Long and wonkish note alert — please refresh your coffee before you start reading! Dear All: I was able to attend and speak at the 12 July 2019 Public Meeting organized by FDA on the LPAD (Limited Population Antibacterial and Antifungal Drug) pathway. The current draft guidance is here and the meeting agenda is found here. The meeting
Dear All (wonkish alert, but the details are fascinating … and with thanks to Kevin Outterson for co-authoring!), Two related items of note for today. First, the PASTEUR Act was introduced today (press release from Rep. Doyle; press release from Rep. Ferguson) into the US House of Representatives by the bipartisan team of U.S. Representatives
Dear All (Wonkish alert! Coffee-up!), Today we have something special: A deep-dive into the future trajectory of AMR-related work developed by Wellcome Trust. The newly released report is here and there is a webinar discussing the report on Wednesday of this week (1500-16:00 GMT on 18 Nov 2020, go here to register). The back story
Dear All (and heads-up for a rather lengthy and wonkish note … settle in for the details), Last week saw substantial AMR-related news released in / around the Davos 2020 World Economic Forum. A brief summary follows, with some supplemental details below my signature. Access to Medicine Foundation (ATMF) released their 2nd scorecard on industry
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
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: 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