Government Action

Fireside Chat with BARDA’s Branch Chief for Antimicrobials

Note: Be sure to take advantage of the BARDA Industry Day(s) event that occurs Monday-Tuesday of this coming week … see newsletter and forward calendar for details. Dear All, In what could be called Part 2 of Excellent 2023 ASM/ESCMID Talks (read the newsletter on Jen Cohen’s talk on how manufacturing underpins both access and

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Japan Pulls for Pandemic Preparedness: Nikkei FT Conference

Dear All, As we discussed in the 5 Nov 2023 “Pulling for Pandemic Preparedness” newsletter, AMR is a global threat: resistance in one part of the world can suddenly appear in your hospital. As an example of that sort of threat, Jason Gale’s 30 Oct 2023 newsletter entitled “Untreatable Typhoid Should Make You Worry About Poop”

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UK Pull (Netflix) pilot: STEDI-based QALY value of new antibiotics implies societal value > 10m GBP/year!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), We’ve written before about the UK’s “Netflix” pilot antibiotic Pull incentive in which England leads the way on showing how it plans to provide its fair share of a global antibacterial Pull incentive (for background on Pull incentives, see this superb 5-minute video explainer). In

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Implementation Handbook on National Action Plans from WHO

Dear All, Continuing on the theme of helping countries develop their own national action plans, WHO released the “WHO implementation handbook for national action plans on antimicrobial resistance: guidance for the human health sector“. The handbook has some great infographics like the one below and will shortly be translated into French, Spanish, and Russian. There

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A Nature Article, a PASTEUR Act Op-Ed, and a VERY Important Phone Number

Dear All, First, Nature published an excellent article entitled “The importance of antimicrobial resistance in medical mycology” by Gow et al. The first sentence of the introduction really packs a punch — “The age of antibiotics, spanning only 80 years, is now entering a period of progressive and widespread emergence of drug-resistant organisms that threaten to bring

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Support the FORWARD and PASTEUR Acts by signing a letter!

Dear All, I’ve written before about the FORWARD Act, a bill introduced last year into Congress with the goal of supporting research in to treatment of endemic fungal diseases with a particular focus on coccidioidomycosis (*). It’s easy to see how this bill and the PASTEUR Act are mutually supportive … both seek to build

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Sign a letter in support of antifungal R&D … in support of PASTEUR!

Dear All: As you know if you are a regular reader of this newsletter, I think that creation of suitable Pull incentives by passage of the PASTEUR Act in the United States is key to building a vibrant pipeline of products to address the international problem of AMR. I’ve also written recently about the FORWARD Act

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NIAID BAA To Support In Vitro Diagnostic Product Development

Dear All, Excitingly, NIAID has released a new BAA (Broad Agency Announcement) entitled “Diagnostics Pre-Clinical Services Program.” Similar to the prior BAA for support of biopharmaceutical product development, this new BAA for diagnostic devices seeks a group who can manage a “multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) type contract” (read that slowly!) and through it offer a comprehensive

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FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The

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New UK 5-year AMR plan: Subscription model details!

Dear All, Today is a newsletter double-header! Coming hard on the heels of the opportunity to support an ESCMID petition to UNGA 2024, the UK today released the details of its next five-year action plan. Excitingly for this audience, there is an updated roadmap for the UK’s next steps in its subscription model. Here are

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