FAIR principles Archives - European Industrial Pharmacists Group (EIPG)

Lessons learnt to transition from Horizon 2020 to the new FP10


by Giuliana Miglierini The European Commission published the ex post evaluation of Horizon 2020 (H2020), the FP8 framework programme for research and innovation (R&I) run in years 2014-2020. The report identifies several areas of possible improvement, which may be taken into Read more

Approvals and flops in drug development in 2023


by Giuliana Miglierini Approvals and flops in drug development in 2023 The European Medicines Agency published its annual highlights, showing 77 medicines were recommended for marketing authorisation, and just 3 received a negative opinion (withdrawals were 19). In 2023 some highly expected Read more

Webinar: Oral Colon Drug Delivery - Design Strategies


EIPG webinar Next EIPG webinar is to be held on Wednesday 21st of February 2024 at 17.00 CET (16.00 GMT) in conjunction with PIER and University College Cork. Anastasia Foppoli, will discuss on the various approaches and the general aspects Read more

European Council’s conclusions on the European Innovation Agenda and research infrastructures

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by Giuliana Miglierini

The European socio-economic framework is undergoing a profound transformative moment, as a result of the new vision impressed by the von der Leyen Commission, with its goals in the field of the Digital and Green transitions. The subsequent crisis caused by the Covid pandemic and the following war at the boundaries of the European Union deeply impacted the already fragile economy, asking for new measures to sustain its competitiveness and ability to innovate.

A major goal of the Commission’s Agenda is to reposition the EU as a global leader in innovation. The European Council endorsed this vision at the beginning of December 2022, by adopting the Conclusions on the New European Innovation Agenda.

The recent crises have shown the need for the EU to support an open strategic autonomy in order to curb the dependencies and vulnerabilities that affect our industry. We have to strengthen the EU’s own capacity in strategic areas. This will not be possible without ambitious investments in innovation”, said Vladimír Balaš, Czech Minister for Education, Youth and Sport, commenting the document.

The European Council also adopted its new Conclusions on research infrastructures (RIs), which complement and complete the framework to support innovation and set the basis for the full development of the European Research Area (ERA).

According to the European Commission, almost two thirds of the EU’s growth is driven by innovation. Despite this, the EU still positions behind other countries as for Gross domestic product expenditure on R&D activities (2.18%, vs 4.52% of South Korea, 3.28% of Japan and 2.82% of the US. Only China slightly follows at 2.14%). The same trend applies also to business enterprise investments in R&D (EU 1.45%, vs 3.63% of South Korea, 2.6% Japan, 2.05% of the US, and 1.66% of China).

The new Innovation Agenda

The Conclusions on the New European Innovation Agenda are the result of a work started in November 2021, when the Council’s Recommendation on a Pact for Research and Innovation (R&I) in Europe highlighted the importance of synergies with sectorial policies and industrial policy, as well as the coordination of R&I policies and programmes to support the development of breakthrough and incremental innovations across the Union. The New European Innovation Agenda was announced by the Commission in July 2022 and is intended to fully exploit the potential of deep tech innovations. In September 2022, the Czech Presidency of the Council started the drafting of the conclusions, and the final text adopted by the Competitiveness Council (Research) at its meeting of 2 December 2022.

All types of innovation play a critical role in driving EU’s competitiveness, states the document, with a particular emphasis on research-driven innovation, deemed able of shaping and creating new markets. Incremental and breakthrough innovation are both essential to maximise the societal and economic value of the resulting outcomes. Investing in higher education and R&I is thus essential to achieve these goals, and to position the EU as a global R&I leader. Social sciences and humanities should also be part of the comprehensive approach to innovation described by the Conclusions.

The diversification of supplies and the mitigation measures to tackle strategic dependencies on external suppliers are critical issues to be faced to compete in the complex global geopolitical scenario. An open approach to international R&I cooperation is still the goal of the European institutions, requiring shared fundamental values and principles with other countries and a balanced and reciprocal approach.

At the regulatory level, flexibility, fit-for-purpose, forward-looking and innovation-friendly remain the preferred keywords to characterise the new framework. The development of breakthrough, deep-tech and disruptive innovations should be supported by standardisation and accreditation, and regulatory adaptation and experimentation.

The Council also supports the role of private R&I investments and strategic use of intellectual assets as a fundamental part of the undergoing transition, as well as further policy reforms at Union, national and regional levels to better encourage the full development and implementation of new technologies, including testing and demonstration facilities.

The European Innovation Council (EIC) Fund has been confirmed as the tool to support investments in innovation. Among others, the Conclusions ask the Commission to implement the EIC’s Scale Up 100 action and to facilitate access to capital for innovative start-ups and SMEs through the InvestEU Programme.

Conclusions on Research Infrastructures

The second document approved in December 2022 updates the vision of the European RI ecosystem, with a particular focus on the system of integrated research infrastructures. Access to RIs is deemed fundamental to support innovation by private, large and medium-small companies. It can take different forms, i.e. proprietary access to RIs, contractual research, joint R&I, training and industrial, supply of top-class products and services to RIs. Research infrastructures are also important to sustain regional development and support the availability of a wide range of skills and relating jobs.

A central part of document is represented by the call to proceed with the implementation of the ERA Policy Agenda for the period 2022–2024 and, in particular, ERA Action 8 (“Strengthen sustainability, accessibility and resilience of RIs in the ERA”). To this instance, a major activity should aim to involve RIs in producing, collecting, processing, storing and providing quality certified scientific data in accordance with the FAIR (Findable, Accessible, Interoperable and Reusable) principles. This action is considered essential to facilitate the sharing and use of data across a broad range of disciplines as well as at the international level.

To improve the RIs’ framework, the invitation of the Council is for the European Strategy Forum on Research Infrastructures (ESFRI) to run a comparative study aimed to identify best practices and elaborate recommendations to national and regional RI stakeholders by the end of 2023. A common approach for the staff of the RIs, especially in the case of a European Research Infrastructure Consortium (ERIC), is also envisaged.

Research infrastructures can’t operate without the support of Technology Infrastructures (TIs); a mapping exercises of the last ones is considered essential in order to proceed with the implementation of the TI concept within the ERA Policy Agenda. Members states and the Commission should also work to better identify the role of RIs in the implementation of Horizon Europe (i.e. European Partnerships and Missions, industrial technology roadmaps, etc.). RIs may also contribute to designing new services based on their different missions and should be supported by long-term investments by member states with the support of the Commission. To this instance, the analysis of possible types of financial support throughout RIs’ life cycle, with identification of good practices and synergies of various funding resources, should be accomplished by ESFRI.

The Council also invited the Commission to present an initiative on a revised European Charter for Access to Research Infrastructures by the end of 2023. A better coordination between ESFRI and the European Open Science Cloud (EOSC) Steering Board would also be needed.


Draft topics for the first IHI calls for proposals

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by Giuliana Miglierini

The Innovative Health Initiative (IHI) published on its website the first draft topics which may be part of the first two calls for proposals, scheduled in June 2022. Interested parties may start the activities needed to build and formalise the research consortia, taking into consideration that the announced topics are draft, pending their approval by the IHI Governing Board and their final version may differ from the drafts.

IHI call 1 shall focus on innovative technologies for the development of decision-support system for improved care pathways, next generation imaging, personalised oncology and access and integration of heterogeneous health data in areas of high unmet public health need.

IHI call 2 shall address cardiovascular diseases and the development of a harmonised methodology to promote early feasibility studies.

The draft topics of IHI call 1

Innovative decision-support systems are important to make available improved care pathways for patients with neurodegenerative diseases and comorbidities. The actions to be undertaken include the enhanced cross-sectoral and sustainable collaboration between healthcare industries, academia and other stakeholders in order to exchange data (through the new European Health Data Space), analytical tools and material for training and professional development of personnel.

Earlier diagnosis should lead to more clinically effective interventions and reduced hospitalisation and facilitate the adherence to therapy. Clinical outcomes are expected to support a better patient stratification, which is needed to develop more patient-adapted interventions, therapeutics and cost-effective pathways for the management of neurodegenerative diseases. Among the expected outcomes is the development of a re-usable, interoperable, easily adaptable, and scalable digital platform, initially targeted to support patients in this therapeutic area, but further expandable in the future to other areas of interest. The action should also involve the development of agreed standards and guidelines to support data collection and operational features of the digital platform. New algorithms may provide (near) real time feedback on health interventions and support the constant monitoring of the patient’s status.

The second topic is focused on the development of high-quality tools, high-quality data, advanced patient imaging and image-guided technologies and processes for improved early diagnosis, prognosis, staging, intervention planning, therapy and management of cancer. Imaging can be part of new combined cancer therapies (e.g., theranostics, chemotherapy, targeted therapy including immunotherapy, radiotherapy and/or surgery). The call should also include the development of improved validation and evaluation methodologies specific to artificial intelligence (AI)and machine learning (ML), with a particular attention to the creation of new solutions that automatically link images to clinical data. This could be applied, for example, to develop minimally invasive interventions guided by medical imaging, or image-driven planning and predictive tools.

The third topic is also aimed to tackle cancer through the development of personalised interventions. This action should contribute to break down silos that are often still characterizing medicine and technological areas. The availability of harmonised approaches should lead to safe and effective innovative health technologies, to the integration of future products, services and tools and the development of more patient-centred tools. Here again, an expected outcome is represented by a dynamic platform for R&I collaboration across different sectors and stakeholders, focusing on the early stages of applied clinical research on cancer and on the testing and validation of multi-modal therapeutic approaches, including novel or emerging technical and clinical concepts and the possible contribution arising from in vitro diagnostics.

Topic 4 of IHI 1 addresses the integration of future products, services and tools along the healthcare pathway to better respond to specific patients’ needs. The availability of interoperable, quality data which reflect the FAIR principles (Findability, Accessibility, Interoperability, Reusability) is central to this action, as well as the development of advanced analytics/artificial intelligence supporting health R&I. Among the main expected outcomes is the long-term access to diverse types of data enabled by the linkage and integration of novel and cross-sectoral sources. Access to interoperable tools should also become possible for citizens and patients to support the self-management of health and the joint decision making process between healthcare professionals and patients.

The draft topics of IHI call 2

Cardiovascular diseases (CDV) remain one of the main causes of death; the development of new tools for the primary and secondary prevention of CDV is the main focus of Topic 1, to be pursued by the identification of existing comprehensive CVD and heart failure (HF) patient datasets, in order to facilitate the diagnosis of atherosclerosis and HF. These data shall be also integrated with those captured by diagnostic tools (e.g., wearables, imaging devices, bio samples/biopsies).

Classical diagnostic screening, in-vitro- diagnostics, ‘multi-omic’ platforms (e.g. genomic, transcriptomic, proteomic and multimodality imaging data), continuous glucose monitoring (CGM) data, continuous electrocardiogram (ECG) from wearable, HF and activity data, wearable devices and digital health applications are all possible sources for the data. Projects may also leverage data in currently available IMI federated databases in compliance with the GDPR regulation governing protection of personal data.

The utility of already existing or new biomarker combinations shall be assessed to detect patients at risk, also making use of AI models to analyse data. Validated data referred to patient reported outcome and experience measure (PROMs and PREMs) may also be considered for use in the clinical setting.

The second draft topic is targeted to establish a harmonised methodology to promote the diffusion of Early Feasibility Studies (EFS) among healthcare professionals. Once again, the availability of digital technologies easily accessible by patients shall be key to this action. Among expected outcomes are the improvement of the quality of clinical evidence on health technology innovation generated through earlier clinical experience, together with the increase of the attractiveness of clinical research for healthcare technologies in the EU.

These activities are essential to enable the fast translation of innovation into the clinical practice, improving access to patients especially where there are only limited or no alternative therapeutic options. This approach to the development of innovative technologies may also benefit regulators and health technologies assessment (HTA) bodies, as well as notified bodies. All stakeholders involved in clinical practice and research may contribute to the early generation of quality data, so to achieve a better understanding of diseases management and treatment options and to support the future development of new medical guidelines.

The creation of hubs of clinical excellence to attract investment may also be considered under this topic, with involvement of developers of medical devices, drug-device combination products, imaging equipment, in-vitro diagnostics, and SMEs.