Dear All, Whew … still catching up after all the activities of World Antimicrobial Awareness Week (WAAW)! More to follow on some of that great content, but for today we have the news that FDA has posted 4 RFPs! All have due dates of 21 Jan 2022: Optimizing dosing strategies for obese patients and in continuous
PK & PK-PD
Dear All: I recently became aware of a technology for real-time continuous in vivo monitoring of drug levels that I thought worth sharing with the broader community. Although we’ve for many years had continuous measures of analytes such as glucose or oxygen where simple chemistry gave a suitable measurement tool, measurement of arbitrary analytes has
Dear All (detailed and wonkish note alert … lots of thinking out loud … get some coffee and settle in!), I wrote previously (link) about FDA’s planned workshop on animal models to support antibacterial development and I was able to listen to the workshop via webcast. As brief context (and please be sure to look
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. Dear All (wonk-ish note alert!), Three technical points for your consideration today. All focus on the subtleties of language, something I always find fascinating
Dear All (moderately long note alert; be sure to note the new list of funding opportunities just below my signature), FDA have announced a public workshop on 5 Mar 2020 to discuss progress and challenges in the development and advancement of various animal models for serious infection. The Federal Register notice is here and registration is here.
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: 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 (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: I’m really not trying to flood your inbox with email, but when ideas surface I do like to pass them on. As an instructive follow-on to the email earlier this week about continuous in vivo measurements of drug concentrations, David Perlin made me aware of a use of MALDI that I’d not previously considered.
Dear All: I recently sent around discussions of ways to measure/estimate drug concentrations both in living animals (aptamer-based probes, Kevin Plaxco’s group) and with sufficient spatial resolution to permit construction of 2d/3d drug concentration maps (MALDI-MSI, David Perlin’s group). In the context of our efforts to learn to better apply PK-PD (e.g., the 14-15 June 2017 NIAID PK-PD workshop),