E.M.V.I. .
European Malaria Vaccine Initiative Strategic Plan
2006 - 2010
(EMVI)
European Malaria Vaccine Initiative Table of Contents
List of Abbreviations ..........................................................................................................................................1 Preface ....................................................................................................................................................................2 1 Background: The Malaria Burden .................................................................................................................4 2 History and Present Results ...........................................................................................................................6
1. Why EMVI was created: ....................................................................................................................6 2. EMVI results 1998 – 2005: ................................................................................................................7
3 Governance ..................................................................................................................................................... 10 4 Malaria Vaccine Development Pipeline.................................................................................................... 13 5 EMVI Scope of Operation.......................................................................................................................... 15 6 Activities 2006 - 2010 .................................................................................................................................... 18
1. Vaccine Development Activities ................................................................................................... 18 Vaccine candidate portfolio management ...................................................................................... 18 Assay development, challenge models and protocol harmonisation ........................................... 19 Optimisation of the Immune Response .......................................................................................... 19 2. Cooperation with other organisations .......................................................................................... 19 3. Fundraising .......................................................................................................................................... 20 4. Communication ................................................................................................................................... 20 5. Staffing and facilities ........................................................................................................................ 21 6. Risk Management ............................................................................................................................. 21
7 Budget 2007 – 2010 ....................................................................................................................................... 22
EMVI Strategic Plan 2006-2010
European Malaria Vaccine Initiative
List of Abbreviations
AMANET EDCTP EC EMVDA EMVI EU GDP GMP MVI NIH SAC USAID WHO African Malaria Network Trust (Tanzania) European and Developing Countries‟ Clinical Trials Partnership European Commission European Malaria Vaccine Development Association European Malaria Vaccine Initiative European Union Gross Domestic Product Good Manufacturing Practice Malaria Vaccine Initiative (USA) National Institutes of Health (USA) Scientific Advisory Committee United States Agency for International Development World Health Organization (Switzerland)
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Preface
Malaria remains a massive public health burden in many of the most resource constraint countries of the world. In the context of the Millennium Development Goals, the European Commission (EC) and several governmental development agencies have committed themselves to reducing the burden of poverty related diseases, including malaria. In the fight against malaria, vaccines are key assets, and therefore, accelerated development of safe and efficacious vaccines is a top priority. The vision of the European Malaria Vaccine Initiative (EMVI) is a world free of the intolerable disease burden of malaria within the coming decades. The mission of EMVI is to contribute to the global efforts to control malaria by:
creating the environment conducive to accel advancing
promising vaccine candidates from preclinical animal experiments to early proof-of-principle studies in humans – and contributing to the coordination of European vaccine research in synergy with on going global co-ordination efforts, 2) and in Developing Countries by building up capacity for malaria vaccine clinical trials through existing networks.
promoting affordability and accessibility of
malaria vaccines in Developing Countries;
aligning all major stakeholders and acting as
a focal point in order to ensure successful development of malaria vaccines for Developing Countries;
communicating to the stakeholders and the
erating the development and clinical assessment of malaria vaccines 1) in Europe by bridging the gap between academic research and clinical trials of malaria vaccines
general public the importance of the EMVI mission, goals, and progress towards the deployment of affordable and efficacious malaria vaccines.
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The specific objective of EMVI is to bridge the conceptual and operational gaps between the bench product - i.e. candidate molecules - and further validation, limited production and clinical testing, thus, making further industrial development and production feasible. EMVI should position itself as the European Malaria Vaccine Development Agency and be recognised as such by all stakeholders.
The Strategic Plan serves to determine EMVI’s position in the malaria vaccine development process and the activities envisioned for the period 2006 - 2010.
(Bonnie Gillepsie, Voices for a Malaria Free Future)
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1
Background: The Malaria Burden
Health: Malaria remains a leading cause of childhood mortality in sub-Saharan Africa with over two million deaths and 400 million cases annually. The most vulnerable groups are children under five years, pregnant women during their first pregnancy, and migrating populations including refugees and visitors. The situation is made considerably worse by the rapid spread of drug-resistant strains of malaria, and insecticide-resistant mosquitoes, which have partially rendered obsolete major methods for controlling malaria. Vaccines, particularly ones which could be delivered through the Expanded Programme on Immunisation, offer the key method of controlling this devastating disease. Education: Because of its severe impact on the health of African children, malaria is also a great impediment to Africa‟s ability to acquire essential knowledge. Despite improvements in the education system in Developing Countries, absence from school, due to malaria remains a significant factor in children‟s acquisition of the knowledge required to contribute to their own and their country‟s development. Development: Malaria is the cause and consequence of poverty in Africa. The African Summit on Roll Back Malaria, Abuja, Nigeria, April 25, 2000, declared that control of malaria would significantly increase Africa‟s economic productivity and income of African families. According to the World Health Organization, Harvard University and the London School of Hygiene and Tropical Medicine, Africa‟s GDP would have been up to $100 billion greater (equivalent to 32%) in 2000 if malaria had been eliminated 35 years ago. This far exceeds current levels of international aid to Africa. Investing in the control of malaria was also rated as a „very good project‟ in terms of socio-economic return by the experts at the Copenhagen Consensus in 2004.
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Affordable essential drugs & vaccines: Target 6 of the Millennium Development Goal 8 (Developing a Global Partnership for Development), “In cooperation with pharmaceutical companies, provide access to affordable essential drugs and vaccines in Developing Countries”. The cost of pharmaceutical products is of particular concern in resource constrained countries, as they are beyond the financial reach of the most vulnerable population segments. State provision is normally selective and very resource-constrained.
Research on, and development of, appropriate drugs and vaccines is a concern in Developing Countries and a challenge for us all. Regardless of the intellectual property regime prevailing in resource constrained countries, there are no commercial incentives for pharmaceutical companies to undertake research on drugs and vaccines that are of specific relevance for populations with very limited purchasing power, see Figure 1.
We in the affluent part of the world have an ethical and moral obligation to safeguard the lives and well being of the most vulnerable group in Africa, the children.
€+
Profit
€+
Profitable vaccines
Profit
Pre-clinical Investment
Clinical
Licensure
Time
Investment
Preclinical
Clinical
Licensure
Time
€-
Malaria vaccines
€Figure 1a: Model of Net Cash Flow over Product Lifetime
Public funding
Figure 1b: Model of no profit-no cost over Product Lifetime
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2 2
History and Present Results
1. Why EMVI was created: In the mid-1990s, the European Commission‟s INCO DC/Health Programme realised that, in spite of decades of national and EC funding of malaria vaccine research, the prospects for the successful clinical development of a European malaria vaccine candidate were bleak. The Commission‟s services (INCO-DC programme) invited international concerted action projects, which, by broad consultation, could identify shortcomings in process development and propose the necessary initiatives to address these. Two concerted actions were approved, AMVTN (now AMANET) and VINCOMAL, comprising twelve malaria vaccine research institutions/groups in Europe and an additional four from Africa, Asia and South America. VINCOMAL produced a report on the problems and bottlenecks in moving bench results into pharmaceutical and clinical development, accompanied by a proposal to address these problems. This led to a proposal from the INCO-DC programme to establish EMVI. The mission of EMVI was defined as contributing to the global efforts to control malaria by providing a mechanism for accelerating development and clinical assessment of malaria vaccines in Europe and developing countries thereby promoting affordability and accessibility of malaria vaccines in developing countries. European and international resources committed to malaria vaccine research were engaged. EMVI was established to bridge conceptual and operational gaps between the bench product i.e. candidate molecules - and further validation, limited production and clinical testing, thus, making further industrial development and production feasible. The proposal was approved by the EU Member States in September 1997 and EMVI officially commenced operations in March 1998. The establishment of EMVI is, thus, directly part of the European Community‟s effort to combat poverty via the improvement of the health of populations in resource-constrained countries. EMVI is directly contributing to the Millennium Development Goals.
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2. EMVI results 1998 – 2005: At the request of the EMVI Board in 2005, an external review was carried out, to evaluate the performance of EMVI and to determine the extent to which it is meeting its objectives. The main conclusion of the review is that “EMVI is on track in achieving its mission”. Operational (technical) tools needed for clinical trial management (full set of SOPs, processes for various types of audits) have been put in place, and are of excellent quality. EMVI has successfully moved three malaria vaccine candidates from the bench through process development, Quality Control, limited GMP production and, pre-clinical toxicology to completion of clinical Phase I trials in Europe. One of the vaccines, MSP3, has completed clinical Phase Ib trials in Burkina Faso in collaboration with AMANET.
Randomisation process in Balonguen, 50 km south of Ouagadougou, Burkina Faso
Given the limited financial and human resources and the absence of a product portfolio at the start of EMVI, the current portfolio of nine vaccine candidates in the development pipeline, including three vaccines currently in clinical development, and a further three vaccines due to enter clinical trials in 2006, represents an outstanding achievement. Without the existence of EMVI, it is inconceivable that a portfolio of such size and quality could have been developed in Europe. The projects currently in the EMVI portfolio have been primarily selected on the basis of an open call procedure. There is now a need to review the portfolio in relation to other global initiatives, and also to identify potential gaps that could merit EMVI support.
Women waiting patiently at a small clinic in Kenya (Bonnie Gillepsie, Voices for a Malaria Free Future)
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Phase III trials were omitted from the scope of EMVI‟s operations, due to the initial amount of funding provided being insufficient for full clinical development. The European Commission has meanwhile actively supported the creation of EDCTP, which has been given the mandate for funding late stage clinical trials. Since EMVI‟s inception, the landscape of organisations involved in malaria vaccine development has undergone radical change. AMANET has grown to become a well established, well respected, pan-African organisation with the capacity and capability in institutional and human resource development. It now has the legal structure (Trust) enabling sponsorship of clinical trials. In parallel, EDCTP has been created to act, among other things, as a funding agency for late stage clinical development. With these three ini iatives fully operational, it is now possible together to design full regulatory and clinical strategies for malaria vaccine development. EMVI has successfully supported AMANET in capacity building and training at African sites. Thus, EMVI has the pivotal role in being able to pull new vaccine candidates in the pipeline into the portfolio from ongoing European projects such as BioMalPar and a new Integrated Project EMVDA. At the same time EMVI also pushes more mature projects developed within EMVI itself into later stage developments using AMANET and EDCTP. The findings and recommendations of the review have subsequently also served as an input for the present Strategic Plan 2006 - 2010
“In the fight against malaria, vaccines are one of the key assets and, therefore, accelerated development of safe and efficacious vaccines is a high priority. The mission and general objective of EMVI, that is bridging the gap between bench research and limited production/clinical development, are still valid. Within Europe, EMVI is the only organisation that is active in this relevant niche.” EMVI review 2005
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Weapon of Mass Destruction
(Photographer Hugh Sturrock)
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Governance
SSI Hosting
Board
Decides
Scientific Advisory Committee (SAC)
Recommends & Advises
Secretariat
Proposes & Executes
Figure: 2: Organisation Chart of EMVI
EMVI is governed by a Board and an Executive Secretariat. The Statens Serum Institut is the contracting Institution and is hosting the EMVI secretariat. EMVI‟s advisory body is the Scientific Advisory Committee (SAC).
EMVI Board is the decision body and is composed of: the representative of the Contracting Institution one representative from each of the European countries and agencies/entities that contribute or pledge financial support to EMVI a representative from the malaria vaccine research community in a malaria endemic area
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representative(s) from industry representatives(s) from the European Com-
mission and the SAC Chairperson (non-voting member) The Board elects a Chairperson and Vice Chairperson. The Board is responsible for: appointing the Scientific Advisory Committee (SAC) from among prominent members of the scientific community setting and adjusting goals developing scientific policies and strategies based on advice from SAC evaluating progress in relation to objectives and goals approving and when possible allocating available funding for research and development in accordance with recommendations made by SAC approving the annual work plan of the Secretariat securing funds from EU Member States and other interested parties. European Malaria Vaccine Initiative (EMVI) is a programme registered at Statens Serum Institut, Copenhagen, Denmark, who appoints a representative to the Board. Contracts signed between EMVI and manufacturers, clinical trial centres or research institutions contain an article stating that arbitration and disputes are governed by the law of Denmark. Contracts are only legally binding with the signature of the Administrator, or her/his mandated
proxy. The Contracting Institution, Statens Serum Institut is responsible for: the management of funds, the establishment of a secretariat for the implementation of Board‟s decisions, financial and technical reports the provision to the Board of reports on the disbursement of financial contributions from Member States and other contributors. day to day supervision of the secretariat. The independent Scientific Advisory Committee (SAC) makes recommendations to the Board on scientific direction and technologies as well as on the choice of applications for funding. A major feature of EMVI is its ability to react quickly and flexibly to new technological innovations and scientific breakthroughs in vaccine development, while remaining focused on the key objective of developing and testing malaria vaccine for use in developing countries. The Board appoints seven scientists to serve as members of the Scientific Advisory Committee for a period of three years. Re-appointment for an additional three-year period is permitted. The following areas of expertise are represented in this group: basic research and immunology, vaccine research and development, process development and clinical trials, field trials of vaccines and/or drugs in malaria endemic areas.
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SAC elects a Chairperson from their midst, who is a non-voting member of the Board. SAC can co-opt additional experts for a period of up to one year at a time, with the approval of the Board, relevant to the nature of submitted proposals or on-going projects. Additional external experts, preferably from DC and industry, can be called on for specialist advice and evaluation of proposals. SAC is responsible for: advising the EMVI Board on all matters of a scientific and technical nature in relation to malaria vaccine development and clinical trials developing EMVI‟s scientific strategies and policies for Board approval recommending new initiatives or re-direction of EMVI initiatives to the Board designing the texts for EMVI Calls for Letters of Interest and/Proposals evaluating Letters of Interest and Project Proposals and submitting recommendations in a written consensus report for prioritised projects to the Board via the secretariat. Each Letter of Interest/Proposal must be evaluated by at least five SAC members, or co-opted SAC members.
on request, providing scientific and technical
advice to the secretariat to assist in its executive function evaluating the progress of on-going EMVI funded research/development. The Secretariat is staffed by experts of proven experience in the fields of malaria research, vaccine development and clinical trials and regulatory affairs. The Secretariat reports to the Contracting Institution, Statens Serum Institut, which is responsible for employment contracts and administrative supervision. The Secretariat has five main functions: management of vaccine development mangement of European clinical phase I and II trials international collaboration with major players information policy financial planning
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4
Malaria Vaccine Development Pipeline
Successful malaria vaccine development requires a series of co-ordinated steps from basic research and identification of lead vaccine candidates, GMP manufacture of these lead candidates, and their evaluation for safety and immunogenicity, Phase I, and when appropriate Phase II in Europe, before they can be clinically tested in Africa for safety, immunogenicity and efficacy (Phase I, II and III). Before registration, national and EU Regulatory Authorities require vaccines to be tested in large multicentre trials of individuals. These activities together form the vaccine development pipeline as drafted in Figure 4. EMVI is not a research undertaking organisation in the traditional sense, and thus is not involved in upstream basic research, focused at antigen discovery. This activity is supported by European Union Member States and/or international (EU) research programmes. EMVI has demonstrated success in creating the infrastructure and processes enabling initial clinical assessment of new malaria vaccine candidates. Sustainability of EMVI In order to sustain the momentum generated by EMVI and reach the next stage of malaria vaccine development, this success must now be leveraged to transform EMVI into a vaccine development agency driven by EMVI, in which all stakeholders commit to a common goal, i.e. to bring malaria vaccines to the ultimate customers. This grouping will comprise all stakeholders with an interest in malaria vaccine development, and clinical trial networks i.e. the malaria scientific community in Europe; the European clinical research infrastructure network (ECRIN) the European vaccine manufacturers; donors, funders (Member States, European Commission, philanthropists etc.); existing malaria networks such as AMANET and EDCTP. Each stakeholder can leverage the value of both what EMVI has already built up and their owncontribution by committing to this collective long term strategy. Each stakeholder must be represented on the EMVI Board.
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Clinical Networks (ECRIN, EDCTP, AMANET…)
Industry & SMEs
What now needs to be done to plan for success?
build on existing strengths already developed
Malaria Vaccine Scientific Community
EMVI
International Organisations (WHO…)
USA Stakeholders (MVI,NIH, USAID..)
Donors Funders
Figure: 3: Diagrammatic Representation of the Malaria Vaccine Development Strategy: Product Devlopment Partnership (PDP)
This agency will be the European driving force for malaria vaccine development, and will be open and accessible to those interested parties, who are capable of contributing key elements to the strategy, and allowing themselves to leverage the value of the whole grouping.
by the stakeholders; integrate industry‟s structured involvement at an early stage in the process; maintain focus on major deliverables; prevent fragmentation of the growing number of malaria vaccine activities; facilitate co-ordination of European malaria vaccine research, thereby enhancing Europe‟s interaction with other international initiatives; provide donors with a clearly identifiable unified entity, engaged in malaria vaccine development; minimize risk for individual stakeholders; create and implement a financial plan involving fundraising from member state countries not yet contributing, philanthropic organisations and the private sector.
Pharmaceutical development / vaccine production
Pre-Clin
GMP Clinical batches Industrial Scale-up
EUROPE Phase Ia
EUROPE Phase IIa AFRICA Phase III
AFRICA Phase Ib AFRICA Phase IIb
Clinical development
Figure 4: MalariaVaccine Development Pipeline
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EMVI Scope of Operation
EMVI‟s scope of operation in the development pipeline is in the niche between promising malaria vaccine candidates developed via basic science and limited industrial production allowing subsequent clinical trials. The activities of EMVI are either performed by EMVI‟s staff directly or contracted out under EMVI‟s supervision and responsibility. EMVI supports financially and technically all activities and actively pursues:
antigen selection, assay standardisation and
these vaccines in a limited number of clinical trial centres in Europe,
defragmentation of European malaria vac-
validation, development of challenge models and development of clinical trial protocols;
the manufacture of promising candidate ma-
cine research by facilitating the coordination of European malaria vaccine research in synergy with on-going global efforts, providing a neutral platform for the development of decision-making criteria, assays standardisation and reference materials, development of partnership with industry and/or public institutions to support the pharmaceutical scale-up and production of clinical batches for full clinical development,
communication, advocacy and raising funds.
laria vaccines in accordance with international quality requirements (GMP);
the clinical plan and regulatory plan for in-
As shown below, Phase Ib, and IIb are currently the prime responsibility of African networks such as AMANET. The funding of Phase 3 clinical trials of candidate vaccines, and required capacity building in Africa, are the prime responsibility of African Networks such as AMANET, using funds from EDCTP or from other donors. EMVI retains the responsibility for product, clinical development plan and regulatory development plans (as submitted to regulatory authorities). EMVI will
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suring coherent and consistent development based on strong rationale and harmonisation of the evaluation criteria used for safety, immunogenicity,
the performance of early phase clinical de-
velopment by sponsoring Phase I and when relevant, validated Phase IIa clinical trials of
European Malaria Vaccine Initiative
also partner with industry in order to ensure the continuity of both pharmaceutical and clinical development. EMVI will be the body that will actively cooperate with like minded organisations such as WHO, MVI, NIH, USAID and Wellcome Trust. Potential areas for collaboration will be determined by EMVI and could include: assay harmonisation, sharing reagents and writing common protocols, external monitoring of clinical trials, harmonisation of methods and information exchange, trial site preparation, common audits
Prerequisites necessary for EMVI to fulfil its mission
1. Technical competence available either through EMVI staff or through competent outsourcing. 2. Neutrality with a broad European mandate and a balanced product portfolio, commitment to providing a public service for malaria vaccine development in Europe. 3. Transparency in selection of supported projects either through calls for proposals or through openly brokered projects upon regular EMVI‟s Board decision. 4. Governance procedures based on clear responsibilities of independent organisational organs.
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Figure: 5: Diagrammatic Representation of the Malaria Vaccine Development Strategy : Product Development Partnership (PDP)
Investment
EMVI sponsored activities
Pre-clinical studies EMVI GMP clinical batches Pre-Clin Regulatory strategy Clinical development plans Early clinical development EMVI GMP Clinical batches
EMVI Phase Ia
Industrial Scale-up
EMVI Phase IIa
Sponsor clinical trials
Trial sites in Africa Human resources/equipment Strengthen capacity for trials
Sponsor clinical trials
AFRICA Phase IIb
AFRICA Phase IIb
AFRICA Phase III
African Networks sponsored activities
FUNDINGS / DONORS
European Member States, European Commission, EDCTP, Charitable Organisations
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Activities 2006 - 2010
It is proposed that EMVI‟s activities 2006 2010 cover the following. A more detailed specification of activities will be made in the annual EMVI Work Plan: 1. Vaccine Development Activities Vaccine candidate portfolio management Vaccine development is a long and risky process, with attrition of candidate vaccine expected at every stage along the research-developmentaccess (R–D–A) continuum. Portfolio management has three key components: Diversification to reduce the reliance on a small number of candidates with similar characteristics, and to ensure the smooth flow of products through the pipeline (i.e. enough products at different stages of development). Rigorous processes to ensure candidates that do not meet specifications are weeded out. Since most product candidates will fail somewhere along the development pipeline, management of multiple candidates helps to insulate funders from the risks inherent in health product development. The success of portfolio management is also highly dependant on the quality of the leads fed into the pipeline, reinforcing the importance of effective translation from research to development. The availability of the right human resources and skills to ensure the process is run effectively is just as important for a public development agency as it is for the private sector. Ensure adequate balance between projects and resources. EMVI should be prevented from falling below the number of products that would statistically be required to ensure „success‟. However, it is not clear what threshold for minimum scale or optimal functioning is required for portfoliomanagement to be most effective. a) An in depth review of the current portfolio by the SAC, possibly complemented by additional expertise as needed. The Secretariat will propose Terms of Reference for this review to the SAC. The output of this review should be recommendations to the Board of (i) which vaccines should be developed further (ii) which new candidates should be brought in and (iii) which projects should be terminated.
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b) Development of a full range of clinical development and regulatory strategies for each candidate product, in order to address all relevant questions most efficiently. This will be conducted within the EMVI Development Agency in close co-ordination with industry, and clinical trial networks in particular. c) Development of performance metrics to measure the achievements for both internal and external (contracts) work. d) Scanning for new malaria vaccine candidates by SAC using open calls with development of criteria for inclusion or exclusion for new candidates. The SAC will recommend to the Board potential new candidates and develop the criteria that determine vaccines‟ progress in the development cycle. Assay development, challenge models and protocol harmonisation EMVI will develop, in consultation with international partners, biochemical, immunological and functional assays to measure the immune responses to candidate vaccines in animals and humans. These assays will form the background for clinical development of selected candidates, and should be validated and available to all groups within the EU landscape. EMVI will support the development of validated challenge models, which can facilitate the selection of the best candidate vaccines for clinical development.
Harmonised clinical protocols, based on existing EMVI protocols will be developed. This will allow comparison of trial results. Optimisation of the Immune Response EMVI will establish an adjuvant platform for malaria vaccine in consultation with public organisations such as i) “The Global Adjuvant Development Initiative” (GADI) which aims at acquiring access to immune modulators such as the CpG motif and MPL, which can be used to supplement the traditional Aluminium Hydroxide adjuvant, and ii) commercial companies such as Protherics (CoVaccine), Seppic (Montanide), GSK (ASO1b/e), Pevion (Virosomes) and others. As this is a dynamic field with new information constantly becoming available, other platforms and formulations may be added to the platform portfolio after comparative testing against the initially agreed platforms/formulations with agreed standard antigens. In consultation with SAC, a limited number of adjuvants or delivery system will be selected for use in pre-clinical and subsequently clinical phase 1a studies in combination with antigens from the EMVI vaccine candidate portfolio. 2. Cooperation organisations with other
EMVI will pro-actively collaborate with other organisations, in particular WHO, MVI, NIH, USAID and Wellcome Trust, and in close consultation with these organisations will explore in more detail the following potential areas for
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collaboration: assay harmonisation, sharing of reagents and harmonisation of protocols, external monitoring of the trials, harmonisation of methods and information exchange, trial site preparation, common audits. EMVI will be given the task of ensuring that synergies are developed with these organisations avoiding unnecessary duplication of efforts. EMVI is an active member of the malaria vaccine funders group which includes WHO, NIAID, USAID, Welcome Trust, Bill and Melinda Gates Foundation, MVI, European Commission and EDCTP. This group, which was created in 2001, has developed a global portfolio review and the malaria vaccine technology roadmap. The rules of engagement with other International Organisations are mainly defined by Memoranda of Understanding (MVI, USAID) or Memorandum of Intent (WHO). In general terms, collaboration can take place on four levels: 1. Separate programming and resourcing, post facto reporting with emphasis on exchange of information. 2. Separate programming and resourcing, early coordination of effort and enhanced collaboration on: seminars/workshops, mutual representation, exchange and discussion of pre-clinical and clinical trial results, design of clinical trials, especially in malaria endemic areas and connected training. 3. Joint programming, separate resourcing with enhanced co-ordination of: strategic planning, work planning, reviews. 4. Joint programming, pooled resourcing with enhanced co-ordination of funding. Any established collaboration should not only raise the visibility and awareness of EMVI, but also be seen as a way to optimise portfolio management, to increase efficiency and thus the chance of success. 3. Fundraising All donors are currently reassessing their future funding modalities with regard to malariarelated initiatives. Donors are increasingly demanding transparency with respect to deliverables, budgeting, spending and good governance. The EMVI driven grouping through product development partnerships should be seen by the donors as the preferred vehicle via which their EMVI funds will have a multiplier effect. EMVI will organise a donor meeting, to present and discuss its strategy and related activities to current as well as potential new donors. Funding sources from the European vaccine industry and philanthropic organisations will be proactively sought. 4. Communication EMVI will improve communication with all stakeholders, especially the Donors, including (formal) work progress reporting, background
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information related to decisions taken and disbursement of funds. In addition to the Annual Report, the EMVI web site is being redesigned to be more informative for both existing and future Donors, scientists, public health authorities and the public in general, interested in malaria vaccines. For both purposes a communication and visibility strategy has been developed. 5. Staffing and facilities Secretariat: Given the ambition and scope of the proposed restructured EMVI, an appropriately staffed secretariat is a prerequisite. This implies that the Secretariat will comprise the following positions: 1 Executive Director; 1 Director of Clinical and Regulatory Affairs, 2 Project Managers, 1 Product Development Manager, 1 Director of Business Development, Fundraising and Communication Officer; 2 Personal Assistants. Given the size and qualifications of the Secretariat staff, the EMVI portfolio can consist of a maximum of 10-15 candidate vaccines, taking into account the increasing claim on staff capacity as products move further along the development pipeline. The core Secretariat will be domiciled in one location, at Statens Serum Institut, Copenhagen Denmark. Contracting Institution: The location of the EMVI secretariat is Statens Serum Institut, Copenhagen, Denmark. 6. Risk Management The main risks that could prevent EMVI from achieving its goals are: (i) Lack of continuity in EDCTP and AMANET would impede the ability of EMVI to develop vaccines beyond Phase I, early Phase II trials. Contingency plans will be drawn up to investigate the use of other clinical trial networks and to find alternate funds (e.g. from industry and other potential funders) to continue EMVI‟s work.
(ii) Lack of member state long term funding. An aggressive communication plan must be developed to demonstrate the enormous achievements already obtained by EMVI, in order to justify continued and increased funding via this route. (iii)Lack of industrial involvement in the long term. Industry needs to be lobbied in order to increase their commitment to Malaria Vaccine Development and the long term funding involved. (iv) Lack of the right human resources and skills to ensure the process is
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run effectively is just as important for EMVI as it is for the private sector. The challenge for EMVI being legally hosted by a Danish governmental institution will be to find the right balance between competencies and the state salary scale. EMVI needs to be in a position to be attractive
7
Budget 2007 – 2010
The estimated EMVI budget for 2007 - 2010 is €19 million. This amount is based on an EMVI Secretariat estimate derived from past experience with the current project portfolio, and an assumption that only two new candidate vaccines will enter pharmaceutical and clinical development over the coming five years. It is further assumed that AMANET will fund Phase Ib, including Ib age de-escalating and initial limited Phase IIb, and that clinical development beyond Phase I-IIb, will be funded by EDCTP.
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Contracting Institution: Statens Serum Institut Artillerivej 5 DK-2300 Copenhagen S Secretariat: Odile Leroy Executive Director Bldg.: 202/323 Telephone: +45 3268 3798/…8288 Fax: +45 3268 3144 E-mail:oly@ssi.dk Web site: www.emvi.org