Alexander (Sander) A. Vinks, PharmD, PhD, FCP
Implementation of Model-based Precision Dosing
Alexander (Sander) A. Vinks, PharmD, PhD, FCP, is developing systems for precision dosing of several different medications to allow the tailoring of dose to individual needs in real time. With the support of an Innovation Fund Award, he and his team have developed an innovative prototype systems pharmacology platform for individualized morphine treatment in neonates. The study involved a multidisciplinary team including Joshua Euteneuer, MD, a neonatology fellow who participates in the T32 Pediatric Clinical Pharmacology Training Program. The study, conducted in parallel with the Perinatal Institute’s Pilot and Feasibility Program grant, developed a rapid bedside test for the measurement of morphine in blood led by Dr. Vinks. This cloud-based technology will help clinicians decide how much morphine to give to newborn babies. The platform, which integrates with the electronic health record, uses genetic markers, demographic data, clinical data and lab results to suggest individualized dosing.
Chie Emoto, PhD
Physiologically-based pharmacokinetic (PBPK) models for precision dosing in neonates
Chie Emoto, PhD, developed an innovative physiologically-based pharmacokinetic (PBPK) model of morphine for neonates and small infants using data obtained from ongoing clinical studies in pediatric patients after tonsillectomy (PI: Senthilkumar Sadhasivam, MD). This predictive computer model helps physicians fine-tune doses to maintain target morphine concentrations in neonates based on patients’ physiological parameters. This study was accepted for publication in CPT Pharmacometrics Systems Pharmacology, which is an official journal of the American Society of Clinical Pharmacology and Therapeutics.
Renewal of NIH Program to Train the Next generation of Pediatric Clinical Pharmacologist
This year our pediatric clinical pharmacology training program was successful in the competitive renewal process. We are now one of five sites in the U.S. awarded a pediatric clinical and developmental pharmacology training grant from the National Institute of Child Health and Development (NICHD
). This postdoctoral program trains clinical investigators to assume leadership roles in evaluating pediatric therapeutics. Many medicines have not been studied for use in children, and few medicines developed are specifically made to treat childhood diseases. One of our major goals is to support and train fellows in applying pharmacokinetics and pharmacogenetics/genomics to individualized therapy. Our program actively participates in the Adult and Pediatric Clinical Pharmacology Training Network established by the National Institutes of General Medical Sciences (NIGMS
) and Child Health and Development as a strategic initiative to increase the pool of pediatric clinical pharmacologists.
Pharmacometrics Program Revolutionizing How We Perform Drug Studies in Children
Our Pharmacometrics Services Program continues to provide unique pediatric expertise to improve pediatric drug development and enhance the success rate of drug studies in neonates, infants, children and adolescents. The program provides modeling and simulation consultation for internal programs and external costumers. Last year’s multiple clinical trials included studies evaluating sirolimus in the treatment of vascular anomalies, everolimus in patients with tuberous sclerosis, hydroxyurea individualized dosing in children with sickle cell anemia, and precision dosing of biologics such as infliximab (Remicade) in Crohn’s disease, and eculizumab (Soliris) and alemtuzumab (Campath) in patients undergoing hematopoietic stem cell transplantation. Our research explores the developmental characteristics and genetic polymorphisms of drug metabolizing enzymes and receptors. Among these projects, Chie Emoto, PhD, leads a study that focuses on developing physiologically-based pharmacokinetic models for morphine, methadone and mTOR inhibitors such as sirolimus.