R&D Insight

Two things: WHO’s looking GLASS + FDA’s advances with PDUFA VI

Dear All: Two things today. Unrelated, but both relevant! WHO’s GLASS: WHO’s Global Antimicrobial Resistance Surveillance System (GLASS) was created during October 2015 and seeks to obtain coordinated and consistent global estimates on resistance rates. In a major report released on 29 Jan 2018, GLASS now provides provides official national AMR data for the period 2016-17 from 40 countries

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Australia calls for Subscription (“Netflix”) models: Report and podcast

Dear All, With thanks to alert reader Liam Sharkey, a post-doc in Melbourne, for the heads-up on this topic, I am very pleased to see the 17 June 2025 report from Australia entitled “Fighting Superbugs: A Subscription-Style Reimbursement Mechanism to Boost Australia’s Arsenal of Antimicrobial Medicines.” This paper is the output from a Nov 2024 roundtable in Canberra

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Stewardship & Access Guide from CARB-X, Wellcome, and partners: Analysis, video chat

Dear All, Novel antibacterial agents, vaccines, and diagnostics will do little if they are not widely available and used responsibly. CDDEP’s recent report entitled “The State of the World’s Antibiotics in 2021” makes this very clear: “… more people in LMICs (low-middle-income countries) die from lack of access to antimicrobials than from resistant infection.” Hence, CARB-X has

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Global livestock resistome: Antibiotic resistance is widespread!

Dear All (and with thanks to Lance Price for co-authoring this deeply wonkish newsletter), Today we turn to the idea of examining livestock manure for the presence of antibiotic resistance genes. You can easily see how this idea plays into the question of how to track and control AMR. Before we dive into the paper, however,

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$ Impact of AMR in your country: Interactive web tool!

Dear All, The 27 Sep 2024 newsletter (“Without action, AMR costs go from $66b to $159b/yr by 2050”) reviewed a report by Anthony McDonnell and a team led by the Center for Global Development in which they created economic estimates of the costs/values of action (and inaction) through 2050, based on 5 possible action/ inaction scenarios.

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WHO: Draft TPPs for MDR bacterial infections

Dear All, Back in 2019-2020, WHO developed a set of TPPs (TPP = Target Product Profile = A description of the desired attributes of a drug) for products for enteric fever, gonorrhea, neonatal sepsis, and urinary tract infections as guides for developers (see the 1 Sep 2019 newsletter for the original call for input and the link

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WHO wants your input on its draft TPPs for needed antibacterial agents

Dear All, Addendum: This project ultimately led to publishing in May 2020 of a set of TPPs for enteric fever, gonorrhea, neonatal sepsis, and urinary tract infections as guides for developers. You can find those TPPs at https://www.who.int/publications/i/item/9789240003897.   WHO has developed a set of draft TPPs (target product profiles) for needed new antibiotics. As part of the

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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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