IMI is a large public private partnership which has committed Euro 5 Billion from the European Commission, the European Pharmaceutical sector and other partners, to enable and accelerate bringing medical innovation to patients. IMI is now 10 years old and already has changed the ecosystem and way of working in developing innovative medicines across the public/private divide. Big data represents a significant piece of this investment and projects in this area are attempting to provide solutions to major challenges including:

1. Data integration from many sources across many jurisdictions and institutions and which need to be validated with regard to their quality and robustness

2. Data interfaces, for example, between research and clinical data and how to overcome the challenges around data protection and access

3. Data standards and who establishes these and how they are deployed

4. How do we scale and sustain some of the successful pilots to ensure the value of the investment?

5. How do we take advantage of the digital revolution to enable more relevant and accurate data capture in the real world?

Much has been done already through IMI projects and beyond and now we need to consolidate through intelligent implementation across the European landscape. With a mixture of generic and disease specific investments, and although many challenges remain, significant progress has been made and examples of success will be described.