Mini Workshop: From Question to Model to Decision: A Practical Framework for Applying Disease Progression Modeling in Clinical Development

Disease progression modelling has matured into a powerful tool for understanding disease biology, predicting treatment impact, and supporting precision medicine strategies. Yet despite its potential, many organisations struggle to translate modelling outputs into decisions because key stakeholders outside modelling functions lack a common framework for evaluating and applying the insights.

This session explores recommendations developed through the Clinical Trials Transformation Initiative (CTTI), bringing together lessons from regulators, industry leaders, and modelling experts on how organisations can better communicate, evaluate, and implement disease progression modelling throughout medical product development.

Key Discussion Points

• Understanding where disease progression modelling delivers unique value compared with other modelling approaches such as PK/PD and PBPK
• Communicating model assumptions, limitations, and outputs across clinical, regulatory, commercial, and executive stakeholders
• Building organisational “multi-fluency” to ensure modelling insights influence decision making rather than remain siloed within specialist teams
• Applying CTTI’s framework and recommendations to increase confidence, consistency, and adoption of disease progression modelling across the development lifecycle
• Case examples illustrating how improved cross-functional engagement enabled more effective development decisions

Speakers: