Dear All: Following hard on the heels of yesterday’s note about the 14 June 2018 Duke-Margolis workshop on development of non-traditional products, we now have a notice regarding a 21-22 Aug FDA workshop on that same topic! The meeting will be on FDA’s White Oak Campus from 8.30a-4.30p (21 Aug) and 8.30a-noon (22 Aug). From the notice: “The purpose
Dear All: Wow! It’s happened! As reported this morning in The Times and The Guardian among others, the UK will announce at Davos that it is committing to a 20-year vision and initial 5-year plan to combat AMR. The plan includes actions to reduce infection rates, to reduce antibiotic use, and most importantly for this audience to find a path to delinked
Dear All: Yes, I know that yesterday’s Scary/Scarier/Scariest newsletter about Achaogen was a downer. That note was as hard to write as I’m sure it was to read! I’ve received multiple comments and questions regarding the path forward and you can expect a follow-up note on this in the near future. For today, an initial way to act for
Dear All: Alan Carr (acarr@needhamco.com, Needham & Company, LLC) writes a superb investment-focused newsletter focused on the antibiotic sector. We all owe him a debt of thanks for his careful analyses. His most recent newsletter (link) is a soups-to-nuts tour that is required reading if you are working in this sector — he covers company status, development program
Dear All: The idea of using real-world evidence (RWE) as a way to support development of novel agents (including antibiotics!) has always intrigued. As you may recall, the 21st Century Cures Act (Cures Act) gave FDA a mandate to evaluate the potential use of RWE to support drug approval. There was a workshop on this on
Dear All, Apologies for the delay, but I’ve held off on this note until the majority of the presentations from the 3-6 Sep 2019 ASM-ESCMID meeting (Boston) were online. You can now access the program, most of the presentations, and the meeting abstracts here. It was a wonderful meeting with over 400 attendees. And, please be sure
Dear All, Committing serial email this afternoon… First, the note I just sent on FMT for Clostridium difficile (link) prompted comments that the organism is now called Clostridioides difficile. This name change slipped past me, I’ll admit! But it does seem a settled change … see this helpful editorial from May 2019 in Lancet ID for a summary of how the new
Dear All, To start your week, we have three tidbits for consideration. First, results from a trial entitled “Colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia (Magic Bullet study): an investigator-driven, open-label, randomized, noninferiority controlled trial” have been published (Critical Care 23:383, 2019, link). Cisneros et al. sought to enroll 496 subjects into this trial but
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
Dear All: Early November will be busy! First, BAARN is having their annual meeting in the Boston area on 6 Nov. See below a note from Michael Gilmore with details. If you are in Boston on that day, I highly recommend this meeting as a superb scientific event & networking opportunity. Second, you can then go from BAARN to