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Session 4, Track A: Accelerate Precision Medicine with Model-Informed Drug Development: From Insight to Regulatory Impact
Session Chair(s)
Amy Chan
Associate Director, Regulatory Affairs, Takeda Canada Inc., Canada
Myriam Salem
National Supervisor, Regulatory Operations and Enforcement Branch, Health Canada, Canada
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.
From Model Uncertainty to Credible Evidence: Harmonised, Fit-for-Purpose Assessment Sarem Sarem, Health Canada
Harnessing Model-Informed Drug Development to Accelerate Development and Strengthen Regulatory Decision-Making: Industry Experience Angelina Habimana, Teva Canada Innovation
Elliot Offman, Certara
Learning Objective : At the conclusion of this session, participants should be able to: - Describe applications of MIDD in addressing regulatory questions across the product lifecycle
- Explain how MIDD evidence is translated into regulatory arguments and assessed by sponsors and Health Canada
- Identify scenarios where MIDD provides the greatest regulatory value
- Discuss how MIDD supports individualized, data-driven development strategies advancing precision medicine
Speaker(s)
From Model Uncertainty to Credible Evidence: Harmonised, Fit-for-Purpose Assessment
Sarem Sarem, PhD, MS, RPh
Senior Assessor, Health Canada, Canada
Harnessing Model-Informed Drug Development to Accelerate Development and Strengthen Regulatory Decision-Making: Industry Experience
Angelina Habimana, MSc
Sr. Dir. Regulatory Affairs, Teva Canada, Canada
Speaker
Elliot Offman, PhD, MS, RPh
Vice President, Certara, Canada
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