A digital twin approach for transforming prescription drug labeling

Drug development entails extensive data collection by sponsors throughout research and development, followed by regulatory review, culminating in essential yet static prescription drug labeling. As study results are typically presented as isolated summaries, the label can underrepresent the drug's integrated effects across biological systems. We propose that sponsors submit a Digital Twin-based companion app alongside traditional documentation to enable a more comprehensive understanding of the investigational drug for review and, after approval, to support personalized prescribing in clinical practice. The development and implementation of the companion app would proceed by aligning with emerging regulatory guidance and by leveraging robust, scalable technical architecture.