Research & Innovation

Opportunities for Vaccine Research in

Horizon 2020

Cornelius Schmaltz, MDEuropean Commission

DG Research and Innovation 'Fighting infectious diseases and global epidemics'

Cornelius.Schmaltz@ec.europa.eu

Workshop on the joint procurement of medical countermeasures29 April 2015Luxemburg

PolicyPolicyResearch andInnovationResearch andInnovation

Overview• Introduction – H2020• Examples of major ongoing vaccine projects in

H2020: I-MOVE+, TBVAC2020, EMI-TB• Opportunities:

• 'Collaborative Research'• SME instrument• IMI2• EDCTP2• Financial Instruments

Research & Innovation

••Excellent Excellent sciencescience

••Industrial Industrial leadershipleadership

••Societal Societal challengeschallenges

• European Research Council• Future and Emerging Technologies• Marie Skłodowska-Curie actions• Research infrastructures

• Leadership in enabling and industrial technologies

• Access to risk finance

• Innovation in SMEs

SC1- Health, demographic changes

and wellbeing (€ 7.4 b)

The new EU programme for research and innovation € 79 billion (2014-2020)

HORIZON 2020 (2014-2020)

Research & Innovation

Collaborative projects

SME instrument

Financial instruments

Eureka Eurostars-2

AAL-2IMI-2

SC1 Health €7.5bn (of €31bn)

Industrial leadership €17bn

Excellent science €24bnHealth in H2020

Future and Emerging Technologies

LEIT Biotech

Marie Skłodowska Curie

Fast Track to Innovation

EDCTP-2

European Research Council

Research Infrastructures

Research & Innovation

EU support in vaccine R&I: strategyDiscovery Preclinical Phase II/ III Regulatory

Capacity building

Translational research Clinical capacity

IMI - precompetitive technology, bottlenecks, few vaccine projects

EDCTP clinical trials program

BioVacSafe

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Phase I vaccine

Small/Large collaborative

projectsSME instrument

Advance

Vaccine research in H2020 – legal base'Specific Programme'1 Societal Challenge 1 'Health, Demographic Change and Wellbeing': •Intro: 'Promotion of health, active ageing, well-being and disease prevention also depend […] on effective preventive tools, such as vaccines […].'•'1.2.3. Developing better preventive and therapeutic vaccines'•'1.3.1. Treating disease, including developing regenerative medicine': There is a need to support the improvement of cross-cutting support technologies for drugs, biotherapies, vaccines and other therapeutic approaches […], to increase success in the drug and vaccine development process (including alternative methods to replace classical safety and effectiveness testing, e.g. the development of new methods); […] to develop new biopharmaceuticals, including therapeutic vaccines; […]•'1.5.2. Improving scientific tools and methods to support policy making and regulatory needs': There is a need to support research, development, integration and use of scientific tools, methods and statistics for rapid, accurate and predictive assessment of the safety, efficacy and quality of health interventions and technologies including new drugs, biologics, advanced therapies and medical devices. This is particularly relevant for new developments in domains concerning biopharmaceuticals, vaccines, […]•1 http://ec.europa.eu/research/participants/portal/desktop/en/funding/reference_docs.html#h2020-legal-basis-sp

Research & Innovation

Why EU support for vaccine R&IPolicy objectives

•High social and economic impact disease eradication, avoid pandemics •Cost-effective for health systems and society•Reduce the risk of AMR•Mantain European leadership in vaccine R&D and manufacturing boost economy

Scientific challenges such as

•Increase effectiveness •Easy to use in developing countries•Serious gaps:

•protective vaccines available only for some diseases; therapeutic vaccines only at beginning•Elderly population

Identify, pilot test, use and disseminate the best study designs

to measure the effectivenes (direct effect)and the impact (indirect and overall effect) of influenza and pneumococcal vaccines

against clinical and laboratory confirmed outcomesin the elderly population

8

I-MOVE+, a scientific public health platform to

Influenza– 17 GP (2000) sentinel networks in 13 countries– EU network of 24 hospitals in 12 countries– Pooling of 6 electronic data bases in 5 countries– Deliverables:

generic protocols, VE and impact results (reports, articles, scientific conferences)

Pneumococcal diseases– A hospital / laboratory network in 6 countries– Registry based studies– Deliverables:

generic protocols, VE and impact results (reports, articles, scientific conferences)

Cost benefit analyses – Group of experts from 5 countries using data from all countries– Deliverables:

generic protocols, VE and impact results (reports, articles, scientific conferences) 9

Study settings in EU / EEA countries

I MOVE + partners

10

Participant No Short name Participant organisation name Country1 EPICONCEPT EPICONCEPT France2 ISCIII Instituto De Salud Carlos III Spain3 HSE Health Service Executive Ireland4 NHSNSS NHS National Services Scotland United Kingdom5 INCDMIC National Institute of Research-Development for

Microbiology and Immunology "Cantacuzino"Romania

6 NIZP-PZH National Institute of Public Health - National Institute of Hygiene

Poland

7 Instituto Nacional de Saúde Dr. Ricardo Jorge Instituto Nacional de Saúde Dr. Ricardo Jorge Portugal8 Organismo Autonomo Instituto De Salud

Publica y Laboral de NavarraInsituto de Salud Pública y Laboral de Navarra Spain

9 RCGP Royal College of General Practitioners United Kingdom10 NLNA National Institute for Public Health and the

Environment (RIVM)The Netherlands

11 Centre Hospitalier Universitaire CIC St Eloi - Centre Hospitalier Universitaire de Montpellier

France

12 Assistance Publique - Hopitaux de Paris Centre Cochin-Pasteur de Vaccinologie, Assistance Publique-Hôpitaux de Paris

France

13 DH Public Health England United Kingdom14 CNIPH Croatian National Institute of Public Health Croatia15 NIVEL Stichting Nederlands Instituut voor Onderzoek

van de GezondheidszorgThe Netherlands

16 UEDIN The University of Edinburgh United Kingdom17 THL National Institute for Health and Welfare Finland18 Statens Serum Institut Statens Serum Institut Denmark19 Robert Koch Institut Robert Koch Institut Germany20 OCMO Office of the Chief Medical Officer Hungary21 Istituto Superiore di Sanità Istituto Superiore di Sanità Italy22 InVS Institut de veille sanitaire France23 UPMC Université Pierre et Marie Curie France24 NIPH Norwegian Institute of Public Health Norway

11

TBVAC2020Advancing novel an promising

TB vaccine candidates from discovery to preclinical and early clinical development

40 partners; Coordinator Tuberculosis Vaccine Initiative(TBVI)

Total EU Budget: € 18.2 millionOther countries: € 5.2 millionProject start: January 2015Duration: 4 years

Horizon 2020:Horizon 2020:TB vaccine research projectsTB vaccine research projects

EMI-TBEliciting mucosal immunity in

tuberculosis

14 partners; Coordinator St George's University of London

Total EU Budget: € 8.0 millionProject start: January 2015Duration: 4 years

http://emi-tb.org/

http://www.tbvi.eu/projects/tbvac2020.html

Research & Innovation

'COLLABORATIVE RESEARCH'

• Biannual workprogrammes (with updates) published by EC • Aims to foster collaboration between

CountriesSectors Diciplines

• Open for the participation of the world but • Minimum: 3 legal entities from 3 different EU Member States or

FP-associated countries

Priorities addressed in 2014-2015:• Vaccine development for poverty related and neglected infectious

diseases• 2014 – Tuberculosis € 25 million• 2015 – HIV/AIDS € 21 million

Understanding the call topics: example

'PHC 2 – 2015'

'Specific challenge'

'Scope'

'Expected impact'

'Type of action'

Inspired by the US Small Business Innovation Research (SBIR)

Single company support possibleTarget group: Innovative SMEsOnly EU SMEs allowed to apply for fundingCompetitive, market-oriented, EU dimensionHealth topic for 2014/15: PHC-12: Clinical validation of

biomarkers and/or diagnostic medical devices

• Next cut-off dates: 17 June, 17 September, 25 November (phase 1 and 2)

New SME instrument

H2020:~€3 billion SC1 Health: ~€500m

SME instrument

Concept & Feasibility

Assessment

Innovation /R&D activities

Commercialisation

Phase 2Phase 1 Phase 3Idea Market

• Feasibility of concept• Risk assessment• IP regime• Partner search• Design study

• Clinical trials• Prototyping• Piloting, scaling-up• Miniaturisation, design• Demonstration• Market replication

• Facilitate access to private finance

• Support via networking, training, coaching, knowledge sharing, dissemination

€50,0006 months

€1 to 5 million36 months

100% funding rate in SC1No direct funding

IMI – Europe’s partnership for health

Partnership2008 - 2024 €2.5

bn

IMI 2 research strategic agenda

http://www.imi.europa.eu/sites/default/files/uploads/documents/IMI2_SRA_March2014.pdf

European Health Priorities to be addressed by IMI2

1.osteoarthritis2.cardiovascular diseases3.diabetes4.neurodegenerative diseases5.psychiatric diseases6.respiratory diseases7.immune-mediated diseases8.ageing-associated diseases9.cancer10.rare/orphan diseases11.vaccines

How to get involved

Organisations bringing own resources to the projectBecome an EFPIA partner in research

Involved in topic incubationBecome an IMI2 Associated Partner

Join a pre-established topic prior to Call launch

Organisations not bringing own resources to the projectSubmit a topic idea

http://imi.efpia.eu/imi2/create-your-imi2Form / join a consortium and submit a proposal

http://www.imi.europa.eu/content/overview-imis-calls-how-participate

Future IMI Calls - Timelines & info

Find out more: http://bit.ly/futuretopicsCall launch: Summer 2015

Disclaimer - All information regarding future IMI Call topics is indicative and subject to change. Final information about future IMI Calls will be communicated after approval by the IMI Governing Board.

Stay in touch

Visit our website www.imi.europa.eu

Sign up to our newsletter bit.ly/IMInewsletter

Follow us on Twitter @IMI_JU

Join our LinkedIn groupbit.ly/LinkedInIMI

E-mail usinfodesk@imi.europa.eu

Research & Innovation

EDCTP2 (2014-2020)1. extended scope to include neglected

infectious diseases, all clinical phases, diagnostics and delivery optimization

2. increased budget: €2 bn, with ~€1.3 bn from European participating states + nearly 700 million from the EU

3. Extended duration – 10 Years (2014-2024)

4. Implemented by the EDCTP Association which has 13 European and 13 African countries as members with equal voting rights in the EDCTP General Assembly

5. EU provides co-funding of €683 million from Horizon 2020 (2014-2020) matching contributions from the European participating states

http://www.edctp.org/

Research & Innovation

How EDCTP operates

Capacity for Clinical Trials in

Africa

Clinical Trials in Africa on PRDs 22

Synergy

Research & Innovation

What EDCTP funds

Diseases: HIV/AIDS, TB, Malaria, NIDs, emerging infectious diseases of particular relevance for Africa, including EbolaNew tools and interventions: Diagnostics, drugs, vaccines and microbicides Capacity Development: Fellowships, Networks, Ethics, RegulatoryGeneral rules for participation: At least 2 legal entities in EU Member States or in countries associated to Horizon 2020 and one legal entity in Sub Saharan Africa 23

H2020 budget:~€2.8 billion

Financialinstruments

• InnovFin Large ProjectsLoans from €7.5 m to €300 m; delivered directly by EIB

• InnovFin MidCap Growth FinanceLoans from €7.5 m to €25 m; delivered directly by EIB

• InnovFin MidCap GuaranteeGuarantees to financial intermediaries (banks, etc.)Loans from €7.5 m to €25 m; implemented by EIB

• InnovFin SME GuaranteeGuarantees / counter-guarantees to financial intermediariesLoans from €25,000 to €7.5 m; implemented by EIF

• InnovFin AdvisoryImprove 'bankability' of large projects

Financial instruments:indirect support

Fast Track to Innovation (FTI)

• Pilot call: €100 million in 2015 ; €100 million in 2016

• Expected impact: Fast development, commercial take-up and/or wide deployment of sustainable innovative solutions

• Time to initial market take-up no later than 3 years after the start of the project.

• Fully bottom-up, close-to-market activities, 70% funding rate

• Restricted to MS and AC, minimum 3, maximum 5 partners, maximum €3 m EU contribution per project

• Eligibility: 60% of the overall project budget allocated to industry participants in the consortium or majority of industry participants

• Next deadline: 29 April 2015

FTI (2015-16):€200 million

Research & Innovation

All H2020 information, including call documentation published on the Participant Portal

http://ec.europa.eu/research/participants/portal/page/home

Research & Innovation

We need experts!Appropriately qualified individuals may apply to work as experts in H2020 evaluations

• Application via Participant Portal

http://ec.europa.eu/research/participants/portal/desktop/en/experts/index.html

HORIZON 2020

Thank you for your attention!

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