R&D Insight

Antibiotics as infrastructure / Call to Action in Ghana

Dear All: Two things today. First, Maryn McKenna has provided the community with an excellent brief perspective on the incentive problem. Entitlted “Antibiotics May Soon Become Useless. Now What?” and published in Wired, she uses the recent approval of omadacycline (Nuzyra) as a springboard to discuss the paradox of antibiotics. She quite logically extends the idea of antibiotics as fire

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FDA-approved surrogate endpoints for developers

Dear All: As requested by Congress as part of the 21st Century Cures Act, the US FDA has now released for public comment a table of surrogate endpoints that can be considered for use by developers: The public docket soliciting comments is here. The web page providing an overview of surrogate endpoints and biomarkers is here. The surrogate

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WHO Pipeline review / Roadmap for susceptibility testing developers

Dear All: Two useful papers have just been released — see titles and abstracts below my signature. Both are Open Access so please do download & read! And just for full disclosure, know that I’m a co-author on both. First, a working group organized by WHO has produced a comprehensive review of the clinical antimicrobial pipeline for both

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SPIDAAR & ATLAS: Data sharing via AMR Surveillance partnerships

Dear All, Building on the ATLAS database (link) that provides open access to data from 2004 to the present out of the multiple surveillance programs that Pfizer has run over that interval, Wellcome Trust and Pfizer have just announced that the underlying database will also be used to support SPIDAAR (Surveillance Partnership to Improve Data

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US National Action Plan for Combatting AMR: 2020-25 update!

Dear All (and with thanks to Kevin Outterson for doing the heavy lifting on this note), As you may recall, the US National Action Plan for Combatting Antimicrobial Resistant Bacteria (US NAP CARB) was launched in 2015 on the heels of the 2013 CDC report on antimicrobial threats (link to that report) and is/was a

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Updating WHO’s Bacterial Priority Pathogen List: Call for advisors

Dear All, Deadline: 15 August 2021: The World Health Organization (WHO) is seeking experts to serve as members of the Advisory Group on the Bacterial Priority Pathogen List (AG BPPL). A “Call for experts” document provides information about the advisory group and the expert profiles being sought for the group. The document also provides information on

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FDA-NIAID phage workshop / Social distancing in the 1800s

Dear All, This webinar merits a standalone newsletter! If you are thinking (or working on) phage, then please mark your calendar for an FDA (CBER; Center for Biologics Evaluation and Research) workshop entitled: Science and Regulation of Bacteriophage Therapy: August 30, 2021—September 1, 2021 The purpose of the public workshop is to exchange information with the

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WHO-FAO-OIE OneHealth survey on research priorities / JPIAMR-VRI integrated resistance database

Dear All, Two brief items today: First, a survey on OneHealth research priorities from WHO/FAO/OIE: “The Tripartite collaboration between World Health Organization (WHO), Food and Agricultural Organization of the United Nations (FAO), and World Organization for Animal Health (OIE)) is joining efforts to develop a One Health priority research agenda on antimicrobial resistance (AMR). “This

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