Medical Affairs Planning and Execution

Leading pre-launch and launch planning efforts for medical and commercial teams

Challenge

Our client was developing an imaging agent to be used during breast surgery. At the start of our engagement the client was initiating a Phase 3 clinical trial and had entered an agreement to co-promote the product within the U.S. The company did not have an internal commercial team so entrusted The NemetzGroup to lead the launch planning effort for the agent.

Approach

The NemetzGroup began the engagement by synthesizing insights and information from across the company in order to identify gaps in strategic thinking and current planning. Once we had developed and gained client buy-in on the strategy, brand plan, assumptions and objectives, we worked with the team to prepare for launch from both commercial and medical perspectives. As integrated members of the internal team, we oversaw all aspects of launch preparation including (but not limited to): agency identification and selection; positioning, messaging and concept development; tactical plan development and execution; field sales and medical affairs training development; communication planning and delivery.

Impact

The client successfully launched the agent in the U.S. and, less than a year later, received approval of an sNDA for an additional indication. Upon launch of the second indication, we worked with the internal team to transition commercial and medical affairs capabilities to an in-house team.