R&D Insight

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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Why vaccines for AMR? What is their value? Grant opportunity for research on this topic / Great NPR TED Radio Hour on vaccines

Dear All:​First, and with a closing date of 12 Sep 2019, Wellcome Trust is offering grants of up to GBP 750k for research investigating the impact of vaccines on antibiotic use and/or antimicrobial resistance (go here for details). The core goal of this funding scheme is to develop data that would support and inform vaccine decision-makers around the world as they

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Extended deadline: NIAID call for proposals for therapeutics & vaccines for resistant bacteria

Also note several new webinars in the forward meeting list! Dear All: NIAID currently has an open BAA (Broad Agency Announcement, HHS-NIH-NIAID-BAA2019-1, link), that calls for proposals across three research areas: Medical Countermeasures (MCMs), therapeutics for resistant bacteria, and vaccines for resistant bacteria. The deadline for Research Area 001 (MCMs) is still 20 May 2019, but the

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CARB-X 2019: Calls announced covering non-traditionals, vaccines-biologics, diagnostics, and direct-acting small molecules

​Aside: There is now an application link for the Mar 2020 Antibacterial R&D GRC meeting. See calendar listing below my signature! Dear All: CARB-X this week announced its 2019 calls for proposals (link). There are four application rounds: Non-traditional approaches: Funding Round 1 will be open for Expressions of Interest June 3 – June 10, 2019, 5 PM

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Upcoming BARDA RFP to acquire antibiotic(s) for biothreat indications!

Dear All: Ready, set, (get ready to) go! I just today learned of this really important US government pre-solicitation notice (lightly reformatted excerpt follows, see here for the whole thing): “The Government seeks an FDA-approved antibiotic(s) for a biothreat indication (Y. pestis, B. anthracis, F. tularensis, B. mallei and/or B. pseudomallei) for delivery to the Office of the Assistant Secretary for Preparedness and Response

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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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