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: 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
Dear All: Released just a few hours ago in parallel with the UN General Assembly meetings, WHO has produced a detailed review of the global pipeline. As they note on their overview webpage, “The report found very few potential treatment options for those antibiotic-resistant infections identified by WHO as posing the greatest threat to health, including
Dear All: Two papers (one with an editorial) that are worth your time. First, we have publication of the long-awaited FNIH (Foundations for the NIH) paper on trial designs for studies of HABP-VABP (Hospital-Associated Bacterial Pneumonia and Ventilator-Associated Pneumonia). The paper also comes with an editorial: Talbot, G. H., A. Das, S. Cush, A. Dane, M.
Dear All: FDA has now posted a final guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) Devices” that discusses the ways that FDA seeks to: Minimize lag time between drug approval and AST device* approval and Provide recommendations on how AST developers and drug developers can coordinate their work with each other and with