Giorgio Clarotti, Health Strategy

Research & Innovation, European

Commission

Rome

Societal Challenge "Health, demographic

change and well-being" – December '17

2SC1 – WP 18-20 - Gio

Research and innovation – a growing priority for the EUHorizon 2020 supports Commission priorities

• Jobs and growth

• Societal challenges

• European industrial leadership and competitiveness

• EU international excellence

Horizon 2020

• Couple research to innovation

• Provide evidence-base for addressing societal challenges, supporting EU policies and better regulation

• Strengthen research capacities and innovation strategies across all Member States

• Multidisciplinary and synergies

• Address people's concerns

2

3

Evidence based policy making

There are many ways to measure impact

Medicines for

children

Health

Technology

Assessment

ATMP

and many others…

Taking the lead in new areas of

growth

Personalised

medicine

Responding to emergencies

Knowledge creation and exploitation

SC1 – WP 18-20 - Gio3

Collaborative

projects

SME

instrument

Financial

instruments

Eureka Eurostars-2

AAL-2IMI-2

SC1 Health €7.3bn (of €31bn*)

Industrial leadership €17bn*

Excellent science €24bn*

Health Research in H2020

Future and

Emerging

Technologies

LEIT Biotech

Marie Skłodowska

Curie

Fast Track to

Innovation

EDCTP-2

European

Research Council

Research

Infrastructures

* Figure to be updated following EFSI investments in 2016-2017 and FP7 recovery in 2016

SC1 – WP 18-20 - Gio4

5

Public-private partnership

Public-public partnerships

Frontier research

Support to innovation

Research Education Innovation

Health research infrastructures Deployment of

innovative solutions

Health research in Horizon 2020

Modelling & predictive

(neuro)sciences

Human Brain

Project

Loans for de-risking R&I

Collaborative health research (SC1)

SC1 – WP 18-20 - Gio5

6SC1 – WP 18-20 - Gio

6

Collaborative health research

(SC1)

Public-private partnership

Public-public partnerships

Frontier research

Support to innovation

Research Education Innovation

Health research infrastructures

Deployment of innovative solutions

Health research in Horizon 2020

Modelling & predictive

(neuro)sciences

Human Brain

Project

Loans for de-risking R&I

7

Health R&D in Europe and in US

• H2020 SC1 Health: 12,5% of EU total

• EU total: 31,1% of US total

• US - Health R&D = 30% of Civil public R&D

• EU – Health R&D = 8% of Civil public R&D

• H2020 – Health (SC1) = 10% of H2020 total

SC1 – WP 18-20 - Gio 7

8SC1 – WP 18-20 - Gio

Various instruments along the value chain

8SC1 – WP 18-20 - Gio

0

200

400

600

800

1000

1200

1400

FP7 Avg 2014 2015 2016 2017 2018 2019 2020

Total Operational budgets (mio€)

TotalOperationalbudgets

Planned-EFSI

SC1 Investment Plan: back-loaded

Evolution of yearly Impact on 2016-2017 work programme (15% for RTD, 20% for CNECT) (Mio€)

*100 m€ GrifolsBioscience - ES*150m€ UK Hospitals* 70 m€ IE PrimaryCare*??? Life Science RDI

*European Fund for Strategic Investment

(President Juncker Investment Plan)

100 m€ 100

m€

9SC1 – WP 18-20 - Gio

SC1 Investment: a balanced portfolio, innovative solutions

Leveraging investment in various type of instruments (Mio€, 2014 to 2017)

• PPP = Public-Private Partnership (IMI-2) = ~ 24% to date, +100% from industry• P2Ps = (JPIs, Art.185, ERA-NETs, EJP) = ~14% to date, + at least 100 % by partners• SME Instrument and Financial Instruments (FTI, EFSI, InnovFin ID) = ~7% to date• Rest of Work Programme = 49 % to date

1

0SC1 – WP 18-20 - Gio

11SC1 – WP 18-20 - Gio

11

Public-Private

Partnership

12SC1 – WP 18-20 - Gio

- 30 November: Launch of Call 13 (16 topics) – EUcontribution: € 124.5m + In-kind contribution from EFPIA&Associated Partners: € 113.5m

- supports health research and innovation, speeding upthe development of innovative medicines, particularly inareas of unmet medical need

- covers the full spectrum of drug discovery anddevelopment

- facilitates collaboration between universities, researchcentres, the pharmaceutical and other industries; SMEs,patient organisations, and medicines regulators

- Strategic Research Agenda based on the WHO PriorityMedicine Report renewed in July 2013

http://www.imi.europa.eu/get-involvedhttp://www.imi.europa.eu/apply-fundinghttp://www.imi.europa.eu/apply-funding/general-overview/tips-applicants

BUDGET: € 3.276 billion2013-2020: EC: €1.638 bn + EFPIA: €1.425 bn

+ Associated Partners: €0.213 bn

1

2

13SC1 – WP 18-20 - Gio

13

Public-Public

Partnership

14SC1 – WP 18-20 - Gio

- EDCTP2 Annual Work Plan 2018 to be adopted mid-2018:EU-funded activities: € 115m + new ParticipatingStates: € 115m

- covers research accelerating clinical development ofmedical interventions to prevent or treat HIV/AIDS,tuberculosis, malaria and other infectious diseases

- includes the development of drugs, microbicides, vaccines,diagnostics and their delivery

- supports coordination of European national researchprogrammes

- funds collaboration between EU, European countries andsub-Saharan African countries

BUDGET: ~ € 1.37 billionEC: € 683 m + MS: € 683 m

www.edctp.org/see-work/strategywww.edctp.org/funding-opportunities/calls

1

4

15

Public Public Partnerships in H2020, SC1

Overall investment by Member States: More than 2500 M€, 7 actions (Feb'16)

JPIs TOTAL INVESTMENT in JOINT Calls and Actions (MS+EC)

Neurodegenerative

Diseases (+CSA/ERA-NET)27 Countries, 2009-2020, ~130 M€ + 10 M€ EC

Anti-Microbial Resis-tance

(+CSA/ERA-NET)22 Countries, 2011-2020, ~50 M€ + 7.8 M€ EC

More Years, Better Life

(+CSA)19 Countries, 2011-2020, < 10 M€ + 2 M€ EC

Heathy Diet for a Healthy

Life (+CSA/ERA-NET)25 Countries, 2010-2020, > 30 M€ + > 5 M€ EC

Total Investment 4 JPIs: ~200 M€ + > 25 M€ from EC

Art.185 Initiatives TOTAL INVESTMENT in JOINT Calls and Actions (MS+EC)

Ambient Assisted Living

(AAL)22 Countries, 2006-2024, ~0.7 B€ + 0.5 B€ EC + Industry

EU & Dev. Cy Clinical Trials

Partners. (EDCTP)14+14 Countries, 2006-2024, ~1 B€ + 1 B€ EC + BM Gates

EU Metrology Pgm for Inno

& Research (EMPIR)28 Countries, 2006-2024, ~0.6 B€ + 0.6 B€ EC

Total Investment 3 Art.185: ~2.3 B€ + > 2 B€ from EC + Others

16

Two HIV paediatric formulas – safe and highly effective at protecting infants during breastfeeding up to 12 months after birth

The Lancet, 18 November 2015

Pyramax® approved as antimalarial for treatment of multiple episodes of malariaEMA news: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015

9 December 2015 – EDCTP receives Science Diplomacy Award at South African Science Forum

17SC1 – WP 18-20 - Gio

- Expected launch date of Call 2018: 5 February2018 focused on: Smart solutions for ageing well (“opencall”).

- The call is addressing solutions for purchase by olderadults as well as for purchase by those who provide theservices for them such as care organisations ormunicipalities.

- Strong involvement of end users: co-creation processwith end users such as older adults, carers, insurers orhealth care service providers in the whole projectlifecycle Strong business and market orientation sought

- Strong business and market orientation (short time tomarket: 2 years after the completion of the project)

BUDGET (indicative): € 26 M*

http://www.aal-europe.eu/get-involved/calls/

SC1 – WP 18-20 1

7

*total budget project call 2018 (EC + MS). Exact figures MS contribution will be available end 2017.

18SC1 – WP 18-20 - Gio

18

Joint Programming initiative on Neurodegenerative Disease Research (JPND)

• 30 countries; EU Member States-led initiative to increase

coordinated investment among participating countries

• Strategic Research Agenda spanning biomedical, healthcare and social science research

• Public database mapping relevant national and European research and infrastructures

• Informing national research agendas/plans

• Currently some EUR 123 million invested in 9 transnational calls (incl. co-fund of 10 million from EC)

Coordinating national research

19

ERA-NET Cofund actions in H2020, SC1Overall investment by Member States: More than 350 M€, 9 actions (Jan '17)Co-Fund: ERA-NET & EJP TOTAL INVESTMENT in JOINT Calls and Actions (MS+EC)

E-RARE 3 Rare Diseases

Runs from ('15-'19)

17 Countries

(19.5 + 5.8 + ~30 Additional Own calls) ~50 M€ (48M€ - 95 % done)

JP cofund, Neurodegene-

rative diseases ('15-'19)

20 Countries

(35 + 10 ? + ? additional) > 40 M€ (46 M€ done, more to do)

TransCan2 Translational

Cancer ('15-'19)

19 Countries

(17 + 6.7 + ~30 Additional Own calls) ~50 M€ (47 M€ - 95% done)

ERACo-Sysmed System

Biology Medicine ('15-'19)

13 Countries

(10 + 4 + Additional Own calls?) > 15 M€ (21 M€ --> More to do)

ERA-NET NEURON Brain

diseases ('16-'20)

17 Countries

(17 + 6.8 + ~40 Additional Own calls) ~60 M€ (40 M€ - 66% done)

ERA-NET JPI Anti-Microbial

resistance ('16-'20)

18 Countries

(21 + 7.8 + Additional Own calls?) > 26.4 (43 M€ done +more todo)

ERA-CVD Cardiovascular

Runs from ('16-'20)

18 Countries

(11.4 + 2.5 + Additional Own calls?) ~20 M€ (14M€ --> More to do)

PM-05-2016 EJP Human

Biomonitoring Initiative 26 Countries, 2017-2022, > 25 M€ + 50 M€ EC (70% fund.)

HCO-03-2017 ERA-NET

Personalised Medicine> 20 Countries, 2018-2023, > 12 M€ + 5-6 M€ EC

Total Investment 8 ERA-NET + 1 EJP: ~250 M€ + 100 M€ from EC

20SC1 – WP 18-20 - Gio

21SC1 – WP 18-20 - Gio

European Innovation Council: pilot 2018-2020 € 2.7 billion to support +5,000 SMEs and innovators

ECOSYSTEM SUPPORT: COACHING, MENTORING for all SME beneficiaries

Test and co-createDemonstrate,

validate

Feasibility / Startup Development

Scale up Investment

Early stagescience & techEmerging tech,Visionary ideas

FTIFast Track to Innovation

FET-OPEN Future

EmergingTechnologies

SME Instrument

Phase 1

SME Instrument

Phase 2Soft blending

HORIZON PRIZES1. Innovative Batteries for eVehicles2. Fuel from the Sun: Artificial Photosynthesis 3. Early Warning for Epidemics4. Blockchains for Social Good5. Low-Cost Space Launch 6. Affordable-HighTech for Humanitarian Aid

MA

RK

ET

CR

EA

TI

NG

21

NEW

21SC1 – WP 18-20 - Gio

22SC1 – WP 18-20 - Gio

22

Full bottom-up and introduction of interviews are the main new features of the evaluation under EIC Pilot

Responsibility

Applicants

H2020 Evaluation team

Experts

Below threshold(s)

Abovethresholds

Invited for interview

Not invited for interview

Proposed for funding

Not proposed for funding

23SC1 – WP 18-20 - Gio

Instrument SME-Instrument

FTI FET-Open EIC Horizon prizesPhase 1 Phase 2

For whom One or more eligible1 SMEs

From 3 to 5

eligible1

entities (mostly

industrial2)

At least 3

entities3

One or more entities

(with restrictions1 for

some of the prizes)

Maximum

funding450,000 € 2.5 M€ 3 M€

3 M€ (RIAs)

0.5 M€ (CSAs)Varies for each prize

Total budget

2018-20164 M€ 1,425 M€ 300 M€

647 M€ (RIAs)

10 M€ (CSAs)40 M€

Focus

Exploring the

feasibility of a

business idea

(~ 6 months)

Breakthrough

innovation &

international

growth

(12-24 months)

Close-to-

market

innovation

Radically

new

technologies

6 different topics

(major societal issues)

(1) Applicants must be established in an EU Member State or in a country associated to Horizon 2020(2) This industry involvement implies: (a) either the allocation of at least 60% of the budget to industry participants in the

consortium, or (b) the presence of a minimum number of two industry participants in a consortium of three or four partners, or of three industry participants in a consortium of five partners

(3) A FET-Open consortium must always include at least 3 participants from 3 different EU Member States or Associated Countries. In addition to these three partners, any legal entity from anywhere in the world can also be included in the consortium.

(4) Per project – with possible exceptions

23

24SC1 – WP 18-20 - Gio

24

EU-funding boosts SMEs deal activity

2010-2015: 4,6 deals per SME (twice more than for non-EU funded SMEs)

Example: NABATIVI project

Source: CORDA/ MedTrack

EU-funding boosts SME's Initial Public Offering

• Example: Immunovia

• Listed at Nasdaq North, market value tripled in 18 months to €300m

Is EU funding worth for SMEs ?

25SC1 – WP 18-20 - Gio

25

Horizon 2020

WorkProgrammes 2018-2020

Political context

26SC1 – WP 18-20 - Gio

26

An attractive, simplified and well-performing programme, highly relevant for stakeholders and societal needs

On track to deliver value for money and to meet its knowledge-creating objectives

Strong EU Added Value through unique opportunities, competition & access to new knowledge

€

Key findings from the H2020 INTERIM EVALUATION

KEY STRENGTHS

27SC1 – WP 18-20 - Gio

27

Key findings from the H2020 INTERIM EVALUATION

KEY AREAS FOR IMPROVEMENT

Underfunding

Has lower success rates than FP7, esp. for high quality proposals

Support for market-creating innovation

Demonstrates potential for breakthrough, market-creating innovation, but it should be strengthened substantially

Greater outreach to civil society

Should better explain the impacts of R&I, and involve even more the users & citizens in agenda-setting & implementation

28SC1 – WP 18-20 - Gio

28

A positioning system in the brain

EU FP5 Life Sciences ('NAPPY') and FP7 Health

('SPACEBRAIN') collaborative research

grants

& ERC grants

EU-supported research: Brain research

29SC1 – WP 18-20 - Gio

29

Treating leukaemia with designer immune cells

EU-supported research: Regenerative medicine

30SC1 – WP 18-20 - Gio

New tissue growth

Project "ESPOIR"

• Heart valve defect (2 in every 100 babies born): valve-replacement surgery very successful BUT limited immune tolerance in young patients, outgrow their valve, re-operations required every 5-10 years

• Implant a decellularised human donor valve: does not activate the immune system, and promotes tissue regeneration

• 121 patients treated: zero valve-related mortality - 83 % of patients free from any re-intervention or re-operation

• Obtained regulatory and reimbursement approval for decellularised human heart valves in DE, CH, NL, IT, UK, BE

EU-supported research: Regenerative medicine

31SC1 – WP 18-20 - Gio

1. Personalised medicine

5. Decoding the role of the environment for health and

well-being

3. Infectious diseases and improving global health

7. Trusted Big Data solutions and Cybersecurity for Health and Care

6. Digital transformation in Health and Care

4. Innovative health, and care systems –Integration of care

2. Innovative health and care industry

Health collaborative research –7 priorities for 2018–2020

© bahtiarmaulana , #110775030, 2017. Source: fotolia.com © robu_s, #101871020, 2017. Source: Fotolia.com, © maxsattana, #174546837, 2017. Source: Fotolia.com; © glopphy, #41555605, 2017. Source: Fotolia.com; © iconimage, #115660282, 2017. Source: Fotolia.com; © Maren Winter, #137474084, 2017. Source: Fotolia.com

32SC1 – WP 18-20 - Gio

7 priorities implemented via SC1 Work Programme 2018–2020 through 3 Calls for proposals

Call 'Better Health and care, economic growth and sustainable health systems'5 main priorities & 32 topics

Call 'Digital transformation in Health and Care'13 topics

Call 'Trusted digital solutions and Cybersecurity in Health and Care'3 topics

Other Actions 2018–2019 7 items

3232SC1 – WP 18-20 - Gio

33SC1 – WP 18-20 - Gio

Priority 1 – Personalised medicine

AIM: Delivering personalised health and care to benefit patients andcitizens

FOCUS: complex disorders, human microbiome, rare diseases and datasharing for enabling personalised medicine, economic models, reinforcinginternational and regional collaboration

POLICY DRIVERS:

Council conclusions on Personalised Medicine

International Consortium on Personalised Medicine

European Reference Networks

33

34SC1 – WP 18-20 - Gio

Personalised Medicine in Work Programme 2018–2020 (I)

• BHC-03-2018: Exploiting research outcomes and applicationpotential of the human microbiome for personalised prediction,prevention and treatment of disease

• BHC-04-2018: Rare Disease European Joint Programme Cofund

• BHC-05-2018: International flagship collaboration with Canada forhuman data storage, integration and sharing to enable personalisedmedicine approaches

• BHC-01-2019: Understanding causative mechanisms in co- andmultimorbidities

• BHC-02-2019: Systems approaches for the discovery ofcombinatorial therapies for complex disorders

3434SC1 – WP 18-20 - Gio

35SC1 – WP 18-20 - Gio

Personalised Medicine in Work Programme 2018–2020 (II)

Coordination and support actions

• HCO-02-2018: Data integration and data-driven in-silico models forenabling personalised medicine - a European standardizationframework

• HCO-04-2018: ERA-NET to support the Joint Programming inNeurodegenerative Diseases strategic plan (JPND)

• HCO-01-2018-2019-2020: Actions in support of the InternationalConsortium for Personalised Medicine

35

36SC1 – WP 18-20 - Gio

Priority 2 – Innovative health and care industry

AIM: Turn innovative knowledge and technologies into practicalapplications benefiting citizens, healthcare systems and businesses

FOCUS: Regenerative medicine, advanced therapeutics and regulatoryscience

POLICY DRIVERS:

Upgrading the single market

36

37SC1 – WP 18-20 - Gio

• BHC-09-2018: Innovation platforms for advanced therapies of thefuture

• BHC-07-2019: Regenerative medicine: from new insights to newapplications

• BHC-10-2019: Innovation Procurement: Next generation sequencing(NGS) for routine diagnosis

Coordination and support actions

• HCO-05-2018: Strengthening regulatory sciences and supportingregulatory scientific advice

Innovative health and care industry in Work Programme 2018–2020

37

38SC1 – WP 18-20 - Gio

Priority 3 – Infectious diseases and improving global health

European One Health Action Plan against Antimicrobial Resistance

Global Action Plan on antimicrobial resistance

38

AIM: Fighting infectious diseases and the growing threat of antimicrobialresistance. Addressing the needs of the most vulnerable and the globalincrease in chronic diseases

FOCUS: Emerging infectious diseases, poverty and neglected diseases,stratified host-directed approaches to communicable diseases, maternaland child health, global collaboration on non-communicable diseases(cohorts, brain research, hypertension, diabetes, cancer

POLICY DRIVERS:

39SC1 – WP 18-20 - Gio

• BHC-15-2018: New anti-infective agents for prevention and/ortreatment of neglected infectious diseases (NID)

• BHC-16-2018: Global Alliance for Chronic Diseases (GACD) - Scaling-up of evidence-based health interventions at population level for theprevention and management of hypertension and/or diabetes

• BHC-18-2018: Translational collaborative cancer research betweenEurope and the Community of Latin American and Caribbean States(CELAC)

• BHC-21-2018: Research on HIV, tuberculosis (TB) and/or hepatitis C(HCV) in patients with mono-, co-infections and/or comorbidities inthe context of fostering collaboration with the Russian Federation

Infectious diseases and improving global healthin Work Programme 2018–2020 (I)

39

40SC1 – WP 18-20 - Gio

• BHC-13-2019: Mining big data for early detection of infectious diseasethreats driven by climate change and other factors

• BHC-14-2019: Stratified host-directed approaches to improveprevention, treatment and/or cure of infectious diseases

• BHC-19-2019: Implementation research for maternal and child health

Infectious diseases and improving global healthin Work Programme 2018–2020 (II)

40

41SC1 – WP 18-20 - Gio

Coordination and support actions

• HCO-06-2018: Establishment of an International Network of SocialSciences Research Centres to help address governance and otherchallenges in the preparedness for and the response to infectiousthreats

• HCO-08-2018: Creation of a European wide sustainable clinicalresearch network for infectious diseases

• HCO-09-2018: Building international efforts on population and patientcohorts

• HCO-10-2018: Coordinating European brain research and developingglobal initiatives

• HCO-11-2018: Strategic collaboration in health research andinnovation between EU and China

Infectious diseases and improving global healthin Work Programme 2018–2020 (III)

41

42SC1 – WP 18-20 - Gio

Priority 4 – Innovative health and care systems –Integration of care

AIM: Develop effective, accessible and sustainable health interventions and integrated care systems

FOCUS: Mental health in the workplace, novel approaches for palliative care, implementation of personalised medicine, HTA, innovation in health care

POLICY DRIVERS:

Upgrading the single market

Cross-border healthcare Directive

42

43SC1 – WP 18-20 - Gio

• BHC-23-2018: Novel patient-centred approaches for survivorship,palliation and/or end-of-life care

• BHC-26-2018: HTA research to support evidence-based healthcare

• BHC-22-2019: Mental health in the workplace

• BHC-25-2019: Demonstration pilots for implementation ofpersonalised medicine in healthcare

Coordination and support actions

• HCO-12-2018: Innovation in healthcare – a CSA towards usingpre-commercial procurement and public procurement of innovativesolutions in healthcare systems

Innovative health and care systems – Integration of carein Work Programme 2018–2020

43

44SC1 – WP 18-20 - Gio

Priority 5 – Decoding the role of the environment, including climate change, for health and well-being

AIM: Improving the risk assessment of environment on health and well-being, and the related socio-economic impact and developing mitigation measures

FOCUS: New testing/screening methods to identify endocrine disrupting chemicals, the development of the 'human exposome' (to allow the assessment of lifelong environmental influences on individuals) and to set the priorities for a new research agenda

POLICY DRIVERS:

WHO Environment and Health Process (since 1989)

The UNFCCC Paris Agreement

The 7th Environment Action Programme (EAP)

REACH and EU relatedpolicies

45SC1 – WP 18-20 - Gio

• BHC-27-2018: New testing and screening methods to identifyendocrine disrupting chemicals

• BHC-28-2019: The Human Exposome Project: a toolbox for assessingand addressing the impact of environment on health

Coordination and support actions

• HCO-13-2018: Setting the priorities for a European environment,climate and health research agenda

Decoding the role of the environment, including climate change, for health and well-beingin Work Programme 2018–2020

45

46SC1 – WP 18-20 - Gio

Call deadlines

BHC + HCO call topicsCalls open: 7 November 2017

Calls close: 18 April 2018

46

ExceptionBHC-15-2018

Lump Sum Funding: a pilot topicCalls open: 7 November 2017First stage: 6 February 2018

Second stage: 4 September 2018

DTH, HCC, and SU-TDS call topicsCalls open: 7 November 2017

Calls close: 24 April 2018

Better Health and care, economic growth and sustainable health systems

Digital transformation in Health and Care

Trusted digital solutions and Cybersecurity in Health and Care

47SC1 – WP 18-20 - Gio

Participant portal – one–stop shop

• Call topics

• NCPs

• Expert registration

• Documents

• Project officers' list for questions

• FAQs

• Rules for participation

• Upload project reports

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

47

48SC1 – WP 18-20 - Gio

• until the UK leaves the EU, EU law continues to apply to and withinthe UK, when it comes to rights and obligations; this includes theeligibility of UK legal entities to fully participate and receivefunding in Horizon 2020 actions

• eligibility criteria must be complied with for the entire duration ofthe grant

• if the United Kingdom withdraws from the EU during thegrant period without concluding an agreement with the EUensuring in particular that British applicants continue to beeligible, you will cease to be eligible to receive EU funding (whilecontinuing, where possible, to participate) or be required to leavethe project on the basis of Article 50 of the grant agreement

Participation of UK entities

48

49SC1 – WP 18-20 - Gio

Thank you!

@EUScienceInnov#InvestEUresearch

#EUHealthResearch

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49