Modeling and simulation now support drug development at all stages of the drug lifecycle, making it critical to understand how these models streamline the process.

Examples of how modeling is used in drug development include:

• Machine learning models can help select the lead drug candidate during the drug discovery phase
• Physiologically based pharmacokinetic (PBPK) models can help to predict the first-in-human dose during the pre-clinical phase or the appropriate drug dose in special populations during the clinical trial phase
• Quantitative systems pharmacology/toxicology (QSP/QST) models can help to predict drug efficacy/toxicity during either the pre-clinical or clinical trial phase

In this training session, Simulations Plus Scientist Celeste Vallejo will provide a brief introduction to drug development, as well as the types of models that are used to solve the most pressing questions in the drug development space. Participants will also be introduced to PBPK models and PBPK software, GastroPlus, as well as QSP/QST models and QST software, DILIsym.

To facilitate learning, participants are encouraged to apply for free software licenses in advance through the University+ program. Applications can be submitted here.

Celeste Vallejo received her Ph.D. in Mathematics from the University of Florida in 2018. She was an MBI post-doc from 2018-2020. During her graduate and postdoctoral career, her research focused mainly on infectious disease modeling. After the completion of her post-doc, she pivoted towards mathematical modeling in the drug development space. She has been with Simulations Plus for almost a year and a half.

Schedule
Tuesday, July 18th from 6:00-8:00 PM
In-person at The Ohio State University in conjunction with the Society for Mathematical Biology Annual Meeting

Agenda
• Introduction to drug development
• Introduction to physiologically-based pharmacokinetic (PBPK) modeling
• GastroPlus Demo
• Introduction to quantitative systems pharmacology/toxicology (QSP/QST) modeling
• DILIsym Demo