Min Dong, PhD

Dong’s research interests include quantitative clinical pharmacology, model informed dose optimization and clinical trial design. She works with investigators in the Division of Hematology on model-informed pharmacokinetically-guided precision dosing studies of hydroxyurea in patients with sickle cell anemia (SCA). Currently two ongoing prospective trials are: Therapeutic Response Evaluation and Adherence Trial (TREAT), and the Hydroxyurea Optimization through Precision Study (HOPS). In addition, she continues to provide pharmacometric services in support of multiple funded research projects in collaboration with investigators in the Cancer and Blood Diseases Institute, the Divisions of Research in Patient Services, Audiology and other clinical divisions. She is also a leader in the Cincinnati Pharmacometrics Center of Excellence program providing high level pharmacometric expertise for pediatric study design optimization, clinical trial simulation, pediatric dose selection optimization, and protocol development for pharmacokinetic (PK) and pharmacodynamic (PD) studies for FDA submission by outside sponsors.

Tomoyuki Mizuno, PhD

Mizuno works with multiple clinical teams to develop and implement pharmacokinetics and pharmacodynamics (PK / PD) model-informed precision dosing (MIPD) strategies in patients of all ages, from neonates to adults. He recently published an innovative population PK / PD model to predict buprenorphine response in neonates treated for neonatal opioid withdrawal syndrome (NOWS), collaborating with the Divisions of Neonatology and Pulmonary Biology. He and his team also developed a neonatal physiologically-based PK (PBPK) model of buprenorphine to investigate the effect of developmental changes in organ functions and patient-specific factors on the buprenorphine disposition in neonates. He participated in multiple projects on MIPD of anti-inflammatory biologics in pediatric patients with inflammatory bowel diseases in collaboration with investigators in the Division of Gastroenterology, Hepatology, and Nutrition. On an ongoing basis he has involvement in several projects of mTOR inhibitors, such as sirolimus and everolimus, in collaboration with investigators in the Division of Neurology, Cancer and Blood Diseases Institute, and external collaborators. He is a leading member of the Cincinnati Pharmacometrics Center of Excellence providing strategic clinical pharmacology consulting and pharmacometrics services to help pharmaceutical and biotechnology companies seeking expertise to determine the optimal clinical trial design and pharmacometrics analysis as part of initial Pediatric Study Plans (iPSP) for FDA submission. Lastly, he is a leader in the division’s PK-guided precision dosing service providing real-time PK assessment and personalized dosing recommendations using Bayesian approaches for various drugs, including immunosuppressants, biologics, and anti-infection medications.

Laura Ramsey, PhD

Ramsey works closely with the Divisions of Human Genetics, Center for Autoimmune Genomics and Etiology and the Division of Oncology to employ pharmacogenetics approaches in clinical and translational studies. Ramsey and collaborators from the Divisions of Research in Patient Services, Clinical Pharmacology and Biomedical Informatics created a webtool that informs clinicians about methotrexate pharmacokinetics for individual patients, mtxpk.org. She receives funding from the National Institute of Child Health and Development to study neuropsychiatric pharmacogenetics in pediatric patients with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience. Ramsey’s lab found that pharmacogenetic variants influenced the response, toxicity and dosing of antidepressants (sertraline, citalopram and escitalopram) in children, which prompted an update in clinical decision support with dosing guidelines through the Genetic Pharmacology Service to optimize dosing and potentially avoid side effects from these medications. The Genetic Pharmacology Service is a multidisciplinary team she co-leads to develop, interpret and implement pharmacogenetic tests in the electronic medical record. She also educates doctors, pharmacists, genetic counselors and nurses on when and how to use pharmacogenetic tests in the clinic.

Sonya Tang Girdwood MD, PhD

Tang Girdwood is a faculty member in the Divisions of Clinical Pharmacology and Hospital Medicine and works closely with the Division of Critical Care Medicine and the Center for Acute Care Nephrology. During her fellowships in the Divisions of Hospital Medicine and Clinical pharmacology, she built the infrastructure to study beta-lactam antibiotic pharmacokinetics and pharmacodynamics in critically ill children. She utilizes pharmacometrics methods to characterize the variability of beta-lactam concentrations at a population level and to identify patient and clinical factors that contribute to the variability. She also evaluates the pharmacokinetic profiles and pharmacodynamics of beta-lactams in individual patients on extracorporeal life support, including Molecular Adsorbent Recirculation System (MARS) therapy, Extracorporeal Membrane Oxygenation (ECMO) therapy and Continuous Renal Replacement Therapy (CRRT). She expanded her research to evaluate relationships between beta-lactam concentrations and toxicity, including acute kidney injury. Her work aims to build evidence to implement antibiotic precision dosing in patients at high risk of morbidity and mortality from ineffective antibiotic exposure or toxicity. Her research receives funding from the K12 Child Health Research Career Development Award. She clinically works on the Division of Hospital Medicine general pediatric teams and complex care team.

Alexander Sander A. Vinks, PharmD, PhD, FCP

In studies funded by the Ohio Third Frontier and the Gerber Foundation, Vinks and a multidisciplinary team of investigators from the Divisions of Neonatology, Pulmonary Biology, Clinical Pharmacology, Information Services, Biomedical Informatics, the Pain Management Center and Pediatric Palliative Care as the Clinical Mass Spectrometry Laboratory implemented a morphine individualized precision dosing tool into workflows of neonatal prescribing clinicians. The study seeks to support and improve neonatal pain and sedation management by implementing decision support at the bedside for morphine and midazolam precision dosing. The study measures the implementation effects by usage statistics and by comparing prescribing patterns to historical patterns from prior to implementation.

Physician Decision Support Dashboard for Monoclonal Antibodies

With support of an Academic Research Center grant, Phillip Minar, MD, and Vinks brought together a multidisciplinary team of investigators from the Inflammatory Bowel Disease Center, the Division of Clinical Pharmacology, IS and Epic, and Human Factors Engineering and Design. This team successfully completed its year two goal of implementing this first-in-class, user-friendly, and electric health record-integrated dashboard for the precision dosing of biologics such as infliximab. A plan is in place for a pilot feasibility study to continue in the next fiscal year including the expansion of the precision dosing platform to include additional biologics such as adalimumab, vedolizumab, and ustekinumab. Clinical Pharmacology and Therapeutics, the leading journal of the American Society of Clinical Pharmacology and Therapeutics (ASCPT) recently published the first results of the implementation of this physician driven decision support dashboard for infliximab.

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 four sites in the U.S. with an active pediatrics specific program supported by the National Institute of Child Health and Development (NICHD). This year the T32 program was successful in its competitive renewal for the next five-year cycle. The goal of the postdoctoral program is to train clinical investigators to assume leadership roles in improving pediatric therapeutics. There are no studies of many medicines for use in newborns and children, and there are few medicines specifically developed to treat childhood diseases. Our program supports and trains fellows in applying pharmacokinetics and pharmacogenetics / genomics principles as part of study design, model-informed drug development 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 continues to experience significant 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 pediatric drug development and regulatory decision-making throughout the clinical development process to increase the success rate of pediatric and adult drug studies. Our team provides expertise in clinical pharmacology, PK / PD support and data analysis, model-informed drug development strategies, PK / PD modeling and simulation, study design optimization, clinical trial simulation, and the development of model-informed precision dosing strategies.

Genetic Pharmacology Service and Pharmacogenetics Implementation Research Center (Precise)

Members of the division, Vinks and Laura Ramsey, PhD, co-lead the Genetic Pharmacology Service (GPS) with Tracy Glauser, MD. The GPS established in 2004 as a multidisciplinary program involving the Divisions of Human Genetics, Neurology, Clinical Pharmacology, and Research in Patient Services. This year, Ramsey presented about the program at the American Academy of Child and Adolescent Psychiatry, Pharmacogenomics Research Network, University of Minnesota Biennial Pharmacogenomics Conference, and Pediatric Academic Societies annual meetings, as well as the Mayo Clinic Department of Psychiatry and Psychology Chair’s Conference and the Clinical Pharmacogenetics Implementation Consortium Informatics Working Group. Ramsey also presented to several local groups, including the Divisions of Neurology, Rheumatology, the UC Genetic Counseling students, the UC College of Pharmacy Students, and the UC Pharmacology & Systems Physiology students. This year, the GPS implemented CYP3A5 testing for tacrolimus dosing recommendations, updated the psychiatry test to include three commonly prescribed antidepressants, added recommendations for ondansetron based on CYP2D6, and updated the opioid dosing recommendations based on CYP2D6.