The Global Antibiotic Research & Development Partnership (GARDP) and the Drugs for Neglected Diseases initiative (DNDi) signed an Alliance Agreement on 21 December, demonstrating the willingness of both organizations to strengthen their collaboration and to develop a more strategic partnership in certain areas.
Dr Bernard Pécoul, DNDi Executive Director, and Manica Balasegaram, GARDP Executive Director
GARDP and DNDi outlined their common vision through the agreement: ‘As non-profit research and development organizations focused on infectious diseases of critical public heath importance, GARDP and DNDi are driving innovation for and equitable access to lifesaving and lifechanging treatments not delivered by the current research and development ecosystem. GARDP and DNDi share a common approach to harness the best of the public, private, non-profit, academic, and philanthropic sectors through open and collaborative approaches, to develop and deliver treatments. For both organizations, know-how and capacity of regions with a high disease burden is an integral part of our global partnership model and a backbone for fostering sustainable innovation and equitable access.’
The new Alliance Agreement aims to maximize impact and value for the organizations, including pooling selected research and development and policy expertise, as well as working together on joint projects in countries such as India and South Africa.
GARDP was launched in 2016 by the World Health Organization (WHO) and DNDi as an important element of WHO’s Global Action Plan on Antimicrobial Resistance. GARDP became a legal entity in 2019, following a successful three-year incubation, hosted by DNDi.
by Balasegaram M, Pécoul B, Gray G, Sharland M, Swaminathan S. The Lancet Infectious Diseases 2019, 19(6):573-574. doi: 10.1016/S1473-3099(19)30214-2
Summary: New-born babies, infants and children are substantially affected by antimicrobial resistance, with an estimated 214,000 newborns dying from drug-resistant bacterial infections in 2015. Guidelines and evidence-based treatments are lacking, and few drug development projects are dedicated to new antibiotics for this population. The authors of this commentary call for:
An appropriately resourced initiative to accelerate completion of paediatric clinical studies of newly registered antibiotics or drugs in the late stages of development.
Additional strategic clinical trials for old and new drugs, targeting key population groups and public health needs.
Recommendations that can be applied in different sub-populations, geographies, and diverse resistance patterns.
The Global Antibiotic Research and Development Partnership (GARDP) is now an independent legal entity following a successful three-year incubation, hosted by the Drugs for Neglected Diseases initiative (DNDi). During this time, GARDP has already begun working with partners to develop antibiotics to tackle drug-resistant infections which pose a threat to global health and development, including the achievement of the Sustainable Development Goals.
Launched in 2016 by the World Health Organization (WHO) and the non-profit research and development (R&D) organization DNDi, GARDP is an important element of WHO’s Global Action Plan on Antimicrobial Resistance (AMR). During its incubation, and through the generous support of donors and partners, GARDP has built a skilled and dedicated team with expertise from a range of sectors and backgrounds led by a Board of Directors comprising leading international experts in the global health arena.
In the last three years, GARDP has formed numerous partnerships with industry, academia and research institutions in support of its clinical programmes to develop antibiotics for drug-resistant infections for children, newborns with sepsis, and sexually-transmitted infections. These collaborations span the drug development lifecycle and include screening chemical libraries for antibacterial activity, assessing the viability of potential antibiotic candidates, and the completion of three clinical trials. Of particular significance is the pivotal, Phase III global clinical trial GARDP is sponsoring for a novel, first-in-class antibiotic to treat gonorrhoea commencing later this year.
GARDP’s Chair of the Board, Professor Ramanan Laxminarayan, said: “GARDP’s provenance from WHO and DNDi, and its significant progress in the last three years have positioned it well to play a key role in helping bring new antibacterials to market. GARDP is also focused on ensuring that we have access to affordable and effective antibacterials for generations to come. On behalf of the GARDP board, I thank DNDi and WHO for their leadership and support during the early years and look forward to the next phase in GARDP’s journey.”
Built on the shared missions of WHO and DNDi, GARDP draws its strength from both WHO’s mandate to drive the global response to AMR and set health priorities, and DNDi’s expertise in harnessing partnerships with the public and private sectors, and building a pipeline for public health needs-driven R&D.
As GARDP’s host, DNDi provided GARDP with its initial governance and support necessary for an effective start-up phase. Going forward, based on a shared commitment to public health-driven R&D and access, DNDi and GARDP will continue to collaborate, sharing specialized R&D expertise and capacity, policy advocacy expertise, and some infrastructure and support services to drive efficiencies. In-country implementation of GARDP’s programmes will be supported by DNDi’s regional network and a joint DNDi GARDP office in Southern Africa.
“We’re proud to have provided the environment to enable GARDP to kickstart its mission to deliver antimicrobial research for patients,” said Dr Marie-Paule Kieny, DNDi Board Chair. “DNDi and GARDP have a shared vision of public health-needs driven research and development that ensures equitable and sustainable access to affordable treatments. We look forward to a strong collaboration in sharing resources and knowledge with GARDP in the future, for the ultimate benefit of the populations served by GARDP and DNDi.”
GARDP will also continue its close collaboration with WHO, leveraging WHO’s expertise and leadership in determining public health priorities, developing target product profiles, stewardship and access, regional networks, as well as access to Member States.
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said: “The rise of drug-resistant bacteria is jeopardizing decades of progress and threatening our ability to prevent and treat infections that were once easy to treat. As one of GARDP’s founders, WHO is committed to continue supporting GARDP and its growing ambitions to tackle one of the biggest threats to global health. GARDP is an essential element of delivering the Global Action Plan on AMR.”
GARDP looks forward to working closely with its founding partners as it enters the next phase in its development. The continued collaboration will help ensure that GARDP’s efforts contribute to a world where antibiotic treatments are developed for all those who need them.
About GARDP
The Global Antibiotic Research and Development Partnership (GARDP) is a not-for-profit research and development organization that addresses global public health needs by developing and delivering new or improved antibiotic treatments, while endeavouring to ensure their sustainable access.
Initiated by the World Health Organization (WHO) and the Drugs for Neglected Disease initiative (DNDi), GARDP is an important element of WHO’s Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships to encourage research and development of new antimicrobial agents and diagnostics. www.gardp.org
About DNDi
A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected diseases, including leishmaniasis, filarial infections, human African trypanosomiasis, Chagas disease, and mycetoma, and for neglected patients, including paediatric HIV patients and people living with hepatitis C virus who cannot access treatment due to high costs. DNDi has delivered eight new treatments to date, including new drug combinations for visceral leishmaniasis, two fixed-dose antimalarials, and DNDi’s first successfully developed new chemical entity, fexinidazole, approved in 2018 for the treatment of both stages of sleeping sickness. www.dndi.org
As part of the ‘Evénement économique 2017’ that took place on November 9, the Geneva Chamber of Commerce, Industry and Services (CCIG), the Department of Security and Economy (DSE) and the Office for the Promotion of Industries and Technologies (OPI) awarded the Innovation Prize 2017 to the Drugs for Neglected Diseases initiative (DNDi). [Français]
The prize was awarded in recognition of DNDi’s innovative and collaborative model, as well as the progress DNDi has made in medical innovation for neglected patients. Since its creation in 2003, DNDi has already developed and implemented seven treatments against malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, and paediatric HIV. DNDi’s portfolio also includes 16 new chemical entities, some of which could be future new medicines to treat neglected diseases and change the lives of patients and healthcare workers.
Pierre Maudet, Conseiller d’État of Geneva Canton speaks to Bernard Pécoul, Executive Director of DNDi, after watching a virtual reality film about sleeping sickness in the Democratic Republic of Congo
“We are very honoured to receive this Innovation Prize here in Geneva, where it all began for DNDi almost 15 years ago,” said Dr Bernard Pécoul, DNDi’s Executive Director. “Innovation is essential when the mission is to develop new treatments for patients who do not represent a profitable market. We had to be innovative to bring together public and private partners into our collaborative model. We will have to continue to be innovative to meet our objectives: developing oral, safe, and effective treatments that are affordable and adapted to field conditions, which are sometimes challenging, in countries where health systems remain fragile. Since innovation is not possible in isolation, we are happy to share this Prize with all of our partners and donors, in Switzerland and around the world”.
A l’occasion de l’Evénement économique 2017 du 9 novembre dernier, la Chambre de commerce, d’industrie et des services de Genève (CCIG), le Département de la sécurité et de l’économie (DSE) et l’Office de Promotion des Industries et des Technologies (OPI) ont décerné le Prix 2017 de l’innovation à l’initiative Médicaments contre les Maladies Négligées (DNDi). [English]
Cette distinction récompense le modèle innovant et collaboratif de DNDi ainsi que les progrès apportés en termes d’innovation médicale en faveur des patients les plus négligés. Depuis sa création en 2003, DNDi a déjà développé et mis sur le marché sept traitements contre le paludisme, la maladie du sommeil, la leishmaniose viscérale, la maladie de Chagas et le VIH/Sida pédiatrique. De plus, son portefeuille de recherche compte 16 nouvelles entités chimiques dont certaines seront les médicaments novateurs de demain pour soigner certaines maladies négligées et changer la vie des patients et du personnel soignant.
Pierre Maudet, Conseiller d’État du Canton de Genève, discute avec Bernard Pécoul, Directeur exécutif, DNDi, après avoir visionné un film en réalité virtuelle sur la maladie du sommeil en République démocratique du Congo
« Nous sommes très honorés de recevoir le Prix de l’Innovation, ici à Genève où tout a débuté pour DNDi il y a près de 15 ans », s’est réjoui le directeur exécutif Dr Bernard Pécoul. « Il faut être innovant lorsqu’on se fixe pour mission de développer de nouveaux médicaments pour des patients qui ne représentent pas un marché lucratif. Etre innovant pour réunir à travers notre modèle collaboratif des partenaires publics et privés. Etre innovant, enfin, pour arriver à l’objectif que l’on s’est fixé : développer des médicaments oraux, sûrs et efficaces, abordables et adaptés aux conditions du terrain, parfois difficiles, dans des pays où les systèmes de santé restent fragiles. Parce qu’on ne peut pas être innovant si on est seul, nous souhaitons partager ce prix avec tous nos partenaires, en Suisse et dans le monde, et l’ensemble de nos donateurs. »
The office will work in close collaboration with a broad range of partners across the South African government, academia, hospitals, and civil society on the development of R&D programmes on paediatric HIV, hepatitis C, and antibiotic resistance, and will be headed by Carol Ruffell, who joins DNDi after more than 20 years of experience in the corporate pharmaceutical industry and in community pharmacy.
“DNDi has a rich history of intensive collaborations with South African partners in the development of new treatments for neglected patients, and we are grateful for the strong support from the South African Department of Health and the Medical Research Council in hosting our liaison office, which will enable us to take these partnerships to the next level, and notably develop R&D projects in the field of antimicrobial resistance,” said Carol Ruffell.
The South African liaison office will be hosted by the South African Medical Research Council (SAMRC), which was one of the seed funders for GARDP, a joint initiative created by DNDi and the World Health Organization, launched in 2016 to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all in need.
“This endeavour is evidence that public-private partnerships have the ability to design responsive interventions, that when taken to scale, can positively transform the socio-economic constructs of our communities where needed,” said Professor Glenda Gray, President & CEO of the SAMRC. “We are delighted to host DNDi and GARDP as they increase their operational activities in South Africa.”
Existing or soon-to-be-launched DNDi and GARDP programmes in South Africa include:
the development and implementation of a new, solid, first-line “4-in-1” fixed-dose formulation for children living withHIV, to replace existing foul-tasting liquid solutions, which have a high alcohol content, require refrigeration and are difficult to store, making them unsuitable for use in resource-poor settings;
the development of better treatment regimens for children co-infected with HIV and TB to counter drug-drug interactions between antiretroviral therapy and anti-tuberculosis medications;
the development of a safe, effective and affordable treatment regimen for hepatitis C that can be used for all patients and all genotypes, thereby radically simplifying hepatitis C treatment and enabling a public health approach to the disease;
a clinical trial to develop a novel, first-in-class, oral antibiotic and one of the only treatments in the R&D pipeline to address the rapidly-growing threat of drug-resistant gonorrhoea;
an observational study to provide an evidence base for the use of antibiotics in neonates with serious bacterial infections, as the currently available standard of care is increasingly becoming less effective due to antimicrobial resistance.
DNDi relies on close collaboration with a number of high-profile South African partners including: Tygerberg Hospital, Cape Town; Shandukani Research Centre, Witwatersrand Reproductive Health and HIV Institute (Wits RHI), Johannesburg; Perinatal HIV Research Unit (PHRU), Johannesburg; Chris Hani Baragwanath Hospital, Johannesburg; Rahima Moosa Mother and Child Hospital, Johannesburg; Enhancing Care Foundation, Durban; University of Cape Town; University of Cape Town Private Academic Hospital (UCTPAH); University of Witwatersrand, Johannesburg, and the Southern Africa Medical Unit, Médecins Sans Frontières (Doctors Without Borders) South Africa.
The South Africa liaison office is DNDi’s ninth office across the world and the third in Africa, and complements the work of the Headquarters in Geneva and of existing regional offices in Rio de Janeiro, New Delhi, Kuala Lumpur, Tokyo, New York, as well as Nairobi and Kinshasa.
Pierre Maudet, Conseiller d’État du Canton de Genève, discute avec Bernard Pécoul, Directeur exécutif, DNDi, après avoir visionné un film en réalité virtuelle sur la maladie du sommeil en République démocratique du Congo
