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CISM- Strategic Plan 2014-2018 FINAL VERSION


TABLE OF CONTENTS Introduction ..................................................................................................................................................... 3 Methodology .................................................................................................................................................... 4 Strategic analysis ............................................................................................................................................... 4 Mission, Vision and Values .................................................................................................................................... 8 Strategy: Rational, goals & objectives ...................................................................................................................... 8 Research program............................................................................................................................................ 11 Organizational structure .................................................................................................................................... 18 Measuring success: monitoring &evaluation ............................................................................................................ 19 Action Plan .................................................................................................................................................... 20 Budget .......................................................................................................................................................... 23 APPENDIX A: EVALUATION OF ACTION PLAN 2010-13 ....................................................................................... 25

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INTRODUCTION The Manhiça Health Research Center (Centro de Investigação em Saúde de Manhiça, CISM) was created in 1996 as a collaborative program between the Ministry of Health in Mozambique (MoH), the National Health Institute (Instituto Nacional de Saúde, INS), the Spanish Agency for International Development Cooperation (Agencia Española de Cooperacional Internacional al Desarrollo, AECID) and the Fundació Clínic per a la Recerca Biomèdica (FCRB) (Hospital Clínic - Universitat de Barcelona) under the bilateral agreements between the Republic of Mozambique and the Kingdom of Spain (Comision Mixta 1994). In order to ensure its long term sustainability, CISM has been run since 2008 by a Mozambican legal entity, Fundação Manhiça (FM), a non-profit institution, created by the Mozambican and Spanish Governments, the Mozambican National Health Institute (INS) and the FCRB. The Universidade Eduardo Mondlane (UEM) and the Fundação para o Desenvolvimento da Comunidade (FDC) joined the Board of Trustees later on. The history of CISM, its achievements and the drive to continue developing and growing its activities are based on the understanding that health, and health research in particular, is a key driver to promote social and economic development of a country and a region. It is through the generation of knowledge and its application that the goal of improving efficacy and equity of health policies can be accomplished. This argument is widely supported internationally and Global Health research has become more relevant in the political agenda. The center leads the contribution of scientific evidence for priority infectious diseases in Mozambique and generally in Sub-Saharan Africa for control measures and the development of new products, whether drugs or vaccines for communicable diseases, in the clinical trial phase. At a national level there is also an increasing interest in health research activities, and CISM, given its strategic links to Mozambican health, research and academic institutions, aims to consolidate itself as a key player in this process. A special mention needs to be made of the role that CISM is playing and will play in the design of strategies and innovative approaches for eventual malaria elimination in Mozambique. Malaria has traditionally been the backbone of the scientific activity at the center and this collaboration with the National Malaria Control Program, the Ministry of Health and others is a great opportunity to strengthen CISM’s leadership position in this area. At the same time, the collaboration with international institutions needs to be at the forefront of CISM’s priorities as a means to maintain scientific excellence. The participation in global networks and regional collaborations with countries that share similar challenges in health are opportunities that need to be pursued in the coming years. On the financial side, the big challenge for the coming period is to continue guaranteeing the core funding. While signing multiannual agreements with the long term partner AECID is a priority, the diversification of the core budget acquires special relevance in this period. CISM needs to explore and exploit all alternative sources of funds aligned with the organization’s values. This goes from cofunding of the core budget with the participation of the center in the national health budget or the inclusion of new public and private international donors, to conducting new activities with resource-generating potential such as consulting projects. All this, together with the strengthening of the capacity to attract research competitive funds, will lead to a more sustainable organization in the current international financial context. In order for all the above-mentioned to be possible, a motivated team is mandatory. Developing the best talent and retaining it continues to be a mayor challenge that CISM needs to address. Having in place a clear professional development plan for the staff at very different levels is key to accomplishing this. The efforts made in the previous period, such as establishing the Manhiça Senior Research Fellowship (MSRF), have been effective and need to be increased. This document is the result of a strategic exercise by the management team at CISM with all the above factors in mind. It is the second time that such an exercise has been carried out and this plan benefits greatly from the structure and rationale of the previous version (2010-2013). The document is structured as follows: the first section briefly presents the methodology used to design the Strategic Plan; the second section shows the results of the strategic analysis on the situation of the center and its environment; the third section presents the vision, mission and values of the CISM; the fourth section describes the strategy of the center; the fifth section focuses on the description of the center’s research program; the sixth section shows the new organizational structure of the center; the seventh section presents the monitoring and evaluation plan; the eighth section describes the action plan and the ninth section presents the

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budget of the Strategic Plan. Finally, in Appendix A, the main goals and corresponding objectives identified in the previous strategic exercise are listed and progress to date is evaluated.

METHODOLOGY This Strategic Plan is the result of a joint effort between the CISM and a group of external collaborators who assisted with the methodology and the final editing of the document. Several interviews with different stakeholders were made in order to complement the analysis. The methodology used to develop the organization’s goals and objectives started with revisiting the center’s Mission and Vision, as well as its guiding values that were defined in the previous Strategic Plan for the 2010-2013 period. Next, the SWOT analysis tool was updated in order to best represent the current internal (Strengths and Weaknesses) and external (Threats and Opportunities) factors relevant to the definition of CISM’s strategy in the 2014-2018 period. With this analysis in mind, the main strategic principles can be outlined and a clear set of goals can be defined. During all this process, the previous Strategic Plan was a key reference document since some of its conclusions are still relevant today. Its structure has also been respected as much as possible, in order to facilitate comparison.

FIGURE 1. DIAGRAM REPRESENTING THE STEPS FOLLOWED TO DEVELOP THE ORGANIZATION’S STRATEGIC GOALS AND OBJECTIVES

STRATEGIC ANALYSIS This section briefly describes some key outputs from the strategic analysis. In particular, results from the SWOT analysis are shown as a summary of key (internal) strengths and weaknesses as well as (external) threats and opportunities. Two tables summarize the main results of this strategic analysis.

CISM TODAY (INTERNAL ANALYSIS) CISM is nowadays an established research center with significant expertise and capacity in some research areas like malaria and most prevalent infectious diseases. The center’s location in an endemic area of the most important causes of death in Mozambique and access to a referral hospital and other health facilities integrated in the national health system are among its major strengths. CISM is managed by Fundação Manhiça (FM), an entity of private law and public utility, non-profit, incorporated under Mozambican law in 2008 by the Spanish and Mozambican governments, the National Institute of Health of Mozambique (INS), the Fundació Clínic per la Recerca Biomedica (Hospital Clínic - Universitat de Barcelona) and Dr. M. Pascoal Mocumbi as honorary founding member. The Universidade Eduardo Mondlane and the Fundação para o Desenvolvimento da Comunidade joined the institution later on. FM has consolidated its boards of governance with the Board of Trustees meeting twice a year and the Board of Governors three times a year. Such boards are advised by the External Scientific Advisory Board (ESAB) whose consolidation and support is a key factor to boost the international competitiveness of the center. Since its creation in 2009 the ESAB has conducted two sessions. During the last session in 2012, the board monitored the work of the researchers, the progress of the strategic plan, and issued a recommendations report aimed at the application of scientific production and talent retention.

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Furthermore, CISM has established solid research platforms, namely the Demographic Surveillance System (DSS) and the Morbidity Surveillance System that are essential to conduct research on the major diseases affecting Mozambique as well as other African countries. The DSS currently covers a population of over 92,000 and an area over 500 km2 and its extension to the entire Manhiça district is planned. The Morbidity Surveillance System covers all health facilities in the study area, which have an activity of over 90,000 outpatient visits per year. CISM has a strong relationship with the Manhiça District Hospital and health centers and posts in its study area. As of 2014, the center had almost 60 health professionals working in health facilities of the study area. This has led to a significant improvement in health coverage for the local population. Although being in a rural area poses difficulties in the upkeep of modern technology, during the last few years the CISM has experienced a great technological leap forward. In terms of laboratory structure, CISM has attained a fully equipped laboratory including immunology and molecular biology areas and a bio-safety level III tuberculosis laboratory in 2010, the same year that a new laboratory sample management system, namely Servolab, was implemented. Furthermore, the laboratory obtained the ISO 9001:2008 certification in late 2009 and has maintained it annually. Between 2010 and 2011 the center fully renovated the electrical system improving the safety and reliability of its supply. In February 2012, the electronic data collection of the Demographic Surveillance System through personal digital assistant mobile devices (PDAs) was implemented and some new projects started to use smartphones that boost the capacity and quality control of data capture.

INTERNAL ANALYSIS Strengths  Well located and integrated in the National Health system  Consolidated FM boards of governance and its councils  Well established research platforms  Current infrastructure (laboratory, electronic data collection and electrical system)  Longstanding training program and consolidated Manhiça Senior Research post-doctoral fellowship  Expertise and multidisciplinary experience  Agreements signed with key academic and research institutions  Good relationship with the community  Good international projection (scientific recognition and participation in global networks)  Commitment of the Spanish government (AECID) Weaknesses  Difficulty to attract and retain talent  Weak partnerships with national institutions  Weak internal management (scientific, communication, procedures, participative management)  Weak administrative and financial management tools and procedures  Lack of structure dedicated to public relations, advocacy and fundraising  Limited capacity of monitoring and evaluation and operational research in health systems  Core funding mainly provided by one donor

The center established a Training Fellowship Program early after its creation with the objective of contributing to the training of Mozambican researchers. This program has been a significant success and as of the end of 2013, the center has contributed to the successful completion of 14 Ph.D. programs and Master’s programs by Mozambican scientists. Moreover, the center has developed two pioneering initiatives in the country for both retention and attraction of national research talent, schemes inspired by international research centers and European and American universities. The Manhiça Senior Research Fellowship (MSRF) established in 2010 has successfully provided an opportunity to Mozambican researchers to build a research career in Mozambique. This post-doctoral fellowship is one of the few of this type in Africa and is based on research excellence, regular external evaluation and competitive salaries. Regular independent expert-review of fellows’ performances is key to achieving scientific excellence, while competitive salaries are necessary to avoid brain drain of highly qualified researchers. Researchers are awarded this fellowship for five years and have a mid-term and final evaluation by an independent panel of experts. The fellowship has been awarded to a total of 6 post-doctoral researchers. Additionally, based on the MSRF, in February 2013 the center created a new professional category (associate senior researcher) for researchers affiliated to any of the institutions of the Board of Trustees, and who can devote only part of their time to research projects carried out in the center. This responded to the urgent need to create further conditions to retain senior health researchers. Nowadays the dedication of researchers mainly to research activities continues to be a challenge for the center and for the partner institutions.

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Research activity has been steadily increasing in the last few years. Malaria has been the strongest area of research, but other areas like HIV-AIDS, tuberculosis, respiratory infections and invasive bacterial diseases and diarrheal diseases have evolved, resulting in a broad portfolio of research projects. The center is currently part of the major research networks in the continent in the area of malaria, and the number of collaborations in other research areas is also growing. The center has a long-standing partnership with the FCRB and its associated research and academic institutions the Hospital Clínic de Barcelona (HCB), the Universitat de Barcelona (with the UB School of Medicine campus), the Centre de Recerca en Salud Internacional de Barcelona (CRESIB) and the Barcelona Institute for Global Health (ISGLOBAL). These partnerships have been key for the development of the center and it is an asset for the future. The partnership with the UB has been critical for the postgraduate training of researchers, who have received their Ph.D. degree from this university. At a national level, the center has agreements with academic institutions like Universidade Eduardo Mondlane and the Facultade de Medicina and Facultade de Veterinaria, as well as the Ministerio de Ciencia e Tecnologia and the Ariel Foundation. CISM has active partnerships with the Instituto Nacional de Saúde and the Universidade Católica de Mozambique. Nevertheless it should intensify the institutional and operational links with national and international institutions that could help strengthen their relations and improve CISM profile in Mozambique and abroad. At the local level, the center maintains a good relationship with the community and relevant issues are managed through the community consultative committee. In terms of general management, the center aims to improve the internal communication (information sharing processes), participative management and general procedures. Management of scientific activities is weak and the center lacks proper tools to follow-up and to evaluate its research activities and results. Although the center has a notable volume of projects and a good rate of publications, the scientific productivity compared to the data generated at the center is still quite low, so there is room for improvement. This situation is a result of many factors, like the limited number of trained researchers or a proper system to monitor and assess research productivity. The recently created position of Deputy Scientific Director should help to address this issue. As for administrative management, during 2013 the administration has incorporated skilled staff responsible for the finance, human resources and project management areas. A human resource tool is fully operational while accounting software has been recently implemented and should be linked to a project management module in order to generate regular budget execution reports to internal and external clients. In terms of human resources management, the implementation of an employees’ evaluation scheme to measure objectives-oriented performance is highly desirable. The center has clearly identified the need to establish local structure dedicated to public relations and advocacy activities to reinforce partnership, networking, awareness and fundraising actions. Additionally, the center also aims to improve the capacity to perform monitoring and evaluation projects and operational research in health systems. With regard to fundraising, it is critical for the CISM to diversify its core activity funding, which has relied on a single main donor the Spanish government- during the twenty years of the center's history. The core activity should be more actively cofunded by other stakeholder institutions, as well as other public and private institutions with solid commitment to the center.

THE GLOBAL AND LOCAL CONTEXTS (EXTERNAL ANALYSIS) Biomedical research has had a substantial boost since the beginning of the nineties. The emergence of new private donors, such as the Bill and Melinda Gates Foundation, and of new initiatives aimed at drastically reducing poverty through improvement of health, have significantly increased the funding for health research in priority diseases. EXTERNAL ANALYSIS Opportunities

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Today it is acknowledged that health research has a key role in the development of low-income countries. Moreover, in-country national research in these countries contributes to the development of knowledge and tools to fight priority diseases and promotes the translation of research results into clinical practice and health policy. As a result, African countries are increasingly interested in supporting national research centers, which should be accompanied by an increase of the state budget contribution to research funding. At the same time, competitiveness for research funds has increased and today African research centers have to meet higher scientific standards.

- Global Health research priority in the international political agenda - Mozambican government support and increasing interest in research activities - Increasing demand for Corporate Social Responsibility related to public health consultancy services among private companies operating in Mozambique - Country's economic growth - Increase in the number of skilled workers

Mozambique is a developing country that has experienced significant growth and improvement in the last years. On the one hand, a major Threats number of international corporations, especially in the natural resource - Difficult access to international research extraction industry, are operating in the country with an increasing social funds and regional leadership due to increasing competition responsibility orientation for local public health interventions. This situation should imply a higher demand for consultancy services that - Scarce research funding at national level would contribute to generating and diversifying the center's funds. - Unfavorable fiscal and immigration policies Moreover there is a higher availability of trained personnel in the country regarding non-profit organizations that should facilitate the recruitment of national staff to contribute to the consolidation and sustainability of the center. On the other hand, there are unfavorable fiscal and immigration policies regarding non-profit organizations that pose difficulties for the suitable execution of project activities. Mozambique is supportive to research activities in the country and to CISM in particular. This national support together with the country economic growth and the stakeholder’s long term commitment create good opportunity to continue developing the center.

MISSION, VISION AND VALUES The Vision and Mission of CISM have been slightly modified from the previous strategic plan to reflect the center’s focus on vulnerable populations in the long run.

MISSION To foster and conduct biomedical research in health priority areas in order to promote and safeguard the health of the most vulnerable population.

VISION To become a Mozambican center of excellence in biomedical research and in the generation of evidence to guide public health policy in Mozambique and other regions.

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VALUES Excellence: Research is always performed following best practices in each area of activity. Ethics: Respect and compliance with the norms and principles of the communities and partners with which we collaborate. Humanity: Oriented towards the physical and mental well-being of people.

STRATEGY: RATIONALE, GOALS & OBJECTIVES Once the internal and external analysis has been carried out and always considering the center’s mission, vision and values, the next step is to extract from it the main principles that will guide the CISM’s development in the coming years. As a first general approach, the three areas representing the most critical aspects for the development of the center’s mission remain those identified in the previous strategic planning exercise: Research, People and Sustainability. Research encompasses all that is directly related with the primary activity of the center. People is related to the center staff and working environment. Finally, Sustainability refers to the issues such as core funding, management, and others that are critical for the center in the long run. The specific goals and objectives that will be introduced are related to one or more of these three critical aspects, according to the following rationale. Research The center’s principal and most important activity is research. CISM conducts research on priority health problems in Mozambique, which are representative of other Sub-Saharan African countries. The commitment of the center to the national priorities and agenda is critical to ensure that the results from the center's activity improve health in Mozambique. Moreover, the center aims to provide guidance to the government by informing public health policymakers and by monitoring and evaluating public health interventions.

FIGURE 2.REPRESENTATION OF THE PIPELINE FROM BASIC RESEARCH TO PUBLIC HEALTH.

The need to raise funds for research –mainly from international sources– and the increasing competition for research funds call for a focused research strategy and an improved scientific production. At the same time, while it is important to contribute to the development of vaccines and drugs, one of the center’s major challenges is to maintain a balance between hypothesis-driven projects and clinical trials. The research strategy seeks on the one hand to optimize the elements that are a comparative advantage of the center. On the other hand, the center needs to strengthen its translational focus to ensure research results are translated into public health policies and clinical practice. In this period the CISM is looking at consolidating itself as leading institution in the generation of scientific evidence focused on health priorities and aiming at informing public policy. Besides the research program, the strategy also focuses on transmitting the knowledge generated and on CISM’s aim to continue to be a major contributor to the training of excellent biomedical research leaders. The CISM is in a unique position to train researchers who will feed the Mozambican research system and provide professionals with research training to the national health system. CISM

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also aims at providing value to the health system by training other types of health professionals such as lab technicians, statisticians and others. In terms of research capacity, while important advances have been made over the previous period, the center needs to continue improving its research platforms. This will be accomplished through the improvement of infrastructure and the increase in the utilization of the appropriate technologies for the center’s research activity. People Having the right team is critical to the successful attainment of the center’s objectives. The labor market in Mozambique is experiencing an improvement in recent years. This means that the pool of well-trained professionals has become bigger, but also, given the economic growth in the country, there are more institutions competing for the best talent. In this landscape, it becomes crucial to ensure the center has an attractive working environment that allows employees to develop their careers. In the past the center’s intense training activity was planned in many instances on a case-by-case basis. In this period, CISM needs to consolidate a Professional Development Plan across the institution. This plan will include the definition of professional tracks in the institution as well as opportunities to develop new skills and have access to other job positions inside the center.

FIGURE 4.FOCUS AREAS OF SUSTAINABILITY STRATEGY

In an open, multicultural, and competitive world, the success of CISM will depend on its capacity to maintain a stimulating working atmosphere and to attract, retain and develop outstanding staff. Sustainability FIGURE 3.FOCUS AREAS OF RESEARCH STRATEGY A significant number of strategic concerns are focused on the sustainability of the institution, in terms of core funding, ability to communicate its mission and activities, engagement with key partners and capacity to successfully manage the center and its research projects.

Raising funds, especially for core activities, has become increasingly hard in recent years and the center should be prepared to face this situation. Fund diversification becomes a very relevant aspect for the next period. The way science is managed is also a key factor for the success of an institution like CISM. For that reason, scientific management tools to allow the follow-up and evaluation of the research activity also need to be part of the strategy when thinking of sustainability. This applies to general administrative capacity as well. There is a need to strengthen the recently implemented accounting software and link it to a project management module in order to generate regular budget execution reports, as well as to ensure administrative procedures to run the research projects and other activities at the center successfully. National and international partnerships need to be strengthened in order to ensure that the center is adequately coordinated and aligned with academic and research institutions in Mozambique and well positioned in the international context. Moreover, the collaborations between the CISM and national institutions such as the INS or the UEM, to which some of the center’s senior staff are affiliated, need to be reinforced. Finally, an internal and external communication strategy would allow the center’s staff to be adequately aligned with its mission and objectives and would improve CISM’s brand image at a local, national and international level.

GOALS & OBJECTIVES The following goals summarize CISM’s strategy for the 2014-2018 period. They have been identified considering the strategic analysis and rationale presented in the previous sections. Each goal is complemented with objectives related to it. Those objectives are then

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translated into more concrete activities in the action plan, where key performance indicators for those activities are included as well. The performance on the goals defined for the 2010-2013 period (included in appendix A) was an important factor when defining this period’s goals, objectives and activities. Given its intrinsic importance for the institution, the strategy for research is expanded in the Research Program section and its objectives are presented for the different research areas.

GOAL 1: TO CONSOLIDATE CISM AS A LEADING INSTITUTION IN GENERATING SCIENTIFIC EVIDENCE FOCUSING ON HEALTH PRIORITIES AND AIMING AT INFORMING PUBLIC POLICY (SEE R ESEARCH PROGRAM ) OBJECTIVE 1.1: To fulfill the center’s scientific objectives (see research program) OBJECTIVE 1.2: To contribute to the translation of research results on health policy at a national and international level

GOAL 2: TO CONTINUE TO BE A MAJOR CONTRIBUTOR TO THE TRAINING OF BIOMEDICAL RESEARCH LEADERS AND HEALTH PROFESSIONALS

OBJECTIVE 2.1: To strengthen the Training Fellowship Program OBJECTIVE 2.2: To strengthen strategic partnerships with national and international academic institutions

GOAL 3: TO IMPROVE RESEARCH SERVICES ' INFRASTRUCTURE AND CAPACITY OBJECTIVE 3.1: To become a reference in laboratory diagnosis of malaria, meningitis and rotavirus OBJECTIVE 3.2: To strengthen laboratory facilities and the service provided to internal clients OBJECTIVE 3.3: To provide valuable laboratory services to external clients OBJECTIVE 3.4:To consolidate the area currently covered by the DSS and complete further expansion OBJECTIVE 3.5: To strengthen the IT infrastructure OBJECTIVE 3.6: To develop and implement more effective data collection systems

GOAL 4: TO IMPROVE ADMINISTRATIVE AND FINANCIAL MANAGEMENT CAPACITY OBJECTIVE 4.1: To consolidate administrative and financial tools and procedures OBJECTIVE 4.2: To ensure expenditure control according to planned budgets OBJECTIVE 4.3: To improve the whole project cycle management OBJECTIVE 4.4: To design and implement a professional development plan

GOAL 5: TO IMPROVE ADVOCACY, FUNDRAISING AND INSTITUTIONAL RELATIONSHIP CAPACITIES OBJECTIVE 5.1:To develop and implement an advocacy strategy OBJECTIVE 5.2: To intensify the funding diversification of the center OBJECTIVE 5.3:To consolidate existing partnerships and reach agreements with new partners OBJECTIVE 5.4: To reinforce institutional relationships and communication

RESEARCH PROGRAM In order to organize and visualize its research program, CISM uses a matrix structure. It captures the different approaches that the center has to tackle health problems. Every specific research focus on that matrix relates to a disease or pathogen in one axis and to a public health area or discipline on the other axis. The research areas are not mutually exclusive, and they are expected to create synergies and to foster new and creative approaches to solve research questions. To avoid redundancy of information, those objectives common to a disease or pathogen area and a public health area or discipline are shown under the disease area while for the disciplines, only the specific objectives are shown.

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The areas that form the center’s research program do not necessarily cover all research that is going to be done at the center in the next few years, but they will be the core of its scientific activity. It is important to take into account that, in a rapidly changing world, the center will need to be prepared to seize opportunities as they appear even if they have not been identified in this strategic planning exercise. The research program at CISM has naturally evolved from the previous strategic exercise in 2010 as will be explained with the revised research matrix, but the criteria it is based on remains relevant in most cases: -

Research is focused on the main diseases responsible for the burden of disease and mortality in Mozambique and other developing countries, with a special attention to the most vulnerable populations. Existing strengths or capacities that the center has potential to acquire in the short-term are maximized. Research objectives take advantage of the center’s research platforms and characteristics that are a comparative advantage for the center. Synergies between the disease/pathogen-focused and public health/research discipline-focused areas are encouraged. There is a balance between projects driven by hypotheses generated by the center and the contribution to the clinical development of drugs and vaccines. The leading position of the center in malaria, historically the backbone of CISM, needs to be preserved. New or recently developed research areas take advantage of existing international networks to build research capacity. The ultimate aim of the research program is to inform public health policy and create public health goods. Part of the research program will be developed in collaboration with researchers from the CRESIB – Hospital Clínic, as well as other research institutional partners.

The next section briefly describes each of the research areas and presents its specific objectives. It starts with the above-mentioned matrix structure of the research program to then cover all the areas on it (both disease/pathogen-focused and discipline-focused).

RESEARCH MATRIX

FIGURE 5. MATRIX STRUCTURE OF THE RESEARCH PROGRAM

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PATHOGEN/DISEASE RELATED AREAS MALARIA Research on this area was the first area of activity of the center and continues to be a flagship at CISM. The presence of researchers with international leadership in this area has been a key contribution to the overall development of CISM and the attainment of international credit. For the next period the center will give continuity to the successful activities on malaria control, such as guaranteeing an adequate description of the local epidemiology, and continuous surveillance of antimalarial drug and insecticide sensitivity, but also move a step ahead and raise the efforts towards the preparation for malaria elimination in Mozambique. CISM will engage in research and strategic planning of innovative approaches towards malaria elimination in Mozambique, in partnership with the National Malaria Control Program, the Ministry of Health and other partners. Main objectives 1. To design and implement malaria elimination strategies in Mozambique 2. To evaluate new drugs for the prevention of malaria in pregnant women - To develop studies in the context of the international consortium for malaria in pregnancy - To understand the physiopathological mechanisms of malaria in pregnancy 3. To understand the physiopathological mechanisms of severe malaria in children including identifying key pathogenic events in parasite sequestration and antimalarial resistance 4. To participate in the development of the RTS,S/AS vaccine candidate (phase III) and to understand the determinants and mechanisms of naturally acquired and experimentally -induced immunity to malaria, primarily in children and pregnant women, including the mode of action of the vaccine - To conduct immunological studies to better understand the way the vaccine candidate works 5. To participate in clinical development of new antimalarial drugs or new formulations of existing ones 6. To measure and understand transmission dynamics and hotspots of malari a in Mozambique

HIV/AIDS The center is located in a high prevalence and incidence area for HIV. In 2005 the CISM collaborated in setting up an HIV day hospital, in accordance with national guidelines. The center has supported the HIV/AIDS hospital ever since, which has allowed to develop research projects in this area. The center is currently conducting research projects to gain a better understanding of the dynamics of non-invasive gastrointestinal inflammation biomarkers during the first year of HIV infection and assess their utility as prognostic markers of progression to AIDS. In addition, since these biomarkers may be potential indicators of recent infection and thus serve as incidence biomarkers, they will be assessed for their ability to distinguish recent from longstanding chronic HIV infection. In the last years, the center has also participated in projects to develop microbicides (multicenter project in the Microbicides Development Partnership, led by the area of Social Sciences), health and immunological status of negative children born to positive mothers, the characterization of recent infections and has benefitted in addition from building capacity for the clinical development of HIV vaccines (AfreVacc network funded by the EDCTP). Main objectives 1. To understand the dynamics of early HIV infection 2. To understand special needs for clinical management of HIV-positive individuals 3. To understand the impact of HIV exposure on infants born to HIV-positive women 4. To participate in HIV vaccine trial networks

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TUBERCULOSIS During the last years the center has provided support to the National Tuberculosis (TB) Control Program in the Manhiรงa district. Counting on a biosafety level III tuberculosis laboratory since 2010, CISM has the opportunity to play an important role in the development of TB drugs, vaccines and diagnostic tools. Building capacity for the development of drugs and vaccines would also be a means to create a research platform that could accommodate a scientific agenda generated by the center. CISM is now part of the TBVACSIN network that has the objective of developing capacity for the development of TB vaccines, as well as the conduct of a phase IIb vaccine trial. The network has received funding from the EDCTP to conduct a baseline TB study in children and a phase Iib vaccine clinical trial. The trial is sponsored by AERAS, who will provide support for capacity building at the CISM. Main objectives 1. To build lab and clinical capacity for the clinical development of TB drugs and vaccines 2. To participate in the clinical development of new tools to fight TB - To participate in at least one anti TB drug trial - To participate in at least one TB vaccine trial, and complete successfully our participation in the Aeras 402 trial (as part of the TBVACSIN network) - To evaluate new diagnostic tools, with an emphasis in children 3. To better understand the epidemiology of TB and molecular characterization of circulating strains in the district of Manhiรงa - To determine the clinical, social and microbiological characteristics of TB disease in the district of Manhiรงa - To estimate the incidence of TB in children under the age of 3 - To describe the TB circulating strains in the district of Manhiรงa, by means of genotyping techniques 4. To establish a TB surveillance platform in the Manhiรงa district, in partnership with the National TB Control Program

PNEUMONIAS AND OTHER BACTERIAL INVASIVE DISEASES Given its location (adjacent to the Manhica district hospital), and the existence of research platforms (demographic, geographic and morbidity) along with highly equipped laboratories, the center has an excellent opportunity for the development of this research area. Over the years the CISM has focused on understanding the epidemiology and burden of pneumonia and other invasive bacterial diseases (IBDs) among children, and was able to generate data that were key for the decision by the Ministry of Health to introduce Haemophylus influenza and pneumococcal conjugate vaccines in the country. In addition, the center has been exploring the potential biomarkers that can be used to differentiate the most common infections in infants (bacterial infections, viral infections and malaria). Currently the center is conducting projects to better understand the regional differences of pneumococcal carriage among HIVinfected and uninfected children across the country, relevant for the evaluation of impact of the PCV vaccine already introduced in the country as well to monitor the trend of circulating strains. For the next period the center will continue the successful activities on pneumonia and IBDs, such as evaluating the impact and effectiveness of PCV vaccines, guaranteeing an adequate description of the local epidemiology, and continuous surveillance of invasive bacterial disease, but also move a step ahead towards the improvement of diagnosis using molecular approaches (biomarkers, strengthening the diagnostic and pathogen identification capacities with new molecular techniques, including the Real Time PCR). Main objectives 1. To evaluate potential biomarkers for the differential diagnosis of IBDs and malaria in children and newborns (together with the Board Institute) 2. To prepare the site for future Phase III clinical trials of a maternal GBS vaccine 3. To evaluate the impact and effectiveness of PCV against pneumonia and IPD among children 4. To assess the direct and indirect effects of PCV introduction on pneumococcal colonization in HIVinfected and HIV-uninfected children

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5. To characterize the pneumococcal serotypes/genotypes among pediatric invasive strains an d map the geographic distribution 6. To characterize hospital-acquired infection and determine antibiotic resistance 7. To participate in the clinical trials of new standard regime of antibiotics

DIARRHEAL DISEASES Over its years of existence, CISM has contributed to the identification of the most important enteropathogens in the study area and the evaluation of the resistance patterns to the most commonly used antibiotics. This has a significant clinical and public health importance and the CISM is one of the few sources of this type of data in Mozambique. Furthermore, during the last 7 years (20062012) the center has participated in the most comprehensive study conducted to date on diarrheal disease (The Global Enteric Multicentre Study – GEMS) which aimed to describe the burden, etiology and sequelae of diarrhea in children in seven countries in Africa and Asia. Given that the center is located in a high HIV prevalence and incidence area, it has also promoted the development of an ancillary study to investigate the relationship between diarrheal disease and HIV in children. This study has generated data with significant implications for defining public health policies in Mozambique on this area. The center is one of the candidate sites in Africa to contribute to the development of an enteric vaccine against some of the most common enteropathogens; it has also built the capacity to conduct clinical trials of such vaccines. Opportunities to participate in a clinical trial may come in the next following years, and the center’s objective is to be in the required forums to be considered as a candidate trial site. Hence, the goal for the next years in this area will be to contribute to a better understanding of the mechanisms of virulence/pathogenesis of the most relevant enteropathogens (particularly enteric bacteria) and to conduct clinical trials on new enteric vaccines candidates. Main objectives 1. To conduct intervention studies on water and sanitation (e.g. Cryptosporidium) 2. To evaluate the effectiveness and impact of the introduction of new vaccines in Mozambique 3. To investigate the virulence/pathogenesis and molecular epidemiology of the most common enteropathogens 4. To contribute to the clinical development of vaccines that are currently in pre -clinical or early clinical phases 5. To assess the existing and new mechanisms of antimicrobial resistance and their dissemination

PUBLIC HEALTH/RESEARCH DISCIPLINE RELATED AREAS CLINICAL AND MOLECULAR EPIDEMIOLOGY The centre has, since the beginning of its activities, attempted to describe the epidemiology and clinical presentation of the most prevalent diseases in the Manhiça district. This has included thorough clinical evaluations of common diseases (malaria, pneumonia, diarrhea, etc) based on data collected through the ongoing morbidity surveillance at Manhiça’s district hospital and peripheral health posts, as well as the molecular characterization of the epidemiology of certain pathogens (e.g. description of circulating serotypes, genotypes and phenotypes, resistance to the drugs and their mechanisms and virulence mechanisms). As this area is transversal to the main disciplines, its objectives are general and can be adapted to different areas of interest. For the near future, the centre will continue conducting clinical and molecular epidemiology studies of the most prevalent pathogens. The next step will be the expansion of activities to basic research aiming to understand the mechanisms of pathogenesis and virulence of the most relevant pathogens.

IMMUNOLOGY AND PATHOPHYSIOLOGY 14/26


Since they were established on 2003, the laboratories of immunology and molecular biology at the CISM have developed the technical infrastructure and know-how to be able to conduct basic immunological and pathophysiological studies. This includes handling, processing and preservation of biological samples (body fluids and tissues) in sterile conditions, in vitro Plasmodium falciparum and human cell culture (including isolation of peripheral blood mononuclear cells and stimulation with antigens), flow cytometry, enzyme-linked immunesorbent assay, immune-fluorescence microscopy, histological examination of tissues for the presence of pathogens such as malaria parasites, real-time quantitative PCR, cryopreservation in liquid nitrogen for malaria, HIV, tuberculosis and diarrheal disease (e.g. rotavirus) studies. All these capacities have been key to conducting immuno-epidemiological surveys as well as studies on immunological and pathological mechanisms of action of the major diseases and candidate vaccines being tested at CISM. In the upcoming years, the intention is to continue conducting immunological studies on the above mentioned disciplines and to extend to bacterial pathogens and non-communicable diseases. It is also expected that the knowledge gained will be used to identify biomarkers specific for the infecting pathogen that can be developed in point of care tests and to work on tools to track temporal trends in the burden of infectious diseases.

CLINICAL EVALUATION OF DRUGS AND VACCINES This transversal area aims to build capacities to facilitate the implementation of clinical trials for the main diseases in which CISM conducts research. Most of the clinical trials conducted at CISM in recent years have been related to the treatment of prevention of malaria. Certain trials required the identification of healthy patient cohorts to be followed as to assess the effect of an investigational product (for instance a malaria candidate vaccine, such as RTS,S). Other trials recruited sick patients, to assess the efficacy and safety of new drugs or formulations of existing drugs. Patients were followed during variable periods of time. As part of the development of this new area, a new clinical trials unit has been constructed to allow admission and follow-up of patients requiring hospitalization. Specific objectives 1.

To build capacity and infrastructures to conduct prevention and treatment (phase I, II, III and IV) clinical trials for drugs and vaccines

2.

To standardize methods and procedures to conduct efficacy and safety clinical trials

MONITORING AND EVALUATION This area is the result of the need to bridge the gap between efficacy studies of disease control strategies and implementation at a large scale. This area aims to generate information on the safety and effectiveness of public health strategies and how different strategies on the same disease interact. This is a strategic area at CISM that will allow the center to better inform public policy on disease control strategies’ deployment and impact. Until now, the center has contributed with a pharmaco-vigilance study on the use of antiretrovirals (ARV) and antimalarial drugs in pregnancy. Future studies will be in the areas of malaria, pneumonias, IBD and rotavirus.

MATERNAL AND REPRODUCTIVE HEALTH CISM has conducted studies on maternal health since its early years. This research area is related mainly to the Malaria and HIV/AIDS areas and has been active in the last years in the characterization of the most prevalent Human Papilloma Virus (HPV) serotypes, in order to evaluate the potential impact of existing vaccines. The center has recently completed a large IPTp trial to evaluate alternative drugs for this control strategy (MiPPAD trials). These studies were funded by the EDCTP and the Bill & Melinda Gates Foundation and enrolled over 1700 pregnant women from the CISM study area. The center has also a strong potential to contribute to the understanding of MTCT through the establishment of a mother-and-child cohort that would allow it to perform research studies to understand such transmission of HIV. On top of that, the availability of the HPV vaccine gives the center a unique opportunity to understand how to approach interventions that are designed for adolescents, an age group that is rarely a target for health interventions in developing countries.

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Specific objectives 1.

To study drug interactions between antimalarials and antiretrovirals in HIV infected pregnant women

2.

To perform a feasibility study for the introduction of an HPV vaccine in Mozambique

SOCIAL SCIENCES AND HEALTH ECONOMICS Over the years of its existence, CISM has contributed greatly to the determination of the efficacy of newly developed key disease control interventions and products. However, the effectiveness of the interventions is further determined when acceptability, access, uptake, cost, and equity can be ascertained. Therefore, the study of demographic, socio-economic characteristics of the population is a crucial step. The center’s demographic and morbidity platforms offer a great opportunity to investigate the interaction between health and demographic and socio-economic variables. However, there is still a challenge as to how to utilize these data to investigate such interactions. By borrowing data collection and analytical approaches from the field of social sciences and medical anthropology, the center has been able to gradually contribute to an in-depth understanding of the interaction between disease outcomes and the social, economic and cultural context of the community. The Social Science Group at CISM acts as coordinator of two multi-centric studies involving 3 to 5 study country sites in Africa and Asia. This group has also been involved in the implementation of base line and end-line situation analyses with regards to specific populations in collaboration with institutions implementing community-based health interventions. So far one such studiy has been conducted in Xai-xai in collaboration with Save the Children and the other is on-going in Boane in collaboration with PATH. Specific objectives 1. To predict the feasibility and acceptability of future community -based innovative public health approaches 2. To identify socio-cultural, economic and structural factors affecting health service perceptions, use and satisfaction 3. To continue documenting traditional perceptions and practices regarding prevention and treatment of childhood illnesses

ORGANIZATIONAL STRUCTURE In order to manage the activities that will lead to the attainment of the goals and objectives described in this strategic plan, the center is organized according to the figure below.

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FIGURE 6. LIST OF THE DIFFERENT AREAS AT CISM AND THEIR MAIN ACTIVITIES

The Directorate of the CISM is the responsible for the attainment of the strategic objectives, the accomplishment of the scientific agenda, the optimization of the center’s resources and establishment of partnerships. The Directorate is formed by the Director, the Scientific Deputy Director and the Administration and Finance Deputy Director. The research structure is organized by areas with a coordinator for each area. The evaluation of research activities will be performed through the Internal Scientific Committee, formed by the most senior principal investigators in the center, and the Institutional Committee of Bioethics for Health. The Research Services Departments provide services to research projects in alignment with the scientific objectives. The Training Unit ensures the coordination of training activities for researchers and other technical staff, whereas the Communications Unit is responsible for the dissemination of the center's activity and supporting the institutional relations.

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FIGURE 7. NEW ORGANIZATIONAL STRUCTURE OF THE CENTER TO MANAGE THE IMPLEMENTATION OF THE STRATEGIC PLAN

MEASURING SUCCESS: MONITORING &EVALUATION There are several mechanisms in place to evaluate the attainment of CISM’s goals and objectives. There are two annual meetings of the Board of Trustees and three annual meetings of the Board of Governors of the FM, in which the center’s performance and delivery of results are evaluated. The FM has in addition an External Scientific Advisory Board (ESAB) comprised of distinguished national and international scientists, many of whom have experience in running organizations like CISM. The ESAB meets regularly and evaluates CISM’s research and technical activities and its performance. Finally, peer review is a critical aspect for the evaluation of research organizations. The ability to publish research results in a high impact journal and the capacity to attract research funds are determined by peer review processes, and are commonly used as a proxy measure of research quality. However, science metrics needs to be complemented with a benchmarking exercise to compare the center with similar national and international research organizations. The ESAB will have a key role in performing this benchmarking evaluation, which will be crucial even when the predetermined targets are met. The performance on the specific objectives on this plan will be monitored as described on the action plan.

ACTION PLAN The following table summarizes the activities proposed to implement the strategic plan and the indicators to measure the performance on those activities (target in brackets). It also provides an indicative chronogram.

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Legend

Q3

Continuous activity Milestone (the number after “Q” indicates the quarter in which the milestone will be accomplished)

GOAL 1: TO CONSOLIDATE CISM AS A LEADING INSTITUTION IN GENERATING SCIENTIFIC EVIDENCE FOCUSING ON HEALTH PRIORITIES AND AIMING AT INFORMING PUBLIC POLICY Objective

Activity

Indicator

To fulfill the center’s scientific objectives

Conduct projects to fulfill the scientific agenda

To contribute to the translation of research results on health policy at a national and international level

Perform seminars and outreach activities

-% of scientific program objectives addressed (80%) - peer-reviewed publications (80% in 1st quartile journals) -# of seminars performed (1 per IP per year)

2014

2015

2016

2017

2018

- other events held (1/year) Establish mechanisms and -mechanisms and instruments that provide data and instruments established evidence to the national health authorities

GOAL 2: TO CONTINUE TO BE A MAJOR CONTRIBUTOR TO THE TRAINING OF BIOMEDICAL RESEARCH LEADERS AND HEALTH PROFESSIONALS Objective

Activity

Indicator

To strengthen the Training Fellowship Program

Review the Training Fellowship policy and requirements

-policy reviewed

Implement a Mentorship Program

-program presented and approved -# of mentees per year

To strengthen strategic partnerships with national and international academic institutions

Sign new agreements with training institutions (UB/ISGlobal, UCM, Unilurio, etc)

2014

2015

2016

2017

2018

2016

2017

2018

Q3 Q2 Q2

-agreements signed

Q2

GOAL 3: TO IMPROVE RESEARCH SERVICES INFRASTRUCTURE AND CAPACITY Objective Activity To become a reference in Obtain required certifications laboratory diagnosis of malaria, meningitis and

Indicator -ISO 1589 obtained WHO certification obtained as reference

2014

2015 Q4 Q2

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rotavirus

laboratory for meningitis WHO certification obtained as reference laboratory for rotavirus To strengthen Improve laboratory facilities and -facility for cellular laboratory facilities and techniques culture built the service provided to -bacteriology and TB internal clients diagnosis procedures improved -new molecular techniques introduced Provide sample cost based on real -service provided data To provide valuable Provide lab services to external -# clients served laboratory services to parties external clients Train external lab technicians -# technicians trained To consolidate the area Extend the DSS coverage to the -district covered currently covered by the entire Manhiรงa district DSS and complete Reintroduce verbal autopsies to -interVA platform active further expansion adults using InterVA platform To strengthen the IT The equipment is infrastructure renewed periodically Consolidate the information Plan for annual structure maintenance of infrastructure implemented List of SOPs defined Define IT processes in terms of equipment management SOPs developed (software and machines) SOPs implemented Bringing innovation and optimization in data capture #Paper free studies based on paper free Electronic questionnaires Implement an application that for research projects facilitates the gathering of (screening studies , etc. ) electronic questionnaires and platforms ( platform To develop and morbidity ) implemented implement more effective data collection systems The data collected on different platforms is integrated Implement an integrated The integrated information system information is shared securely with investigators

Q4 Q4 Q1 Q3 Q4 Q2 Q1 Q2 Q4 Q4 Q4 Q1 Q3 Q4 Q1

Q4

Q2

Q3

GOAL 4: TO IMPROVE ADMINISTRATIVE AND FINANCIAL MANAGEMENT CAPACITY Objective To consolidate administrative and financial tools and procedures

Activity Complete the implementation of the admin Management tool including a) accounting and HR b) grant management Create and implement new procedures to ensure appropriate level of management and

Indicator -new functions implemented

-new procedures implemented

2014

2015

2016

Q1 a)

Q1 b)

2017

2018

Q1Q4

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accountability

To ensure expenditure control according to planned budgets

Provide regular grant budget execution information to budget holders

Reinforce the expenditure approval procedure To improve the Including pre-award in the whole project cycle whole project cycle management To design and Write a career development implement a policy proposal: professional a) scientific development plan b) technical and management and implement final policy Implement a career development policy

-reporting system implemented

Q4

-new procedure implemented -whole project cycle implemented

Q3 Q3

-proposal written and accepted a) Q4

-policy implemented

b) Q1

a) Q1

b) Q3

GOAL 5: TO IMPROVE ADVOCACY, FUNDRAISING AND INSTITUTIONAL RELATIONSHIP CAPACITIES Objective To develop and implement an advocacy and institutional relationships strategy To intensify the funding diversification of the center

Activity Define and communicate new advocacy strategy Strengthen institutional relationship activities

Find alternative funders for the center’s activities

Provide profitable consulting services in the areas of expertise

To consolidate existing partnerships and reach agreements with new partners

To reinforce institutional relationships and communication

Indicator -documents created and communicated -new plan for institutional relationships approved

2014

2015

2016

2017

2018

Q2

Q2

potential Core funders identified and contacted

Q3

potential project funders identified and contacted -consulting unit active

Q4

Q4

Increase the number of joint projects with current partners

-# agreements signed

Establish collaboration agreements with new partner institutions Develop new joint initiatives with national and regional research institutions Participate in new research exchange programs with national and international partners Strengthen internal communication

-# agreements signed

Q2

Q3 -# new joint initiatives established

Q3

-# visiting researchers

internal communication plan approved

Q2

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internal communication plan implemented Strengthen external communication

Q4

external communication plan approved external communication plan implemented

Q2

Q3

BUDGET Developing and sustaining a biomedical research center in rural Africa poses significant financial challenges. Ensuring funds to sustain and provide long-term stability to CISM is critical for the successful attainment of the center’s objectives. For the development of the previous strategic plan the CISM already conducted a budgeting exercise to estimate the resources necessary to sustain the basic infrastructure and activities that make the center attractive to both researchers and funders. This exercise has been reviewed during the 2014 planning and budgeting process. Ensuring the funding for these core activities – such as maintaining the basic activity of the Demographic Surveillance System (DSS) and the morbidity platform, the indispensable laboratory capacity, equipment and maintenance, etc. – is crucial for the center sustainability. Since the beginning of CISM’s activities these core costs have been mainly supported by the Spanish Agency for International Development Cooperation (AECID) but as mentioned beforehand, it would be highly desirable to diversify the sources of funding through other stakeholders and other public and private institutions with solid commitment to the center. Moreover the center has structural services and activities not covered by the above mentioned core budget but supported by research projects overheads and utilization-based contributions, as well as, to a lesser extent, by own- income-generating activities like the center accommodation service. These additional structural activities of support to projects are mainly additional general management, administrative and logistic services, required when there are several projects running in the center. ESTIMATED BUDGET Research activities Malaria HIV/AIDS and sexually transmited diseases Tuberculosis Respiratory infections, invasive bacterial diseases and diarrheal diseases Other TOTAL (USD) Structural activities Core activities Support to projects TOTAL (USD) TOTAL (USD)

2014

2015

2016

2017

2018

TOTAL (USD)

2.085.914

2.503.097

3.003.717

3.604.460

4.325.352

15.522.541

174.514

226.868

294.929

383.407

498.430

1.578.149

237.537

256.540

277.064

299.229

323.167

1.393.537

1.606.015

1.734.496

1.873.256

2.023.116

2.184.965

9.421.848

1.412.349 5.516.329

1.525.337 6.246.339

1.647.363 7.096.328

1.779.152 8.089.365

1.921.485 9.253.399

8.285.686 36.201.760

1.800.000 734.663 2.534.663 8.050.992

1.890.000 771.396 2.661.396 8.907.734

1.984.500 809.965 2.794.465 9.890.794

2.083.725 850.464 2.934.189 11.023.554

2.187.911 892.987 3.080.898 12.334.297

9.946.136 4.059.474 14.005.610 50.207.371

TABLE 1. ESTIMATED BUDGET FOR CISM DURING THE PERIOD 2014-2018

The table above shows the estimated budget for the 2014-18 period, both for structural activities and the implementation of the research program. The budget for research activities is distributed according to pathogen/disease-related areas, one of the axes of the center’s research program. The budget for structural activities includes the core and the support to projectse activity costs.

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APPENDIX A: EVALUATION OF ACTION PLAN 2010-13 Goal 1 - To develop and implement a biomedical research agenda focused on health priorities and aimed at informing public policy

Objective To fulfill the center scientific objectives (see scientific program)

Performance indicator (target in brackets) - Percentage of scientific program objectives addressed by ongoing and completed projects (80% of scientific program objectives addressed) - Peer-reviewed publications (80% of projects results published in a journal in the first quartile)

Achievement - >80% of Scientific Program objectives addressed - 100% peer reviewed publications (although low publication level among national principal investigators) - 81% of projects results published in a journal in the first quartile out of total CISM publications - 2013: 20 out of 24 (83%) 2012: 18 out of 23 (78%) 2011: 41 out of 51 (80%) 2010: 14 out of 17 (82%)

2 - To continue to make a major contribution to the training of the next generation of biomedical research leaders in Mozambique

To contribute to the translation of research results on health policy at a national and international level

- External seminars delivered at international conferences or research centers (each principal investigator gives at least one external seminar per year) - Colloquia and other outreach programs held in Mozambique to improve translation of research results to policy (at least one event per year)

- Principal Investigators have given external seminars at international Conferences (American Society, etc) and at National level (Science and Technology Journeys)

To strengthen the Training Fellowship Program

- Terms of reference for the Training Fellowship Program (created by mid 2010) - Number of Training Fellows (at least one training fellow recruited each year) - Number of master’s and PhD thesis supervised by the CISM’s personnel (at least two master’s thesis and one PhD thesis at the end of the period) - Introductory courses curricula (at least 2 courses – on basic epidemiology and data management)

- Terms of reference created in 2010 - 14 Training Fellows recruited during 2010-2013 - 17 Master’s and 14 PhD thesis supervised by the CISM’s personnel

To establish in-house introductory courses to support the fellows’ scientific training

To strengthen the relationship with Mozambican academic institutions to improve the center’s capacity to attract the best graduate students

- Signed agreements with Mozambican academic institutions (agreement signed with UEM by 2010)

- Collaboration established with the Faculty of Medicine to contribute in the master program (courses on demography, epidemiology, ethics in public health and research methods – qualitative and quantitative) - Agreement signed with the Eduardo Mondlane University (March 2011), the Faculties of Medicine (July 2005) and Veterinary (December 2012). The agreements with the National Institute of Statistics and National Institute of Health are still pending

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Goal 3 - To improve the laboratory capacity and quality

4 - To improve data capturing and management tools

Objective To implement a Laboratory Information System and a Laboratory Management System

Performance indicator (target in brackets) - Laboratory activity reports (all laboratory activity managed using the new Laboratory Information and Management Systems by mid 2010) - Costs reports (accurate costing of all laboratory tests and activities by 2011)

To maintain the laboratory ISO 9001 certification

- Audit reports related to ISO certificate (ISO certification maintained) - Nature and number of Internal and External findings of audits reports (all audit findings solved in subsequent audit) - Tuberculosis laboratory activity (capability of performing high quality TB diagnosis and drug resistance tests by 2010) - Laboratory facilities (building of new facilities started by 2013)

To set up a new tuberculosis laboratory To design and start building new laboratory facilities To implement data capturing through PDAs To implement new data management software meeting clinical trials requirements

5 - To improve the professional development of CISM’s staff

To design and implement a professional development plan

6 - To implement scientific management tools

To establish an Internal Scientific Committee To establish a centralized scientific database to manage the center’s research activity To establish an integrated administrative management tool (accounts, projects, HR‌)

7 - To improve the administrative and financial management capacity

- Studies and other processes utilizing PDAs for data capturing (100% of projects with field based work besides clinical trials and 100% of demographic surveillance activity) - Number of clinical trials, other research projects and clinical procedures managed with new data management software (100% of clinical trials, 90% of other research projects and 100% of clinical procedures) - Professional development plan (designed and implemented by the end of 2010) - Annual professional reviews (one professional review conducted every year for core staff) - Skill training events organized by the center (at least one training event per department each year) - Functioning Internal Scientific Committee with regular meetings (at least 10 meetings held every year) - Research activity database (100% of research activity included in the center database) - Administrative tool for administrative management (installed and operational in 2010)

Achievement - New laboratory and management system Servolab implemented in March 2010 - Laboratory stock management software implemented in October 2009. The costs report is pending to establish the link between Servolab and Laboratory Stock management software - ISO Certification maintained annually. Last audit done in October 2013 - Audit findings solved - Tuberculosis laboratory started activity in November 2009 - Activity canceled due to financial constraints - PDAs for data capturing 100% implemented in the demographic surveillance system and mobile devices in 20% of the research studies - 100% of research studies are managed with new data management software Open Clinica - Professional development plan design ongoing (available by mid 2014) - Core staff reviewed annually - Skill training events planned and organized annually by CISM Training Department in collaboration with each Department - Internal Scientific Committee has 11 meetings per year (monthly except January) - 100% of research activity is included in the center database

- Administrative tool partially implemented in 2010 with the Human Resource module. Finance module installed in 2013 and fully operational in mid 2014. Project module not started (installed at the end 2014)

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Goal

Objective To establish new administrative procedures To reorganize the administration staff to meet department requirements

To increase the number of projects fully managed by the center administration

8 - To secure and expand funding for core and project activities

To secure funding for the center’s core activities To establish an evaluation system for principal investigators (PI) based on scientific performance and fund raising capacity

To identify additional forms / mechanisms for funding of core activities 9 - To consolidate existing partnerships and seek new national and international partners

Performance indicator (target in brackets) - Administrative procedures documentation (100% of administrative procedures documented and documentation available to the center personnel) - Administration job profiles (Job profiles available for all administrative positions) - Staff training (administrative personnel fulfilling required capacities according to their job profiles)

- Number of projects fully managed by the CISM administration (90% of research activity managed directly by the center administration by the end of the period) - Number and nature of annual audit reports and follow-up of recommendations (all issues raised in audit reports are solved in the following audit) - Core funding contract (core funding secured every year) - Evaluation system for the center’s principal investigators (evaluation system created and implemented by the end of 2010) - Extramural research funding / eligible PIs ratio (increase of the total amount / eligible PIs ratio by 5% every year until the end of the period) - Number of awards/eligible PI (increase of the annual number of awards / eligible PIs ratio by 5% every year) - New core funding sources (at least one new core funding source identified and secured at the end of the period)

To consolidate strategic partnerships through specific agreements

- Signed agreements with strategic partners and stakeholders (agreements signed with UEM, MISAU, INS e INE by 2010)

To create and consolidate national research networks

- Active partnerships with other research centers (at least 1 active by 2010 and 2 active by 2012)

Achievement - Administrative procedures ongoing (available at the end 2014) - Administration job profiles available for all positions. Selection of Logistics Area Manager ongoing - HR, Projects and Finance Area Managers fulfill required capacities according to their job profiles. During 2014 the remaining positions will be trained - 80% of CISM activity managed by CISM administration - Last FM financial audit in 2012. Issues raised in audit reports partially solved in the following audit (administrative procedures ongoing) - Core funding secured every year (for a period of 5 years during 2008-2012 and in a year base for 2013) - Created the Manhiça Senior Research Fellowship, a five years post-doctoral fellowship with a mid-term and final evaluation by an independent panel of experts

- New core funding sources ongoing (Ministry of Health, Ministry of Science and Technology, European Union, Private donors, etc) - Signed agreements with  Eduardo Mondlane University (March 2011)  Ministry of Science and Technology (August 2011)  Faculty of Medicine (July 2005)  Faculty of Veterinary (December 2012)  Ariel Foundation (July 2013) - Active partnerships with the National Institute of Health and the Catholic University of Mozambique

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Goal

Objective To establish research exchange programs with strategic partner institutions

Performance indicator (target in brackets) - Number of visiting researchers from partner institutions (increase of 5% in 2010 and 2011 and 2% in 2012 and 2013) - Number of center researchers visiting partner institutions (increase of 5% in 2010 and 2011 and 2% in 2012 and 2013)

10 - To design and implement an internal and external communication strategy

To design and implement an internal and external communication plan

- Level of execution of the communication plan (plan fully implemented by 2011) - Visits to the website from Mozambique (yearly increase in 5% first two years and 2% afterwards) - Presence of the CISM and CISM’s activities in the media (at least two results per year communicated through the media) - Meetings of the CAB held (at least two meetings per year)

To create a community advisory board (CAB) for community participation in the center’s activities

Achievement - Number of visiting researchers from partner institutions 2010:12; 2011: 9, 2012: 16; 2013:29 - Number of center researchers visiting partner institutions 2010: 10; 2011:14 : 2012:12 , 2013:14 - Communication plan elaborated and implemented in 2010 - 15.000 visits to the website per year - Mass media communication of 3 events per year - Community advisory board meetings held twice a year

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