Building Translational & Clinical Evidence Packages That Gets Both Internal & External Stakeholder Buy-In

Regulatory acceptance of MIDD evidence is the goal, but it is rarely where the resistance starts. Before a model reaches a submission, it has to survive scrutiny from clinical scientists who distrust mechanistic outputs, biostatisticians who speak a different statistical language, and senior leaders weighing up whether to back a modelling strategy they cannot directly evaluate. Internal buy-in is not a soft problem: it is what determines whether a model is stress-tested enough to hold up when regulators push back. This workshop addresses both sides of the credibility challenge, building the internal case for MIDD and QSP outputs alongside the regulatory one, because the two are more connected than most teams treat them.

This workshop will gather experts to discuss:

• Examine what a credible pre-IND MIDD package looks like across different modalities, including small molecules, ADCs, and biologics, and where the bar is currently set by FDA and EMA
• Discuss the growing role of New Approach Methodologies (NAMs) and in vitro data in supplementing or replacing animal studies, and how to integrate these into your modelling framework
• Work through case examples of pre-clinical MIDD submissions that succeeded or fell short, identifying the decisions, datasets, and documentation that made the difference

Speakers: