east netherlands event better data to promote research ... · digicare1 pillar 2: better data to...
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HORIZON 2020The EU Framework Programme for Research and Innovation
Better data to promote research disease prevention and personalised health and care
Jana Makedonska Policy Officer-Programme Officer Unit
Innovative and Personalised Medicine Health Directorate Directorate-General for Research and Innovation European Commission
DigiCare1 Pillar 2 Better data to promote research prevention and personalised health and care
Actions bullCoordination of data sharing and infrastructure for prevention and personalised medicine research (incl genomic and health data)
bullSecure access and exchange of health research data
bullPilot actions on rare diseases epidemic monitoring and RWD to address patientsrsquo needs
1 Communication on enabling the digital transformation of health and care in the Digital Single Market empowering citizens and building a healthier society
bull Set up a mechanism for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research This includes a European network on genomics with efforts to link also with ongoing -omics and human cell mapping initiatives
bull Support the development of technical specifications for secure access and cross-border exchange of genomic and other health datasets within the internal market for research purposes [hellip]
bull Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
bull Support all the above by mobilising funds from Horizon 2020 and the Connecting Europe Facility [hellip] within the current envelopes and consider further support from the next multi-annual financial framework
DigiCare Pillar 2 Better data to promote research disease prevention and personalised health and care
Personalised medicine refers to a medical model using characterisation of individualsrsquo phenotypes and genotypes (eg molecular profiling medical imaging lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time andor to determine the predisposition to disease andor to deliver timely and targeted prevention
Definition developed by the Advisory group for the H2020 Health demographic change and well-being challenge
Council Conclusions on Personalised Medicine (PM) for patients (2015C 42103)
ldquoOmicsrdquo
Technologies
Data
Samples
Statistics
RampD the basics
RampD stratifying
tools
RampD test in human
In patients
Uptake in healthcare
Towards the market
Clinical trials methodologies
Patient -recruitment
Diagnostics amp therapies
Approval processes
Regulatory aspects
Pricing amp Reimbursement
Health economy
HTA
Novel models of healthcare organisation
Prediction - Prevention ndash Treatment - Cure
Availability amp usability in the clinic
Patient perspective
Equal treatment
Social and legal issues
Education and training
Personalised medicine across the medical innovation cycle
BiomarkersIdentification
Qualification Validation
Data modelling tools
Technical aspects amp challenges
Funding research in Personalised Medicine bull FP7 209 projects = euro1334 millionbull H2020 160 projects = euro870 million IMI JU 40 projects asymp EU euro430 million + EFPIA in-kind contribution euro 420 million
Fostering collaborationbullSet up international platforms for collaboration and coordination in health research (including personalised medicine) to support data sharing and analytics (eg International Consortium for Personalised Medicine (ICPerMed) and its supporting ERA-Net Cofund on Personalised Medicine IRDiRC Human Cell Atlas European Hub for Epigenome Consortium etc)
bullRegional and national initiatives
bullLinking resourcesusing common standards for faster diagnosis better prevention anticipating disease outbreaks
Policy coordination
Bringing together
research and healthcare
Research collaboration
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
Setting International Standards
G2MC
International Consortium for Personalised Medicine
bull Collaboration of research funders and policy makers from EU Member States and beyond
bull Establish Europe as a global leader in PM research bull Support the PM science base through a coordinated
approach to research bull Provide evidence to demonstrate the benefit of PM
to citizens and healthcare systems bull Pave the way for PM approaches for citizens
bull Implementation of a Roadmap based on PerMed Strategic Research Agenda (SRIA)
WH
ATW
HY
HO
W
bullAustria bullBrazil bullCanada + British helliphellipColumbia Region bullCroatia bullCyprus bullCzech Republic bullDenmark bullEstonia bullEU as observer bullFinland bullFrance bullGermany bullHungary bullIreland bullIsrael
bull Italy + Lombardy Regionbull Lithuaniabull Luxembourgbull Moldovabull Netherlandsbull Norwaybull Polandbull Portugalbull Romaniabull Sloveniabull Spain + Regions Basque
Country amp Navarrabull Swedenbull Switzerlandbull Turkey
28 countries and 4
regions 11 Health Ministries
6 Science and
Education Ministries
Members active in the IC PerMed
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
DigiCare1 Pillar 2 Better data to promote research prevention and personalised health and care
Actions bullCoordination of data sharing and infrastructure for prevention and personalised medicine research (incl genomic and health data)
bullSecure access and exchange of health research data
bullPilot actions on rare diseases epidemic monitoring and RWD to address patientsrsquo needs
1 Communication on enabling the digital transformation of health and care in the Digital Single Market empowering citizens and building a healthier society
bull Set up a mechanism for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research This includes a European network on genomics with efforts to link also with ongoing -omics and human cell mapping initiatives
bull Support the development of technical specifications for secure access and cross-border exchange of genomic and other health datasets within the internal market for research purposes [hellip]
bull Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
bull Support all the above by mobilising funds from Horizon 2020 and the Connecting Europe Facility [hellip] within the current envelopes and consider further support from the next multi-annual financial framework
DigiCare Pillar 2 Better data to promote research disease prevention and personalised health and care
Personalised medicine refers to a medical model using characterisation of individualsrsquo phenotypes and genotypes (eg molecular profiling medical imaging lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time andor to determine the predisposition to disease andor to deliver timely and targeted prevention
Definition developed by the Advisory group for the H2020 Health demographic change and well-being challenge
Council Conclusions on Personalised Medicine (PM) for patients (2015C 42103)
ldquoOmicsrdquo
Technologies
Data
Samples
Statistics
RampD the basics
RampD stratifying
tools
RampD test in human
In patients
Uptake in healthcare
Towards the market
Clinical trials methodologies
Patient -recruitment
Diagnostics amp therapies
Approval processes
Regulatory aspects
Pricing amp Reimbursement
Health economy
HTA
Novel models of healthcare organisation
Prediction - Prevention ndash Treatment - Cure
Availability amp usability in the clinic
Patient perspective
Equal treatment
Social and legal issues
Education and training
Personalised medicine across the medical innovation cycle
BiomarkersIdentification
Qualification Validation
Data modelling tools
Technical aspects amp challenges
Funding research in Personalised Medicine bull FP7 209 projects = euro1334 millionbull H2020 160 projects = euro870 million IMI JU 40 projects asymp EU euro430 million + EFPIA in-kind contribution euro 420 million
Fostering collaborationbullSet up international platforms for collaboration and coordination in health research (including personalised medicine) to support data sharing and analytics (eg International Consortium for Personalised Medicine (ICPerMed) and its supporting ERA-Net Cofund on Personalised Medicine IRDiRC Human Cell Atlas European Hub for Epigenome Consortium etc)
bullRegional and national initiatives
bullLinking resourcesusing common standards for faster diagnosis better prevention anticipating disease outbreaks
Policy coordination
Bringing together
research and healthcare
Research collaboration
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
Setting International Standards
G2MC
International Consortium for Personalised Medicine
bull Collaboration of research funders and policy makers from EU Member States and beyond
bull Establish Europe as a global leader in PM research bull Support the PM science base through a coordinated
approach to research bull Provide evidence to demonstrate the benefit of PM
to citizens and healthcare systems bull Pave the way for PM approaches for citizens
bull Implementation of a Roadmap based on PerMed Strategic Research Agenda (SRIA)
WH
ATW
HY
HO
W
bullAustria bullBrazil bullCanada + British helliphellipColumbia Region bullCroatia bullCyprus bullCzech Republic bullDenmark bullEstonia bullEU as observer bullFinland bullFrance bullGermany bullHungary bullIreland bullIsrael
bull Italy + Lombardy Regionbull Lithuaniabull Luxembourgbull Moldovabull Netherlandsbull Norwaybull Polandbull Portugalbull Romaniabull Sloveniabull Spain + Regions Basque
Country amp Navarrabull Swedenbull Switzerlandbull Turkey
28 countries and 4
regions 11 Health Ministries
6 Science and
Education Ministries
Members active in the IC PerMed
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
bull Set up a mechanism for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research This includes a European network on genomics with efforts to link also with ongoing -omics and human cell mapping initiatives
bull Support the development of technical specifications for secure access and cross-border exchange of genomic and other health datasets within the internal market for research purposes [hellip]
bull Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
bull Support all the above by mobilising funds from Horizon 2020 and the Connecting Europe Facility [hellip] within the current envelopes and consider further support from the next multi-annual financial framework
DigiCare Pillar 2 Better data to promote research disease prevention and personalised health and care
Personalised medicine refers to a medical model using characterisation of individualsrsquo phenotypes and genotypes (eg molecular profiling medical imaging lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time andor to determine the predisposition to disease andor to deliver timely and targeted prevention
Definition developed by the Advisory group for the H2020 Health demographic change and well-being challenge
Council Conclusions on Personalised Medicine (PM) for patients (2015C 42103)
ldquoOmicsrdquo
Technologies
Data
Samples
Statistics
RampD the basics
RampD stratifying
tools
RampD test in human
In patients
Uptake in healthcare
Towards the market
Clinical trials methodologies
Patient -recruitment
Diagnostics amp therapies
Approval processes
Regulatory aspects
Pricing amp Reimbursement
Health economy
HTA
Novel models of healthcare organisation
Prediction - Prevention ndash Treatment - Cure
Availability amp usability in the clinic
Patient perspective
Equal treatment
Social and legal issues
Education and training
Personalised medicine across the medical innovation cycle
BiomarkersIdentification
Qualification Validation
Data modelling tools
Technical aspects amp challenges
Funding research in Personalised Medicine bull FP7 209 projects = euro1334 millionbull H2020 160 projects = euro870 million IMI JU 40 projects asymp EU euro430 million + EFPIA in-kind contribution euro 420 million
Fostering collaborationbullSet up international platforms for collaboration and coordination in health research (including personalised medicine) to support data sharing and analytics (eg International Consortium for Personalised Medicine (ICPerMed) and its supporting ERA-Net Cofund on Personalised Medicine IRDiRC Human Cell Atlas European Hub for Epigenome Consortium etc)
bullRegional and national initiatives
bullLinking resourcesusing common standards for faster diagnosis better prevention anticipating disease outbreaks
Policy coordination
Bringing together
research and healthcare
Research collaboration
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
Setting International Standards
G2MC
International Consortium for Personalised Medicine
bull Collaboration of research funders and policy makers from EU Member States and beyond
bull Establish Europe as a global leader in PM research bull Support the PM science base through a coordinated
approach to research bull Provide evidence to demonstrate the benefit of PM
to citizens and healthcare systems bull Pave the way for PM approaches for citizens
bull Implementation of a Roadmap based on PerMed Strategic Research Agenda (SRIA)
WH
ATW
HY
HO
W
bullAustria bullBrazil bullCanada + British helliphellipColumbia Region bullCroatia bullCyprus bullCzech Republic bullDenmark bullEstonia bullEU as observer bullFinland bullFrance bullGermany bullHungary bullIreland bullIsrael
bull Italy + Lombardy Regionbull Lithuaniabull Luxembourgbull Moldovabull Netherlandsbull Norwaybull Polandbull Portugalbull Romaniabull Sloveniabull Spain + Regions Basque
Country amp Navarrabull Swedenbull Switzerlandbull Turkey
28 countries and 4
regions 11 Health Ministries
6 Science and
Education Ministries
Members active in the IC PerMed
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Personalised medicine refers to a medical model using characterisation of individualsrsquo phenotypes and genotypes (eg molecular profiling medical imaging lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time andor to determine the predisposition to disease andor to deliver timely and targeted prevention
Definition developed by the Advisory group for the H2020 Health demographic change and well-being challenge
Council Conclusions on Personalised Medicine (PM) for patients (2015C 42103)
ldquoOmicsrdquo
Technologies
Data
Samples
Statistics
RampD the basics
RampD stratifying
tools
RampD test in human
In patients
Uptake in healthcare
Towards the market
Clinical trials methodologies
Patient -recruitment
Diagnostics amp therapies
Approval processes
Regulatory aspects
Pricing amp Reimbursement
Health economy
HTA
Novel models of healthcare organisation
Prediction - Prevention ndash Treatment - Cure
Availability amp usability in the clinic
Patient perspective
Equal treatment
Social and legal issues
Education and training
Personalised medicine across the medical innovation cycle
BiomarkersIdentification
Qualification Validation
Data modelling tools
Technical aspects amp challenges
Funding research in Personalised Medicine bull FP7 209 projects = euro1334 millionbull H2020 160 projects = euro870 million IMI JU 40 projects asymp EU euro430 million + EFPIA in-kind contribution euro 420 million
Fostering collaborationbullSet up international platforms for collaboration and coordination in health research (including personalised medicine) to support data sharing and analytics (eg International Consortium for Personalised Medicine (ICPerMed) and its supporting ERA-Net Cofund on Personalised Medicine IRDiRC Human Cell Atlas European Hub for Epigenome Consortium etc)
bullRegional and national initiatives
bullLinking resourcesusing common standards for faster diagnosis better prevention anticipating disease outbreaks
Policy coordination
Bringing together
research and healthcare
Research collaboration
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
Setting International Standards
G2MC
International Consortium for Personalised Medicine
bull Collaboration of research funders and policy makers from EU Member States and beyond
bull Establish Europe as a global leader in PM research bull Support the PM science base through a coordinated
approach to research bull Provide evidence to demonstrate the benefit of PM
to citizens and healthcare systems bull Pave the way for PM approaches for citizens
bull Implementation of a Roadmap based on PerMed Strategic Research Agenda (SRIA)
WH
ATW
HY
HO
W
bullAustria bullBrazil bullCanada + British helliphellipColumbia Region bullCroatia bullCyprus bullCzech Republic bullDenmark bullEstonia bullEU as observer bullFinland bullFrance bullGermany bullHungary bullIreland bullIsrael
bull Italy + Lombardy Regionbull Lithuaniabull Luxembourgbull Moldovabull Netherlandsbull Norwaybull Polandbull Portugalbull Romaniabull Sloveniabull Spain + Regions Basque
Country amp Navarrabull Swedenbull Switzerlandbull Turkey
28 countries and 4
regions 11 Health Ministries
6 Science and
Education Ministries
Members active in the IC PerMed
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
ldquoOmicsrdquo
Technologies
Data
Samples
Statistics
RampD the basics
RampD stratifying
tools
RampD test in human
In patients
Uptake in healthcare
Towards the market
Clinical trials methodologies
Patient -recruitment
Diagnostics amp therapies
Approval processes
Regulatory aspects
Pricing amp Reimbursement
Health economy
HTA
Novel models of healthcare organisation
Prediction - Prevention ndash Treatment - Cure
Availability amp usability in the clinic
Patient perspective
Equal treatment
Social and legal issues
Education and training
Personalised medicine across the medical innovation cycle
BiomarkersIdentification
Qualification Validation
Data modelling tools
Technical aspects amp challenges
Funding research in Personalised Medicine bull FP7 209 projects = euro1334 millionbull H2020 160 projects = euro870 million IMI JU 40 projects asymp EU euro430 million + EFPIA in-kind contribution euro 420 million
Fostering collaborationbullSet up international platforms for collaboration and coordination in health research (including personalised medicine) to support data sharing and analytics (eg International Consortium for Personalised Medicine (ICPerMed) and its supporting ERA-Net Cofund on Personalised Medicine IRDiRC Human Cell Atlas European Hub for Epigenome Consortium etc)
bullRegional and national initiatives
bullLinking resourcesusing common standards for faster diagnosis better prevention anticipating disease outbreaks
Policy coordination
Bringing together
research and healthcare
Research collaboration
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
Setting International Standards
G2MC
International Consortium for Personalised Medicine
bull Collaboration of research funders and policy makers from EU Member States and beyond
bull Establish Europe as a global leader in PM research bull Support the PM science base through a coordinated
approach to research bull Provide evidence to demonstrate the benefit of PM
to citizens and healthcare systems bull Pave the way for PM approaches for citizens
bull Implementation of a Roadmap based on PerMed Strategic Research Agenda (SRIA)
WH
ATW
HY
HO
W
bullAustria bullBrazil bullCanada + British helliphellipColumbia Region bullCroatia bullCyprus bullCzech Republic bullDenmark bullEstonia bullEU as observer bullFinland bullFrance bullGermany bullHungary bullIreland bullIsrael
bull Italy + Lombardy Regionbull Lithuaniabull Luxembourgbull Moldovabull Netherlandsbull Norwaybull Polandbull Portugalbull Romaniabull Sloveniabull Spain + Regions Basque
Country amp Navarrabull Swedenbull Switzerlandbull Turkey
28 countries and 4
regions 11 Health Ministries
6 Science and
Education Ministries
Members active in the IC PerMed
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Funding research in Personalised Medicine bull FP7 209 projects = euro1334 millionbull H2020 160 projects = euro870 million IMI JU 40 projects asymp EU euro430 million + EFPIA in-kind contribution euro 420 million
Fostering collaborationbullSet up international platforms for collaboration and coordination in health research (including personalised medicine) to support data sharing and analytics (eg International Consortium for Personalised Medicine (ICPerMed) and its supporting ERA-Net Cofund on Personalised Medicine IRDiRC Human Cell Atlas European Hub for Epigenome Consortium etc)
bullRegional and national initiatives
bullLinking resourcesusing common standards for faster diagnosis better prevention anticipating disease outbreaks
Policy coordination
Bringing together
research and healthcare
Research collaboration
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
Setting International Standards
G2MC
International Consortium for Personalised Medicine
bull Collaboration of research funders and policy makers from EU Member States and beyond
bull Establish Europe as a global leader in PM research bull Support the PM science base through a coordinated
approach to research bull Provide evidence to demonstrate the benefit of PM
to citizens and healthcare systems bull Pave the way for PM approaches for citizens
bull Implementation of a Roadmap based on PerMed Strategic Research Agenda (SRIA)
WH
ATW
HY
HO
W
bullAustria bullBrazil bullCanada + British helliphellipColumbia Region bullCroatia bullCyprus bullCzech Republic bullDenmark bullEstonia bullEU as observer bullFinland bullFrance bullGermany bullHungary bullIreland bullIsrael
bull Italy + Lombardy Regionbull Lithuaniabull Luxembourgbull Moldovabull Netherlandsbull Norwaybull Polandbull Portugalbull Romaniabull Sloveniabull Spain + Regions Basque
Country amp Navarrabull Swedenbull Switzerlandbull Turkey
28 countries and 4
regions 11 Health Ministries
6 Science and
Education Ministries
Members active in the IC PerMed
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Fostering collaborationbullSet up international platforms for collaboration and coordination in health research (including personalised medicine) to support data sharing and analytics (eg International Consortium for Personalised Medicine (ICPerMed) and its supporting ERA-Net Cofund on Personalised Medicine IRDiRC Human Cell Atlas European Hub for Epigenome Consortium etc)
bullRegional and national initiatives
bullLinking resourcesusing common standards for faster diagnosis better prevention anticipating disease outbreaks
Policy coordination
Bringing together
research and healthcare
Research collaboration
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
Setting International Standards
G2MC
International Consortium for Personalised Medicine
bull Collaboration of research funders and policy makers from EU Member States and beyond
bull Establish Europe as a global leader in PM research bull Support the PM science base through a coordinated
approach to research bull Provide evidence to demonstrate the benefit of PM
to citizens and healthcare systems bull Pave the way for PM approaches for citizens
bull Implementation of a Roadmap based on PerMed Strategic Research Agenda (SRIA)
WH
ATW
HY
HO
W
bullAustria bullBrazil bullCanada + British helliphellipColumbia Region bullCroatia bullCyprus bullCzech Republic bullDenmark bullEstonia bullEU as observer bullFinland bullFrance bullGermany bullHungary bullIreland bullIsrael
bull Italy + Lombardy Regionbull Lithuaniabull Luxembourgbull Moldovabull Netherlandsbull Norwaybull Polandbull Portugalbull Romaniabull Sloveniabull Spain + Regions Basque
Country amp Navarrabull Swedenbull Switzerlandbull Turkey
28 countries and 4
regions 11 Health Ministries
6 Science and
Education Ministries
Members active in the IC PerMed
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Setting International Standards
G2MC
International Consortium for Personalised Medicine
bull Collaboration of research funders and policy makers from EU Member States and beyond
bull Establish Europe as a global leader in PM research bull Support the PM science base through a coordinated
approach to research bull Provide evidence to demonstrate the benefit of PM
to citizens and healthcare systems bull Pave the way for PM approaches for citizens
bull Implementation of a Roadmap based on PerMed Strategic Research Agenda (SRIA)
WH
ATW
HY
HO
W
bullAustria bullBrazil bullCanada + British helliphellipColumbia Region bullCroatia bullCyprus bullCzech Republic bullDenmark bullEstonia bullEU as observer bullFinland bullFrance bullGermany bullHungary bullIreland bullIsrael
bull Italy + Lombardy Regionbull Lithuaniabull Luxembourgbull Moldovabull Netherlandsbull Norwaybull Polandbull Portugalbull Romaniabull Sloveniabull Spain + Regions Basque
Country amp Navarrabull Swedenbull Switzerlandbull Turkey
28 countries and 4
regions 11 Health Ministries
6 Science and
Education Ministries
Members active in the IC PerMed
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
International Consortium for Personalised Medicine
bull Collaboration of research funders and policy makers from EU Member States and beyond
bull Establish Europe as a global leader in PM research bull Support the PM science base through a coordinated
approach to research bull Provide evidence to demonstrate the benefit of PM
to citizens and healthcare systems bull Pave the way for PM approaches for citizens
bull Implementation of a Roadmap based on PerMed Strategic Research Agenda (SRIA)
WH
ATW
HY
HO
W
bullAustria bullBrazil bullCanada + British helliphellipColumbia Region bullCroatia bullCyprus bullCzech Republic bullDenmark bullEstonia bullEU as observer bullFinland bullFrance bullGermany bullHungary bullIreland bullIsrael
bull Italy + Lombardy Regionbull Lithuaniabull Luxembourgbull Moldovabull Netherlandsbull Norwaybull Polandbull Portugalbull Romaniabull Sloveniabull Spain + Regions Basque
Country amp Navarrabull Swedenbull Switzerlandbull Turkey
28 countries and 4
regions 11 Health Ministries
6 Science and
Education Ministries
Members active in the IC PerMed
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
bullAustria bullBrazil bullCanada + British helliphellipColumbia Region bullCroatia bullCyprus bullCzech Republic bullDenmark bullEstonia bullEU as observer bullFinland bullFrance bullGermany bullHungary bullIreland bullIsrael
bull Italy + Lombardy Regionbull Lithuaniabull Luxembourgbull Moldovabull Netherlandsbull Norwaybull Polandbull Portugalbull Romaniabull Sloveniabull Spain + Regions Basque
Country amp Navarrabull Swedenbull Switzerlandbull Turkey
28 countries and 4
regions 11 Health Ministries
6 Science and
Education Ministries
Members active in the IC PerMed
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
State of the play
bullICPerMed Conference 2018 Personalised Medicine in Actionlsquo Berlin 20-21 Nov 2018 bullAction Plan 2017 set of activities forming the work programme over the next two years bullERA PerMed a European Research Area Network (ERA-Net) to align funding of national (and regional) support to trans-national research projects first call February 2018 bullThe ICPerMed secretariat is funded by a CSA grant from the EC It runs all operations and acts as an umbrella for other relevant CSA grants addressing health economy cooperation between regions international cooperation clinical trials design etc
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
bullERA-Net for Personalised Medicine bullTo implement parts of the ICPerMed Action Plan bullStarted on 1st December 2017 runs 5 years bullOver 30 million Euros total investment bull32 partners from 23 countries (all in ICPerMed) bullFirst co-funded call launched 9 February 2018 Smart combination of pre-clinical and clinical research with data and ICT solutions bullhttpwwwerapermedeu
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Projects supporting ICPerMed
ICPerMed SecretariatPerMed
EU-AU on PM
ERA-PerMed (2018-2022)
2015 20172012 2013 20182014 2016 2019 2020 2021 2022 2023
CSA
ERA-NET
IA
Follow-up
Regional aspects
Health economy
EU-CELAC on PM
Clin trials models
EU-China on PM
In silico models
To be determined
PM demonstration pilots WP 18-19 budget earmarked for 2020
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull International aspect Build links with third countries by analysing the potential and advantages of collaboration in personalised medicine [hellip] and promoting international standards in the field For the 2019 call the project should focus on China
bull Regional aspect Establish and support networking between regions and interregional cooperation in European countries in particular linking remote or sparsely populated regions with regions harbouring critical mass of medical and personalised medicine expertise (2018 call)
bull Healthcare- and pharma-economic models for personalised medicine interlinking European public health approaches with medical practice and financing Research in and development of new health- and pharma economic models for personalised medicine including prevention to capture value and to develop relevant health financing models (2018 call)
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
SC1-HCO-01-2019 Actions in support of the International Consortium for Personalised Medicine
Scope Each action should focus on one of the following fields
bull Standardisation for clinical study design Establish innovative clinical trial design methodology for personalised medicine including guidelines for research and reflection papers (2019 call)
CSA EU contribution EUR 15-2 million
Next deadline 16 April 2019
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Fostering collaborationbull1 M Genomes initiative 1 million genomes accessible in the EU by 2022 through a secure and trusted data infrastructure bullBuild on international efforts to establish a strategy for the next-generation population and patient cohorts Horizon2020 topic (CSA) SC1-HCO-09-2018 Building international efforts on population and patient cohorts bullSC1-BHC-31-2019 Pilot actions to build the foundations of a human cell atlas (closing date 16 April 2019)
Mechanisms for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
A dedicated partnership to facilitate the alignment of regional agendas and cross-regional cooperation in personalised medicine
The Smart Specialisation Platform for Industrial Modernisation (S3P-Industry) aims to support EU regions committed to generate a pipeline of industrial investment projects following a bottom-up approach implemented through interregional cooperation cluster participation and industry involvement
16 Thematic Partnerships already established under this platform fully open to regions and aimed at bringing those willing to co-invest
Two thematic partnerships are focused on Health
Medical technologies (created in 2017)
Personalised Medicine (created in 2018) ndash To align complementary assets infrastructures and work to integrate value chains across different technology sectors for PM It will bring the agenda to implement PM to the next level
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Technical specifications for secure access and cross-border exchange of genomic and other health datasets
bull(RIA) SC1-BHC-05-2018 International flagship collaboration with Canada for human data storage integration and sharing to enable personalised medicine approaches
bull(CSA) SC1-HCO-02-2018 Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework
bull(PCP) SC1-BHC-10-2019 Innovation Procurement Next generation sequencing (NGS) for routine diagnosis (closing date 16 April 2019)
bullOngoing SPIDIA4P project (2017-2020) (CSA) Standardisation of pre-analytical procedures for in-vitro diagnostics for personalised medicine
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Infrastructure for rare diseases research bull3 consecutive ERA-Nets (E-Rare 12 3) for coordinated national research funding programmes bullFP7 projects Neuromics and EuRenOmics discovering genetic basis of 130 rare diseases bullFP7 project RD-Connect overcoming silos data sharing for research and better data analysis bull Orphanet a reference portal for
information on rare diseases bullSC1-BHC-04-2018 Rare Disease European Joint Programme Co-fund
Biomarker study
Registry
Clinical trial
Biobank
Natural history
copy philipus 5073973 2018 Source Fotoliacom
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Data mining infrastructure for early detection of infectious threats
bull FP7 large scale pilot COMPARE (title COllaborative Management Platform for detection and Analyses of (Re)emerging and foodborne outbreaks in Europe) (2014 ndash 2019)
bull SC1-HCO-09-2018 Building international efforts on population and patient cohorts
bull SC1-BHC-13-2019 Mining big data for early detection of infectious disease threats driven by climate change and other factors (closing date 16 April 2019)
bull SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention treatment andor cure of infectious diseases (two stage)
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Clinical decision making
Regulatory decision making clinical and market access development plansHTA relative
effectivenessHTA health economic models for PM
HTA Health Economic Evaluation
Policy making Outcome-based managed entry
agreements
Health Data
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
Launch pilot actions pooling data and resources across the EU to demonstrate the benefits of advancing research disease prevention personalised medicine health technology assessment as well as clinical and regulatory decision making
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
REAL-WORLD DATA GUIDANCE FOR HEALTH TECHNOLOGY ASSESSMENT CLINICAL
DECISION MAKING (DM) REGULATORY DM AND POLICY MAKING
REAL-WORLD DATA SYNTHESIS WORK FROM H2020 IMI1 IMI2 BD4BO
OTHER PROGRAMMES
bull RWD for policy and regulatory decision making support projects on clinical and market access development plans and outcome-based managed entry agreements (ongoing projects eg COMED IMPACT-HTA ROADMAP HARMONY topic European Health Data Framework etc)
bull RWD for Health-Technology Assessment (HTA) methods and tools to use RWD for HTA (relative effectiveness assessment and health economic models) considering different types of technologies (pharmaceuticals medical devices etc) and different disease areas (eg COMED IMPACT-HTA HARMONY BigDataHeart H2020 topic SC1-BHC-26-2018 HTA research to support evidence-based healthcare)
bull RWD for clinical decision making H2020 topic (RIA) SC1-BHC-06-2020 Digital diagnostics ndash developing tools for clinical decisions integrating in vitro and in vivo diagnostics)
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Future work WP 2020 draft
Call 1 ndash Better health and care economic growth and sustainable health
systems
11 Personalised medicine
bull SC1-BHC-06-2020 Digital diagnostics - developing tools for clinical decisions
integrating in vitro and in vivo diagnostics
bull SC1-HCO-01-2018-2019-2020 Actions in support of the International
Consortium for Personalised Medicine
12 Innovative health and care industry
14 Innovative health and care systems ndash integration of care
Call 2 ndash Digital transformation in Health and Care
Call 3 ndash Trusted digital solutions and Cybersecurity in Health and Care
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Articles and videos on our activities bullPerspective for the Journal Personalised Medicine Enabling personalised medicine in Europe by the European Commissionrsquos funding activities wwwfuturemedicinecomdoifull102217pme-2017-0003
bullClinical and Translational Sciences Personalised Medicine in Europe httponlinelibrarywileycomdoi101111cts12446full
bullVideo How co-operation paves the way for personalised medicine issued by the American Society for Human Genetics (ASHG) for the ASHG conference in Orlando October 2017 httpsyoutubevSpSwLZ54nY
Thank you
Thank you