ISSUE: In the pharmaceutical industry, real world data and evidence (RWD/E) is increasingly being used to define, differentiate, and deliver value across the drug life cycle. However, as an emerging and underdeveloped capability within organisations, there are considerable challenges to its effective use. The challenge of finding the appropriate organisational structure to reduce the gap between a company’s RWD/E ambition and its ability to deliver on it, is a topic of lively debate within industry. While some advocate for a more centralised approach, with the creation of companywide Centre of Excellence (CoE), others are pushing for more distributed groups of RWD/E experts and tools across the organisation. In between these two extremes, there is an option of adopting a hybrid approach.

OVERVIEW: Panellists will debate the merits and limitations of three distinct organisational models of RWD/E generation (i.e., centralised, federated, and hybrid), exploring how each relate to defined guiding principles and governance practices. Callum Caldwell will moderate the panel and provide an overview of the challenges facing industry, with respect to RWE generation, and capabilities (i.e., skills, processes, technologies, human resource, and expertise) required. Each panellist will take 5-10 minutes to describe a selected organisational model and advocate for its use. Maurille Feudjo Tepie will argue for the pooling of resources within a single group, function or CoE – a centralised model. Simon Teal will argue for a federated model (RWE practitioners spread throughout an organisation), where governance may be mandated through guidelines and Standard Operating Procedures (SOPs). Paul Petraro will advocate for a hybrid approach, where RWE use case will drive the organizational practice. The panel will conclude asking for audience perspectives and questions. The panel will be a rare chance for cross-industry leaders and RWE practitioners to come together, share learnings and discuss topics usually deemed commercially sensitive.