Initiated by the World Health Organization (WHO) and the Drugs for Neglected Disease initiative (DNDi) in May 2016, GARDP is an important element of WHO’s Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships to encourage R&D of new antimicrobial agents and diagnostics.
GARDP benefits from its unique parentage, drawing strength from both WHO’s mandate to drive the global response to antimicrobial resistance and set health priorities, and DNDi’s expertise in harnessing partnerships to build a pipeline for neglected diseases and deliver not-for-profit, needs-driven R&D.
The origins of GARDP
Starting in 2014, WHO and DNDi jointly developed the concept of setting up a new product development partnership through various consultations with Member States and other stakeholders. The idea was to set up a new initiative that would eventually become a dedicated entity, similar to DNDi’s own incubation by the medical humanitarian organization Médecins Sans Frontières (MSF) in 2003. DNDi’s consultations with its founding partners and key global public health actors during the revision of its business plan identified drug-resistant infections as an important area of unaddressed patient needs, paving the way for the incubation of GARDP.
In 2015, WHO Member States adopted the GAP-AMR from which the need to ‘create new public-private partnerships for R&D of new antimicrobial agents and diagnostics’ was identified. A technical consultation was held at WHO with Member States and other key stakeholders to discuss the proposed concept of such a product development partnership. With the support emanating from this meeting, DNDi’s Board of Directors approved the incubation of GARDP.
Initiated and incubated through close collaboration between WHO and DNDi, GARDP was launched in May 2016. Since then, GARDP received seed funding and pledges from the governments of Germany, Netherlands, South Africa, Switzerland, and the United Kingdom of Great Britain and Northern Ireland as well as from MSF.
By early 2017, GARDP had secured EUR 6.5 million in seed funding, built a team of 10, facilitated 11 expert meetings in 6 countries on specific disease areas, regional issues, project reviews, and sustainable access. A Scientific Advisory Committee of AMR and drug development experts had been set up. With their expert review and DNDi’s Board of Directors’ validation, GARDP began launching three programmes with one more in development. In July 2017, GARDP signed its first partnering deal with Entasis Therapeutics to develop a new treatment for drug-resistant gonorrhoea. Germany hosted a pledging event for GARDP in September, where a number of countries and foundations pledged more than EUR 56 million to GARDP.
Significant progress to address global health priorities such as drug-resistant infections in children, newborns with sepsis, and sexually-transmitted infections was made during GARDP’s final year under its incubation by DNDi. Activities included undertaking a global observational study in 11 countries, conducting two clinical trials, accelerating the development of antibiotics for children, recovering molecules for their potential value for antimicrobial drug development; and sharing the knowledge of established antimicrobial researchers and those starting their careers through REVIVE.
Several new public and private partnerships were formed spanning the drug development lifecycle, including with Takeda and Eisai, two Japanese pharmaceutical companies, to screen their chemical compounds for antibacterial activity, leveraging knowledge and sharing expertise from a strategic partnership with Sandoz, the Novartis generics division, to accelerate the development of antibiotics for children and a research collaboration with the University of Liverpool, UK to support evaluation of new treatment options for newborns with sepsis.
In July, GARDP was established as an independent Swiss Foundation and an initial board of directors appointed.
Marking the end of its incubation in DNDi, GARDP and DNDi agreed to an ongoing collaboration for a period of three years. Based on their shared commitment to public health-driven R&D, DNDi and GARDP will continue to collaborate sharing specialized R&D expertise and capacity, policy advocacy expertise, and with support from DNDi’s regional network for in-country implementation.