# Physiologically-Based Pharmacokinetic (PBPK) Modeling of Asthma Drugs during Pregnancy

> **NIH NIH K23** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2024 · $167,001

## Abstract

PROJECT SUMMARY/ABSTRACT
This is an application for a K23 award for Dr. Kathleen M. Job, a clinical pharmacologist and young
investigator pursuing patient-oriented clinical research into how pregnancy and chronic disease
influences drug disposition and action. This K23 award will provide Dr. Job with support necessary for
career development in the following areas: (1) advanced pharmacometric techniques; (2) pregnancy
and maternal-fetal science; (3) clinical trial design and management in pregnant populations; and (4)
leading an interdisciplinary research program. By acquiring these skills, Dr. Job will fulfill her career
goal of becoming an independent investigator who advances clinical care by integrating physiology
and pharmacology into approaches for designing, conducting, and interpreting clinical trials in
pregnant individuals. To achieve these goals, Dr. Job has assembled a mentoring team comprising a
primary mentor, Dr. Kevin Watt, an expert in PBPK modeling in special populations, and co-mentors,
Dr. Torri Metz, a specialist in maternal-fetal medicine and clinical research, Dr. Christina Chambers,
an expert in epidemiology of drugs during pregnancy and health outcomes, and Dr. André Dallmann,
a leader in physiologically-based pharmacokinetic (PBPK) modeling in pregnant populations.
Asthma is the most common chronic condition associated with pregnancy and affects up to 300,000
pregnancies every year in the United States. Asthma drugs are critical for achieving and maintaining
proper control of asthma symptoms. The pharmacokinetics of these drugs can be affected by the
altered physiology and lead to unacceptable drug-related toxicity or treatment failure. Progressive
changes to physiology occur throughout pregnancy. In the current proposal, Dr. Kathleen Job will
determine optimal dosing of two common asthma medications in pregnant individuals. In Aim 1, she
will develop maternal-fetal PBPK models for these asthma medications. In Aim 2, she will evaluate
model predictions with data from prospective clinical pharmacokinetic studies in pregnant individuals
with asthma. In Aim 3, she will develop pharmacodynamic models for the drugs of interest in pregnant
individuals with asthma with data collected as part of the prospective clinical pharmacokinetic studies
in pregnant individuals. Findings will inform a Phase II/III Phase II/III safety and efficacy trial in
pregnant individuals with asthma and build a platform that can be applied to dosing of any drug at any
stage of pregnancy. This research will prepare Dr. Job to design and implement scientifically rigorous
and ethical drug trials in pregnant populations.

## Key facts

- **NIH application ID:** 10985761
- **Project number:** 1K23HD112591-01A1
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** Kathleen Marie Job
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $167,001
- **Award type:** 1
- **Project period:** 2024-07-16 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10985761

## Citation

> US National Institutes of Health, RePORTER application 10985761, Physiologically-Based Pharmacokinetic (PBPK) Modeling of Asthma Drugs during Pregnancy (1K23HD112591-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10985761. Licensed CC0.

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