Case Study

Rho And Anthera Pharmaceticals' Collaborative Partnership In Cystic Fibrosis

By Monica Frazier, Ph.D., RAC, Research Scientist

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Rho was leading the SOLUTION study, which was designed to show Anthera’s product was not less effective (non-inferior) than the comparator product in the study, when the scope of work expanded to include supporting Anthera through a seamless transition after they decided to change their European CRO approximately 4 months into the study.

Anthera also asked Rho to lead additional complex studies in the liprotamase development program (SIMPLICITY and EASY studies), as well as to provide regulatory support through the preparation and submission of the Sollpura Biologics License Application (BLA) with the Food and Drug Administration (FDA) and the corresponding Marketing-Authorization Application (MAA) through the European Medicines Agency (EMA).

As this collaborative relationship grew, the Rho team worked hard to ensure that timelines were met, the quality of deliverables was high, and that they continued to exceed Anthera’s expectations.

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