# Animal Efficacy and Pharmacometric Modeling Core

> **NIH NIH U19** · UNIVERSITY OF MARYLAND BALTIMORE · 2021 · $994,870

## Abstract

ABSTRACT
 The objective of the multispecies efficacy and pharmacometric modeling core is to serve as a consortium-
wide resource to aid in the development of MCMs for the treatment of ARS and/or DEARE. Core B accomplishes
this objective through the provision of a comprehensive and flexible set of services to bring new and repurposed
medical countermeasures (MCM) towards Investigational New Drug (IND) application for the mitigation and/or
treatment of acute radiation sickness (ARS) and the delayed effects of acute radiation exposure (DEARE) in
victims of radiological or nuclear incidents. Core B has the capability to conduct safety, pharmacology, and MCM
efficacy studies in rabbit, minipig, and non-human primate (NHP) models of total and partial body irradiation. The
Core is led by Dr. Isabel L. Jackson, an associate professor with expertise in the development of rodent, rabbit,
minipig, and NHP models of ARS/DEARE and MCM screening and Dr. Joga Gobburu, PhD, MBA who brings a
broad background in translational medicine to the projects stemming from his experience with hands-on drug
development, and regulatory affairs. The Core has in-house capabilities to monitor hematological and serum
chemistry parameters, conduct routine-coagulation and tissue factor tests, and provide analytical support
services for biomarker identification, species-specific assay development and qualification, and validation. To
ensure the quality and integrity of the data generated, all studies under Core B can be conducted in compliance
with a quality management system that complies with the FDA’s Good Laboratory Practice regulations with
independent Quality Assurance Unit (QAU) oversight as outlined in 21 CFR 58.35. Expertise in advanced
preclinical trial design and statistical and pharmacokinetics (PK) support, including pharmacometric modeling
and simulation for dose/regimen selection and dose-scaling to humans are available. Finally, Core B will
establish a standardized framework for data archiving and a blood and tissue repository to align with the NIH’s
3 R’s for animal reduction, refinement, and replacement in collaboration with the coordinating center core.
Availability of tissue and blood samples from sham-irradiated and total or partial body irradiated animals may be
utilized by the broader CMCR consortium to advance new target identification, medical countermeasure
discovery and development, and biodosimetry technologies.

## Key facts

- **NIH application ID:** 10194366
- **Project number:** 5U19AI150574-02
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Isabel Lauren Jackson
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $994,870
- **Award type:** 5
- **Project period:** 2020-06-16 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10194366

## Citation

> US National Institutes of Health, RePORTER application 10194366, Animal Efficacy and Pharmacometric Modeling Core (5U19AI150574-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10194366. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*
