Proprietary modeling platforms to support regulatory interactions: A vendor’s perspective

Authors: DiBella J
Conference: SOT
Software: GastroPlus®
Division: Simulations Plus

Proprietary Modeling Platforms – The Reality…
• Proprietary modeling platforms are:
– Driving the vast majority of internal R&D activities at companies
• >200 global customers for Simulations Plus; 100s more outsource modeling projects
– Integrated into 100s of university courses (for free) to teach and train students
– Implementing significant (and consistent) innovation driven through collaborations
between commercial software vendors, companies, and government/academic groups
• Examples include funded consortiums through IMI, Cosmetics Europe, and the FDA
– Accessed by trained regulatory scientists globally to efficiently support filings/applications

By John DiBella

Society of Toxicology 58th Annual Meeting and ToxExpo, March 10-14, 2019, Baltimore, MD