INNOVATE (Integrated National Network for Obstetric and Pediatric AdVAncement in Therapeutic Education)

About This Grant

ABSTRACT Optimizing the safe and effective use of therapeutics in pregnancy and childhood is a critical public health need. These populations have historically been understudied in clinical research and lack evidence-based dosing guidance for most therapeutics. The Integrated National Network for Obstetric and Pediatric AdVAncement in Therapeutic Education (INNOVATE) T32 program will directly address this gap through specialized training in obstetric and pediatric clinical pharmacology. The program will offer a rigorous, interdisciplinary research training experience anchored in three core scientific domains relevant to obstetric and pediatric clinical pharmacology: 1) Pharmacokinetics/Pharmacodynamics and Clinical Trials, 2) Pharmacoepidemiology and Data Science, and 3) Translational Research. The INNOVATE T32 Program will leverage existing training opportunities through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Clinical Pharmacology Training Network (CPTN), and will capitalize on the robust infrastructure, expertise, and collaborative environment across four outstanding institutions: Duke University, Indiana University, University of North Carolina at Chapel Hill, and the University of Utah. The national scope of the program enhances its impact by fostering cross-institutional collaboration, peer learning, and access to unique research environments. The program will also utilize the extensive research and training resources available through the Pediatric Trials Network (PTN) and the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub, providing trainees with unparalleled access to cutting-edge data, tools, and multidisciplinary mentorship. We anticipate supporting four post-doctoral fellows each year, with each fellow receiving two years of funding through the program. Each post- doctoral fellow will develop a research project under the guidance of accomplished faculty mentors, while also engaging in structured career development activities to support their growth as independent investigators. The training of each fellow will be guided by an Individual Development Plan. The post-doctoral fellows will participate in the monthly INNOVATE Forum, a virtual platform that promotes peer interaction, professional development, and focused discussions on topics such as scientific rigor, reproducibility, and responsible conduct of research. Didactic and experiential learning will be complemented by individualized mentorship, interdisciplinary exposure, and frequent evaluation to ensure progress. Program outcomes and effectiveness will be continuously monitored and refined with input from an External Advisory Board composed of national leaders in pediatric and obstetric therapeutics, clinical pharmacology, and regulatory science. Through the completion of a robust research project and structured mentorship, the INNOVATE T32 program will prepare post-doctoral fellows to pursue impactful careers focused on advancing therapeutic development and precision dosing in pregnancy and childhood.