Science Inventory

The Road From Animal Models to New Approach Methods for Protecting Human and Animal Health

Citation:

Kaplan, B., A. Hoberman, W. Slikker, M. Smith, E. Corsini, T. Knudsen, M. Marty, S. Sobrian, S. Fitzpatrick, M. Ratner, AND D. Mendrick. The Road From Animal Models to New Approach Methods for Protecting Human and Animal Health. Arkansas Bioinformatics Consortium (AR-BIC) 10TH ANNUAL CONFERENCE Real-World Impact of AI, Little Rock, AR, February 26 - 27, 2024. https://doi.org/10.23645/epacomptox.25621485

Impact/Purpose:

Poster presented to Arkansas Bioinformatics Consortium (AR-BIC) 10TH ANNUAL CONFERENCE 2024

Description:

The Road From Animal Models to New Approach Methods for Protecting Human and Animal Health Barbara L. F. Kaplan1, Alan M. Hoberman2, William Slikker Jr3, Mary Alice Smith4, Emanuela Corsini5, Thomas B. Knudsen6, M. Sue Marty7, Sonya K. Sobrian8, Suzanne C. Fitzpatrick9, Marcia H. Ratner10, and Donna L Mendrick11 1Center for Environmental Health Sciences, Department of Comparative Biomedical Sciences, College of Veterinary Medicine, Mississippi State University, Mississippi State, MS; 2Charles River Laboratories, Inc., Horsham, PA; 3Retired, National Center for Toxicological Research, Jefferson, AR; 4University of Georgia, Athens, GA; 5Department of Pharmacological and Biomolecular Sciences ‘Rodolfo Paoletti' Università degli Studi di Milano, Italy; 6US Environmental Protection Agency; Research Triangle Park, NC; 7Dow, Inc., Midland, MI; 8Howard University College of Medicine, Washington DC ; 9Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD; 10Boston University Chobanian & Avedisian School of Medicine 11Retired, National Center for Toxicological Research, US Food and Drug Administration, Silver Spring, MD Background: There is interest in the use of alternative methods to supplement or supplant animal use in basic biomedical, pharmacological, and regulatory research. New approach methods (NAMs) refer to any technology, methodology, approach, or assay used to understand effects and mechanisms of drugs or chemicals with a focus on the 3Rs. The purpose of this work was to provide a balanced view of the current state of use of animal models and NAMs as approaches to development, safety, efficacy, and toxicity testing of drugs and chemicals. Methods: A working group of toxicology experts from the Scientific Liaison Coalition (SLC) representing academia, industry, and government, used the scientific literature and their experience and expertise to review the state of the science on animal use and NAMs. Results: The working group found that there is historical value in animal use for many biological discoveries. An examination probed successes and challenges in selecting the appropriate animal model for deciphering mechanism of action, identifying adverse effects, or understanding disease processes. Next, we summarized in vitro replacement assays, including the importance of engineered microsystems and newer human cell-based assays that, combined with computational models, advance the potential to improve mechanistic understanding and regulatory decision-making of human toxicity. Finally, we assembled a list of limitations of animal use and NAMs. Conclusions: While it is unlikely that all animal studies will be able to be replaced entirely, with the continued advancement in NAMs, it is possible that NAMs will likely be an important component by which discovery, efficacy, and toxicity testing of drugs and chemicals is conducted and regulatory decisions are made. The participation of biologists, computational modelers, toxicologists, and veterinarians looking at alternatives from a multifactorial perspective will propel the field forward likely using both animal models and NAMs. Disclaimer The SLC is a coalition of more than a dozen scientific, biomedical, and health-based professional societies with the goal of improving public health through a collaborative interdisciplinary approach. The contents and perspectives of this abstract are solely the responsibility of the authors and do not necessarily reflect the views or policies of their employers or SLC member societies.