After spending years of his life researching and teaching on poverty-related diseases, including HIV/AIDS, malaria and tuberculosis (TB), as well as capacity building to empower others to research these diseases, it was a natural step for Professor Charles Mgone to take on his present role as executive director of European and Developing Countries Clinical Trials Partnership (EDCTP), to coordinate the funding and administration of its research projects.
EDCTP was established in 2003 with the goal of accelerating R&D of new or improved interventions, such as drugs, vaccines, microbicides and diagnostics to combat these diseases, through funding clinical trials and capacity strengthening to ensure that trials are conducted following internationally accepted standards and applicable ethical and regulatory guidelines.
To achieve this, EDCTP provides a platform for European member states to combine their efforts into a single scientific strategy, with common funding and a central administration to partner with their counterparts in sub-Saharan Africa. It also fosters synergy with like-minded organisations, including the private sector, such as industry, funders and public-private partnerships.
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Biography Born in Tanzania, Charles Mgone trained as a clinician in Tanzania and the UK, practising and teaching paediatrics as well as conducting research. While in the UK he took a PhD in Medical and Molecular Genetics, continuing afterwards with study of infectious diseases including measles, malaria, HIV/AIDS, chlamydia and other sexually transmitted infections. During this period he was the deputy director and later the acting director of the Papua New Guinea Institute of Medical Research. He has served as advisor at international and national levels, particularly on malaria and HIV/AIDS but also on child health and public health issues. He has written for peer-reviewed journals and was the chief editor of the Papua New Guinea Medical Journal. He is the current chief editor of the Tanzania Paediatric Journal. Prof Mgone was network director of the African Malaria Network Trust (AMANET), responsible for developing and overseeing capacity development of African institutions and scientists conducting clinical trials. He joined EDCTP as head of the Africa office in Cape Town where he was responsible for fostering of African ownership and commitment to the EDCTP programme by engaging with policy makers, scientific community, networks of excellence, NEPAD and African Union. Prof Mgone has been executive director of the European and Developing Countries Clinical Trials Partnership (EDCTP) since February 2007. |
Trained as a paediatrician, Mgone studied genetics in Glasgow, Scotland, from where he moved to Papua New Guinea to research how people’s genes resist disease and what makes some more susceptible to certain diseases.
“In particular at that time I was working on malaria, sexually transmitted infections, especially HIV/AIDS, but also chlamydia and human papilloma viruses,” he states.
This work led him back to Africa, where he supported capacity development on research and development for a malaria vaccine, before taking his current position at EDCTP.
“My original role was to bring the African commitment, African voice, African researchers’ priorities to the forefront,” he continues.
Some of the projects in which EDCTP has been instrumental include: the development of a fixed dose combination of paediatric ART (Antiretroviral Treatment); the simplification and shortening of tuberculosis treatment; the simplification of intravenous Artesunate treatment of severe childhood malaria; early studies on novel anti-TB vaccines and the establishment of networks for conducting clinical trials.
He highlights the trials EDCTP is funding to investigate the safety profiles of drugs on particular populations, such as pregnant women, malnourished children, the elderly or those living with HIV/AIDS, which are not normally carried out in the development of new drugs, where trials tend to be on general adult populations.
Regarding paediatric formulations, Mgone explains the difficulties of many drugs not being formulated for children, resulting in pills having to be split and dosages not being tailored to the recipient.
“You can imagine, in a village situation, even in developed countries, it may not be very easy to give the correct dosages and it is not user-friendly either,” he states. This is why EDCTP undertook the CHAPAS trial using fixed dose combination ‘baby pills’ on HIV-infected children, which resulted in the development of Pedimune for this market.
EDCTP is working with many public-private partnership groups, including Medicines for Malaria Venture (MMV), with which it conducts research and development of new drugs against malaria. Mgone is also keen to develop a relationship with UNITAID, which has a patent pool, to partner on clinical trials in the field of HIV/AIDS.
EDCTP is also working with the TB Alliance and companies working in that field, like Bayer, to research how TB treatment can be shortened and simplified. Studies are focusing on new diagnostics for TB, as well as biomarkers.
“Unfortunately, with tuberculosis we do not understand the immunity of the disease very well. So when we’re testing new vaccines, for instance, how can you tell if they are effective? What are the indicators? We’re trying to find more indicators and in this we’re working with industry as well,” Mgone says. Regarding treatment for TB, he explains that the BCG vaccination that is used today was first used in 1921 and there has been little improvement since then: “And we know it is not the ideal vaccine, although it protects children against severe forms. But it doesn’t stop the contagious form acquired by adults. So we are working with Emergent BioSolutions and Aeras, a non-profit product developer, as well as institutions in the south and the north, to conduct trials in this.
“I mention this now because we are approaching phase III with some of the products and these trials are more expensive and require multiple partners, both for conducting trials and for production and up-scaling if they are viable and registered. We will bring all the stakeholders together to overcome these issues, including the design of the trials, how to bring several funders together, finding the sites where the trials can be conducted and so forth. Once we have taken scientific advice, we’ll hold a stakeholder meeting, which I hope could take place within the next few months.
“In the case of HIV, we’re working with IAVI [International AIDS Vaccine Initiative] and the Bill and Melinda Gates Foundation. For instance, with the Gates Foundation we put funds together to support capacity to conduct clinical trials. The whole philosophy of EDCTP is really to work in partnerships.
“We want to extend this, so we are having face-to-face meetings with industry heads and those responsible for corporate social responsibility so that we can understand what they want and how we can get them to participate more in EDCTP programmes. We have a meeting with them in The Hague at the end of June to establish a strategy for working more closely together. We will ask them what areas they are interested in regarding our scope in HIV, TB, malaria and now neglected tropical diseases.”
In their dealings with EDCTP, pharmaceutical companies are offering services including provision of investigational products, taking the role of clinical trials sponsors, monitoring of trials and, in a few cases, limited funding.
“One of the ways I can see the industry helping us is in capacity development, because it requires sound regulation and sound ethical review to carry out its work, just as we do,” Mgone continues. “Industry cannot directly support this because of conflict of interest, but a surrogate, like the World Health Organisation or us, can work with them on clinical trial registration, for instance. They can help us fund those activities without going into them directly. They can also help with clinical trial monitoring. We are also looking at training and whether they can be associated with that. We are looking at all the areas where we can find synergies besides the actual conducting of the trials themselves. It is all looking very positive.”
Mgone explains that EDCTP is expanding its remit to include neglected infectious diseases, including human African trypanosomiasis (sleeping sickness), filariasis (elephantiasis) and leishmaniasis. It will also encompass support for all phases of clinical trials (I-IV) including health services optimisation research to investigate how best to deliver the products.
EDCTP will continue to develop as a major broker of partnerships playing a key role in leveraging funds, expertise and synergies between various players, particularly in the Africa-Europe partnership. Although its activities remain focused on sub-Saharan Africa, “because that’s where the epicentre of the HIV, tuberculosis and malaria pandemic is”, there are plans to extend its reach to collaborations with developing countries outside sub-Saharan Africa, says Mgone.
“The work we’re doing is the mainframe work, like the mother ship, and we can dock other satellite projects on to it; as long as they fit the main model, they are welcome,” Mgone clarifies. “Consider TB, for example. Clinical trials will have to take place in India and China. So under the current model, we fund the activities in Africa, which amounts to around 70 per cent of all the global clinical trials, while our partners, like TB Alliance, fund the work in India and China. The same applies to the work we’re doing in malaria; we fund the African component and the Gates Foundation funds the Asian component.”
Despite the financial crisis, the participating member states and the European Commission have pledged to continue with the programme and even increase funding. As Mgone states: “As a matter of fact, it is at times like this that everyone needs to work together and in synergy to avoid waste, duplication and fragmentation of efforts. EDCTP offers a more cost-effective and unified means of tackling poverty-related diseases.”
Since EDCTP was set up, European member states have become more used to working together, jointly funding and centrally running their programmes, he believes, adding that African scientists have come out strongly as co-owners of the programme and taken leadership in research, while networks have proliferated beyond partnerships based on traditional and colonial ties. Plus, he is pleased that there is African representation at the General Assembly, which is the supreme body of EDCTP in charge of policy making.
Mgone sees the main challenges as ensuring that clinical trials are conducted under stringent international standards and that the outcomes will translate into policies. “EDCTP addresses this issue by funding capacity building activities such as training to undertake trials; north-south networking to facilitate technology transfer and south-south networking to ensure having a critical mass of scientists, sharing of resources and proliferation of capacities. Besides ensuring successful outcomes this aims to foster sustainability of the programmes and the developed capacity,” he explains.
Additionally, EDCTP supports ethics reviews and regulatory frameworks through training and funding ethics committees, national regulatory authorities and registration of clinical trials to enable implementation of best practice.
However, he is under no illusion about the difficulties surrounding coordination of the multiple partners involved: “The other international funders, public-private partnerships and industry have their own programmes and philosophies, so there are bound to be different approaches towards tackling the common goal of fighting diseases of poverty. The main challenge is therefore to ensure that they share their plans, coordinate their programmes and harmonise their activities. This is not easy, but it is improving.
”Despite the hurdles, he is proud of the achievements of EDCTP so far: “Bringing together European member states and sub-Saharan African counterparts to work for a common cause in a genuine mutual partnership is very gratifying,” he concludes.
The Interviewer
Linda Banks is editor of PME