To ensure maximal impact, WP9 activities will run concurrently with the activities of WP2-7 as part of an iterative process, harnessing the substantial clinical and regulatory expertise present within IDEA-FAST through the Exploitation and Impact Sub-Committee (EIS) to achieve these goals. The EIS will be set up at project start and will be chair by EMP. This direct involvement will mean that recognised experts in the field will be engaged with IDEA-FAST from its inception and will assist in key decisions and direct further development of promising digital endpoint candidates in the relevant WPs. WP9 will coordinate the engagement with regulatory authorities include early guidance from the EMA ITF and the formal process for Scientific Advice request. Using the ASSIST tool, WP9 will perform a socio-economic impact assessment based on cost-benefit analysis and modelling. Allowing for a multi-stakeholder perspective, this analysis will provide a comprehensive, systemic forecast of the impact the digital endpoints may have in the next few years. WP9 will enlist the expertise of members of the consortium to ensure that IP is protected and that the findings and data generated by IDEA-FAST are widely disseminated to maximise impact. Activities will include engaging with key stakeholders such as the general public, patients & support groups, clinicians and healthcare specialists, industry and regulatory agencies (FDA, EMA). This work will be assisted by the establishment of a project website, use of social media (e.g. Twitter, LinkedIn) and printed materials (leaflets, newsletters etc.). Results will be incorporated into relevant clinical practice guidelines and disseminated through specialist meetings, workshops, conferences and journals.
EFPIA support: Janssen will co-lead WP9 and we expect EFPIA partners to also contribute throughout the WP9 tasks. They will support the engagement with stakeholders, particularly regulatory agencies and industry, provide logistic and organisational support for dissemination events, and lead the commercialisation activities.
O9.1 Effective dissemination of the results of IDEA-FAST to all relevant stakeholders
O9.2 Identify and manage the intellectual property developed
O9.3 Ensure optimal exploitation plans are drawn up, including an exploitation roadmap and specific business plan for commercialising the developed technology beyond the end of the project
O9.4 Develop effective strategy for sustainability
O9.5 Coordinate submission to EMA ± FDA for scientific advice of the IDEA-FAST digital endpoints
O9.6 Assess and ensure strategic alignment and impact on healthcare system regulation, EU health policy as well as the EU digital single market strategy
D9.1 Detailed dissemination plan
D9.2 Definition of the exploitation and socio-economic evaluation framework
D9.3 Final report on workshops and dissemination events
D9.4 Final plan on exploitation, socio-economic impact, sustainability and translation into trial use clinical practice