Refreshing an Existing Integrated Evidence Generation Plan (IEGP) for a Mature Program

A biopharma company’s Medical Affairs team needed help to update an IEGP for a molecule with a large volume of existing data and evidence generation activity by incorporating new scientific learnings and external market evolution.

We begin by defining the strategic priorities for the annual IEGP. A situation analysis identified the most impactful internal and external events affecting the patient, regulatory, and competitive landscape. We then created a set of IEGP data priorities based on the latest lifecycle strategy and situation analysis. Next, we identified and prioritized evidence gaps. Finally, we developed solutions to address the most important gaps by building preliminary study concepts, complete with study designs, timing, and estimated costs. These were refined via cross-functional workshops.

Instead of being reactive to investigator proposals, the team invested in the research that mattered the most for the molecule’s strategy. Previously ignored data needs of non-traditional stakeholders and non-US/EU markets were incorporated into the global plan.