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: Given our collective interest in finding oral antibiotics, a recent article in J Med Chem on the evolution of our understanding of Lipinski’s Rule of 5 (Ro5) prompts me today to share it along with a recent webinar and links to both Lipinski’s original paper as well as his 2016 commentary: The original
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
Long note alert— apologies! Get a cup of coffee and settle in… Dear All: My 22 Apr 2019 note entitled Scary, Scarier, Scariest: Achaogen / FT editorial / CBS “60 Minutes” on AMR (link) caused a number of you to write expressing your related concerns and frustrations. Many thanks for those thoughts! A core theme in those
Dear All: I have previously written about the challenge of applying health technology assessment (HTA) to estimate the monetary value of an effective antibiotic: To my knowledge, the most detailed attempt to estimate the value of antibiotic was in 2014 by Sertkaya et al. In that analysis, the value that the developer might receive through sales ranged from -$5 to +$40m across six
Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I’ve now had a chance to read it in detail and thought I would share my thoughts as a way to provoke discussion. As a reminder, the
Dear All (and with thanks to Kevin Outterson for substantial help with this newsletter), On August 2, 2019, the US government agency that administrates Medicare & Medicaid (CMS) announced several significant changes to hospital antibiotic reimbursement in US hospitals, effective October 1, 2019 (link to the very detailed Federal Register notice; go here for user-friendly summaries in Health
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 (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