Periodic Reporting for period 1 - ISIDORe (Integrated Services for Infectious Disease Outbreak Research)
Période du rapport: 2022-02-01 au 2023-07-31
The COVID-19 pandemic, as well as previous epidemics, demonstrated how vulnerable Europe, and the rest of the world, are to infectious diseases. We were not ready for COVID-19 notably due to a lack of sustained support for research and development into preparedness, particularly during the intervals between major disease outbreaks. This was, among others, compounded by the lack of coordination of research capacities in Europe and around the world.
To address the latter point, European Research Infrastructures work across borders to provide scientists access to high-quality, cutting-edge capacities and services, in a rapid, trusted, equitable and cost-effective manner. The ISIDORe consortium of seventeen major European life sciences research infrastructures and infectious diseases networks, coordinated by ERINHA, was formed to improve Europe’s global service and research capacities, supporting research on epidemic-prone pathogens. Through this federation, the ISIDORe project gathers a wide variety of research and innovation capacities, for fundamental to preclinical and clinical research, to be leveraged by user communities to improve our readiness and responsiveness to pandemic threats, by rapidly supporting needs-driven research to increase knowledge of epidemic-prone pathogens and to develop intervention measures.
To address the latter point, European Research Infrastructures work across borders to provide scientists access to high-quality, cutting-edge capacities and services, in a rapid, trusted, equitable and cost-effective manner. The ISIDORe consortium of seventeen major European life sciences research infrastructures and infectious diseases networks, coordinated by ERINHA, was formed to improve Europe’s global service and research capacities, supporting research on epidemic-prone pathogens. Through this federation, the ISIDORe project gathers a wide variety of research and innovation capacities, for fundamental to preclinical and clinical research, to be leveraged by user communities to improve our readiness and responsiveness to pandemic threats, by rapidly supporting needs-driven research to increase knowledge of epidemic-prone pathogens and to develop intervention measures.
The first half of ISIDORe mostly focused on implementing provision of the project’s broad range of services. The consortium produced an online comprehensive catalogue of services, representing the whole pipeline for pandemic preparedness and response research, including analytical services (structural biology, imaging and sequencing), ex vivo and in vivo models, immune-monitoring and profiling services, support for diagnostic, therapeutic and vaccine development, access to clinical samples, regulatory advice and planning of clinical trials, as well as social sciences and epidemiology services.
This led to the launch of multiple calls for proposals for free of charge transnational access (TNA) to our extensive, unified service offer. To maximise the relevance of the research we support, these calls were designed by key health and research authorities who are represented on ISIDORe’s Strategic Advisory Board: CEPI, EC DG R&I, ECDC, EFPIA, HERA, EMA, GloPID-R, FAO, WHO and WOAH.
With the first two calls for proposals, ISIDORe activated its ‘challenge-driven’ approach and demonstrated its responsiveness for supporting emergency response research and epidemic management. In May 2022, we launched our TNA programme dedicated to SARS-CoV-2 variants of concern. Two months later, we responded to the multi-country outbreak of MPox. Now closed, both these response calls for proposals resulted in the selection of user projects that are expected to increase knowledge of COVID-19 and Mpox, and advance the development of novel countermeasures.
The ISIDORe project then moved on to implementing its ‘preparedness-driven approach’ with four additional calls for proposals that aim to address potential future outbreaks, epidemics or even pandemics. Here, the scientific strategy focuses on a list of specific pathogens based on their epidemic or pandemic potential (ISIDORe’s Priority Preparedness Pathogens) and the lack of countermeasures to fight them. It was established once again by ISIDORe’s Strategic Advisory Board for maximum relevance. Still open, these calls focus on Risk Group 4 pathogens, respiratory pathogens, vector-borne pathogens, and other pandemic-prone pathogens, and were launched in November 2022. The many projects selected through these calls will help increase our readiness to infectious threats.
In the first half of the project and across the 6 calls for proposals, ISIDORe received 298 initial expressions of interest and 129 full applications to TNA services, of which 99 applications were selected for implementation.
Given that the ISIDORe project is expected to generate a lot of data, especially through the implementation of user projects selected for access to our services, ISIDORe is working with the By-COVID project to develop workflows to deposit data in the COVID-19 data portal or other repositories, and thereby make links with EOSC tools and services for data analysis. Making these data, and the metadata that goes with them, openly available for other researchers, method developers and manufacturers will enable further research to be conducted. Furthermore, a FAIR Data Management Plan (DMP) for the project defines rules for data to be rapidly as open as possible. The strategy for data management, and the characteristics of an umbrella DMP, were validated by the ISIDORe community, and formalised in a peer-reviewed publication (https://doi.org/10.5334/dsj-2023-035).
Finally, to improve continuously the quality of its service portfolio, we collected feedback from both the service users and the ISIDORe service providers to identify gaps or potential for improvement in the service portfolio. We also mapped the applicable quality and safety relevant international and national laws, policies, international and European standards, guidelines as well as scientific recommendations and best practices for biospecimen handling to improve and facilitate these procedures across ISIDORe partners.
This led to the launch of multiple calls for proposals for free of charge transnational access (TNA) to our extensive, unified service offer. To maximise the relevance of the research we support, these calls were designed by key health and research authorities who are represented on ISIDORe’s Strategic Advisory Board: CEPI, EC DG R&I, ECDC, EFPIA, HERA, EMA, GloPID-R, FAO, WHO and WOAH.
With the first two calls for proposals, ISIDORe activated its ‘challenge-driven’ approach and demonstrated its responsiveness for supporting emergency response research and epidemic management. In May 2022, we launched our TNA programme dedicated to SARS-CoV-2 variants of concern. Two months later, we responded to the multi-country outbreak of MPox. Now closed, both these response calls for proposals resulted in the selection of user projects that are expected to increase knowledge of COVID-19 and Mpox, and advance the development of novel countermeasures.
The ISIDORe project then moved on to implementing its ‘preparedness-driven approach’ with four additional calls for proposals that aim to address potential future outbreaks, epidemics or even pandemics. Here, the scientific strategy focuses on a list of specific pathogens based on their epidemic or pandemic potential (ISIDORe’s Priority Preparedness Pathogens) and the lack of countermeasures to fight them. It was established once again by ISIDORe’s Strategic Advisory Board for maximum relevance. Still open, these calls focus on Risk Group 4 pathogens, respiratory pathogens, vector-borne pathogens, and other pandemic-prone pathogens, and were launched in November 2022. The many projects selected through these calls will help increase our readiness to infectious threats.
In the first half of the project and across the 6 calls for proposals, ISIDORe received 298 initial expressions of interest and 129 full applications to TNA services, of which 99 applications were selected for implementation.
Given that the ISIDORe project is expected to generate a lot of data, especially through the implementation of user projects selected for access to our services, ISIDORe is working with the By-COVID project to develop workflows to deposit data in the COVID-19 data portal or other repositories, and thereby make links with EOSC tools and services for data analysis. Making these data, and the metadata that goes with them, openly available for other researchers, method developers and manufacturers will enable further research to be conducted. Furthermore, a FAIR Data Management Plan (DMP) for the project defines rules for data to be rapidly as open as possible. The strategy for data management, and the characteristics of an umbrella DMP, were validated by the ISIDORe community, and formalised in a peer-reviewed publication (https://doi.org/10.5334/dsj-2023-035).
Finally, to improve continuously the quality of its service portfolio, we collected feedback from both the service users and the ISIDORe service providers to identify gaps or potential for improvement in the service portfolio. We also mapped the applicable quality and safety relevant international and national laws, policies, international and European standards, guidelines as well as scientific recommendations and best practices for biospecimen handling to improve and facilitate these procedures across ISIDORe partners.
We were able to assemble an unprecedented catalogue of RI services relevant to tackle infectious diseases epidemics, to support research linked to detecting, assessing and combatting pandemic-prone pathogens. From the outset, we were able to offer an impressive range of relevant cutting-edge services, from structural biology to clinical trials, by way of bio-imaging, high-throughput capacities, state-of-the-art in vitro and in vivo models for supporting diagnostic, therapeutic and vaccine development that will be of interest to public and private life sciences communities.
The ISIDORe project was designed to be able to respond rapidly to epidemic outbreaks through RI services. While we had anticipated that this would concern the emergence of SARS CoV 2 variants, our response to the multi country Mpox outbreak confirmed the relevance of our approach. It is notable that our Mpox emergency programme was launched even before the outbreak was declared a public health emergency of international concern by the WHO and with a programme that prioritised TNA topics of interest for the entities represented in the StAB and a special focus on the EU specific interests.
Furthermore, the ISIDORe scientific strategy has been designed to support the development of novel or adapted epidemic intervention tools and measures, especially through specific TNA sections (diagnostics, therapeutics, vaccines as well as social sciences, and vector control), in line with our strategic board priorities. Out of about 100 selected user projects, at least half were submitted in these specific sections and will contribute to the development of intervention tools and measures; ISIDORe’s potential in contributing to advancing our preparedness to epidemics and pandemics is therefore very high.
The ISIDORe project was designed to be able to respond rapidly to epidemic outbreaks through RI services. While we had anticipated that this would concern the emergence of SARS CoV 2 variants, our response to the multi country Mpox outbreak confirmed the relevance of our approach. It is notable that our Mpox emergency programme was launched even before the outbreak was declared a public health emergency of international concern by the WHO and with a programme that prioritised TNA topics of interest for the entities represented in the StAB and a special focus on the EU specific interests.
Furthermore, the ISIDORe scientific strategy has been designed to support the development of novel or adapted epidemic intervention tools and measures, especially through specific TNA sections (diagnostics, therapeutics, vaccines as well as social sciences, and vector control), in line with our strategic board priorities. Out of about 100 selected user projects, at least half were submitted in these specific sections and will contribute to the development of intervention tools and measures; ISIDORe’s potential in contributing to advancing our preparedness to epidemics and pandemics is therefore very high.