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 (long note alert … there’s a lot of material below my signature): Just published today is an IDSA White Paper entitled “Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-spectrum Indications, and Unmet Needs.” The paper is accompanied by an editorial by George Drusano. As the papers are free to download (links below). The white paper reviews the
Dear All (and with apologies … long note alert!): Yesterday’s AMDAC was very productive. For reference, all the materials are here and a reasonably detailed set of notes are found below my signature. For further color, David Shlaes has also posted a summary on his Perfect Storm blog. FDA nicely positioned the question for the day as “It will
Dear All: FDA today hosted their eagerly awaited workshop on animal models in support of narrow-spectrum agents for A. baumannii (Abau) and P. aeruginosa (Pae). It was a really full & interesting day at the end of which my confidence that we can actually register narrow-spectrum agents for these two pathogens (and others that are even less frequent) is
Dear All: The ~150 of us who gathered in Washington yesterday and today for the NIAID’s PK-PD workshop enjoyed a very rich conversation. It’s really hard to capture the full debate, but here is a brief slide set and as well a written summary of the meeting that provide the main points. More materials can be found online at this
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
Dear All: I missed it personally, but by all reports the session on 3 June 2017 at ASM Microbe entitled “Development of New Drugs and Strategies for Hospital-Acquired Pneumonia Caused by MDR Pathogens” during ASM Microbe was an outstanding survey of this challenging area during which Shampa Das, Mike Dudley, and Sumati Nambiar gave great
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