Understanding global PMA implications for a gene therapy

Client Issue

A leading biotech company sought to evaluate market receptivity for its breakthrough Phase III drug in a rare hematology disorder.

CRA Approach

We reviewed the available data to establish the market landscape in the context of an expected competitor launch in an expanded indication and then developed research materials and screening criteria for execution of payer and KOL interviews. Interviews were conducted to determine the value perception of the drug in the new indication and understand likely P&MA outcomes. We analysed the research findings to develop insights and deliver recommendations to address the strategic business questions.

Client Impact

Our work provided global and geographic-specific assessment of the marketplace for the indication expansion, assessment of anticipated competitor positioning, evidence requirements, unmet needs assessment, and issues framework. The project provided consolidated insights regarding payer receptivity of the potential expanded indication, including cross-market and local perspectives. It also delivered recommendations on value perception, P&MA strategy, and evidence requirements.

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