R&D Insight

R&D Implications: Global Burden of Disease is 28% Infectious!

17 Sep 2024 update: This is now the second of a 3-part newsletter series! See also part 1 (“#AMRSOS! GRAM report: ‘at least 1.27m deaths/year directly attributable to AMR’“) and part 3 (17 Sep 2024: “#AMRSOS! AMR could worsen, killing 39m during 2025-2050”). See also the 31 Aug 2026 newsletter entitled “#AMRSOS! The (human) cost of AMR:

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Milken webinar: Innovative financing models for antimicrobials

Note: I’ve been away on holiday (see the newsletter’s postscript) and so there are multiple new items in both the meetings calendar and the list of funding opportunities: TB! PACCARB! Funding for antifungals! Funding for R&D in India! Look closely!  Dear All: The AMR Multi-Stakeholder Partnership Platform (AMR MSPP) collaborated with the Milken Institute on

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Antimicrobial Effectiveness: The strategic economic value of antibiotics

Dear All (and with thanks to Lucy Naga for being the lead author on this economic-focused newsletter), Antimicrobials are the quiet safety net of modern medicine. They underpin everything from routine infections to cancer treatment and surgery. They also support animal health and food production. Antimicrobial Effectiveness (AME, the ability of these medicines to remain

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AWaRe antibiotic usage – Is 70% Access a good target?

Dear All: An important and instructive analysis of optimal global antibiotic usage targets has just been published in Lancet Public Health. To follow the plot, here are the links you need: The new paper: Cook et al.: “Benchmarking AWaRe: estimating optimal levels of AWaRe antibiotic use in 186 countries, territories and areas based on clinical

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WHO: Virtual discussion on challenges of evidence generation

Dear All: WHO have announced a very interesting 2-h virtual dialogue on optimal evidence generation across the antibiotic R&D lifecycle! Here are the details you need:  When: 31 Aug 2026 (virtual, 2-4p CET):  What: A dialogue on challenges such as fragmented regulatory requirements, trade-offs in clinical trial design, and gaps between evidence generated for regulatory

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WHO Webinars: Pediatric antibiotic R&D and Bacteriophage Community of Practice

Dear All: Two important webinars have just been announced! 22 July (virtual, 2-3.30p CET): The WHO AMR Department and the WHO GAP-r (Global Accelerator for Pediatric Formulations) are hosting an industry dialogue on pediatric and neonatal antibiotic development: The discussion will cover timing of pediatric and neonatal studies, extrapolation from adult data, feasibility of trial

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FDA guidance on Substantial Effectiveness; EMA concept paper on Evaluation of Antifungal Agents): Comments sought!

Dear All: Both FDA and EMA have very recently released important documents for comment. See below the links and commentary on the two documents. == FDA: The Substantial Evidence guidance, further updated: Comments due 22 Sep 2026 ==FDA have released a further revision of their Dec 2019 draft guidance entitled “Demonstrating Substantial Evidence of Effectiveness

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Mirror Bacteria: An AMR threat of unprecedented magnitude

Dear All (wonkish but stick with it … I’m going to try very hard to de-wonk it; addendum: see also the follow-up newsletters, most recently on 22 Dec 2025), In an absolutely terrifying paper and technical report in today’s issue of Science, we are introduced in detail to the concept of “mirror” bacteria in which

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The threat of mirror bacteria: Ongoing conversations (2025 wrap-up)

Dear All, Regular readers will be aware of the global conversation now happening around the threat arising from the potential to create viable organisms that are (at a molecular level) the mirror images of existing organisms. If this is new to you (or, if you’d like a refresh), here are the links you need: 18

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