ANTIMICROBIAL RESISTANCE SOLUTIONS
WITH DR. JOHN H. REX
Latest Newsletters
Dear All, Pushing this one out as a direct quote from the online materials posted yesterday by FDA. Looks interesting! All best wishes, --jrThe U.S. Food and Drug Administration is conducting a national listening tour to meet directly with pharmaceutical and biotech CEOs. Held in major innovation hubs across the country, the CEO Forums will be led by FDA Commissioner Marty A. Makary, M.D., M.P.H., along with Principal Deputy Commissioner Sara Brenner, M.D., M.P.H and Director of FDA’s Center for Biologics Evaluation and Research, Vinay Prasad, M.D., M.P.H. These forums are part of a new initiative to gather direct input from biotechnology and pharmaceutical leaders on how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.Please use the registration form below to express your interest in attending one of the CEO forums being held across the country. RequirementsRegistrants must have at least one active Investigational New Drug (IND), New Drug Application (NDA) or Biologics License Application (BLA) on file with the FDA.While participation by a CEO is preferred, registration is also open to the company's CEO or a Chief Medical Officer or Head of Research and Development. Interested companies should only register for...
Dear All,As in previous years ...
Dear All (wonkish alert ......
Latest Government Action
Dear All,If you represent a US-based organization with an interest in AMR, there is an opportunity to sign a letter advocating for AMR-related funding in the FY2026 US Government (USG) budget.Founded in 2014, IDSA's S-FAR (Stakeholder Forum on Antimicrobial Resistance) has been steadily coordinating messages to the USG from professional groups with an interest in AMR. Today, there is an opportunity to be a part of the process for FY2026 by signing this draft letter. As a signatory, you would be joining the Association for Professionals in Infection Control and Epidemiology (APIC), American Society of Microbiology (ASM), Society for Healthcare Epidemiology of America (SHEA), AdvaMed Dx, BIO, Food and Animal Concerns Trust (FACT), and Infectious Diseases Society of America (IDSA) in supporting a request for FY 2026 funding for domestic and global antimicrobial resistance (AMR) programs. The letter is similar in structure to a letter sent last year in providing recommendations for funding of AMR-related work across all parts of USG (CDC, ASPR (including BARDA and CARB-X), NIAID, FDA, etc.)You can sign this year's letter here: https://forms.gle/2ppBt83LUEvXWU557. Please note that signatories should be US-based organizations. The deadline for signatures is 9 May 2025.Many thanks to our colleagues at IDSA for organizing this effort! All best...
Dear All, Sadly, I must...
Dear All (and with thanks...
Dear All, The Global Leaders Group on Antimicrobial...
Dear All,BARDA has released a...
R&D Insight
Dear All,Once again, we’re going to...
Dear All:I missed it personally,...
Dear All: (18 June addendum: the...
Dear All: Two things on...
Addendum: This is the third...
Dear All,I've written before about...
Dear All: Verbatim comments from...
Dear All,Pew Charitable Trusts have...
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
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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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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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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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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Assessing antibiotic value: DTR, fire extinguishers, and a view from Australia
Dear All (wonkish note alert — refresh your coffee before proceeding — with thanks to Kevin Outterson for co-authoring this note!), The intertwined questions of ...
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Mirror Bacteria: An AMR threat of unprecedented magnitude
Dear All (wonkish but stick with it … I’m going to try very hard to de-wonk it), In an absolutely terrifying paper and technical report ...
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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 (link) on DTR as part of the language of resistance and 7 June 2020 (link) on ...
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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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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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Scary, Scarier, Scariest (Part 2): What can YOU do about it?
Long note alert— apologies! Get a cup of coffee and settle in… Dear All: My 22 Apr 2019 note entitled Scary, Scarier, Scariest: Achaogen / FT ...
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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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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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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...