Periodic Reporting for period 1 - ISW (In Silico World: Lowering barriers to ubiquitous adoption of In Silico Trials)
Reporting period: 2021-01-01 to 2022-06-30
The ISW consortium aims at lowering the primary barriers that are currently preventing a faster uptake of In Silico Trials. The six project’s objects are:
• O1 - Better models
• O2 - Validation collections
• O3 - Technical standards and regulatory barriers
• O4 - Responsible Research & Innovation
• O5 - Scalability and efficient computing
• O6 - Re-training and education
• O1 - Better models
• O2 - Validation collections
• O3 - Technical standards and regulatory barriers
• O4 - Responsible Research & Innovation
• O5 - Scalability and efficient computing
• O6 - Re-training and education
The ISW consortium was able to create a management and coordination infrastructure that allowed all the objectives set for this first reporting period to be achieved within the set limits.
The project’s objectives are being pursued through nine work packages, each one dedicated to one specific objective. Among the most important results achieved so far, it is worth mentioning the completion of the development and validation of the two Fast Accreditation Tracks solutions, BoneStrength and UISS-TB, which have already embarked on the path that will lead them to obtain Qualification Advice from the EMA.
Moreover, with a view to the creation of a new European technical standard for the qualification of In Silico solutions, and in order to break down the regulatory barriers that still prevent their complete diffusion, within the Multi-stakeholder Advisory Board, the pool of regulatory experts has been extended to create a so-called Regulatory Cluster.
ISW communication office established the internal communication framework. The project visual identity (logos, letterheads, etc.) was released, ISW public web site was launched, and all other visual materials like posters and roll-ups have been finalized.
From the perspective of scalability and efficiency, work has already begun to collect the requirements of the various ISW solutions in order to optimize computational costs through an advanced simulation environment which provides access computation and storage resources in local and the main European e-infrastructures such as PRACE, EOSC, Eudat, as well as future EuroHPC.
Re-training and education both represent key-objectives needed to accelerate the uptake of In Silico Solution: for this reason, ISW consortium organized a series of meetings aimed to define the Intended Learning Outcomes (ILO) that are relevant for each category of stakeholders.
The project’s objectives are being pursued through nine work packages, each one dedicated to one specific objective. Among the most important results achieved so far, it is worth mentioning the completion of the development and validation of the two Fast Accreditation Tracks solutions, BoneStrength and UISS-TB, which have already embarked on the path that will lead them to obtain Qualification Advice from the EMA.
Moreover, with a view to the creation of a new European technical standard for the qualification of In Silico solutions, and in order to break down the regulatory barriers that still prevent their complete diffusion, within the Multi-stakeholder Advisory Board, the pool of regulatory experts has been extended to create a so-called Regulatory Cluster.
ISW communication office established the internal communication framework. The project visual identity (logos, letterheads, etc.) was released, ISW public web site was launched, and all other visual materials like posters and roll-ups have been finalized.
From the perspective of scalability and efficiency, work has already begun to collect the requirements of the various ISW solutions in order to optimize computational costs through an advanced simulation environment which provides access computation and storage resources in local and the main European e-infrastructures such as PRACE, EOSC, Eudat, as well as future EuroHPC.
Re-training and education both represent key-objectives needed to accelerate the uptake of In Silico Solution: for this reason, ISW consortium organized a series of meetings aimed to define the Intended Learning Outcomes (ILO) that are relevant for each category of stakeholders.
The aim of the InSilicoWorld project is to accelerate the uptake of modelling and simulation technologies for the development and regulatory assessment of medicines and medical devices (hereinafter referred generically as in silico trials technologies), by developing innovative solutions that address the main barriers to their uptake. Eventually, InSilicoWorld will speed up the uptake of in silico testing, increase the trust in these innovative technologies by the main stakeholders, change the design of regulatory trials to include in silico technologies, and consolidate the regulatory pathways based on in silico trials. The long-term impact will be the reduction of the costs and duration of the development a regulatory assessment of new medical products, while maintaining or improving the level of safety provided by conventional approaches.