A STEP Towards a Career in Clinical Pharmacology

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Picture of all workshop participants

Thanks to the generous support from the Society of Toxicology Supplemental Training for Education Program (STEP), I was able to attend the Certara Simcyp: incorporating population variability into mechanistic prediction of pharmacokinetics and modeling pharmacokinetic-pharmacodynamic workshop in Princeton, New Jersey, in November 2016. While The University of Colorado, Denver, my institution, offers an excellent introductory course to pharmacokinetics, pharmacodynamics, and modeling software, an exclusive course on Simcyp simulation modeling has yet to be offered. Thanks to STEP funding I attended the week-long intensive course that provided hands-on training with model-based drug development and selection and design of clinical studies. 

The workshop provides a better understanding and builds necessary skills to simulate and predict pharmacokinetics of drugs in target populations, while assessing the pharmacodynamic effects in these target populations. Using compound specific in vitro and in vivo data along with system specific information, it is possible to simulate and understand drug behavior in various target populations to understand pharmacokinetic-pharmacodynamic properties that may eventually lead to enhanced precision medicine. The use of the Simcyp simulator may enable the identification of individuals whose genetic and physiological characteristics may place them at greater risk for adverse drug events. The simulator also includes modules for pediatric populations and animal studies.

The course was comprised of lectures, delivered by leading experts in each field of pharmacokinetics and pharmacodynamics, interspersed with small group interactive workshops and demos of practical examples of model-based approaches with tutors. Topics covered included in vitro-in vivo extrapolation, prediction of drug-drug interactions, whole body physiologically-based pharmacokinetic modeling and inter-individual variability, and modeling of therapeutic proteins, to name a few. An added perk of the workshop was interacting and networking with other professionals from biotech and pharma companies and learning the ways in which industry and government utilize pharmacokinetic modeling for better prediction of safety and efficacy of drugs currently under development.         

The use of pharmacokinetics and pharmacodynamics for the enhanced design and application of clinical studies is vital. My professional career goal is to become a highly trained, independent research scientist with a versatile background that will allow me to pursue a career in clinical kidney pharmacology and toxicology, focusing on therapeutic interventions that target traditional and non-traditional risk factors in patients with kidney disease. My work as a translational researcher is enhanced as a result of the Simcyp workshop because the methodological and analytic skills pertaining to pharmacokinetics and simulation software for model-based drug development are essential and will greatly benefit my work designing clinical studies. I would highly recommend this course for individuals seeking knowledge in pharmacokinetic-pharmacodynamic modeling to improve the selection and design of clinical studies and drug development. 


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