A flexible, multidimensional, global organization

GARDP

The Global Antibiotic Research & Development Partnership (GARDP) and Penta have joined forces to tackle drug-resistant infections in children. The strategic collaboration aims to accelerate paediatric development of antibiotic treatments including clinical trials designed to meet regulatory requirements and trials with a focus on public health interventions to inform treatment guidelines.

GARDP is a not-for-profit R&D 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 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 R&D of new antimicrobial agents and diagnostics. GARDP’s programmes on sexually-transmitted infections, neonatal sepsis, paediatric antibiotics and antimicrobial memory recovery, evaluation and exploratory research are designed to address global public health priorities.

Building on Penta’s international network of clinical trial sites and paediatric experts, GARDP and Penta’s partnership consolidates plans to develop a global children’s antibiotic platform, whose objectives include:

  • the development of a streamlined paediatric development plans acceptable to regulatory authorities;
  • the acceleration of regulatory approval of treatments by ensuring children’s trials are started as early as possible;
  • the incorporation of innovative designs to maximise the information that can be gained from each trial.

GARDP and Penta have established strong relationships with academic and/or government institutions from across Asia, Africa, Europe and South America. Partnerships with countries including Kenya, Greece, India, South Africa and Thailand underpin recent GARDP and Penta collaborations. These include a pharmacokinetic clinical trial in Kenya, to assess safety and dosing of the antibiotic fosfomycin in newborns, which recently completed enrolment; and a large-scale global observational study on neonatal sepsis, collecting clinical information in up to 3,000 newborns in 19 hospitals in 11 countries. Such engagement from countries worldwide, will be critical to the success of the platform and its trial networks.

A briefing note with further background on the need for children’s antibiotics and the partnership is available here.