A European Academic Network for Vaccine Research An Idea from the Danish Mirror Group under ETPGAH Working group: Jens Kjær – Boehringer Ingelheim DK Poul Bækbo – Danish Pig production Anders Miki Bojesen – KU LIFE Henrik Stampe Lund – DTU Veterinary Gregers Jungersen – DTU Veterinary

The idea: Vaccine Production Antigen DeliveryAdjuvantsAntigen Discovery T-cell Immunology Innate Immunology Pillars of generic vaccine technologies Foundation of vaccine oriented and applied research European Academic Network for Vaccine Research Pediment of cross-disciplinary expertises Advisory Body Industry Vet Authorities Regulatory (Emea) Research New R&D Projects Endemic diseases Minor market vaccines Generic vaccine platform

Why build a vaccine network? The ETPGAH background Our concerns The solution Deliverables Strengths How do we do it?

The ETPGAH background December 2005May 2006 August 2007

Vaccines are ”all over” ETPGAH ”It is important to provide incentives for vaccine research and to ensure that if vaccines and tests are developed, they are genuinely answering the users’ demands, reach the correct targets and comply with international standards on quality, safety and efficacy.” ”Over the next 10 years it is vital to foster a creative environment for fundamental research and to stimulate investment in research, in particular in the fields of molecular biology, immunology, genomics, bioinformatics etc.” ”An EU-wide review of the current state of fundamental science as it impacts on the development of vaccines, pharmaceuticals and diagnostics is required for the major diseases”

Our concerns IPR and dissemination of knowledge Interactions and technology transfers between ”human” and veterinary medicine Transfer of knowledge from prioritised diseases to minor organisms – minor species (MOMS) Secure Research in Generic Vaccinology Independent assessment of vaccines and vaccine efficacy

The solution? A European Academic Network for Vaccine Research will –Create trust between involved parties –Secure dissemination from advances made in prioritised disease areas to other areas –Establish a consensus platform for generic needs in fundamental and applied vaccine R&D i.e. Promote soft indicators for improved quality and quantity of European vaccine research

Suggested structure: Vaccine Production Antigen DeliveryAdjuvantsAntigen Discovery T-cell Immunology Innate Immunology Pillars of generic vaccine technologies Foundation of vaccine oriented and applied research European Academic Network for Vaccine Research Pediment of cross-disciplinary expertises Advisory Body Industry Vet Authorities Regulatory (Emea) Research New R&D Projects Endemic diseases Minor market vaccines Generic vaccine platform

Deliverables Collection of (or access to) recognised expertises within all aspects of vaccine R&D Provide overview of Vaccine R&D as well as fundamental research capacities in EU –Annual review of vaccine research in EU? Identification of critical areas of fundamental research in need of targeted research funding One-stop-shopping for consultancy on novel vaccine R&D projects Independent assessment of vaccine issues, e.g. commissioned from Emea, EU, Industry

Strengths Academic foundation limits Industry IPR “protectionism” In line with ETPGAH Vision, Strategy and Action Plan Will contribute to capacity building in EU Can function as independent advisory and decision supportive organ Closes a gap in European vaccine R&D

How can it be done? The realization of the Danish proposal is deliberately not very detailed. This should give all supporting parties an opportunity to contribute and take co- ownership First action is to get support from a number of countries (mirror groups?) and The EU Commission

A European Academic Centre for Vaccine Research Recommendation: Foundation of a European Academic Centre for Vaccine research and vaccine development including vaccines for exotic diseases as well as in improvement of control of endemic diseases. ”European Technology Platform for Global Animal Health - Vision 2015” refers to the limited progression in vaccines (p.23). Objective: The purpose of the centre is to create a basis for the development (and production) of new and better vaccines in the future. Specification: - To reach the long term perspective: Design of effective and cost-efficient vaccines and research in next generation vaccines we need a closer determination of subjects and areas of generic nature - innate immunity, T cell immunity, DNA-vaccines, bioinformatics, antigen delivery. - Reduced antimicrobial usage by use of vaccines. - Need for rapid tests. - The research centre take responsibility for a research training programme for young researchers. - Construction of a system addressed to decision-support among European authorities. - The essence of this multi level capacity building is an attempt to bring basic and applied research closer together and create mutual trust between the involved participants. European added value: The overall European perspective is to produce one coherent value chain from research idea to vaccine production. This initiative could contribute at ”strengthening the scientific foundation of the Community animal health policy” (ACTION PLAN for the implementation of the EU Animal Health Strategy, COM (2008) 545 final, p. 5).

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