Submitted by Kary Thompson and Elise Lewis, Chairpersons of the upcoming 2014 Continuing Education course, "Nonclinical Pediatric Drug Development: Considerations, Study Designs, and Strategies (PM11)."
Drugs for Kids? You bet!
Due to a historic lack of drug development for children 0 to 17 years old, “off-label” drug use is common place in pediatrics. According to a recent study, 96 percent of children admitted to a pediatric intensive care unit received drug treatments without pediatric labeling. Numerous problems are associated with this practice including a lack of data in children; uncertainty about whether a drug is effective in children for a particular disease; concerns about the side-effect profile; and a lack of PK information to support appropriate dosing. There is a critical need for effective, safe medicines for children; in recognition of this, worldwide health authorities now require pediatric plans for all drugs in development.
As part of the multidisciplinary needs of pediatric drug development, safety evaluation is a critical component, as children are simply not scaled-down adults. This 2014 SOT Annual Meeting Continuing Education (CE) course “Nonclinical Pediatric Drug Development: Considerations, Study Designs, and Strategies” will address the regulatory, scientific, and strategic inputs required to support the safe use of pharmaceuticals in children.This course will feature speakers from both the US Food and Drug Administration and European Medicines Agency, to provide the regulatory scaffold, followed by speakers addressing the nuts and bolts of juvenile toxicity testing for small molecules and biologics.
A new CE topic for SOT, this course is sure to be a valuable resource for scientists in a variety of settings. To register, please visit the 2014 SOT Annual Meeting website, where you can also access a full listing of the CE courses.