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Innovation Partnership for a Roadmap on Vaccines in Europe

Final Report Summary - IPROVE (Innovation Partnership for a Roadmap on Vaccines in Europe)

Executive Summary:
The “Innovation Partnership for a Roadmap on Vaccines in Europe” (IPROVE) aimed to establish a clear vision of the priority innovations and technologies in vaccine and vaccinology necessary to address infectious and non-infectious threats of importance to public health in Europe and beyond. The project started in December 2013. The roadmap – published in March 2016 – inform strategic decisions on the priorities for future vaccine investment in innovation and technological development at the level of the EU as well as of individual Member States. The project is key to strengthen Europe's competitiveness and leading position in vaccinology, ensuring that Europe will maintain its leadership position and capacity to tackle unmet medical needs. Additional goals include favouring a more structured vaccine innovation agenda, tackling changing medical needs and supporting strained healthcare system budgets.

Through a consultation process involving experts from public health and regulatory bodies, small and medium-sized enterprises (SME), large industry, academia, research organisations, civil society organisations, as well as funding and policy bodies, the project analysed the entire vaccine innovation chain, from needs identification and conceptualisation to discovery and development, including interventions necessary to improve education curricula, and vaccine perception and awareness by the public.

The IPROVE consortium comprises four renowned organisations in the vaccine field in Europe:
- Vaccines Europe (VE), a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA) representing all major research-based vaccine global companies as well SMEs operating in Europe;
- the European Vaccine Initiative (EVI), a leading European Product Development Partnership supporting the development of effective, accessible, and affordable vaccines against diseases of poverty;
- the Sclavo Vaccines Association (SVA), a non-profit association whose main objective is to promote vaccine research targeted towards the discovery and study of advanced immunisation technologies; and
- EATRIS, a European consortium of 69 academic institutions of excellence in translational research, working together to advance candidates into clinical development.

The roadmap is available at:

Project Context and Objectives:
IPROVE, the Innovation Partnership for a Roadmap on Vaccines in Europe aimed to develop a vision on future priorities for funding and programming initiatives at EU level in the field of vaccines and vaccination. The consortium, composed of 4 leading European organisations in the vaccines field (Vaccines Europe, European Vaccine Initiative, Sclavo Vaccines association and European Infrastructure for Translational Medicine), established a coordinated and comprehensive European vision on gaps, needs, and priorities to spur vaccine innovation in Europe.

Key topic areas covered by IPROVE
The IPROVE consultation process that led to the preparation of the final roadmap has been structured in a series of key broad pillars corresponding to focal areas that the consortium members consider essential to cover in a holistic manner needs and priorities to bring vaccine/ vaccinology innovation. These pillars include, but will are not limited to, the themes described here below:

Pillar 1: Innovative research and development. i) advanced immunisation technologies; ii) delivery systems and adjuvants; iii) early prediction of vaccine efficacy and safety; iv) vaccines for different age groups; v) systems biology for human immunology and vaccinology; vi) strengthening the link between human and animal vaccine research. More broadly, understanding of needs in terms of translational research for better integration of clinicians, vaccine developers and basic researchers is required to ensure that vaccine research is targeted and translatable.

Pillar 2: Innovative vaccine production and delivery. In this we cover issues related to the need of improving vaccine production platforms, particularly in terms of facility design and capacity (to enable increases in production). We also include aspects concerning vaccine delivery devices and routes. Examples are skin-induced immunity or mucosal vaccination, such as oral, intranasal, and pulmonary routes, which would improve vaccination convenience but also immune response compared to injection routes.

Pillar 3: Training in vaccinology and vaccines perception and awareness. IPROVE addresses the needs and gaps in training programmes for the training of the next generation of researchers in vaccinology and to foster synergies between existing training schemes. Successful vaccination requires that vaccines be made available and affordable through appropriate R&D and production. They must also be accessible through effective health systems, and their impact must be assessed to allow continuous improvement.

Pillar 4: Infrastructure needs. This pillar focuses on infrastructure needs required to fulfil the vaccines pipeline in Europe, as well as identify opportunities for synergies with existing infrastructure programs and avoid unnecessary duplication. Research infrastructures provide the scientific community with facilities, resources and services necessary for conducting top-level research in their respective fields and they have proved to be necessary to enable frontier research and innovation that is needed for addressing current and future challenges in biomedical research. Topics that will covered include (but not limited to) infrastructure needs for well-characterized animal studies (needs for validated models for efficacy and safety testing), small to medium scale vaccines production, and dedicated facilities for clinical trials.

Pillar 5: Needs for vaccine SMEs to support research on innovation. Key aspects of the consultation process includes i) encouragement and mobilisation of new ideas and new elements to improve the research and innovation agenda for SMEs, ii) allow the SMEs to express experiences and endorse and raise ideas, iii) elaborate strategies to enhance SME involvement in research and innovation activities in the vaccine arena, iv) access to risk/venture capital.

Pillar 6: Therapeutic vaccines development. The past few years have seen a renewed focus on therapeutic vaccines. Many companies have announced important steps forward in the development of an array of new therapeutic vaccines against various forms of cancer, infectious diseases, Alzheimer’s disease, and other conditions. It is likely that multiple first-of-their-kind therapeutic vaccines will become available in the next decade. Areas for consultation covered under this pillar included the following: i) Development of novel assays for safety and efficacy predictions; ii) Patient selection criteria (personalized approach); iii) Discussion of guidance for the definition of specific regulatory guidelines. With specific regard to cancer therapeutic vaccines under development the following additional topics were explored: a) Major hurdles limiting efficacy of cancer vaccines; b) Combined strategies of cancer immunotherapy (immune checkpoint blockades); c) Anticancer drugs and radiotherapy as adjuvant immunotherapies.

A unique European coordination initiative

IPROVE was a first attempt to develop a holistic view on this important sector as no similar project with a European scope has ever been funded by the EU’s programme. Three main features contributed to the uniqueness of the IPROVE initiative.

(1) Taking a cross-cutting capabilities, capacities rather than a disease-based approach IPROVE focused on building critical stakeholder consensus on the priority gaps and challenges as well as recommendations for EU-level action on common topics of interest to bolster vaccine innovation across the entire innovation chain. The consortium considered that certain disease-based approaches have already been funded and explored to some extents with the support of existing and previously funded initiatives at national, EU, and international levels, including further to the publication of the recently updated WHO Report on Priority Medicines for Europe. Therefore, the project concentrated efforts on technologies and cross-cutting horizontal bottlenecks that must be overcome to allow the delivery of new generation vaccines in each of the key areas of unmet medical needs.

It is thought that this could help supporting a more targeted approach in the allocation of funding, by strategically investing in the most promising partnership models and forward-looking. Efforts should be directed towards projects and players with higher potential for delivering true innovation in order to clearly meet the health, demographic change, well-being and security challenges of today, in line with the goals of the EU multi-annual financial framework.

(2) Aligning and prioritising on future EU efforts
Much of what emerged from the IPROVE consultation process confirms and builds on research initiatives already happening across different countries in Europe. These however lack the intent for pan-European coordination and alignment across the different sets of stakeholders at EU level that should help their implementation.
Therefore, the added value of IPROVE is that it allowed different sets of stakeholders to share their ideas on what should be on top of the vaccine R&D agenda, align in this regard, and finally prioritise on the main focus areas for EU intervention, with potential for cross-fertilisation. Through this prioritisation, the aim is to help policy-makers and funders identify the most relevant technologies where investment is key in the short and medium term.

(3) Fostering better interaction between EU stakeholders
Europe currently benefits from the presence of a core set of more or less formalised national and regional vaccine ‘clusters’ in some EU Members States, such as France (Corevac, Lyon Biopôle), UK (UK Vaccines R&D Network), Belgium (Flanders vaccines), Italy, and the Netherlands. Building on this environment, IPROVE created the momentum and gave impetus to encourage increased interaction not only within but also across such clusters. This should help laying the foundation for favouring the establishment of an actual European working network across the disciplines and experts between public and private, but also public-to-public and private-to-private. IPROVE should be regarded as a first milestone in the above directions, and the successfulness of its ambition will depend on stakeholder ownership and responsibility to implement its recommendations, particularly at the EU political level. Furthermore, though agreement on the content of such recommendations exists, more coordination and investment will be in needed as to better understand what are the best models of collaboration and financing mechanisms to implement them.

Project Results:
The roadmap has highlighted that it remains a clear necessity to continue investing in the basic and fundamental science underpinning vaccine research. This research needs to be multidisciplinary and connected across microbiology, immunology, structural biology systems and bioinformatics. A more rational approach for antigen selection and vaccine design should be prioritised and recommendations are made on the need to support and accelerate research into novel adjuvants, the development of vaccine vectors, and prime-boost strategies, as well as, the investigation of novel routes of immunisation.

From a development perspective, goals include the simplification and a more evidence-based and less empirical approach to the design of clinical studies, better tools and approaches for data collection, extraction, analysis, and interpretation in order to support more efficient translation of innovation into practice. Furthermore, the roadmap calls for more attention to innovation of the manufacturing, regulatory and quality control cycle, to enable more affordable, faster, more flexible and less wasteful production. We critically point out the need for more funding and partnership across sectors to support the networks and multidisciplinary infrastructures that are essential to vaccines’ R&D innovation.

The consultation also reinforced the fact that vaccines are only as good as their vaccine implementation programmes, and that more must be done to understand and address vaccination hesitancy on the part of both the general public and healthcare professionals. Perhaps reassuringly, the IPROVE findings and recommendations are broadly consistent with those of similar initiatives in EU Member States or further afield. IPROVE highlights the potential added value of a more pan-European approach that has the political will, policy and financial environment which reinforces co-operation but also facilitates the development of physical European Research Clusters for vaccines that bring the science, entrepreneurs, investors and the most innovative vaccine producers together. Such a pan-European approach will require a political, policy and fiscal framework across public health, regulatory, and funding domains that recognises, incentivises and rewards the immense value of vaccination. In this regard, developing a long-term vision and commitment is paramount in respect to facilitating the establishment of effective partnerships across stakeholders at all levels.

It is beyond the scope of IPROVE to define the specific mechanisms and financial instruments that can build this pan-European vaccine ERA, however reflection is invited, and it is recommended that the EU fosters such thinking as a critical next step in order to sustain its leadership in this strategic sector.

The main priorities and specific recommendations have been clustered around each pillars:

Potential Impact:
The consortium believes the "strategic European roadmap for the vaccines of tomorrow: a joint stakeholder reflection" could have the following direct impacts :

• Improve the understanding of different stakeholder perspectives, needs and priorities, breaking down silos and fostering a cooperative, cross-functional and more effective translational approach to vaccines R&D. This include understanding of the needs and challenges faced by particularly relevant actors to this public health and economic sector, such as vaccine SMEs.

• Provide stakeholders operating across the policy, research, programming, and financing domains with a solid evidence base analysing Europe’s research and innovation resources, gaps and needs in innovative vaccines R&D which is currently lacking. This in turn will contribute to consolidate the European Research Area to create a genuine single market for vaccine innovation.

• Improve the efficacy and efficiency of research funding and investment in European vaccines and vaccinology to facilitate and increase the drive to develop innovative vaccines through novel cooperative approaches, risk sharing and venture capital attraction. This is in line with the driving rationale underpinning the Horizon 2020 strategy on the need to create a science environment encompassing a research to market product/innovation approach.

• Align the activities of the major stakeholders from public and private sectors, including industry (both SMEs and larger pharmaceutical companies) national bodies and academia, with the aim of promoting synergies between centres of excellence in different disciplines making up the meta-discipline of vaccines and minimise competition and unnecessary duplication.

• Contribute effectively to key debates around the need to improving healthcare systems sustainability and quality of life vis-a-vis emerging and changing healthcare needs and demographic landscape. In particular, the IPROVE pillars around the need to strengthen quality and extent of training in vaccines and vaccinology, and the importance of innovating and rationalising delivery and implementation of vaccination policies stress the key role played by immunisation programmes and prevention – where spending in the EU currently averages about 3% – at a time of crisis and tighter public budgets.

• Inform short to long term strategic decisions on the priorities for the new Horizon 2020 Framework Programme for Research and Innovation (2014 – 2020) that represents the main European instrument for strengthening science and tackling major societal challenges including health. However, research funding is not always the appropriate solution to boosting innovation as other non-funding measures might be needed. This is why IPROVE provides policy and decision makers, at both EU and national levels, with a comprehensive roadmap to create the best environment in terms of instruments, framework conditions, and management and technical capabilities. This in turn will ensure that Europe sustains its leadership in vaccines and that the vaccines R&D sector and the industry continues to address existing and emerging medical needs as well as contribute to Europe’s competitiveness. These advances will lead to contributions to the i-economy goals in the health sector and improved quality of life and health of European citizens.

List of Websites:
The IPROVE roadmap is available online either through a full electronic version or a downloadable PDF: