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.
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.
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.