In contrast to mice, NHPs demonstrate all of the features of infection of humans by Mtb, particularly the formation of granulomas that have very similar physiology to those in human infection and immune responses that parallel those of humans. The cost of genomic sequencing is, at best, approximately $2000 per animal, not including the significant personnel costs necessary to analyze the data (Bimber et al. 2013; Vasbinder and Locke 2016), the European Union (Olsson et al. They also discuss early experiments using chimpanzees, which, while unsuccessful in themselves, provided information that was useful for development of the SIV-macaque animal model. Vision research provides one of the most clear-cut examples of the advantages of NHP preclinical models because of the close physiological similarities between humans and NHPs. [48], In the 21st century billions of animals have been used for human's benefit through animal testing of consumer products, in the United States and dozens of other countries. ESEC is a proponent of dissection choice legislation and policies which provide students the right to choose alternatives to animal use in their education. ART, however, does not completely eliminate HIV from the body; a reservoir of the virus can be reactivated if drug therapy is stopped. The United States is the only country that continues wide-scale housing of chimpanzees in laboratories and permits their use in invasive research. 4 0 obj C [6], Under Capaldo, the board and staff developed and attempted to implement a succession of new strategies with which to achieve the organization's sole mission of ending the use of animals in science and replacing them with non-animal and scientifically superior alternatives. In 2016, a white paper published by the National Association for Biomedical Research briefly discussed scientific breakthroughs that required the use of NHPs (National Association for Biomedical Research 2016). This report contains brief comments on some aspects of the use of NHPs for translational research and concludes: The NIH remains confident that the oversight framework for the use of nonhuman primates in research is robust and has provided sufficient protections to date. A more detailed report published by the Scientific Committee on Health, the Environment and Emerging Risks of the European Union (The SCHEER Report) discusses the same conclusion from the European perspective, and, in addition, provides information about several aspects of the use of NHPs for translational research (SCHEER 2017). JP However, despite a relative lack of supply, investigators were able to develop a macaque-based model to help understand pathogenesis (Dudley et al. This article discusses the development of preclinical NHP models, tests of potential therapies, and methods for neuroprotection. 2017). . Fairly complete draft-level genomic sequences have been published for rhesus and cynomolgus macaques, vervets, and marmosets. NEAVS also works to educate the public, lawmakers, and others about the needs of primates used in research, , Pang W, Agui T, Lee BH. The Use of Chimpanzees in Biomedical and Translational studies using NHPs depend on the availability and characterization of animals, high-quality animal husbandry and welfare, and the development of assays and technologies. Michael Mustari reviews the use of NHP models aimed at understanding the causes of and ameliorating conditions that lead to blindness or lack of visual acuity in humans, including problems of eye alignment (strabismus), lazy eye (amblyopia), unsteady gaze (nystagmus), and defective eye movements. Q Therefore, changes in transportation policies by the major airlines have been inhibitory, but not disastrous. [7], Today, NEAVS continues its work through public outreach, education, legislation and policy change, supporting animal sanctuaries, and funding the development of alternatives to animals in research and science education.[9]. [3], Author Cleveland Amory was NEAVS president from 1987 until 1998. Neeves. . Topics covered in detail include: tuberculosis; viral hepatitis; HIV/AIDS; neurodegenerative disorders; Substance abuse disorders; vision and prevention of blindness; disorder associated with psychosocial processes, such as anxiety, depression and loneliness; cardiovascular disease; metabolic disease, such as obesity and metabolic syndrome; respiratory disease; and female reproduction, prenatal development and women's health. J Abstract and Figures. Department of Health, Office of Newborn Screening. 2016; Sasaki 2015; Sasaki et al. [83] K. Leiderman, S.S. Sindi, D.M. Last month, the National Institutes of Health (NIH) announced in the journal Nature that it will ask grant applicants to use both male and female animals in biomedical NHPs were critical preclinical models for development of these antiviral drugs (Van Rompay 2017; Veazey and Lackner 2017). I am not aware of any publication that has examined the comparative rigor with which studies using different species (for example, rodents versus NHPs or other large animals) have been performed. Kept in sterile environments with little attention or enrichment, treated roughly for not cooperating, and transported under unacceptable conditions, the pain and distress that animals used in research experience actually starts long before they enter a laboratory. Some basic discoveries may be obtained from studies using rodents (reviewed by Zubari and Lutz 2016) and other models, such as zebrafish (Danio rario), fruit flies (Drosophila melanogaster), and nematodes (Caenorhabditis elegans) (reviewed by Strange (2017)). Peabody agreed, and Greene began organizing a number of Boston's influential individuals. Cost must probably be decreased further to allow for whole genome sequencing of large numbers of animals. Besides the obvious ethical and welfare concerns, this also casts doubt on the validity of any results obtained using such animals. "[1], The New England Anti-Vivisection Society (NEAVS) was founded in 1895 in Boston, Massachusetts, in response to the migration of European vivisection practices to the United States. Funded by the National Heart, Lung, and Blood Institute. Investigators in all parts of the world, including the United States, Europe, and Asia, would greatly benefit from reviews that summarize the capabilities of these Asian centers in more detail. R In the context of NHP-based studies, it is important to note that centers such as the NPRCs maintain very detailed computerized animal records that include many of these data. CROs still have the ability to move animals from Asia to the United States. , Mehra S, Lackner A, Kaushal D. Griffin 2017). [12] The resulting alternative was later used by a number of product and cosmetics companies. The well-established difference in the response of Indian- versus Chinese-origin rhesus macaques to infection by simian immunodeficiency virus is a graphic example of this phenomenon (Harding 2017 and references therein; Van Rompay 2017). The crux of my testimony is that imposing a dichotomy between ethical and scientific argumentsas asked to do by Arrowsmith These conclusions regarding rigor appear mainly to be based on studies using rodents. Second, once drugs have been developed by the companies and their collaborators, Phase II and Phase III human clinical trials can have failure rates of 50% or more (Hay et al. As this article was being written, the US Food and Drug Administration temporarily suspended research aimed at understanding aspects of nicotine addiction using squirrel monkeys, apparently based on a direct request of the primatologist, Dr. Jane Goodall, to the FDA Commissioner (McGinley 2017). NEAVS funds scientists developing alternatives, and advocates for policies requiring use of validated animal alternatives in research and testing. The field of NHP-based translational research will benefit from a direct comparison of requirements for animal welfare across centers in all countries that supply NHPs for translational investigations. (2015), Phillips et al. National Association for Biomedical Research For the papers in this issue of the journal, translational research is defined broadly to include both efforts aimed at developing or validating NHP models that are directly relevant to studies of human disease as well as the use of NHPs in later stages of translation that help validate drug targets; evaluate the efficacy of therapies, vaccines, or devices; and test toxicity of pharmaceuticals before testing in human clinical trials. Alternatives like in vitro, computer simulations, cell and tissue samples, and mannequins are reducing the millions of sentient animals forced into painful experiments worldwide. . , Emborg ME. Within the continental United States, most species of NHPs can be moved very safely by truck. Proof of principal of this approach has been reported by Cornish et al. Webbe included when sending NBS cards in for testing. The development of vaccines that prevent infection of humans by Hepatitis A and B viruses and antivirals that provide curative therapies for hepatitis C virus infections is one of the clearest examples of the critical nature of an NHP preclinical model, in this case the chimpanzee (Pan troglodytes). Nevertheless, there are now several examples of creation of genetically modified monkeys that can be used for translational research. Large nonprofit NHP centers in the United States include the seven US National Primate Research Centers (NPRCs, https://www.nprcresearch.org) and other facilities, such as the New Iberia Research Center (http://nirc.louisiana.edu/), The Michale E. Keeling Center for Comparative Medicine and Research (https://www.mdanderson.org/research/departments-labs-institutes/programs-centers/michale-e-keeling-center-for-comparative-medicine-and-research.html), the Caribbean Primate Research Center (http://cprc.rcm.upr.edu/), and the Wake Forest University Primate Center (http://www.wakehealth.edu/ccmr/). Neeves. The short generation times of mice and their fecundity contribute to the success of these technologies. In some cases, animals can be moved to the continental United States from offshore sites by charter companies. Optimal health of animals is also a component of experimental reproducibility. They summarize data for disorders associated with ovarian and uterine function and deleterious conditions associated with pregnancy. WebNEAVS was nominated in the public awareness category for our Project R&R: Release and Restitution for Chimpanzees in U.S. Laboratories campaign (releasechimps.org). 2023 Nonprofit Metrics LLCTerms of Service and Privacy Policy. [7], In September 2017, Nathan Herschler, J.D. Even when a variant animal is identified, there may be no phenotypic assay for the potential disease condition in the NHP. , Akiota MT, Mohr EL, Weiller AM, Lehrer-Brey G, Weisgrau KL, Mohns MS, Breitbach ME, Rasheed MN, Newman CM, Gellerup DD, Moncla LH, Post J, Schultz-Darken N, Schotzko ML, Hayes JM, Eudailey JA, Moody MA, Permar SR, OConnor SL, Rakasz EG, Simmons HA, Capuano S, Golos TG, Osorio JE, Friedrich TC, OConnor DH. (2014), and Van Rompay (2017). As reported by company scientists, estimates of failure rate range from 89% (Begley and Ellis 2012) to 7580% (Prinz et al. . Our data and tools help professionals prospect for nonprofits, research opportunities, benchmark their clients, and enrich existing information. 2013, 2017). PJ Search for other works by this author on: Trial watch: Phase II and Phase III attrition rates, 20112012, Raise standards for preclinical cancer research, Whole-genome characterization in pedigreed non-human primates using genotyping-by-sequencing (GBS) and imputation, Whole genome sequencing predicts novel human disease models in rhesus macaques, Naturally-occurring nonhuman primate models of psychosocial processes, Contributions of non-human primates to neuroscience research, Progress and prospects for genetic modification of nonhuman primate models in biomedical research, Genome editing in nonhuman primates: Approach to generating human disease models, Functional disruption of the dystrophin gene in rhesus monkey using CRISPR/Cas9, Exome screening to identify loss-of-function mutations in the rhesus macaque for development of preclinical models of human disease, Baboons as a model to study genetics and epigenetics of human disease, Nonhuman primates and translational researchcardiovascular disease, Marmosets are stars of Japans ambitious brain project, A rhesus macaque model of Asian-lineage Zika virus infection, Translational research in the nonhuman primate model of tuberculosis, Comparison of the Canadian and US laws, regulations, policies and systems of oversight for animals in research, Progress in genetics and genomics of nonhuman primates, Genomic tools for the use of nonhuman primates in translational research, Use and importance of nonhuman primates in metabolic disease research: Current state of the field, Clinical development success rates for investigational drugs, Accelerating biomedical discoveries through rigor and transparency, A second generation human haplotype map of over 3.1 million SNPs, Development and validation of a SNP-based assay for inferring the genetic ancestry of rhesus macaques (Macaca mulatta), TALEN-based generation of a cynomolgus monkey disease model for human microcephaly, Improving bioscience research reporting: The ARRIVE guidelines for reporting animal research, The chimpanzee model of viral hepatitis: Advances in understanding the immune response and treatment of viral hepatitis, Autism-like behaviors and germline transmission in transgenic monkeys overexpressing MeCP2, The next step in translational research: Lessons learned from the first preclinical randomized controlled trial, Bringing genome-wide association findings into clinical use, In retrospect: A decade of shared genomic associations, Advances in vision science and prevention of blindness using nonhuman primates, National Association for Biomedical Research, National Research Council (US) Institute for Laboratory Animal Research, Laboratory animal laws, regulations, guidelines and standards in China Mainland, Japan and Korea, Protecting animals and enabling research in the European Union: An overview of development and implementation of directive 2010/63/EU, Generation of transgenic marmosets expressing genetically encoded calcium indicators.
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