Keys of Collaboration to Enhance Efficiency and Impact of Modeling and Simulation

Modeling and Simulation (M&S) can be a key factor in efficient drug development. It is well recognized that collaboration of multiple disciplines is critical to the success of M&S in supporting drug development decisions. This chapter provides guidance on how the main collaborators (biostatistics, clinical research and clinical PK-PD) can achieve co-ownership of M&S efforts to make better informed decisions on trial designs. The clinical development program of corifollitropin alfa is presented as an example of successful model-based drug development. Throughout a long-lasting collaborative effort, biostatistics and clinical PK-PD scientists have learned to appreciate each other’s methods, all collaborators have shared their expertise to integrate physiological and pharmacological concepts with clinical data and clinical research has started to pro-actively conduct model-informed trials. Cultural barriers and logistical difficulties were overcome, resulting in an organizational structure that ensures better informed decisions on trial designs and more efficient drug development.