The "Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional)" funding opportunity supports exploratory and developmental research projects under the R21 mechanism. This grant aims to advance translational and clinical research that fosters precision medicine for pregnant and lactating women, fetuses, neonates, and children, including those with disabilities. Administered by the National Institutes of Health (NIH), specifically involving the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute on Drug Abuse (NIDA), this funding opportunity seeks to bridge the significant gap in pharmacological and therapeutic knowledge for these underrepresented and vulnerable populations.

The initiative's purpose is to develop and evaluate novel models, tools, devices, and technologies that enhance therapeutic understanding and promote drug safety and efficacy in maternal and pediatric contexts. Projects may include developing pharmacometric models, biologics, and precision dosing systems, and using artificial intelligence and machine learning to refine data analysis in pediatric trials. Research can also investigate pharmacokinetics and pharmacodynamics unique to these populations, and drug transfer through the placenta or breastmilk, and their biological effects.

Funding is intended for projects lasting up to two years, with a total combined direct cost not exceeding $275,000 and a maximum of $200,000 in any single year. The opportunity is open to a wide array of applicants, including higher education institutions, nonprofit organizations, small and large businesses, local and tribal governments, and international entities. The grant supports both new and resubmission applications and does not require cost-sharing.

Applications should conform to NIH’s stringent formatting and submission requirements, including the submission of a Data Management and Sharing Plan and alignment with the NIH Grants Policy Statement. Letters of Intent are encouraged but not required, and should be submitted 30 days prior to the application deadline. Key submission dates include standard NIH due dates, with the earliest submission date being January 16, 2025, and the final expiration date being May 8, 2026.

Evaluation criteria include the significance and innovation of the research, feasibility and rigor of the approach, and qualifications of investigators and institutional environment. Additional attention is given to milestones and timelines, especially for clinical trials. Projects unrelated to maternal or pediatric pharmacology, or those outside the purview of the participating Institutes/Centers, will not be considered.

Applicants are encouraged to reach out to designated scientific contacts to discuss alignment with Institute priorities. Successful applications will contribute meaningfully to the development of safe, effective therapeutics for pregnant and lactating women, children, and those with disabilities, supporting NIH’s broader goals in public health and scientific innovation.