DIA EUROPE 2021

Advances in disease biology understanding and the use of innovative, complex trial designs coupled with a strong public health focus are paving the way for new approaches to drug development. Focus of this session will be to discuss the concept of trans-diagnostic drug development in a fresh context. A specific drug target often appears in a range of different diseases, and as such drugs may have the potential to be effective across a variety of indications. The traditional approach to development of such drugs has for many years been approval of one indication within one diagnostic category, with subsequent sequential addition of new indications as part of the life cycle management. However, there has been a shift away from this traditional thinking in recent years. We are seeing the emergence of FDA, PMDA – and now also EMA – approvals of ‘tumour-agnostic’ or ‘histology-independent’ oncology therapies. Therefore, based on the recent oncology examples could the ‘trans-diagnostic’ or, ‘disease agnostic’ treatment concept become more relevant in the future across different therapeutic areas? In this session we will be discussing the case for trans-diagnostic approaches beyond oncology from a regulators, patient and industry perspective.