Periodic Reporting for period 2 - TRANSVAC-DS (DESIGN STUDY FOR A EUROPEAN VACCINE INFRASTRUCTURE)
Reporting period: 2021-12-01 to 2023-02-28
The EC-funded projects TRANSVAC1 and TRANSVAC2 formed the basis of a trans-European vaccine infrastructure, offering qualified candidates a range of services across the various stages of the vaccine development pipeline. The TRANSVAC-DS project seeks to solidify the successes of these efforts by transitioning the TRANSVAC initiatives into a self-sustaining model.
This transition relies upon the experience gained during the course of the previous TRANSVAC projects. The TRANSVAC-DS partners will work together to provide state-of-the-art services for vaccine developers and training courses in highly-demanded vaccinology subjects through a sustainable business model. A wide range of technologies and proficiencies are required to develop a novel vaccine, posing a significant barrier to small- and mid-size enterprise (SME) biotechnology/pharmaceutical companies and academic groups. These users are expected to be major beneficiaries of the final consortium. Additionally, society at-large will be provided a robust European vaccine development network and access to additional vaccines to address existing gaps and deficiencies in the human and veterinary prophylactic/therapeutic vaccine arsenal and to better prepare for emerging diseases.
The TRANSVAC-DS project has provided detailed reports outlining the current needs in the European vaccine landscape and detailing the conceptual design for a permanent vaccine infrastructure to address these needs, including a business plan and implementation plan. Together, these documents provide a clear framework and roadmap of how TRANSVAC-DS partners will work to establish a sustainable European vaccine infrastructure.
This transition relies upon the experience gained during the course of the previous TRANSVAC projects. The TRANSVAC-DS partners will work together to provide state-of-the-art services for vaccine developers and training courses in highly-demanded vaccinology subjects through a sustainable business model. A wide range of technologies and proficiencies are required to develop a novel vaccine, posing a significant barrier to small- and mid-size enterprise (SME) biotechnology/pharmaceutical companies and academic groups. These users are expected to be major beneficiaries of the final consortium. Additionally, society at-large will be provided a robust European vaccine development network and access to additional vaccines to address existing gaps and deficiencies in the human and veterinary prophylactic/therapeutic vaccine arsenal and to better prepare for emerging diseases.
The TRANSVAC-DS project has provided detailed reports outlining the current needs in the European vaccine landscape and detailing the conceptual design for a permanent vaccine infrastructure to address these needs, including a business plan and implementation plan. Together, these documents provide a clear framework and roadmap of how TRANSVAC-DS partners will work to establish a sustainable European vaccine infrastructure.
Significant progress was made towards establishing the framework for a self-sustaining TRANSVAC infrastructure during the project period. The highlights of the completed work are summarized below.
o The current playing field was analysed through literature reviews, interviews, focus groups, and surveys of experts in the vaccine field, and summarized in a Gaps and Needs report and publication.
o Based on the identified gaps and needs of the user base, potential business models and legal structures were explored and down-selected according to selected quantitative and qualitative criteria. A Dynamic business model with bio-holding and contract development partnership aspects was chosen as the preferred operating framework although other opportunities, including additional public funding, will also be pursued when possible.
o A business plan and implementation plan for a sustainable vaccine infrastructure was then developed based on the selected business model. A socioeconomic impact analysis was performed, including key performance indicators to serve benchmarks for measuring the success of the infrastructure.
o Stakeholders in the proposed infrastructure were identified, and catalogued, and important stakeholders were contacted and presented with an outline of the proposal. A corresponding stakeholder contact strategy and dissemination policy were also developed, and the project was presented within numerous relevant external forums.
o Ethical guidelines for the project were written, including a living ethical guidelines document to guide the implementation of the infrastructure and ensure compliance with all relevant statutes.
o The current playing field was analysed through literature reviews, interviews, focus groups, and surveys of experts in the vaccine field, and summarized in a Gaps and Needs report and publication.
o Based on the identified gaps and needs of the user base, potential business models and legal structures were explored and down-selected according to selected quantitative and qualitative criteria. A Dynamic business model with bio-holding and contract development partnership aspects was chosen as the preferred operating framework although other opportunities, including additional public funding, will also be pursued when possible.
o A business plan and implementation plan for a sustainable vaccine infrastructure was then developed based on the selected business model. A socioeconomic impact analysis was performed, including key performance indicators to serve benchmarks for measuring the success of the infrastructure.
o Stakeholders in the proposed infrastructure were identified, and catalogued, and important stakeholders were contacted and presented with an outline of the proposal. A corresponding stakeholder contact strategy and dissemination policy were also developed, and the project was presented within numerous relevant external forums.
o Ethical guidelines for the project were written, including a living ethical guidelines document to guide the implementation of the infrastructure and ensure compliance with all relevant statutes.
The choice of a combination bio-holding/contract development partnership is expected to ensure that the infrastructure is not just a provider of research services but of expertise and scientific/business guidance for users, and that the consortium is invested in the final outcome and impact of the vaccines. The gaps/needs analysis ensures that the initiative will target real needs of users and the broader marketplace.
While the envisioned infrastructure is not yet established, the consortium will continue preparations for a permanent European infrastructure. The TRANSVAC-DS project has provided a solid foundation on which to build, and a working relationship between partners is ongoing. This is aided by the continued involvement of most partners within the ISIDORe RI consortium, and contact will be maintained with all partners to both ensure as many TRANSVAC services as possible will continue to be available in the near-term, and also continue advancing towards a long-term sustainable format.
While the envisioned infrastructure is not yet established, the consortium will continue preparations for a permanent European infrastructure. The TRANSVAC-DS project has provided a solid foundation on which to build, and a working relationship between partners is ongoing. This is aided by the continued involvement of most partners within the ISIDORe RI consortium, and contact will be maintained with all partners to both ensure as many TRANSVAC services as possible will continue to be available in the near-term, and also continue advancing towards a long-term sustainable format.