Research on Digestive and Liver Diseases in FP7 Maria José Vidal-Ragout, MD, PhD Head of Unit, Medical Research Directorate-General for Research & Innovation European Commission

Content 1. EU digestive and liver disease's research: How does it work? 2. What has been addressed? 3. The future: Horizon 2020

Provide evidence-based solutions for clinical challenges and develop preventive approaches Address common risk factors (e.g. obesity, alcohol, infection, lifestyle, etc.) and identify vulnerable populations Foster improved diagnosis, early detection and stratified therapies Provide proof-of-concept for the establishment of integrated care approaches Strategic objectives for research on digestive and liver diseases

How? EU research on digestive and liver diseases Collaborative Research Public- Private Partnerships IMI Capacity Building infrastructures Legislation Directives, Regulations Bottom-up research ERC, People International co-operation GACD MS Coordination ERA-NET JPIs

EU digestive and liver diseases 'research Schemes and funds (in Million Euro)

EU digestive and liver diseases’ research What’s being funded € 382,8 million on research on digestive and liver diseases ( )  development of new therapies  Large-scale genetic studies  mechanistic and animal model studies  computer simulation of digestive system  Stem cells research and artificial liver  mathematical modelling of cell proliferation and tissue organization in tumours  molecular analysis of hepatitis virus  development of imaging tools  IT applications for patient support  comorbidities  training and mobility programmes

DNA methylation kits for clinical analyses of liver and colon cancers The Use of Methylated DNA Immunoprecipitation (MeDIP) in Cancer for better Clinical Management Altered epigenetic status: prognostic markers for colon cancer patients EU health research delivers results to patients

Role of inflammation in tumour initiation and progression Prognostic markers for GIST patients EU health research concentrates scarce resources

EU health research fosters evidence- based best clinical care

7 academic partners, 2 SMEs 5 years € 2.9 million Start date: March academic partners, 2 SMEs 5 years € 2.9 million Start date: March 2008 EU health research contributes to tailor treatment to individual patients From ethiopatogenetic insight into innovative therapy

Public Private Partnerships: – the Innovative Medicines Initiative MIP-DILI: Mechanism-Based Integrated Systems for the Prediction of Drug-Induced Liver Injury 10 academic partners, 6 SMEs, 11EFPIA partners 5 years € 32.4 million Start date: February academic partners, 6 SMEs, 11EFPIA partners 5 years € 32.4 million Start date: February 2012  Develop models that take into account the natural differences between patients  Evidence-based evaluation of both currently available and new laboratory test systems

Challenges in research on digestive and liver diseases Better prevention Novel biomarkers for disease Investigator-driven CTs Stratified patient populations and targeted therapies Innovative technology and devices Increased incidence of lifestyle associated diseases, e.g. alcohol consumption Co-morbidity, e.g. ageing, obesity, diabetes Patient-reported outcomes © pixologic, # , Source :

Digestive and liver diseases Cancer Towards joint programming in research Working together to tackle common challenges more effectively, EU COM (2008) 468 Low coordination, high fragmentation, invest less than in the US Improvements still need to be made… EU research budget represents only ~ 5% of research expenditure in MS

Increasing pressure on European healthcare systems Raising costs Over-utilisation of care, differences in outcomes, rapid expansion and shortening life cycles of technologies and insufficient comparative assessment of current practices and approaches To address significant challenges…

…and benefit from opportunities Stratified and subsequently personalised medicine can deliver cost savings and better outcomes for patients But the building blocks are many and linked, requiring clinical trials, a better understanding of disease and comorbidity, and efforts to translate results to the clinic

Horizon 2020: The next Framework Programme for research and innovation Europe needs cutting edge research and innovation Essential to ensure competitiveness, growth and jobs Vital to tackle pressing societal challenges 3% of GDP invested in R&D: headline target of Europe 2020 Proposed budget: €80bn, a 46% increase compared to FP7

Horizon 2020 novelties Simplification: Simpler programme architecture, a single set of rules Easy to use cost reimbursement model: one project - one funding rate Less paperwork in preparing proposals Reduce time to grant by 100 days Inclusive approach: More support for innovation and activities close to the market Strong focus on creating business opportunities New SBIR-like scheme dedicated to SMEs Renewed successful partnerships: EDCTP IMI © Fotolia.com

Horizon 2020: Health, Demographic Change and Wellbeing Challenge Proposal: ~ €8.5bn Understanding the determinants of health (including environmental and climate related factors), improving health promotion and disease prevention; Developing effective screening programmes and improving the assessment of disease susceptibility Improving surveillance and preparedness Understanding disease Developing better preventive vaccines Improving diagnosis Using in-silico medicine for improving disease management and prediction Treating disease Transferring knowledge to clinical practice and scalable innovation actions Better use of health data Improving scientific tools and methods to support policy making and regulatory needs Active ageing, independent and assisted living Individual empowerment for self-management of health Promoting integrated care Optimising the efficiency and effectiveness of healthcare systems and reducing inequalities through evidence based decision making and dissemination of best practice, and innovative technologies and approaches.

Horizon 2020: Health Challenge: S ome of the key features Adapting to an ageing population Pursuing the path to more personalised medicine Translational research (clinical trials) Harnessing and encouraging private sector capability Coordinating national efforts Reducing costs (comparative effectiveness research) Expanding global cooperation

Thank you!

Role of inflammation in tumour initiation and progression Prognostic marker for GIST patients 5H2TB inhibitor reduces liver fibrosis EU health research delivers results to patients