I have been a clinical researcher for more than 40 years. I was recruited to Cincinnati Children's in 2000, and have served as the director of the Division and the T32 Clinical Pharmacology fellowship program until my retirement in 2023. My research and multi-disciplinary projects are in pharmacokinetic-pharmacodynamic (PK/PD) and pharmacometrics 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) and their GeneSightTM Psychotropic pharmacogenomic test 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 (RoadMABTM) and personalized reduced-intensity conditioning with melphalan in patients undergoing hematopoietic stem cell transplantation.
As professor emeritus, I have continued mentoring and PK/PD project work with the faculty in the Cincinnati Pharmacometrics Center of Excellence on model-informed drug development (MIDD) and model-informed precision dosing (MIPD) programs.

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:

• Roger Jelliffe Individualized Therapy Award from the American College of Clinical Pharmacology (2021)
• 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 in over 300 presentations at national and international conferences. I have published over 290 peer-reviewed manuscripts, 280 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 have served on the editorial board of several journals, most recently as associate editor of Clinical Pharmacology & Therapeutics.