ANTIMICROBIAL RESISTANCE SOLUTIONS
WITH DR. JOHN H. REX
Latest Newsletters
Dear All,No, EMA has not decided to set up shop on the beach! Rather, the point of this newsletter is that I heard a fascinating talk on the idea of "regulatory sandboxes" during the recent BEAM-AMR meeting. I had not previously heard of this idea, but it turns out that the concept of regulatory sandbox has been around for some years in the financial world with the idea being that of “a ‘safe space’ in which businesses can test innovative products, services, business models and delivery mechanisms without immediately incurring all the normal regulatory consequences of engaging in the activity in question.” So, it then turns out that the European Commission (EC) began a few years ago to consider the idea of using regulatory sandboxes to explore areas where scientific advances were struggling to progress due to a mismatch between the science and the current regulatory frameworks. The online information on this is currently somewhat scattered, but here are some links to get you started:9 Dec 2025: https://gdprlocal.com/eu-regulatory-sandbox/: An excellent introductory blog16 Dec 2025: A Q&A document regarding the European Biotech Act that alludes to sandboxes as as controlled environments for companies to experiment and trial innovative solutions, regulatory procedures and technologiesJuly 2025: A...
Dear All (a wonkish guide...
Dear All (and with thanks...
Latest Government Action
Dear All,I'm delighted to be able to say that PASTEUR 2026 was (re)introduced into the US Congress this week! It's an improved version relative to the version introduced into the prior 3 sessions of the US Congress (see below for discussion of that), so I think we can safely call it "PASTEUR v2.0" as well as by its more official name of PASTEUR 2026. Here are the links you need:PASTEUR 2026 (v2.0)On congress.gov, it is "H.R.7352 - To amend the Public Health Service Act to establish a program to develop innovative antimicrobial drugs targeting the most challenging pathogens and most threatening infections, and for other purposes."But, you can't (yet) download from congress.gov ... instead, use this text (.pdf) of the newly introduced versionA section-by-section analysis of the ActPress releases and commentaryOne-pager about the newly introduced version of PASTEURPress release by the five house representatives who are sponsoring the billAnd excitingly, six additional representatives have joined the bill as of today (to follow this, look at the "Date Cosponsored" column on that webpage)Press releases from IDSA and BIOBackground and context on the ideas behind PASTEUR as well as its potential value16 June 2021 newsletter ("PASTEUR Act re-introduced and levels up antimicrobial economics for strong innovation!"). This newsletter gives a...
Dear All,There are more details...
Dear All (and with thanks...
Dear All,Referring back to the...
Dear All,Attention phage developers --...
Dear All,D-Day and the momentous Normandy...
Dear All,If you represent a...
R&D Insight
Dear All (long, wonkish note...
This newsletter is part of...
Dear All: This is your...
Dear All: I would like...
Dear All:FDA’s approval of delafloxacin...
Dear All, Two important new...
Dear All, I realized after...
Dear All: A Federal Register notice has...
Dear All:Sweden has been a...
Dear All,I just today learned...
Dear All, Two quick updates...
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
1/19 videos
1
Episode 18 w/Robin Hiley- Fireside Chat
19:48
2
Episode 17 w/ Ella Balasa and Rob Purdie of WHO Task Force of AMR Survivors - AMR Fireside Chat
38:24
3
Episode 16 w/ Ramanan Laxminarayan, PhD - AMR Fireside Chat
32:59
4
Episode 15 w/ Mark Albrecht, PhD - AMR Fireside Chat
43:55
5
Episode 14 w/ Lynn Silver - AMR Fireside Chat
56:23
6
Episode 13 w/ Kevin Outterson - AMR Fireside Chat
30:01
7
Episode 12 w/ Tina Joshi, PhD - AMR Fireside Chat
34:22
8
Episode 11 w/ Martin Heidecker - AMR Fireside Chat
32:31
9
Episode 10 w/ Anna Govett - AMR Fireside Chat
14:54
10
Episode 9 w/ Fatema Rafiqi, PhD - AMR Fireside Chat
34:10
11
Episode 8 w/ Ghada Zoubiane, PhD - AMR Fireside Chat
35:04
12
Episode 7 w/ Trevor Lithgow, PhD - AMR Fireside Chat
35:41
13
AMR Snapshots: Episode 2 - John Rex (Editor-In-Chief, AMR.Solutions)
26:25
14
Episode 6 w/ Maryn McKenna - AMR Fireside Chat
45:50
15
Episode 5 w/ Christine Årdal - AMR Fireside Chat
43:44
16
Episode 4 w/ Peter Beyer - AMR Fireside Chat
39:21
17
Episode 3 w/ Kevin Outterson - AMR Fireside Chat
11:45
18
Episode 2 w/ Henry Skinner, PhD - AMR Fireside Chat
15:44
19
Episode 1 w/ Kevin Outterson - AMR Fireside Chat
52:56
De-risking vaccine development: Insights spanning decades of experience
Dear All (with thanks to Vega Masignani for co-authoring this newsletter), While the work needed to create new antibacterial agents is the primary topic of ...
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News from Davos 2020: Some positive signs, but overall a fragile antibiotic market at a tipping point
Dear All (and heads-up for a rather lengthy and wonkish note … settle in for the details), Last week saw substantial AMR-related news released in ...
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Chemical vs. drugs (Part 2): How do you discriminate? / More on halicin
This newsletter is part of a series — here are the links to Part 1, (this one is Part 2), Part 3, Part 4, and Part 5. Also relevant ...
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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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Language matters: CRE vs. CPE; SDD vs. I; and MDR, XDR, PDR, UDR vs. DTR
Note: See also these related newsletters: 13 Jan 2019 on DTR as part of the language of resistance, 7 Jun 2020 on using DTR to estimate ...
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What does an antibiotic cost to develop? What is it worth? How to afford it?
Dear All (long, wonkish note alert!): Today we have a 3-part discussion of cost and value with this summary 3-part message: Developing antibiotics is expensive, ...
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FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference
Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference ...
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Developing antibiotics for children: There are no easy answers
Aside: If you’ve enjoyed the prior discussions of movies to inspire antibiotic R&D and very apropos given the theme of today’s newsletter, please check out the ...
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Two new oral drugs for gonorrhea!
Dear All (wonkish … but worth it … get ready to follow the links!), Greetings in the new year! As a marvelous way to end ...
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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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Melinta goes bankrupt / Never let a good crisis go to waste
Dear All (long-ish, wonk-ish note alert … lots of details to absorb): This newsletter has a followup here. Sadly, Melinta Therapeutics, Inc. declared bankruptcy just ...
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FDA Workshop: Animal Models To Support Antibacterial Development (5 Mar 2020, post-meeting notes)
Dear All (detailed and wonkish note alert … lots of thinking out loud … get some coffee and settle in!), I wrote previously (link) about ...
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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...
See also This related newsletter:...
Dear All (and with thanks...
Dear All (Wonkish alert! Coffee-up!),Today...