Developing non-traditional antimicrobial therapies & preventatives: Events on 22 April (ECCMID, Madrid) and 14 June (Washington)

Dear All:

As recently summarized by Pew Trusts’ reviews of the antimicrobial pipeline, there is a lot of interest in non-traditional (alternative) antimicrobial agents but there has also been a lot of concern that they are harder to develop than more traditional agents. If you’ll permit me to (briefly) coin the term Fleming Antibiotic to describe things like penicillin, I find it helpful to approach the challenge of non-traditional products by envisioning a continuum defined by these ideas:

  • Fleming antibiotic:
    • Qualitatively, is like a penicillin in that it has the spectrum for a defined syndrome and the speed required to be suitable as standalone therapy (SSSS, if you like acronyms)
    • By virtue of these properties, it is readily developed as monotherapy using standard non-inferiority trial designs.
  • Non-Fleming = non-traditional = everything else
    • This category captures anything not completely having the Spectrum-Syndrome-Speed-Standalone properties of a Fleming Antibiotic. 
    • This can include phage, antibodies, small molecules, large molecules, microbiome … it doesn’t matter. It’s non-Fleming because of what it does (or, rather, what it does NOT do).
    • Most often used in combination with a base therapy and hence may have to be studied in a trial where it is possible to see superiority of the combination relative to the base therapy alone. Showing this type of superiority can be very challenging!

I’ll admit to having long been fascinated by the potential for non-traditional products: the idea of, for example, a virulence factor inhibitor really appeals to me! But, and as was discussed in Czaplewski et al. “Alternatives to antibiotics—a pipeline portfolio review”, LancetID, 2016), such products are often hard to develop because of issues such as the need to show superiority, the very narrow spectrum of some products, and/or product effects that are not well captured by the clinical endpoints used in our trials.

If this tension resonates with your work, you will be interested in knowing about two upcoming discussions of non-traditional products.

First, there is an interactive session on Sunday 22 Apr 2018 during ECCMID (Madrid, 9-11am, Hall G) entitled “Expediting antibacterial development: core lessons and key tools for a rocky road.” In a session co-sponsored by CARB-X and GARDP, there will be talks by Marco Caveleri (EMA), Sumati Nambiar (FDA), and William Hope (PK-PD guru). I am the 4th speaker and will be covering the problem of non-traditional products. I am working closely with my co-speakers on this talk with the goal of presenting a good perspective on possible approaches. I’m also going to work with my co-speakers to make the slides from the symposium promptly available.

Second, the Duke-Margolis Health Policy Center has recently announced a 14 June 2018 workshop entitled “Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics”. Running from 8:30am-5:00pm on that day and supported by a cooperative agreement with FDA, “this public event will focus on the range of non-traditional pharmaceutical approaches being developed to combat bacterial infections. Speakers will address the importance of development in this area, the full spectrum of technologies currently under development, and the outstanding scientific challenges in assessing efficacy of these products in pre-clinical and clinical settings. Discussion will help to prioritize challenge areas in which additional considerations and research will need to be developed moving forward.”

I hope to see you at one or both of these events! 

All best wishes, –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/

Upcoming meetings of interest to the AMR community:

Dear All,
 
The IDWeek 2024 program committee is again seeking programs on novel antimicrobial agents and novel diagnostics for presentation in pipeline sessions! Here’s what is sought:

  • “Industry partners are invited to submit antimicrobials that are in preclinical stages of development (Phase II and III preferred) or recently approved after January 2024.
  • “The pipeline sessions will include antibacterials, antifungals, and antivirals (excluding COVID-19 and HIV).
  • “The committee also invites companies developing novel diagnostic technologies with a minimum of some preliminary proof of concept data to submit.” 

This is a great opportunity to tell the story of your development project! The deadline to submit is Wednesday, June 26 via the application portal. Any questions should be directed to program@idsociety.org. Please share this email with anyone you think might be interested in applying!
 
In addition, I’ll also note that those with a more general story to tell should look at the BugHub Stage (and the Global BugHub stage). Both BugHub variants seek “presentations that touch on your experience of working in infectious diseases and presentations that ultimately lead to a greater understanding of our diverse field” via a TED Talk-esque speech about your work. The deadline for applications is 26 June, the same as for the pipeline sessions.

I look forward to seeing you there! 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/. All opinions are my own.

John’s Top Recurring Meetings

Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details. 
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here for the meeting’s general website. You can’t register (yet) for the 2024 event, but save the date!
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Save the date! More details to come!
  • 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. Go here to register

Upcoming meetings of interest to the AMR community:

  • [NEW]  9 Apr 2024 (virtual, 830a-10a ET): GARDP’s next REVIVE webinar entitled “Progressing a discovery project – Criteria and challenges.” Register here.
  • [NEW] 9 Apr 2024 (virtual, 10a-1130a ET): CDC webinar “Impacts of Antimicrobial Resistance on Cancer Care.” Click here for details and to register.
  • 10-11 Apr 2024 (virtual): Sepsis Alliance AMR Conference, a 2-day conference focused on “Practical technologies to manage sepsis and counteract the expanding challenge of antimicrobial resistance.” Go here for details and to register.
  • 26 Apr 2024 (Barcelona, Spain): ESCMID workshop entitled “Using Data Science and Machine Learning for Infection Science: A Hands-on Introduction.” Click here to register or here for more details. 
  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
  • 26-31 May 2024 (Montreal, Canada): EDAR7, the McGill AMR Centre’s 7th edition of their Environmental Dimension of Antimicrobial Resistance conference. Go here for details; final abstract deadline is 21 Dec 2023.
  • 28-29 May 2024 (in person, Uppsala, Sweden): Uppsala Antibiotic Days, a broad-ranging 2-day program hosted by the Uppsala Antibiotic Center. Go here for details and to register.
  • [NEW] 30-31 May 2024 (face-to-face in Rockville, Maryland as well as online, 8.30-5.30p ET on 30 May, 9-2.40p on 31 May): NIAID-sponsored workshop entitled “Towards realizing the promise of adjunctive immune therapy for invasive fungal infections”. The agenda covers host immunity to invasive fungal infections, immune modulators in the context of fungal infections; and strategies for testing immune modulators as adjunctive therapy. Go here for more details and to register.
  • 9-13 June 2024 (in person, Ascona, Switzerland): “New Approaches to Combat Antibiotic-Resistant Bacteria, 2nd Edition” is a Sunday-Thursday residential workshop focused on the deep biology of AMR. Sponsored by NCCR AntiResist (a Swiss National Science Foundation consortium), the scientific program has the feel of a Gordon Conference. Space is limited, so you are encouraged to apply promptly — go here for details.
  • 13-17 June 2024 (Atlanta, Georgia): ASM Microbe, the annual meeting of the American Society for Microbiology. You can’t register yet, but you can go here for general details.
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. See Recurring Meetings list, above.
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above. 
  • 19-27 Oct 2024 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance). Now in its 8th year, Patrice Courvalin directs the program with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Seating is limited, so mark your calendars now if you are interested. Applications open in March 2024 — go here for more details.
  • 4-5 Dec 2024 (in person, Washington, DC): “Fungal Dx 2024: Fungal Diagnostics in Clinical Practice” is a 2-day in-person workshop organized by ISHAM‘s Fungal Diagnostics Working Group. The program and registration links are available at https://fungaldx.com/; the agenda is comprehensive and features an all-star global list of speakers.

Share

Tragedy of the (Antibiotic) Commons: A true market failure

Dear All, In a 28 Feb 2024 newsletter entitled “How Economists (And Finance Ministers) Think…”, we reviewed an important new paper on the economics of antibiotics from Anthony McDonnell and his colleagues at CGD (Center for Global Development). The paper’s core theme was that the antibiotic market represents a set of market failures which collectively converge

Ready, set, go! AMR appropriations in the US FY2025 budget

Dear All, If you follow US politics, you will know that the USG (US Government) is beginning its appropriations process for FY2025 (Federal Year 2025). In preparation, a letter calling for AMR-related funding has been drafted by the Infectious Diseases Society of America (IDSA), AdvaMedDx, American Society for Microbiology (ASM), Association for Professionals in Infection Control

2024 CARB-X funding rounds: Treatment, Prevention, and Diagnostics

Note: The fabulous ICARe course organized since 2016 by Patrice Courvalin is urgently seeking additional sources of funding. This one-week intensive residential program is the only soup-to-nuts training program in all things AMR on the planet and routinely gets rave reviews for its content as well as the way it creates fruitful collaborations (and job opportunities). If you know of avenues for support for this extraordinary

Scroll to Top