R&D Insight

BARDA seeks information: Are you creating an antibiotic for Yersinia or other biothreat Gram-negatives?

Dear All, BARDA is interested in hearing from antibiotic developers about antibiotics which could be used under Emergency Use Authorization (EUA) or marketing authorization for the treatment and/or PEP (post-exposure prophylaxis) of a biothreat indication, specifically: Y. pestis, F. tularensis, and/or B. pseudomallei. Here’s the core message from the pre-solicitation notice: Topline: “The U.S. Government

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Lessons in Discovery from Lynn Silver + Pro-con on alternatives to antibiotics

Dear All: “Good decisions come from experience, and experience comes from bad decisions … and paying attention.” You’ve probably heard the first part of that before, but the “… and paying attention” is my addition and reflection upon reading Lynn Silver’s most recent commentary in the Springer Series Topics in Medicinal Chemistry, edited by Jed Fisher, Marvin

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FDA analysis of 40-years of antibacterial development: Dheman et al.

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Just out in CID is a paper in which FDA analyzes trends in antibacterial development from 1980-2019. To fully appreciate this paper, you need to look both at it and three other papers: FDA’s paper (https://doi.org/10.1093/cid/ciaa859): Dheman N, Mahoney N, Cox EM, Farley

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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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Language matters: CRE vs. CPE; SDD vs. I; and MDR, XDR, PDR, UDR vs. DTR

Note: See also these related newsletters: 13 Jan 2019 (link) on DTR as part of the language of resistance and 7 June 2020 (link) on using DTR to estimate antibiotic value. There is also a 5-minute DTR explainer on YouTube that you might find useful. Dear All (wonk-ish note alert!), Three technical points for your consideration

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Categories of resistance: MDR, XDR, PDR, UDR, and (new!) DTR

Note: See also these related newsletters: 20 Feb 2020 (link) on DTR as part of the language of resistance and 7 June 2020 (link) on using DTR to estimate antibiotic value. There is also a 5-minute DTR explainer on YouTube that you might find useful. Dear All: When thinking about studies of resistant pathogens, issues

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Timely guidelines, regularly updated: COVID-19, C. difficile, and beyond

Dear All, During the 18-19 Nov 2019 FDA-IDSA-NIAID-Pew workshop on ways to enhance antibacterial research (link), we spent some time discussing the slow pace of updates to most guidelines. With the notable exception of the rapid guidance updates used in the HCV community (link), most guidelines are updated infrequently and each update feels like a Herculean

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