Research
Pediatric Pharmacology Research and Development Center
Children’s Medical Center of Dallas
Background
Researchers from the TTUHSC School of Pharmacy have collaborated with the Department of Pediatrics at the University of Texas Southwestern Medical Center (UTSWMC) to support their NIH proposal for establishing a Pediatric Pharmacology Research Unit (PPRU) at the Children’s Medical Center of Dallas. This proposal was funded January, 2004, and UTSWMC’s PPRU is part of a nationwide network to conduct clinical research for pediatric pharmaceutical labeling.
Development of pediatric pharmaceuticals requires both preclinical and clinical research. The capability for preclinical research was not part of the PPRU network. As a result, the School of Pharmacy developed a proposal with the collaboration of UT-Southwestern and Children’s Medical Center to establish a preclinical research group to support the PPRU network and conduct industrially and federally sponsored research. Such a capability will provide added value to pediatric pharmaceutical clinical research and clearly differentiate UTSWMC’s PPRU.
Funding for the Pediatric Pharmacology Research & Development Center (PPRDC) was obtained in part from the School of Pharmacy Center for Research Excellence Awards (October, 2003). The primary function of the PPRDC is to conduct preclinical research that is required for pediatric pharmaceutical labeling. The Center’s early stage analytical laboratory will support such research and development.
PPRDC Features
- Center located at the Children’s Medical Center of Dallas
- Center is a core laboratory for Texas Tech University Health Sciences Center researchers
- Center collaborates with faculty and staff at Children’s on pediatric pharmacology-related research & development
- Center laboratory
-
- GLP compliant
- cGMP compliant
- 21 CFR Part 11 compliant
Key PPRDC Faculty
PPRDC Program Director
Richard Leff, PharmD
Professor & Regional Dean
TTUHSC School of Pharmacy – D/FW
PPRDC Laboratory Director
Trey Putnam, PhD
Assistant Professor
TTUHSC School of Pharmacy – D/FW
PPRDC Pharmaceutical Consultant
Reza Mehvar, PhD
Professor
TTUHSC School of Pharmacy – Amarillo
PPRDC Research Associate
Sarah Swenson
TTUHSC School of Pharmacy – D/FW
PPRU Principal Investigator
George McCracken, MD
Professor of Pediatrics
GlaxoSmithKline Distinguished Professor of Pediatric Infectious Disease
The Sarah M. and Charles E. Seay Chair in Pediatric Infectious Disease
U Texas Southwestern Medical Center at Dallas
Chief of Pathology – Children’s
Beverly Rogers, MD
Professor of Pathology
U Texas Southwestern Medical Center at Dallas
Specific PPRDC Aims
The aims of the PPRDC parallel the aims of the PPRU to:
- Conduct studies of
-
- Bioavailability
- Formulations
- Drug Metabolism
- Pharmacokinetics/dynamics
- Gather and promote accrual of clinical data for pediatric age-specific labeling of drugs
- Conduct research on novel and innovative approaches in pediatric pharmacology
- Develop and apply pharmacogenomic tools for conducting pharmacology clinical trials
- Develop proteomic tools in clinical studies
- Provide training in clinical and developmental pharmacology
PPRDC / PPRU Synergy
- The PPRDC specific aims parallel PPRU aims
- PPRDC provides analytical capabilities in compliance with FDA guidelines
- PPRU provides clinical research capabilities in compliance with FDA guidelines
- Combined expertise of PPRDC and PPRU investigators provides the critical skills to facilitate pediatric pharmaceutical development
- Pediatric “molecule to market” concept can best be achieved by the research synergy between TTUHSC, UTSWMC and Children’s Medical Center
Analytical Instrumentation
Conclusions
- The PPRDC is the first TTUHSC initiative to stimulate pharmacy research in D/FW
- The PPRDC is a significant resource to D/FW-based pharmacy faculty for research support
- A significant collaboration between UT Southwestern, Children’s Medical Center, and TTUHSC to facilitate pediatric research and product development is formed
- Combined preclinical and clinical pediatric research capabilities are unique to the D/FW- based collaboration
- The training of pharmacy students and postgraduate residents and fellows will be enhanced in the area of pediatric pharmacotherapy.
Speculations
- We speculate that the competency of pharmacy graduates will be enhanced in the area of pediatric pharmacotherapy
- We speculate that more pharmacy graduates will pursue careers in pediatric pharmacy
- We speculate that the collaboration with UT Southwestern, Children’s Medical Center and TTUHSC will enhance research opportunities in pediatric pharmaceutical research
- We speculate that the PPRDC will be self funding with enhanced research revenues