Demonstrating the value of a proven executable path forward

The Challenge

A top mid-sized biotech adopted the fairly common prelaunch approach of, “Oh we will license it for rest of world” believing that prelaunch work would fall to the commercial partner and suddenly found themselves concerned about being behind. Management wanted to understand the European landscape for their orphan drug, determine the gaps in the preparations and address the open workstreams necessary for a timely launch.

Solution

In this case, we initiated our Navigator processes. We first orchestrated a workshop and a series of conversations to obtain cross functional buy on the work underway as well asunderstanding the importance of prelaunch activities. These initial discussions also demonstrate the current status of preparations. In parallel, we developed our European landscape report revealing the true value of the asset and what commercialization will look like in an Ex-US marketplace.

Based on these initial steps, we ultimately prepared a comprehensive 16-month plan, executed the required prelaunch activities across multiple functions to bring the team up to launch readiness. The client eventually outlicensed the product but was able to demonstrate they properly prepared the product and the licensor would be on time to market.

Results

Our Navigator launch plan and local market execution enabled the following:

• Brought the client back on schedule, avoided a delayed launch timeline and avoided damage to their asset’s value in Europe
• Prepared market access preparations, studies and global dossiers demonstrating the path to reimbursement
• Initiated valuable KOL management engagements building physician support
• Brought cross functional alignment and deliverables allowing for an easier prioritization of work and alignment of resources