The VAC2VAC governance is multi-layered comprising the General Assembly, the Steering Committee (SC), the Scientific and Ethics Advisory Committee (SEAC) and the Work Package 7 coordination team.
The robust management structure will support rapid and effective decision making and drive the implementation of the project.
Overall management of the VAC2VAC consortium will be delivered by Work Package 7 whose participants include the Project Coordinator (EVI) and a Scientific Management Team (SMT).
The VAC2VAC project is funded by IMI and is coordinated by the European Vaccine Initiative (EVI).
Scientific Management Team
The composition of the Scientific Management Team (SMT) reflects the involvement of different stakeholders in VAC2VAC. Companies developing human vaccines are represented by two of the leading European companies: Sanofi Pasteur and GlaxoSmithKline Biologicals, whereas companies developing veterinary vaccines are represented by Zoetis. Intravacc represents the public research organisations participating in VAC2VAC.
The SMT will work collegially to ensure strong scientific leadership and is responsible for the strategic direction of the activities and for the overall scientific oversight of the project.
The Steering Committee (SC) is composed of all Work Package leaders plus one representative from each of the VAC2VAC industry partners. Moreover, a representative from IMI and the chair of the Scientific and Ethics Advisory Committee (SEAC) are invited to join the SC as non-voting members. The primary function of the SC is to review and act on any significant issues involving the scope or budget of the project. The SC meets at least quarterly.
Scientific and Ethics Advisory Committee
The external Scientific and Ethics Advisory Committee (SEAC) is a non-executive consultative body for the consortium aimed at providing crucial recommendations before critical decisions are taken by the Steering Committee (SC).
The SEAC assists in the annual monitoring of the project and, if necessary, helps to solve conflicts between participants. The SEAC comprises outstanding scientists with relevant expertise to the activities conducted by the VAC2VAC consortium.
Members of the VAC2VAC SEAC are:
Dr. Lorenzo Montrasio (SEAC chair) – Senior Scientific Officer, Council of Europe – Bioethics Unit; former Head of Biological Medicinal Product unit at AIFA
Dr. Karl-Heinz Buchheit, retired – Former Head of the Department of Biological Standardisation, OMCL Network & HealthCare (DBO), EDQM
Dr. Dean Smith – Associate Director, Centre for Biologics Evaluation (CBE), Advisor to the Director General, Biologic & Genetic Therapies Directorate (BGTD), Health Canada (HC)
Dr. Robin Levis – Deputy Director, Division of Viral Products (OVRR/CBER), US FDA
Dr. Judy MacArthur Clark. Executive Director, JMC Welfare International and Leader, UK Government International 3Rs Programme.
Dr. Laurent Mallet – Head of the Department of Biological Standardisation, OMCL Network & HealthCare, EDQM (since December 2019)
Dr. Lukas Bruckner, retired – Former Head of the OMCL for Immunological Veterinary Medicinal Products, Institute of Virology and Immunology in Mittelhäusern
The General Assembly of VAC2VAC includes one representative from each consortium member and meets once a year.