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ARS, DEARE, and Multiple-organ Injury

A Strategic and Tactical Approach to Link Radiation Effects, Animal Models, Medical Countermeasures, and Biomarker Development to Predict Clinical Outcome

MacVittie, Thomas J.1; Farese, Ann M.1; Kane, Maureen A.2

doi: 10.1097/HP.0000000000001050
COMMENTARY
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1University of Maryland School of Medicine, Baltimore, MD;

2University of Maryland School of Pharmacy, Baltimore, MD.

The authors declare no conflicts of interest.

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MCART Animal Model Series

The collaborative research team identified as the Medical Countermeasures Against Radiological Threats (MCART) Consortium and respected colleagues provided a series of three issues in Health Physics, published in 2012 (volume 103, issue 4), 2014 (volume 106, issue 1), and 2015 (volume 109, issue 5). The research effort was focused on defining strategic and tactical approaches required to clarify the relationship between multiple-organ injury in the acute radiation syndrome (ARS) and delayed effects of acute radiation exposure (DEARE) and to link radiation effects, animal models, medical countermeasures, and biomarker development to predict clinical outcome. The issues reflected the essential requirement of a clinically relevant animal model research platform designed to adhere to the criteria of the US Food and Drug Administration (FDA) guidance document for product development under the FDA’s Animal Rule and the qualification process for drug development tools (US FDA 2014, 2015).

The March 2019 issue of Health Physics focused on ARS, DEARE, and multiple-organ injury as well, providing a strategic and tactical approach to link radiation effects, animal models, medical countermeasures, and biomarker development to predict clinical outcome.

Continuing this topic, the issue herein is focused on two sections: (1) biomarkers— a multidisciplinary approach to predict clinical outcome in nonhuman primate (NHP) and mouse models of ARS and DEARE, and (2) murine models of acute radiation-induced multiple organ injury.

THOMAS J. MACVITTIE

University of Maryland, School of Medicine

Baltimore, MD

tmacvittie@som.umaryland.ed

ANN M. FARESE

University of Maryland, School of Medicine

Baltimore, MD

afarese@som.umaryland.edu

MAUREEN A. KANE

University of Maryland, School of Pharmacy

Baltimore, MD

mkane@rx.umaryland.edu

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Acknowledgments

This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contracts HHSN272201000046C awarded to the University of Maryland School of Medicine and HHSN272201500013I awarded to SRI International.

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REFERENCES

US Food and Drug Administration. Guidance for industry and FDA staff: qualification process for drug development tools [online]. 2014. Available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm230597.pdf. Accessed 20 March 2018.
US Food and Drug Administration. Guidance for industry: product development under the Animal Rule. Washington, DC: US Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CEBR); 2015. Available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm399217.pdf. Accessed 16 February 2018.
© 2019 by the Health Physics Society