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: Along with our co-authors...
Dear All,Once again, we’re going to...
Dear All (and with thanks...
Dear All,For those of you...
Dear All,I have recently become...
Dear All,FDA have announced that...
Dear All,I wrote in the...
Dear All: Three brief items...
Dear All, The BEAM Alliance, along...
Dear All: Early November will...
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
Lessons in Discovery from Lynn Silver + Pro-con on alternatives to antibiotics
Dear All: “Good decisions come from experience, and experience comes from bad decisions … and paying attention.” You’ve probably heard the first part of that ...
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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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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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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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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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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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NIAID workshop: What is a robust PK-PD package?
Dear All: The ~150 of us who gathered in Washington yesterday and today for the NIAID’s PK-PD workshop enjoyed a very rich conversation. It’s really ...
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Draft EMA antibacterial guidance: Analysis
Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft ...
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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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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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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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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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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...