Case Study
Interim CMO
How we stepped in to lead the Medical function of a gene therapy biotech through a critical inflection point
Challenge:
- CMO left the organization while the only product was in clinical hold
- Stakeholder engagement and PI management was lacking
- The client did not have any clear plan to get to resolution of the clinical hold, and had not aligned on a strategy of engagement with the FDA
Approach:
- Provided a CMO office assessment and roadmap
- Filled the CMO role, as well as that of VP Clinical Development
- Changed the dynamics of engagement and interaction with key KOLs and the various PIs
- Delivered Medical and Clinical leadership to engage executive team, lead Medical function, and provide a direction for resolving the clinical hold
Results:
- The client’s culture and governance structure underwent a radical change
- SSI clarified and led the way towards clinical hold resolution
- We helped transform the perception of the Medical Office across the organization, leadership team, and BoD
- We greatly improved the client’s KOL/PI relationships