Animal Models for Therapeutic Strategies

June 13, 2011 - PRLog -- Animal Models for Therapeutic Strategies

Report Summary

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.

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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 United States and various European countries, as well as other jurisdictions (national and local), have sets of animal welfare regulations. Central to these regulations is implementation of the 3Rs (Reduction, Refinement, and Replacement.) Academic and corporate research organizations have been incorporating these regulations into their research practices.

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 Europe.

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.

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