Prof.ssa Angela Santoni Delegato Nazionale Salute SC1 ...Prof.ssa Angela Santoni Delegato Nazionale...

Prof.ssa Angela Santoni Delegato Nazionale Salute SC1 - Horizon 2020

Department of Molecular Medicine

WP 2014-2015 Personalising health and care

Understanding health, ageing and disease Effective health promotion, disease prevention, preparedness

and screening Improving diagnosis Innovative treatments and technologies

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

WP 2016-2017 Call - Personalised Medicine

1.1 Understanding health, well-being and disease1.2 Preventing disease1.3 Treating and managing diseases

1.4 Active ageing and self-management of health1.5 Methods and data1.6 Health care provision and integrated care

WP 2018-2019

Call - Better Health and care, economic growth and sustainable health systems

1.1 Personalised medicine1.2 Innovative health and care industry1.3 Infectious diseases and improving global health1.4 Innovative health and care systems - Integration of care1.5 Decoding the role of the environment, including climate

change, for health and well-being.1.6 Supporting the digital transformation in health and care

Call - Digital transformation in Health and Care

Call - Trusted digital solutions and Cybersecurity in Health and Care

4SC1 – WP 18-20 ‘19 - 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

Priority 1.1 Personalised medicine

• SC1-BHC-06-2020: Digital diagnostics – developing tools for supporting clinical decisions by integrating various diagnostic data – RIA

Scope:

Develop tools/platforms that use information from most relevant diagnostic means, resulting in accurate detailed, structured, systemic, and prioritised assessment of the health status in a patient.

The proposed solutions should integrate various data sources such as medical records, in vitro and in vivo diagnostics, medical imaging , -omicsdata, functional tests (lab on chip), etc.

Impact:

Increase EU's capacity to innovate in the area of medical instruments

Improve the quality and sustainability of healthcare systems through quicker and more encompassing diagnosis of medical conditions

Contribute to the growth of the European diagnostics sector, in particular for SMEs

Reinforce EU's role among world leaders in the production of medical diagnostic devices

One stage call, EU contribution 40 million (between EUR 8 and 15 million)


SC1-HCO-01-2018-2019-2020: Actions in support of the International Consortium for Personalised Medicine – CSA

Scope: Action should focus on building links with third countries by analysing the potential

and advantages of collaboration in personalised medicine with those countries. For the 2020 call, the project should focus on the African Union as a group of countries. Alignment with GACD and EDCTP

ICPerMed secretariat: The project should continue the work done by the secretariat for ICPerMed

Impact: International aspect: Integrating the country/group of countries into ICPerMed

activities. Support wider adoption of standards developed in Europe. Contributetowards the UN Sustainable Development Goal 3: Ensure healthy lives andpromote well-being for all at all ages

ICPerMed secretariat: Ensure continuity of the operations of ICPerMed beyond2020. Increase the visibility of the consortium and provide harmonised vision forthe further development of personalised medicine

EU contribution between EUR 1.5 and 2 million


SC1-HCO-03-2020: Bridging the divide in health research and innovation – boosting return on investment - CSA•Scope: For the benefit of health R&I in low performing countries

improve governance and managerial practices increase the organisations’ international profile Health research policies to attract and retain talents create a culture that rewards scientific performance and innovation

Impact: More organisations from low performing countries among top

international health R&I institutes Ability to attract funding and talents Ultimately, increased participation rate in Framework Programme


SC1-HCO-14-2020 ERA-NET:Sustained collaboration of national and regional programmes in cancer research


Scope:

Alignament of national, regional research funding programmes on translational cancer research

Impact:

Identification of common research and innovation priorities, taking into account international developments where relevant.

Leveraged funding, through transnational collaborative research and innovation on cancer, based on a common strategic research agenda

Demonstrated sharing of data and analyses of funded cancer research and their impact

EU contribution EUR 5 million

SC1-HCO16 – 2020 ERA-NET: Sustained collaboration of

national and regional programmes in research on brain-related diseases and disorders of the nervous system

- Participation of third countries



Scope:Coordination in a sustained manner national and regional researchprogrammes in the area of brain-related diseases, excludingneurodegenerative diseases, by implementing transnational calls withEU co-funding resulting in grants to third parties.

Impact: Joint investment of national and regional programmes in the area of

brain-related neurological diseases; Increased common activities of national research programmes and

projects; Leveraging synergies with other pertinent key players in Europe; Contribution to the establishment of Brain research ERA


• SC1-HCO-17-2020: Coordinating and supporting research

on the human microbiome in Europe and beyond - CSA

Scope: Platform for collaboration across various R&I programmes on human

microbiome, including also interaction with omics, impact of drugs, nutritional and environmental aspects

Map progress and state-of-play for specific disease and health issues Propose strategic research agendas on human microbiome for future actions

Impact: Harmonisation and increased comparability of metagenomics and human

microbiome data in Europe and beyond Improved coherence and reduction of overlap between national, EU and other

funding ensuring efficient use of available resources Reinforced collaborations and synergies in Europe and beyond, basis for the

development of joint research programmes and alignment Internationally agreed methods, standards and procedures Engagement of citizens, scientists and political stakeholders Integration of metagenomics and human microbiome into other multilateral

co-operation areas

EU contribution 2 million (between EUR 1.5 and 2 million)

Priority 1.2 Innovative health and care industry

SC1-BHC-08-2020: New interventions for Non Communicable Diseases – RIA

Scope: Propose novel or refined interventions for patients suffering from non-

communicable diseases. Conduct clinical trial(s), supported by proof-of-concept of clinical safety

and efficacy of the therapy Preclinical research must be completed at the time of proposal

submission. Demonstrate potential clinical benefit, including consideration Of patient-reported outcomes when relevant.

Impact: Therapeutic strategies with the highest potential to generate meaningful

advances in clinical practice and care for patients with non –communicable diseases.

Improved patient-centred outcomes and impact on the disease burden ofindividual patients and health care systems.

EU contribution 80 million (between EUR 4 and 6 million)


• SC1-BHC-11-2020: Advancing the safety assessment of chemicals without the use of animal testing - RIA

Scope: Integrative approaches in human biology and related toxicity pathways to

propose and demonstrate scientifically valid means for comprehensive safety assessment of chemicals without resorting to animal testing

Establish the scientific credibility of the approaches for a variety of relevant decision-making contexts and regulatory requirements

Cooperation with complementary initiatives in and outside the EU, including with industry, and Joint research Center (JRC)

Impact: Scientifically sound, practicably implementable non-animal solutions

deployable to inform safety assessment of chemicals across sectors Recognition from regulatory bodies and their engagement to translate

results, methods and solutions into safety assessment practice Reduced use of laboratory animals in safety testing



SC1-HCO-18-2020: Developing an adaptive methodological framework for improved clinical investigation and evaluation of high-risk medical devices - CSA

Scope: Review of the clinical investigation designs currently in practice and

identification of gaps Methods to generate data in the context of a clinical investigation and in

daily pratice in accordance with the new Regulation on medical devices Exchange of best practices and creation of a pool of scientific expertise on

clinical evaluation of high-risk medical devices

Impact: Improved safety and efficacy of high-risk medical devices for the benefit

of the patient Higher quality and reliability of clinical data needed for conformity

assessment and continuous market access Improved knowledge of relevant legislative frameworks and regulatory

requirements among all stakeholders involved in the development ofhigh-risk medical devices



SC1-HCO-19-2020 Reliable and accessible information on celland gene therapies - CSA

Scope: Strategies to convey accurate and up-to-date information on cell and gene

therapies using multiple contemporary modalities, including a website Provide expertise on human stem cells, regenerative medicine, genome

editing and gene therapy Involve EMA, the Heads of Medicines Agencies network and/or EUnetHTA

network Cover all stages of product development such as manufacturing guidelines

and requirements, national and international regulations, data and clinical management as well as market approval and acceptability

Impact: Communicate to patients and the public objectively, accurately and

transparently, the latest developments and actual treatments available inthe field in order to avoid misconceptions.

Better informed decision making by regulatory and healthcare authorities. Improved products development


Priority 1.3 Infectious diseases and improving global health

SC1-BHC-17-2020: Global Alliance for Chronic Diseases

(GACD) 2 Prevention and/or early diagnosis of cancer – RIA


Scope:implementation research for the prevention and/or early diagnosis of cancer on in LMIC and/orin vulnerable populations in HIC.

Impact: Advance local, regional or national cancer prevention and/or early diagnostic

health policies, alleviating the global burden of cancer; Establish the contextual effectiveness of cancer intervention(s), including at

health systems level Improve tailored and affordable prevention and/or early diagnosis Provide evidence and recommendations to national programmes and policies

focusing on prevention, screening, and/or early diagnosis; Reduce health inequalities and inequities, including due consideration of

socio-economic, gender and age issues where relevant, in the prevention and/or early diagnosis of cancer at both local and global levels;

Provide pathway to cancer care for the patients diagnosed with cancer; Maximise the use of existing relevant programmes and platforms (e.g. research, data, and delivery platforms)

SC1-BHC-20A-2020: Pre-commercial procurement (PCP) for integrated care solutions

Scope:Facilitate the uptake of innovative rapid diagnostics for infectious diseases into healthcare practice using pre-commercial procurement (PCP).

Impact:

Reduced fragmentation of demand for innovative solutions in the area of integrated care; Increased opportunities for wide market uptake and economies of scale for the supply side through the use of joint specifications, wide publication of results and where relevant contribution to standardisation, regulation or certification


EU contribution between EUR 5 and 6 million


SC1-BHC-20B-2020: Public procurement (PPI) of innovative solutions for diagnostics for infectious diseases

Scope: Facilitate the uptake of innovative rapid diagnostics for infectious diseases

into healthcare practice using public procurement of innovative solutions (PPI).This topic will contribute to the EU One Health Action Plan against Antimicrobial Resistance

Impact: Implementation of rapid diagnostic tools for infectious diseases in clinical

pratice. Create new opportunities for market uptake and economies of scale for the

supply side of rapid diagnostics in the area of respiratory tract infections Reduced fragmentation of demand for innovative solutions



SC1-BHC-33-2020: Addressing low vaccine uptake - RIA

Scope: To increase the understanding of the determinants of low vaccine uptake

in specific contexts in Europe and/or design and test strategies to increasevaccination rates. The finding must be gathered onto a set ofrecommendations useful for public health authorities.

Proposals to include social science and public health related disciplines,and create links with existing European and/or international initiatives.

Impact: Contribute to improve vaccine coverage in Europe Develop practical and readily implementable guidelines to aid public

health authorities in Europe to increase vaccination rates Work towards meeting the goals on vaccination set out in President

Juncker's State of the Union address (2017) and CouncilRecommendations on strengthened cooperation against vaccinepreventable diseases



SC1-BHC-34-2020: New approaches for clinical management and prevention of resistant bacterial infections in high prevalence settings – RIA

Scope: Identification of best practices, and development/validation of

interventions for prevention and clinical management of resistant bacterial infections in high prevalence settings

Take into account the variety and capacities of local health care/nosocomial infrastructures, and trends of resistance development

Demonstrate cost effectiveness and feasibility, and study practical implementation in 2 or more European regions with high prevalence levels

Impact: Availability of tested cost effective models for prevention and treatment

in settings with high prevalence levels of resistant infections Reduced spread of resistant hospital acquired infections Generation of knowledge that can be of use for other countries around

the globe, including low and middle income countries

EU contribution 25 million (between 10-15 million)


SC1-BHC-35-2020: Creation of a European wide sustainable network for harmonised large-scale clinical research studies for infectious diseases - RIA

Scope: European-wide multidisciplinary network providing a platform for a rapid

response in the conduction of clinical studies related to severe infections Developing new, or making use of existing approaches to rapidly perform

large-scale clinical trials delivering optimal preventive or therapeutic interventions to patients affected by infectious diseases

Building on successful European projects such as PREPARE, COMBACTE; working with existing global networks and infrastructures such as ECRIN.

Impact: Reduce the cost and time by efficiently implementing clinical trials for

diagnosis, prevention and treatment of infections Contributing to EU policies, including the "Council Recommendation on

strengthened cooperation for vaccine preventable diseases" and theCommunication "A European one health action plan against AMR

EU contribution 30 million (between EUR 25 to 30 million)

SC1-HCO-07-2020: ERA-NET to support the Joint Programming Initiative on Antimicrobial resistance (JPIAMR) – 3rd Country participation


Scope:Pool of the necessary financial resources from participating national or regional research programmes in the area of AMR by implementing a transnational joint call for proposals resulting in grants to third parties with EU co-funding. This should scale up the implementation of the JPIAMR Strategic Research Agenda and the European One Health Action Plan against AMR.

Impact:Reduce the cost and time of clinical trials for diagnosis, prevention and treatment of infections.Attract industry back to invest in the development of anti-infectives.Strengthen the operational capacity and the required infrastructures for clinical research.Maintain Europe's leading role in combating AMR and controlling infectious diseases.Ensure global collaboration between networks in Europe and other countries/regions to optimise a coordinated response to infectious diseases.


Priority 1.4 Innovative health and care systems - Integration of care

SC1-BHC-24-2020: Healthcare interventions for the management of the elderly multimorbid patient – RIA

Scope: Proposals should focus on interventions for effective, integrated

approaches, to improve the management of multimorbid elderly patients. Proposals may stratify patients, develop the clinical concept of intrinsic

capacity, define quality performance indicators for multimorbidity, strengthen cooperation among health professionals and use social innovation.

Aspects of independent living, fragmentation of treatment, polypharmacy, adherence to treatments.

Cost effectiveness and inequalities should be addressed.

Impact: New patient-oriented healthcare models for multimorbid elderly patients. New clinical guidelines and best practices. Cost containment in healthcare interventions for multimorbidity. Develop or modify quality key performance indicators of multimorbidity.

EU contribution 50 million (between EUR 4 to 6 million)Two stage call

SC1-BHC-37-2020: Towards the new generation of clinical trials –trials methodology research – RIA-LS


Scope:Focus on methodology research and develop innovative solutions to improve the design, conduct and analysis of clinical trials. Proposals should identify and validate methods that will improve the generalizability of evidence generated through differently designed trials, including personalized medicine approaches and combinatorial interventions.In this topic, the European Medicines Agency (EMA) and the Commission Expert Group on Clinical Trials will support the selected applicant consortium in the implementation of the action.

Impact: Improved relevance, quality and efficiency of clinical trials conducted

with public funding. Potential to establish a novel clinical trial methodology supported by

regulatory authorities.



SC1-HCO-20-2020 - Coordination of clinical research activities of the European Reference Networks (ERNs) - CSA

EU contribution 2 million (between EUR 1.5 to 2 million)

Scope:Enhancement of research and innovation capacity of the ERNs in view of achieving the goals of the International Rare Diseases Research Consortium (IRDiRC) for bringing new diagnostic tools and therapies more efficiently to the patients and for developing methodologies to assess the impact of diagnoses and therapies on rare disease patients, taking into account sex and gender differences where relevant.

Impact: Along the IRDiRC vision to enable all people living with a rare disease to receive an accurate diagnosis, care, and available therapy within one year of coming to medical attention by 2027. Contribute to the development of a comprehensive European ecosystem for rare diseases

Priority 1.5 Decoding the role of the environment, including climate change, for health and well-being

SC1-BHC-29-2020: Innovative actions for improving urban health - addressing environment, climate and socioeconomic factors - RIA Scope: Build the evidence base of effective policies, developing and testing new

initiatives to improve urban health and environment in Europe Develop and test effective interventions and/or policies for improved

urban health, reduced health inequalities and improved environment In Europe. Proposals could address physical or mental health, or both.

Possibility to link up internationally with other relevant urban health initiatives

Impact: More robust evidence for policy making on improved urban health in the

EU Improved population health, physical and mental, in urban areas of the

EU Reduced health inequalities in urban areas Improved environment and reduced climate footprint



SC1-BHC-36-2020: Micro- and nano-plastics in our environment: Understanding exposures and impacts on human health – RIA

Scope: Policy-relevant scientific data in support of improved human health risk

assessment of micro and/or nano-plastics (MNPs). Considering inter alia: Sources for MNP and transmission to humans; Methods for identification and quantification of MNPs incl. human

biomonitoring; Toxicology and uptake of MNP and additives/adsorbed contaminants; Fate in the GI tract, bioaccumulation, cell uptake, targets in organs,

immune response

Impact: Better understanding of the health impacts of exposure to MNPs Advancing health risk assessment of MNPs Contributing to the European Strategy for Plastics in a Circular Economy

and other relevant policies


TASSO DI SUCCESSO Complessivo SC1 Bandi 2014-2015

27

No. topics BudgetMill. EUR

Proposte presentate Proposte finanziate Tasso di successo

49 1.050,7 2326 202 8%

No. Partecipanti italiani in proposte presentate No. Partecipanti italiani finanziati

Tasso di successo partecipanti Italiani

2.537 203 8%

No. Proposte presentate a coordinamento italiano

No. Coordinamenti italiani finanziati Tasso di successo coordinatori Italiani

318 (13% del totale EU) 15 4,7%

Partecipazione

Coordinamento



38 684,76 1047 141 13%



1.179 166 9,9%



141 (13,4% del totale EU) 11 7,8%

2016-2017

TASSO DI SUCCESSO Complessivo SC1 Bandi 2018

28



30 581 562 94 16,7%



723 105 14,5%



84 (15% del totale EU) 9 10,7%

Partecipazione

Coordinamento

0

50

100

150

200

250

Categoria 1

Serie 1 Serie 2 Serie 3

0

500

1000

1500

2000

2500

3000

Categoria 1


N° domandepresentate

N° Partecipantifinanziati

2014-15

2014-15

2016-17

2016-17

2018

2018

0

2

4

6

8

10

12

14

16

Categoria 1


0

2

4

6

8

10

12

14

16

Categoria 1 Categoria 2


0

2

4

6

8

10

12

14

16

Categoria 1 Categoria 2


N° Coordinamentifinanziati

% successoPartecipanti

% successoCoordinamenti

2014-15

2014-15

2014-15

2016-17

2016-17

2016-17

2018

2018

2018

0

2

4

6

8

10

12

14

16

18

Categoria 1


% successo

2014-15

2016-17

2018

http://www.apre.it/media/459686/apre_panoramica_partecipazione_h2020.pdf



- SC1-BHC-06-2020: Digital diagnostics – developing tools for supporting clinical decisions by integrating various diagnostic data –RIA

One stage call, EU contribution 40 million (between EUR 8 and 15 million)

- SC1-HCO-01-2018-2019-2020: Actions in support of the International Consortium for Personalised Medicine – CSA


- SC1-HCO-03-2020: Bridging the divide in health research and innovation – boosting return on investment - CSA


- SC1-HCO-14-2020 ERA-NET: Sustained collaboration of national and regional programmes in cancer research


- SC1-HCO16 – 2020 ERA-NET: Sustained collaboration of national and regional programmes in research on brain-related diseases and disorders of the nervous system Participation of third countries


- SC1-HCO-17-2020: Coordinating and supporting research on the

human microbiome in Europe and beyond - CSA EU contribution EUR 5 million


- SC1-BHC-08-2020: New interventions for Non Communicable Diseases – RIA


- SC1-BHC-11-2020: Advancing the safety assessment of chemicals without the use of animal testing – RIA


- SC1-HCO-18-2020: Developing an adaptive methodological framework for improved clinical investigation and evaluation of high-risk medical devices – CSA


- SC1-HCO-19-2020 Reliable and accessible information on cell and gene therapies – CSA



- SC1-BHC-17-2020: Global Alliance for Chronic Diseases (GACD) 2 Prevention and/or early diagnosis of cancer – RIA


- SC1-BHC-20A-2020: Pre-commercial procurement (PCP) for integrated care solutions


- SC1-BHC-20B-2020: Public procurement (PPI) of innovative solutions for diagnostics for infectious diseases


- SC1-BHC-33-2020: Addressing low vaccine uptake – RIAEU contribution 9 million (between EUR 2 and 3 million)

- SC1-BHC-34-2020: New approaches for clinical management and prevention of resistant bacterial infections in high prevalence settings – RIA

EU contribution 25 million (between 10-15 million)

- SC1-BHC-35-2020: Creation of a European wide sustainable network for harmonised large-scale clinical research studies for infectious diseases – RIA



- SC1-HCO-07-2020: ERA-NET to support the Joint Programming Initiative on Antimicrobial resistance (JPIAMR) – 3rd Country participation



- SC1-BHC-24-2020: Healthcare interventions for the management of the elderly multimorbid patient – RIA

EU contribution 50 million (between EUR 4 to 6 million) Two stage call

- SC1-BHC-37-2020: Towards the new generation of clinical trials– trials methodology research – RIA-LS


- SC1-HCO-20-2020 - Coordination of clinical research activities ofthe European Reference Networks (ERNs) – CSA

EU contribution 2 million (between EUR 1.5 to 2 million)


- SC1-BHC-29-2020: Innovative actions for improving urban health - addressing environment, climate and socioeconomic factors – RIA


- SC1-BHC-36-2020: Micro- and nano-plastics in our environment: - Understanding exposures and impacts on human health – RIA


Call 1."Better health and care, economic growth and sustainable health systems”

(DG RTD Directorate Research and Innovation)






TASSO DI SUCCESSO Complessivo SC1 Bandi 2014-2015-2016-2017-2018

40



117 2.316,46 3.935 437 11%



4.439 474 10,6%



543 (13,8% del totale EU) 35 6,4%

Partecipazione

Coordinamento



41

42

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Prof.ssa Angela Santoni Delegato Nazionale Salute SC1 ...Prof.ssa Angela Santoni Delegato Nazionale...

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