Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional)

Grants to USA, Canada, and International IHEs, agencies, nonprofits, and for-profits for research projects relating to the use of pharmaceuticals in children and pregnant women. Applicants are advised that required registrations may take several weeks to complete. Funding is intended for research that will determine safe and effective medications for the target populations.
The objectives of this funding opportunity announcement (FOA) are to support basic, translational and clinical research to (1) advance the understanding of underlying mechanisms of drug action; (2) discover and develop novel therapeutics; (3) enhance the usage of existing drugs or drug repurposing for safer and more effective medications in pregnant and lactating women and children. The overall goal is to improve safe and effective precision therapeutics for pregnant and lactating women and for neonates and children.Proposed research activities should also align with the OPPTB’s research priorities to expand the knowledge in pharmacokinetics, pharmacodynamics, pharmacogenomics, biomarkers, new drug development and drug repurposing for the treatment of maternal and pediatric diseases.Knowledge deficits in maternal and pediatric pharmacology may require interaction between disciplines, in which case a multiple integrated and interactive research team to address interrelated research areas are encouraged.For the purpose of this FOA, maternal and pediatric therapeutics is defined to encompass:Therapeutic treatment of obstetric and breastfeeding conditions;Physiological changes that occur in a woman’s body during pregnancy, the post-partum period, and during lactation that impact the distribution or effects of administered therapeutics;Passage of drug from mother to fetus during pregnancy and to child during breastfeeding, including the effects of those drugs on the fetus or child;Therapeutic treatment of pediatric disease, particularly where there are unique pediatric conditions or pharmacodynamic differences from adult disease;Physiological changes that occur across the entire spectrum of pediatric development from birth through adolescence that impact the distribution or effects of administered therapeutics.Applications that apply scientific discoveries generated from the basic science laboratory and preclinical studies to clinical studies/trials in maternal and/or pediatric populations are appropriate for this FOA.