We are interested in applications that align with the following research priorities. For more information about NICHD’s research themes, cross-cutting topics, and aspirational goals, visit the plan’s Scientific Research Themes and Objectives.
Understanding Differences and Heterogeneity in Pediatric Disease Treatment
Strategic Plan Theme 5: Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities
Strategic Plan Aspirational Goal: Facilitate application of precision medicine approaches in children
Gap: There is a lack of safe and effective therapies for many pediatric conditions. This is driven by a poor understanding of how drug action and pathophysiology differ for pediatrics versus similar conditions in adults and how individual factors (e.g., developmental stage genomics and microbiome) contribute.
Priority: Research to quantitatively understand differences in drug action and related pathophysiology between childhood and adult disease and conditions unique to pediatrics. This includes developing tools (e.g., biomarkers, outcome measures, and physiologically based pharmacokinetic/pharmacodynamic models) to support pediatric drug discovery and development and to facilitate the application of precision medicine approaches in children. NICHD considers applications for pediatric conditions that have significant efforts at other NIH institutes (e.g., pediatric oncology, juvenile diabetes) to be of lower programmatic priority.
Pharmacology and Pathophysiology of Pregnancy
Strategic Plan Theme 5: Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities
Strategic Plan Aspirational Goals: Identify genomic changes and exposure risks that explain or predict fetal loss; Use understanding of immune factors in pregnancy and placental development to determine reasons for pregnancy rejection
Gaps: There is a lack of effective and safe therapies for conditions that arise during pregnancy or for existing co-morbidities that contribute to high rates of maternal morbidity and mortality. A key requirement for the advancement of therapeutics that can restore the foundation for healthy pregnancies is understanding how drug action is altered during normal pregnancy, the post-partum period, and lactation.
Priority: Developmental pharmacology research and approaches that explore the intersections of physiological changes in women and during fetal development with drug action (e.g., pharmacokinetic, pharmacodynamics, and pharmacogenomics) and with molecular pathways that may serve as novel therapeutic targets for disease-modifying therapies specific to these populations. Critical areas include pain management in pregnant and lactating women and treatment of gestational diabetes, preeclampsia, and prevention of preterm delivery.
Novel Alternatives to Traditional Pediatric and Obstetric Clinical Trials
Strategic Plan Theme 5: Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities
Strategic Plan Aspirational Goal: Facilitate application of precision medicine approaches in children
Gap: Significant challenges exist in the design and execution of pediatric and obstetric clinical trials, including recruitment, retention, and ethical concerns, among others.
Priority: Development of innovative approaches and algorithms to determine drug dosing, safety, and effectiveness in children and in women during pregnancy and lactation. This includes artificial intelligence-driven modeling and simulation methods, novel approaches to utilizing existing data and archived biosamples/biospecimens, and pragmatic trials.
Population- and Individual-Specific Diagnostic and Therapeutic Devices
Strategic Plan Theme 5: Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities
Strategic Plan Aspirational Goal: Facilitate application of precision medicine approaches in children
Gap: There is a lack of devices to support diagnosis, drug delivery, and non-drug therapy appropriate for use in neonates, children, and pregnant and lactating women.
Priority: Development of devices specific to these populations, accounting for individual differences, that can advance precision medicine through individualized diagnosis, drug delivery, and non-drug therapy. This may include 3D bioprinting, AI-driven diagnostic and decision-making tools, novel drug delivery devices, and formulations.
New Uses for Drugs, Biologics, and Other Therapeutics
Strategic Plan Theme 5: Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities
Gap: There is a lack of safe and effective medications for children and pregnant women. This is partially due to the historical lack of inclusion of these populations across the drug development process.
Priority: Research and the development of approaches and technologies to identify drugs, biologics, pharmaceutical assets, etc., that may have new therapeutic uses for pediatric conditions or in pregnant and lactating women. This includes the development and use of preclinical experimental models (e.g., animal models and human biomimetics) and computation models or the accumulation of real-world evidence in support of new therapeutic uses.