The EU Framework Programme for Research and Innovation ... · PDF file6/1/2016 · The EU Framework Programme for Research and Innovation The societal challenge ... NCP for Life Sciences

HORIZON 2020

The EU Framework Programme for Research and Innovation

The societal challenge 'Health, demographic change and well-being' Work Programme 2017

Cornelius Schmaltz Head of Unit, Health – Strategy

DG Research and Innovation

National Network and Information Event 2017 NCP for Life Sciences Cologne – 01 June 2016

Image credit: Adam Fagen – Rallying for medical research / Creative commons usage license https://creativecommons.org/licenses/by-nc-sa/2.0/legalcode

National Network and Information Event 2017 NCP for Life Sciences Cologne – 01 June 2016

Image credit: Adam Fagen – Rallying for medical research / Creative commons usage license https://creativecommons.org/licenses/by-nc-sa/2.0/legalcode

The societal challenge 'Health, demographic change and well-being' Work programme 2017 Cornelius SCHMALTZ

Head of Unit, Health –

Strategy

DG Research and

Innovation

Health research in Horizon 2020

Support through all funding instruments

Health Research in H2020

* Figure to be updated following EFSI investments in 2015

Collaborative

projects

SME

instrument

Financial

instruments

Eureka Eurostars-2

AAL-2 IMI-2

SC1 Health €7.3bn (of €31bn*)

Industrial leadership €17bn*

Excellent science €24bn*

Future and

Emerging

Technologies

LEIT Biotech

Marie Skłodowska

Curie

Fast Track to

Innovation

EDCTP-2

European Research

Council

Research

Infrastructures

Collaborative projects

Public-private partnership with pharma, open to

other partners

Public-public partnerships with EU Member States

& beyond

Blue sky research

Grants for small businesses

Loans for small and big R&I companies

Knowledge triangle: Higher education,

business, R&I

Health research: different programmes serving different communities & purposes

HORIZON 2020

European Innovation Partnership on Active and Healthy Ageing

Implemented through various instruments

Societal Challenge 1: 'Health, demographic change and well-being'

How do we invest our funding?

• Better health for all

• A more competitive European health

industry and care sector

• Maximising the digital potential

• Addressing health as a global challenge

Carlos Moedas

EU Commissioner for

Research, Science and

Innovation

3 Os:

• Open Innovation

• Open Science

• Open to the World

Infectious Diseases

(2014-2017)

Human biomonitoring

(2016)

Maternal and child health

(2016-2017)

Health ICT

(2014-2017)

Healthy ageing

(2014-2017)

Personalised medicine (2014-2017)

2014-15: EUR 1.3 B

2016-17: EUR 1.4 B

Strategic planning &

coordination of national initiatives

Implementation in SC1 Work Programme 2016-2017

A large number of research and innovation topics and

coordination topics in the SC1 Work Programme 16-17

European Personalised

Medicine Consortium

'Personalised Medicine'

• Policy focus with around 600 participants expected

• Official launch of International Consortium for personalised Medicine (IC PerMed)

• Five thematic sessions based on PerMed SRIA

Personalised Medicine Conference 1-2 June 2016 - Charlemagne Building, Brussels

https://ec.europa.eu/research/conferences/2016/permed2016/index.cfm

Societal Challenge 1

Collaborative research

Work Programme 2017

The SC1 Work Programme 2017 in brief

Call 'Personalised Medecine' 11 topics (34 in 2014-2015, 11 in 2016): 7 in RTD Health

Including 'co-ordination activities' 4 topics (17 in 2014-2015, 12 in 2016): 3 in RTD Health

- SME Instrument: 2 Topics (unchanged from 2016),1 in RTD Health

- Other Actions: 12 items (incl. InnovFin ID & "Birth Day Prize") € 935

million

Topics amended in SC1 WP 2017 calls

• PM-07 (Promoting Mental Health): Reference to migrants

• PM-20-2017: Development of new methods & measures for improved economic evaluation + efficiency measures in health sector

• SC1-HCO-07–2017: Global Alliance for Chronic Diseases (GACD) – Topic on mental health developed

• NEW HOA: Support to the 'World RePORT', Tracking research outcomes

• Additional budget: 48 M€, +35 M€ to SMEs-5, +13 M€ to PM-02,-08,-10

SC1-PM-02-2017 – New concepts in patient stratification

• Novel concepts for disease mechanism-based patient stratification

• Multidimensional, longitudinal data

• Validation in pre-clinical and clinical studies

• Consider regulatory aspects

• Focus on complex diseases having high prevalence and high economic impact

• RIA, 4-6 million EUR EU contribution

SC1-PM-03-2017 – Diagnostic characterisation of rare diseases

• Apply –omics and other high-throughput approaches for the molecular characterisation

• Promote common standards and terminologies for rare disease classification, suport bionformatics tools, facilitate data sharing

• Exchange between stakeholders from different countries/regions

• Contribute to objectives and follow guidelines of IRDiRC

• RIA, 15 million EUR EU contribution

SC1-PM-07-2017 – Promoting mental health and well-being in the young

• Population-oriented primary prevention interventions

• Biological, psychological and social determinants

• Young: up to 25 years (or subgroups)

• Assessment for mental well-being outcomes as well as economic and social benefits and impact on ↓ inequalities

• Qualitative + quantitative analysis


SC1-PM-08-2017 – New therapies for rare diseases

• Clinical trials on substances where orphan designation has been given by EC (at the latest at the time of full proposal call closure)

• Take into account protocol assistance from EMA

• Clear recruitment strategy

• Concise feasability assessment

• Centre of gravity clearly clinical trial

• Contribute to the objectives of and follow guidelines of IRDiRC

• 4-6 million EUR EU contribution

SC1-10-2017 – Comparing the effectiveness of existing healthcare interventions in the adult population

• Compare the use of currently available preventative or therapeutic healthcare interventions in adults

• Focus on interventions with high public health relevance and socio-economic impact

• Cost effectivenes analysis must be included

• COS to be used as endpoints

• RCTs, pragmatic trials, observational studies, large-scale databases and meta-analyses to be considered

• 4-6 million EUR EU contribution

SC1-PM-11-2016-2017 – Clinical research on regenerative medicine

• Target regenerative medicine therapies ready for clinical (in-patient research)

• Later stages of clinical research preferred

• Include authorisation to conduct clinical trials and ethical approvals or provide evidence of regulatory engagement and that approval is close

• Any diseases, but justify choice

• RIA, 4 to 6 million EUR EU contribution

SC1-PM-20-2017 – Methods research for improved health economic evaluation

• Improved or new methods for:

• Understanding variations in costs and health outcomes within and across countries (which factors on the supply and demand side have major effects)

• Integrating data on costs and health outcomes from different sources (RCTs, observational studies, registries, surveys, eHealth records, real-world data)

• Method and approaches to be validated re applicability


SC1-HCO-03-2017 – Implementing the Strategic Research Agenda on Personalised Medicine • National or regional research programmes implement a

joint call for proposals

• Implement key areas of Per Med SRA,

• To be informed by output (but not duplication) of CSA under HCO-05-2016 (Coordinating PM research)

• Demonstrate impact on national and transational programmes and leverage effect on EU research and competitiveness, develop key indicators

• ERA-NET Cofund, 5 million EUR EU contribution

SC1-HCO-07-2017 – Global Alliance for Chronic Diseases (GACD) prevention and management of mental disorders

• Implementation research (prevention, early identification, management strategies) in LMIC and/or in vulnerable populations in HIC

• Build on interventions with proven effectiveness

• Test intervention, understand barriers and facilitators, assess health economics, propose pathway to embed intervention into policy and practice


SC1-HCO-08-2017 – Actions to bridge the divide in European health research and innovation • Activities that can help less performing countries and

regions to build capacities and exploit opportunities to eventually increase their participation in EU-funded collaborative projects

• Synergies with EU Structural and Investment Funds

• Concrete measures for tackling structural barriers to health research and innovation (capacity, skills, policy, regulatory environment, …)

• CSA, up to 1 million EUR EU contribution

SME Instrument in SC1 Work Programme 2017

• SMEInst-05-2016-2017 - Supporting innovative SMEs

in the healthcare biotechnology sector

• Cell technology (phase 2: all deadlines, phase 1:

no deadlines in 2017)

• Validation of biomarkers or diagnostics medical

devices (only phase 2 and only 1st cut-off date in

2017)

The Horizon Prize - Better use of Antibiotics is offering a cash reward of €1 million to the person or team who can most effectively develop a rapid test that will allow healthcare providers to distinguish at the point-of care between patients with upper respiratory tract infections that require antibiotics and those that can be treated safely without them

Upper Respiratory Tract Infections include pharyngitis, sinusitis, otitis and bronchitis

Who can join the contest? Any single person and legal entity or groups of legal entities in EU Member States or in countries associated to Horizon 2020, the EU's research and innovation programme

Timeline: Deadline for submissions: 17/08/2016 - Award decision at the end of 2016.

Website: www.ec.europa.eu/horizonprize/antibiotics

http://www.ec.europa.eu/horizonprize/antibiotics

Maternal and child health initiative

• Conference on R&I for maternal and newborn health

• 8 December, Brussels

• Registration open end September

Proposal submission

and evaluation

Single-stage evaluation (4 RIA topics and 2 CSA topics)

• SC1-PM-03-2017: Diagnostic characterisation of rare diseases

• SC1-PM-11-2016-2017: Clinical research on regenerative medicine

• SC1-PM-20-2017: Development of new methods and measures for improved economic evaluation and efficiency measures in the health sector

• SC1-HCO-03-2017: Implementing the Strategic Research Agenda on Personalised Medicine

• SC1-HCO-07-2017: Global Alliance for Chronic Diseases (GACD)

• SC1-HCO-08-2017: Actions to bridge the divide in European health research and innovation

Two-stage evaluation (4 RIA topics)

• SC1-PM-02-2017: New concepts in patient stratification

• SC1-PM-07-2017: Promoting mental health and well-being in the young

• SC1-PM-08-2017: New therapies for rare diseases

• SC1-PM-10-2017: Comparing the effectiveness of existing healthcare interventions in the adult population

Single-stage evaluation process

Peer-review evaluation by independent experts

1. Proposal submission

2. Remote (home)

individual evaluation

3. Consensus Group

meeting (Brussels)

4. Feed-back (ESR) to

applicants

Eligibility check by the

Commission

Individual assessment reports with

individual scores and comments on

each proposal

Evaluation Summary Report

(ESR) with consensus scores and comments on

each proposal


2. Remote (home)


3. Consensus Group

meeting (Brussels)

4. Invitation to Stage 2

and general information

to successful applicants


Commission

Individual assessment reports with individual scores and

comments on each proposal

Evaluation Summary

Report (ESR) with consensus

scores and comments on each proposal

Two-stage evaluation process


Stage 1

4. Feedback (ESR) to

unsuccessful applicants

For each budget-split identified in the

work programme, the overall threshold for Stage 1 will be set at a level that allows the total requested budget of proposals admitted to Stage 2 be as

close as possible to 3 times the available budget

Two-stage evaluation process

Which threshold for advancing from Stage 1

to Stage 2 ?

Stage 1 Stage 2


(only those qualifying after Stage 1)

2. Remote (home)


3. Consensus Group

meeting (Brussels)

4. Feed-back (ESRs Stage 1 and 2) to applicants


Commission

Individual assessment reports with individual scores and

comments on each proposal

Evaluation Summary

Report (ESR) with consensus

scores and comments on each proposal


Two-stage evaluation process Stage 2

Participant portal – a non-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

Cross-cutting items

International

cooperation

SC1 and international cooperation

• Reference to specific multi-lateral initiatives

• Mutual opening of research programmes with Third Countries (US)

• Funding Third Countries entities by their own funding agencies for participating to Horizon 2020 (Switzerland, Australia, etc)

• Specific actions

Cross-cutting items

Clinical Trials

Section I

I. Template

'Essential information about clinical studies'

Template Essential information about clinical studies

• Use of template mandatory for certain single-stage and second-stage topics, if a clinical study is included

• But: no eligibility criterion, no disadvantage when information provided in other part of proposal;

• Rather: more and more appreciated (applicants, evaluators) as an opportunity for structured information

• These topics are listed in the template.

Applicability

Providing structured information to experts for evaluation

Giving applicants the chance to provide detailed information about clinical studies without page limitations. Reasons: - Detailed but important information, e.g. about Scientific Advice Meetings, relevant (regulatory) guidelines, in- / exclusion- criteria, etc. - potentially high number of studies

Providing necessary information to request 'unit costs'

Available under 'call documents'1 and in submission system

1e.g.: http://ec.europa.eu/research/participants/portal/doc/call/h2020/sc1-hco-01-2016/1677602-essential_information_for_clinical_studies_en.pdf

Purpose



Ethical considerations have to be addressed in the respective separate section of the proposal.

Risks and contingency plans have to be addressed in the respective section of the proposal (part B.3.2 and table 3.2.a) … If contingency plans are not outlined in the proposal (and the grant agreement), your grant agreement might be terminated and/or the EU contribution significantly reduced if a study cannot proceed as planned.

Scope

"Extensions of project duration can generally not be granted in H2020. Significantly delayed key study milestones (e.g. 'first patient/first visit') might lead to the termination of the grant agreement."

Section II

II. Status recruitment sites

Status of Recruitment sites

Clinical centres whose contribution is limited to

subject recruitment or treatment may have status of:

• Full beneficiary –> always preferred!

But: if obstacles for centres to become beneficiary (or

linked third party), two other options remain:

• Use of in-kind contributions provided by third parties against

payment (Art. 11 MGA) – patient data are considered as in-

kind contribution.

• Subcontractor (Art. 13 MGA)

• Please note: It is not possible to reimburse recruitment sites

based on Article 10 MGA.

Status of Recruitment sites

Use of in-kind contributions provided by third parties against payment (Art. 11 MGA)

• Third parties must be identified in DoA

• no profit, reimbursement of unit / actual costs (!)

• requires prior agreement with beneficiary – prior to start of

work, not necessarily prior to signature of GA

• agreement might be 'ad-hoc'/specific to project

• 25% indirect costs can be claimed (by the 3rd party itself,

not by the beneficiary!) when actual or unit costs are used

Subcontracting

Subcontractor (Art. 13, MGA)

• task (!) must be identified in DoA

• agreed 'price per patient/subject', profit possible

• best price/quality ratio, transparency equal treatment

• public bodies: internal rules and applicable legislation

related to public procurement

• No indirect costs for beneficiary! But in case of 100%

reimbursement rate of direct costs, no more "shortfall" for

linked beneficiary

Section III

III. Subcontracting

Subcontracting

Research Organisations (CROs)

• Only limited part of the action can be sub-contracted (Art. 13 MGA)

• Academic CROs exist (e.g. ECRIN network) – might be willing to become beneficiary!

• Commercial CROs usually work 'for profit' →

Commission will consider accepting subcontracting

• Please note: It is not possible to reimburse CROs based on Article 10 MGA.

Subcontracting

CROs

Rule of thumb for amount of subcontracting:

• If clinical study is the main activity of the project:

Core study expertise cannot be subcontracted, but

certain parts (GMP manufacturing, monitoring etc.)

might be subcontracted as long as general regulatory

expertise is available and the study design, high-level

study management and oversight remain as tasks within

the consortium (budget share: not essential criterion!)

• If clinical study is just a small part of the project, i.e. most of the project is preclinical activity:

Study might be subcontracted in its entirety

Section IV

IV. Unit costs for clinical studies

(for more detailed information on this and all other issues related to clinical studies in Horizon 2020, please check here: http://www.healthncp.net/news-events/webinar-clinical-studies-horizon2020-proposals)

Unit Costs What/Why

What are unit costs for clinical studies?

An alternative way of claiming costs for clinical trials:

proposal describes what is needed to do the study (resources, identical in each centre)

each beneficiary/third party that wants to use the unit costs, lists the costs of these resources in year n-1 – based on its closed accounts

Why unit costs?

No need for time sheets and detailed actual costs for each patients.

Only items that are audited: Number of patients enrolled and correctness of historical costs listed.

Section V

V. Mandatory deliverables

Deliverables

1)'First study subject approvals package', for each included CS (prior to enrolment of first study subject):

a. Final version of study protocol as submitted to regulators / ethics committee(s) (no need to change deliverable if later amendments)

b. Registration number of clinical study in a WHO- or ICMJE- approved registry (Please note: Result posting for the study must be possible)

c. Approvals (ethics committees and national competent authority if applicable) required for invitation / enrolment of first subject in at least one clinical centre

Mandatory deliverables (1)

Deliverables

2)'Midterm recruitment report', for each included CS:

Deliverable to be scheduled for the time point when 50% of the study population is expected to have been recruited. The report shall include an overview of recruited subjects by study site, potential recruiting problems and, if applicable, a detailed description of implemented and planned measures to compensate delays in the study subject recruitment.


Deliverables

3)Report on status of posting results in the study registry(s), for each included CS:

Report on the status of the result posting including timelines when final posting of results is scheduled after end of funding period.


TIME TABLE WP 2018-2020

TIME TABLE for WP 18-20