Funding Opportunity Number: PAR-25-110
Deadline: June 5, 2025, October 5, 2025
Objectives
The objectives of this notice of funding opportunity (NOFO) are to support translational and clinical research to (1) advance precision medicine in pregnant persons and lactating persons, and children/adolescents through the development of novel tools, models, and other technologies that could have a direct clinical or health impact; (2) enhance the understanding of the underlying mechanisms of drug action, including the role of pediatric ontogeny and the dynamic physiological changes that occur during pregnancy, lactation, or the post-partum period; and (3) discover and develop novel therapeutics or enhance the usage of existing drugs or drug repurposing for safer and more effective medications in pregnant, lactating, and postpartum persons, neonates, and children.
The overall goal is to improve safe and effective precision therapeutics for pregnant and lactating persons, fetuses, neonates, and children, including those with disabilities.
Scope
For the purpose of this NOFO, translational research in maternal and pediatric pharmacology and therapeutics encompasses tools, models, biomarkers, other technologies, and new and repurposed therapeutics that drive innovation for the safe and effective treatment of fetal, pediatric, obstetric, and lactating patients, including those with disabilities. Research on the physiological changes that impact drug distribution, effectiveness, and safety in these patients as well as the passage of drug from a from mother to fetus during pregnancy and to child during lactation, including the effects of those drugs on the fetus or child, are within scope of this announcement.
Examples of topics include, but are not limited to, the following:
- Development of a novel device using molecular or other biomarkers to predict drug effectiveness and fetal exposure in pregnant patients diagnosed with hyperemesis.
- Generation and use of machine-learning models to integrate multi-omics biosample data and patient data to guide precision prescribing in pregnant / lactating patients.
- Studies leveraging existing real-world data and bioinformatics to develop and validate in silico models to evaluate repurposed therapeutics to prevent preterm birth.
- Studies utilizing novel biological therapeutics (e.g. genome editors, exosomes, tissue constructs, etc.) to treat severe neonatological conditions impacting multi-organ systems, or studies that develop novel drug delivery systems to treat severe neonatological conditions in utero.
- Developing a precision dosing model that takes into account delayed gastric emptying, altered volume of distribution, and other physiologic changes due to a disabling condition.
- Validation and implementation of multi-drug class pharmacogene platforms for precision prescribing in pediatric patients in general pediatric practice.
- Development and use of microphysiological systems using iPSC-derived placental organoids to assess placental transfer and potential fetal disposition of drugs.
- Development of time-dependent physiologically based pharmacometric models incorporating changes in components of drug metabolism pathways to predict drug exposure changes during the pregnancy and post-partum periods to the pregnant/post-partum mother and fetus/breastfeeding child.
- Generation and validation of systems pharmacology models that evaluate the impact of pediatric ontogeny on drug absorption, distribution, metabolism, and excretion of biological therapeutics.
- Development of a decision-support tool designed to promote informed decision-making and communicate drug safety and risk information to parents/legally authorized representatives of children who are eligible for clinical trials, including those with disabilities.
- Development of machine learning or other tools to facilitate data extraction, harmonization, or interoperability for pediatric clinical trials; development of automated clinical data processing tools for adverse event or outcome assessment in pediatric clinical trials.
- Development of novel drug safety prediction methodologies for neonatal and pediatric patients using pharmacoepidemiologic data.
- Studies evaluating or facilitating the implementation of a label change initiated by the BPCA program into clinical practice.
- Development of pediatric pharmacodynamic measures where PD measures in pediatric populations are currently lacking, incorporating modeling that distinguishes age ranges or other variables.
Applications that are involved in inter- and multi-disciplinary collaborations and interactions are highly encouraged.
For more information, please see the opportunity webpage.