Two research calls: FDA (rabbit VAP models) and JPIAMR (aquatic pollutants)

Dear All, Two important new research calls are now out.

First, FDA is offering research funding of up to $1m to support creation of rabbit models of ventilator-associated bacterial pneumonia (VAP or VABP, depending on your preferred abbreviation) due to carbapenem-resistant strains of A. baumannii and P. aeruginosa.

  • The call for proposals is via FDA Broad Agency Announcement (FDABAA-20-00123N, link), an ongoing open solicitation for R&D to support regulatory science. This particular call addresses goal 2.4.2 from that BAA and builds on conversations that began at a 1 Mar 2017 workshop on narrow-spectrum agents for those two species (go here for workshop materials and here for my workshop notes).
  • The goal is a model that meaningfully evaluates human clinical response to therapy for VABP. Details on FDA’s objectives for the program are here (with a brief excerpt from same found below my signature). Proposals should be submitted to the Broad Agency Announcement (FDABAA-20-00123N; priority area 2.4.2). A Quad Chart and White Paper are due by February 28, 2020.
  • This is so good to see! The conversation about ways to really leverage animal models as predictive tools for human infections definitely needs to continue to progress. 

Second, three of the EU Joint Programming Initiatives (JPI Water, JPI Oceans, and JPIAMR) have announced a joint transnational callentitled AquaticPollutants for research and innovation projects on risks posed to human health and the environment by pollutants and resistant pathogenspresent in the water resources.

  • The Aquatic Pollutants call is planned to open on 17 Feb 2020 with pre-proposals due 16 April 2020.
  • Call themes will encompass ways to (i) Measure pollutants & resistant bacteria, (ii) Evaluate Risk, and (iii) Take Action on these risks.
  • More details are here. Again, a great project … its excellent to see the joint planning across the 3 JPIs!

Ho, ho, ho!  –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog/

FDA Rabbit VABP Model Objectives
FDA is interested in advancing regulatory science to facilitate the development of novel antibiotics against carbapenemase-resistant strains. As one may anticipate some uncertainties in a clinical trial specifically targeting carbapenemase-resistant strains, such as prior antibiotic treatment or concomitant antibiotic treatment, data from animal models may provide informative data. Validating the predictive ability of animal models of ventilator-associated pneumonia against susceptible and resistant strains would increase the utility of animal models in predicting a human clinical response.

FDA will prioritize White Papers submitted in response to the FDA Broad Agency Announcement by the February 28, 2020 deadline that propose efforts focused on developing or refining rabbit animal models of ventilator-associated pneumonia utilizing a carbapenemase-resistant strain of Pseudomonas aeruginosa or Acinetobacter baumannii.  Proposed efforts may include a systematic approach to reproduce the pathophysiology of human disease in an animal species following challenge with the infectious agent and may include median lethal and/or infectious dose determination, natural history of infection, serial pathogenesis studies, and determination or validation of a humanized dosing regimen.  Efforts should include a systematic approach to develop/adapt or refine an existing animal infection model with consideration of similarities and differences between animal and human disease.

Upcoming meetings of interest to the AMR community:

  • 16 Jan 2020 (Washington, DC): Duke-Margolis meeting entitled (approximately) “improving Payment Policies for Antibiotics.” This meeting will run 10:30am – 4:30pm ET. Go here to register.
  • [NEW] 21 Jan 2020 (1700-1830 CET, online): GARDP-sponsored webinar entitled “Testing for the potential of emergence of resistance.” Go here to register.
  • [NEW] 28-29 Jan 2020 (Rockville, MD, NIAID campus): Two-day workshop entitled “Understanding the Biology, Antifungal Resistance and Clinical Implications of Candida auris.” Draft agenda is here and registration is here.
  • 20 Feb 2020 (London, UK): Westminster Health Forum conference entitled “Antimicrobial resistance – coordinating a global response and progress on the UK strategy.” Go here for details.
  • [NEW] 24 Feb 2020 (London, UK): One-day workshop hosted by Royal College of Nursing and the Longitude Prize entitled “Developing point-of-care diagnostics for urinary tract infections (UTIs): addressing clinical need in the UK.” Register here.
  • 26-27 Feb 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • [NEW] 27 Feb 2020 (1700-1830 CET, online): GARDP-sponsored webinar entitled “PK/PD murine infection models: Focus on study elements, variability, and interpretation of results.” Go here to register.
  • 1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): Gordon Research Conference (GRC) on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Go here for details.
  • 12-13 Mar 2020 (Basel): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-, ENABLE-supported (among a long list!) Conference on Novel Antimicrobials and AMR Diagnostics. Details are here, poster deadline is 12 Dec 2019.  
  • 16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details. 
  • 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
  • 25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 27-28 Jun 2020 (Bryant University, Rhode Island): Drug Resistance Gordon Research Seminar entitled “Mechanisms and Approaches to Overcoming Drug Resistance in Cancer, Infectious Disease and Agriculture” for graduate students and postdoctoral scientists. Go here for details … this immediately precedes the GRC listed just next
  • 28 Jun-3 Jul 2020 (Bryant University, Rhode Island): Gordon Research Conference (GRC) entitled “Strategies to Disrupt Drug Resistance in Infectious Disease, Cancer and Agriculture.” Go here for details.
  • 1-4 Sep 2020 (Dublin): Annual ASM-ESCMID Conference on Antibiotic Development #5! Mark your calendar now and go here for details.
  • 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • 22-25 Sep 2020 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 17-25 Oct 2020 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. The date is set for 2020 and the program will ultimately appear here. Registration is limited to 40 students and opens 15 Mar 2020.
  • 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)

Share

Share on twitter
Share on facebook
Share on linkedin
Share on email
Share on whatsapp
Share on reddit

Pull incentives in the EU / Statements by Commissioner Kyriakides

Dear All, Stella Kyriakides, the European Commissioner for Health and Food Safety, made some really interesting statements before the European Parliament’s health committee (ENVI) on Thursday of last week (22 April). Per this Exchange of Views on the EP’s multimedia center and this news report, here are some highlights: In the Exchange of Views at 00:03:44, she said: “Later

WHO seeks experts for critical antibiotics advisory group

Dear All, WHO have opened a call for experts to be part of an Advisory Group on their Critically Important Antimicrobial (CIA) List. Background: As discussed in this 12 Oct 2020 newsletter, WHO and FDA’s Center for Veterinary Medicine (CVM) rank antibiotics to determine which can be used in animals vs. those that must preserved for

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)

Scroll to Top