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. 2023 Feb:138:105327.
doi: 10.1016/j.yrtph.2022.105327. Epub 2022 Dec 28.

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

David Ackley  1 , Joanne Birkebak  2 , Jorg Blumel  3 , Todd Bourcier  4 , Christina de Zafra  5 , Andrew Goodwin  4 , Wendy Halpern  3 , Danuta Herzyk  6 , Sven Kronenberg  7 , Robert Mauthe  8 , Jacintha Shenton  9 , Dana Shuey  10 , Ronald L Wange  4
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Free article

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

David Ackley et al. Regul Toxicol Pharmacol. 2023 Feb.
Free article

Abstract

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.

Keywords: 3Rs; Developmental and reproductive toxicity; Nonclinical safety; Nonhuman primate; Toxicology; Toxicology study designs.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: David Ackley, Joanne Birkebak, Jorg Blumel, Christina deZafra, Wendy Halpern, Danuta Herzyk, Sven Kronenberg, Robert Mauthe, Jacintha Shenton and Dana Shuey are employed, respectively, by the following pharmaceutical companies and as employees may hold stock in their respective companies: Eli Lilly, Gilead, Genentech, Seagen, Genentech, Merck, Roche, Pfizer, Amgen, and Incyte.Todd Bourcier, Andrew Goodwin and Ronald Wange are employed by the United States Food and Drug Administration Center for Drug Evaluation and Research.

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