PMx Commercial and Regulatory Strategy

PMx commercial and regulatory strategy

Situation

A mid-sized oncology-focused biopharmaceutical firm was interested in indication expansion for its multi-billion dollar on-market drug.

Strategy& was asked to develop a commercial and regulatory strategy from development through launch.

How we helped

Strategy& developed the commercial and regulatory strategy in three phases. First, a product and market assessment was completed to establish CDx product label and indications, evaluate the competitive landscape, understand how customers would respond to the CDx, and perform a rigorous health economic analysis to inform on pricing and reimbursement.

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The next phase involved taking this market-back perspective and rationalizing it with R&D and regulatory constraints. Product requirements were revised based on R&D feasibility, and a high-level timeline of R&D and regulatory steps were outlined to support the development, market readiness, and launch of the CDx.

Key risks were identified and appropriate risk mitigation plans were outlined. Partnership considerations for Dx development and commercialization were also outlined.

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The final phase was the development of a detailed implementation plan that outlined a recommended strategy, and accounted for additional partnership and regulatory pathway scenarios, including war gaming the effects of potential changes in regulations.

Results

The resulting deliverable provided a clear plan for CDx development, approval, and incorporation into the Rx label for the desired indication with target annual product revenue of $600 MM.

In addition to providing guidance for the indication expansion, the project was a viable pilot that informed the client’s design and execution of similar CDx projects for additional tailored indications.