Pharmetheus offers consulting services focused on the application of quantitative approaches to support drug research, development and life-cycle decisions.
Modeling and simulation has played an important role in supporting regulatory approvals of caplacizumab for treatment of acquired thrombotic thrombocytopenic purpura (aTTP). For example, in 2018 the EMA agreed that clinical studies of caplacizumab in the pediatric population are not feasible. Alternatively, a modeling and simulation approach was applied to identify an appropriate dosing strategy in children. As a result, in Europe, a pediatric label extension was approved in 2020.
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Our way of working, with traceability and accountability from data programming to report delivery, is well adapted to, and highly compatible with, current regulatory requirements.