R&D Insight

Clostridioides difficile / CARB-X Year 3 Annual Report / White House OSTP seeks input on the US Bioeconomy

Dear All, Committing serial email this afternoon… First, the note I just sent on FMT for Clostridium difficile (link) prompted comments that the organism is now called Clostridioides difficile. This name change slipped past me, I’ll admit! But it does seem a settled change … see this helpful editorial from May 2019 in Lancet ID for a summary of how the new

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Colistin is nephrotoxic / Antibiotic stewardship knowledge gaps / Fire extinguisher video

Dear All, To start your week, we have three tidbits for consideration. First, results from a trial entitled “Colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia (Magic Bullet study): an investigator-driven, open-label, randomized, noninferiority controlled trial” have been published (Critical Care 23:383, 2019, link). Cisneros et al. sought to enroll 496 subjects into this trial but

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WHO Pipeline Review: “The world is running out of antibiotics”

Dear All:  Released just a few hours ago in parallel with the UN General Assembly meetings, WHO has produced a detailed review of the global pipeline. As they note on their overview webpage, “The report found very few potential treatment options for those antibiotic-resistant infections identified by WHO as posing the greatest threat to health, including

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Weekend reading: HABP-VABP study design; Overview of AMR initiatives

Dear All: Two papers (one with an editorial) that are worth your time. First, we have publication of the long-awaited FNIH (Foundations for the NIH) paper on trial designs for studies of HABP-VABP (Hospital-Associated Bacterial Pneumonia and Ventilator-Associated Pneumonia). The paper also comes with an editorial: Talbot, G. H., A. Das, S. Cush, A. Dane, M.

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FDA workshop: Clinical trial designs for agents for non-tuberculous mycobacterial infection on 8 Apr 2019

 REDear All: I just heard to today that FDA is holding a public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease” on 8 April 2019 from 8.30a-5.00p. Register here. Per their website, “the purpose of the public workshop is to discuss the clinical trial design considerations, including endpoints, related to the

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NIAID seeks your comments as it updates its strategic research framework

Dear All: In 2014, NIAID set out a 5-year strategic framework for research on Antimicrobial Resistance (download it here). That document laid out these 7 areas for intensive efforts to combat AMR: Systems Biology and Antibacterial Resistance: New Directions for Drug Discovery–Using a holistic approach to examine molecular networks of host-pathogen interactions and global changes in response to

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WHO wants to hear from all pre-clinical antibiotic developers (18 Mar 2019 deadline)

​Dear All: Are you doing preclinical antibiotic R&D? If so, WHO wants to hear from you! As you know, WHO has published these two analyses of priority pathogens and antibacterial agents currently in Phases 1-3: Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug resistant bacterial infections, including tuberculosis (2017, link) 

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FDA Guidance: Coordinating susceptibility (AST) device approval with drug approval

Dear All: FDA has now posted a final guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) Devices” that discusses the ways that FDA seeks to: Minimize lag time between drug approval and AST device* approval and Provide recommendations on how AST developers and drug developers can coordinate their work with each other and with

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