Dear All, Pushing this one out as a direct quote from the online materials posted yesterday by FDA. Looks interesting! All best wishes, –jr The U.S. Food and Drug Administration is conducting a national listening tour to meet directly with pharmaceutical and biotech CEOs. Held in major innovation hubs across the country, the CEO Forums will
Dear All, As in previous years (27 Mar 2024 newsletter), IDWeek 2025 will feature pipeline-focused sessions for both antimicrobials and diagnostics. If you have a product that is pre-approval (or only very recently approved), you are invited to present at one of these sessions. Here are the details on how to apply to participate: “Industry partners
Dear All (unapologetically wonkish … very important material!), Let’s set the scene today by considering two quotes: Prosaic: “The successful treatment of patients with cancer has long depended on the capacity to manage infectious complications.” (Shropshire 2025, cited below) Blunt translation: “Your cancer will be controlled, but then you may die of infection.” (Abdul Ghafur,
Dear All (wonkish alert … lots of details here … take your time and absorb it all!), I’ve written several times about the concept of DTR, or Difficult-to-Treat resistance, that was proposed in 2018 by Kadri et al. Today we will consider an important update from Kadri and colleagues in which the idea of DTR
Dear All, We’ve previously discussed the availability of large surveillance datasets from the Vivli AMR Register. In particular, you should review Patricia Bradford’s summary of ways to use these data in the 20 Oct 2024 newsletter entitled “Vivli: Access to Industry’s Susceptibility Surveillance data.” Vivli have now announced their 2025 Vivli AMR Surveillance Data Challenge. This particular challenge is
Dear All, No one is safe until we’re all safe! In the 7 April 2025 newsletter on antibiotic access (“UNSLAP: You reach for the antibiotic … and it’s not there!”), Louise Norton-Smith and I concluded that we need to work to address all the elements of the long and delicate supply chain from manufacturing to local
Dear All (and with thanks to Stephan Harbarth for co-authoring this newsletter), A new review by Ursula Theuretzbacher and colleagues from GARDP provides an opportunity to (i) discuss the preclinical antibacterial pipeline (the new paper), (ii) remind you of a recent review of the Gram-negative clinical pipeline, and (iii) share an excellent Industry-level perspective on
Dear All, As you know, WHO have been steadfastly producing both priority pathogens lists (PPLs) and pipeline reviews. My current summaries of both are found at https://amr.solutions/pathogens-and-pipelines/. WHO began this process in 2017 with an initial focus antibacterial agents. To date, they have released multiple antibacterial pipeline reviews (2017, 2018, 2019, 2020, 2021 and 2023, see
Dear All, I wrote in the 19 Feb 2025 newsletter about HERA’s 13m EUR call for rapid point-of-care susceptibility devices. The call is now live! Title: Development of a Rapid Point-of-care Antimicrobial Susceptibility Testing Diagnostic Medical Device (HADEA/2025/CPN/0006) Funding and Tenders portal link: https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/tender-details/2e5c607e-6e55-4268-b99a-730c5db350b7-CN “This call for tenders aims to speed up the development of an in
Dear All, Two quick updates this evening. First, you will recall that CARB-X have announced their initial 2025 funding round (26 Feb 2025 newsletter), with a call for applications for funding of work on (i) small molecules for Gram-negative infection and (ii) diagnostics for typhoid. In support of these calls, TPPs (target product profiles) for both