R&D Insight

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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18-19 Nov 2019 FDA-IDSA-NIH-Pew Workshop: Enhancing Antibacterial Trials in the US

Dear All, Long note alert: Set aside at least 30 minutes for this one … there’s a lot of important material here. Last week’s workshop entitled “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States” was an unusual and unusually instructive meeting. You can go here for the meeting materials but as there are

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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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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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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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Novo REPAIR Impact Fund is open for EU proposals: 10 May 2019 deadline

Dear All: The Novo REPAIR Impact Fund is open for its second round of EU-based proposals! Four projects have been funded to date by this $165m project. Could you be among the next?  Initial non-confidential proposals are due 10 May 2019. The broad scope is Discovery through Phase 1 for projects focused on therapeutics to address antibacterial resistance.

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