Potential value of animal microphysiological systems

Paul C Brown¹, Barry H Hooberman², Brianna L Skinner³, Claudia Wrzesinski⁴, Dayton M Petibone⁵, Kevin A Ford¹, Kristi Muldoon-Jacobs⁶, Kyung E Sung⁴, Luis G Valerio Jr⁷, Nakissa N Sadrieh¹, Paul C Howard⁸, Peter L Goering⁹, Shelby A Skoog⁹, Suzanne C Fitzpatrick⁶, Tracy Chen³, Tracy C MacGill³, Donna L Mendrick¹⁰

Affiliations

¹ U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
² U.S. Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD, USA.
³ U.S. Food and Drug Administration, Office of the Chief Scientist, Silver Spring, MD, USA.
⁴ U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
⁵ U.S. Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA.
⁶ U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of the Center Director, College Park, MD, USA.
⁷ U.S. Food and Drug Administration, Center for Tobacco Products, Office of Science, Division of Nonclinical Science, Beltsville, MD, USA.
⁸ U.S. Food and Drug Administration, Office of Regulatory Affairs, Rockville, MD, USA.
⁹ U.S. Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
¹⁰ U.S. Food and Drug Administration, National Center for Toxicological Research, Silver Spring, MD, USA.

PMID: 39133010
DOI: 10.14573/altex.2311141

Free article

Potential value of animal microphysiological systems

Paul C Brown et al. ALTEX. 2024.

Free article

. 2024 Aug 7.

doi: 10.14573/altex.2311141. Online ahead of print.

Authors

Affiliations

¹ U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
² U.S. Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD, USA.
³ U.S. Food and Drug Administration, Office of the Chief Scientist, Silver Spring, MD, USA.
⁴ U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
⁵ U.S. Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA.
⁶ U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of the Center Director, College Park, MD, USA.
⁷ U.S. Food and Drug Administration, Center for Tobacco Products, Office of Science, Division of Nonclinical Science, Beltsville, MD, USA.
⁸ U.S. Food and Drug Administration, Office of Regulatory Affairs, Rockville, MD, USA.
⁹ U.S. Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
¹⁰ U.S. Food and Drug Administration, National Center for Toxicological Research, Silver Spring, MD, USA.

PMID: 39133010
DOI: 10.14573/altex.2311141

Abstract

Microphysiological systems (MPS) are designed to recapitulate aspects of tissue/organ physiology in vivo, thereby providing potential value in safety and efficacy assessments of FDA-regulated products and regulatory decision-making. While there have been significant advances in the development, use, and proposals of qualification criteria for human organ MPS, there remains a gap in the development using animal tissues. Animal MPS may be of value in many areas including the study of zoonotic diseases, assessment of the safety and efficacy of animal therapeutics, and possibly reduction of the use of animals in regulatory submissions for animal therapeutics. In addition, the development of MPS from various animal species enables comparison to animal in vivo data. This comparison, while not always critical for all contexts of use, could help gain confidence in the use and application of human MPS data for regulatory decision-making and for the potential identification of species-specific effects. The use of animal MPS is consistent with the replacement, reduction, and refinement (3Rs) principles of animal use by identifying toxic compounds before conducting in vivo studies and identifying the appropriate species for testing.

Keywords: MPS; NAMs; chip; multiple species; regulatory.

Plain language summary

Microphysiological systems (MPS) mimic aspects of organs in humans or animals. These systems may provide information useful for FDA-regulated products. While there have been significant advances in the development of MPS made from human cells, there remains a gap in the development of MPS using animal cells. FDA believes animal MPS may be of value in many areas including the study of diseases transmitted from animals to humans, assessment of the safety and efficacy of animal drugs, and reduction of the use of animals in regulatory submissions. The development of animal MPS enables comparison to data from studies conducted in animals. This comparison provides confidence in the use of human MPS data for regulatory decision-making. The use of animal MPS is consistent with the 3Rs principles of animal use by allowing identification of toxic compounds before conducting animal studies and by helping select the appropriate species for further testing.

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Potential value of animal microphysiological systems

Affiliations

Potential value of animal microphysiological systems

Authors

Affiliations

Abstract

Plain language summary

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