ANTIMICROBIAL RESISTANCE SOLUTIONS
WITH DR. JOHN H. REX
Latest Newsletters
Dear All (and with thanks to Patricia Bradford for leading on this newsletter),Did you know you can access raw datasets of antimicrobial susceptibility surveillance data that have been generated by the pharmaceutical industry? Indeed such datasets exist and we’d like to ensure everyone is aware of their availability and potential!Background: The 20 Oct 2023 newsletter discussed Vivli, a nonprofit entity dedicated to advancing human health through data sharing. Vivli supports a clinical data sharing platform that was created in 2013 from a project by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard.The AMR focus: Vivli seeks to enable innovative re-use of surveillance data shared by GSK, Johnson & Johnson, Merck, Pfizer, Shionogi, Paratek, Venatorx, and Venus Remedies. Vivli was funded in June 2022 by Wellcome to launch the AMR Register (amr.vivli.org). The AMR Register provides access to high-quality antimicrobial susceptibility surveillance data (MIC by organism) generated by the pharmaceutical industry. Surveillance programs conducted by industry are mandatory and comply with regulatory agency requirements for commercial approval and post-approval commitments for new antimicrobial agents. By sharing their data via the AMR Register, pharmaceutical companies thereby uphold their agreements with regards to data transparency.The AMR register currently has nine member companies: What’s in the data?The data hosted...
Latest Government Action
This is the fifth of a 5-part newsletter series. There is an initial 27 Sep 2023 newsletter introducing the EPA concept note, a second (28 Sep 2023) newsletter that expands on the EPA concept note, a third (12 Jan 2024) newsletter about ending the use of streptomycin spray on citrus crops, and a 4th newsletter (27 Jan 2024) containing some additional resources. Dear All, Excitingly, the US EPA (Environmental Protection Agency) has now finalized a framework for reviewing the AMR (resistance) risks of antibacterial and antifungal pesticides. Here's a summary to get you started: When used in crop or animal agriculture, antibacterials and antifungals fall under the regulation for pesticides provided by FIFRA (the Federal Insecticide, Fungicide, and Rodenticide Act). Yes, I know that idea sounds odd ... pesticides? Well, it's a regulatory term. See the 27 Sep 2023 AMR.Solutions newsletter if you want to go deeper on this. FIFRA requires that use of the pesticide according to label specifications will not generally cause "unreasonable adverse effects on the environment" which are in turn defined to mean “(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or "(2) a human dietary risk from residues that result from a use of...
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,CARB-X have opened their...
Dear All (long, wonkish note...
Dear All, The Duke-Margolis team...
Dear All:I missed it personally,...
Dear All: Given our collective...
Dear All,Some great news today! We...
Dear All: The Novo REPAIR...
Aside: If you've enjoyed the...
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
1/17 videos
1
Episode 16 w/ Ramanan Laxminarayan, PhD - AMR Fireside Chat
32:59
2
Episode 15 w/ Mark Albrecht, PhD - AMR Fireside Chat
43:55
3
Episode 14 w/ Lynn Silver - AMR Fireside Chat
56:23
4
Episode 13 w/ Kevin Outterson - AMR Fireside Chat
30:01
5
Episode 12 w/ Tina Joshi, PhD - AMR Fireside Chat
34:22
6
Episode 11 w/ Martin Heidecker - AMR Fireside Chat
32:31
7
Episode 10 w/ Anna Govett - AMR Fireside Chat
14:54
8
Episode 9 w/ Fatema Rafiqi, PhD - AMR Fireside Chat
34:10
9
Episode 8 w/ Ghada Zoubiane, PhD - AMR Fireside Chat
35:04
10
Episode 7 w/ Trevor Lithgow, PhD - AMR Fireside Chat
35:41
11
AMR Snapshots: Episode 2 - John Rex (Editor-In-Chief, AMR.Solutions)
26:25
12
Episode 6 w/ Maryn McKenna - AMR Fireside Chat
45:50
13
Episode 5 w/ Christine Årdal - AMR Fireside Chat
43:44
14
Episode 4 w/ Peter Beyer - AMR Fireside Chat
39:21
15
Episode 3 w/ Kevin Outterson - AMR Fireside Chat
11:45
16
Episode 2 w/ Henry Skinner, PhD - AMR Fireside Chat
15:44
17
Episode 1 w/ Kevin Outterson - AMR Fireside Chat
52:56
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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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 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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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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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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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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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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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 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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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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Public meeting on the LPAD Pathway: Post-meeting thoughts (wonkish)
Long and wonkish note alert — please refresh your coffee before you start reading! Dear All: I was able to attend and speak at the
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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...