ANTIMICROBIAL RESISTANCE SOLUTIONS
WITH DR. JOHN H. REX
Latest Newsletters
Dear All, We often talk about the problem of lack of access to new antibiotics. In late 2021, for example, we explored data showing that multi-year delays in access to new antibiotics were common even in high income countries (19 Aug 2021 newsletter with YouTube discussion). But as we'll learn today, that analysis considers only one possible facet of "lack of access." In an instructive new paper, Baraldi, Ardal, Aho, Popescu, and Melaku have given us a powerful new analytical framework showing that there are at least six (6!) possible meanings of "Lack of Access" to antibiotics. Here are the links you need: The paper by Baraldi et al.: "The multifaceted nature of lack of access to antibiotics: types ofshortage and specific causes, consequences, and solutions" Clinical Microbiology and Infection, https://doi.org/10.1016/j.cmi.2024.11.012, 2024. A 2003 white paper summarizing indicators used as part of the Millennium Development Goals (MDGs), the predecessor to the current UN Sustainable Development Goals (SDGs): The white paper (the relevant text is on page 97) The MDG website The SDG website (the SDGs replaced the MDGs in 2015) So, what are the 6 variations on the idea of "Lack of Access"? The paper by Baraldi et al. focuses on 4 ways...
Dear All, Just released, the...
Dear All, The Global Leaders Group on Antimicrobial...
Latest Government Action
Dear All,BARDA has released a fascinating Sources Sought Notice (SSN) seeking data on antibacterials near, at, or beyond Phase 2. I've never seen one before, but an SSN is market research with which BARDA will "collect feedback from current and prospective antibiotic development partners" that will "serve as continued market research for potential future acquisitions and programs." While this might sound like just another pipeline review, we'll see in a moment that the query goes well beyond the relatively high-level pipeline reviews maintained by WHO (see the Bugs & Drugs webpage). Here is the link to the SSN along with its title, lightly broken up for ease of reading:SSN No.: BARDA-CBRN-11042024"Antimicrobial Resistance Project BioShield:"BARDA Antibiotic for Treatment of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia or Bloodstream Infections"Caused by Drug-Resistant Bacteria or Biothreat Pathogens."The mention in the title of the SSN of "Project BioShield" is our further clue that this is part of BARDA's goal of having at least one MCM for all CBRN threats (translation: one Medical Counter-Measure for all Chemical, Biological, Radiological, and Nuclear threats) as part of their 2022-2026 Strategic Plan. To follow this in more detail, see the 4 Jun 2022 newsletter for more on BARDA's strategic plan and the 12 Nov...
Dear All, Greetings from Porto...
Dear All,During the GLG AMR...
Dear All,Well, ECCMID 2024 (Barcelona)...
Dear All (moderately wonkish, so...
R&D Insight
Dear All, The Global Leaders Group on Antimicrobial...
Dear All, Two brief items...
Dear All, Released on 21 Oct...
Dear All: Potpourri! Four things...
Dear All, Some regulatory updates...
Dear All: FDA today posted...
Dear All,Whew ... still catching...
Dear All: The new Novo...
Can you help?
Dear All,I have just learned that Lifeline, the musical formerly known as The Mould that Changed the World, is seeking scientists, medics, and healthcare professionals to be part of the cast for a portion of a planned 5-week off-Broadway run of the show around the time of the High-Level Meeting (HLM) on AMR at UNGA 2024 in New York City...
Dear All, Heads up! Having...
Note: Be sure to take...
Update on 11 October 2023: The...
Dear All,Along with more than...
Dear All (and with thanks to...
Dear All, Two items for...
Dear All, Three things today......
Dear All, Greetings from ECCMID...
Dear All,A key theme of...
Dear All,Following hard on the...
Dear All, A short one...
Dear All, We are swimming...
Antimicrobial resistance poses a catastrophic threat. If we don’t act now, any one of us could go into hospital in 20 years for minor surgery and die because of an ordinary infection that can’t be treated by antibiotics. And routine operations like hip replacements or organ transplants could be deadly because of the risk of infection.
AMR Fireside Chats
1/18 videos
1
Episode 17 w/ Ella Balasa and Rob Purdie of WHO Task Force of AMR Survivors - AMR Fireside Chat
38:24
2
Episode 16 w/ Ramanan Laxminarayan, PhD - AMR Fireside Chat
32:59
3
Episode 15 w/ Mark Albrecht, PhD - AMR Fireside Chat
43:55
4
Episode 14 w/ Lynn Silver - AMR Fireside Chat
56:23
5
Episode 13 w/ Kevin Outterson - AMR Fireside Chat
30:01
6
Episode 12 w/ Tina Joshi, PhD - AMR Fireside Chat
34:22
7
Episode 11 w/ Martin Heidecker - AMR Fireside Chat
32:31
8
Episode 10 w/ Anna Govett - AMR Fireside Chat
14:54
9
Episode 9 w/ Fatema Rafiqi, PhD - AMR Fireside Chat
34:10
10
Episode 8 w/ Ghada Zoubiane, PhD - AMR Fireside Chat
35:04
11
Episode 7 w/ Trevor Lithgow, PhD - AMR Fireside Chat
35:41
12
AMR Snapshots: Episode 2 - John Rex (Editor-In-Chief, AMR.Solutions)
26:25
13
Episode 6 w/ Maryn McKenna - AMR Fireside Chat
45:50
14
Episode 5 w/ Christine Årdal - AMR Fireside Chat
43:44
15
Episode 4 w/ Peter Beyer - AMR Fireside Chat
39:21
16
Episode 3 w/ Kevin Outterson - AMR Fireside Chat
11:45
17
Episode 2 w/ Henry Skinner, PhD - AMR Fireside Chat
15:44
18
Episode 1 w/ Kevin Outterson - AMR Fireside Chat
52:56
Language matters: CRE vs. CPE; SDD vs. I; and MDR, XDR, PDR, UDR vs. DTR
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
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FDA AMDAC – Developing Single-Pathogen agents for P. aeruginosa and A. baumannii
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
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Reimbursing for innovative antibiotics / Encouraging updates from the AMR conference
Dear All (with thanks to Kevin as the lead author on this note and also with a wonkish note alert … refresh your coffee and
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NIAID workshop: What is a robust PK-PD package?
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
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FDA Workshop: Animal models in support of narrow-spectrum agents for A. baumannii and P. aeruginosa
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
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How hard (and how) to Pull? Net value of Pull via a Transferrable Exclusivity Extension (TEE)
Dear All (wonkish alert … get your coffee!), EFPIA have recently released a report estimating the value of a Transferable Exclusivity Extension (TEE, report, press
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Global survey of novel antibiotic reimbursement models / PASTEUR Act introduced to US House
Dear All (wonkish alert, but the details are fascinating … and with thanks to Kevin Outterson for co-authoring!), Two related items of note for today.
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Non-traditional antibiotics: A pipeline review and an analysis of key development challenges
Dear All, Non-traditional alternatives to antibiotics have excited a lot of interest in the past few years but we’ve seen relatively few of these progress
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In Praise of Non-Inferiority
Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the
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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
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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
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Impact of PASTEUR: 9.9m lives saved, ROI of 125:1
Dear All (and with thanks to Kevin Outterson for being lead author on this newsletter), (wonkish alert on this one … refresh your coffee and
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The thoughtless person playing with penicillin treatment is morally responsible for the death of the man who succumbs to infection with the penicillin-resistant organism.
The bipartisan PASTEUR Act is the strongest bill ever written to strengthen antibiotic development and use. It will fix our market failures, expand the pipeline for next generation antibiotics, and save lives. We can’t sit on our hands as this public health crisis arrives – we have to act now.
Summaries
Notes: Newsflash ... BARDA have...
Aside: If you've enjoyed the...
Dear All,See also this related...
Dear All (and with thanks...
Dear All (Wonkish alert! Coffee-up!),Today...