Getting an Emerging Company Ready for Launch in Less Than One Year

A clinical stage biotech company had been focused on R&D for two decades. One of the assets the company had out-licensed was returned to it after a pivotal data readout. With the “clock ticking,” the company reached out to Blue Matter to help them get ready to launch in about one year.

Our work involved five major components – most of which occurred in parallel. Our first step was to establish the launch team structure, governance, and ways of working. Next, we conducted a situation analysis and devised a launch strategy, focusing on the key issues, objectives the client needed to achieve, and tradeoffs the client would need to make. The third major component was an integrated launch roadmap that cut across all relevant functions. Fourth, we developed a granular execution plan that defined the sequence of interdependent material reviews, internal communications, and external stakeholder engagement. Finally, we provided overall launch management support, focusing on the Launch Core Team and key workstreams.

The client was fully launch ready by the time of its PDUFA date. Leaders and team members across functions had a broad understanding of the launch situation, strategy, and integrated cross-functional execution plan to drive a successful launch.