Canada Annual Meeting

Model-Informed Drug Development (MIDD) is playing an increasingly important role in supporting efficient drug development and evidence-based regulatory decision-making. Health Canada has recognized pharmacometrics and MIDD as valuable quantitative approaches in regulatory submissions, while the recently adopted ICH M15 guideline provides a harmonized framework for the assessment of MIDD evidence. This session will provide a joint industry and Health Canada perspective on how MIDD is applied in practice and how model-based evidence is interpreted in support of filed submissions. Using case studies across the product lifecycle, the session will illustrate how approaches such as population PK/PD, exposure-response analyses, PBPK, and QSP can address key regulatory questions related to dose optimization, bridging strategies, and indication or population expansion. It will also explore how MIDD supports the advancement of more individualized, precision-oriented development approaches. By combining sponsor and regulator perspectives, the session will help attendees better understand when MIDD provides the greatest regulatory value, how to position it effectively in submissions, and what considerations may shape regulatory confidence in model-informed evidence.