Dr. Drolet ‘Thought Leader’ for Pediatric Trials Network
Pediatric Trials Network Subcontract: Pediatric Thought Leader for Timolol in the “Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care (PTN POPS)”
Dr. Drolet has been asked to serve as “thought leader” and provide her dermatology expertise to leaders of the Pediatric Trials Network (PTN), based at Duke University, as they successfully integrate the drug timolol into their priority list of drugs included in the POPS protocol. The PTN is sponsored by the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the POPS study, as part of the Best Pharmaceuticals Act for Children (BPCA), will characterize the 3 pharmacokinetics of understudied drugs that are administered to children regularly by their treating physicians.
Approximately 2,000 children, less than 21 years of age, are participating nationally and internationally in the study. The PTN hopes to generate data to shrink the gap between pediatric and adult dosing information available to prescribing physicians for their pediatric patients.
Timolol, a beta-blocker originally approved for the treatment of glaucoma, is commonly used in the treatment of infantile hemangiomas, but has no FDA-approved indication as such. Timolol was prioritized after Dr. Drolet presented data to the FDA and BPCA in November of 2012. Dr. Drolet will serve as clinical expert and provide guidance regarding the use of timolol for infantile hemangiomas, and pharmacokinetics (PK), safety and efficacy of the drug in treatment of infantile hemangiomas.
This four-month subcontract is a potential first step in the Medical College of Wisconsin becoming a “POPS site”, which will allow for the participation of patients being treated with other understudied drugs at Children’s Hospital of Wisconsin.