FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations

The nonhuman primate (NHP) has always been a limited resource for pharmaceutical research with ongoing efforts to conserve. This is due to their inherent biological properties, the growth in biotherapeutics and other modalities, and their use in small molecule drug development. The SARS-CoV-2 pandemic has significantly impacted the availability of NHPs due to the immediate need for NHPs to develop COVID-19 vaccines and treatments and the China NHP export ban; thus, accelerating the need to further replace, reduce and refine (3Rs) NHP use. The impact of the NHP shortage on drug development led DruSafe, BioSafe, and the United States (U.S.) Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) to discuss this issue at their 2021 annual meeting. This meeting identified areas to further the 3Rs in NHP use within the current nonclinical safety evaluation regulatory framework and highlighted the need to continue advancing alternative methods towards the aspirational goal to replace use of NHPs in the long term. Alignment across global health authorities is necessary for implementation of approaches that fall outside existing guidelines. This article captures the proceedings from this meeting highlighting current best practices and areas for 3Rs in NHP use.

Automated summary

The limited availability of nonhuman primate (NHP) as a resource for pharmaceutical research due to biological properties, growth in biotherapeutics, and NHP use in drug development has been further impacted by the SARS-CoV-2 pandemic and the China NHP export ban. Efforts to replace, reduce, and refine (3Rs) NHP use have been accelerated. A meeting held by DruSafe, BioSafe, and the U.S. FDA CDER identified areas to promote the 3Rs in NHP use and highlighted the importance of advancing alternative methods for long-term replacement of NHPs.