Opportunity Information: Apply for PA 18 688

The grant opportunity titled "Developmental Pharmacodynamics and Models of Drug Effects in Pediatrics (R01 Clinical Trial Optional)" (Funding Opportunity Number PA-18-688) is a National Institutes of Health (NIH) discretionary grant designed to strengthen the evidence base for how drugs actually work in children across different stages of development. The main focus is developmental pharmacodynamics, meaning the age-related differences in drug effects, response intensity, and mechanisms of action in pediatric patients. The FOA is looking for multidisciplinary, investigator-initiated projects that can span basic science, translational work, and clinical research, with the goal of generating practical, defensible data that improves how clinicians choose and dose therapies for infants, children, and adolescents.

A central aim of this announcement is to support studies that build and solidify pharmacodynamic data across pediatric age groups and connect those findings to pharmacokinetic-pharmacodynamic (PK-PD) relationships for drugs used in children. In practical terms, applicants are encouraged to propose research that links what the body does to a drug (pharmacokinetics, such as absorption, distribution, metabolism, and elimination) to what the drug does to the body (pharmacodynamics, such as physiologic effects, biomarker changes, and clinical outcomes). Because children are not simply "small adults," the FOA emphasizes the developmental angle: maturation of organ systems, changing receptor expression, evolving immune and endocrine function, and age-dependent disease biology can all shift drug response in ways that standard adult-derived models cannot reliably predict. The opportunity supports projects that can clarify these age-related response patterns and develop or refine models of drug effects that are truly pediatric-relevant.

The mechanism is an R01, which typically funds substantial, hypothesis-driven research programs rather than pilot-only efforts. The "Clinical Trial Optional" designation indicates that applicants may propose clinical trials if appropriate, but a clinical trial is not required. This allows projects to range from laboratory-based mechanistic studies and modeling work to translational studies using pediatric specimens or opportunistic sampling, as well as clinical investigations where drug effects and response markers are measured directly in pediatric participants. The expectation is that funded work will help determine, improve, or validate PK-PD relationships in children, which can ultimately support safer and more effective dosing strategies, better therapeutic monitoring approaches, and improved clinical decision-making for pediatric drug therapy.

Eligibility is broad and includes many types of domestic organizations and governmental units. Eligible applicants listed include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other entities. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations. This broad eligibility structure is meant to encourage participation from diverse institutions and communities, which matters in pediatrics because disease burden, treatment access, and medication response can vary across populations and settings.

Administratively, the opportunity is under the NIH with CFDA number 93.865 and falls within the funding activity category "Health, Income Security and Social Services." The FOA was created on 2018-03-01, and the original closing date listed is 2021-05-07. The source data provided does not specify an award ceiling or the expected number of awards, so applicants would typically look to the full FOA text and NIH institute/center budgets or paylines for practical expectations around project scale and competitiveness. Overall, the program is aimed at filling persistent knowledge gaps in pediatric drug response by supporting research that can explain and predict developmental differences in pharmacodynamics and establish stronger PK-PD evidence for therapies commonly used in pediatric care.

  • The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Developmental Pharmacodynamics and Models of Drug Effects in Pediatrics (R01 Clinical Trial Optional)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
  • This funding opportunity was created on 2018-03-01.
  • Applicants must submit their applications by 2021-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, For-profit organizations other than small businesses, Small businesses, Others.
Apply for PA 18 688

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