The Patient-Centric Formulation Compass: A Proposed Bottom-Up Framework to Translate Population Insights into Product...

Patient-centricity is increasingly recognized as an important objective in pharmaceutical development. However, despite growing emphasis on incorporating patient perspectives into medicine design, limited guidance exists on how patient-centric insights can be systematically translated into administration route and formulation selection during early development. This white paper discusses the challenge associated with integrating patient-centric considerations into formulation-related decision-making and presents the authors' perspective on how these challenges may be addressed through a structured framework. To support this objective, the Patient-Centric Formulation Compass (PCFC) is proposed as a framework that links patient and disease understanding with administration route selection, formulation assessment, developability considerations, and downstream development planning. The framework consists of four sequential stages: 1) assessment of the target population and disease, 2) identification of suitable administration routes and formulation options, 3) evaluation of drug candidate compatibility and optimization opportunities, and 4) consolidation of the resulting knowledge into a transparent development summary. Rather than introducing new patient-centric principles, PCFC aims to operationalize and connect existing concepts within a structured and repeatable decision-support approach that may facilitate multidisciplinary discussion and formulation strategy development. The framework is proposed as a reference model that organizations may adapt to their own context and expertise. Its utility and impact should be evaluated through broader application across diverse development programs and therapeutic areas.