R&D Insight

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 newly released 4-minute YouTube discussion of a scene from Master and Commander in which antibiotics could have saved a young man’s arm! Dear All (Wonkish alert! There’s a lot of

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WHO 2017 Priority Pathogens List

Dear All: The new WHO priority pathogen list for R&D has been released! It’s entirely focused on bacteria both otherwise has a lot of similarity the CDC list. FYI, CARB-X will use both lists going forward. Links to WHO materials are below. I have also prepared a short slide deck (updated on 22 Dec 2017) that shows

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WHO 2020 clinical/preclinical pipeline review; Chat with WHO’s Peter Beyer

Dear All, WHO have today updated their 2019 clinical/preclinical pipeline review by releasing their 2020 analyses of both the clinical and pre-clinical antibacterial product pipelines (the new 2020 report, the press release). Their 2020 review of antibacterial products in Phase 1 and beyond covers both traditional (n = 43) and non-traditional products (n = 27)

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FDA-NIAID-CDC: Developing drugs for gonorrhea, 23 Apr 21 workshop

Dear All, FDA, NIAID and CDC have announced a public workshop on development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will cover both nonclinical (preclinical) and clinical trial design considerations: Animal models Clinical pharmacology considerations Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.

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FDA workshop: Revising the process for importance-ranking of human antimicrobials to guide their use in animals

Dear All, FDA have announced that they will hold a virtual public workshop on 16 Nov 2020 (9.30a-4.00p EST) entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” Go here for the FR notice, here for extended details, including registration, and here for

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Commissioner Gottleib (New FDA initiatives, need for Pull incentives) + updated Pew pipeline analyses

Dear All: It was a HUGE day at the Pew Charitable Trusts today! First, Commissioner Scott Gottleib gave a superb and very exciting speech. You can either read or listen to the entire speech. There is also a panel discussion after his talk that is worth replaying. Here are some highlights from Commissioner Gottleib’s talk: FDA is working to coordinate

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Young people and AMR: A global summit! A video game!

Dear All, Today we have two hopeful signs from our younger colleagues about the future of AMR! First Global AMR Youth SummitThe World Health Students’ Alliance (WHSA) has announced a 3-day virtual event (20-22 Nov 2020, see details below) where “youth around the world come together to discuss, learn, and get empowered about various AMR-related

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AMR Action Fund ($1b for P2-3): Video chat with new CEO! New committed funds!

Dear All, I’ve written before about the AMR Action Fund (9 Jul 2020 newsletter): In brief, it is ~$1b pledged by over 20 leading pharmaceutical companies to support the Phase 2-3 studies needed to bring 2-4 new antibiotics to approval by 2030 Stated differently, the AMR Action Fund provides Push incentives for Phase 2-3 to complement the Push Incentives

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Vaccines to turn back the tide of antimicrobial resistance

Dear All, As part of their Immunization Agenda 2030: A Global Strategy to Leave No One Behind, WHO have now published an AMR-focused action framework that summarizes ways we should seek to use vaccines both to reduce antibiotic use and to prevent the further emergence of antimicrobial resistance. Here are the links you need —

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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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