PDF to HTML - Convert PDF files to HTML files

Udenrigsudvalget 2014-15 (1. samling)
URU Alm.del Bilag 25
Offentligt

Danish Organisation Strategy

for

International AIDS Vaccine

Initiative (IAVI)

2014-2018

September 2014

PDF to HTML - Convert PDF files to HTML files

1. Objective

1.1.

Objective of strategy

This strategy for the cooperation between Denmark and the International AIDS Vaccine Initiative (IAVI) forms

the basis for the Danish contributions to IAVI and is the central platform for dialogue and partnership with the

organisation. It follows the guidelines for short organisation strategies for organisations receiving less than DKK

35 million in annual contribution from Denmark. It follows and outlines the Danish priorities for IAVI’s

performance within the framework established by IAVI’s own

Strategic Plan 2011-2015

. The Danish strategy

for IAVI follows the duration of the Danish organisation strategy for the ‘sister’ initiative, the International

Partnership for Microbicides (IPM) covering 2014-2018. The present organisation strategy will be revised, if

warranted by IAVI’s strategy covering 2016 onwards.

1.2. Objectives of the organisation

IAVI was established in 1996 as a non-profit Product Development Partnership (PDP) and has since then grown

to become a respected and effective partner in the global HIV/AIDS response. The organisation provides

leadership within the field of research and development of AIDS vaccines with a special focus on the virus

strains which are prevalent in developing countries. The objectives of IAVI are to accelerate the development

of AIDS vaccines by identifying opportunities and gaps in the field and ensure that IAVI invests its resources in

areas that add most value; to harness partnerships to expand the diversity and number of novel AIDS vaccine

candidates; and to build support for AIDS vaccine development.

IAVI works with its partners in developed and developing countries to identify gaps in existing research and to

design, prioritise and prepare infrastructure for clinical testing of AIDS vaccine candidates. Its niche within the

broader field of research and development is translational work taking scientific results through the chain of

development of a pharmaceutical product and preparing roll-out of the product to end users. The organisation

is also concerned with capacity development – creating research infrastructure in the South – and advocacy

efforts to mobilise awareness about AIDS vaccine research.

2. The organisation

2.1. Basic data and management structure

IAVI is a partnership of five types of collaborators: i) Bio-tech industry (such as GlaxoSmithKline, Crucell and

Algonomics; ii) Academic institutions and government laboratories (incl. Imperial College, University of Oxford,

Aarhus University and Statens Serum Institut; iii) African research institutions (incl. Kenya AIDS Vaccine

Initiative/University of Nairobi, Wellcome Trust-KEMRI, Uganda Virus Research Institute; iv) Multilateral and

Civil Society Organisations (WHO, UNAIDS, AIDS Fondet, Kenya AIDS NGO Consortium; and v) other Project

Development Partnerships, including the International Partnership for Microbicides.

Headquartered in New York, IAVI is a global organisation with regional offices in Amsterdam, Nairobi,

Johannesburg and New Delhi. It is organised to work with 100 key collaborators including researchers, policy

makers and civil society organisations representing key populations and affected communities in 23 countries.

IAVI has recently commenced initial development of a new strategy covering 2016 onwards.

PDF to HTML - Convert PDF files to HTML files

The governing body of IAVI is

organised around the Board of

Directors which is responsible

for overseeing management

and strategic direction. The

Board has 13 members, each

elected for staggered three-

year terms. The directors are

recruited based on academic

and organisational merit

within the fields of experience

in government, industry,

private foundations and non-governmental organisations. The members of the Board are not paid or

remunerated for their services to the organisation. Two advisory committees (Scientific and Policy Advisory

Committee, respectively) provide strategic advice on governance and policy to the senior leaders.

2.2. Mission and mandate

IAVI’s mission is to create the conditions for a world without AIDS through the discovery of an AIDS vaccine

which can be effective throughout the world. It is a leading organisation in the field of AIDS vaccine research

and development working to expedite the identification of a preventive AIDS vaccine through public-private

partnerships.

The core of the organisation’s mandate is to ensure that a future preventive AIDS vaccine will be effective and

available throughout the world, thus also for people in the South who are not a priority for the for-profit

pharmaceutical industry. The organisation works with key populations such as male and female sex workers,

men who have sex with men, and other vulnerable groups to ensure their participation in a plan for the

distribution and uptake of a future vaccine.

2.3. Achievements and mode of operation

Achievements

IAVI has made substantial achievements within its prime areas of work: to conduct AIDS vaccine trials and

related epidemiological research, to develop research and technical capacity in developing countries, and to

build support for AIDS vaccines.

Regarding the first area of work, IAVI has achieved a robust and promising scientific track record. Since 2000,

the organisation has tested 15 new vaccine candidates in 26 clinical trials and has built strong clinical and

laboratory consortia in Sub-Saharan Africa and India. In 2009, the AIDS vaccine field had a significant year,

achieving results that prove that making a preventive, effective vaccine is possible. The evidence included

positive results from the first human AIDS vaccine trial where a vaccine candidate protected 30% of volunteers

Organisational background facts

Established

1996

Headquarters

New York, USA

Regional offices

Amsterdam, The Netherlands; Nairobi, Kenya;

Johannesburg, South Africa; New Delhi, India

Collaborations

More than 100 in Europe, Japan, India, Africa and the US

(academia, industry,

governments)

CEO

Margaret G. McGlynn

Human resources

155 employees located in the US, Europe, Africa, and

India locations.

Previous Danish funding

2012-2014: 15 M DKK

2012-13: 7.5 M DKK

2010: 10 M DKK

2001-2008: 65 M DKK

PDF to HTML - Convert PDF files to HTML files

from HIV infection

; the discovery of new broadly neutralising antibodies that can prevent HIV infection from

the major HIV virus types circulating globally; and results from a study in monkeys in which a vaccine was

shown to clear infection from 50% of the population. In 2013, IAVI and partners demonstrated cutting-edge

progress in two priority areas of AIDS vaccine science

. The new scientific knowledge generated from the

testing of IAVI candidates will be used in vaccine design and creates a space for optimism. Researchers globally

are now turning these discoveries into the next generation of powerful new vaccine candidates. The next set of

efficacy trials to test these concepts is anticipated to begin in 2016/2017. The work of IAVI has a positive “add-

on effect“, beyond the immediate scope of IAVI. IAVI makes its research findings and results available to other

research groups, thereby contributing to potentially faster development of a vaccine.

Over the last two years, IAVI has taken the strategic decision to diversify its product pipeline to include four

different vaccine strategies, each with multiple different candidates, with a goal of ensuring it continues to

support and/or fund the best opportunities in the field, and therefore contributes to finding an AIDS vaccine in

the fastest possible time.

IAVI has built clinical research capacity across Africa through the establishment of a network of Clinical

Research Centres with highly skilled staff. These centres are learning environments for the national partners

through the establishment of tests and processes to permit valid comparison of clinical data. More than 1,600

clinicians and laboratory staff have received training in good clinical practice, and South-based junior

investigators are increasingly being promoted to principal investigators or trial directors. This contributes to the

retention of talented African researchers and clinicians. The creation of local academic opportunities is in line

with Danish wishes to strengthen South-driven research.

Mode of Operation

IAVI works through a diverse range of institutional, strategic and ad-hoc partnerships. These partnerships

harness expertise and resources, improve the quality and impact of IAVI’s work, build and share knowledge

between developed and developing countries, and raise the visibility and influence of those most affected by

the AIDS pandemic.

With the aim of increasing the engagement in and ownership of the national health response in regions most

affected by the pandemic, IAVI and its partners have developed a well-established programme for research

capacity building work in Eastern and Southern Africa, with a focus on research and related activities that will

benefit the most vulnerable populations. This programme includes continued investment in skills transfer,

training and mentoring of African researchers and research technicians. This helps build southern based

research capacity and works to ensure that the highest scientific and ethical standards are applied in

conducting vaccine trials and related epidemiological studies.

IAVI takes a comprehensive public health approach to engaging communities in AIDS vaccine research and is

committed to a response that requires within its work approach a range of prevention interventions including,

The trial is commonly referred to as ‘the Thai trial’ (or RV-144) as it was conducted in Thailand, involving more than 16,000 volunteers.

Those areas being ‘broadly neutralising antibodies’ and ‘replicating viral vectors’.

PDF to HTML - Convert PDF files to HTML files

for example, increasing access to sexual and reproductive health education and services, particularly for

women, young people and vulnerable populations such as men who have sex with men (MSM), and voluntary

HIV counselling and testing, with referrals for appropriate treatment, care and support for all volunteers in

IAVI’s clinical trial programmes.

2.4. Effectiveness of the Organisation

IAVI has been subject to several independent evaluations and reviews over the past years. In the

Irish Aid

Review of Support to Product Development Partnerships

and the

Review of Denmark’s Support to the Response

to HIV/AIDS

(both 2011) the organisation has been characterised as a relevant partner because of its unique

focus on HIV vaccine research and development and for its ability to foster clinical and research capacity with

its collaborating research consortia in the South. The Danish review was in favour of the PDP modality and

noted “that

vaccine development is a high-risk but high-return investment which only public sector institutions

are willing to finance”

and recommended that the Ministry of Foreign Affairs considered increasing its funding

to this purpose

. The Irish review noted that “IAVI

continues to provide value for money. IAVI is contributing to

building scientific and regulatory capacity and infrastructure in developing countries which should foster

economic growth”.

In an independent Evaluation of the International AIDS Vaccine Initiative 2003-2009, initiated by the World

Bank, the conclusion was also positive acknowledging that “IAVI

has been a leader in developing capacity in the

developing world for clinical trials, and for helping to enable trials to be carried out effectively, efficiently, and

to high ethical standards”.

The evaluation noted, however, that there was room for improvement with regard

to benchmarks to measure how IAVI compares to other organisations and to the relatively high turnover

among key personnel.

Due to a general downturn in funding, the budget of IAVI shrank and IAVI was downsized to become a smaller,

more cost-effective organisation. Measures taken to overcome a more than 20% cut in budget included a

reduction in senior management; overall organisational structure/staffing across all departments; placing

greater emphasis on improving operational and business practices and efficiencies; prioritising research and

development where IAVI would have the greatest impact on the field without compromising projects that

could advance the most promising work in the portfolio.

The organisational reform addressed the issues raised by the World Bank evaluation by establishing

measurable benchmarks and by developing and investing in standardised recruitment policies and retention

strategies. The downsizing process naturally influenced IAVI’s research and development portfolio and the

organisation is actively working to attract further funding. Increased funding would among other enable

accelerated design and development of a broadly neutralising antibody vaccine candidate, thereby increasing

the likelihood of finding a universally effective vaccine faster.

Following the organisational restructuring process, IAVI adopted a centralised monitoring and evaluation

system that includes a performance framework with targets which are mapped to IAVI’s strategic goals and

This was done through an extraordinary grant of 7.5 million DKK in 2012.

PDF to HTML - Convert PDF files to HTML files

annual work plans. The adjunct indicators were revised in order to measure annual organisational

achievements as well as broader impact against the strategic plan. IAVI collects project progress data on a

quarterly basis and reports to donors on an annual basis.

Key strategic opportunities and challenges

Opportunities

There is a solid concord between Danish priorities and IAVI’s objectives. As expressed in

The Right to a Better

Life: Strategy for Denmark’s Development Cooperation

(2012), Denmark is determined to be at the forefront of

international efforts to promote sexual and reproductive health and rights and in the response to HIV/AIDS. In

the

Strategy for Denmark’s Support to the International Fight against HIV/AIDS

(2005) emphasis is put on a

comprehensive, evidence-based and balanced prevention-treatment response. An effective vaccine is the

optimal way to provide protection to people at risk of being infected with an incurable disease and thereby

prevent a huge amount of human suffering and reduce the costs and burden on health systems and budgets.

Another advantage of a vaccine is that it would free women (and men) from the difficulty of negotiating

consistent condom use with a sex partner

. A vaccine could protect them without exposing them to the risk of

gender-based violence that often follows such intimate talks. This is particularly relevant for the most

vulnerable population groups including sex workers and MSM. The

Review of Denmark’s Support to the

Response to HIV/AIDS

(2011) assessed IAVI positively and concluded that investment in vaccines was a

strategically sound way for Denmark to contribute to preventing HIV and AIDS.

Another priority of the Danish strategy is to reach vulnerable population groups through a rights-based

approach. While first and foremost a research and advocacy organisation, IAVI also provides health services to

the volunteering trial participants (more than 16,000 individuals since 2004). In line with the ethical standards

that such bio-medical trials must adhere to, the participants are offered counselling, health information, HIV

testing and referral to national treatment programmes in case of a positive test result. In addition, IAVI

supported projects have tested more than 300,000 individuals for HIV. IAVI is engaged in identifying and

reaching out to under-served population groups providing services and advocating for their right to health care.

These efforts are in direct alignment with the priority that Denmark assigns to gender equality and human

rights in its development corporation within the

Strategic Framework for Gender Equality, Rights and Diversity

(2014).

Denmark prioritises the need to address stigma and discrimination of vulnerable groups such as MSM, male

and female sex workers and injecting drug users. IAVI’s open and evidence-based work with these groups is of

strong symbolic, political and health related value. This is exemplified through a new consortium to develop a

network of research centres in Kenya and South Africa aiming to identify, follow and treat MSM. Furthermore,

IAVI’s research centre in Uganda covers a large cohort from the fishing communities; a group identified as

highly underserved by HIV/AIDS and broader health care services in the 2013 evaluation of Danish, Irish and

USAID support to HIV/AIDS in Uganda.

Acknowledging that a condom provides protection against a wider range of sexually transmitted diseases.

PDF to HTML - Convert PDF files to HTML files

Challenges

With an estimated 35.5 million people living with HIV (2013), the AIDS pandemic remains a global health

challenge in spite of remarkable increase in access to treatment, unprecedented international political

commitment, resource mobilisation and civil society engagement. Every day 6,300 people become infected,

and the daily death toll of AIDS is estimated at 4,300. With the advent of antiretroviral therapy (ARVs), an AIDS

diagnosis is no longer a death sentence but rather a chronic condition. However, in a situation where more

people become infected with HIV than the number of people eligible (and able) to access medicines, it is not

possible to ‘treat our way out of the pandemic’. Current estimates show that even with the full scale-up of

existing HIV prevention tools, which include not only access to ARVs but also education, condom provision and

adult circumcision, it would still not be feasible to truly end the pandemic. Only with a vaccine, will it be

possible to “Get to Zero”, with even a modestly effective vaccine having a significant impact on the number of

HIV infections over time

The greatest challenge in developing an effective AIDS vaccine is that the HIV virus rapidly mutates which has

led to great regional diversity. Consequently, a vaccine developed for one region, for example North America

and Europe, may not prove to be effective in Africa where the burden of disease is highest. Currently, industry

research into an AIDS vaccine is limited due to perceived uncertain return on investment compared to research

and development cost. IAVI’s research focuses on a new generation of vaccine candidates that would be

effective against all types of HIV circulating globally, with a focus on vaccines suitable for developing countries

and at a cost that is affordable in resource-constrained settings.

Many of the challenges that the field of product development faces are of relevance for IAVI – as it is the case

with its ‘sister organisation’ IPM. It is particular challenging to sustain momentum for investment in scientific

discovery of an AIDS vaccine rather than allocating funds to already existing health technologies. However,

comparative analysis conducted on behalf of the Copenhagen Consensus Centre (2011) has demonstrated that

vaccine development is estimated to be a much more cost-effective investment compared to expanding

already existing technologies. According to conservative projections, an AIDS vaccine with only 50% efficacy,

which would reach as few as 30% of the population, would still avert 5.6 million new infections in low and

middle income countries between 2015 and 2030.

Failure is always a risk in research, and roll-out of an effective vaccine to the end users is not around the

corner. But it is closer than it has ever been and significant scientific progress has been made over the past

couple of years. Denmark believes in the need to invest and engage on this matter with a long-term and risk

willing perspective in an effort to sustain momentum for investment in AIDS vaccines. Denmark’s partnership

with IAVI takes point of departure in the recognition that identifying an AIDS vaccine is a long and risky haul.

Denmark will remain a partner in this journey and support the on-going efforts of IAVI and other partners to

advocate for sustained resource flows, including by facilitating communication to/with a broader, non-

technical audience.

Modeling project – UNAIDS, Futures Institute, IAVI, AVAC.

PDF to HTML - Convert PDF files to HTML files

4. Priority results to be achieved

The priority results defined for Denmark’s assistance to IAVI are determined by

The Right to a Better Life:

Strategy for Denmark’s Development Cooperation

as well as in

Strategy for Denmark’s Support to the

International Fight against HIV/AIDS.

Denmark’s assistance to IAVI will be part of the ambition to control the

AIDS pandemic and to promote a human rights-based approach towards groups who are most vulnerable to

HIV infection.

In IAVI’s strategic plan covering 2011-2015 three objectives are outlined:



Accelerating the development of HIV/AIDS vaccines by identifying opportunities and gaps in the field

and ensuring that IAVI invests its resources in areas that add most value;

Harness partnerships to expand the diversity and number of novel AIDS vaccine candidates; and

Building support for AIDS vaccine development.

In support of these objectives, the three Danish priority areas for IAVI are:



Support the research in and development of AIDS vaccine candidates to be used in developing

countries.

The objectives include contributing to the continued progress in the clinical pipeline of AIDS

vaccines relevant for parts of the world with the highest burden of HIV and strengthening of research

capacity in developing countries and of South-driven research capacity.

Continued institutional reform process.

In line with the already ongoing efforts to improve the

efficiency, effectiveness and added value of IAVI, the objectives include to promote the optimisation of

IAVI’s systems and resources; to support IAVI’s own capacity to respond timely to and to continue to

work in partnership with academia, industry, civil society as well as a diversified group of donors.

Sustained efforts to combat corruption and misuse of funds.

Objectives include: To ensure increased

rigour and transparency in the management of funds through the consistent implementation of the

quality management system and standard operating procedures in accordance with the organisation’s

Code of Conduct, Conflict of Interest Policy and Whistle-blower Policy.



5. Budget

The budget for the Danish contribution to IAVI for the coming five years is shown in the table below:

2014

Commitment in DKK million

Annual releases in DKK million

2015

2016

2017

2018

Denmark provides un-earmarked, core funding to IAVI. IAVI currently has a strong and diversified donor base,

but most of the donors offer earmarked funding. Only 25% of funding is un-earmarked. It is the un-earmarked,

The numbers for 2015/18 are preliminary and subject to parliamentary approval.

Committed in 2012 (15 million DKK for 2012-2014).

PDF to HTML - Convert PDF files to HTML files

core support which provides flexibility, enabling IAVI to make data-based decisions and to follow science

quickly in new directions.

IAVI receives financial support from 12 government and multilateral agencies, including Denmark, the

Netherlands, Norway, United States, United Kingdom, Ireland, Japan as well as private foundations, particularly

the Bill & Melinda Gates Foundation. In-kind support is received from private sector companies including

GlaxoSmithKline, Google, and Bristol-Myers Squibb.

6. Summary results matrix

The below framework based on IAVI’s own monitoring and evaluation system forms the basis of monitoring of

Denmark’s support to IAVI. The support will be monitored through the annual PDP Funders report and annual

audited accounts submitted to the donors by IAVI. In addition, the annual donor meeting enables dialogue with

IAVI management and with other donors to the organisation.

Intended Results

(selected

Indicators

(selected from IAVI’s

Baseline

from IAVI’s own monitoring

own monitoring framework)

framework)

Goal

To develop AIDS vaccine(s)

meeting the needs of the

most vulnerable to HIV and

AIDS, with partners across

the world

Priority Area 1: Support the research in and development of AIDS vaccine candidates to be used in developing

countries

Objective 1: To expand

Clinical pipeline of AIDS

1) Number of active Phase I and 1) IAVI has 3 active Phase

the pipeline of AIDS

vaccine candidates

II clinical trials;

I / II clinical trials ongoing;

vaccine candidates

expanded

2) Number of active AIDS

vaccine efficacy trials

2) IAVI is currently

conducting no AIDS

vaccine efficacy trials

1) 80% of CRCs & key staff

meet necessary

qualification standards to

conduct clinical trials

Objective 2: To

strengthen the research

capacity in developing

countries and of South-

driven research capacity

Clinical and behavioural

science research capacity in

developing countries

sustained and

strengthened

1) % of clinical research centres

and key staff meet necessary

qualification standards to

conduct clinical trials and

relevant behavioural studies

among key populations;

2) Number of active

epidemiology, clinical research

studies and relevant

behavioural studies

2) IAVI is currently

conducting 7

epidemiology studies

with 1 clinical research

study to be initiated in

2014

PDF to HTML - Convert PDF files to HTML files

Objective 3: Ensure that

momentum remains

high for financial

support to investing in

AIDS vaccines

Global investment in AIDS

vaccines research and

development, and in the

future, accessibility of key

populations to these

vaccines is sustained

1) Number of documented

instances, including national

and international

commitments, for which

stakeholders publicly endorse

efforts to develop AIDS vaccines

and to ensure access to them;

2) Number of documented

instances in which stakeholders

utilise IAVI policy outputs or

policy outputs to which IAVI has

contributed

1) At least 30

documented instances

per year publicly

endorsing efforts to

develop AIDS vaccine

R&D and ensure access to

them;

2) At least 20

documented instances

per year in which

stakeholders utilise IAVI

policy outputs or policy

outputs to which IAVI has

contributed

Priority Area 2: Efficiency, effectiveness and added value of IAVI including institution reform process

Objective 4: To assist

IAVI’s systems and

1) Number of business

1) At least 1 business

IAVI in its efforts of

resources optimised with

improvements

improvement identified &

adopting a leaner

regards to efficiency,

implemented to optimise

implemented annually

organisation structure

effectiveness and added

IAVI’s performance;

value

2) % of spending on general

2) Max. 12.5% spent by

and administrative

IAVI on G&A expenses

expenses of IAVI’s annual

annually

expenses;

3) % of staff turnover on an

3) Maintain max. 15%

annual basis;

level staff turnover

4) IAVI maintains stable

4) IAVI generates at least

funding

US$ 60m p.a.

Priority Area 3: Effort to combat corruption and misuse of funds

Objective 5: Continued

To ensure increased rigour

1) Results of internal controls

improvement with

and transparency in the

conducted;

regards to preventing

management of funds

financial fraud and to

through the consistent

2) Results of quarterly

ensure that funds are

implementation of the

reviews of clinical trial

appropriately utilised

quality management

centre spending and on-

for their defined

system & standard

site audits;

purposes

operating procedures

under the direction of the

3) Results of annual financial

Global Quality Assurance

audits

Unit

PDF to HTML - Convert PDF files to HTML files

Annex 1: IAVI’s projected funding 2014

BMGF; $15,8 ; 26%

USAID; $26,5 ; 44%

Private Sector &

Other; $2,7 ; 4%

Ireland; $1,3 ; 2%

Norway; $1,0 ; 2%

UK DFID; $1,6 ; 3%

Japan; $1,9 ; 3%

Denmark; $0,9 ;

US NIH; $3,7 ; 6%

Netherlands; $4,9 ;

BMGF: Bill and Melinda Gates Foundation

US NIH: National Institutes of Health

PDF to HTML - Convert PDF files to HTML files

Annex 2: Overview of IAVI Financial expenses in USD

Applied research

Preclinical development

Clinical trials

Cohort and site development

Research and Development

Fundraising

Vaccine advocacy, education

and policy/access

General and administrative*

Other Expenses

Total Expenses

2012 Research and Development

Expenses

24,525,940

8,833,142

14,942,097

4,153,763

52,454,942

2012 Expenses

As % of

total

52,454,942

2,878,942

6,766,992

9,825,676

19,470,718

71,925,660

100

* 13% of total expenses. G&A costs cover indirect costs applied to support the entire organisation i.e. expenditures incurred in the day-

to-day operations of IAVI which are not directly related to specific projects or programmes. This includes contributions to rent, utilities,

insurance, office supplies, legal and management costs.

2012 represents the latest audited financial accounts for IAVI.