Horizon 2020 'Health, demographic change and wellbeing' - 2015 call

Jan-Willem van de Loo, PhDScientific Officer

DG Research and Innovation

Directorate E – Health Research

European Commission

NCP, The Hague, 3 July 2014

What is Horizon 2020

− Responding to the economic crisis to invest in future jobs and growth

− Addressing people’s concerns about their livelihoods, safety and environment

− Strengthening the EU’s global position in research, innovation and technology

http://ec.europa.eu/research/horizon2020http://ec.europa.eu/research/horizon2020

The EU’s 2014-20 programmefor research & innovation

A core part of Europe 2020, Innovation Union &European Research Area

Not legally binding

Breakdown EU R&I Funding

Multiannual Financial

Framework (MFF)

• Overall EU Budget (2014-2020), 960 billion

Framework Programme

(FP)

• Research budget (Horizon 2020: € 78.6 billion, 4th EU budget)

Specific Programme

(SP)

• Pillar 3-Societal challenges : € 29.7 billion; Health, demographic change and wellbeing: € 7.5 billion (challenge 1)

Work Programme

(WP)

• calls for proposals on broad topics defined by EC

Not legally binding

Horizon 2020 - what's new?

• A single programme bringing together three separate programmes/initiatives*

• Coupling research to innovation – from research to retail, all forms of innovation

• Focus on societal challenges facing European society e.g.health and ageing, clean energy and transport

• Simplified access, for all companies, universities, institutes inall EU countries and beyond

The 7th Research Framework Programme (FP7), innovation aspects of

Competitiveness and Innovation Framework Programme (CIP), EU contribution to the European Institute of Innovation and Technology (EIT)

Not legally binding

Three priorities

Excellent science

Industrial leadership

Societal challenges

Not legally binding

Recap: the 'Health, demographic change and wellbeing' challenge

Proposed funding 2014-2020 (million EUR)

Of which 5,151 million available for Horizon 2020 calls for proposalsOf which 5,151 million available for Horizon 2020 calls for proposals

Not legally binding

Coming soon…Innovative Medicines Initiative 2

www.imi.europa.eu

European & Developing Countries Clinical Trials Partnership (EDCTP2)

www.edctp.org

Active and Assisted Living 2www.aal-europe.eu

European Innovation Partnership on Active and Healthy Ageing

https://webgate.ec.europa.eu/eipaha

Strategic Initiatives

The International Initiative for Traumatic Brain Injury Research

(InTBIR)

http://intbir.nih.gov/

International rare diseasesresearch consortium

(IRDiRC)www.irdirc.org

Not legally binding

IMI2*: 2014-2024

• Key objectives:

• success rate + 30% clinical trials on priority medicines**

• clinical proof of concept in immunological, respiratory,

neurological and neurodegenerative diseases

• new and approved diagnostic markers for four of these diseases

and at least two new medicines which could either be new

antibiotics or new therapies for Alzheimer’s disease.

• Proposed budget: €3.28 billion, equally shared between public and private

partners

• Simplification: common H2020 rules, IPR

• Info day: 30 September Brussels

*Innovative Medicines Initiative 2, Art 187, JTI, PPP**WHO Report, Priority Medicines for Europe and the World 2013 Update

Not legally binding

EDCTP2*: 2014 - 2024

• Broader scope

HIV/tuberculosis/malaria +

neglected infectious diseases, all

clinical phases, diagnostics and

delivery optimisation

• More EU co-funding

€683 million

• Longer duration

10 years

• Publication of draft work plan

expected July 2014

*European and developing countries clinical trials partnership 2, Art 185, P2P

Not legally binding

AAL2*: 2014 - 2022

• AAL: €600 million from 22 EU countries + EU funding €150 million

• Scope AAL 2: Market-oriented ICT research in assisted living technologies & services

• New instruments: e.g. prizes or innovation grants

• More EU co-funding: Participating countries pay €225 million (indicative), EU pays up to €175 million (indicative, ~40% of total public funding)

• AAL Forum: 9-12 September 2014, Bucharest

*Ambient assisted living Joint Programme, Art 185, P2PNot legally binding

• Ageing population

• Increased disease burden

• Unsustainable and unequal health & care systems

• Health & care sector under pressure to reform

The challenges

Not legally binding

• Translating science to benefit citizens

• Improve health outcomes

• Support a competitive health & care sector

• Test and demonstrate new health & care models, approaches and tools

• Promote healthy and active ageing

Horizon 2020 - Societal Challenge 1

Do also look elsewhere! EU support of health-related research & innovation is not limited to Societal Challenge 1

Not legally binding

Two-year work programme

Stronger focus on end-users

Broad, less 'prescriptive', topics

Challenge-driven

What's new?

Not legally binding

Simpler and faster

• Single set of simpler andmore coherent participation rules

• New balance between trust & control

• Two funding rates for different beneficiaries and activities (100%, 70%)

• Single flat rate (25%) to calculate overhead or «indirect costs»

• Forthcoming financial regulationwill make things simpler

• time-to-grant of 8 months (5 + 3)(exceptions for the ERC and in duly justified cases

Image courtesy of ponsuwan/ FreeDigitalPhotos.net Not legally binding

More opportunities for SMEs

• Integrated approach - around 20% of the total budget for societal challenges and LEITs to go to SMEs

• Simplification of particular benefit to SMEs (e.g. single entry point)

• A new SME instrument will be used across all societal challenges as well as for the LEITs*

• A dedicated activity for research-intensive SMEs in 'Innovation in SMEs'

• 'Access to risk finance' will have a strong SME focus (debt and equity facility)

Image courtesy of Vlado/ FreeDigitalPhotos.net

*Leadership in enabling & industrial technologies: ICT,

nanotechnologies, materials, biotechnology, manufacturing, spaceNot legally binding

Funding: who's eligible?

• Horizon 2020 is open to participation from across the world

• By default:

• Member States (including overseas departments andoverseas territories)

• Associated Countries

• exhaustive list of countries in annex to workprogramme (but: no longer BRIC + Mexico in this list!)

• Participants from other countries are funded inexceptional cases:

• when provision is made in the call text

• bilateral agreement (e.g. USA, Health challenge – NIH)

• when the Commission deems it essential (case by case assessment)

Not legally binding

What stays:

Grants as main funding instrument

Standard collaborative actions

Coordination and support

Use of Grant Agreements

Actual costs

Funding: building on FP7

Not legally binding

• Grants to SME instrument

• Grants to Programme co-fund actions

• Specific provisions targeting innovation:

• pre-commercial procurement,

• procurement of innovative solutions

• and inducement prizes

• Enhanced use of other lump-sums, flat rates and unit costs

Funding: what's new

'CureVac's success opens up the possibility of a real European breakthrough in the delivery of vaccines to areas where they are needed most. This technology could save lives – exactly the type of innovation an EU inducement prize should support'.Máire Geoghegan-Quinn, European Commissioner for Research and Innovation

Not legally binding

Keeping flexibility where needed.

Funding: a single set of rules

etc.

EU FinancialRegulation

Specific rules for participation

Covering all H2020

research and

innovation actions

EU FinancialRegulation

Specific rules for participation

Not legally binding

• Implemented via EASME agency

• Bottom-up approach

• Continuous submission, several call deadlines per year

• Only SMEs are eligible

SME Instrument (1)

Not legally binding

SME instrument (2)

Concept & Feasibility

Assessment

InnovationR&D activities

Commercialisation

Phase 2Phase 1 Phase 3

Idea Market

• Feasibility of concept

• Risk assessment• IP regime• Partner search

• Design study

• Development,

prototype, testing• Miniaturisation/design• Clinical trials

• Etc.

• Facilitate access to

private finance• Support via

networking , training,

coaching, knowledge sharing, dissemination

Lump sum: ~ 50.000 €~ 6 months

EU funding: 1 to 5 M€12 to 36 months

No direct funding

Not legally binding

Conditions for Participation

Minimum conditions

� collaborative research:

At least three legal entities each established in a different Member State or an Associated Country

� ERC, SME instrument, programme co-fund, coordination and support, training and mobility

actions:

One legal entity established in a Member State or an Associated Country

Additional Conditions?

See SME instrument

Not legally binding

Personnel costs

• Wider acceptance of average personnel costs

• Acceptance of supplementary payments

• for non-profit organisations up to 8000 euros/year/person

• Simplifying participation for SMEs

• Keeping of time records reduced

Cost reimbursement

Not legally binding

Controls and Audits

Financial viability � Restricted to coordinators for projects ≥ €500,000

Certificate for

Financial

Statements

� Only for final payments/per beneficiary/for actual costs ≥ €325,000

� Optional Certificates on average personnel costs

Ex-post audits

� Provisions in Horizon 2020 Regulation!

� Commission's audits up to two years after payment of the balance

� Audit strategy focused on risk and fraud prevention

Extrapolation � New Financial Regulation will apply

� Continuity with FP7Guarantee Fund

Not legally binding

• Ownership for the participant who generates results

• joint-ownership only in specific circumstances

• Protection where appropriate

• Dissemination

Intellectual Property Rights

Kept:

Not legally binding

The Work Programme 2015 in brief

Call for 'co-ordination activities'15 topics (10 in 2014, 5 in 2015)

Call 'personalising health and care'34 topics (15 in 2014, 17 in 2015, 2 open in both years)

€ 1,21

billion

Not legally binding

Modelling and predicting sensitivity totargeted therapies in colorectal cancers (RIA)

• - Determining resistance biomarkers• Molecular profiling of colon cancer patient samples• Building and screening of predictive in vitro models• Screen for genes mediating resistance and sensitivity to targeted therapies in CRCs• Building of new algorithms to accelerate the design of rational therapies

• - Design stratified, biomarker-driven phase II trials

Start fundingresearch project

January 2011

2013

Start laboratory experiments

May 2011

Validation in animalexperimentsAugust 2011

Publication in NatureMarch 2012

First patient in trialat NKI

November 2012

20122011

First clinical responsesApril 2013

Not legally binding

• Linking national/regional cancer registries for research to improve quality of data collection, optimise cancer control in Europe and evaluate therapy effectiveness

� Important contributions to improving data quality, geographical coverage, standardisation, linkage with screening and clinical registries, evaluation of clinical care

� Preparing for personalised cancer care in an aging society

� Portal for continuous submission of data

� EuropeanCancer Observatory: enhanced access to cancer stats

� Cornerstone for the creation of a European Cancer Information System (ECIS) by JRC

Public–Public Partnership on cancer registries through national programme managers, owners, funders (ERA-NET)

Not legally binding

PersonalisingHealth and Care

& Co-ordination activities

Not legally binding

Advancing active and healthy ageing

Integrated, sustainable, citizen-centred care

Improving health information, data exploitation

and providing an evidence base for health

policies and regulation

Innovative treatments and technologies

Improving diagnosis

Effective health promotion, disease prevention,

preparedness and screening

Understanding health, ageing & disease

The Horizon 2020 Health Challenge:8 main areas

'personalising health and care'

'coordination activities'

Various ERA-NET topics, Global Alliance for

Chronic Diseases (GACD), Coordination Actions

€ 1,21

billion

Not legally binding

Revisions to WP 2014-2015*

• HOA 8 – 2015: Inducement Prize: An innovative test to reduce the use of antibiotics in the management of upper respiratory tract infection

• HOA 7 – 2015: eHealth Inducement Prize: Food scanner• HCO 17 – 2015: Towards sustainability and globalisation of the Joint Programming Initiative

on Neurodegenerative Diseases• HCO 6 – 2015: Global Alliance for Chronic Diseases. Prevention and treatment of lung

diseases• HCO 3 - 2015: EU Reference Networks deleted• PHC 9, 15, 33 – 2015: single stage, PHC 33: budget increase• PHC 21, 25, 27, 28, 29, 30 - 2015: single stage

*pending approval by the Programme Committee and the European Commission

Not legally binding

Understanding the call topics: example

'PHC 2 – 2015'

'Specific challenge'

'Scope'

'Expected impact'

'Type of action'

Not legally binding

• Systems medicine approaches (2015)

• Common mechanisms of diseases and potential co-morbidities (2015)

Unravelling health and disease

Not legally binding

• Inter-sector cooperation for environment- and health-based interventions (2015)

• Vaccine platforms for HIV (2015)

From "omics" … to prevention

Not legally binding

• In vivo medical imaging technologies (2015)

• Clinical validation of biomarkers (2014, 2015)

=> SME focus

Biomarkers and novel diagnostic tools

Not legally binding

• Therapies for rare diseases (2015)

• Tools and technologies for advanced therapies (2015)

• Clinical research on regenerative medicine (2014, 2015)

• Comparing and establishing effectiveness of health interventions in children (2015)

Finding cures and comparison of existing treatments

Not legally binding

• Early risk detection and intervention (2015)

• Promoting mental wellbeing in the ageing population (2015)

Adding more life to our years

Not legally binding

• Piloting personalised medicine in health and care systems (2015)

• Self-management of health and disease:

• patient empowerment supported by ICT (2015)

• based on predictive computer modelling (2015)

The citizen in the centre

Not legally binding

• Public procurement of innovative eHealthservices (2015)

• ICT systems for integrated care (2015)

• eHealth sectorial inducement prize (2015)

The citizen in the centre (2)

Not legally binding

• Digital representation of health data to improve diagnosis and treatment (2015)

• Improve predictive human safety testing (2015)

• eHealth interoperability (2014)

Big Data for research

Not legally binding

• European Reference Networks (2015)

• Global Alliance for Chronic Diseases - GACD (2015)

Support for European and International Initiatives

Not legally binding

• Brain-related disorders, antimicrobial resistance, cardiovascular diseases (2015)

Completing the European Research Area

Not legally binding

ERA-NET Cofund – main features

ERA-NET Cofund: implementation of a co-funded joint call for proposals(compulsory, at least one co-funded call per Grant Agreement)*

EU contribution: mainly a proportional contribution to total public funding of the joint call

Additional EU contribution to coordination costs on the basis of unit costs for additional activities, including additional calls without top-up funding

Reimbursement rate: ERA-NET Plus reimbursement rate from FP7 (33%) applies

Co-funded calls: proposal evaluation and selection according to Horizon 2020 standards

Not legally binding

Funding opportunities -proposal submission

Not legally binding

Submission

� Competition is high, success rates are modest

� Only submit a short proposal when competitive in (sub)area of interest

� Only submit a short proposal if beyond state-of-the-art

� Only submit if motivated to long-term collaboration with others

� Keep in mind what it takes after your proposal gets through the 1st stage; when it gets funded

� Be clear about your objectives …and potential pitfalls

� Preferably submit in English language

Not legally binding

Submission in H2020

� Self-checks for SME status, financial viability

� Proposal part B closely matches evaluation criteria

� Proposal template aligned with Grant Agreement “Description of Work (DoW/Annex I)”

� Strict implementation of page limits*

*watermark across excess pages

Not legally binding

� Please, provide essential information (submission tool) 1.1 Identifier

1.2 Study design and endpoints

1.3 Scientific advice / protocol assistance

1.4 Subjects/population(s)

1.5 Sample size

1.6 Statistical methods

1.7 Conduct

1.8 Orphan designation

1.9 Calculation of ‘unit costs per patient’ for clinical studies (if relevant)

� Actual or unit costs• Beneficiary estimates resources needed, based on actual costs

• Voluntary, i.e. beneficiary decides

� Patient recruitment sites

• Full beneficiary – preferred, never discouraged!

• Third party 'making available its resources'

• Subcontractor, eg CRO

Clinical trials/studies:

Not legally binding

Participant portal – a one-stop shop

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

• Call topics

• NCPs !

• Expert registration

• Documents

• Project officers' list for questions

• FAQs

• Rules for participation

• Upload project reports

• Etc.

Not legally binding

Use search tools provided

Not legally binding

Do you look beyond your favoritetopic/programme?

Not legally binding

Check call updates

Not legally binding

Use extensive support provided

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

http://www.fitforhealth.eu

Not legally binding

Proposal evaluation

Not legally binding

Initial outcomes–PHC, HCO and SME

PHC 2014 two stage:

• 1651 evaluated• 626 progress to stage 2 (deadline 19 August, results in October)• Available budget €303 million

• Info sent May

PHC 2014 single stage:

• 451 proposals evaluated• Available budget €185.2 million• Info to be sent September

HCO 2014• 49 proposals evaluated

• Available budget €40 million• Info to be sent September

SME topic (PHC 12)• 213 proposals for phase 1 evaluated• Available budget €6.61 million

• Info to be sent July

SME call stage 1• 2666 proposals for phase 1 received• 2507 with 1 SME

• 119 with 2 SMEs• 34 with 3 SMEs• 6 with 4 SMEs

Not legally binding

Important dates

subject to ongoing inter-institutional negotiation! Confirmation most likely late July

Submission deadlines foryour proposals 2015

Two-stage topics: 14 October 2014 & 21 April 2015

Single stage topics: 24 February 2015 and 21 April 2015

SME instrument:

• Phase 1: 3 cut-off dates: 18/06 ; 24/09 ; 17/12/2014

• Phase 2: 2 cut-off dates: 09/10 ; 17/12/2014

Check with your national contact pointshttp://ec.europa.eu/research/participants/portal/desktop/en/support/national_contact_points.html

Not legally binding

Proposal evaluation

• Criteria & scoring – in the General Annex to the Work Programme

• Proposal evaluation process involving at least 3* external experts per proposal – in Commission Guidelines

*5 or more experts in Health, demographic change and wellbeing Challenge

Not legally binding

1. Excellence � Ground-breaking nature (e.g. level of

ambition, beyond the state-of-the-art,novel approach, addresses challenge, … )

� Conceptually robust; trans-disciplinarity considered…

Award criteria: Research and Innovation Actions (RIA); Innovation Actions (IA); SME instrument

Not legally binding

Award criteria: Research and Innovation Actions (RIA); Innovation Actions (IA); SME instrument

2. Impact […] extent to which project outputs contribute to:� The expected impacts listed in the work programme under

the relevant topic;

� Enhancing innovation capacity and integration of new knowledge;

� Strengthening the competitiveness and growth of companies by developing innovations meeting the needs of European and global markets;

� Effectiveness of the proposed measures to communicate the project, disseminate and/or exploit the project results, and appropriate management of IPR.

Not legally binding

3. Quality and efficiency of implementation� Coherence and effectiveness of the work plan, including

appropriateness of the allocation of tasks and resources*;

� Competences, experience and complementarity of the individual participants, as well as of the consortium as a whole;

� Appropriateness of the management structures and procedures, including risk management**.

Award criteria: Research and Innovation Actions (RIA); Innovation Actions (IA); SME instrument

* financial, human resources, equipment, facilities, subcontracting of services** contingencies, timelines

Not legally binding

Scoring/weights/thresholds

As in FP7, each criterion scored out of 5*; thresholds will be applied for each criterion and the total score, different depending on the call and action

Unlike FP7, for Innovation Actions and SME instrument…

� impact criterion weighted by factor of 1.5� Impact considered first when total scores are equal

*half-marks possible

Not legally binding

Priority of proposals with equal total score

For each group of tied proposals

-First consider those that "fill gaps" in the Work Programme

-Of those, look at score for 'excellence', then at score for 'impact'(reverse for Innovation actions & SME instrument)

-If still equal, look at SME budget

-If still equal look at gender balance in key personnel

-If still equal, consider other factors (overall portfolio, wider H2020, EU objectives etc.)

-Then repeat for those that don't "fill gaps"

Not legally binding

Time to grant: fast

How?

• No detailed negotiations

• Legal entities will be validated in parallel

• No more paper: e-communication & e-signature of grants

• Be prepared

Not legally binding

HORIZON 2020

Thank you and good luck with your proposal!

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