Taking a STEP to Better Understand Safety and Efficacy of Compounds: Next STEP Application Deadline October 9


By Rosa Chan posted 08-24-2017 13:52


Through the generous support of the Society of Toxicology (SOT) Supplemental Training for Education Program (STEP), I attended the Certara Simcyp: Model-informed Drug Development workshop held in San Francisco, California, from July 10–14, 2017. This was a week-long intensive workshop providing scientists with the necessary understanding and skills to simulate and predict the pharmacokinetics of drugs in any relevant populations and assess pharmacodynamic effects at an early stage using the Simcyp software. The course was comprised of lectures delivered by leading experts in the field interspersed with small group interactive workshops and demos of practical examples of model-based approaches with tutors.


SOT STEP Recipient Rosa Chan pictured second from the far left of the first seated row  

The workshop was taught by multiple instructors, including Drs. Iain Gardner, Sibylle Neuhoff, Eleanor Howgate, Shriram M. Pathak, Amaka Ezuruike, Ciaran Fisher, and Mano Chetty. During the workshop, I also was able to interact and network with other scientists and learn the ways in which the pharma, biotech industry, and government utilize pharmacokinetic modeling as an assessment tool for better prediction of the safety and efficacy of drugs currently under development. 

As a participant of this workshop, I was able to learn how to use several of the platforms provided by the Simcyp software for modeling and simulation of drug absorption, distribution, metabolism, and excretion (ADME) in virtual human populations and virtual laboratory animals. I was able to create simulations and predict pharmacokinetics of drugs, while assessing the pharmacodynamic effects in specific target populations. We also applied physicochemical properties of a compound along with in vitro and in vivo data to help create different models. The use of the Simcyp simulator helps scientists assess the risk of individuals with specific genetic and/or physiological characteristics who may be at greater risk for developing adverse drug events. The Simcyp population-based simulator also is a very sophisticated platform for simulation of drug-drug interactions. Overall, I gained an understanding of the different types of questions that can be answered using this high-level software.

During the course of my graduate studies, I have become interested in understanding more about the drug discovery field and using my toxicological background to help improve and expedite the process. My research at the University of California, San Francisco, is focused on investigating the potential of the Biopharmaceutics Drug Disposition Classification System (BDDCS) as a methodology for evaluating toxicological outcomes of therapeutic agents. The goal of this research is to advance the understanding of toxicities associated with the liver and the skin, the two organs most commonly involved in serious adverse drug reactions through the application of physicochemical properties on in vitro screening assay data and human clinical data. Specifically, my work has implications in terms of physicochemical drug properties and in vitro assays that should be carried on for the evaluation of Stevens Johnson Syndrome/toxic epidermal necrolysis (STS/TEN) and drug-induced liver injury (DILI).

The Certara Simcyp workshop has provided me with the current flow of knowledge in drug safety and assessment using computational models and systems biological approaches. I believe that learning Symcyp will help me characterize adverse events on the basis of empirical endpoints and integrates in vitro and in vivo toxicity data available via computational modeling. “Off-target” reactions are critical to understanding adverse safety events because these reactions cannot be predicted from a drug’s known pharmacological properties. My career goal is to become an expert in bridging the gap between the in vitro toxicology assays and the PK/PD analysis in order to allow for more rapid translation of therapeutic targets.

Graduate students who have passed their candidacy exams are eligible to apply for STEP Program support. The next deadline for applications is October 9.