A STEP into the Next Generation PK/PD Analysis: Simcyp Workshop on PBPK Modeling

This fall, I was fortunate to receive generous funding from the Society of Toxicology (SOT) Supplemental Training for Education Program (STEP) to attend a one-week comprehensive Simcyp® Workshop. This workshop was hosted by Certara and held at the Nassau Inn, Princeton, New Jersey, from October 22–26, 2018. The workshop program consisted of a series of lectures as well as hands-on activities to give an overview of various functions and analyses available through Simcyp® simulator.

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Simcyp® simulator is a sophisticated simulator accepted as the standard for population-based pharmacokinetic (PBPK) modeling in more than a thousand institutions, including not only the top pharmaceutical companies but also regulatory agencies including the US Food and Drug Administration. This tool allows users to incorporate population variability to better predict the behavior of various drug candidates in humans. This model-informed approach has been increasingly incorporated into a decision-making process for Investigational New Drug and New Drug Applications. Moreover, such an approach is being utilized for the design of clinical studies.

Certara provides an established training program in Simcyp® at different locations around the world including the US. The program trains the participants to optimally use compound-specific and system-specific data to simulate and interpret pharmacokinetic and pharmacodynamic profiles of a drug in different target populations. The workshop was led by a team of six expert scientists from Certara. A wide array of topics were covered comprehensively during the lectures that were immediately followed by the corresponding hands-on exercises. I was trained on predictions of basic PBPK profile of a drug, PK profiles in special populations including elderly and pediatric patients, drug-drug interactions, alterations in drug PK profiles based on enzyme levels and dosage forms, drug permeability in the brain, and the effects of transporters.

Participants worked in a team of two for hands-on exercises under the guidance of Certara scientists. These exercises allowed the trainees to navigate different tools of Simcyp® simulator to appropriately use them for the questions being asked. It was exciting to learn how this model-based approach can fill numerous gaps and limitations in current drug development that is generally performed in a limited set of models. Along with advanced drug testing platforms including three-dimensional cell models as well as organ-on-a-chip, the simulation-based analysis can help better predict the population response to the drugs and therefore improve the quality of drug development.  

For my dissertation research, I studied the importance of efflux transporters in modulating the levels and consequently efficacy and/or toxicity of various chemicals in the brain. Predicting transporter activity through simulations can be very useful especially for assessing drug exposure in the brain because human models and data are often limited. This workshop greatly expanded my skill set and knowledge in the transporter field and prepared me better for my career goal as a scientist who can effectively utilize various tools to design and perform translational studies which bring out meaningful consequences to protect human health.

I am very grateful for this valuable opportunity generously supported by the SOT STEP Award. I strongly encourage all graduate students to take advantage of this award which allows the students to participate in the events or the programs that are not accessible at their home institutions. Broadening the training experiences can help you guide and reach your career goals more efficiently. The next application deadline for the STEP award is May 1, 2019.

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