Alexander "Sander" A. Vinks, PharmD, PhD, FCP

Electronic Health Record (EHR)-embedded Decision Support Platform for Individualized Precision Drug Treatment in Neonates

In a study funded by the Gerber Foundation, Dr. Sander Vinks, PharmD, PhD, FCP, is working with a team of investigators from the Divisions of Neonatology, Pulmonary Medicine, Pharmacy, Information Services, and the Pediatric Palliative Care Team as well as the Clinical Mass Spectrometry Laboratory to implement a morphine individualized precision dosing decision tool into workflows of neonatal prescribing clinicians. This study seeks to support and improve neonatal pain management by implementing a precision dosing dashboard for morphine. The study will measure the implementation effects by usage statistics and by comparing prescribing patterns to historical patterns from prior to implementation. We will also continue to collect pain and sedation scores, vital signs, and predicted and measured morphine concentrations, comparing prescribing patterns to historical patterns from prior to implementation.

Chie Emoto, PhD

Physiologically-based pharmacokinetic (PBPK) model of morphine and developmental changes in transporter expression in neonates

Dr. Chie Emoto, PhD, in collaboration with Dr. Tsuyoshi Fukuda, worked on the refinement of a physiologically-based pharmacokinetic (PBPK) model of morphine using data from Dr. Fukuda’s CCTST T1 study in neonates and ontogeny profiles of the OCT1 transporter and UGT2B7 enzyme. An earlier prototype model used clinical data in children after tonsillectomy obtained in collaborative clinical studies with colleagues in the Department of Anesthesiology. One of the leading journals of the American Society of Clinical Pharmacology and Therapeutics (ASCPT), CPT Pharmacometrics Systems Pharmacology accepted this study for publication. In addition, a presentation of the results occurred at the International Transporter Consortium (ITC) and Special Population (SPO) Community joint meeting during the 2018 ASCPT Annual Meeting in Orlando, FL. Expansion of this study will now include neonatal PBPK-pharmacodynamic modeling of morphine incorporated with OCT1 genotype-dependent developmental expression with the support of a recent NIH R21 grant awarded to Dr. Emoto.

Min Dong, PhD

Dr. Min Dong, PhD, has been a team leader in the Pharmacometrics Center of Excellence Program providing high level pharmacometrics expertise for pediatric study design optimization, clinical trial simulation, pediatric dose selection optimization, and protocol development for pharmacokinetic (PK) and pharmacodynamic (PD) studies. She has recently been invited to present lectures on Pharmacometrics to students as part of the graduate education program at the UC Department of Pharmacology and Systems Physiology. She is providing pharmacometric services in support of multiple research projects in collaboration with Divisions of Anesthesiology, Research in Patient Services, and Audiology. Dr. Dong is also continuing her efforts on the model-informed precision dosing studies of hydroxyurea in children with sickle cell anemia in collaboration with the Division of Hematology.

NIH T32 Pediatric Clinical Pharmacology Postdoctoral Training Program

The Division of Clinical Pharmacology is proud of its fellowship program in pediatric clinical pharmacology which is one of only five sites in the US with an active program supported by the National Institute of Child Health and Development (NICHD). The National Institute of Mental Health (NIMH) and NICHD have selected our T32 clinical pharmacology program to be the first training program to pilot the training of the next generation of clinical researchers in pediatric clinical psychopharmacology. NIMH has identified a critical gap in their research portfolio in early stage pediatric clinical trial design, and we are the first program awarded this important training position. The goal of the postdoctoral program is to train clinical investigators to assume leadership roles in improving pediatric therapeutics. The study of many medicines isn't done for use in newborns and children, and few medicines are specifically developed to treat childhood diseases. Our program supports, and trains, fellows in applying pharmacokinetics and pharmacogenetics/genomics principles as part of study design as well as precision medicine approaches. We actively participate in the Adult and Pediatric Clinical Pharmacology Training Network established by NICHD, and the National Institutes of General Medical Sciences (NIGMS), as a strategic initiative to increase the pool of well-trained pediatric clinical pharmacologists.

Pharmacometrics Center of Excellence

Our program has experienced considerable growth with our service offerings, increased project diversity, and client base, including in-house, biopharmaceutical, biotechnology, and specialty pharmaceutical companies seeking expertise to determine optimal clinical trial design and pharmacometrics analysis as part of pediatric investigational plans for FDA submission. Our center offers strategic clinical pharmacology consulting and pharmacometric services to help clients improve drug development and regulatory decision-making throughout the clinical development process to increase the success rate of pediatric and adult drug studies. Our team has demonstrated expertise in clinical pharmacology, providing PK/PD support and data analysis, model-based drug development strategies, PK/PD modeling & simulation, study design optimization, clinical trial simulation, and the development of model-informed precision dosing strategies.

Genetic Pharmacology Service and Pharmacogenomics Implementation Research Center (Precise)

Members of the division participate in the Genetic Pharmacology Service (GPS) established in 2004 as a multidisciplinary program supported by the Divisions of Human Genetics, Pharmacy, and Research in Patient Services. The experiences of the GPS team to improve patient outcomes and safety through the use of pharmacogenetic testing were presented for multiple audiences including the Children's Hospital Association and were recently published in the journal Clinical Pharmacology & Therapeutics under the title: "Implementation of Pharmacogenetics at Cincinnati Children’s Hospital Medical Center: Lessons Learned Over 14 Years of Personalizing Medicine".