Overview of 3Rs opportunities in drug discovery and development using non-human primates

Abstract

Non-human primates (NHPs) are included within safety testing programmes for potential new medicines when justified as the relevant species for use. Although the NHP is often the only relevant species for the testing of large molecule biotherapeutics, a proportion of small molecule compounds may also require testing in NHPs, when other non-rodent species are unsuitable. Whilst the toxicology studies continue to be required for regulatory submissions, there are opportunities to both reduce the number of animals and refine procedures used within the studies, by implementation of best practice study designs and processes identified by NC3Rs-industry data sharing projects. With the rapid expansion of biotherapeutics within the industry expected to continue or increase, the number of compounds within company pipelines, and hence the number of NHPs used for testing, are likewise anticipated to grow. A wider acceptance and adoption of established 3Rs approaches should continue to minimise the use of NHPs whilst maximising the potential these new therapies bring to improve human health.