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Letter from Chairman and Executive Director

                    Bernard Pécoul
Bernard Pécoul
Executive Director
and

Marcel Tanner
Marcel Tanner
Chairman of the Board
                



The year 2013 marked the 10-year anniversary of DNDi

…and provided us the opportunity to reflect not only on our own work, achievements, and lessons learned, but also on the broader landscape of research and development (R&D) for neglected diseases and how it has evolved since DNDi was launched. It was also an opportunity to reinforce the voices and perspectives from the disease-endemic regions where DNDi is rooted, and to open our debates to questioning the future orientations of the organization.

The momentum today is a sign of advancement and engagement
One of the most striking outcomes of the 10-year reflection is that, while DNDi was established in what was a neglected disease R&D vacuum, we are now in a true landscape, with many initiatives and actors engaging in one way or another, albeit not yet in a coordinated manner. While admittedly this landscape is fragmented and even fragile in many ways, there is no doubt that the momentum today is a sign of advancement and engagement. But global progress has taken time to bear fruit. A recent analysis of the R&D pipeline for neglected diseases showed that the past ten years have only seen a small increase in the percentage of drugs and vaccines approved for neglected diseases, but that this slight increase was primarily in repurposing or combining existing drugs – so-called incremental improvements.

Truly new drugs have not yet made their way to the end of the development pipeline. While short-term improvements have had a great impact, that of a new, simple oral treatment for a deadly disease such as sleeping sickness for example, would be enormous, and requires greater resources and commitment, especially when such tools are vital to supporting the control and elimination targets established by the WHO.

DNDi started out as an experiment, and such experiments require innovation, risk taking, knowhow, anticipation, and solid partnerships. While the first decade of DNDi has rendered important results – six treatments delivered and a robust drug development pipeline established, with 12 new chemical entities (NCEs) in pre-clinical and clinical development – it has also provided some key lessons that we will endeavor to translate into the DNDi of the next decade. To do this, we began by analysing the DNDi model and what we consider the four key pillars of the organization:
  • the patient needs’ driven approach must remain central to our priority setting and decision making processes;
  • a commitment to sharing knowledge and an access-oriented intellectual property policy are vital in a field where R&D incentive is lacking;
  • diversifying and balancing funding sources ensures scientific independence; and
  • innovative partnerships are crucial.

Sustainability is the fundamental issue
DNDi conducted this analysis in order to inform all stakeholders, partners, and donors who share DNDi’s vision and mission of the necessity of establishing a more sustainable framework for neglected disease R&D.

Sustainability is the fundamental issue. For example, sustaining and increasing funding is more important than ever as new chemical entities are reaching clinical trial phases, typically the most costly part of drug development. New incentives, new funding sources and mechanisms, including those that pool funding sources together to specifically target priority R&D, are essential. The financial fragility of many organizations is a constant threat to many crucial projects and is a disincentive to enter into – and stay in – the field. Another example concerns regulatory capacities in developing countries. In addressing developing countries’ health needs, many argue that stringent regulatory authorities are the only qualified institutions to evaluate medicines. However, only endemic countries themselves can assess the risks and benefits of health products for the diseases affecting their own populations. It is thus of paramount importance that the regulatory capacities of these countries be strengthened, and regional harmonization – where appropriate – be supported in the long term.

The DNDi model, while just one example, has experimented with new ways of partnering and conducting R&D for neglected diseases. By expanding on its own lessons learned after ten years, and as part of a global process of WHO member states to move towards a global framework for the financing and coordination of R&D for the priority health needs of developing countries, DNDi proposed projects aimed at demonstrating the principles laid forth by the WHO Consultative Expert Working Group (CEWG). ‘The Visceral Leishmaniasis Global R&D and Access Initiative’ was selected. It aims to demonstrate that coordination, transparency, capacity building, and innovative research and financing incentives can truly and effectively boost development and delivery of treatments for patients in need, and will ensure that the cost of treatments is not linked to the investment made in their development.

Learn from all innovative approaches to ensure translation into an effective framework
This process holds the promise of ensuring that needs, and not markets, will drive the development and delivery of essential health tools to those in need of them. But we will have to humbly learn and apply the lessons from DNDi and other experimental approaches to ensure translation into an effective framework, based on open models of innovation and access. With 70% of the world’s poor living in middle-income countries, the challenges of access to essential medicines need to be revisited and addressed in new ways.

DNDi will continue to work to deliver on its mandate, and to ensure that the future direction of the organization is one that is rooted in the needs of neglected patients and the innovation they deserve, both in terms of science and in how we operate, as we gear up for the next exciting decade.



    signature Pecoul                           signature Tanner
Dr. Bernard Pécoul                 Prof. Marcel Tanner
Executive Director                    Chairman

 





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