ANTIMICROBIAL RESISTANCE SOLUTIONS
WITH DR. JOHN H. REX
Latest Newsletters
Dear All, An updated version of FDA's very helpful Q&A entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers" has just been released. Here are the links you need to get started: The new June 2025 guidance itself The webpage about the guidance The prior (May 2022) guidance (note that I can't find this online so have posted the copy that I downloaded previously) A comparison of the 2022 and 2025 documents as generated by Acrobat [key context] The 27 May 2022 newsletter that discussed both the prior FDA iterations of this guidance (May 2022, August 2017) as well as a pair of EMA guidance documents (a general guidance, a pediatric guidance) that were also released May 2022 This 2024 paper by FDA staff: Ghosh M, Iarikov D, Qi X, Rubin D, Shurland S, Goodwin A, Wei X, Chilukuri D, McMaster O, Miller T, Kim P, & Sherwat A. Flexible Development Programs for Antibacterial Drugs to Address Unmet Medical Needs. Emerging Infectious Disease journal. 2024;30(11):2227; https://doi.org/10.3201/eid3011.231416. This paper is notable for its detailed discussion of the path to approval for sulbactam-durlobactam (XACDURO) for HABP-VABP for Acinetobacter baumannii via a non-inferiority trial that used a 20% non-inferiority margin. For...
Dear All,Referring back to the...
Dear All,Attention phage developers --...
Latest Government Action
Dear All,Referring back to the actions planned following the 2024 UNGA HLM on AMR (UN General Assembly High-Level Meeting on AMR; 1 Oct 2024 newsletter and our dedicated UNGA 2024 webpage), you will hopefully recall the commitment to create an Independent Panel on Evidence for Action against AMR (IPEA).The broad idea is the data from an independent panel would have great credence and encourage governmental action. The importance of creating of an IPEA was specifically noted in paper #4 from the 10-20-30 Lancet series (Mendelson et al. Lancet 2024 and the 23 May 2024 newsletter) and has been supported by funding promises of €2.5 million from the European Commission along with commitments of GBP 10 million each from the United Kingdom and Saudi Arabia.And the hope is that this will move quickly. A roadmap released 14 Mar 2025 calls for work to ensure that the IPEA "is established and commences its work as soon as practicable in 2025."So, how do you create an IPEA? How is it organized? How is it governed? To answer that question, we today have papers from the Quadripartite Joint Secretariat on AMR (QJS) on possible ways to create an IPEA ... and we are all invited to comment on the best approach. Here are the...
Dear All,Attention phage developers --...
Dear All,D-Day and the momentous Normandy...
Dear All,If you represent a...
Dear All, Sadly, I must...
Dear All (and with thanks...
R&D Insight
Dear All: Two things on...
Dear All: Following hard on...
Dear All: FDA today posted...
Dear All,The US Department of...
Dear All, Your vote counts! The...
Dear All: First up, NIAID has...
Dear All,I learned today from...
Dear All, Some regulatory 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
1/18 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
New pipeline analysis: Cancer projects were funded 17x more than antibacterials during 2011-2020
Dear All (wonkish alert: coffee up, settle in, and read the reports!), As you will recall, WHO’s most current pipeline review found that globally we ...
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IDSA White Paper on developing narrow-spectrum antimicrobials + editorial by G. Drusano
Dear All (long note alert … there’s a lot of material below my signature): Just published today is an IDSA White Paper entitled “Developing Antimicrobial ...
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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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Push! Pull! Push! Pull! / Highlights from Davos 2018
Dear All: Three important documents were released at / during / around the World Economic Forum meeting that occurred this week in Davos. First and foremost, ...
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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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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 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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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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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 ...
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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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New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule
Dear All (and with thanks to Kevin Outterson for substantial help with this newsletter), On August 2, 2019, the US government agency that administrates Medicare & ...
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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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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...