How the sausage is made: A day of advocacy for PASTEUR

Dear All,

Along with more than 50 others, I spent Tuesday 12 Sep 2023 on Capitol Hill visiting offices of members of Congress (Senate and House) seeking support for the PASTEUR Act.

If you’re a regular reader, you’ll know that we now have substantial bipartisan support for PASTEUR: it was re-introduced as The Pioneering Antimicrobial Subscriptions To End Up-surging Resistance (PASTEUR) Act of 2023 (H.R. 2940, S. 1355) by Senators Michael Bennet & Todd Young and by Representatives Scott Peters, Drew Ferguson, Mike Levin, & Jake LaTurner.

The goal of 12 Sep 2023 was to build that support by visiting Senate and House offices of members of Congress who were not yet co-sponsors of the Act, raise awareness, and hopefully get them to become co-sponsors and thereby ensure passage during this session of Congress.

The day was organized by 5 leading organizations: the Biotechnology Innovation Organization (BIO), the Cystic Fibrosis Foundation (CFF), the Infectious Diseases Society of America (IDSA), the Partnership to Fight Infectious Disease (PFID), and The Pew Charitable Trusts as a follow-on to their previous joint statements of support for PASTEUR,

In the course of the day, my team of five visited 6 offices (two senators, 4 representatives); collectively, over 70 offices were visited. I’ve learned that visits of this type are a well-practiced process, but the scale of this day with about a dozen teams visiting multiple offices was impressive.

In each office, we meet with staff who were willing to consider the idea for / with their member of Congress. In my team’s visits, there was consistently good awareness of the concept of AMR and an interest in hearing more about PASTEUR. The questions raised were as I would have expected:

  • What will it cost? 
  • Why is this a benefit to US citizens and / or my district?
  • Who is already supporting? 

We were ready with answers to all of this:


Especially important to me were questions on how we ensure that we’re buying useful new antibiotics. On this, it was incredibly helpful to be able to explain and support the selective nature of PASTEUR by pointing to the UK’s fabulous pilot project and to be able to back this up if needed with facts about how Canada, the EU, and Japan are in the game. Years and years of effort have gone into building those consensus ideas … many thanks are due to those involved in DRIVE-AB, the UK AMR Review, creation of the principles of STEDI, and so much more.


Wow! What a great day … and I am impatient but optimistic about PASTEUR! We’ve never had more co-sponsors, never visited this many offices in one day, never had such broad and deep understanding of the issues on the Hill. And, the fact that the key stakeholder groups spent so much time and energy on Hill visits last week tells you that they see value investing more at this moment.

The day ended with a reception for hill staffers … by my guess, there were > 150 attendees. We heard brief comments by several members of congress and then there was a special guest: Rob “Gronk” Gronkowski (4-time Super Bowl champion tight end) who took the time to attend and call out his support in particular to push for new options for managing Valley Fever (coccidioidomycosis). Having support from this well-known football player is incredibly helpful in terms of both public engagement and creating impact on the Hill for PASTEUR — many thanks to Gronk for making time to attend!

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And those of you who are US citizens can reinforce the messages from Gronk and the five societies! To do so, please use this alert from IDSA. The alert is open to everyone in the US—you don’t have to be an IDSA member. Individuals can personalize the message to Congress that IDSA developed. These messages really are read by congressional staff, and if they receive a lot of them, it can significantly increase the likelihood of a Representative or Senator cosponsoring the bill. IDSA has made this alert quick and easy … so please do it now and also share this with your friends!


Wow! It was absolutely fascinating to have a glimpse of how the sausage is made (see footnote below my signature), to discover a fabulous bit of signage in one of offices regarding hand hygiene, and to have a chance to really appreciate the value of the years of effort that have gone into creating the multi-stakeholder support for PASTEUR. Woot, woot!

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With thanks to all, –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.

PS: The full quote is “Laws are like sausages, it is better not to see them being made” and is generally attributed to Otto von Bismarck (1815-1898), the Prussian statesman.

Current funding opportunities (most current list is here)

  • HERA Invest was launched August 2023 with €100 million to support innovative EU-based SMEs in the early and late phases of clinical trials. Part of the InvestEU program supporting sustainable investment, innovation, and job creation in Europe, HERA Invest is open for application to companies developing medical countermeasures that address one of the following cross-border health threats: (i) Pathogens with pandemic or epidemic potential, (ii) Chemical, biological, radiological and nuclear (CBRN) threats originating from accidental or deliberate release, and (iii) Antimicrobial resistance (AMR). Non-dilutive venture loans covering up to 50% of investment costs are available. Applications are accepted on a rolling basis; go here for all the details.
  • The ENABLE-2 consortium has announced a call to support hit-to-lead compound development by researchers at publicly-funded European universities. The call is focused on molecules with the potential to be direct-acting therapies for one or more of the following priority pathogens: ESBL-producing/carbapenem-resistant Enterobacteriaceae (E. coli, K. pneumoniae), P. aeruginosa, A. baumannii, methicillin-resistant S. aureus, or vancomycin-resistant E. faecium. The Call is open continuously, applications are reviewed at intervals, and funding is non-dilutive. Expressions of interest received before 30 Sep 2023 would be considered in November 2023. Applications received after this date will be evaluated in the spring of 2024 (date to be decided). Go to https://www.ilk.uu.se/enable2/apply/ for further details.
  • 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/).
  • These things aren’t sources of funds but would help you develop funding applications
    • 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.
    • Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-XC-CAMP, and FIND, it pulls together real-life insights into a succinct set of tutorials.
  • 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):

  • 18 Sep 2023 (virtual, 3-4p CET): Jointly hosted by the US CDC and the WHO, a webinar entitled “Fungal Diseases – Global Challenges and Opportunities” will kick-start CDC’s Fungal Disease Awareness Week (FDAW). The goal of the webinar is to provide an in-depth perspective on fungal diseases and discuss challenges related to antifungal resistance. Go here to register; the full program for the week can be seen at the FDAW webpage.
  • 19-22 Sep 2023 (Boston, USA): ASM-ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent development focused meeting … highly recommended! Go here for details and to register. 
  • 21 Sep 2023 (New York City, USA, in person 6.30-8.00p ET): In partnership with the governments of the UK and Nigeria, the Center for Global Development (CGD) will launch its final report from a CGD working group studying possible purchasing systems that will improve access, stewardship, and innovation for antimicrobials in LMICs at an event entitled “A Path Towards Affordable and Effective Antimicrobials: Six Recommendations to Improve Antimicrobial Innovation, Access, and Stewardship,” Go here for more details and to register: the event will be held at the Sixth Floor Loft (873 Broadway, Sixth Floor, New York, NY 10003). The discussion will focus on the political and operational steps needed to ensure access to and stewardship of affordable and effective antimicrobials — and you can readily see how this is is step towards building consensus around priorities for the discussion of next year’s high-level meeting (HLM) at UNGA 2024.
  • 27 Sep 2023 (virtual, 10a-11a EST):  Milken Institute webinar entitled “What’s Next for the UK’s Subscription Model in the Fight Against Antimicrobial Resistance”. Go here to register.
  • 4 Oct 2023 (Museum of Science, Boston, MA; in person, 11.30a-2.30p ET): Co-sponsored by the Boston’s Museum of Science and the Rijksmuseum Boerhaave (Netherlands), you can attend a luncheon and panel discussion entitled “Celebrating 300 Years of Innovation and Beyond: How van Leeuwenhoek’s Discovery of the Microworld Sparked a Medical Revolution, with a Focus on Antimicrobial Resistance.” Go here for details and to register. I knew about Boston’s MOS but did not know about the exceptional collection of the Rijksmuseum Boerhaave which seeks to “… show what science is all about: curiosity, guts, creativity and perseverance.” Fascinating!
  • 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.
  • 11-15 Oct 2023 (Boston, USA): IDWeek 2023, the annual meeting of the Infectious Diseases Society of America. Go here for details and to register. 
  • 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.
  • 6-7 Feb 2024 (online): Antimicrobial Chemotherapy Conference. This is an annual, free of charge conference that is co-organized by GARDP and the British Society for Antimicrobial Chemotherapy (BSAC). Details to follow — for now, just mark your calendar.
  • [NEW] 17-22 Mar 2024 (Ventura Beach, CA, in person): Gordon Research Conference (GRC) entitled “New Antibacterial Discovery and Development” with a 16-17 Mar 2024 pre-conference Gordon Research Seminar (GRS) for young doctoral and post-doctoral researchers. An intensive residential meeting, GRCs are highly recommended for networking and deep research insights. Apply here for the GRC and here for the GRS.x
  • 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.
  • 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.

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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