I have been a researcher for more than 37 years and began working at Cincinnati Children's in 2000. My research is in pharmacokinetic-pharmacodynamic (PK/PD) modeling and simulation, systems pharmacology, physiologically based pharmacokinetics (PBPK) and pharmacogenetics/genomics. I am also interested in applying population and simulation methods to inform pediatric clinical trial design and therapeutic drug management by implementing model-informed precision dosing strategies and clinical decision support tools.
I became interested in this research early in my career when I directed a therapeutic drug monitoring and clinical toxicology laboratory. I realized that every patient is different in terms of how the body metabolizes drugs and how patients very much differ in their response to medications. The ongoing paradox is that the drug development process is based on selecting a safe and effective dose for the 'average' patient. My program's goal is to promote the implementation of precision medicine and individualized precision dosing, tailoring doses to individual needs. We also work to predict how patients will respond to medications using pharmacogenetics/genomics to select the best drug and corresponding dose.
Some of our notable work includes implementing the Genetic Pharmacology Service (GPS) in 2004 and the formation of the successful startup company AssureX (now Myriad Genetics) that resulted from the GPS initiative. In recent years we have been successful in the development and implementation of electronic health records (EHR) integrated clinical decision support platforms for model-informed precision dosing. These achievements cover a variety of drugs and indications, including neonatal pain management with morphine (NeoRelief), precise hydroxyurea therapy in sickle cell anemia (HdxSim), optimizing infliximab, adalimumab and vedolizumab dosing in patients with inflammatory bowel disease (RoadMAB) and personalized reduced-intensity conditioning with melphalan in patients undergoing hematopoietic stem cell transplantation.
For additional information, please see: Personalized Medicine through Model-informed Precision Dosing: What's Here – What's Near? and Genomics Ushers in Era of Personalized Medicine.
I am honored to have received many awards and appointments throughout my career, including:
- The American Society for Clinical Pharmacology and Therapeutics (ASCPT) Mentor Award (2020)
- The Cincinnati Children's Research Foundation Senior Mentoring Award (2017)
- The Cincinnati Children's Research Foundation Endowed Chair (2015)
- The International Association Therapeutic Drug Monitoring & Clinical Toxicology Charles E. Pippenger Award (2015)
- President, International Association for Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) (2009-2011)
- Executive Board Member, American Board of Clinical Pharmacology, Inc. (2008-2020)
- Fellow, American College of Clinical Pharmacology (2002-present)
- Board certification in clinical pharmacology (2001)
I have presented my research as an invited speaker at 260 national and international conferences. I have published over 250 peer-reviewed manuscripts, 260 abstracts, 20 book chapters and invited reviews, and I am co-editor of a book on the Fundamentals of Antimicrobial Pharmacokinetics and Pharmacodynamics (over 38,000 chapter downloads). I’m on the editorial board of several journals, and I am an associate editor of Clinical Pharmacology & Therapeutics.