Y2021

Open call to fund an EU-based novel antibacterial to IND

Dear All, GNA NOW (part of the IMI AMR Accelerator; this 25 Mar 2021 press release is a good overview of the AMR Accelerator) has just announced an open call to identify a novel mechanism candidate antibacterial to add to its portfolio. For those not familiar with it, the IMI AMR Accelerator is a 295 m€ IMI program

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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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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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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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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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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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All-in cost of a new antibiotic from discovery to 10 years on market

Dear All (and with thanks to Kevin Krause for co-authoring this newsletter), The elements that contribute to the all-in cost of an antibiotic have been reviewed in two prior newsletters: 6 Mar 2020 (focused on cost of R&D to approval): What does an antibiotic cost to develop? What is it worth? How to afford it? 7 Jan

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Sunday 10 Jan: UCSF-Stanford regulatory conference with FDA

Dear All, New on the meetings calendar today is the 10 Jan 2021 UCSF-Stanford Innovations in Regulatory Science Summit. Per the meeting website: “It is a gathering of leaders in the academia, industry and regulatory sectors to discuss the role of regulatory science in medical product development.   “The 2021 Summit will have a major focus on

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Jan-Feb meetings; CDC releases Healthcare Epidemiology RFP

Dear All: Happy New Year! I hope everyone was able to take a least a brief break over the holidays. Two things for today. First, there are two meetings in January and one in February that have just popped onto my radar. See the meetings calendar for a pair of Keystone Symposia on the microbiome,

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