AMR Hearing in Congress, PASTEUR re-introduced … and more!

Dear All, It’s been a busy 48 hours .. three (and a half) things for you!

First up, you will find notes below my signature on today’s “Antimicrobial Resistance: Examining an Emerging Public Health Threat” hearing in the US House of Representatives. The recording of today’s hearing is now available on YouTube. It was a fabulous 2 hours of discussion about AMR and I highly recommend listening to it when you have the time. In my notes, I include links to particular time stamps in the video should you want to hear more about the subjects discussed.

Second, the PASTEUR Act has been reintroduced! As you may recall, all pending legislation dies at the end of each 2-year session of Congress. As PASTEUR did not pass during the 117th Congress, it needed to be reintroduced to the 118th (current) session. Done!

Helpfully, the Wall Street Journal released an article about the push for the PASTEUR Act. The article is short, excellent summary for the uninitiated. Definitely shareworthy on your social media! 

Third, and as well-timed and very pertinent perspective on the way that long-term efforts reap dividends, CARB-X has released its annual report. The report is beautifully laid out and has some great graphics. It is wonderful to see that CARB-X has been very busy strengthening the R&D chain. Amazing progress — please make time to look through the report itself!

As to that final half … there are very exciting things afoot in the EU with an AMR-related proposal from the European Commission … stay tuned for a separate newsletter on same!

YOW! Well done to all involved and particularly to those involved in today’s hearing! Exciting times!

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.

== Detailed Notes from today’s hearing of the House E&C Committee == 
During the opening comments, I found it very instructive to hear the various ways that the members of the subcommittee became interested in AMR. Opening statements were given by Chair Griffith, Ranking Member CastorChair Rodgers, and Ranking Member Pallone. Each opening statement recognized the threat that is AMR while also highlighting that there was a need to understand how to improve current US government efforts. Chair Griffith made a particular remark that this was about fact finding, not promoting legislation (even though PASTEUR was mentioned several times as part of answers during the Q&A). Their interest in AMR was evident and several mentioned the fact that COVID-19 has sparked an overall public interest in pandemic preparedness. There were remarks about the hearing that had happened yesterday afternoon in regards to the value of this. And with that, we were off to the Q&A!

Each summoned witness gave short statements before the floor opened for questions. Each read an opening statement; you may also want to read their written Witness Testimony here. Think of the testimonies as assigned reading for the hearing! 

First up was Mary Denigan-Macauley of the US Government Accountability Office (GAO). The GAO has been making motions to increase federal funding to fight AMR for several years now. A GAO report to Congress in March 2020 provided an in-depth report about the US government efforts to monitoring antibiotic resistance and what needed to change in order for the country to counter spread of AMR. This report was referenced multiple times during the hearing so make sure to add that to your reading! 

She highlighted 4 key areas for improvement which were a) the precise magnitude of this problem is not known and data is not complete, b) limitations on diagnostics in terms of development and use, c) the R&D pipeline is weak and it needs to be fixed (and, non-traditional therapies need to be investigated), and d) Antibiotic stewardship and monitoring needs to be improved.

Next was Kevin Outterson of CARB-X who spoke of resistance eating away at antibiotics like rust on a bridge and that we “put [new antibiotics] on a shelf, behind glass like they are a fire extinguisher”. This naturally segued into paying for antibiotics like fire extinguishers and how we don’t currently do that as a society. He pushed for a subscription program and, by proxy, the PASTEUR Act. “It’s time to invest in the future of antibiotics again.” Agreed!

Up next was Amanda Jezek of IDSA who highlighted some infection statistics before advocating for good antimicrobial stewardship. She mentioned staffing of ID physicians at hospitals as part of good stewardship and that the lack of ID physicians across the country was an issue. She also noted how poor pay and medical student debt were contributing to the issue. Phage therapy and additional research should also be pursued as a possibility. During a quick microphone fix, she mentioned off-hand that “ID people are used to dealing with the unexpected”. Truer words have never been said!

Finally, Amy J. Mathers of the University of Virginia School of Medicine spoke on behalf of the American Society for Microbiology (ASM). As a frontline physician, she spoke of her experience with patients that have drug-resistant bugs and also her work with promoting good antibiotic stewardship at her hospital. She advocated for better research and diagnostics to help counter AMR. Staffing shortages and interest as AMR as a career are a problem — “we need more people post-pandemic in the clinical lab.”

Now, to the Q&A  —

Current funding opportunities (most current list is here)

  • [UPDATED – New application round] CARB-X again has an open-round for funding applications with a deadline of 1 May 2023. Applications are sought for any of 3 themes (oral products, vaccines for neonatal sepsis, gonorrhea products) as described in this newsletter!
  • The AMR Action Fund is now open to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to contact@amractionfund.com.
  • BARDA’s long-running BAA-18-100-SOL-00003 offers support for both antibacterial and antifungal agents. This BAA has offered 4 deadlines/year since 2018 … check the most current amendment for details.
  • INCATE (Incubator for Antibacterial Therapies in Europe) is an early-stage funding vehicle supporting innovation vs. drug-resistant bacterial infections. The fund provides advice, community, and non-dilutive funding (€10k in Stage I and up to €250k in Stage II) to support early-stage ventures in creating the evidence and building the team needed to get next-level funding. Details and contacts on their website (https://www.incate.net/).
  • It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
  • In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).


Upcoming meetings of interest to the AMR community (most current list is here):

  • 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.
  • 3-5 Jul 2023 (Tours, France): 9th Symposium on Antimicrobial Resistance in Animals and the Environment (ARAE). Sponsored by INRAE (French National Research Institute for Agriculture, Food, and Environment, itself a merger of merger of INRA, the French National Institute for Agricultural Research, and IRSTEA, the French National Research Institute of Science and Technology for the Environment and Agriculture), this conference has been running since 2005. Go here for details.
  • [NOW OPEN FOR APPLICATIONS!] 7-15 Oct 2023 (residential, Annecy, France): ICARe, the Interdisciplinary Course on Antibiotics and Resistance. Now in its 7th year, this course is a deep-dive into the world of antibiotic development. Intense, rigorous, and HIGHLY recommended. Seats are always limited … apply sooner rather than later! Go here for details.
  • 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.

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.

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