What are the most needed new products to address AMR?

Abstract

Background: The Global AMR R&D Hub (the Hub), launched in May 2018 following a call from the G20, supports global priority setting and evidence-based decision-making on allocation of resources for AMR R&D through the identification of gaps, overlaps and potential for cross-sectoral collaboration and leverage in AMR R&D. It is currently a global partnership of 16 countries, the European Commission and two philanthropic foundations. The OECD, FAO, OIE, and WHO are observers. A key activity for the Hub is to promote increased investments into incentives to support the replenishment of pipelines with priority candidates. An Expert Advisory Group (EAG) was established by the Hub to identify products (diagnostics, therapeutics or preventives) where there is the greatest unmet need to address AMR and estimate the market potential of these products. The focus of the work is on the WHO AMR priority pathogen list and tuberculosis. Methods and materials: The process for identifying the products of greatest need included reviewing the literature, epidemiology, other relevant work and examining the R&D pipeline. After considering this analysis, EAG members and other experts identified where the greatest unmet need was through an online survey. The results of the survey were summarized and themes and recommendations were grouped under key areas which were further discussed and agreed to by the EAG and the Hub's Board of Members. Results: The EAG prioritized five products where the need was perceived as the greatest: a diagnostic to reduce antibacterial use, a diagnostic to inform targeted treatment, two new therapeutics for multi-drug resistant Gram-negative infections and a multi-disease vaccine. For each of the five prioritized products a high-level outline was developed that describes the patient population and desired aspects of the products while considering the applicability for different settings. Conclusion: Ongoing review and refinement of the products and outlines is occurring based on the release of relevant updated data and recommendations from other initiatives. These outlines will be used to inform the market sizing for calculation of the market potential of each of the products, which will inform the Hub's incentive work. The outlines and estimations of the patient populations will be presented.