Conference: ICoP 2026 India
Date: January 28 - 31, 2026
Location: Fortune Valley View, Manipal
Where to hear Certara insights and expertise
Presenters: Maitri Sanghavi, Research Scientist
Co-chair: Suraj Bhansali, Vice President
This session will explore how population-based mechanistic PBPK models implemented within the Simcyp Simulator can significantly improve drug development and regulatory interactions. Drawing on real-world case studies and practical project experiences, the talk will highlight how physiologically based biopharmaceutic and pharmacokinetic modelling can de-risk development, optimize formulation strategy, guide clinical study design, and support regulatory interactions.
Attendees will gain a good understanding of how mechanistic modelling can be integrated into development workflows to enhance efficiency, reduce costs, and support more predictable outcomes in both generic and innovative drug programs.
Presenter: Harshbir Sandhu, Senior Scientist
The poster will be on display throughout the duration of the conference. Harshbir will be available on January 29 and 30 from 12:15 PM to 1:45 PM to present his abstract and answer any questions.
Gene therapies are advancing rapidly, yet quantitative frameworks for dose translation have lagged behind. In this work, focused on AAV-based gene therapy, we present a modular mechanistic modeling framework that captures the full journey from AAV biodistribution and viral transduction through transgene expression and protein biodistribution, enabling process-specific interspecies scaling. By explicitly identifying where traditional allometric approaches break down and applying tailored scaling strategies, the framework reduces uncertainty in human dose–response prediction and helps prioritize key translational experiments. The platform is agnostic to vector, transgene, tissue, and indication, and has already been used to support first-in-human dose justification for IND submissions.
