CASE STUDY

Interim CMO

How we stepped in to lead the Medical function of a gene therapy biotech through a critical inflection point

Challenge:

  • The client had gaps throughout the Medical office in both capability and bandwidth
  • 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 initially provided a CMO office assessment and roadmap
  • Filled personnel 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