202001 T32 Postdoctoral Training in Pediatric Clinical Pharmacology

Program seeks Council approval for the “Pediatric Clinical and Developmental Pharmacology Training Network” (PCDPTN) initiative. This initiative supports a program designed to help ensure that a diverse and highly trained workforce is available in the area of pediatric pharmacology, which currently has a limited number of researchers.

During the last cycle of this initiative twenty-eight fellows graduated from the program. Currently there are fifteen fellows completing the program. These fellows were involved in ninety-four projects and were authors in 237 publications.

While this initiative has been successful, there remains a shortage of pharmacologists trained in pediatric clinical pharmacology. This is evidenced by the number of failed pediatric drug trials for which neither efficacy nor safety could be demonstrated, many of which the lacked appropriate pharmacologic studies.  Additionally, the Best Pharmaceuticals for Children Act (BPCA) requires pediatric clinical pharmacologists to be included in existent NIH career development programs.

As well as increasing the size of the workforce, this program will incorporate advances in science that are having a significant impact on clinical pharmacology. One example is the evolution of clinical pharmacology from perfecting pharmacokinetic studies for dose estimation to the incorporation of model-informed drug development. Another is the genomic (and now multi-omics) revolution leading to the discovery of new therapeutic targets and biomarkers that will enable innovative therapeutic approaches and biomarkers in pediatrics. Inclusion of emerging approaches such as these in the education of the next generation of pediatric clinical pharmacologists is essential to assuring the workforce will be modern, effective, and ready to realize the goal of precision pediatric therapeutics.

The goal is this initiative is to develop clinician-scientists who will be leaders in the field of pediatric clinical pharmacology research. This will be accomplished by providing training and experience in the methods and conduct of basic and clinical drug research in the different phases of pediatric drug development and fostering interaction with pediatric subspecialists to address deep knowledge gaps in pediatric therapeutics.

This initiative aligns with the NICHD’s Strategic Plan 2020, particularly Theme 5, which promotes the goal of advancing safe and effective therapeutics and devices for children, pregnant and lactating women, and people with disabilities, and with its ongoing Scientific Stewardship through promoting an inclusive scientific workforce that fosters research training.

This initiative aligns with the OPPTB’s research priorities to expand the knowledge and training in pharmacokinetics, pharmacodynamics, pharmacogenomics, outcome measures, and biomarkers for pediatric disease treatment.

Program Contact

Aaron Pawlyk
Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)

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