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Daniel Gonzalez Lab

Gonzalez-LabI am an Associate Professor in the Division of Pharmacotherapy and Experimental Therapeutics (DPET) at the UNC Eshelman School of Pharmacy. DPET seeks to improve lives by leading the world in translating experimental and clinical pharmacology discoveries into precision medicine.

The primary goal of my research program is to optimize pharmacotherapeutic efficacy and safety through the use of innovative clinical trial designs and application of mathematical modeling and simulation techniques, with an emphasis in pediatric populations. This is first accomplished by characterizing the differences in pharmacokinetic (PK) and pharmacodynamic (PD) relationships across human development, elucidating and quantifying influential factors of drug disposition, and the degree of interindividual variability surrounding them. Assessment of such changes are then related to deviations in drug effects and overall patient outcomes. With such characterizations established, optimal dosing regimens are derived, with a clinical impact in patient populations for which evidence-based dosing recommendations are frequently absent.

My experiences have afforded a highly collaborative and multidisciplinary research program that leverages pharmacological, mathematical, and statistical concepts for better-informed clinical trial design and medical decision-making. My research group is involved in numerous drug development programs focused on evaluating pediatric use of both new and off-patent therapeutics. As a principal investigator, I have received funding from the National Institutes of Health as well as the Thrasher Research Fund, have authored over 70 manuscripts and abstracts to advance such practice, and have served as the primary research advisor for 7 post-doctoral fellows and 3 graduate students.

Clinical Pharmacology Studies in Children

Quantification of pharmacokinetic (PK) and pharmacodynamic (PD) parameters and the factors that influence them constitute the major focus of my research program. The unique constellation of ethical and logistical considerations inherent to pediatric drug trials present immense challenges in accruing sufficient data through traditional approaches. Children thus represent a vulnerable and understudied patient population, resulting in widespread off-label use of medications.

By performing clinical pharmacology studies and employing both population and physiologically-based PK/PD modeling and simulation techniques, we seek to characterize differences in drug exposure and effect across the pediatric age spectrum and identify the clinical correlates most associated with favorable pharmacotherapeutic outcome. The ultimate goal of such an approach is the provision of pediatric dosing information to clinicians for the betterment of patient care.

My group is directly involved in drug development programs focused on characterizing PK/PD properties, safety, and efficacy of new and off-patent drugs in the pediatric population.


Use of Electronic Medical Record Data to Assess Drug Disposition, Efficacy, and Safety

There are often ethical and logistical challenges to performing clinical trials in the pediatric population. Electronic medical record (EMR) data represents an easily accessible and voluminous resource for the assessment of drug efficacy and safety outcomes. In addition, for drugs where drug concentrations are assessed as part of routine medical care, these data can be used to validate existing PK/PD models. My group is involved in multiple projects focused on characterizing the clinical pharmacology properties of drugs widely used in the pediatric population using EMR data.

Daniel Gonzalez, Pharm.D., Ph.D.

Daniel_GonzalezDaniel Gonzalez’s research interests include pediatric clinical pharmacology and the application of mathematical modeling and simulation techniques to characterize the pharmacokinetics and pharmacodynamics of drugs, guide dosage selection, and improve drug safety in children.

 

Fernando Carreño, Ph.D., M.S.

Fernando_CarrenoFernando Carreño is a UNC/GlaxoSmithKline (GSK) pharmacokinetics/pharmacodynamics post-doctoral fellow. He graduated as a Pharmacist from the State University of Maringá in Brazil and then obtained a Master’s in Pharmaceutical Sciences degree from Federal University of Rio Grande do Sul in Brazil. Fernando worked as a clinical pharmacist in the adult intensive care unit at Mãe de Deus Hospital before returning to graduate school to complete PhD training. He received his PhD degree in Pharmaceutical Sciences in 2019 from Federal University of Rio Grande do Sul. Fernando has experience in pharmacokinetics, microdialysis and evaluation of drug delivery to the brain using lipid core nanocarriers. His current research interests include population pharmacokinetic/pharmacodynamics and physiologically-based pharmacokinetic (PBPK) modeling of clinical data to characterize drug disposition and individualize dosing in the pediatric population.


Jaydeep Sinha, Ph.D.

Jaydeep-SinhaJaydeep Sinha is a trained pharmacometrician, and currently working in the Gonzalez Lab as a postdoctoral research fellow. Jaydeep completed his Ph.D. in pharmacometrics at the Otago Pharmacometrics Group of University of Otago, New Zealand, where he primarily researched the influence of body size and composition on drug dosing in differently sized population groups (e.g., patients with obesity). Prior to obtaining his Ph.D., Jaydeep had completed his B.Pharm and M.Pharm degrees from Jadavpur University in Kolkata, India and had worked in reputed drug discovery based organizations for six years. The majority of his work experience was at Biocon-Bristol Myers Squibb Research Center (BBRC) in Bangalore, India, where he primarily worked as a translational pharmacokinetics (PK)-pharmacodnamics (PD) modeling and simulation (M&S) scientist for five years. Jaydeep has also worked as a PK scientist in the drug metabolism and pharmacokinetics (DMPK) group of Advinus Therapeutics Limited (now Eurofin Avinus), which is a global CRO supporting drug development. Jaydeep’s current research focus includes the application of pharmacometric approaches (e.g., population PK and physiology-based PK [PBPK]) in optimizing drug dosing in pediatric patients in order to ensure the safe and effective use of drugs in this vulnerable group of patients.

Sara Salerno, Pharm.D.

Sara SalernoSara Salerno is a graduate student in the Division of Pharmacotherapy and Experimental Therapeutics. Sara obtained her pharmacy degree in 2013 from the University of California, San Francisco. She was involved in several projects during pharmacy school such as studying resistance in acute myeloid leukemia patients on a FLT3 inhibitor drug and developing a population pharmacokinetic model for fludarabine in pediatric patients. Her dissertation research is focused on characterizing cytochrome P450 3A-mediated drug-drug interactions in the pediatric population.


Jacqueline Gerhart, M.S.

jacqueline_gerhartJackie Gerhart is a graduate student in the Division of Pharmacotherapy and Experimental Therapeutics.  Jackie obtained her Bachelor’s and Master’s degrees in biomedical engineering from Drexel University.  Prior to joining UNC, she worked on numerous drug metabolism and pharmacokinetic projects in drug development at GlaxoSmithKline. Her research interests include leveraging modeling and simulation techniques to characterize alterations in pharmacokinetics in children and adolescents with obesity.


Stephen Balevic, M.D., M.H.S.

Stephen_BalevicStephen Balevic is an Adult and Pediatric Rheumatologist at Duke University and a clinical researcher at the Duke Clinical Research Institute (DCRI). His research interests are in clinical trials and precision medicine through population pharmacokinetic/pharmacodynamic modeling. He completed his clinical and research fellowships as well as a Master of Health Science Degree in Clinical Research at Duke University. He also completed the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) sponsored, collaborative UNC-Duke Clinical Pharmacology T32 Training Program. He is currently a graduate student in the Division of Pharmacotherapy and Experimental Therapeutics at the UNC Eshelman School of Pharmacy. He also serves as the principal investigator on several foundation grants studying hydroxychloroquine and azathioprine pharmacokinetics and exposure-response in lupus. He is also a principal investigator or co-investigator for several clinical trials at the DCRI.

PhD Students

Name Year(s) Degree(s) Current Position
Christoph Hornik 2015-19 M.D., Ph.D., M.P.H. Associate Professor of Pediatrics, Duke University, Durham, NC

Academic Post-Doctoral Fellows

Name Year(s) Degree(s) Current Position
Nilay Thakkar 2015-16 Ph.D.  

Clinical Pharmacologist, Clinical Pharmacology & Modeling and Simulation at GlaxoSmithKline, Philadelphia, PA

Nikolas Onufrak
*Co-mentored by
Dr. Alan Forrest
2015-17 Pharm.D.  

Pharmacometrician, Institute for Clinical Pharmacodynamics, Schenectady, NY

Shufan Ge 2017-18 Ph.D.  

Manager, Modeling & Simulation, Pharmacokinetics, Pharmacodynamics, and Metabolism at Sanofi, Bridgewater, NJ

Samit Ganguly 2018-2020 Ph.D.  

Scientist, Clinical Pharmacology at Regeneron Pharmaceuticals, Tarrytown, NY

 

IQVIA Pharmacokinetics/ Pharmacodynamics Post-Doctoral Fellows

Name Year(s) Degree(s) Current Position
Vadryn Pierre
*Co-mentored by
Dr. Kim Brouwer

2014-15 Ph.D. Clinical Pharmacokineticist, MedImmune, Gaithersburg, MD
Michael Hwang 2016-17 Pharm.D. Clinical Pharmacokineticist, MedImmune, San Francisco, CA
Sherif Sharaby
*Co-mentored by
Dr. Julie Dumond

2017-18 Pharm.D. Clinical Pharmacist, Community Medical Centers, Fresno, CA

 

Nuventra Pharmacokinetics/ Pharmacodynamics Post-Doctoral Fellows

Name Year(s) Degree(s) Current Position
Shirley Wu 2018-19 Pharm.D. 2nd Year Fellow at Nuventra

 

UNC-Duke Collaborative Clinical Pharmacology T32 Post-Doctoral Fellows

Name Year(s) Degree(s) Current Position
Ryan Beechinor 2016-18 Pharm.D. Clinical Oncology Pharmacist, Department of Pharmacy, University of California, Davis Medical Center