R&D Insight

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. Dear All (wonk-ish note alert!), Three technical points for your consideration today. All focus on the subtleties of language, something I always find fascinating

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FDA workshop: Animal models to support antibacterial development (5 Mar 2020)

Dear All (moderately long note alert; be sure to note the new list of funding opportunities just below my signature), FDA have announced a public workshop on 5 Mar 2020 to discuss progress and challenges in the development and advancement of various animal models for serious infection. The Federal Register notice is here and registration is here.

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WHO Review of the Preclinical and Clinical Antibacterial Pipeline

Dear All, WHO has today released two exhaustive reviews of the antibacterial R&D universe (and by way of full disclosure, let me say upfront that I participated in the clinical pipeline discussion): The preclinical pipeline (link) This one includes a fascinating data-mining tool that explores the 252 antibacterial products being developed in 145 institutions around the

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Japan’s antibacterial R&D landscape / Japan calls for Pull incentives

Dear All: Late last year, I had the opportunity to hear a presentation on antibiotic R&D in Japan by Norio Ohmagari. Based in Tokyo at the National Center for Global Health and Medicine Hospital (link), Norio is Director of its (i) AMR Clinical Reference Center, (ii) Disease Control and Prevention Center, and (iii)  WHO Collaborating

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Help update the WHO clinical antibacterial pipeline analysis

Dear All: As you know, WHO produced a pipeline update with a cut-off date of 1 July 2018. It’s now published both as a manuscript (Theuretzbacher et al. Lancet ID 2018, link) and a set of summary tables (link). Team WHO would like to update this analysis with a cut-off date of 1 Aug 2019. They

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Scary, Scarier, Scariest (Part 2): What can YOU do about it?

Long note alert— apologies! Get a cup of coffee and settle in… Dear All: My 22 Apr 2019 note entitled Scary, Scarier, Scariest: Achaogen / FT editorial / CBS “60 Minutes” on AMR (link) caused a number of you to write expressing your related concerns and frustrations. Many thanks for those thoughts! A core theme in those

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18-19 Nov 2019 FDA-IDSA-NIH-Pew Workshop: Enhancing Antibacterial Trials in the US

Dear All, Long note alert: Set aside at least 30 minutes for this one … there’s a lot of important material here. Last week’s workshop entitled “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States” was an unusual and unusually instructive meeting. You can go here for the meeting materials but as there are

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