Dear All (wonkish note alert — refresh your coffee before proceeding — with thanks to Kevin Outterson for co-authoring this note!), The intertwined questions of (i) the cost to develop a new antibiotic and (ii) how much we should pay for such a new antibiotic have been an increasingly frequent newsletter topic, with a real
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
Dear All (wonkish note alert … top-up your coffee and settle in!), Today we have a tour of a recent paper in Clinical Infectious Diseases in which FDA presents a very instructive analysis of endpoints used in recent CABP (Community-Acquired Bacterial Pneumonia) trials and how data such as these might permit further convergence of global
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
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
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
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
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
Dear All, As those of us who have had the privilege of standing at the bedside and delivering care know first hand, the magical power of a safe and effective antimicrobial agent is little short of magic. Sometimes, the (nearly) dead can get up and walk! With that idea in mind, I was just blown
Dear All: As you will hopefully recall from November 2019, Theuretzbacher et al. published a review of the preclinical pipeline that summarized data on 407 companies active in the preclinical R&D space during the window Sep 2016 through 1 May 2019. Go here for the newsletter about that paper and go here for my master summary