This is the third of a 5-part newsletter series. There is an initial 27 Sep 2023 newsletter introducing the EPA concept note, a second (28 Sep 2023) newsletter that expands on the EPA concept note, a 4th newsletter (27 Jan 2024) containing some additional resources, and a fifth newsletter (11 Oct 2024) about the EPA’s collaborative framework for evaluating the AMR risks of antibacterial and antifungal pesticides.
Dear All,
Your alert co-reader in Australia (Christine Carson at U Western Australia), wrote recently to alert me to a ruling on the question of streptomycin spray on citrus. To reprise:
- The 27 Sep 2023 newsletter (“EPA Concept Note (Part 1): AMR Risks Of Antibacterial Or Antifungal Pesticides”) introduced us to these ideas:
- In legal terms, “pesticide” means “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest…”
- So, both use of an azole to control mold on plants or use of streptomycin to combat citrus disease (aka, citrus greening) would be classified as their use as a pesticide.
- And the point of the newsletter was that EPA have released a concept note and started a process to evaluate “… a Framework To Assess the Risk to the Effectiveness of Human and Animal Drugs Posed by Certain Antibacterial or Antifungal Pesticides.”
- In short, this is the plant agriculture equivalent of the goal of reduced use of antibiotics in animal agriculture.
- And as aside, the docket for the concept note has received more than 5k comments! Yow!
- The follow-up 28 Sep 2023 newsletter (“EPA (Part 2, Streptomycin!) / $104m ARPA-H BAA And AMR Project”) was triggered by a note from Christine … she pointed out a lawsuit filed with the US 9th Circuit Court of Appeals by a coalition of health and environmental groups including the NRDC (a US-based international environmental advocacy group) vs. EPA over the use of streptomycin sprays to control citrus greening:
- Briefly, the lawsuit argued that EPA had failed to ensure that the use of streptomycin would not cause unreasonable harm to human health or the environment.
- At the time of that newsletter, the state of the Court’s analysis was not known — there some audio and video recordings available from the court hearing but no further insight.
- And now we come to the denouement: The 9th Circuit Court has ruled! Quoting from a press release from the Center for Biological Diversity:
- “In the ruling, the Court determined the EPA’s 2021 decision to allow spraying of streptomycin on citrus crops across the country to be unlawful under the Federal Insecticide, Fungicide, and Rodenticide Act and the Endangered Species Act.
- “The Court also held that the seriousness of the EPA’s errors required it to vacate the agency’s approval of the pesticide.”
- Translation: No more streptomycin spray for citrus greening!
- The full-length Court judgement is interesting reading … even just the first few paragraphs give you a good sense of the logic.
Very glad to see this … streptomycin is a member of the very important aminoglycoside antibiotic class and needs to be protected for human use! And hopefully the bigger picture is that EPA’s approval process going forward will be amended based on the final version of the conceptual framework now being discussed in the concept note that triggered this series of 3 newsletters:
Thanks, Christine, for this update!
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.
- BARDA’s long-running BAA (Broad Agency Announcement) for medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases is now BAA-23-100-SOL-00004 and offers support for both antibacterial and antifungal agents (as well as antivirals, antitoxins, diagnostics, and more). Note especially these Areas of Interest: Area 3.1 (MDR Bacteria and Biothreat Pathogens), Area 3.2 (MDR Fungal Infections), and Area 7.2 (Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens). Although prior BAAs used a rolling cycle of 4 deadlines/year, the updated BAA released 26 Sep 2023 has a 5-year application period that ends 25 Sep 2028 and is open to applicants regardless of location: BARDA seeks the best science from anywhere in the world! See also this newsletter for further comments on the BAA and its areas of interest.
- FDA have released a BAA covering a wide variety of regulatory topics. See this newsletter for general details; also note in particular an RFP for work on urine-specific breakpoints for uUTI. Early concept papers are due 6 Nov 2023; full proposals are due 19 Feb 2024.
- NIAID have a BAA open through 13 Mar 2024 for projects covering vaccines, therapeutics vs. selected pathogens (specific viruses, fungi, and bacteria), and sequencing-based diagnostics. See this newsletter for further details.
- JPIAMR have an AMR Interventions call that is open for pre-applications through 14 Mar 2024. The call covers interventions for both fungi and bacteria. Go here for full details. Note that there is an informational 24 Jan 2024 webinar for applicants.
- ARPA-H have an Open BAA that is accepting applications through 14 March 2024. It is quite wide-ranging in its scope and definitely includes AMR-related projects. See this newsletter for discussion of the BAA and an AMR project that it now supports.
- 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. A closing date is not posted insofar as I can see — applications are accepted on a rolling basis; go here for more 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 open on an ongoing basis 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.
- 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-X, C-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).
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!
- 6-7 Mar 2024 (Basel, Switzerland): The 8th AMR Conference 2024. Go here to register!
- 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!
Upcoming meetings of interest to the AMR community:
- [Post-meeting video available] 12 Dec 2023 (virtual, 1-2.15p ET): Duke-Margolis held the third and final installment of their webinar series for policymakers combating AMR with a webinar entitled “Improving Regulatory Practices to Sustain Antibiotic Innovation.” The webinar featured perspectives from experts affiliated with the FDA, Industry, GARDP, CARB-X, and the Center for Global Development. The webinar was excellent and is available for streaming; prior webinars occurred on 9 May 2023 on the Need for New Antibiotics, and on 29 Aug 2023 on Preparedness for AMR Threats (also see their related October 2023 report on Preparedness and Post-Market Incentives for Novel Antibiotics).
- 22 Jan 2024 (virtual, 5p-6.30p CET): ‘What do the various non-commercial actors in the antibiotics R&D ecosystem do?’ with Erin Duffy (CARB-X), Peter Beyer (GARDP) and Laura Marin (JPIAMR). Click here to register.
- 24 Jan 2024 (online, 9a-1p London): Webinar entitled “Priorities and next steps for tackling antimicrobial resistance in the UK”, sponsored by the Westminster Health Forum. Featured speakers include Dame Sally Davies and the focus is on the UK’s 20-year vision and 5-year action plan for AMR. Go here for details and to register.
- 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). Go here to register.
- 8 Feb 2024 (in person, Liverpool, UK, 8.30a – 4p): 2024 BioInfect Conference. A full-day AMR conference that includes a keynote from Lord Jim O’Neill (Chairman of the UK AMR Review). Go here for details and to register.
- 27 Feb 2024 (in person, New York City, 3-6.30p ET): Hosted by the AMR Industry Alliance (AMRIA), “A Call-to-Action in the Fight Against AMR: Priorities for Progress at the 2024 UN High-level Meeting on AMR” is a symposium (3-5.30p) and reception (5.30-6.30p). Precise details are pending … for now, we are advised to hold the date. I’ll post updates as I receive them … presumably this will also appear on AMRIA’s website.
- 6-7 Mar 2024 (Basel, 6-7 Mar 2024): See Recurring Meetings list, above.
- 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.
- 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.
- 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.