Manica Balasegaram: 2017 a year in review


15 Dec 2017

Dear friends and colleagues,

The year 2017 was an extraordinary first full year of activity for the Global Antibiotic Research & Development Partnership (GARDP).

We began the year as a start-up, established in mid-2016 as a joint initiative by the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative (DNDi) to develop new antibiotic treatments to address antimicrobial resistance.

Thanks to you, we are now ending the year as an established R&D partnership with three R&D programmes launched, an independent Scientific Advisory Committee, a seven-year business plan, a liaison office in Cape Town, South Africa, and an additional EUR 56.5 million in newly raised funds. The year was also witness to our first biotech company partnership with Entasis Therapeutics.We have now also built a small but growing core team of 15, with already 120 external contributors to GARDP programmes.

Among the many we wish to thank in 2017, we must highlight, of course, our founding institutions WHO and DNDi, which is also hosting us in Geneva.

We also want to thank the governments and institutions that have given pledges and funded GARDP thus far: the German Federal Ministry of Health; the German Federal Ministry of Education and Research; the Luxembourg Development Cooperation and Humanitarian Aid; the Luxembourg Ministry of Health; Médecins Sans Frontières; the Monaco Ministry of Foreign Affairs and Cooperation; the Netherlands Ministry of Health, Welfare and Sport; the South African Medical Research Council; the Swiss Federal Office of Public Health; the UK Department of Health; the UK Department for International Development; and the Wellcome Trust.

GARDP programme achievements by the end of 2017

The Sexually Transmitted Infections (STIs) Programme, launched this year, will develop a new treatment for drug-sensitive and drug-resistant gonorrhoea for integration in the syndromic management of STIs. In July 2017, GARDP entered its first partnership agreement with biotech company Entasis Therapeutics to co-develop the antibiotic zoliflodacin in a global Phase III clinical trial. Zoliflodacin is from an entirely new class of antibiotic and the only drug in clinical development specifically targeted to gonorrhoea treatment. Study partners were confirmed for combination and resistance induction studies; a manufacturing partner for pharmaceutical development was identified; and feasibility Phase III and trial site selection began.

The Neonatal Sepsis Programme, also launched this year, will develop and deliver a new first-line treatment for clinically diagnosed neonatal sepsis, and a new treatment for confirmed multidrug-resistant pathogens. During the year, a feasibility and microbiology survey was completed, and an epidemiological survey has started in preparation for global observational study. Ethics and regulatory approval was received for a study on fosfomycin pharmacokinetics, and paediatric programme scoping criteria were established.

In September this year, GARDP launched the Antimicrobial Memory Recovery Programme and paved the way for the November soft launch of the REVIVE hub, an online space for inventors, chemists, and researchers to connect. Already, 124 of some 400 identified experts have engaged in the programme. Five companies have shared assets for GARDP, with 20 ‘recovered’ molecules now being actively explored. This programme aims to recover the knowledge and assets from the ‘golden era’ of antibiotic drug discovery and development, while the search for new classes of antibiotics is being pursued.

GARDP is currently conducting a scoping exercise for a fourth programme, the Paediatric Antibiotic Platform, with plans to optimize current treatments and accelerate the development of new antibiotics for children through improvements in dose, duration of treatment, and formulation, or through new drug combinations. GARDP is also building a strategy for drug discovery to support all of its programmes.

Fundraising

A successful fundraising event was hosted in September this year by the German Federal Ministry of Health and the German Federal Ministry of Education and Research, in follow-up to the Berlin Declaration of the G20 Health Ministers, particularly the pledge to invigorate research and development efforts to find new drugs. A total of EUR 56.5 million was pledged by the Governments of Germany, Luxembourg, the Netherlands, the Principality of Monaco, South Africa, Switzerland, the United Kingdom, and the Wellcome Trust.

Thank you to all our partners for your incredible engagement and support in 2017! We look forward to continuing, expanding, and reinforcing our collaborations with all of you worldwide to address antimicrobial resistance through our public health-oriented R&D programmes in 2018 and beyond.

Best regards,
Dr Manica Balasegaram
Director, GARDP


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