Work Package 1

WP1, on behalf of the B1MG consortium, will invite representatives from all major and relevant stakeholder groups (academia, policy-makers, health care providers, research infrastructures, industry, and citizens representatives, among others) to co-create a stable framework to systematically tackle the challenges defined by the project.

The stakeholders, with the national mirror groups/WP5, will tackle the issues in three distinct areas, creating a space of dialogue for building an agenda that will include:

1. A decision making framework for public-private involvement and increased literacy in personalised health amongst the stakeholders;
2. A framework for future proofing the area to facilitate emerging health technologies integration into the healthcare systems and
3. identifying future mechanisms of cooperation between stakeholders within and outside the EU.

Through the development of a problem statement and the framework document for each thematic area, the Stakeholder Coordination Group (SCG) will generate recommendations based on the assessment of their own integration processes, as well as monitoring multimodal genomic medicine programmes outside Europe to increase interactions with a global Personalised Medicine community.

Close attention will be paid to key projects and programmes outside of Europe, such as the MASTER KEY project from Japan, the Qatar Precision Medicine National Strategy, Genome Canada, Therapeutic Innovation Australia and the US-based Personalised Medicine Coalition. Experts from these initiatives will be invited to participate in expert panels.

Participants: EAPM (Denis Horgan), EMBL (Jan Korbel), DTL-Projects (Ruben Kok), EATRIS (Toni Andreu).

Participants' roles: EAPM to establish the Stakeholder Coordination Group and establish the terms of reference for its operation. Linked to the 1+MG working groups, EMBL and EAPM will coordinate the development of the problem statement and framework documents. DTL-PROJECTS to act as the link with the EU Member States, as well as the mirror groups, to ensure alignment. EATRIS to act as the link with other infrastructures, such as ELIXIR, BBMRI, ECRIN and non-EU initiatives.

The value chain for the use of genomic data into clinical decision making represents a strong operational challenge, not only for the integration and FAIRification processes at early stages during data generation, but during the entire translational value chain. This process is defined by a complex fabric of interconnectedness of research, healthcare, policy, reimbursement, industry and regulatory domains, whose success can only occur through structural and cross- sectional collaboration.

In the specific case of the B1MG project, the definition of process becomes even more challenging due to the multinational nature of the initiative. Through this task, stakeholder perspectives will be brought to the technical WPs (2, 3, 4, and 5) in charge of creating the genomic translational pipeline.

WP1 will create, within the B1MG domain and in close collaboration with WP6 (see Task 6.4), a stakeholder portal to deliver tools and define workflows to de-risk and improve the flow of data generation and integration towards patients. These tools will help reduce cross-border barriers, and facilitate the development of operational pipelines based on the integration of genomic and health data.

Participants: EATRIS (Toni Andreu, Anne-Charlotte Fauvel), DTL-Projects (Ruben Kok), EAPM (Denis Horgan), EMBL (Jan Korbel), ELIXIR Hub (Andrew Smith, Erin Haskell, Martin Cook via Task 6.4)). All partners via project boards.

Participants' roles: EATRIS to define the operational framework for the portal. DTL-PROJECTS to ensure that it is integrated into the operational WPs (1, 2, 3, and 4) workflows. EAPM and EMBL to ensure that the Stakeholder Coordination Group will provide inputs. ELIXIR Hub to align the stakeholder portal with the communication strategy defined in WP6.

The Cancer Mission, foreseen by Horizon Europe and the development of the EJP RD, represent two major landmarks in the European Research Area, demonstrating the need for a digital research infrastructure for genomics-based health research and patient care.

Both initiatives, as well as the proposed partnership on Personalised Medicine, define a full cross-border translational pipeline where the generation of high-quality FAIRified genomic data will be embedded into the health care decision-making process.

To solve challenges related to the specific development of both initiatives, B1MG will generate a toolbox of solutions (WP2 to 5), including tools specific for these domains, optimising the process for data integration fully adapted to the Cancer and Rare Diseases research challenges.

Participants: DTL-Projects (Ruben Kok, GertJan B. van Ommen), EAPM (Denis Horgan), EATRIS (Toni Andreu, Anne-Charlotte Fauvel), EMBL (Jan Korbel). All partners via project boards.

Participants' roles: DTL-PROJECTS to deliver to the Use Cases the outcomes of the different WPs and to ensure alignment with the mirror groups. EATRIS to provide operational support to DTL-PROJECTS. EAPM and EMBL to ensure that the Stakeholder Coordination Group can provide inputs to the rare diseases and cancer domains.