Personalized Nanomedicine: Integrating Molecular Stratification with Engineered Delivery Systems

Personalized medicine aims to tailor therapy based on patient-specific molecular and biological characteristics, while nanomedicine focuses on engineering delivery systems to overcome pharmacokinetic and biological barriers. Despite major advances, both fields are limited when applied separately. This review discusses integrating patient stratification with rational nanocarrier design, a combination termed personalized nanomedicine, as a framework to maximize therapeutic index. With emphasis on clinically validated and late-stage examples, we analyze how molecular stratification informs therapeutic design, with particular focus on translational constraints and engineering trade-offs. Results: Personalized medicine enables precise target identification and patient stratification but does not address delivery barriers that limit therapeutic distribution and safety. Conversely, nanomedicine overcomes delivery challenges but exhibits patient- and disease-dependent variability. Merging these approaches allows nanocarrier design to be tailored to disease biology and patient-specific barriers to effective treatment. Recent clinically successful examples demonstrate that co-optimizing biological targeting and delivery engineering can improve translational robustness. Conclusions: Personalized nanomedicine represents a convergence of molecular stratification and engineered delivery systems, a fusion that facilitates context-dependent therapeutic design rather than one-size-fits-all formulations. While significant translational and regulatory challenges remain, treating delivery design as an integral component of personalization offers a viable path toward broader clinical implementation. Continuing to integrate patient profiling with nanoengineering principles will be essential for translating personalized nanomedicine from promising case studies into standard clinical practice.