Advancing Strategic Impact Through Externally Sponsored Research

Session details:

This presentation will highlight the strategic importance of Externally Sponsored Research (ESR), including Investigator-Initiated Studies (IIS) and Collaborative Research (CR), as a critical component of scientific engagement and long-term portfolio growth. We will discuss how ESR programs support evidence generation beyond registrational trials, strengthen partnerships with key investigators, and contribute to lifecycle management and potential label expansion strategies. 
The session will explore current trends in leveraging externally generated data to address clinical gaps, evaluate new sub-populations, and generate real-world evidence aligned with evolving standards of care. We will also outline structured strategies to align ESR investments with broader Evidence Generation Plans (EGPs), ensuring scientific rigor, compliance, and cross-functional governance. 
Finally, we will review operational models that enable scalable, compliant execution—highlighting governance frameworks, standardized review processes, FMV oversight, and cross-functional alignment. This presentation will provide practical insights into how a well-structured ESR program can drive scientific value while maintaining regulatory and compliance integrity.