Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)


OPPTB 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 evidence-based therapeutic approaches. The goal of this effort is to assure that medications are appropriately tested for dosing, safety, and effectiveness within their target populations.

Multiple gaps in knowledge regarding the use of therapeutics in children and pregnant women have resulted in inadequate labeling and frequent off-label use of prescription drugs in these two populations. One of the branch's major activities is implementation of the Best Pharmaceuticals for Children Act (BPCA). The BPCA legislation promotes the prioritization of off-patent drugs that need further study in pediatrics and allows NICHD to sponsor clinical research of the prioritized therapeutics and disseminate results to improve drug labeling. 

New Drug Development and Drug Repurposing

Gap: There is currently a lack of safe and efficient medications for children and pregnant women. In fact, both populations, have often been considered pharmaceutical "orphans."

Priority: Support projects to identify drug targets for children and pregnant women for conditions specifically relevant to these populations, including neonatal/pediatric pain, rare diseases, infectious diseases, cardiovascular disease (including hypertension), Type 2 and gestational diabetes, pulmonary disease (including bronchopulmonary dysplasia), preterm labor, and preeclampsia. These targets can be used for the development of new drugs or to repurpose appropriate existing drugs.

Novel Alternatives to Traditional Pediatric and Obstetric Clinical Trials

Gap: Significant hardship exists in the design and execution of pediatric and obstetric clinical trials, secondary to many obstacles including recruitment, retention, and ethical concerns.

Priority: Support initiatives to develop innovative approaches and algorithms to predict drug dosing, safety, and effectiveness in children and in women during pregnancy and lactation. This includes modeling and simulation methods and advanced methods of utilizing existing data, such as electronic medical records.

Developmental Pharmacology and Pathophysiology of Pregnancy

Gap: A requirement for the development of safe and efficient medications for pregnant and lactating women is the knowledge of mechanisms of drug action (pharmacokinetics, pharmacodynamics, pharmacogenomics) in these populations and in their preclinical models to decrease the risks of adverse events and toxicity.

Priority: Support developmental pharmacology initiatives and initiatives that explore mechanisms of drug action in pregnant and lactating women. Critical areas include pain management in neonates and pregnant women, treatment of Type 2 and gestational diabetes, and preterm birth. 

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 and lactating 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.

Pediatric Formulations

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.

Therapeutic Devices

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.

  • Rohan Hazra, Acting Branch Chief
  • Cenia Davis, Administrative Assistant
  • George Giacoia, Medical Officer
    Main Research Areas: Developmental pharmacology; pharmacology biomarkers; drug delivery systems and formulations; mechanisms of adverse drug reactions in children; training
  • Zhaoxia Ren, Medical Officer
    Main Research Areas: Pharmacoepidemiology: pediatric and obstetric; obstetric pharmacology
  • Perdita Taylor-Zapata, Medical Officer
    Main Research Areas: Pediatric medicine; pharmacology: pediatric clinical trials design and implementation
  • Katerina Tsilou, Medical Officer
    Main Research Areas: Pediatric medical devices; pediatric pharmacogenetics and personalized medicine


  • Pediatric Pharmacology Training in the United States: At the most recent T32 Fellows' meeting, OPPTB's Dr. George Giacoia discussed NICHD's efforts to enhance the pediatric pharmacology program through effective collaborations and innovative research projects. 
  • Primary Pediatric Hypertension Workshop: OPPTB sponsored a stakeholder workshop at 6710B Rockledge Drive, Bethesda, Maryland, on September 25, 2017. The meeting highlighted the gaps in current treatment guidelines on pediatric hypertension.
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