Preparing an emerging biotechnology company for accelerated approval

Situation

Our client was ready to submit two indications to the FDA for accelerated approval. However, with just 12-18 months to launch, they lacked a commercial strategy and launch approach for the indications. They had just one person in the commercial team and no time to recruit and train new members.

Solution

The task required an embedded consultant who could join the client’s team to develop a cross-functional launch strategy from the ground up. Our consultant provided the regulatory expertise needed to efficiently and effectively navigate the accelerated approval process and liaise with Regulatory, Manufacturing, Compliance, Legal, R&D, and other internal teams, allowing the project to keep to the required timelines.

With access collaborated with colleagues at Avalere Health to define the budget and go-to-market scenarios around data readout/launch. These scenarios fueled a successful launch strategy that drove differentiated positioning.

Success

The consultant developed and implemented the cross-functional launch plans on time, within 6 months. Through the joint efforts of our embedded consultant and wider team, the client was able to manage all aspects of the launch process, including training their client R&D teams on commercialization to ensure future success.