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The Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB), formerly the Obstetric and Pediatric Pharmacology Branch (OPPB), promotes basic, translational, and clinical research to improve the safety and efficacy of therapeutics, primarily pharmaceuticals and to ensure centralization and coordination of research, clinical trials, and drug development activities for obstetric and pediatric populations.
The Branch is responsible for developing and supporting a comprehensive national effort to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, infancy, childhood, and adolescence using therapeutic approaches including medications that are appropriately tested within their target populations.
Implementation of the Best Pharmaceuticals for Children Act (BPCA) activities at the NICHD is among the major activities for the Branch.
New: Research Priorities
Developmental Pharmacology and Pathophysiology of Pregnancy
Gap: A requirement for the development of safe and efficient medications for children and pregnant women is knowledge of mechanisms of drug action (pharmacokinetics, pharmacodynamics, pharmacogenomics) in these populations and in their pre-clinical models that will lead in decrease the risks of adverse events and toxicity.
Priority: Support developmental pharmacology initiatives and initiatives that explore mechanisms of drug action in pregnant women. Critical areas include pain management in neonates and pregnant women, treatment of Type 2 and gestational diabetes), and preterm birth.
New Drug Development and Drug Repurposing
Gap: There is currently a lack of safe and efficient medications for children and pregnant women. In fact, children have often been named the pharmaceutical orphans.
Priority: Support projects to identify of drug targets for children and pregnant women for conditions specifically relevant to these populations, including (but not limited to) neonatal/pediatric pain, rare diseases, Type 2 and gestational diabetes, preterm labor, and preeclampsia. Use these targets to develop new drugs or repurpose appropriate old drugs.
Novel Alternatives to Traditional Pediatric and Obstetric Clinical Trials
Gap: Significant hardship in the design and execution of pediatric and obstetric clinical trials, secondary to ethical obstacles.
Priority: Support initiatives to develop innovative approaches and algorithms to predict drug safety and effectiveness in children and pregnant women. This includes modeling and simulation methods, and advanced methods of utilizing existing data, such as electronic medical records.
Outcome Measures for Pediatric and Obstetric Clinical Trials
Gap: Outcome measures and biomarkers that reflect diseases/conditions and predict drug safety and effectiveness in children and pregnant women are lacking.
Priority: Support initiatives for the identification of outcome measures and biomarkers in this population. Outcome measures and biomarkers related to pain, sedation, Type 2 and gestational diabetes, and acute kidney injury would be highly relevant.
Gap: Appropriate formulations for pediatric populations remain elusive or absent.
Priority: Support initiatives for the development of palatable and safe (i.e., without harmful excipients) formulations for children.
Gap: Development of non-drug therapeutics, such as devices, is needed to improve therapeutic treatment for the fetus and for children.
Priority: Support development of non-invasive drug delivery systems and devices to measure drug safety or efficacy non-invasively.