Periodic Reporting for period 1 - INNO4COV-19 (Boosting Innovation for COVID-19 Diagnostic, Prevention and Surveillance.)
Okres sprawozdawczy: 2020-10-01 do 2021-09-30
The novel corona virus causing COVID-19 overwhelmed Europe and the world in just a few weeks’ time. Small and Medium-sized Entrerprises (SMEs) are put at very high risk by the slowdown or shutdown of economic life in their countries – exactly those companies who ensure the development of innovative solutions urgently required for counteracting the impacts of COVID-19 and for helping to control possible future outbreaks alike. In view of this situation, accelerated uptake of innovative technologies to tackle COVID-19 is most needed. The mission of INNO4COV-19 is to create a lab-to-fab platform and a collaboration resource where companies and reference laboratories will find the tools for developing and implementing innovative technologies - from idea assessment to market exploitation. Moreover, the project is committed to supporting the commercialization of more than 30 new products for combatting COVID-19 over the next 2 years.
Presence of leading applied research EU institutions in the Consortium will help to obtain a huge impact and to find and attract innovators across Europe to offer new solutions for COVID-19 pandemic and other potential future outbreaks. Europe needs to reinforce its technological leadership and rebuild an industrial sector capable to protect our citizen’s safety and well-being, and INNO4COV-19 will help in catalyzing the change.
Presence of leading applied research EU institutions in the Consortium will help to obtain a huge impact and to find and attract innovators across Europe to offer new solutions for COVID-19 pandemic and other potential future outbreaks. Europe needs to reinforce its technological leadership and rebuild an industrial sector capable to protect our citizen’s safety and well-being, and INNO4COV-19 will help in catalyzing the change.
During the first year of Inno4covid-19 the consortia has focused their efforts on the two open calls launch and the selection of 30 projects to be financially supported. Under the umbrella of INNO4COV-19 we have now under development 30 technology-based projects from 3rd parties, which will provide solutions in the fight against COVID-19 and that will found the preparedness of our systems for potential future outbreaks. In the first year of the project we have not only selected, contractualized and subsidize these projects, but also assigned an INNO4COV-19 representative to each selected project with the aim to closely monitor and support the successful implementation and achievement of the stated objectives and milestones. In addition, we have opened an open call for outside experts to be integrated in the evaluation panels. This action also resulted in an increase of our stakeholders’ network.
We have also moved forward on the creation of Technology Development Platforms focused in supporting the full development of (i) innovative diagnostic and screening systems (Subplatform 1); (ii) environmental surveillance systems and data analytics as a sentinel for viral (re)emergence and spread in communities (Subplatform 2); (iii) low-cost sensors and wearables, as well as telemedicine and telepresence solutions (Subplatform 3); (iv) and protective equipment for people and safer public (Subplatform 4). These are the 4 subplatforms of INNO4COV-19 hub. During this first year, the consortia has been working closely with the INNO4COVID-19 internal test cases owners and with some of the third parties to better prepare the subplatforms for the real needs. We believe that we have been successful in this quest because we have already provide technical, business and regulatory support to third party projects. Still related with the project outputs and services to be provided related to regulatory issues, we would like to highlight the analysis and compilation of the EU regulatory landscape for medical devices, in vitro diagnostic medical devices, and personal protective equipment as well as the guidelines for adaptation of quality systems’ and ‘Guidance document on how to adapt quality systems to comply with appropriate Standards e.g. ISO 13485:2016. Moreover we have established a framework of an efficient management of the Early Advice/Early Dialogue processes, the timeframes of each of the phases and the templates to be filled by applicants or requesters of HTA advice and support. Systematic overview of the processes done by other HTA bodies is also being conducted, and is expected to be finished at the end of 2021. The best standards will be included in the processes to be ultimately performed. This will also be revised in those cases that could have been already performed.
As planned we have also started to engage with important stakeholders. Namely , we have identify relevant stakeholders covering start-ups, SMEs, Big Industries, national or EU funded projects, OITBs, networks and key research players and infrastructures, pilot plants and Contract Development and Manufacturing Organizations specialized in Medtech. Policy makers and public and private procurers. Moreover, as side result of the open calls, as aforementioned, we have interact and engaged with external experts with whom the Consortium had discussions related with standards and scientific regulatory frameworks.
Regarding the dissemination and exploitation, we have actively worked on the dissemination of the open calls, as well as in their results, as it can be found in or media channels and website http://www.inno4cov19.eu/ .
We have also moved forward on the creation of Technology Development Platforms focused in supporting the full development of (i) innovative diagnostic and screening systems (Subplatform 1); (ii) environmental surveillance systems and data analytics as a sentinel for viral (re)emergence and spread in communities (Subplatform 2); (iii) low-cost sensors and wearables, as well as telemedicine and telepresence solutions (Subplatform 3); (iv) and protective equipment for people and safer public (Subplatform 4). These are the 4 subplatforms of INNO4COV-19 hub. During this first year, the consortia has been working closely with the INNO4COVID-19 internal test cases owners and with some of the third parties to better prepare the subplatforms for the real needs. We believe that we have been successful in this quest because we have already provide technical, business and regulatory support to third party projects. Still related with the project outputs and services to be provided related to regulatory issues, we would like to highlight the analysis and compilation of the EU regulatory landscape for medical devices, in vitro diagnostic medical devices, and personal protective equipment as well as the guidelines for adaptation of quality systems’ and ‘Guidance document on how to adapt quality systems to comply with appropriate Standards e.g. ISO 13485:2016. Moreover we have established a framework of an efficient management of the Early Advice/Early Dialogue processes, the timeframes of each of the phases and the templates to be filled by applicants or requesters of HTA advice and support. Systematic overview of the processes done by other HTA bodies is also being conducted, and is expected to be finished at the end of 2021. The best standards will be included in the processes to be ultimately performed. This will also be revised in those cases that could have been already performed.
As planned we have also started to engage with important stakeholders. Namely , we have identify relevant stakeholders covering start-ups, SMEs, Big Industries, national or EU funded projects, OITBs, networks and key research players and infrastructures, pilot plants and Contract Development and Manufacturing Organizations specialized in Medtech. Policy makers and public and private procurers. Moreover, as side result of the open calls, as aforementioned, we have interact and engaged with external experts with whom the Consortium had discussions related with standards and scientific regulatory frameworks.
Regarding the dissemination and exploitation, we have actively worked on the dissemination of the open calls, as well as in their results, as it can be found in or media channels and website http://www.inno4cov19.eu/ .
INNO4COVID-19 is supporting in total 35 new technologies that will not only tackle COVID-19 pandemic issues, but also prepare us for future pandemic outbreaks. All of these technologies are innovative and go beyond the state of the art in their fields.
Beyond the technologies supported, we are building a lab-to-fab platform and a collaboration resource where companies and reference laboratories will find the tools for developing and implementing innovative technologies - from idea assessment to market exploitation.This platform will offer services within 4 different domains (subplatforms): (i) innovative diagnostic and screening systems (Subplatform 1); (ii) environmental surveillance systems and data analytics as a sentinel for viral (re)emergence and spread in communities (Subplatform 2); (iii) low-cost sensors and wearables, as well as telemedicine and telepresence solutions (Subplatform 3); (iv) and protective equipment for people and safer public (Subplatform 4). And it will range from general services to very specific and tailored services.
With this action we aim to foster SME’s growth and the whole “KET-COV-19” ecosystem. Also to facilitate the establishment of a fully functional innovation platform by pan-European supporting developers in the last steps of the value chain. This accelerates the translation of innovation to the market.
Thus, INNO4COV19 contributes to the European, as well as global, capacity in the management of COVID-19 pandemic. This increases preparedness and prompt response to COVID-19 outbreaks.
Beyond the technologies supported, we are building a lab-to-fab platform and a collaboration resource where companies and reference laboratories will find the tools for developing and implementing innovative technologies - from idea assessment to market exploitation.This platform will offer services within 4 different domains (subplatforms): (i) innovative diagnostic and screening systems (Subplatform 1); (ii) environmental surveillance systems and data analytics as a sentinel for viral (re)emergence and spread in communities (Subplatform 2); (iii) low-cost sensors and wearables, as well as telemedicine and telepresence solutions (Subplatform 3); (iv) and protective equipment for people and safer public (Subplatform 4). And it will range from general services to very specific and tailored services.
With this action we aim to foster SME’s growth and the whole “KET-COV-19” ecosystem. Also to facilitate the establishment of a fully functional innovation platform by pan-European supporting developers in the last steps of the value chain. This accelerates the translation of innovation to the market.
Thus, INNO4COV19 contributes to the European, as well as global, capacity in the management of COVID-19 pandemic. This increases preparedness and prompt response to COVID-19 outbreaks.