Held at Pharmetheus exhibition booth (#8). No registration required.
Topics
ICH M15 in action: From question of interest to regulatory decision
This presentation will introduce the MIDD evidence assessment table and show how it can be used to structure the evidence from Question of Interest through model risk, evaluation, totality of evidence, and residual uncertainty. A caplacizumab case study will illustrate the approach in a real regulatory setting.
Monday October 12, 3:45 PM, Emma Hansson
Objective first, method second: Why the estimand definition comes first in pharmacometric covariate modeling
This presentation will introduce how adopting the ICH E9(R1) estimand framework clarifies the distinction between mechanistic understanding (conditional effects) and clinical decision-making (unconditional effects). Using examples, it will show how defining the estimand first resolves common reporting fallacies and aligns quantitative evidence across regulatory and clinical workflows.
Tuesday October 13, 3:45 PM, Niclas Jonsson
MIDD in hyperaccelerated drug development: The Depemokimab regulatory submissions
This session delivers actionable advice on maximizing development speed while ensuring rigorous quality and high-impact regulatory outcomes, featuring a case study on the depemokimab regulatory submissions for Severe Asthma and CRSwNP.
Wednesday October 14, 1 PM, Jakob Ribbing