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...
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Dear All,Referring back to the...
Dear All,Attention phage developers --...
Dear All,D-Day and the momentous Normandy...
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R&D Insight
Dear All,As those of us...
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Dear All,I wrote in the...
Dear All: Here's a potpourri...
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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...
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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
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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UK to expand NHS Subscription Pilot! Consultation Period launches
Dear All (and with thanks to Kevin for co-authoring), The UK NHS England Pilot is known to us all as the first real attempt at an antibiotic ...
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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, ...
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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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Lancet: 10-20-30 targets to address AMR by 2030
Dear All (wonkish alert … but definitely worth the effort! Refill your coffee!),Ramanan Laxminarayan and about 40 colleagues from around the world have just published in ...
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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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Novel Biology, Novel Utility, & the Illusion of Skill: What to develop? What to reward?
Dear All (wonk-ish note alert and also with particular thanks as always to Kevin Outterson for helping to refine this newsletter): Sparked at least in ...
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FDA: Early endpoints and late endpoints suggest a path to global regulatory convergence (Bart et al.)
Dear All (wonkish note alert … top-up your coffee and settle in!), Today we have a tour of a recent paper in Clinical Infectious Diseases ...
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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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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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FDA workshop: Insights on inhaled antifungals and antibacterials
Dear All (wonkish alert … coffee up!), FDA held a workshop on 25 Sep 2020 on development of inhaled antifungal (AF) therapies with a focus ...
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Plazomicin (Achaogen) financial post-mortem: #PassPASTEUR
Dear All (and with thanks to Kevin for co-authoring and also a wonkish alert … get your coffee and settle in for the details), If ...
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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...