Defining Patient-Centric Specification in a Risk-Based Control System

Defining limits for analytical method outputs is a central element of a control strategy. Traditional approaches usually focus on ensuring process consistency, while in more advanced approaches the understanding of structural-function relationships are utilized. This enables definition of patient centric limits that focus on controlling the impact of CQAs on product efficacy and patient safety. In certain cases, those limits and can be defined independent from a specific analytical method and where indicated can extend beyond a therapy specific clinical history. Process consistency control and change management are an integral part of the patient-centric specification and risk-based control strategy approach. The presentation will provide some practical examples for the definition of patient-centric specifications and process consistency control.

Presented by Gerald Gellermann, Scientific Officer at Novartis

Gerald currently works as Scientific Officer at Novartis Technical Research and Development (TRD) Biologics. He is member of the Novartis ICHQ12 implementation team and leads the TRD biologics QbD and Control Strategy initiative. Prior to joining Novartis, he gained professional experience in CMC and analytical development during his time at Roche and in neuroscience research and diagnostic division at Abbot/AbbVie. Gerald holds a Master’s degree in Biology from the University of Constance and a PhD in Molecular Biology from the University of Jena (both Germany).