Overview/Mission
OPPTB supports research and research training on the development and use of safe and effective therapeutics for children and pregnant and lactating women.
The branch promotes basic, translational, and clinical research to evaluate and improve the safety and efficacy of multiple types of therapeutics, such as (but not limited to) pharmaceutical drugs, biologics, medical devices, and regenerative tissue constructs. The branch develops and supports comprehensive national efforts to increase the knowledge base for understanding appropriate therapeutic treatment of diseases and conditions during pregnancy, the postpartum period, and lactation, and for children during infancy, childhood, and the transition from adolescence to adulthood. Branch-supported research includes expanding the genomic understanding and phenotypic characterization of drug responses and leveraging advanced multi-omics technologies; novel clinical trial approaches, data science, and artificial intelligence methods; and pharmacometric modeling tools to inform prevention and treatment strategies. The goal of these efforts is to ensure that therapeutics are appropriately tested for dosing, safety, and effectiveness for individuals within the populations of interest. Individualized and precision-medicine approaches are an important component to treating diseases of these populations.
Multiple knowledge gaps regarding the use of therapeutics in children and pregnant and lactating women have led to inadequate labeling and frequent off-label use of prescription drugs and devices. One of the branch's major activities is implementation of the Best Pharmaceuticals for Children Act (BPCA) legislation, which promotes the prioritization of off-patent drugs and therapeutic areas that need further study in pediatrics. The BPCA allows NICHD to sponsor clinical research of the prioritized therapeutics and to disseminate results to improve pediatric drug labeling. The branch is also active in implementing the recommendations of the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC).
- Branch Research Focus and Mission: Addresses gaps in knowledge about pharmacokinetics, pharmacodynamics, pharmacogenomics, outcome measures, and biomarkers of disease prevention and treatment for the safe and effective use of therapeutics for children and pregnant and lactating women
- Advancing Knowledge in Pharmacology and Therapeutics in Pediatric, Obstetric, and Lactating Populations: Expands research to help ensure safety and effectiveness of medications and therapeutics for children and pregnant and lactating women in the prevention, treatment, and management of diseases and disorders
- Translational Research in Maternal and Pediatric Pharmacology and Therapeutics: Supports translational and clinical research to advance precision medicine through the development of novel tools, models, and other technologies
- Enhancing Medical Devices for Children and Pregnant and Lactating Women: Encourages research that will lead to development of medical devices that will adapt to the needs of growing children as well as for obstetric and gynecologic applications
- Best Pharmaceuticals for Children Act (BPCA) : Seeks to improve pediatric therapeutics through non clinical and clinical research that improves knowledge of pediatric medications; examples of activities under this program includes the following:
- Pediatric Trials Network
: Conducts clinical research to improve the knowledge of dosing, safety, and effectiveness of therapeutics used in neonates and older children and inform drug labeling for these populations - T32 Principles of Pediatric Clinical Pharmacology and Therapeutics Lecture Series: Trains a diverse and highly skilled workforce in new technologies and their application to pediatric therapeutics, integration, and synergistic interaction; includes a weekly webinar (from October to June) on topics in pediatric clinical pharmacology
- Pediatric Trials Network
- Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub: Aggregates, presents, and expands available knowledge, tools, and expertise in maternal and pediatric therapeutics to the broader research, regulatory science, and drug development communities; this national resource comprises a Knowledge and Research Coordination Center and Centers of Excellence in Therapeutics
OPPTB supports training and career development opportunities for researchers and clinicians who intend to focus on maternal and pediatric pharmacology.
- Like other DER branches, OPPTB utilizes the following mechanisms:
- Clinical Pharmacology Training Network (CPTN): Seeks to ensure a diverse and highly trained workforce is available in pediatric pharmacology-related clinical and biomedical fields by fostering entry points for aspiring clinician-scientists, cultivating early intellectual curiosity, and maintaining continuity, thus promoting and sustaining career development
- Postdoctoral Training in Pediatric Clinical Pharmacology (F32/T32) Program: Supports postdoctoral research and career development trainees at the clinical pharmacology-biomedical sciences interface to help ensure that a diverse and highly trained workforce is available in pediatric pharmacology
- Pediatric Clinical Pharmacology Research Career Development (K12) Program: Through a national network of mentors and scholars, the program allows scholars to conduct their research independently, while getting formal mentorship and support from national-level clinical pharmacologists, thus ensuring competitiveness for major grant support
Contact Lesly Samedy Bates with questions about OPPTB training and career development opportunities.
Highlights
- Now Available: HEAL KIDS (Knowledge, Innovation, and Discovery Studies) Pain Program. NICHD is leading activities for the KIDS Pain Program, part of NIH's Helping to End Addiction Long-term® Initiative (NIH HEAL Initiative®), through two Requests for Application (RFAs), RFA-HD-24-011 and RFA-HD-24-012. Check out these newly posted Frequently Asked Questions and the recording from a technical assistance webinar related to the KIDS Pain Program and the RFAs on the HEAL Initiative website.
- OPPTB participates in NICHD’s activities related to COVID-19 and leads components related to drug dosing in pediatric COVID-19 patients .
- Developing a Framework to Address Issues for Research Specific to Pregnant and Lactating Women (National Academies): This ongoing effort will develop a framework that enables researchers to address various issues related to research on pregnant and lactating women. Outcomes from this project will complement implementation of PRGLAC recommendations to improve research endeavors and evidence specific to this population. Visit the website to learn more about the project, upcoming and past workshops and meetings, publications, and other details.
- Advancing Bioprinting and Regenerative Medicine Solutions for Obstetric, Gynecologic, and Pediatric Applications Workshop. This workshop, held November 16-17, 2021, was a transdisciplinary discussion on the state-of-the-art of tissue-construct manufacturing using 3D printing of biological, cellular, and tissue-based products (a.k.a., bioprinting) and regenerative medicine in the context of obstetric, gynecologic, and pediatric applications. Visit the meeting page to access recordings from Day 1 and Day 2.
- BPCA Stakeholders Meetings. Access minutes from recent meetings or access the meetings archive for older minutes.
- Rapid Acceleration of Diagnostics Technology (RADx® Tech) for Maternal Health Challenge. This challenge, part of the NIH Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative, prioritizes home-based or point-of-care diagnostic devices, wearables, and other remote sensing technologies to extend postpartum care in regions lacking access to maternity care. Learn about the RADx Tech Challenge winners.
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