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1 MISSION-BASED PROGRESS WITHIN THE NEXT FRAMEWORK PROGRAMME (FP9) April 2018

IBEC's Mission-Based Progress within FP9

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MISSION-BASED PROGRESS WITHIN THE NEXT FRAMEWORK PROGRAMME (FP9)

April 2018

· 2 · MISSION-BASED PROGRESS WITHIN THE NEXT FRAMEWORK PROGRAMME (FP9)

MISSION-BASED PROGRESS WITHIN THE NEXT FRAMEWORK PROGRAMME (FP9)

Essential features that missions should holdGlobal challenges should outline citizens’ needs and foster collaborations among multiple actors. The new proposed Mission-oriented approach should be transversal and with a clear focus on global challenges that address societal needs. Once this directionality

1 while encompassing social sciences and humanities

approaches that pursue sustainability and inclusiveness will be needed. As well as looking towards improving

2

new directions for change and offering added value

missions would have the same economical weight or see the same rate of growth.

and innovation led-growth. Missions are not broad challenges nor sector or technologies, there must be concrete problems solved by different sectors tackling a challenge they must be a vehicle for setting a knowledge-based growth economy, towards the kind of society we pursue.

mission-oriented innovation approach will depend on the risk taken and the obtained impact across society3. IBEC suggests the European Commission to use a combination of bottom-up and top-down instruments (combing low and high TRLs) to build up this mission

on the most recent insights in science and technology should be selected.

The mission can be a good coordination envelope cluste ing for acommon goal. This approach can result in focus areas that can actuate across FP9 work programs with a cross-cutting nature (

be

,

implemented is another Global

enclosing t

contributingto a mission.

IBEC’s agrees with the selected by

realistic missions should not carry so much weight

Finding intermediate goals to measure impact is a

portfolios (containing high TRLs). This kind of follow- ,

milestones have not been achieved, is detrimental to it

unsuitable for these measures. We only foresee this

model combining both systems (less reporting and more

reports and meetings.

Public engagement seems to be a crucial feature for

design)4. European civil society is pretty conscient

community knows the capabilities and the progress

, an disclose a

trilateral co-design among these three groups of

mission. Limiting the co-design to only some of them might be inconvenient for FP9’s future.

· 3 ·MISSION-BASED PROGRESS WITHIN THE NEXT FRAMEWORK PROGRAMME (FP9)

1 First Gago Conference on European Policy. 14th of February 2018.2 Mision-oriented R&I policies: In-depth case studies. Case Study Report: Energiewende. 2018

3 Mission-Oriented Research & Innovation in the European Union. A problem-solving approach to fuel innovation-led growth. Mariana Maz-zucato. European Comission. 2018

4 Mission-Oriented Research and Innovation Policy: A RISE Perspective. European Comission. 2018

5 Towards a Mission-Oriented Research and Innovation Policy in the European Union: An ESIR Memorandum: Executive Summary. European Comission. 2017

6 The Structure of FP9. Norges Artktiske Universitet. Thorbjørg Hroarsdot-tir 25.01.2018.

portfolios between the different pillars and work programmes among FP9. If it pretends to be even more

governancelearned from other similar initiatives should be applied

without regional and national authorities’ commitment

envisaged.

only funding private bodies with public money is an important asset for this mission approach5. For that

a

settled for the

rest of work programmes should regulate missions, avoiding unclear scenarios.

pro-active participant in the co-design of this mission-

Evolution plus Revolution

process/technology development/innovation in a certain area and “Transforming missions” with transformative potential for society6. This mission approach must be

points out very wisely to preserve feasibility and

evolution and revolution can co-exist nurturing EU with simultaneous growths at different speeds.

Size mattersRecent reports have addressed the granularity of the missions on a scope basis3

narrow might be an advantage to implement missions

said about the dimension of these missions. Are we

other running initiatives? We understand that different

thresholds could be applied to be able to cluster the needed instruments within these ‘new focus areas’, and to assure a certain commitment of accomplishment

relevance, as candidates reinforcing the mission-oriented approach to global challenges (focused on societal

)more the moon-shot concept that is being sought.

Needs and WillsWhich challenges will be addressed is also another key aspect. One of the European Union principles is

action satisfactorily, and when added value can be provided. s

will the Commission fund

issues that are relevant for European society but not properly addressed, or will they bend to the media’s hot topics and bandwagons?

CONTACT:

Institute for Bioengineering of Catalonia (IBEC)

www.ibecbarcelona.eu

4

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Missions and Technologies for a Better and Easier Life

Mission statement

Goal/Visions

Expected Impact

How does success look like

BioFABrication for tailored ADVANCEd therapies by 2030 (ADVANCEFAB 2030)

Goal/Visions The goal of this technological mission is to exploit the potential of innovative technologies in regenerative medicine and biofabrication, for the future of healthcare sciences. Bridging personalized medicine and these new technologies is fundamental to achieve a rational roadmap to deliver the dream of long-lasting advanced therapies.

Expected Impact by 2030 This proposal will transform European healthcare and linked markets, creating collaborations with the industrial community by:

Developing manufactured functional tissues and organs,thus eliminating transplantation waiting lists Developing advanced 3D in vitro models to betterunderstand pathological mechanisms and advanced therapies for rare and life-threatening diseases Developing new drugs and enable repurposing of existingoff-the-shelf medicines through 3D in vitro models, identifying the most effective therapies for patients Produce tissues and organs generating less immunereaction than donor tissues Stimulating new regenerative medicine and biofabricationindustries Transforming traditional surgical practice by personalizedin-situ robotic bioprinting of advanced therapies Creating a hub between partners that will guaranteeprofessional knowledge diffusion and democratic access to new regenerative medicine therapies through biofabrication and organ-on-chip technologies

How does success look like? Timely advancement of these technologies requires cooperation amongst a range of disciplines, close collaboration between academia and industry, which will be boosted by combining these proposals. Moreover, such an integrated approach will in our view deliver:

The first integrated artificial organ biofabrication line as aprototype clinical printing room;

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Underlying challenge

Good manufacturing practice (GMP) Robotic 3D bioprintersfor use in the operating theatre;Human 3D mini-tissues and -organs for bioreactor-basedhigh throughput automated screening and analysis fortoxicity assays, drug development and other relevantindustries, working towards personalized drug treatmentand testing;An open access database with digital information includingmodels of human 3D tissues and organs to improvestrategies and approaches developed for new therapies.European network for basic research, GLP safety testing ofbiomaterials, GMP production guidelines and facilities,required standardization and quality control strategies foradvanced therapies validation and translation;Achieve a common regulatory hallmark to facilitate clinicaland manufacturing development on a mid-long-termfuture, utilizing current actions in the field, such a as theEMA Guidelines on human cell-based medicinal products(EMEA/CHMP/410869/2006).Automatization of procedures and workflows necessary tolower the barrier to market entry for advanced therapies.

Underlying challenge Scientific and commercial competition from the United States and Asian countries in advanced therapies, in vitro models and biofabrication, requires that Europe not only provides resources to maintain technological competitiveness but also to strategically invest in this quickly developing area. The clustering would build on Europe’s track record of stem cell biology, biofabrication, engineering, advanced material science, and GMP manufacturing of medical therapies. Europe is already in a dominant position in stem cell biology, biofabrication, engineering and advanced material science and is home to many of its pioneers. Our initiative will capitalize on the ongoing success and demonstrate European technological superiority and leadership. Advanced therapies are expected to develop into a 5 billion Euro industry in 2017, with a yearly growth rate of 13.0% over the next 10 years, with biofabrication playing a pivotal role in this growth. The global market for bioprinting reached $263.8 million in 2015. The market should reach $295 million in 2016 and $1.8 billion by 2021, growing at a compound annual growth rate (CAGR) of 43.9% from 2016 to 2021. Despite some promising regenerative medicine strategies already clinically used, in most cases their development is still a “black box” of complex information. We aim at tackling this information gap while improving biofabrication technologies that have a pivotal role in most of the stages of these novel strategies. This will allow large-scale articulation of information between the EU partners promoting a faster and efficient development of functional advanced functional therapies.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

In addition, organ-on-chip technology is in its infancy but is also developing extremely rapid. Organ-on-a-chip and microtissues have been identified by the European Pharma-Industry as an essential requirement to reduce animal testing in the drug development cycle and improve early stage rejection of unsatisfactory compounds. This has the potential of reducing drug development costs by 1B Euros each new molecule.

Typology (technological/societal/scientific/All)

Disciplines/technologies/innovation

Scientific, Technological, Industrial, Regulatory, transformational mission with high impact on public health and society.

This mission will involve physicists, chemists, biologists, clinicians, robotic/mechanical and biomedical engineers, pharmacologists, computer scientists and mathematicians.

Potential Activities Additive manufacturing (3D Printing of biomaterials/tissues)Biofabrication for Human Complex 3D Tissues and OrganPrinting.Regenerative, precision and personalized medicineAgeing and Technologies for the ElderlyAdvanced materials for bioinks developmentSmart scaffolding responsive to environment changesTissue Engineering for automated generation of human tissuesand organsPatient-Specific human tissue- and organ-on-a-chip models forhigh throughput analysisStandardized and quality controlled advanced therapiesDevelop self-healing tissuesIn silico modelling for therapeutic predictionStem cells engineering and cell reprogrammingMicrofluidics and microelectronicsMultifunctional bioreactors for complex tissuesFundamentals of disease mechanisms and modelling

Key Actors involved Industry including SMEs and academia, healthcare systems along the entire industrial value-chain, citizens and society. This mission will mainly gather competences from DG RTD, and DG-REGIO. Some minor involvement of DG-EAC can be overseen.

Relevant: SDGs

This mission is contributing to the following SDGs: Ensure healthy lives and promote well-being for all at all ages(SDG3) Promote sustained, inclusive and sustainable economic growth,full and productive employment and decent work for all (SDG8). Build resilient infrastructure, promote inclusive and sustainableindustrialization and foster innovation (SDG9). Reduce inequality within and among countries (SDG10)

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

EC policies and legislation (national/EU level)

Strategic Agenda's

Council conclusions on Personalised medicine for patients15054/15 (07/12/2015).The Knowledge of Future: Intelligent policy choices for Europe2050. Strategic foresight in EU R&I policy Wider use, more impact.New Horizons: Future Scenarios for Research & InnovationPolicies in Europe (BOHEMIA group report).The opinion of the European Economic and Social Committee onPromoting the European single market combining biomedicalengineering with the medical and care services industry (2015/C291/07).Communication from the commission on effective, accessibleand resilient health systems. COM (2014)215 final (04/04/2014)Growing the European Silver Economy (23/02/2015)Study on EU Positioning: An Analysis of the InternationalPositioning of the EU Using Revealed Comparative Advantagesand the Control of Key Technologies

Alliance for Regenerative MedicineTissue Engineering and Regenerative Medicine InternationalSociety (TERMIS)IC PerMedEuropean Institute of Technology (EIT)Innovative Medicines Initiative 2 (IMI2)Global 3D Printing HubEmerging and Strategic Technologies for Healthcare (ESTHER)

Instruments to be used (Grants, loans, prizes, ERA nets, cPPP, JTIs, other schemes)

Grants and co-funding instruments should be fostered and prioritized in FP9.Among grant funding instruments, Research and Innovation Actions, as well as Innovation Actions, should be the leading edge of FP9. Instruments to tackle the existing gap between low technology readiness level (TRL) and high TRL projects that are able to diminish this ‘death valley’ are needed. Current tools (ERC-PoC or FET Launchpad) are not enough. Of all the funding instruments for market-oriented innovation, we would give priority to the Fast Track to Innovation (FTI) pilot as an instrument that promotes close-to-the-market innovation because of its inclusive characteristics: it invites bottom-up proposals and is open to all types of beneficiaries. Bottom-up calls at low TRL levels could also be enhanced by the next work programme. These approaches allow us to improve, think big and go beyond the state of the art, and could be useful for current identified challenges in the mid- to long-term. We consider that one out of four calls should be bottom up (25%), with the rest being top-down (75%) in FP9. On the other hand, top-down topics should avoid ambiguity and be well-defined and explicit, steering clear of predefining solutions and methodologies to address each particular challenge.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Other funding programmes (synergies)

In fact, FP9 could be a good context in which to try to reorganize the current situation of the PPPs-JTIs, as some of them overlap in their strategic agendas. In addition, harmonizing the governance models and providing better access to those initiatives could also be improved. an alignment of accessibility.

As mentioned in Lamy’s report, a better alignment of EU and national and/or interregional R&I investment (ERANETs, JPIs, etc.), is required for added value and better-oriented objectives and ambitions. As Structural Funds (ERDF and ESF) are 256 billion €, and H2020 70,2 billion €, at first glance it seems beneficial to join forces and try to enhance research and innovation within the EU with both budgets. In any case, as one of the focus areas of the European Structural and Investment Funds (ESIF) is to specialize the EU regions in research and innovation, there will be synergies already. Nevertheless, two issues should be pointed out: (1) these synergies must not be used as an excuse to reduce FP9’s budget in cases where no synergistic effect will result; and (2) synergies with Structural Funds (ESIF) must be addressed with a strong commitment to the Commission and the member states by removing current barriers (i.e. State Aid), as allocation of ESIF funds strongly depends on national politics and priorities, which are not always aligned with H2020-ESIF synergy. Training for young researchers and entrepreneurs might also be addressed synergically with other EU programmes that pursue education, such as ERASMUS+ (14.7M€, DG-EAC) and/or EIT-KICs.

KPI's and specific targets (timeline and line-milestones)

These technologies have been already identified as an important future industry, exemplified by recent significant investments in countries like the U.S., Japan, Canada, and China. Hence, the proposed mission will directly:

1. Improve European healthcare and the lives of ageingEuropean citizens.

2. Guarantee citizens access to the new personalizedmedicine therapies.

3. Activate structural exploitation of research result dynamicsin order to maximize the impact of scientific activities andstimulate the growth of resulting innovative value chains.

4. Standardize academic research and commercial productionof fabricated therapies.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

5. Lead the development and convergence of digitalizedstrategies with biofabrication, organ-on-chip andregenerative medicine.

6. Create a strong relationship with existing Europeaninfrastructures (BBMRI, ECRIN, EATRIS) and Flagships (HBPand Graphene)

7. Create coherence within the rapidly emergingbiofabrication industry;

8. Stimulate the cosmetic, pharmaceutical, agriculture, foodand robotic industries by testing and reducing moleculetoxicities.

Duration

Expected leverage effect from private side

2030

Broad participation from all relevant stakeholders’ industry, including non-industry with a significant contribution with private resources - at least 50%.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Missions and Technologies for a Better and Easier Life

Mission statement

Goal/Visions

Expected Impact

How does success look like?

AVoid the use Of anY research ANIMals beyond 2030 (AVOYANIM 2030)

Goal/Visions Full replacement, avoiding completely the use of any research animals. It includes the use of human volunteers, tissues and cells, mathematical and computer models, and established cell lines

Expected Impact by 2030 This proposal will transform European healthcare and linked markets, creating collaborations with the industrial community by:

Effective animal-free test methods for regulatory

acceptance.

Rigorous validation of testing methods, assessment

approaches, products, services.

Reduced use of laboratory animals in safety testing.

Development of biomimetic systems using cutting edge

technologies (multi-organ-on-chip, pluripotent stem cell

engineered organoids incorporating mutations driving

genetic disease, microfabrication, etc.).

How does success look like? Integration of differentiated human iPSCs in testing devices and their applications in human safety processes increase the potential for success in assessing it. Current in vitro 2D models do not take into account the physiological microenvironment (cell-cell and cell-matrix interactions) in which the cells grow. They neither provide tissue multicellular characteristics. For that reason, there is now substantial interest in developing fully functional 3D tissues that mimic animal tissue structure, performance and cell-renewal characteristics. New developments in 3D culture that include novel cell sources (i. e. organoids) and technical developments (i. e. bioprinting) represent a unique opportunity in this area. Proposals should cover the following:

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Underlying challenge

Develop advanced tools and platforms for safety testingand risk assessment in a human background (benefitingfrom human pluripotent stem cells derivatives).Consortiums connecting technology providers, platform ortest developers and end-users.Advances in science and technology fields to extendunderstanding of complex biological pathways oftoxicological relevanceFurther development and validation of routine non-animalapproaches for toxicity testing of chemical substances."Read across" between chemical substances in differentresearch & regulatory domains.International cooperation with complementary initiatives.Develop appropriate molecular or cell-based systemsthrough the integration of computational modelling tools,key enabling technologies, bioengineered ‘organs-on-chip’and biomimetic systems and upgraded versions of geneediting technology.

Underlying challenge Industry relies profoundly on animal and in vitro two-dimensional models to develop human safety testing. However, there are many ethical issues surrounding animal studies and thoughtful concerns also exist regarding their biological relevance to humans. The ability to extrapolate animal model data to human conditions is limited. These shortcomings, together with regulatory restrictions limiting the use of animal models, have generated interest in developing human-based tissue-like models that can be used in toxicity testing, drug screening and personalized medicine applications. To extend their use, tissue-like models should be coupled with high-throughput read-out platforms including biosensors and iPSC technology for chemical testing. The European Union has been a leader in supporting in the past non-animal testing strategies for regulatory purposes, with great examples such as the European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM); the European Partnership for Alternative Approaches to Animal Testing (EPAA); or the EU-funded coordination project, AXLR8. Gathering this background hallmark, we now should focus on addressing specific societal or sectorial needs strategically aligned with concrete stakeholder requirements. European society deserves to face a horizon with human safety testing procedures free of animal testing, considering all the previous policy-making that has been done in the past.

Typology (technological/societal/scientific/All)

Scientific, Technological, Industrial, Regulatory, transformational mission with high impact on public research, health and society.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Disciplines/technologies/innovation

This mission will involve physicists, chemists, biologists, clinicians, robotic/mechanical and biomedical engineers, pharmacologists, computer scientists and mathematicians.

Potential Activities improved dosing strategies for in vitro models.experimental design and best practice in in vitro modeldevelopment and reportingproviding access to reference compounds for thebenchmarking of new technologies.Biomimetic in vitro platformsBioinformaticsImagingSynthetic biologyMathematical and computer modellingBioengineeringAdditive manufacturing (3D Printing of biomaterials/tissues)Tissue EngineeringPatient-Specific human tissue- and organ-on-a-chip models forhigh throughput analysisStem cells engineering and cell reprogrammingMicrofluidics and microelectronicsMultifunctional bioreactors for complex tissues

Key Actors involved Industry including SMEs and academia along the entire industrial value-chain, citizens and society. This mission will mainly gather competences from DG RTD, and DG-REGIO. Some minor involvement of DG-EAC can be overseen.

Relevant: SDGs

EC policies and legislation (national/EU level)

This mission is contributing to the following SDGs: Ensure healthy lives and promote well-being for all at all ages(SDG3) Promote sustained, inclusive and sustainable economic growth,full and productive employment and decent work for all (SDG8). Build resilient infrastructure, promote inclusive and sustainableindustrialization and foster innovation (SDG9). Make cities and human settlements inclusive, safe, resilient andsustainable (SDG11). Ensure sustainable consumption and production patterns(SDG12)

Directive 2010/63/EU revising Directive 86/609/EEC on theprotection of animals used for scientific purposes.COMMUNICATION FROM THE COMMISSION TO THEEUROPEAN PARLIAMENT AND THE COUNCIL on the animaltesting and marketing ban and on the state of play in relationto alternative methods in the field of cosmetics /*COM/2013/0135 final.ECHA's reports on the use of alternatives to testing on animals.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Strategic Agenda's

Council Decision 2003/584/EC, on the protection of animalsused for experimental and other scientific purposesStudy on EU Positioning: An Analysis of the InternationalPositioning of the EU Using Revealed Comparative Advantagesand the Control of Key Technologies

European Partnership for Alternative Approaches to AnimalTesting (EPAA)National Centre for the Replacement Refinement & Reductionof Animals in Research.European Union Reference Laboratory for alternatives toanimal testing (EURL-ECVAM).Tissue Engineering for Drug Development and SubstanceTesting (TEDD) platform.CAAT-Europe (Centre of Alternatives to Animal Testing)European consensus-platform for alternatives (ECOPA)The Federation of Laboratory Animal Science Associations(FELASA)Fund for the Replacement of Animals in Medical Experiments(FRAME)International Council for Lab Animal Science (ICLAS)

Instruments to be used (Grants, loans, prizes, ERA nets, cPPP, JTIs, other schemes)

Grants and co-funding instruments should be fostered and prioritized in FP9.Among grant funding instruments, Research and Innovation Actions, as well as Innovation Actions, should be the leading edge of FP9. Instruments to tackle the existing gap between low technology readiness level (TRL) and high TRL projects that are able to diminish this ‘death valley’ are needed. Current tools (ERC-PoC or FET Launchpad) are not enough. Of all the funding instruments for market-oriented innovation, we would give priority to the Fast Track to Innovation (FTI) pilot as an instrument that promotes close-to-the-market innovation because of its inclusive characteristics: it invites bottom-up proposals and is open to all types of beneficiaries. Bottom-up calls at low TRL levels could also be enhanced by the next work programme. These approaches allow us to improve, think big and go beyond the state of the art, and could be useful for current identified challenges in the mid- to long-term. We consider that one out of four calls should be bottom up (25%), with the rest being top-down (75%) in FP9. On the other hand, top-down topics should avoid ambiguity and be well-defined and explicit, steering clear of predefining solutions and methodologies to address each particular challenge. In fact, FP9 could be a good context in which to try to reorganize the current situation of the PPPs-JTIs, as some of them overlap in their strategic agendas. In addition, harmonizing the governance models and providing better access to those initiatives could also

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Other funding programmes (synergies)

be improved. an alignment of accessibility.

As mentioned in Lamy’s report, a better alignment of EU and national and/or interregional R&I investment (ERANETs, JPIs, etc.), is required for added value and better-oriented objectives and ambitions. As Structural Funds (ERDF and ESF) are 256 billion €, and H2020 70,2 billion €, at first glance it seems beneficial to join forces and try to enhance research and innovation within the EU with both budgets. In any case, as one of the focus areas of the European Structural and Investment Funds (ESIF) is to specialize the EU regions in research and innovation, there will be synergies already. Nevertheless, two issues should be pointed out: (1) these synergies must not be used as an excuse to reduce FP9’s budget in cases where no synergistic effect will result; and (2) synergies with Structural Funds (ESIF) must be addressed with a strong commitment to the Commission and the member states by removing current barriers (i.e. State Aid), as allocation of ESIF funds strongly depends on national politics and priorities, which are not always aligned with H2020-ESIF synergy. Training for young researchers and entrepreneurs might also be addressed synergically with other EU programmes that pursue education, such as ERASMUS+ (14.7M€, DG-EAC) and/or EIT-KICs.

KPI's and specific targets (timeline and line-milestones)

Replacement the use of live animals for experimentation by using several tools to be developed and implemented in the public research entities and private companies:

in vitro systems using tissues, whole cells or parts of cellssystems based on biochemical approaches, i.e. usingsynthetic (macro)molecules as proxies of (reactive) toxicitytargets. Such methods are referred to as "in chimico"in silico computer-based models and approaches – oftentermeduse of 'omics' technologies (e.g. transcriptomics,proteomics and metabolomics)non-testing approaches such as 'read-across' technique

Duration

Expected leverage effect from private side

2030

Broad participation from all relevant stakeholders’ industry, including non-industry with significant contribution with private resources - at least 50%.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Missions and Technologies for a Better and Easier Life

Mission statement

Goal/Visions

Expected Impact

Human-Artificial Intelligence collaboration for Good (SAPIENS 5.0)

Goal/Visions The general vision of Sapiens5.0 is to achieve a viable and dignified society by augmenting human decision-making through the collaboration with Artificial General Intelligence (AGI) systems. The general scientific and technological objectives in the different tiers of the value chain of Sapiens5.0 are: (1) Artificial General Intelligence (AGI) - Identification of the fundamental principles of AGI - Reliable, reproducible, sustainable and safe, large-scale realization and deployment of AGIs, satisfying the specific needs of different application areas. (2) The Human Condition - Identification of the multi-scale ontology and phenomenology of the human condition and its biological, psychological, sociological and cultural roots - Theory advancement to understand and explain the human condition following a network of networks paradigm - Identification of core principles underlying human intelligence and their transfer to AGI (3) Supporting technologies - Deliver alternative hardware architectures for the implementation and deployment of AGI - New concepts to integrate AGI with existing technology platforms - New interfaces to allow access and control of AGI by humans (4) Supporting frameworks - Realize structures and frameworks for the sustainable deployment of AGI in society - Realize appropriate governance and ethics structures for the regulation of AGI in society

Expected Impact by 2030 The Sapiens5.0 program has many benefits in the distinct aspects of life and well-being represented in specific use cases at both the individual citizen and global societal level. First, we focus on personalized citizen AGI empowerment in education, wellbeing and identity. Here we will follow UNESCO standards where life-long education aims to empower learners to assume active roles to face and resolve global challenges and to become proactive contributors to a more peaceful, tolerant, inclusive and secure world: Education: Personalized citizen AI empowerment in education, wellbeing and identity: AGI enhanced and individualized lifelong

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

How does success look like

Underlying challenge

education with emphasis of social empowerment developing a sense of autonomy and self-confidence and acting individually and collectively to change social relationships and the institutions and discourses that alleviate the UNs Sustainable Development Goals (SDG). How to provide children and youth with the appropriate skills and capabilities required to create a more equal and sustainable world for future generations consistent with the strategic plan of the Center for Global Education while empowering older generations towards continuous development and self-realization. Wellbeing: Is defined by improved self-efficacy and self-esteem, a greater sense of control, increased knowledge and awareness of existential context, intentional behaviour change and a greater sense of community, broadened social engagement and social support. Sapiens5.0 will empower citizens through collaborations with AGI systems to manage their own wellbeing and life results based on a new science of the human condition and consistent with the latest guidelines provided by the World Health Organization on an integrated approach aligned with the UN’s SDGs . Identity: the outlook on the future is grounded in the sense of identity both individually and collectively. Sapiens5.0 proposes that the grounding of this identity is dependent on cultural heritage and the knowledge that citizens have of their social and cultural context. In order to empower citizens and assist them in complex decision making on their future and their contribution to a Dignified and Viable Society we have to assure that they can understand their cultural embedding. For this S5.0 will deploy AGI enhanced systems for life-long learning of cultural heritage combined with AGI enhanced systems for the research and conservation of cultural heritage.

How does success look like? Building on an emerging alternative multi-disciplinary scientific paradigm for understanding the human condition bridging science and humanities and AGI build on the notion of networks of networks, accelerated with a dynamic learning model where AGI technologies developed in S5.0 will be in turn applied to the science of the human condition itself, building a knowledge accelerator. Sapiens5.0 will target breakthroughs in three interlocked grand S&T challenges: realizing a Dignified and Viable Society based on 1) a fundamental understanding of the Human Condition, 2) augmented with Humane AGI and 3) implemented using beyond the state of the art sustainable hardware substrates.

Underlying challenge Sapiens5.0 tackles a grand science and technology (S&T) challenge, possibly the grandest challenge facing this generation: the long-term survival of our society. The unique S5.0 proposition is the answer to the challenge of building a viable and dignified society through sustainable Human-AI collaboration which requires

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

interdisciplinary, future-focused solutions. S5.0 comprises an international consortium from academia, industry and civil society that is committed to realizing advances on three interlocking scientific challenges central to the long-term stability of human societies: beyond the state of the art Humane Artificial General Intelligence (AGI), a new integrated science of the human condition and a new class of sustainable AGI compatible computation systems.

Typology (technological/societal/scientific/All)

Disciplines/technologies/innovation

Scientific, Technological, Industrial, transformational mission with high impact on society.

This mission will mobilize Europe’s leading researchers, research institutions, national research programs, industry and civil society spanning the natural sciences, engineering as well as the social sciences and humanities.

Potential Activities The final deliverable of the Sapiens5.0 project is a comprehensive technology and socio-economical suitable Humane Artificial General Intelligence supporting a Dignified and Viable Society. This technology will include: 1. Personalized citizen Humane AGI systems with use cases in

education, wellbeing and identity (citizen level) 2. Society level AGI “oracles” for global governance and decision

support including, risk management and conflict resolution between people or organizations for an inclusive bio-electronic society (society level)

3. Sustainable AGI specific hardware systems (realization)4. Guidelines for human interaction and acceptability in the

perspective of human evolution and the long-termappropriateness of AGI

Key Actors involved Sapiens5.0 is uniquely positioned to address its grand S&T challenge in terms of large-scale integration across disciplines and the involvement of relevant stakeholders from academia, industry and society at large.

Steering Committee: Institut de Bioenginyeria de Catalunya (IBEC) (Coordinator) Max-Planck-Gesellschaft Fondazione Istituto Italiano di Tecnologia Ceska Zemedelska Univerzita V Praze Uniwersytet Mikolaja Kopernika W Toruniu Commissariat a l‘Energie Atomique et aux Energies Alternatives University of Sheffield Kungliga Vetenskapsakademien Universite Paris Diderot - Paris

This mission will mainly gather competences from DG RTD, DG-CONNECT, DG-SANTÉ, DG-AGRI, DG-CLIMA, DG-EAC, DG-ENV, DG-ECHO, DG-FISMA, DG-GROW, DG-DEVCO, DG-JUST, DG-MARE, DG-

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

HOME, DG-MOVE, DG-TRADE and DG-REGIO, Association for the Advancement of Artificial Intelligence (AAAI), IBM, Amazon, Apple, Google, Microsoft, Accenture, Intel, Facebook, SAP, Sony.

Relevant: SDGs

EC policies and legislation (national/EU level)

Strategic Agenda's

This mission is contributing to all the SDGs by mapping them on a few underlying dimensions recognizing their interdependencies and the need for human-AGI collaboration in all domains. Emphasis is placed on:

Wellbeing: Ensure healthy lives and promote well-being for all atall ages (SDG3) Education: Ensure inclusive and equitable quality education andpromote lifelong learning opportunities for all (SDG4). Growth: Promote sustained, inclusive and sustainable economicgrowth, full and productive employment and decent work for all (SDG8). Resilience: Build resilient infrastructure to promote inclusive andsustainable industrialization and foster innovation (SDG9) and to build peace, justice and strong institutions (SDG 16). Equality: Reduce inequality within and among gender (SDG5), insociety and between countries (SDG10) Sustainability: in Energy (SDG7), cities and communities(SDG11), consumption/production (SDG12) Earth systems: Climate action (SDG13) sustaining life in the sea(SDG14) and on land (SDG15)

Mission-Oriented Research and Innovation in the EuropeanUnion: A problem-solving approach to fuel innovation-ledgrowth. Mariana Mazzucato. European Commission 2018.Towards a Mission-Oriented Research and Innovation Policy inthe European Union: An ESIR Memorandum: ExecutiveSummary. European Commission 2017.Europe is back: Economic, Financial, Social and TechnologicalTrends in a Changing World. European Political Strategy Centre2018. Funding - Awareness - Scale - Talent (FAST). Europe is back:ACCELERATING BREAKTHROUGH INNOVATION. European Commission 2018. LAB – FAB – APP: Investing in the European future we want.Report of the independent High-Level Group on maximising the impact of EU Research & Innovation Programmes. European Commission 2017. New Horizons: Future Scenarios for Research & InnovationPolicies in Europe (BOHEMIA group report). European Commission 2017.

World Economic Forum’s Council on the Future of AI andRobotics.Data & Society’s Intelligence and Autonomy Initiative

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

AI Now InitiativeEthics of Governance and Artificial Intelligence FundOne Hundred Year Study on Artificial Intelligence (AI100)AI, Ethics and Governance ProjectThe Partnership on AIIEEE Global Initiative for Ethical Considerations in ArtificialIntelligence and Autonomous Systems

Instruments to be used (Grants, loans, prizes, ERA nets, cPPP, JTIs, other schemes)

Other funding programmes (synergies)

Grants and co-funding instruments should be fostered and prioritized in FP9. Among grant funding instruments, Research and Innovation Actions, as well as Innovation Actions, should be the leading edge of FP9. Priority must be placed on RIA building a strong multi-disciplinary scientific base for future innovation in the service of society. These must be augmented with instruments to tackle the existing gap between low technology readiness level (TRL) and high TRL projects that are able to diminish this ‘valley of death’ are needed. Current tools (e.g. ERC-PoC or FET Launchpad) are not enough. Of all the funding instruments for market-oriented innovation, we would give priority to the Fast Track to Innovation (FTI) pilot as an instrument that promotes close-to-the-market innovation because of its inclusive characteristics: it invites bottom-up proposals and is open to all types of beneficiaries. All of these programs stand or fall with the quality of the review process for selection and quality control. Investments must be made to also elevate this to the highest possible standards. Bottom-up calls at low TRL levels must be enhanced by the next work programme especially given the need for a new science and technology to sustain humanity in the coming century. These approaches allow us to think big, tackle relevant and big challenges and go beyond the state of the art, and are essential for the challenges identified in Sapiens5.0 in the mid- to long-term. We consider that one out of four calls should be bottom up (25%), with the rest being top-down (75%) in FP9. However, top-down topics should avoid ambiguity and be well-defined and explicit, steering clear of predefining solutions and methodologies to address each particular challenge. In fact, FP9 I an opportunity to reorganize the current situation of the PPPs-JTIs, as some of them overlap in their strategic agendas and in addition some of these agendas run the risk of not being up to international standards. In addition, harmonizing their governance models and access to those initiatives could also be improved.

As mentioned in the Lamy report, a better alignment of EU and national and/or interregional R&I investment (ERANETs, JPIs, etc.), is required for added value and better-oriented objectives and ambitions. As Structural Funds (ERDF and ESF) are 256 billion €, and H2020 70,2 billion €, at first glance it seems beneficial to join forces and try to enhance research and innovation within the EU with both

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

budgets. In any case, as one of the focus areas of the European Structural and Investment Funds (ESIF) is to specialize the EU regions in research and innovation, there will be synergies already. Nevertheless, two issues should be pointed out: (1) these synergies must not be used as an excuse to reduce FP9’s budget; and (2) synergies with Structural Funds (ESIF) must be addressed with a strong commitment from the Commission and the member states to removing current barriers (i.e. State Aid), as allocation of ESIF funds strongly depends on national politics and priorities, which are not always aligned with H2020-ESIF synergy. Training for young researchers and entrepreneurs should also be addressed synergically with other EU programmes that pursue education, such as ERASMUS+ (14.7M€, DG-EAC) and/or EIT-KICs.

KPI's and specific targets (timeline and line-milestones)

SAPIENS 5.0 main scientific and technological objectives are supported by operative targets: Bring together a critical mass of European academic, industrial,governmental, NGOs and civil society partners, working in a global context. Create a highly effective technology transfer pipeline, allowingsociety and industry to rapidly absorb and exploit academic/scientific discoveries and technological advances while providing pertinent use-dependent requirements. Align with European and national priorities to guarantee its successful long-term operation and maximal impact on the national industrial and research communities and societies. Engage European societies through engagement of keystakeholders in civil society and targeted dissemination of mission goals and progress to citizens, decision makers, and public and private stakeholders Together, the scientific and technological objectives andoperative targets will allow us to reach distinct societal goals: Contribute to sustainable development as defined through theUnited Nations Sustainable Development Goals by introducing AGI-human collaboration. Boost European wellbeing and economic growth by creating neweducation, life-long learning, jobs and investment opportunities. Have measurable impact on core markers such as expectedhealthy life expectancy, completion of higher education, creation of SMEs, etc.

Duration

Expected leverage effect from private side

10 years, 2030

Broad participation from all relevant stakeholders’ industry, including non-industry with a significant contribution from private resources.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Missions and Technologies for a Better and Easier Life

Mission statement

Goal/Visions

Expected Impact

How does success look like?

BioEngineered Living Systems (BELS)

Goal/Visions Our mission is to create a new scientific discipline for building living, multi-cellular machines that solve real-world problems in health, security, and the environment. The asserted goal of work in BioEngineered Living Systems (BELS) is to support the “greater good” of society, identifying constructive, efficient, new pathways for solving functional, real-world needs. This mission will be achieved through integrated research and education efforts, human resource development, diversity and outreach programs, and knowledge transfer activities.

Expected Impact by 2030

To fully realize the potential of BELS. Control methods as composable functions should have inputs, outputs, and perform some transformation on the living systems. The functions will operate in space and time and at defined scales. While they always perform operations physically, their impact can be both physical and regulatory / information-processing. Functions have specific energy usage, operate at different modalities and may require coordination among multiple cells and time scales. While the concept of a function is relatively straightforward, implementing a design framework that effectively integrates different modes of control modalities remains a challenge. 3D multicellular simulation tools such as Morpheus and others integrate gene regulation, cell signalling, and biomechanics, and may serve as a useful basis for BELS design tools. But missing are effective abstractions that support BELS 3D organ and multicellular machine design objectives, akin to gene circuit design tools.

How does success look like? The success of engineering systems rests on the formulation of effective design principles that guide the creation of complex systems. Accordingly, achieving the BELS goals of creating complex synthetic multicellular structures with defined behaviours will require the establishment of experimentally verified rules and practices that guide the efficient and predictable formation of these systems. The key to success will be the integration of traditional engineering concepts, such as creating and characterizing reusable parts, establishing rules for composition of such parts, appropriate layers of abstraction, and modular system design, along with design

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Underlying challenge

principles that consider the unique properties and interactions of the biological substrate.

Underlying challenge One of the grand challenges facing our scientific community today is to develop the capability to design, engineer and produce complex living systems or “biological machines." These systems might arise from the guided differentiation of a cluster of pluripotent cells, drawing upon our capabilities to apply chemical, physical, or electrical cues to direct co-differentiation, as well as the intrinsic properties of cell populations to produce functional interactions through emergence.

Typology (technological/societal/scientific/All)

Disciplines/technologies/innovation

Scientific, Technological, Industrial, Regulatory, transformational mission with high impact on society.

This mission will mobilize Europe’s leading researchers, research institutions, national research programs, industry and civil society from the following disciplines: Developmental biology, Stem cell biology, Synthetic biology, Mechanobiology, Tissue engineering, Biomaterials, Biofabrication and manufacturing, Multi-scale computational modelling and Ethics for ELS.

Potential Activities Actions needed on new technologies required for development and manufacture of ELS:

Imaging: High-resolution high content imaging of large, multi-cellular structures; label-free methods; 4D imaging.Computational analysis: Multi-scale modelling, agent-basedmethods, data-driven modellingBioprinting: Simultaneous printing with single-cell resolution ofthe matrix and multiple cell types.Scaffold design: Artificial and natural biomaterials withcontrollable chemistry and mechanical stiffness.Microfluidics: Systems that enable spatiotemporal control ofcodifferentiation processes.Biofabrication: Providing appropriate cell-matrix stimuli fororganoid growth and stability.Optogenetics: The capability to regulate the spatiotemporalpatterning of co-differentiation in growing ELS.Robotics: Methods to handle high-volume production oforganoids and other BELS for industrial applications.

Key Actors involved Industry including SMEs and academia, healthcare systems along the entire industrial value-chain, citizens and society. This initiative is being activated at other global markets such as USA (leading MIT) or Asia (leading the University of Tokyo & KIST). Here in Europe, the co-design of this mission could be coordinated among the Centre for Genomic Regulation (CRG), European Molecular

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Biology Laboratory (EMBL) and the Institute for Bioengineering of Catalonia (IBEC). EU must remain at the leading edge of this burgeoning challenge which is the conception of engineered living systems. For that reason, a global cooperation scenario among all international contexts would a beneficial approach for EU interests.

This mission will mainly gather competences from DG RTD, DG-CNECT, DG-SANTÉ and DG-REGIO.

Relevant: SDGs

EC policies and legislation (national/EU level)

Strategic Agenda's

This mission is contributing to the following SDGs: Ensure healthy lives and promote well-being for all at all ages(SDG3) Promote sustained, inclusive and sustainable economic growth,full and productive employment and decent work for all (SDG8).

The Knowledge of Future: Intelligent policy choices for Europe2050. Strategic foresight in EU R&I policy Wider use, more impact.New Horizons: Future Scenarios for Research & InnovationPolicies in Europe (BOHEMIA group report).

EBICS: Emergent Behaviours of Integrated Cellular Systems.White paper on Engineered Living Systems: The Promise ofEngineered Living Systems

Instruments to be used (Grants, loans, prizes, ERA nets, cPPP, JTIs, other schemes)

Grants and co-funding instruments should be fostered and prioritized in FP9. Among grant funding instruments, Research and Innovation Actions, as well as Innovation Actions, should be the leading edge of FP9. Instruments to tackle the existing gap between low technology readiness level (TRL) and high TRL projects that are able to diminish this ‘death valley’ are needed. Current tools (ERC-PoC or FET Launchpad) are not enough. Of all the funding instruments for market-oriented innovation, we would give priority to the Fast Track to Innovation (FTI) pilot as an instrument that promotes close-to-the-market innovation because of its inclusive characteristics: it invites bottom-up proposals and is open to all types of beneficiaries. Bottom-up calls at low TRL levels could also be enhanced by the next work programme. These approaches allow us to improve, think big and go beyond the state of the art, and could be useful for current identified challenges in the mid- to long-term. We consider that one out of four calls should be bottom up (25%), with the rest being top-down (75%) in FP9.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Other funding programmes (synergies)

On the other hand, top-down topics should avoid ambiguity and be well-defined and explicit, steering clear of predefining solutions and methodologies to address each particular challenge. In fact, FP9 could be a good context in which to try to reorganize the current situation of the PPPs-JTIs, as some of them overlap in their strategic agendas. In addition, harmonizing the governance models and providing better access to those initiatives could also be improved. an alignment of accessibility.

As mentioned in Lamy’s report, a better alignment of EU and national and/or interregional R&I investment (ERANETs, JPIs, etc.), is required for added value and better-oriented objectives and ambitions. As Structural Funds (ERDF and ESF) are 256 billion €, and H2020 70,2 billion €, at first glance it seems beneficial to join forces and try to enhance research and innovation within the EU with both budgets. In any case, as one of the focus areas of the European Structural and Investment Funds (ESIF) is to specialize the EU regions in research and innovation, there will be synergies already. Nevertheless, two issues should be pointed out: (1) these synergies must not be used as an excuse to reduce FP9’s budget in cases where no synergistic effect will result; and (2) synergies with Structural Funds (ESIF) must be addressed with a strong commitment to the Commission and the member states by removing current barriers (i.e. State Aid), as allocation of ESIF funds strongly depends on national politics and priorities, which are not always aligned with H2020-ESIF synergy. Training for young researchers and entrepreneurs might also be addressed synergically with other EU programmes that pursue education, such as ERASMUS+ (14.7M€, DG-EAC) and/or EIT-KICs.

KPI's and specific targets (timeline and line-milestones)

Key steps to achieve Engineered Living Systems:

Initial stages: 1. Produce a conceptual design meeting the ultimate

functionality 2. Identify the individual initial components

Top Down Engineering: 3. Produce a detailed design indicating the location of each

component in order to facilitate their interactions. 4. Manufacture the components and assemble them

following this design. 5. Assemble the system.

Emergent Engineering: 3. Determine how to guide the emergence of form and

function

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

4. Allow the system to self-assemble and emerge into thedesired structure.

Duration

Expected leverage effect from private side

2030

Broad participation from all relevant stakeholders from academia, high-tech SMEs and clinical.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Missions and Technologies for a Better and Easier Life

Mission statement

Goal/Visions

Expected Impact

Converge to a transdisciplinary disruptive transformative patient centred personalised

medicine strongly built on emerging technologies for a new ERA of healing & healthcare 4.0 for a

global society (Trans4mMED)

Goal/Visions The objective is to drive a transformation in the current healthcare situation by developing a game changing strategy and promoting a paradigm shift in the health and life sciences field.

The grand challenge: To restructure current research efforts, moving from multi totransdisciplinary, and also converging stakeholders through strategic interactions towards a more predictive rather than reactive healthcare. To develop efficient, personalised and patient centredregenerative medicine therapies along with more effective early diagnosis tools and prevention care, patient empowerment and out-of-hospital/ remote care. To put the emphasis on patient involvement and responsibility,rather than only the providers’ responsibility.

Expected Impact by 2030 The integration and convergence of fields will lead to a new era in healthcare based on regenerative, precision and personalised-medicine therapies centred on the patient. Furthermore, it will generate new avenues for predicting and preventing disease. The action will build on the critical mass of experts from different fields, which will generate the momentum to provide a continuous and tangible development of different advanced therapies for regenerative, precision and personalised medicine. The vision behind the emerging areas of predictive, preventive, personalised and participative healthcare is the radical improvement of the quality of life of billions of patients worldwide. Economic benefits and impact The new science and technologies developed as part of this initiative will contribute to a new way of thinking about healthcare, which will impact how it is managed. The promotion of personalised medicine, based on newly developed technologies will bring a long-term reduction in healthcare costs. Potential savings will vary depending on the diseases that are being addressed. For example, the use of personalised medicine tests can reduce hospitalisation rates by 30%5 or provide $2.000 USD in savings per patient6. The market

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

perspectives are also positive, with the personalised medicine market estimated to reach $2.4 trillion USD by 2022, and $130 billion just related to regenerative medicine. Social benefits and impact The initiative will result in new scientific and technological findings that, on the one hand, can underlie future investments in health-related infrastructure, and on the other, lead to the development of solutions and therapies with an impact on society and the patient. For example, the development of new therapies will allow a shift from reactive treatments to preventive ones; new tests will help identify targeted therapies that improve the outcomes of treatments, reduce potential side-effects and potential adverse drug reactions; personalised therapies can also increase patients’ adherence to treatments. Another impact is the increased involvement of ICT in the sector and the importance of big data, which is relevant to society (considering the management and security of data). Lastly, advances in these scientific and technological fields have the potential to lead to new businesses and employment opportunities. Effects on research, collaboration and research talent The project will have an important impact on research, by converging and integrating R&D from the wide array of scientific areas and technologies related to the health and life sciences. This will be supported by the more than 300 associated partners and supporters involved in the project, which are fully committed to advancing transdisciplinary cross-border R&D aligned with the scientific and technological roadmap. The initiative will amalgamate diverse S&T disciplines into long-lasting platforms, which will nurture trans-disciplinary research ad collaboration, resulting in a new era of European medical R&D. It is expected that this also contribute to a long-term cultural shift within the European S&T community, including a new way of thinking and different approaches to R&D among researchers, technology developers, decision-makers and others. Creation of EU-added value and enhancing outcomes of research programmes EU-added value will be created through the long-lasting collaborations that will be established between the various aforementioned actors. Their involvement in the Preparatory Action will support the development of the S&T roadmap taking, taking into consideration all perspectives in a quasi-quadruple helix approach. Regional and national authorities play a particularly important role as they will define their own priorities and make available complementary funding. By engaging with authorities, the action will be better positioned ensure a greater coherence between the initiative’s priorities

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

How does success look like?

Underlying challenge

and those at regional and national level. The initiative will also contribute to enhancing the value of these Partnering Projects and the programmes that funded them by providing specific platforms and benefits that will increase their international visibility.

How does success look like? New and successively complex S&T challenges to attain regenerative, precision and personalised medicine therapies integrated with predicting and preventing disease tools will be available to shift the current paradigm. Therefore, Trans4mMED seeks to converge and transform these multiple scientific areas and establishing a strong culture of collaboration between key EU players including decisions-makers in diverse scientific disciplines, research policy and funding, patient interest groups, different national healthcare systems, regulatory and governmental bodies in a true public-private partnership.

Underlying challenge Healthcare systems throughout the world, including in the EU, are currently trying to address the challenges that result from an ageing population, the growth in chronic diseases, burgeoning technical possibilities and public expectation. To meet this challenge, the development of efficient, personalised patient centred, including regenerative medicine based therapies, must be developed, accompanied by the development of more effective early diagnosis tools and prevention care, patient empowerment and out-of-hospital/remote care, resulting in patient centred healthcare that will serve to improve the sustainability of healthcare systems across the life course.

Typology (technological/societal/scientific/All)

Disciplines/technologies/innovation

Scientific, Technological, Industrial, Regulatory, transformational mission with high impact on public health and society.

This mission will involve academia and industry core and associated members with multidisciplinary backgrounds ranging from biomaterials and biofabrication to synthetic biology and epigenetics

Potential Activities Promote partnerships and innovation networks to encouragecross-disciplinary and cross border collaboration in R&D bylaunching calls for specific challenges - moonshot projects –for the development of patient centred regenerativemedicine therapies addressing unmet clinical needs.Stimulate collaborative pre-competitive and transdisciplinaryresearch in all disease areas.Integrate big data and ICT solutions for patient centredhealthcare.

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Support translational research infrastructures and enforcedata harmonisation fostered by specific ICT infrastructuresdesigned to facilitate patient-specific data acquisition,analysis and integration for the generation of predictive andpreventive information and supporting the development ofeffective therapies.Encourage early and systematic dialogue and engagementbetween innovators, patients and decision-makersthroughout all regulatory steps.

Key Actors involved Industry including SMEs and academia, healthcare systems along the entire industrial value-chain, citizens and society. More Information on current supporters: http://web.spi.pt/fetflagship-personalisedhealthcare/

Steering Committe: UNIVERSIDADE DO MINHO (Coordinator) INSTITUT DE BIOENGINYERIA DE CATALUNYA (IBEC) CONSIGLIO NAZIONALE DELLE RICERCHE ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM FRAUNHOFER GESELLSCHAFT FOUNDATION FOR RESEARCH AND TECHNOLOGY HELLAS ISTITUTO ORTOPEDICO RIZZOLI ISTITUTO SUPERIORE DI SANITA LUDWIG BOLTZMANN GESELLSCHAFT NATIONAL UNIVERSITY OF IRELAND GALWAY FORNASARI PIER MARIA UNIVERSITE LYON 1 CLAUDE BERNARD UNIVERSITEIT MAASTRICHT UNIVERSITAT BASEL UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA UNIVERSITY OF SOUTHAMPTON TARTU ULIKOOL UNIVERSITAIR MEDISCH CENTRUM UTRECHT

This mission will mainly gather competences from DG RTD, DG-SANTÉ and DG-REGIO.

Relevant: SDGs

This mission is contributing to the following SDGs: Ensure healthy lives and promote well-being for all at all ages(SDG3) Promote sustained, inclusive and sustainable economic growth,full and productive employment and decent work for all (SDG8). Build resilient infrastructure, promote inclusive and sustainableindustrialization and foster innovation (SDG9). Reduce inequality within and among countries (SDG10)Sustainable cities and communities (SDG11)

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

EC policies and legislation (national/EU level)

Strategic Agenda's

Council conclusions on Personalised medicine for patients15054/15 (07/12/2015).Mission-Oriented Research and Innovation Policy: A RISEPerspective.Strategic foresight in EU R&I policy Wider use, more impact.New Horizons: Future Scenarios for Research & InnovationPolicies in Europe (BOHEMIA group report).Open to the World: Research & Innovation Across Borders.European Commission 2017.The opinion of the European Economic and Social Committee onPromoting the European single market combining biomedicalengineering with the medical and care services industry (2015/C291/07).Communication from the commission on effective, accessibleand resilient health systems. COM (2014)215 final (04/04/2014)Growing the European Silver Economy (23/02/2015)

Alliance for Regenerative MedicineTissue Engineering and Regenerative Medicine InternationalSociety (TERMIS)IC PerMedEuropean Institute of Technology (EIT)Innovative Medicines Initiative 2 (IMI2)Emerging and Strategic Technologies for Healthcare (ESTHER)

Instruments to be used (Grants, loans, prizes, ERA nets, cPPP, JTIs, other schemes)

Grants and co-funding instruments should be fostered and prioritized in FP9.Among grant funding instruments, Research and Innovation Actions, as well as Innovation Actions, should be the leading edge of FP9. Instruments to tackle the existing gap between low technology readiness level (TRL) and high TRL projects that are able to diminish this ‘death valley’ are needed. Current tools (ERC-PoC or FET Launchpad) are not enough. Of all the funding instruments for market-oriented innovation, we would give priority to the Fast Track to Innovation (FTI) pilot as an instrument that promotes close-to-the-market innovation because of its inclusive characteristics: it invites bottom-up proposals and is open to all types of beneficiaries. Bottom-up calls at low TRL levels could also be enhanced by the next work programme. These approaches allow us to improve, think big and go beyond the state of the art, and could be useful for current identified challenges in the mid- to long-term. We consider that one out of four calls should be bottom up (25%), with the rest being top-down (75%) in FP9. On the other hand, top-down topics should avoid ambiguity and be well-defined and explicit, steering clear of predefining solutions and methodologies to address each particular challenge. In fact, FP9 could be a good context in which to try to reorganize the current situation of the PPPs-JTIs, as some of them overlap in their

Institute for Bioengineering of Catalonia · Baldiri Reixac, 10-12 · 08028 Barcelona · +34 934 031 198 · [email protected] · www.ibecbarcelona.eu

Other funding programmes (synergies)

strategic agendas. In addition, harmonizing the governance models and providing better access to those initiatives could also be improved. an alignment of accessibility.

As mentioned in Lamy’s report, a better alignment of EU and national and/or interregional R&I investment (ERANETs, JPIs, etc.), is required for added value and better-oriented objectives and ambitions. As Structural Funds (ERDF and ESF) are 256 billion €, and H2020 70,2 billion €, at first glance it seems beneficial to join forces and try to enhance research and innovation within the EU with both budgets. In any case, as one of the focus areas of the European Structural and Investment Funds (ESIF) is to specialize the EU regions in research and innovation, there will be synergies already. Nevertheless, two issues should be pointed out: (1) these synergies must not be used as an excuse to reduce FP9’s budget in cases where no synergistic effect will result; and (2) synergies with Structural Funds (ESIF) must be addressed with a strong commitment to the Commission and the member states by removing current barriers (i.e. State Aid), as allocation of ESIF funds strongly depends on national politics and priorities, which are not always aligned with H2020-ESIF synergy. Training for young researchers and entrepreneurs might also be addressed synergically with other EU programmes that pursue education, such as ERASMUS+ (14.7M€, DG-EAC) and/or EIT-KICs.

KPI's and specific targets (timeline and line-milestones)

The following indicators (non-exhaustive list) will be considered to measure the above impacts: (1) Level of transdisciplinarity of research collaborations; (2) Integration of big data and ICT in the developed solutions; (3) Level of stakeholder engagement & patient participation in R&D; (4) Number of relevant national and regional authorities involved in the initiative; (5) Early career researchers involved in transdisciplinary R&D; (6) Percentage of non-EU experts in project strategic bodies; and (7) Number of non-EU organisations involved in research collaborations.

Duration

Expected leverage effect from private side

2030

Broad participation from all relevant stakeholders’ industry, including non-industry with a significant contribution with private resources.