Albireo is a small biotechnology company whose lead candidate is a drug called odevixibat being developed for a rare pediatric liver disease called progressive familial intrahepatic cholestasis, or PFIC. The company intended to file its first marketing applications for an indication that was new, not only to it, but to regulators as well, so we were blazing a trail.
We needed an efficient plan for completing and filing those applications in the US and EU following database lock of our randomized, blinded Phase 3 trial. With limited staff and being our first foray as a team to undertake such an endeavor, it was critical that the project be managed expertly. This is where ImprovementatWork came in and truly enabled us to be successful. By being able to offload the process and planning part of the project, we were able to concentrate on the subject matter itself. Johan and Anne-Marie and their team seamlessly integrated themselves into our organization and became a critical part of our operation.
IAW’s level of planning and the granularity with which they programmed our activities was essential to our success. IAW was a pleasure to work with, and I would use them again in a heartbeat.
Martha (Muffy) Carter, Chief Regulatory Officer, Albireo Pharmaceuticals
