# Pediatric and Developmental Pharmacology for Inflammatory and Infectious Diseases

> **NIH NIH P50** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2020 · $711,940

## Abstract

OVERALL PLAN ABSTRACT
For our UC San Diego Research in Pediatric Developmental Pharmacology (RPDP) Center, we propose the
innovative, cross-disciplinary program entitled “Pediatric and Developmental Pharmacology for Inflammatory
and Infectious Diseases”. The overall goal of the UC San Diego RPDP Center is to advance the knowledge of
clinical and basic pharmacology, pharmacokinetics (PK) and clinical therapeutics of antimicrobial and anti-
inflammatory agents in infants, children and adolescents. The UC San Diego RPDP brings together leading
experts in pediatric clinical pharmacology, PK/pharmacodynamics (PD) computational modeling, infectious
disease therapeutics, quantitative drug assay development, microbial pathogenesis, innate immunity,
microbiome, metabolomics, and developmental cell biology to provide a robust, multifaceted analysis of the
important and complex issues under study. Building upon an extensive track record of accomplishments in
basic and clinical infectious disease and pharmacology research (former NICHD-funded Pediatric
Pharmacology Research Unit for 16 years and most recently as an RPDP Center), the UC San Diego RPDP
will continue to provide a robust scientific, clinical and organizational infrastructure with a highly functioning
Administrative Core whose strong Clinical Pharmacology Section will support and execute the proposed
Projects and highly successful Outreach and Training Section will help educate the next generation of pediatric
pharmacologists. The UCSD RPDP Center will conduct non-clinical, clinical and translational studies that
interconnect as they evaluate anti-inflammatory therapies and maturational changes in drug disposition, drug
effects, and drug safety. Project 1 (clinical study) will evaluate the safety, PK and PD-biomarker relationships
of anakinra, an anti-inflammatory IL-1 pathway blocker, in a Phase I/IIa dose escalation study in infants and
children with acute Kawasaki disease and coronary artery damage. Project 2 (basic project tied to Project 1)
provides a highly-innovative PD study of anti-inflammatory therapies (including anakinra) prescribed to children
upon the host-microbe interactions, notably susceptibility to common pediatric infections. Project 3 will focus on
understanding the functional maturation of renal drug clearance of anti-inflammatory therapies (and thus also
tie into Project 1) and will develop renal organoids from human human pluripotent stem cells to characterize
developmental changes in transporter markers and activity. The Pilot Project, which brings together world-
renowned basic scientists with an NIH new investigator, assesses the microbiome and metabolomic changes
in cystic fibrosis patients newly colonized with Pseudomonas treated with a short-course of azithromycin. Thus
the UC San Diego RPDP Center will integrate highly productive basic scientists and state-of-the-art non-clinical
laboratory facilities with pharmacometricians and clinician-researchers to improve our ...

## Key facts

- **NIH application ID:** 9970233
- **Project number:** 5P50HD090259-05
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** EDMUND Vincent CAPPARELLI
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $711,940
- **Award type:** 5
- **Project period:** 2016-09-20 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9970233

## Citation

> US National Institutes of Health, RePORTER application 9970233, Pediatric and Developmental Pharmacology for Inflammatory and Infectious Diseases (5P50HD090259-05). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9970233. Licensed CC0.

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