R&D Insight

FDA Listening Sessions for CEOs, CMOs, or heads of R&D

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

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IDWeek 2025: Present your novel antimicrobial or diagnostic

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

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Vaccine development: Polytheism vs. Monotheism

Dear All (and with a wonkish alert!), The idea of more (and better) vaccines to prevent (or even be part of treating) bacterial infections has long intrigued. We certainly do have several good bacterial vaccines, but why not more? As part of this ongoing discussion, I really enjoyed a paper that came out back in

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Manufacturing underpins both access and stewardship: Cefiderocol as a case study

Update: There is a 14 April 2025 follow-up to this newsletter. Dear All, Prompted by an excellent talk by GARDP’s Jennifer Cohn at last week’s ASM-ESCMID Developer’s conference, today I’d like to pull together several threads showing how responsible manufacturing and access are intertwined. (And if you missed the ASM-ESCMID meeting, you missed some great

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Impact of AMR on cancer therapy

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,

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Vivli’s 2025 AMR Surveillance Data Challenge

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

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Manufacturing underpins access in LMICs: An update on cefiderocol

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

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Vaccines to turn back the tide of antimicrobial resistance

See also This related newsletter: 14 Jul 2022, entitled “WHO Vaccine Pipeline Review; CDC On Impact Of COVID On AMR.” This 20 Oct 2024 report from WHO: “Estimating the impact of vaccines in reducing antimicrobial resistance and antibiotic use: technical report” This 25 Apr 2024 paper in Lancet Global Health by Hausdorff and colleagues: “Facilitating

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Most current global summary of Pull incentives

Dear All, I was recently asked about a ready summary of the current state of play of Pull incentives around the globe. In response, here are two related resources: First, WHO and the Global AMR R&D Hub jointly author an update on the state of incentives for R&D. Their most current report is dated 14 Oct

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