Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional)

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.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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.

• City or township governments
• County governments
• For profit organizations other than small businesses
• Independent school districts
• Native American tribal governments (Federally recognized)
• Native American tribal organizations (other than Federally recognized tribal governments)
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• Private institutions of higher education
• Public and State controlled institutions of higher education
• Public housing authorities/Indian housing authorities
• Others (see text field entitled "Additional Eligibility Criteria" for clarification)
• Small businesses
• Special district governments
• State governments