Building the Regulatory Case: How to Use In Silico Modeling as an Accelerator in CMC Submissions Without Creating New Risk
Day 2 Manufacturing 5.0 Stage
07/10/2026 15:45 - 16:10pm
Contributors
Bikash Chatterjee : President and Chief Science Officer - Pharmatech Associates- A USP Company
Nima Yazdanpanah : Principal - Procegence
In silico modeling offers compelling efficiency gains in CMC development, but its value is maximised when the regulatory strategy is designed from the outset. This presentation examines how sponsors can structure computational modelling programs to satisfy regulatory expectations while tangibly accelerating development timelines.
The session will draw on real case studies from small and large molecule process scale-up and predictive stability programs that have been successfully submitted to FDA and highlight the decision points at which in silico evidence can substitute for, supplement, or de-risk empirical testing, and where it cannot. The presentation addresses current regulatory expectations across US, EU, and ICH jurisdictions, the prerequisites that determine whether a modelling program will be credible, and the documentation practices that underpin a successful regulatory submission.