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A Protocol for Using Gene Set Enrichment Analysis to Identify the Appropriate Animal Model for Translational Research

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Protecting Human and Animal Health: The Road from Animal Models to New Approach Methods.

Barbara L F Kaplan¹, Alan M Hoberman², William Slikker²

¹Center for Environmental Health Sciences, Department of Comparative Biomedical Sciences, College of Veterinary Medicine, Mississippi State University, Mississippi State, Mississippi (B.L.F.K.); Charles River Laboratories, Inc., Horsham, Pennsylvania (A.M.H.); Retired, National Center for Toxicological Research, Jefferson, Arkansas (W.S.); University of Georgia, Athens, Georgia (M.A.S.); Department of Pharmacological and Biomolecular Sciences, 'Rodolfo Paoletti' Università degli Studi di Milano, Milan, Italy (E.C.); US Environmental Protection Agency, Research Triangle Park, North Carolina (T.B.K.); Dow, Inc., Midland, Michigan (M.S.M.); Howard University College of Medicine, Washington DC (S.K.S.); Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, Maryland (S.C.F.); Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts (M.H.R.); and National Center for Toxicological Research, US Food and Drug Administration, Silver Spring, Maryland (D.L.M.) bkaplan@cvm.msstate.edu.

Pharmacological Reviews

|February 13, 2024

Summary

Animal models are crucial for biological research, but new approach methods (NAMs) are emerging to enhance drug safety and efficacy testing. While NAMs offer promise, a balanced approach integrating both animal studies and NAMs is currently essential for comprehensive health assessments.

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Area of Science:

Biomedical research
Toxicology
Pharmacology

Background:

Animal models have historically been vital for understanding human and animal biology, physiology, and disease.
Concerns exist regarding the sufficiency of animal models for predicting human toxicity and efficacy in drug and chemical safety assessments.
The principles of replacement, reduction, and refinement (3Rs) are driving the development of New Approach Methods (NAMs).

Purpose of the Study:

To provide a balanced perspective on the current use of animal models and NAMs in drug and chemical development.
To evaluate the roles of both traditional animal studies and NAMs in safety, efficacy, and toxicity testing.
To discuss the ongoing transition towards incorporating NAMs in research and regulatory decision-making.

Main Methods:

Review of current scientific literature on animal models and NAMs.
Analysis of the principles of the 3Rs in the context of developing and applying NAMs.
Discussion of the validation and regulatory acceptance of NAMs.

Main Results:

NAMs are technologies and assays focused on the 3Rs to understand drug/chemical effects and mechanisms.
While NAMs show progress, complete replacement of animal models is not yet feasible.
Both animal models and NAMs provide unique, essential data for a comprehensive understanding of biology and health protection.

Conclusions:

Continued development and validation are necessary for widespread regulatory acceptance of NAMs.
A combination of multiple NAM assays may be required to achieve sufficient biological coverage.
Integrating data from both animal models and NAMs is crucial for advancing drug discovery, safety assessment, and protecting human and animal health.