New Horizons for Vaccine R&D&I in Europe

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1 New Horizons for Vaccine R&D&I in Europe Health, Demographic Change and Wellbeing Ruxandra Draghia-Akli MD, PhD Directorate E - Health Research DG - Research & Innovation European Commission

2 Why EU support for vaccine R&D? high impact eradication, pandemics cost-effective for health systems and society technological innovations may boost economy societal target groups (elderly, children,...) vaccine R&D in Europe and the world protective vaccines for only some diseases therapeutic vaccines only at beginning

3 World vaccine market (Kalorama Information and IMS Health) Annual growth rate global vaccine market 9-10 % Annual growth rate global pharma market 4-5 % Share vaccines of total pharma market ~4% in 2012

4 Vaccines - high impact health intervention 20th Century Impact of Vaccines Vaccine Preventable Disease Peak Cases Cases 2006 % Reduction Diphtheria 30, Measles 763, Mumps 212,932 6, Pertussis 265,269 15, Polio (acute) 42, Polio (paralytic) 21, Rubella 488, Congenital Rubella 20, Smallpox 110, Tetanus Courtesy of St Plotkin, 2010

5 EU-funded vaccine research FP to million + 63 million for EDCTP vaccine projects FP to million collaborative projects (in nego) million for IMI > 54 million other (infrastructures, ERC, Marie Curie) ~ 50 million /year EU-funded vaccine R&D in past 11 years

6 EU support in vaccine R&D Discovery Preclinical Phase I/IIa Phase II/ III Regulatory small/large collaborative projects: ADITEC EDCTP trials program: EU & MS IMI - precompetitive technology, bottlenecks, few vaccine projects BioVacSafe Translational research Clinical capacity

7 H2020 Societal Challenge 1 Health, Demographic Change and Wellbeing

8 Horizon 2020: What's new in Vaccine Research? FOCUS ON INNOVATION Trigger the entire innovation chain with broad topics (from basic to close to market research) Prevention is a priority Patient oriented calls- personalised medicine Technology platforms/infrastructures, clinical trials and product technology oriented

9 Multiplicity of opportunities ( ,SC1) SME focus/instrument (clinical validation of biomarkers) Cooperative projects (epidemics, TB, HIV) Global Initiatives (support for international infectious disease preparedness research, ERA-NET antimicrobial resistance) Infrastructures New financing models (e.g. TB) PPPs: IMI2 and EDCTP2

10 ADITEC STRATEGY-30 million EUR, 13 clinical trials Courtesy of D. Medaglini, 2014

11 IMI2 Scope and Objectives IMI2 will expand the scope of IMI1 to cover the entire medical research and innovation value chain Actively involve life science industries other than pharmaceuticals; for example the vaccine, the animal health or the biomedical imaging industry Enable top quality research and innovation with great public health benefits and commercial possibilities Pave the way for the breakthrough vaccines, medicines and treatments which we will need in the near future Develop new therapies for diseases with high unmet needs, such as Alzheimer's disease, and limited market incentives, such as antimicrobial resistance

12 IMI2 budget and way forward Overall Budget : 3.27 Billion Euro of which 1.64 from EU All EU funding goes to SMEs, medium-sized industrial partners, academia, patient organisations and regulatory agencies Agreement between the institutions reached: Vote on the formal opinion of the European Parliament in ITRE committee in March and in plenary in April, followed by adoption by the Council Preparations ongoing for launch of IMI2 and first calls in summer

13 EDCTP time for renewal Commission proposal for EDCTP 2: Broader scope + neglected infectious diseases, all clinical phases, diagnostics and delivery optimisation More EU co-funding almost 683 million Longer duration 10 years

14 New Horizons for Vaccine Research and Innovation First Day- 12 March- two sessions 1. Vaccine Innovation: with People - for People 2. Innovation in Vaccine Design Second Day- 13 March- one session 3. Vaccine Innovation: Who pays?

15 Objectives of the conference Define a strategy plan, priorities and concrete actions that should require financial and/or political support in the future years at European and global level

16 HORIZON 2020 Thank you for your attention! Find out more: