Opportunities and challenges for use of minipigs in nonclinical pharmaceutical development: Results of a follow-up IQ DruSafe survey.

Autor: Clarke DO; Lilly Corporate Center, Indianapolis, IN, USA., Datta K; Bristol Myers Squibb, Summit, NJ, USA., French K; GSK, Collegeville, PA, USA., Leach MW; Pfizer Inc., Cambridge, MA, USA., Olaharski D; Relay Therapeutics, Cambridge, MA, USA., Mohr S; F. Hoffmann-La Roche AG, Basel, Switzerland., Strein D; Boehringer Ingelheim, Ridgefield, CT, USA., Bussiere J; Amgen, Thousand Oaks, CA, USA., Feyen B; Johnson & Johnson Innovative Medicine, Beerse, Belgium., Gauthier BE; Sanofi, Montpellier, France., Graziano M; Organon, Jersey City, NJ, USA., Harding J; Exscientia (formerly represented Astra Zeneca), Oxford, UK., Hershman K; Novartis AG, East Hanover, NJ, USA., Jacob B; Merck, Rahway, NJ, USA., Ji S; Johnson & Johnson Innovative Medicine, Springhouse, PA, USA., Lange R; Abbvie, North Chicago, IL, USA., Salian-Mehta S; Gilead Sciences Inc, Foster City, CA, USA., Sayers B; Incyte Corporation, Wilmington, DE, USA., Thomas N; Bayer AG, Berlin, Germany., Flandre T; Novartis AG, Basel, Switzerland. Electronic address: thierry.flandre@novartis.com.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 Oct 30; Vol. 154, pp. 105729. Date of Electronic Publication: 2024 Oct 30.
DOI: 10.1016/j.yrtph.2024.105729
Abstrakt: 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.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: This publication was developed with the support of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ, www.iqconsortium.org). IQ is a not-for-profit organization of pharmaceutical and biotechnology companies with a mission of advancing science and technology to augment the capability of member companies to develop transformational solutions that benefit patients, regulators and the broader research and development community.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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