Program seeks Council approval for an initiative titled “Maternal and Pediatrics Precision in Therapeutics Hub (MPRINT)”.
The explosion in biomedical knowledge and the growing number of disease targets dictate the need to reevaluate traditional approaches to pharmacology and therapeutics, in particular how drugs are studied in all children throughout their development and in pregnant and lactating women. There is a pressing need for innovation in therapeutics and for the adoption of disease-oriented and patient-oriented approaches in our populations. Although significant progress in pharmacology has been demonstrated, current models of drug development have not fulfilled the need for a bidirectional feedback of clinical research (outcome measures, endpoints, safety signals) into basic science research such as molecular targets and drug transporters, as well as the translation of basic science findings into clinical research. Additionally, there needs to be an expansion in basic science research that can be translated and systematically integrated into clinical applications in order to address the major gaps in knowledge. Therefore, a team science approach which includes the involvement of subspecialists, clinical trialists, pharmacologists, as well as experts in technology and basic research is needed. A transformation in drug development is at hand.
We propose an integrated program applicable to at least five different branches within NICHD (OPPTB, PPB, PGNB, MPIDB, PTCIB, IDDB) and the National Center for Medical Rehabilitation Research. The Maternal and Pediatrics Precision in Therapeutics Hub (MPRINT) will be designed to be a hub of pharmacology expertise, basic science research, and technology platforms that can be utilized by relevant NICHD clinical trials, investigator-initiated programs, and other NIH-wide clinical programs to advance the development of pharmaco-therapeutics in children and pregnant and lactating women. There are three main goals of the MPRINT program:
- To better Understand Ontogeny: We must find the answers to questions such as the developmental impact on drug targets, transporters, outcome measures and biomarkers first before precision-medicine can be done well.
- To better Conduct Clinical Trials: With improved data validation and data quality we can decrease the rate of failed trials in pediatrics and develop more strategic trial designs in both obstetrics and pediatrics.
- To create Novel Technology platforms that will support and inform obstetric and pediatric therapeutics such as utilization of artificial intelligence in data science research.
Our vision is that this initiative will provide both a hub of expertise in obstetric and pediatric pharmacology (research and trial design), as well as a hub of research activity in addressing therapeutic-focused- gaps in current knowledge about obstetric and pediatric pharmacology.
The ultimate purpose for the program is to create a platform for an integrated approach to pediatric and obstetric therapeutics research to create synergy across our Institute-funded research.
This initiative aligns with the NICHD’s Strategic Plan 2020, particularly Theme 5, which promotes the goal of advancing safe and effective therapeutics and devices for children, pregnant and lactating women, and people with disabilities.
This initiative aligns with the OPPTB’s research priorities to expand the knowledge and training in pharmacokinetics, pharmacodynamics, pharmacogenomics, outcome measures, and biomarkers.
Program Contact
Perdita Taylor-Zapata
Obstetric & Pediatric Pharmacology & Therapeutics Branch (OPPTB)
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