OPPTB supports research and research training on the development and use of safe and effective therapeutics for children and pregnant and lactating people.
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 people 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).
- 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 Persons (National Academies): This ongoing effort will develop a framework that enables researchers to address various issues related to research on pregnant and lactating people. 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.