FDA workshop on non-traditional antibacterials (21-22 Aug 2018)

 Please be sure to look closely at the events calendar: Q&A with Scott Gottlieb, Lipinski on Lipinski, and more!

Dear All: FDA’s 21-22 Aug 2018 workshop on the development of non-traditional antibacterial agents was an excellent discussion of core challenges in this area. The agenda plus all the meeting materials (including the public comment slides and replays of the webcasts) are available on this web page. There’s a lot here to digest, so let me offer this guided tour:

  • In the opening session,
    • Kevin Outterson and I provided an initial overview that discusses the core problem of showing value, the challenges with defining the idea of a Non-Traditional (NT) product, and why this matters to CARB-X.
    • Helen Boucher brought the challenges in the clinic together with the promise of NT products in her discussion of two powerful case vignettes. Any of us could be the patient who needs these products!
    • Owen McMaster provided a summary of key Pharmacology and Toxicology issues — my takeaway here was that the guidelines for NT products were not uniform but you should attempt where possible to apply the usual rules. When this is not possible, well-reasoned adaption is the order of the day.
    • Similarly, Tracey (Xiaohui) Wei discussed Clinical Pharmacology issues with a focus on highlighting some of the unusual ADME and dose-selection issues that may arise, especially with biological products.
    • Kalavati Suvarna rounded out the session by surveying the microbiology issues that arise with NT products.
  • The heart of the meeting was then a series of hypothetical but realistic case scenarios:
    • Drug X-1: A monoclonal for preventing VABP (Mary Beth Dorr and Mayurika Ghosh)
    • Drug Z-2: An approach to preventing gut microbiome disruption (and hence C. difficile infection) due to beta-lactam drugs (Michael Kaleko and Ramya Gopinath)
    • Drug Z-3: Reducing the risk of infection due to an MBL-producer by preventing acquisition of same (John Rex)
    • Drug Z-4: A chimeric bacteriophage endolysin as an adjunct for S. aureus infections (Cara Cassino and Ed Weinstein)

My takeaway messages from the day are as listed just below. An expanded slide deck on this topic is found here.

  • “Non-Traditional” is a very broad term and requires qualification
    • Sub-dividing into NT Structure vs. Goal (see also the opening Outterson-Rex talk) may help a bit
  • Current development tools are often suitable
    • There may be gaps around measures of delayed (indirect) benefit
    • There may be gaps around evaluation of combination products
  • The lack of a tool (or path) can be managed
    • New approaches have been / can be developed
  • The product’s whole effect must be considered
    • Don’t be seduced by a pretty mechanism
  • A high-level guidance document might be useful
    • But we’re not ready to commit to many details

My closing thought is that I think that 10-15 years from now we will view many non-traditional products as “business as usual.” This rather reminds me of the comment that “All Art was once Contemporary.”  If you want to dig a little deeper into the philosophy side, you could even (re)read Thomas Kuhn’s The Structure of Scientific Revolutions in which he discusses the contrast between small incremental changes and significant paradigm shifts. Some of the products we are discussing are incremental, but ideas around products with delayed (indirect, or community-level) benefits could represent a substantial shift in perspective.

Meditatively yours, –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/

General notes of interest for the AMR community

  • Novo’s REPAIR Impact fund will re-open for proposals during the window 4 Sep – 11 Oct. Watch for further news here.
  • IMI AMR Accelerator programme Pillar A within IMI Call 15: Capability-building network to manage the whole accelerator and strengthen AMR science. This is a two-stage call, with letter of intent from applicants expected on 24 Oct 2018.
  • IMI AMR Accelerator programme Pillar B: Tuberculosis drug development network within IMI Call 15: Tuberculosis drug development network to collaboratively progress TB compounds and validate new tools for TB drug development. This is a two-stage call, with letter of intent from applicants expected on 24 Oct 2018.
  • IMI Call 16: A series of individual programs where a single EFPIA partner works with a consortium to progress compounds for for TB, non-tuberculous mycobacteria, and Gram-negatives. This is a one-stage call, with full proposal from the EFPIA and applicant consortium expected on 24 Oct 2018.

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

48,015 → 0: Antibacterial discovery is hard. Really, really hard.

Dear All (and with thanks to Patricia Bradford for co-authoring this newsletter), When you are seeking novelty, antibacterial discovery is hard … really, really, REALLY hard. And it gets even harder if you want activity vs. Gram-negative bacteria. As the latest proof of this, a paper from GARDP’s Blasco et al. describing use of an

Call for Pull: Swiss Roundtable on Antibiotics

Dear All, To end the week, we have a really lovely paper from the Swiss Roundtable on Antibiotics (a multidisciplinary, non-profit Swiss association). Here are the links you need: The new (25 March 2024) paper entitled “Effective antibiotics for the Swiss health care system: today and in the future.” A prior (7 Feb 2023) paper

Help PASTEUR cross the finish line: Action Alert from IDSA!

Dear All, Today’s news is that the House PASTEUR sponsors (Drew Ferguson [R-GA-3], Scott Peters [D-CA-50], Jake LaTurner [RKS-2] and Mike Levin [D-CA-49]) are urging House leadership to authorize the PASTEUR Act without initially having funding attached. Although this may seem counterintuitive, initial passage as a $0 bill is a solid strategy — it is common

Scroll to Top