Science and international development

Written evidence submitted by International AIDS Vaccine Initiative (Int Dev 24)

About IAVI

IAVI is a global not-for-profit, public-private partnership, with offices in the United States, Africa, India and Europe. Our mission is to ensure the development of preventive AIDS vaccines that are not only safe and effective, but also accessible to all people. To that end, IAVI invests the bulk of its resources in the research and clinical assessment of candidate vaccines against strains of HIV that are prevalent in the developing world, where some 95% of new HIV infections occur.

IAVI’s operational strategy is predicated on the conviction that addressing HIV/AIDS and developing a preventive vaccine will require the contributions of researchers worldwide, and especially from countries most burdened by the epidemic. IAVI is also guided by the belief that local scientific and technological capacity is critical to the sustainability not only of the global AIDS vaccine effort but of development efforts in general, since such capacity is what underpins innovation. Investing in capacity building in the context of AIDS vaccine research can have benefits that reach far beyond ending HIV/AIDS.

Our research and product development teams work with more than 40 academic, commercial and government institutions to develop and evaluate candidate HIV vaccines. So far, IAVI and its partners have designed 21 AIDS vaccine candidates, and already evaluated 12 of these in early stage human trials in Asia, Africa, Europe and North America. To do this critical work, we, together with local research institutions, have developed a network of sophisticated laboratories and clinics, including in India and in southern and eastern Africa. Our Human Immunobiology Laboratory at Imperial College London is a central hub that co-ordinates the work of the laboratories engaged in informing the design of novel vaccine candidates and in evaluating their ability to prevent HIV infection and AIDS. IAVI also conducts policy and advocacy programmes to help advance AIDS vaccine R&D worldwide, and supports a comprehensive approach to HIV and AIDS that balances the expansion and strengthening of existing HIV prevention and treatment programmes with targeted investments in research for new HIV/AIDS prevention tools.

Written submission

We wish to restrict our written submission to questions 1 and 2 as they relate to AIDS vaccines and the committee inquiry regarding scientific capacity in developing countries.

Question 1:
How does the UK Government support scientific capacity building in developing countries and how should it improve?

The UK is a strong supporter of R&D for AIDS vaccines, both in terms of investments made

through DFID’s research strategy and by public and private institutions in the UK research field more broadly. The UK government has, quite rightly, taken a long-term view and has demonstrated commitment in its portfolio approach to R&D investments, including by funding IAVI. Strong and sustained leadership of this kind is required if we are to eliminate AIDS. The need to sustain this commitment cannot be overemphasised when faced with an unsustainable and growing treatment bill as global HIV incidence remains high and the population of people living with HIV, and hence our pool of infection, grows. IAVI praises UK leadership in the global arena. The UK is globally the 3rd largest investor in R&D for AIDS vaccines, and in Europe the largest single national investor.

Funding from DFID has made a major contribution to supporting IAVI’s efforts to build and maintain scientific capacity in developing countries in the following ways:

1. Build strong networks of clinical trial sites;

2. Foster national research partnerships;

3. Develop a centre of excellence in London to equip, monitor and train scientists in developing countries to conduct clinical trials; and

4. Establish vaccine preparedness programmes

1. Building strong networks of clinical trial sites

Since its inception, IAVI has made engagement with developing countries a priority in its approach. To ensure that a future AIDS vaccine would be effective and accessible by people in countries hardest hit by HIV/AIDS, IAVI made a deliberate choice to engage researchers, governments and communities in these countries from the start. The value this would bring to building sustainable capacity and expertise amongst these stakeholders was a particular incentive for this approach.

The first step was to build the capacity to conduct clinical trials in developing countries, where most of those studies would take place. Since 1998, IAVI has built a network of clinical trial research centres in southern and eastern Africa. IAVI conducted its first clinical trial of a candidate vaccine in collaboration with the Kenya AIDS Vaccine Initiative (KAVI) and the United Kingdom’s Medical Research Council.

IAVI’s approach:

To achieve the scale necessary to conduct Phase I clinical trials in the developing world, IAVI engaged with local research institutes and supported the building of a network of clinical trial sites for testing HIV vaccine candidates to the highest standards of medical science, safety, and ethics. The network of state-of-the-art laboratories and research and health services staff were equipped and trained to process, test, and store tens of thousands of blood samples, and possess the infrastructure for transportation and communication.

2. National research partnerships

IAVI formed partnerships with governments in Uganda, India, Kenya, Rwanda, South Africa and Zambia to establish and foster national research partnerships. IAVI also sought out the best national scientists, technicians, public health professionals and community outreach workers to join its country project teams.

3. Develop a centre of excellence to support clinical trials in developing countries

Key to supporting the clinical trial network was the establishment of IAVI’s Human Core Immunology Laboratory (HIL) in London, in collaboration with Imperial College London and housed at the Chelsea and Westminster Hospital, to train and equip clinical trial sites as well as to help coordinate trials conducted in each country. The HIL helps to train staff at the network’s collaborating research centres (CRCs) and to standardise methods and reagents for research, according to international Good Clinical Laboratory Practice (GCLP) guidelines that the HIL helped develop - and ensuring that data generated by labs supported by IAVI are comparable at all times. Today, all IAVI research labs supporting clinical trials have achieved the international standards of GCLP.

4. Establish vaccine preparedness programmes

Pioneering a sustainable network of clinical trial sites in the developing world also required a strong local presence and a foundation of trust between research partners, host country governments, media, and communities. IAVI introduced a vaccine preparedness programme to increase awareness, understanding, and national involvement in HIV vaccine clinical trials, and has included setting up community advisory boards to enhance recruitment and improve voluntary counselling and testing and other HIV/AIDS health services. The goal was to prepare for trials of experimental HIV vaccines, both IAVI-sponsored candidates and products developed by other organisations, to ensure support by governments and communities alike, and develop greater ownership of the research by those engaged in it.

Today, the network of IAVI-supported research centres powers IAVI’s vaccine development programme. Our approach emphasises building local capacity by training local researchers and developing the infrastructure required to conduct vaccine trials, and clinical HIV studies that describe the epidemic and lay the groundwork for future vaccine efficacy trials.

Threats posed by funding cuts

Sustaining the gains IAVI has seeded in the developing countries in which it operates requires sustained investment. The on-going global economic crisis has inevitably led governments and other funding entities to review, and in many cases, cut their funding. In 2010 global investments in HIV/AIDS R&D fell for the second year running, down 5.9% from 2009. [1] IAVI too has seen a decline in its income since the onset of the global economic crisis in 2008.

For 15 years IAVI has worked tirelessly with support from donors like DFID, to build a strong cadre of scientific personnel who have access to the latest equipment, research and support to maintain internationally recognised standards of research practice in developing country settings. Any cuts to funding threatens to undermine many of the gains we have made in building scientific research capacity in developing countries.

When faced with funding shortfalls, research organisations like IAVI have to make tough decisions about sustaining the overall operation to ensure we remain true to our mission. IAVI aims to maintain its various clinical trial sites around the world to test AIDS vaccine candidates as they move through our pipeline. However, cuts to IAVI’s funding remain a significant threat to undermining scientific capacity in developing country settings.

IAVI is currently in receipt of a multi-year grant from DFID which comes to an end in 2012. This grant has been enormously beneficial in helping IAVI in its mission and, as outlined above, in building and strengthening scientific capacity in developing country settings. As we enter 2012, IAVI working hand-in-glove with DFID hopes to agree and sign a further multi-year grant that will allow us to sustain the investments made thus far in building scientific capacity.

 

Question 2:
What are the most effective models and mechanisms for supporting research capacity in developing countries?
 

Product Development Partnerships (PDPs) are a class of not-for-profit organisations focused on developing new products to meet health challenges in the developing world and bringing them to market as quickly as possible. PDPs are currently developing new technologies to diagnose, treat and prevent a range of diseases which impact seriously on the health and livelihoods of people living in low- and middle-income countries.

Although PDPs vary in terms of their focus and approach, all PDPs realise their mission by co-ordinating the contributions of the private, public and not-for-profit sectors. PDPs work with others to engage and direct the public and private sectors to address the scientific, economic, legal and political challenges that exist in developing new health technologies for use in developing countries and ensuring rapid and widespread access and use.

PDPs such as IAVI play a key role in accelerating R&D for new health technologies. In 2009, PDPs had nearly 150 biopharmaceutical, diagnostic and vector-control candidates in various stages of development, including 32 in late-stage clinical trials. The recent evaluation carried out by the Government of The Netherlands and the World Health Organisation’s action plan on innovation in health care confirmed the high impact of PDPs on developing countries and argued that PDPs provide an "optimal funding allocation at all stages of research and development, in a manner best designed to maximise public health returns in the developing world."

IAVI is unwavering in its dedication to ensuring the development of an AIDS vaccine suitable for use in developing countries where AIDS has taken the greatest toll. Further, clinical capacity-building efforts provide near-term ancillary benefits with far-reaching consequences, contributing to economic growth and poverty reduction by strengthening partner countries’ technical and human ability to formulate, implement, and lead research strategies, integrating local researchers into global knowledge networks, and strengthening national legal, regulatory, and policy systems.

Capacity-building in developing countries is integral to the work of PDPs. PDPs collaborate with developing country partners to advance candidates in the R&D pipeline and invest significant resources in partner countries to support and expand existing physical and systemic infrastructures in the communities in which they operate. A few examples of PDP support for scientific capacity-building include:

· diversifying economies

· enhancing local firm’s abilities to compete globally

· enhancing knowledge-generating institutions’ abilities to conduct science and develop new technologies and adapt existing ones

· creating jobs, and

· strengthening governments’ abilities to use science in policymaking.

Additionally PDPs such as IAVI with the ultimate goal of developing and increasing access to health technologies and improving public health play a unique role in strengthening developing countries’ scientific capacities by:

· linking developing countries to international knowledge networks

o IAVI Neutralizing Antibody Consortium [1]

o DNDi Leishmaniasis East Africa Platform [2]

· building health research infrastructure

o Examples of IAVI’s clinical research partners include: Kenya AIDS Vaccine Initiative (KAVI), and the Uganda Virus Research Institute (UVRI) [3] . For example, UVRI’s HIV Vaccine Programme consists of state-of-the-art laboratories, clinical space and administrative offices. It was the first programme in sub-Saharan Africa to receive GCLP accreditation and was selected in 2005 to be a central laboratory in the Consortium for AIDS Vaccine Development.

o DNDi Leishmaniasis Research and Treatment Centre in Ethiopia - Africa's first clinical research facility dedicated to visceral leishmaniasis

o Medicine for Malaria Venture (MMV) improved R&D capacity and capabilities in 39 of 55 research centres in over 24 malaria-endemic countries

o Foundation for Innovative New Diagnostics (FIND) has been working with the Lesotho Ministry of Health to upgrade the national TB reference laboratory

· Increasing health research human resources

o IAVI, MMV, TB Alliance, DNDi all invest in Good Clinical Laboratory Practice (GCLP) accreditation of laboratory workers at their clinical research centres to ensure compliance with international standards

· Strengthening the evidence-base to inform policymaking

o MVI is currently working with WHO and African countries to establish decision-making processes around vaccine use

o IAVI works with developing country partners to mathematically model the potential impact of an AIDS vaccine and conduct analysis of their biopharmaceutical innovation systems

Yet PDPs like IAVI are facing funding cuts. In the most recent G-Finder report (a report that tracks investments in R&D for neglected diseases), it is worth noting that PDPs collectively saw funding cuts of US$ 47 million in 2010. This is a worrying trend that threatens the development of new products to combat neglected diseases. [2]

Appendix I:

Potential issues in AIDS vaccines Research studies and lessons learned (IAVI Policy Research Paper #6)


[1] G-Finder, 2011 Is Innovation under threat. Policycures available from http://www.policycures.org/downloads/g-finder_2011.pdf

[2] http://www.policycures.org/downloads/g-finder%20summary%202011.pdf


[1] IAVI’s Neutralizing Antibody Consortium (NAC) was formed in 2002 as a pioneering effort to launch the first large-scale collaborative research effort to address a fundamental hurdle in HIV vaccine design: how to elicit antibodies that neutralize a broad range of HIV strains.

[2] The overall aim of the platform is to strengthen clinical research capacity, which is lacking in part due to the remoteness and geographic spread of the patients, most of whom live in the most impoverished regions of Africa

[3] In Kenya, IAVI is partnering with the University of Nairobi and Kenya AIDS Vaccine

[3] Initiative (KAVI). In Uganda, IAVI is partnering with the Uganda Virus Research Institute (UVRI) under an agreement with the Government of Uganda signed in August 2001.

[3]

[3]

[3]

[3] International AIDS Vaccine Initiative

[3]

[3] 16 December 2011

Prepared 22nd December 2011