Program seeks Council approval for the “Maternal and Pediatric Precision in Therapeutics (MPRINT)” initiative. MPRINT will aggregate, expand, and present the existing knowledge, tools, and expertise in maternal, lactation, and pediatric therapeutics, ultimately benefiting the broader research, regulatory science, and drug development communities. This initiative is designed to advance progress in these underrepresented areas, complementing and advancing ongoing MPRINT efforts.
Advances in therapeutic discovery, development, and precision medicine for pediatric, pregnant, and lactating populations have historically lagged in comparison to non-pregnant adults. Studies supporting therapeutics in these populations are often small and in isolation. Integration and application of data from various studies will augment clinical trial innovation and the use of real-world evidence will, together, address key gaps in understanding. The MPRINT initiative will facilitate this integrative approach by consolidating existing knowledge, supporting innovative clinical trial design, incorporating pharmacogenomic knowledge around individual heterogeneity thus catalyzing research in maternal and pediatric precision therapeutics and progress in these critical areas of healthcare.
Specialized MPRINT Centers will provide the expertise, research platforms, and technological resources necessary to support innovative NICHD clinical trials, investigator-initiated programs, and other NIH-wide efforts and disseminate information from key findings. The primary goals of the next iteration of MPRINT are:
- Consolidate and Curate Educational Resources for therapeutics-focused research in these Special Populations
- Facilitate NICHD Coordination of Multisite Clinical Therapeutic Trials
- Advance Biosample Research, Focusing on Genomics and Human Milk
- Leverage Real-World Evidence to Strengthen Mother-Baby Linkage
- Apply Real-World Data Approaches to Address Key Knowledge Gaps
- Promote PBPK Modeling for Safer, Cost-Effective Trials
The program's focused scope will strengthen integration with the NICHD multisite network, supporting drug prioritization efforts, including the Best Pharmaceuticals for Children Act (BPCA) and Research Specific to Pregnant and Lactating Women (PRGLAC) Taskforce, as well as the consolidation of resources for including pregnant and lactating women in clinical trials.
This redesigned initiative proposes the enhancement of MPRINT Centers, where focuses will include:
- Integration of existing ontologies to enhance knowledge gap identification and the development of predictive tools, advancing our understanding of maternal and pediatric pharmacology.
- Addressing knowledge gaps relating to effects of medication classes on human milk composition and their potential effects on human milk quality and infant outcomes (scientific areas of four DER Branches: OPPTB, MPIDB, PGNB and PPB)
- Example: Responsibility for curating the LactMed™ database, enhancing its utility in clinical settings.
- Leveraging NICHD’s multisite network biosamples and data as well as MPRINT’s analytical capabilities to specifically address the lack of clinical data and evidence in pediatric and maternal pharmacogenomics.
This initiative aligns with the NICHD's Strategic Plan 2020, particularly Theme 5, which focuses on advancing safe and effective therapeutics and devices for children, pregnant and lactating women, and individuals with disabilities. It supports the mandates of the BPCA legislation and addresses several of the PRGLAC Taskforce efforts. It also addresses many of Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)'s research priorities and the priorities of other NICHD branches (MPIDB, PGNB and PPB).
Alignment with HIV/AIDS priorities:
This proposed concept aligns with the NICHD’s research focus on the “treatment of HIV/AIDS in infants, children, adolescents, and women, including pregnant and breastfeeding women”, as well as MPIDB’s research priority on emerging and re-emerging infectious diseases that affect pregnant women, infants, children, and adolescents.
The MPRINT initiative has the potential to accelerate HIV/AIDS research through multidisciplinary collaborations and innovative approaches, enhancing prevention, treatment, and outcomes, especially for vulnerable populations. Key efforts include knowledge base tools & resources, pharmacometric analyses in anti-infective drug development, and studies on the effects of anti-infective agents on human milk composition.
For renewal concepts:
Currently, MPRINT functions as a central hub for integrated research, driving progress in therapeutic-focused research and addressing critical gaps in maternal and pediatric therapeutics. By fostering a collaborative environment that bridges basic and clinical science, MPRINT creates synergies across Institute-funded initiatives, paving the way for the development of safe and effective therapeutics for maternal and pediatric populations. Key outcomes of the current MPRINT initiative include:
- Development of the Knowledge Base (KB), serving as a comprehensive resource for accessing vital data and tools related to maternal and pediatric therapeutics, including pharmacokinetics, pharmacodynamics, pharmacogenetics, pediatric ontogeny, and the physiological changes associated with pregnancy and lactation. This resource plays a critical role in the prioritization efforts for PRGLAC and contributes significantly to BPCA initiatives, advancing therapeutic development for these populations.
- Development of investigator-proposed Optional Core focusing on real-world evidence (RWE) has been leading efforts on mother-baby record linkage and identifying lactation in electronic health records (EHRs) across the MPRINT Hub.
- Development and refined protocols for conducting clinical studies, validated mouse models, and published multiple significant papers. One of the key findings was a surprising discovery that certain drug classes can impact human milk composition and microbiome diversity, adding an important dimension to our understanding of drug effects on lactating mothers and infants.
- Development of pediatric PheCODEs and the development of algorithms to track maternal opioid use. Work in pharmacogenomics (PGx) outreach has been validated through video-based education, and ongoing clinical studies continue to expand knowledge in this critical area of research.
- Development of the Collaborative Online Perinatal & PEdiatric Repository (COPPER), a resource designed to gather and compile information on maternal and pediatric-focused biobanks, as well as residual biospecimens from existing studies, with the aim of facilitating their use in future research initiatives. A 1-yr supplement as part of OPPTB’s overall biomarker discovery, validation, and qualification strategy.
While we can only provide a brief overview of the significant progress made by all components of the MPRINT Hub over the past three years, a comprehensive record of its advancements, including publications and deposited data/resources, can be accessed on the MPRINT Hub website.
Program Contact
Lesly Samedy-Bates
Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)
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