Flandre, Thierry, Clarke, David O., Datta, Kaushik, French, Kevin, Leach, Michael W., Olaharski, Drew, Mohr, Susanne, Strein, Devon and Hershman, Kenneth (2024) Opportunities and challenges for use of minipigs in nonclinical pharmaceutical development: Results of a follow-up IQ DruSafe survey. Regulatory toxicology and pharmacology : RTP, 154. p. 105729. ISSN 1096-0295

Abstract

Minipigs are valid nonrodent species infrequently utilized for pharmaceutical research and development (R&D) compared with dogs or nonhuman primates (NHPs). A 2022 IQ DruSafe survey revealed a modest increase in minipig use by pharmaceutical companies compared with a prior 2014 survey, primarily in the development of oral small molecules and parenteral protein molecules. Some companies considered using minipigs more often due to NHP shortages and regional ethical concerns with using NHPs and dogs. However, for most pharmaceutical companies, minipigs still represent ≤5% of their nonrodent animal use. Key challenges noted by companies to wider adoption of minipigs were high test article requirement, limited historical control data, and lack of relevant reagents or assays. Additionally, some companies expressed uncertainties about contract research organization (CRO) capabilities and experience, a perception not shared by respondent CROs. These latest survey results indicate persistence of many concerns previously identified in 2014. Several case studies are included to illustrate areas of expanded minipig use as well as the challenges that hinder broader adoption. Ongoing, focused, and industry-wide initiatives to address the identified or perceived challenges may lead to more frequent or routine consideration of minipigs as a test species in pharmaceutical R&D.

Item Type:	Article
Keywords:	drug development, minipig, pharmacology, pharmacodynamic, pharmacokinetic, species selection, toxicology
Date Deposited:	04 Dec 2024 00:45
Last Modified:	04 Dec 2024 00:45
URI:	https://oak.novartis.com/id/eprint/54240