R&D Insight

Discussing Details of ATMF’s 2021 AMR Benchmark Report!

Dear All, As you may remember, last fall I wrote a newsletter about ATMF’s 3rd update to the AMR Benchmark series. You are encouraged to read the report but in brief, the key messages are (i) the pipeline is small with most innovation coming from small biotech, (ii) stewardship and access planning are increasingly seen (but access itself

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EPA (Part 4): Further resources

This is the fourth 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 fifth newsletter (11 Oct 2024) about the EPA’s collaborative framework for evaluating the AMR

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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 in a meaningful way (go here for Pew’s recent survey of the development landscape). Providing insights into the challenges of this area, two valuable and complementary articles on non-traditional antibiotics have recently

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Stewardship & Access Guide from CARB-X, Wellcome, and partners: Analysis, video chat

Dear All, Novel antibacterial agents, vaccines, and diagnostics will do little if they are not widely available and used responsibly. CDDEP’s recent report entitled “The State of the World’s Antibiotics in 2021” makes this very clear: “… more people in LMICs (low-middle-income countries) die from lack of access to antimicrobials than from resistant infection.” Hence, CARB-X has

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FDA AdComm #2 on inhaled ciprofloxacin (11 Jan 2018); IMI Call for AMR diagnostics (28 Feb 2018 deadline)

Dear All: Two new events on the near-term horizon. First, FDA has announced an Antimicrobial Drugs Advisory Committee for 11 Jan 2018  (and materials from the meeting can now be found here). Per the FR notice, this AMDAC will cover Aradigm’s inhaled ciprofloxacin for non-CF bronchiectasis and is almost certainly a discussion of the results Aradigm’s ORBIT-3

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CARB-X Novel Chemistry for AMR Challenge

Dear All, Happy New Year! As a great start for January, Team CARB-X have announced (i) that they will have two funding calls during 2026 (April and then Q4) and (ii) that a theme focused on finding new chemical scaffolds will be part of both calls. Applications to these target-based therapeutics funding calls will require defined chemistry

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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 dig in!) Bonnifield and Towse of the Center for Global Development have released a blog post and a paper estimating the potential impact of the PASTEUR Act. Here’s what you need:

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Extending STEDI to diagnostics: STRIDES

Dear All (and with thanks to Betsy Trainor for co-authoring), The idea of the STEDI values of an antibiotic (its fire extinguisher-like values) comes up often. As a reminder, the STEDI values are Spectrum, Transmission, Enablement, Diversity, and Insurance. As a good example, consider Enablement: knowing that an antibiotic exists as a backup makes safe

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FDA analysis of 40-years of antibacterial development: Dheman et al.

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Just out in CID is a paper in which FDA analyzes trends in antibacterial development from 1980-2019. To fully appreciate this paper, you need to look both at it and three other papers: FDA’s paper (https://doi.org/10.1093/cid/ciaa859): Dheman N, Mahoney N, Cox EM, Farley

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Antibacterial R&D is very hard! Two great pipeline reviews + an Industry-level view

Dear All (and with thanks to Stephan Harbarth for co-authoring this newsletter), A new review by Ursula Theuretzbacher and colleagues from GARDP provides an opportunity to (i) discuss the preclinical antibacterial pipeline (the new paper), (ii) remind you of a recent review of the Gram-negative clinical pipeline, and (iii) share an excellent Industry-level perspective on

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