Wonkish

FDA analysis of 40-years of antibacterial development: Dheman et al.

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Just out in CID is a paper in which FDA analyzes trends in antibacterial development from 1980-2019. To fully appreciate this paper, you need to look both at it and three other papers: FDA’s paper (https://doi.org/10.1093/cid/ciaa859): Dheman N, Mahoney N, Cox EM, Farley

Read More »

Developing systemic & inhaled antibiotics for lung infections

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

Read More »

Draft EMA antibacterial guidance: Analysis

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

Read More »

Scary, Scarier, Scariest (Part 2): What can YOU do about it?

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

Read More »

Modeling the value of an effective antibiotic — Megiddo et al.

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

Read More »

Categories of resistance: MDR, XDR, PDR, UDR, and (new!) DTR

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. Dear All: When thinking about studies of resistant pathogens, issues of case-finding and statistical design are frequent topics of debate. As an example, the

Read More »

The hunt for oral antibiotics: Beyond Lipinski’s Rule of Five

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

Read More »
Scroll to Top