Breakthrough treatments for the most neglected diseases: diversifying approaches is required to expand the development pipeline with new chemical entities

Graeme BilbeGraeme Bilbe, Research & Development Director, DNDi
[November 2015]

Addressing the lack of patient-adapted treatments for those suffering from neglected diseases is no easy task. DNDi’s initial short-term strategies were designed to quickly provide improved treatments through new formulations or combinations of existing drugs, and/or improved treatment regimens. Six new treatments have been delivered since 2003.

The FACT project: a successful approach to solving public health needs

Jean-Rene KiechelJean-René Kiechel, Senior Pharma Advisor & Product Manager, DNDi
[June 2015]

The beginning of the current millennium saw a radical change in the way malaria was treated. In 2001, in response to rising chloroquine resistance, the WHO recommended replacing this monotherapy with artemisinin-based combination therapies, known as ACTs. The Drugs for Neglected Diseases Working Group of the MSF Access Campaign and WHO-TDR came together with other experts and stakeholders from both non-endemic and endemic countries to form the Fixed-Dose Combination Therapies (FACT) consortium in 2002, with projects subsequently transferred to DNDi when it was established in 2003.

Chagas Disease in Colombia: An opportunity to lead the way towards change

Rafael VilasanjuanRafEric Stobbaertsael Vilasanjuan, ISGlobal and Eric Stobbaerts, DNDi Latin America – members of the Global Chagas Disease Coalition
[April 2015]

During the month that celebrates International Chagas Disease day, Colombia, via its Ministry of Health has confirmed its commitment to the disease, a reason for optimism for the entire region. Aware of the difficulty of access to diagnosis and treatment (less than 1,000 patients treated), an action plan has been proposed to tackle Chagas Disease under the leadership of the Ministry of Health and Social Protection. A model project supported by DNDi and capable of being implemented in other locations arose as an example and brings hope not only to the 437 thousand infected persons and roughly 4.8 million people at risk of being infected in the country, but also for other affected countries.
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Will Crisis See a Long-Awaited Response to Lack of Innovation and Access Come from Public Leadership?

Bernard PécoulBernard Pécoul, Executive Director, DNDi
[February 2015]

While the epidemic peak of the Ebola crisis slightly begins to wane and with it potential avenues for treatment beginning to emerge, the global health community simply cannot go back to business as usual. A strong public opinion has been mobilized and with Ebola now a household term, there is simply no turning back. A hard stance is being taken on many fronts, including policy makers, scientists, pharmaceutical companies, philanthropists, civil society members, global health experts, and journalists to ensure that beyond this one crisis, the lessons learned from several hitherto seemingly unrelated public health issues be brought together and examined with the same scrutiny. But we cannot stop there; a comprehensive and lasting solution could be at our doorsteps but requires a serious look at what is not working currently, and what is!

Strengthening the Malaria Treatment Arsenal for Children in Africa

Dr Bernhards OgutuDr Sodiomon SirimaDr Bernhards Ogutu, KEMRI, Kenya and Dr Sodiomon Sirima, CNRFP, Burkina Faso
[November 2014]

Today, we have results of a large clinical trial conducted in three countries across both East and West Africa by DNDi in partnership with the Central National de Recherche et de Formation sur le Paludisme (CNRFP) in Burkina Faso, the Kenya Medical Research Centre (KEMRI) in Kenya, the National Institute for Medical Research (NIMR), and the Ifakara Health Institute in Tanzania. ASMQ (artesunate-mefloquine) fixed dose combination (FDC) has proven safe and efficacious in treating children with uncomplicated P. falciparum malaria in Africa, and is non-inferior to artemether-lumefantrine (AL).

Learning to deliver: Challenges in NTD drug research and development

Graeme BilbeDr Graeme Bilbe, Research & Development Director, DNDi
[September 2014]

DNDi and other not-for-profit drug research and development (R&D) organizations have explored new R&D pathways to develop and deliver safe, adapted, and affordable treatments for neglected diseases. Most of these new pathways have shown signs of success, while several have faced challenges that span across the drug discovery and development processes.

Conducting clinical trials for sleeping sickness in remote areas of the Democratic Republic of the Congo – Overcoming Operational Challenges and Reaping Health System Benefits

Wilfried MutomboDr. Wilfried Mutombo, Coordinating investigator, Fexinidazole study for HAT
[July 2014]

At the time DNDi and its partners are extending the clinical trial on fexinidazole, the first new oral treatment tested for sleeping sickness, to the early stages of the disease in adults and to children between 6 and 14 years of age, it is important to remember how clinical trials in remote areas of a country such as the Democratic Republic of the Congo (DRC) can be a daunting challenge, but can also bring lasting benefits to local communities and researchers, and to the health system overall.

Modern drug discovery and the fight against NTDs: How can the PDP model enhance and accelerate the R&D process?

Robert Don Charles MowbrayRobert Don, Discovery & Preclinical Director, and Charles Mowbray, Head of Drug Discovery, DNDi
[May 2014]

Important advances have been made in recent years to optimize the use of existing medicines to treat neglected tropical diseases (NTDs) but, while providing urgently needed improvements on previous treatments, they are often still not ideal. There remains an urgent need to design and develop modern drugs to treat these diseases.

Global Alliance for the Treatment of Chagas Disease: Thinking About the Patients

Sylvia GoldSilvia Gold, President, Mundo Sano Foundation
[April 2014]

American Trypanosomiasis, more commonly known as Chagas disease, no longer reflects the geographical scope of the disease. Today, Chagas disease affects people around the world. It is hard to imagine that a disease, discovered over a century ago, which today can be easily diagnosed and for which effective treatment exists, continues to be a problem of severe health impact.

Time for a Reality Check for Neglected Diseases

Bernard Pécoul Bernard Pécoul, Executive Director, DNDi
[February 2014]

The field of neglected disease R&D today is experiencing what could be characterized as a phase of shifting sands: after long inaction for decades, we are now experiencing both remarkable advances and rude set-backs. The innovative ideas, incentives, and R&D partnerships, such as DNDi, that emerged over the last decade are right at the nexus of these movements – of governments, industry, philanthropy, and civil society, among others – and they thus impact directly on our work. They provide a constant reality check that reminds us of just how fragile the field of not-for-profit drug development for neglected diseases is, be it in times of advances or in times of set-backs. We have to take this seriously into account and feed our reflections, debates, and efforts to secure the sustainability of the environment in which we work to solve, in the long term, the problems of millions of patients.

WHO R&D ‘Demonstration Projects’: A Member State-driven step towards a sustainable global framework for neglected disease R&D

Jean-François AlesandriniJean-François Alesandrini, Fundraising & Advocacy Director
[November 2013]

WHO Member States and experts, after weeks of consultations, are in the process of selecting ‘demonstration projects’ to address the unmet medical needs of developing countries. The overall objective of this process is to evaluate and assess new innovative mechanisms to coordinate and fund public health research and development (R&D).

The Role of Neglected Disease-Endemic, Emerging-Economy Countries in Neglected Disease R&D: Latin America on the Rise

Eric StobbaertsEric Stobbaerts, Head of DNDi Latin America
[September 2013]

As DNDi marks its 10 years of existence, the time is ripe to assess the achievements and difficulties experienced in order to move into a new decade with new approaches. For Latin America, in particular, this period is unique, even transformative, as it is marked by unprecedented economic and social strengthening of the region. This growth brings with it the crucial role of Latin America’s public and private sectors in contributing meaningfully to the neglected disease research and development landscape. The activities of DNDi Latin America are focused on contributing to this process and have expanded with increasing opportunities to partner with ministries of health and national control programmes, but also other non-governmental and private-sector actors, to address the needs of patients suffering from neglected tropical diseases endemic in the region.

African Dynamics to Tackle Neglected Diseases

Monique WasunnaMonique Wasunna, Head of DNDi Africa
[July 2013]

As Head of DNDi Africa, I was honored to bear witness to the special event recently co-hosted in Nairobi by DNDi and the Kenyan Medical Research Institute (KEMRI) to celebrate a decade of Research & Development (R&D) for Neglected Diseases (ND) in Africa. Ten years ago, about 70 participants met in Nairobi to discuss the first steps of what was to lead to 10 years of experiences, learning, and first successes of DNDi in Africa. On June 4th and 5th, we were more than 430 committed and passionate researchers, scientists, decision-makers, and donors to explore the opportunities and remaining challenges for R&D for neglected diseases in Africa. The presence of representatives from 33 countries, of which 21 African countries, and the keen interest of African and international media for the issues we covered is, in itself, an achievement for those who fight to place and keep neglected diseases on national and international public health agendas.

Connect to Fight Neglect: A Decade of Medical Innovations for Neglected Patients

Bernard Pécoul Bernard Pécoul, Executive Director, DNDi
[May 2013]

A decade ago, research and development (R&D) for neglected diseases was at a standstill. At the time, Médecins Sans Frontières/Doctors Without Borders (MSF) was experiencing firsthand in the field what it meant to be unable to treat patients with neglected diseases, because treatments did not exist or were inadequate. So MSF decided to commit its 1999 Nobel Peace Prize money to R&D for neglected diseases and, with six key public health partners worldwide – MSF, the Indian Council of Medical Research, Brazil’s Oswaldo Cruz Foundation, the Kenya Medical Research Institute, the Ministry of Health of Malaysia, Institut Pasteur in France, and the Special Programme for Research and Training in Tropical Diseases (WHO/TDR) – DNDi was launched in 2003.

Now is not the time to retreat from the fight against NTDs

Bernard Pécoul Bernard Pécoul, Executive Director, DNDi
[March 2013]

Last year saw an important cornerstone laid in the fight against neglected tropical diseases (NTDs), and one that highlighted the need to keep NTD research and development (R&D) on the global public health agenda. In January 2012, the World Health Organization (WHO) launched its NTD strategy, ‘Accelerating Work to Overcome the Global Impact of Neglected Tropical Diseases: A Roadmap for Implementation’, which set forth specific, time-bound targets for the prevention, control, elimination, or eradication of the 17 WHO-defined NTDs by 2020. The goals were set high, and key actors came together to commit to these goals at the ‘Uniting to Combat NTDs’ meeting in London in January 2012. At this meeting, major private, public, international, and non-governmental partners, including DNDi, aligned their efforts to support the WHO roadmap and accelerate progress toward eliminating or controlling 10 of the 17 NTDs by 2020 as put forth in the resulting ‘London Declaration on Neglected Tropical Diseases’.

Advocacy for sustainable elimination strategy for sleeping sickness

Florent MboDr Florent Mbo Kuikumbi, provincial coordinating physician of North Bandundu for the National Human African Trypanosomiasis Control Programme (DRC)
[December 2012]

Sleeping sickness has several facets. We have to cover all of the endemic areas with surveillance efforts, otherwise there will always be pockets than can later lead to epidemics. Today, for example, in Bandundu Province in the DRC, we can only say we are controlling the disease, not eliminating it. We have to be able to cover all of the disease pockets and follow them for some time.

Regulatory Harmonization in Developing Countries Needed to Speed up Neglected Patients’ Access to New Drugs

altNathalie Strub-Wourgaft, Medical Director, DNDi
[October 2012]

The need for regulatory harmonization (i.e. either allowing for centralized drug registration in multiple countries as one single approval, or mutual recognition which entails expediting registration in additional countries once a drug has been registered in a primary country with sufficient regulatory  capacities) in order to reduce the duplication of research efforts, use resources more efficiently, and especially to speed up the process to reach patients, was identified decades ago in Europe.