Considerations from the pharmaceutical industry (IQ MPS affiliate) workshop on animal microphysiological systems and 3Rs in drug development
Most complex in vitro models (CIVM) and microphysiological systems (MPS) are composed of human cells, with the goal of evaluating diseases, efficacy, safety, and pharmacokinetic questions specifically for humans. The hope with CIVM/MPS is that they will eventually improve our predictivity of clinical responses and reduce or replace animal use in research, supporting the 3Rs concept of only using animals in research when necessary. Given the potential of animal-based models to advance this field by comparing existing in vivo animal data with new animal-based MPS responses, there are currently few CIVM and MPS utilizing animal tissues. Animal-based MPS may also have specific utility for cross-species comparisons or species-specific mechanistic questions on zoonotic diseases, and therapies for animals. Animal-based MPS may help expand in-vitro-to-in-vivo correlations, advance the field, and establish confidence in the predictive nature of such platforms. The IQ MPS-FDA workshop provided an interactive venue for pharmaceutical companies and regulatory agencies such as the U.S. Food and Drug Administration (FDA), NC3Rs (UK), Health Canada, NIH/NCATS, NIHS and PMDA (Japan), Danish Medicines Agency, European Commission, NIEHS/NICEATM, HHS, NIST, EURL ECVAM, and the IQ MPS Affiliate, a collaboration of pharmaceutical companies, to jointly discuss considerations of animal-based MPS and applications where animal-based MPS are of potential value.
Authors
- Jason E. Ekert (ORCID: https://orcid.org/0000-0003-4164-1640)
- Paul C. Brown (ORCID: https://orcid.org/0000-0002-2295-4345)
- Myriam Lemmens (ORCID: https://orcid.org/0000-0003-3591-4999)
- Dayton M. Petibone (ORCID: https://orcid.org/0000-0001-7591-2790)
- John P. Gleeson (ORCID: https://orcid.org/0000-0003-2917-6758)
- Reiner Class (ORCID: https://orcid.org/0000-0002-0899-5992)
- Leslie J Valencia (ORCID: https://orcid.org/0000-0001-7110-3187)
- Amy M. Avila
- Anna K. Kopec (ORCID: https://orcid.org/0000-0002-2377-9876)
- Rhiannon N. Hardwick (ORCID: https://orcid.org/0000-0001-9052-1309)
- Qiang Shi (ORCID: https://orcid.org/0000-0002-9030-8572)
- May S. Freag (ORCID: https://orcid.org/0000-0003-1493-945X)
- Manti Guha (ORCID: https://orcid.org/0000-0003-1576-3580)
- Kate Harris (ORCID: https://orcid.org/0000-0002-0663-9302)
- Christine C. Orozco (ORCID: https://orcid.org/0009-0001-4971-5491)
- Ronald L. Wange (ORCID: https://orcid.org/0000-0001-9593-3572)
- Matthew P. Wagoner
- Kevin A. Ford (ORCID: https://orcid.org/0009-0008-6025-6151)
- Jessica A. Bonzo (ORCID: https://orcid.org/0000-0003-2403-9981)
- Robert Geiger
- J Gosset
- Philip G. Hewitt (ORCID: https://orcid.org/0000-0002-2741-3409)
- David M. Stresser (ORCID: https://orcid.org/0000-0002-8577-1714)
- Mayra García
- Donna L. Mendrick
- Tomomi Kiyota (ORCID: https://orcid.org/0000-0002-0862-6441)
- Qun Li (ORCID: https://orcid.org/0000-0002-9128-5405)
- Patrick J. Devine
- Gonçalo Gamboa da Costa
- Nakissa Sadrieh (ORCID: https://orcid.org/0009-0007-7623-7812)
- Chris Hinckley
- Josephine M McAuliffe
- Amy Tran-Guzman
- Francesco Nevelli
Institutions
- Novartis (Switzerland) (CH)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- National Center for Toxicological Research (US)
- United States Food and Drug Administration (US)
- Center for Drug Evaluation and Research (US)
- Pfizer (United States) (US)
- UCB Pharma (United States) (US)
- National Centre for the Replacement Refinement and Reduction of Animals in Research (GB)
- Takeda (United States) (US)
Publication Details
- Journal
- ALTEX
- Published
- 2025-01-01
- DOI
- https://doi.org/10.14573/altex.2503261
- Citations
- 1
- Primary Topic
- Animal testing and alternatives
- Type
- article
- Field-Weighted Citation Impact
- 2.35