FDA workshop: Animal models to support antibacterial development (5 Mar 2020)

Dear All (moderately long note alert; be sure to note the new list of funding opportunities just below my signature),

FDA have announced a public workshop on 5 Mar 2020 to discuss progress and challenges in the development and advancement of various animal models for serious infection. The Federal Register notice is here and registration is here. The workshop will be webcast and it has these goals:

  • Review the progress and challenges in the development of small and large animal models of serious bacterial infections funded by FDA, BARDA, and NIH.
  • Understand the pharmacokinetic considerations in animal model development.
  • Understand the role that animal models currently play in antibacterial drug development
  • Determine potential priorities for future research and development in this area

As FDA makes clear in their announcement, this workshop builds on a 1 Mar 2017 workshop on this same theme (link to my prior notes). In brief, that prior workshop focused on ways to support development of narrow-spectrum agents for A. baumannii (Abau) and P. aeruginosa (Pae).

The core context is that (i) it is hard to design development programs for drugs focused specifically on these two important but rare organisms and (ii) it is also hard to find ways to support small clinical programs with strong animal model data. Yes, we have examples of using the Animal Rule for biothreat pathogens but Abau and Pae lack the explosive virulence that makes primate models of plague and the like so very compelling. Rather, preclinical models of Pae and Abau have to date required a lot of manipulation of the host and have simply not been very good mimics of human disease.

As a good summary of the difficulties around this issue, I suggest you start your reading with this IDSA-supported white paper (Boucher et al., J Infect Dis 216:228–236, 2017, link). This paper uses the discussion from yet another (!) prior workshop (18-19 Jul 2016, link for even more materials) of a hypothetical Drug X-1 with a spectrum limited to P. aeruginosa. Even with a full day of debate by an active group of discussants. plausible development programs for X-1 were not evident.

This new workshop is thus timely and fits well with ongoing efforts by FDA, NIH, and BARDA to find a way forward by funding work in this space. I do not pretend to have a complete list, but one example is the currently open call (link) from FDA for applications to create 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.

So, this should be a very instructive conversation and I look forward to hearing how it builds on the prior debates. If you can’t be there in person, I suggest you plan to attend by webcast!

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions//blog/

PS: With coronavirus so much in the news, let me briefly mention some reference sources that I’ve found unusually helpful:

  • For quick read, Barry Bunin wrote (CEO of CDD, the Collaborative Drug Discovery initiative) wrote a good blog post (link)
  • CDC has a great summary web page (link)
  • Ditto for ECDC with its excellent summary web page (link)

Current funding opportunities:

  • Open now through 28 Feb 2020: FDA call for applications to create 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. Go here for details.
  • Open now through 16 Mar 2020: CC4CARB, NIAID’s call for applications to fund an innovative Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB). Go here for details.
  • Open now through 9 Apr 2020: NIAID Broad Agency Announcement (BAA) soliciting contract proposals for preclinical and clinical development of vaccines, therapeutic, and diagnostics for microbial pathogens. Go here for more.
  • Dates for the 2020 funding rounds for Novo REPAIR Impact Fund will be announced May 2020. Go here for current details.
  • 2020 funding rounds for CARB-X have not been announced.

 

Upcoming meetings of interest to the AMR community:

  • 12 Feb 2020 (Alderley Park, UK): “2020 Bioinfect Conference” sponsored by Bionow (link), the NW England life science accelerator. Go here to register.
  • 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.
  • 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.
  • 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.
  • [NEW] 5 Mar 2020 (FDA, White Oak Campus, 8.30a-5.00p EST): FDA workshop entitled “Advancing Animal Models for Antibacterial Drug Development.” FR notice is here and registration is here. The workshop will be webcast.
  • 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. 
  • 26-30 Mar 2020 (Atlanta, GA): CDC- and SHEA-sponsored 6th International Conference on Healthcare Associated Infections. Go here for details.
  • 30 Mar 2020 (everywhere): Deadline for applications for the Molecular Mycology pathogenesis course at Marine Biological Laboratory, Woods Hole. Now in its 24th year, the hands-on residential course runs 17 July to 2 Aug and gets rave reviews. Go here for more.
  • 9 Apr 2020 (everywhere): Final date for applications for NIAID/DMID call (link) for AMR-related vaccines, therapeutics, and diagnostics.
  • 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
  • 25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 18-22 Jun 2020 (Chicago), ASM Microbe 2020. Go here for details.
  • 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)
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.

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