New Horizons for Vaccine R&D&I in Europe

Ruxandra Draghia-Akli MD, PhDDirectorate E - Health Research

DG - Research & InnovationEuropean Commission

Health, Demographic Change and Wellbeing

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

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

Vaccines - high impact health intervention20th Century Impact of Vaccines

Vaccine Preventable

DiseasePeakCases

Cases2006

%Reduction

Diphtheria 30,508 0 100.0

Measles 763,094 55 99.9

Mumps 212,932 6,584 95.9

Pertussis 265,269 15,632 92.2

Polio (acute) 42,033 0 100.0

Polio (paralytic) 21,269 0 100.0

Rubella 488,796 11 99.9

Congenital Rubella 20,000 1 99.3

Smallpox 110,672 0 100.0

Tetanus 601 41 92.9Courtesy of St Plotkin, 2010

FP6 - 2002 to 2006• 210 million € + 63 million € for EDCTP vaccine projects

FP7 - 2007 to 2013 • 223 million € collaborative projects• 22 + 6 (in nego) million € for IMI • > 54 million € other (infrastructures, ERC, Marie Curie)

~ 50 million €/year EU-funded vaccine R&D in past 11 years

EU-funded vaccine research

EU support in vaccine R&DDiscovery Preclinical Phase I/IIa Phase II/ III Regulatory

small/large collaborative projects:

Translational research Clinical capacity

IMI - precompetitive technology, bottlenecks, few vaccine projects

EDCTP trials program: EU & MS

ADITEC

BioVacSafe

H2020 – Societal Challenge 1Health, Demographic Change and Wellbeing

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

Horizon 2020: What's new in Vaccine Research?

• 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

Multiplicity of opportunities (2014-2015,SC1)

ADITEC STRATEGYADITEC STRATEGY--30 million EUR, 13 clinical trials30 million EUR, 13 clinical trials

Courtesy of D. Medaglini, 2014

• 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

IMI2 Scope and Objectives

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 ITREcommittee in March and in plenary in April, followed by adoptionby the Council

Preparations ongoing for launch of IMI2 and first calls in summer

EDCTP – time for renewalCommission proposal for EDCTP 2:

Broader scope+ neglected infectious diseases, all clinical phases, diagnostics and delivery optimisation

More EU co-fundingalmost €683 million

Longer duration10 years

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?

New Horizons for Vaccine Research and Innovation

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

Objectives of the conference

HORIZON 2020

Thank you for your attention!

Find out more:www.ec.europa/research/horizon2020