Wonkish

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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Non-traditional antibiotics: A pipeline review and an analysis of key development challenges

Dear All, Non-traditional alternatives to antibiotics have excited a lot of interest in the past few years but we’ve seen relatively few of these progress in a meaningful way (go here for Pew’s recent survey of the development landscape). Providing insights into the challenges of this area, two valuable and complementary articles on non-traditional antibiotics have recently

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Melinta goes bankrupt / Never let a good crisis go to waste

Dear All (long-ish, wonk-ish note alert … lots of details to absorb): This newsletter has a followup here. Sadly, Melinta Therapeutics, Inc. declared bankruptcy just before the end of 2019 (link). Formerly known as Rib-X (link), Melinta went public in 2017 through a reverse merger with Cempra (link); and via a series of deals had four

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Modeling the value of an effective antibiotic — Megiddo et al.

Dear All: I have previously written about the challenge of applying health technology assessment (HTA) to estimate the monetary value of an effective antibiotic: To my knowledge, the most detailed attempt to estimate the value of antibiotic was in 2014 by Sertkaya et al.  In that analysis, the value that the developer might receive through sales ranged from -$5 to +$40m across six

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Draft EMA antibacterial guidance: Analysis

Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I’ve now had a chance to read it in detail and thought I would share my thoughts as a way to provoke discussion. As a reminder, the

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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. Dear All: When thinking about studies of resistant pathogens, issues of case-finding and statistical design are frequent topics of debate. As an example, the

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The hunt for oral antibiotics: Beyond Lipinski’s Rule of Five

Dear All: Given our collective interest in finding oral antibiotics, a recent article in J Med Chem on the evolution of our understanding of Lipinski’s Rule of 5 (Ro5) prompts me today to share it along with a recent webinar and links to both Lipinski’s original paper as well as his 2016 commentary:  The original

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Push! Pull! Push! Pull! / Highlights from Davos 2018

Dear All: Three important documents were released at / during / around the World Economic Forum meeting that occurred this week in Davos. First and foremost, we have the final report from DRIVE-AB. It’s a substantial document and you’ll need to set aside an afternoon to read it. As a way to get started, my 11 Sep 2017

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