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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This notice is to inform the research community that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) seeking applications that will establish Translational Research Resource Platforms to facilitate, support, and conduct therapeutic-focused research for maternal and pediatric populations. As part of the Maternal and Pediatric Precision in Therapeutics (MPRINT) initiative, this FOA will focus on resource platforms to support concerted multidisciplinary team science efforts that leverage existing and prospective resources (biobanks, biological sample repositories, omics data, tissue specific genomic/epigenomic atlases, EHRs, etc.) and develop innovative technologies and analytic tools to advance therapeutic research for maternal and pediatric precision therapeutics.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in Summer 2022 with expected due date in Winter 2022.

This FOA will utilize the U24 (Clinical Trial Not Allowed) activity code. As this is a cooperative agreement, awardees are expected to work with NICHD program staff and collaborate with ongoing and future NICHD-supported networks. Details of the planned FOA are provided below.

BACKGROUND

The rapidly evolving biomedical research with emerging technologies has enabled translational research to fill the gap between basic and clinical research and facilitate the transfer of scientific discoveries into clinical practices. However, there remain significant knowledge gaps and unmet needs in effective prevention and treatment of many pregnancy complications and associated adverse outcomes (i.e., preeclampsia, preterm birth, stillbirth) as well as pediatric conditions at different development stages. The accumulation of biological samples and datasets from ongoing research networks have increased the need to create research resource platforms for translational research to advance safe and effective therapeutics in maternal and pediatric populations. There is also a need for tools to transform these data into usable knowledge, such as biomarkers, to advance precision therapeutics for maternal and pediatric diseases and conditions.

Biomarkers are essential components of translational research in identifying targeted therapies aiming to enable precision therapeutics. There are different types of biomarkers including, for example, molecular, imaging, physiologic, and digital biomarkers. Such biomarkers can have many applications such as serving as patient-specific measurable indicators of normal biological processes or responses to therapeutic interventions. Some examples of biomarker utility are facilitating the evaluation of therapeutic intervention on disease severity and progression, stratifying patients into risk categories, improving clinical trial outcome measures. Moreover, biomarkers can serve as predictive indicators of drug safety and toxicity as well as provide guidance to drug dosing in individual patients.

Biological samples and phenotypic data collected from clinical research and trials are rich resources for translational research to identify and validate novel and high-quality biomarkers that will accelerate the discovery of new drugs and targets, facilitate risk stratification for clinical trials, and provide predictive diagnostics and treatment responses for personalized medicine. For example, the biological samples that were collected from pregnant women across pregnancy and linked to clinical data of the mothers and their newborns will be a valuable resource to discover novel preventive, diagnostic, and therapeutic biomarkers and that could potentially advance the development of preventive strategies and novel drugs for precision therapeutics in maternal and pediatric populations.

The MPRINT Hub was recently established by NICHD and primarily focuses on aggregating, presenting, and expanding the available knowledge, tools and expertise in maternal and pediatric therapeutics research. This FOA, as part of MPRINT initiative, aims to develop translational research resource platforms to advance maternal and pediatric therapeutics research through leveraging existing and prospective resources through collaborative multidisciplinary team science efforts. The TRRPs will work with the MPRINT Knowledge and Research Coordination Center on the implementation and dissemination of data and tools. The TRRP awardees are expected to attend the MPRINT annual and other regular meetings.

RESEARCH OBJECTIVES AND SCOPE

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.

The objectives of this FOA are to support multidisciplinary groups of researchers to conduct collaborative, team-based science utilizing cutting-edge technologies and adapting innovative approaches to:

• Develop analytic tools and lab platforms to advance precision therapeutics in maternal and pediatric populations.
• Enable and accelerate the discovery of biomarkers with translational potential for therapeutic targets of maternal or pediatric conditions.
• Validate and support the qualification of biomarkers for maternal and pediatric conditions.

Applicants are encouraged to form collaborations with NIH supported research networks, such as the Maternal Fetal Medicine Units Network (MFMU), Neonatal Research Network (NRN), Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (NuMoM2b), International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) and Pediatric Trials Network (PTN), and leverage existing resources (e.g., biobanks, biospecimen repositories, omics data, tissue specific genomic/epigenomic atlases and EHRs). Applicants are also encouraged to explore collaborations with groups that are experienced in the use of public-private partnerships (PPPs) to advance the qualification of drug development tools, such as the Foundation for the NIH’s Biomarker Consortium (https://fnih.org/our-programs/biomarkers-consortium).

Examples of translational resource platform-related activities suitable for this FOA, include, but are not limited to:

• Discover or validate novel biomarkers using real-world data (RWD) for patient stratification, targeted therapies, and/or drug safety prediction.
• Discover and validate biomarkers of novel therapeutic potentials or predicting adverse pregnancy outcomes (i.e., pre-eclampsia, preterm birth).
• Develop informatics tools or utilize systems approaches, especially artificial intelligence tools, that integrate various types of data, including genomic, proteomic, metabolomic, or phenotypic data, to support the identification and validation of biomarkers in advancing precision medicine.
• Develop common analytic platforms and perform analysis of existing biological samples addressing high priority questions for translational and therapeutic research
• Generate data and support filing for regulatory qualification of a biomarker with the FDA.
• Develop innovative strategies to identify and fill gaps in biological samples and data collections.
• Develop models/algorithms evaluating potential targets and toxicities of novel therapeutic strategies for pregnant, lactating, and pediatric populations.

TBD

Applications are not being solicited at this time.

Please direct all inquiries to:

Zhaoxia Ren, M.D., Ph.D.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

301-402-9340

[email protected]