Case Study 1 – Strategic Positioning for Optimal Commercialization

Identifying the Issue
Our client was developing an oral oncology drug to enter the market in 4-5 years. This drug would be an oral analog of a current injectable cancer drug. The injectable drug is expected to be generic within one year after market launch of the oral analog. Proposed clinical trials for the oral analog drug had been targeted for the same tumor types as the injectable precursor, with endpoints targeted for non-inferiority.

The Role of DK Pierce & Associates
We assessed the changing trend in drug coverage decision making for oncology agents, and quickly learned that an oral agent, even an analog of an injectable drug, would be scrutinized as a new drug. Therefore, clinical data needed to demonstrate clinical value to the system. If the clinical trials targeted similar tumors to the injectable, without demonstrating superiority, our client would have to amend pricing to expect payer market uptake. After further research, we anticipated that the target tumors would have at least two additional novel drug competitors, and one other generic agent in addition to the precursor analog.

Demonstrated Outcomes
As a result of our findings, the client modified its entire drug development strategy to:

• Target smaller tumor types, or those with greater unmet needs
• Attempt to design select clinical trial endpoints for superiority, or better toxicity management for patients

The client felt they had a better strategic plan for market commercialization, and a blueprint for approaching payers with a clinical message of value to the health system.