PRODUCT STRATEGY
First-in-Class Oncology Product Launch
SITUATION
The newly appointed Chief Commercial Officer of a clinical-stage biopharmaceutical company needed to move quickly to prepare for a first-in-class oncology product launch. After receiving breakthrough therapy status for its lead indication, the company needed to build out a new commercial organization and prepare for its first ever launch in just 12 months.
OUR ROLE
We collaborated closely with the client to develop a comprehensive commercial launch plan and spearhead the launch readiness process leading up to FDA approval. Through meticulous coordination of cross-functional workstreams, we identified key dependencies, mitigated risks proactively, and supported the leadership team in critical decision-making.
IMPACT
Within a year, the client grew from a clinical-stage biopharmaceutical company with no commercial infrastructure to one with a fully-integrated commercial organization, equipped with a nationwide sales force and ready for a successful launch ahead of the anticipated FDA decision (PDUFA) date.
