An IQ Consortium Perspective on The Scientific Committee on Health, Environmental and Emerging Risks Final Opinion on the Need for Nonhuman Primates in Biomedical Research, Production and Testing of Products and Devices (Update 2017)

Abstract

The recent Scientific Committee on Health, Environmental and Emerging Risks Final Opinion on “The need for nonhuman primates in biomedical research, production and testing of products and devices” (2017 SCHEER) highlights approaches that could significantly contribute to the replacement, reduction, and refinement of nonhuman primate (NHP) studies. Initiatives that have the potential to affect NHP welfare and/or their use are expected to be appropriate, fair, and objective and publicly disseminated information focused on NHPs in biomedical research, which includes toxicologic and pathologic research and testing, should be objectively evaluated by stakeholder scientists, researchers, and veterinarians. Thus, IQ Consortium member companies convened to develop an informed and objective response, focusing on identifying areas of agreement, potential gaps, or missing information in 2017 SCHEER. Overall, the authors agree that many positions in the 2017 SCHEER Opinion generally align with industry views on the use of NHPs in research and testing, including the ongoing need of NHPs in many areas of research. From the perspective of the IQ Consortium, there are several topics in the 2017 SCHEER that merit additional comment, attention, or research, as well as consideration in future opinions.

The Influence of Geographical Origin, Age, Sex, and Animal Husbandry on the Spontaneous Histopathology of Laboratory Cynomolgus Macaques (Macaca Fascicularis): A Contemporary Global and Multisite Review of Historical Control Data

“…5,17 Environmental factors, such as early or late exposure to infectious agents, the microbiome, housing and social dynamics, diet and water source at the breeding or holding facilities, and air quality, may modulate the rate and occurrence of spontaneous histopathology findings. 5 With the modern implementation of very high standards of NHP housing and husbandry by most breeders and test facilities in recent years, 1 it is likely that the animal genetics and the microbiome, including early or lack of exposure to pathogens, play a bigger role in the differences observed between Asian and Mauritian macaques. Due to their total isolation for centuries, Mauritian macaques have developed different immune responses related to their major histocompatibility complex allele concentrations.…”

“…The laboratory nonhuman primates (NHP) play a crucial role in the nonclinical safety assessment of pharmaceuticals and vaccines, as the most phylogenetically proximate animal model to humans. 1,2 The cynomolgus macaque, which is the most common laboratory NHP species used in toxicology studies that shares many anatomic, physiological, and immunological similarities to humans, is often used as a pharmacologically relevant laboratory animal species in biopharmaceutical drug development and some vaccine research models. 3 However various factors, such as ethical considerations and responsible and efficient use of animals, 4 the increase in biotherapeutic development, and supply shortages in the face of increased demand, have sometimes resulted in the use of lower numbers of cynomolgus macaques per group in a study relative to rodent studies.…”

“…7 However, while a wealth of genetic, genomic, and bioinformatics information has been developed for rhesus macaques, there is less information on cynomolgus macaques. 3,7 It is known, though, that captive stocks of cynomolgus macaques originate from at least one of the three following populations: (1) native Indochinese or mainland macaques, which originate from Thailand, Cambodia, or Vietnam, and are frequently captivebred in China, and have a higher genetic variation; (2) macaques from the southern region of the Isthmus of Kra into insular Asia and Philippines which are more homogenous compared to Indochinese macaques; and (3) non-native cynomolgus macaques on the Island of Mauritius, which have a very low genetic diversity when compared to native Asian macaques, presumably due to the founding effects (Mauritian macaques were derived from an estimation of around 20 founding animals), and total isolation. [8][9][10] Due to these geographical origins, Indochinese or mainland macaques are alternatively referred as "continental," while those from the Philippines, Indonesia, and Mauritius are often referred to as "insular" or in the case of those from Mauritius referred to as "Island" macaques.…”

Evaluation of an enrichment programme for a colony of long-tailed macaques (Macaca fascicularis) in a rescue centre

“…28 of 02-02-2019), despite strong constraints on their use by national and international rules and evidence of important currents of ethical opposition to their use at the global level. Indeed, the European Commission has produced a very restrictive report on the subject (Adams et al 2019), while an independent Dutch institute has even stated that the use of monkeys should be halted immediately, calling it an unsustainable model, not only because of ethical issues, but also for scientific and legal reasons (Koëter et al 2016).…”

Special Issue on the Pathobiology of Laboratory Nonhuman Primates: A Review of Species, Substrain, Geographical Origin, Age, and Modality-Related Factors

“…The laboratory nonhuman primate (NHP) continues to play a crucial role in the discovery and development of biopharmaceutical and vaccines, and model development for many human disease conditions in basic research. 1 In nonclinical development of biopharmaceuticals such as monoclonal antibodies, NHPs are often the only pharmacologically relevant species, and the rapidly increasing number of these molecules in development has resulted in increased use of NHP. 2 However, ethical considerations and recent efforts to reduce the use of NHPs, coupled with the current shortage in the supply of laboratory NHPs, brought about by increased NHP usage for vaccine and drugs development during the COVID-19 pandemic, have amplified calls to explore and implement science-driven ways for more effective use of animals and to maximize the knowledge gained from animal studies using the fewest numbers of animals possible.…”