Asset medical lifecycle plan

The challenge:

US and EU regulatory agencies provided the client with new guidance on generating supportive evidence for the proposed launch indication and future indications for a breakthrough vaccine. The client team wished to understand the potential impact of this information on the lifecycle and to develop an updated indication strategy.

Our solution:

We identified key criteria for populations of interest and the relevant decision-making criteria to aid prioritization. We also assessed potential indications, including their evidence and regulatory needs, and facilitated a team workshop to align on prioritization of data generation initiatives and indications.

The results:

Ultimately, we leveraged guidance received from regulatory authorities and input from the cross-functional team to develop an indication expansion strategy for long-term success.