Community-driven solutions for the AMR problem: outcomes from a regulator-innovator workshop on challenges across AMR innovation, access, and adoption.

Abstract

Antimicrobial resistance (AMR) is a global threat that requires innovative solutions to protect our future and avoid repeating the mistakes of our past. To do this, innovation and regulation need to work together to deliver new therapeutics, diagnostics, and vaccines in a timely and risk-proportionate manner. Funders recognize that providing product developers with access to technical, regulatory, and experiential knowledge derisks their investment and maximizes the likelihood of success. The Global Antimicrobial Innovation Fund (GAMRIF) is a global funder in AMR innovation across One Health with a Lower Middle-Income Country focus; in 2024, it increased its innovator support structure to include a regulatory science team at the Medicines and Healthcare products Regulatory Agency (MHRA). As part of its discovery work, the GAMRIF-MHRA team held a 2-day meeting convening innovators, product developers, manufacturers, regulators, funders, and access and policy experts to interrogate the product journey across development, regulation, manufacturing, and market access to identify common challenges and generate practical solutions to address them. Here we present a summary of the meeting content, and recommendations and next steps based on delegate engagement and feedback.