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,Pew Charitable Trusts have...
Dear All: Ready, set, (get...
Aside: Please look closely at...
Dear All: EU's IMI (Innovative...
Dear All, National Institute of...
Dear All: Two links to...
Dear All, I realized after...
This is the first of...
Dear All:FYI, see below an...
Dear All,I was fascinated by...
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
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 ...
Read More →
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 ...
Read More →
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 ...
Read More →
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 ...
Read More →
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 ...
Read More →
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 & ...
Read More →
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 ...
Read More →
The 6 meanings of “Lack of Access” (UNSLAP)
Dear All, We often talk about the problem of lack of access to new antibiotics. In late 2021, for example, we explored data showing that multi-year ...
Read More →
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 ...
Read More →
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 ...
Read More →
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 ...
Read More →
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 ...
Read More →
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...