NICHD originally issued a request for applications (RFA) in 2010 to create the Specialized Centers in RPDP, and then recompeted the RFA in 2016. The centers are funded through NICHD's Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB).
Through the centers, OPPTB seeks to:
- Establish predictive nonclinical models including animal studies; cell-, tissue-, and organ-based systems; computational and systems modeling; and integration of signals and information from multiple systems to evaluate response- and age-specific toxicity, particularly neurologic and behavioral effects.
- Establish interdisciplinary approaches that utilize nonclinical approaches integrated with clinical approaches to understand developmentally specific responses and toxicities.
- Perform nonclinical and clinical research to understand mechanisms of age- and development-related changes in metabolism and response to medicinal products.
- Develop age-appropriate outcome measures to determine response or toxicity.
- Incorporate the use of medicinal products as tools to understand developmental metabolism and pharmacology.
- Develop, calibrate, and validate pharmacodynamic (PD) assessments to evaluate response and toxicity for different pediatric populations.
The overall goals for the centers are to:
- Investigate fundamental mechanisms of changes in drug disposition and response from birth through adolescence.
- Provide an arena for multidisciplinary interactions between basic and clinical scientists interested in establishing high-quality translational research programs in pediatric pharmacology.
- Serve as national resource for training and career development of new scientists electing to pursue careers in the conduct of translational research in high-priority areas of pediatric developmental pharmacology.
- Facilitate important community outreach and education efforts to increase awareness and convey the importance and implications of this research.
Sites within the Specialized Centers for RPDP currently aim to:
- Advance clinical and basic pharmacology, pharmacokinetic, and clinical therapeutic knowledge of antimicrobial and anti-inflammatory agents used in infants, children, and adolescents
- Identify the best combinations of biomarkers to predict response and toxicities and evaluate the therapeutic benefit of treating children with life-threatening cancers who are at high risk for severe adverse drug effects
- Increase the body of knowledge on variability in pediatric drug response through genomic- and ontogeny-linked dose individualization and clinical optimization
- Bridge PD biomarkers and clinical outcomes in pediatric inflammatory diseases and investigate novel anti-inflammatory therapies in children to find specific inflammation biomarkers that can be used to monitor therapy
- University of California, San Diego
- Indiana University-Purdue University at Indianapolis
- Children’s Mercy Hospital (Kansas City, Missouri)
- Children's National Medical Center (Washington, DC)
NICHD Contact: Zhaoxia Ren