R&D Insight

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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Let’s make a pull incentive happen in the US during the 116th Congress!

Dear All: I’ve written a lot about the need for pull incentives, preferably delinked (some papers to read, comments by TATFAR, highlights from Davos 2018, and the UK commits to trying delinkage).  Now, I am delighted to report that a really serious effort is underway in the US to make something happen during the 116th Congress. The essential document can be

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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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Updated EMA antibacterial guidance: Draft released for public consultation

Dear All: Dated 19 Dec 2018 and marked as released for public consultation on 14 Jan 2019, EMA has posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I have not yet had a chance to study in detail and will

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Categories of resistance: MDR, XDR, PDR, UDR, and (new!) DTR

Note: See also these related newsletters: 20 Feb 2020 (link) on DTR as part of the language of resistance and 7 June 2020 (link) on using DTR to estimate antibiotic value. Dear All: When thinking about studies of resistant pathogens, issues of case-finding and statistical design are frequent topics of debate. As an example, the

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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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