R&D Insight

WHO Collaborating Centres for AMR: A rapidly growing group!

Dear All, I recently learned about the designation of Stanford as a WHO Collaborating Centre (WHOCC) for AMR and Stewardship. This caused me to dig a bit more into the way that WHO has created a global network of Collaborating Centres. WHOCC designation represents a sustained and productive collaboration with WHO (link). As an example, Stanford’s

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18-19 Nov 2019 FDA-IDSA-NIH-Pew Workshop: Enhancing Antibacterial Trials in the US

Dear All, Long note alert: Set aside at least 30 minutes for this one … there’s a lot of important material here. Last week’s workshop entitled “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States” was an unusual and unusually instructive meeting. You can go here for the meeting materials but as there are

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BARDA RFP: Antibiotic for HABP/VABP or Bloodstream Infection

Dear All, BARDA have published an RFP (Request for Proposals) under which it would support clinical development and then stockpiling of an antibiotic for “treatment of bacterial pneumonia or bloodstream infections.” Here are the data you need to get started: RFP #: 75A50125R00005 https://sam.gov/opp/494fc05d7c4940abad0273cdb465079a/view Submission deadline is 26 Aug 2025 Quoting liberally from the online

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The threat of mirror bacteria: Ongoing conversations

Dear All, I wrote in a 12 Dec 2024 newsletter (“Mirror Bacteria: An AMR threat of unprecedented magnitude”) about the really disturbing possible threat from creation of “mirror” bacteria in which all chiral elements of the bacterium are replaced by their enantiomeric counterparts. Such bacteria are predicted to be able to evade many (if not most)

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Vaccination to prevent AMR: Insights from Wellcome

Dear All (and with thanks to Vega Masignani for co-authoring this newsletter), Waaaay back in 2019 (pre-COVID … remember that?), Wellcome put out a call for grants focused on understanding the value of vaccines in combatting AMR (4 June 2019 newsletter entitled “Why vaccines for AMR? What is their value? Grant opportunity for research on

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Updated FDA Q&A on Antibacterials for Unmet Medical Need

Dear All, An updated version of FDA’s very helpful Q&A entitled “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers” has just been released. Here are the links you need to get started: The new June 2025 guidance itself The webpage about the guidance

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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 newsletter mentioned below), 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 all chiral elements of

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Jan 2025 PACCARB meeting cancelled as new administration takes the reins

Dear All, Sadly, I must report that the 27th meeting of PACCARB (the US Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria) planned for 28-29 Jan 2025 has been cancelled “as the new Administration considers its plan for managing federal policy and public communications.” This 22 Jan 2025 article in the New York Times provides additional details

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In Praise of Non-Inferiority

Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the ideas here are VERY confusing, I suggest you make the time to watch the video, read the newsletter, and then watch the video one more time. I have yet to

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Antibacterial guidance (including pediatrics): Parallel EMA+FDA updates

Dear All (Wonkish alert! Get some coffee and settle in!), Almost in parallel, EMA and FDA have released updates to key antibacterial guidance documents! Here are the links you’ll need and I’ve highlighted the key documents. To go deeper, you’ll need to pick through everything and I provide a tour further below in this newsletter:  EMA’s

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