more effectively move from
preclinical animal studies to human clinical trials. Pharmaceutical and
biotechnology company researchers have been increasingly applying
pharmacokinetic/pharmacodynamic (PK/PD) modeling to all stages of drug
development. This especially includes moving from preclinical animal studies to
human clinical trials. These models, as well as biophysical models such as those
developed by Novartis and physiological models such as those developed by
Entelos, can help researchers more effectively use animal model data in the
design of clinical trials. In particular, they can help researchers reduce drug
attrition in clinical trials due to suboptimal dosing.
Entelos’ virtual NOD mouse model for type 1 diabetes can
be described as a “virtual animal model.” This mathematical model is made
possible by the extensive studies that have been carried out over 30 years with
the living NOD mouse, and the acceptance by the diabetes research community of
the usefulness of this mouse model and its relatively faithful modeling of
human disease. The virtual NOD mouse is designed to help researchers design
more effective animal studies using fewer animals, and hopefully to design more
effective and successful clinical trials of agents designed to prevent
progression to type 1 diabetes. Nevertheless, the usefulness of the virtual NOD
mouse in enabling researchers to discover innovative drugs that achieve proof
of concept in clinical trials, let alone reach the market, remains to be
confirmed.
Chapter 6, which focuses on the mouse, concludes with a
discussion of the issue of developing more predictive animal models of drug
efficacy, specifically more predictive mammalian models. The two main reasons
for researchers’ difficulties in producing predictive mouse models are 1)
differences between the mouse and humans, and 2) major unknown factors in
disease biology. These unknown factors have been revealed, for example, by
studies in human genetics showing that common variants do not account for most
of the heritability of disease, the discovery of the role of copy number
variation and of non-coding DNA sequences in human disease determination, and
the discovery in recent years of new layers of cellular regulation based on
small regulatory RNAs and epigenetics. Although these factors make developing
predictive animal models difficult, researchers can use animal models to learn
about unknown or poorly understood areas of disease biology. This is expected
to lead to the development of improved animal models and the development of new
therapeutic strategies and drugs.
Researchers can also bridge some of the differences
between the mouse and humans by creating humanized mouse models. In some cases,
other mammalian species may be better models for certain diseases (e.g., rats
for cardiovascular diseases, pigs and ferrets for cystic fibrosis) than the
mouse. As discussed in Chapter 7, there are new technologies for producing
gene-modified disease models based on these mammalian species.
Developing animal models that are more predictive of
efficacy is an iterative process. But progress is being made, as researchers
apply new knowledge and experimental approaches Executive Summary in
elucidating the biology of particular diseases to creation of animal models.
Researchers developing new drugs for complex diseases are well advised to test
drugs in more than one animal model and in mouse strains of different genetic
backgrounds. They should also, if possible, employ translational efficacy
and/or pharmacodynamic biomarkers to link the efficacy seen in preclinical
studies with clinical results.
TABLE OF CONTENTS
CHAPTER :
INTRODUCTION
1.1. Uses of Model Organisms
Basic Research
Developing Therapeutic Strategies
Target Evaluation
Preclinical Studies
1.2. Why Do We Need New Animal Models?
Animal Models Used in Drug Discovery and Preclinical Studies Need to be More
Predictive of Clinical Results
Can animal models be replaced with human cellular models in drug discovery?
New Animal Models to Aid Researchers in Understanding Disease Biology and
Developing New Therapeutic Strategies
1.3. The Issue of Animal Welfare and Its Effects on Animal Research in Drug
Discovery and Preclinical Studies
The 3Rs
The Effects of Public Perception and Behavioral Research on Support of Animal
Research
CHAPTER 3 : THE FRUIT FLY DROSOPHILA
MELANOGASTER AS A MODEL SYSTEM
3.1. Introduction
3.2. Use of RNAi Screens to Identify Drug Targets in Drosophila Cells and a
Novel Approach to Cancer Therapy
3.3. A Drosophila Model for Human Glioma
3.4. Conclusions
CHAPTER 5 : XENOPUS TROPICALIS: AN EMERGING
MODEL SYSTEM
5.1. Introduction
5.2. Developing Genetic and Genomic Tools for X. tropicalis
5.3. Studies with X. tropicalis with Relevance to Human Disease
5.4. Conclusions
CHAPTER 7 : EMERGING MAMMALIAN MODEL
SYSTEMS
7.1. Introduction
7.2. The Reemergence of the Laboratory Rat
7.3. Site-Directed Mutagenesis in Mammalian Models Other than the Mouse
7.4. Zinc-Finger Nuclease Genome Editing to Produce Knockout Rats
7.5. Creating Knockout Mice and Rats from Cultured Spermatogonial Stem Cells
7.6. Production of Transgenic Marmosets That Transmit Transgenes to Their
Offspring
7.7. Conclusions
CHAPTER 9: OUTLOOK
9.1. Animal Welfare Issues
9.2. “Established” and “Emerging” Animal Models
9.3. Advantages of Using Invertebrate Models and the Zebrafish in Drug
Discovery Research
9.4. Animal Model Studies Help Researchers Learn About New Aspects of Disease
Biology
9.5. Developing More Predictive Animal Models of Drug Efficacy
10.2. Davide Molho, DVMCorporate Senior Vice President Charles River
10.3. Brian W. Soper, PhDResearch Affiliates Program, Scientific
10.4. Ann Sluder, PhDDirector of BiochemistryScynexisResearch Triangle Park, NC
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