R&D Insight

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

Read More »

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

Read More »

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

Read More »

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Evidence guidance, further updated: Comments due 22 Sep 2026 ==FDA have released a further revision of their Dec 2019 draft guidance entitled “Demonstrating Substantial Evidence of Effectiveness

Read More »

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

Read More »

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

Read More »

Chemicals vs. drugs (Part 3): XKCD has the final word

This newsletter is part of a series — here are the links to Part 1, Part 2, (this one is Part 3), Part 4, and Part 5. You might also enjoy the discussion of AI-supported discovery in this May 2026 video from Nature.  Dear All, As a coda to the two newsletters on Chemicals, Drugs, and Halicin (link and

Read More »

NIAID RFA: Centers for Accelerating Phage Therapy (CAPT-CEP)

Dear All, 3 June 2026 update: NIAID has funded a 3-center coordinated network under this RFA! See the parallel announcements from the Gladstone Institutes (Center for PhAIge Therapy),  Stanford University (Center for Phage Pharmaceuticals), and the University of Pittsburgh (Center for Accelerating Phage Therapy). I was delighted to learn today that NIAID https://med.stanford.edu/news/all-news/2026/06/bollyky-niaid-grant.htmlhas released RFA-AI-24-069, a

Read More »
Scroll to Top