Government Action – AMR.Solutions

BARDA seeks info on Phase 2+ antifungals for Candida and Aspergillus

John Rex — Fri, 22 May 2026 18:01:03 +0000

Dear All:

As discussed in prior newsletters, BARDA is constantly working to ensure it has adequate medical countermeasures (MCMs) for a variety of possible threats. The titles of these newsletters give a quick review of their recent work — note in particular the Fireside Chat and the newsletter discussing the ongoing BAA (Broad Agency Announcement) for antibacterial and antifungal MCMs:

22 July 2025: “BARDA RFP: Antibiotic for HABP/VABP or Bloodstream Infection”
5 Nov 2024: “BARDA seeks deep insight on antibacterials near/beyond end-of-Phase 2”
26 Sep 2023: “BARDA Medical Countermeasures BAA: Substantial updates”
12 Nov 2023: “Fireside Chat with BARDA’s Branch Chief for Antimicrobials”

Continuing with their theme of seeking to understand what’s available (and possibly procure products for a government stockpile), we have today the announcement by BARDA of this RFI (Request For Information):

Title: “Medical Countermeasures for the Treatment of Drug-Resistant Fungal Infections“
Notice ID (link to webpage and detailed RFI document): RFI-MCM-TDRFI-BARDA-2026
Concept: “… gain information regarding first-in-class antifungals in development for the treatment of drug-resistant Candida species, including Candida auris, and/or drug-resistant Aspergillus species.“
Scope: “First-in-class small molecule or peptide-based antifungals that are currently in Phase 2 clinical trials or beyond (e.g., including FDA- or EMA-approved).”
Due date: 21 June 2026

While this is not a funding round (see the BAA for that!), the “RFI will serve as continued planning for potential future acquisitions and programs.” With this, we can see that responses to this RFI will build BARDA’s understanding of available products and could lead to stockpiling.

While only a few companies are currently in position to respond to this RFI (see the 1 April 2025 newsletter for WHO’s most recent antifungal pipeline review), it is interesting to be aware of (and be reminded of) the work that is constantly ongoing to ensure our long-term safety!

With thanks to Team BARDA and best wishes 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.

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, the small meeting format of BEAM’s AMR Conference (March) and GAMRIC (September-October; formerly, the ESCMID-ASM conference series) creates excellent global networking. IDWeek (October) and ECCMID (April) are much larger meetings but also provide opportunities for networking with a substantial, focused audience via their Pipeline sessions. Hope to see you there!

[UPDATED INFO] 22-24 Sep 2026 (Lisbon, Portugal): The 2nd GAMRIC, the Global AMR Innovators Conference (London, UK). Formerly the ESCMID-ASM (or ASM-ESCMID depending on location) Joint Conference on Drug Development for AMR, 2026 will be the 11th year for this series that is now under the joint sponsorship of CARB-X, ESCMID, BEAM Alliance, GARDP, LifeArc, Boston University, and AMR.Solutions. The ongoing series employs the successful format of prior meetings with a single-track meeting and substantial networking time. The 2025 meeting was a sell-out success: a written summary is here and the videos are here. Registration for the 2026 meeting is now open and the near-final program is here: in addition to a keynote lecture by Karen Bush on the threat to beta-lactams due to the emergence of PBP3 mutations, there are sessions on funding, access, program design for narrow-spectrum agents such as phage, development for pediatrics, and more. The main abstract submission window is closed but late-breaker abstracts will be accepted 8-22 July 2026.
21-24 Oct 2026 (Washington, DC, USA): IDWeek 2026, the annual meeting of the Infectious Diseases Society of America. I would expect the program to continue to provide a substantial opportunity to present a product to a large audience (see also adjacent note about ESCMID) as well as opportunities to present at an IDWeek Pipeline Session.
23-24 Mar 2027 (Basel, Switzerland): The 10th AMR Conference (3-4 Mar 2026) is now over and offered a rich program that included a 10-year retrospective (we’ve done a lot!), regulatory updates, discussions of how to pursue development in China, and much more … in addition to being a superb opportunity for networking! I am told the session videos will soon be available on the conference website.
9-13 April 2027 (Stockholm, Sweden): ESCMID Global 2027, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Details won’t be out for some months, but the website is here. I do know that the meeting schedule will again include a Science Policy Forum on Friday 9 April 2027 (see here the newsletter about the 2026 science policy forum) and all who are interested in Pull incentives and the antibiotic ecosystem should plan to be there!)..

Upcoming meetings of interest to the AMR community:

4-8 June 2026 (Washington, DC): ASM Microbe, the annual meeting of the American Society for Microbiology. The meeting format is evolving and next year will combine 3 meetings (ASM Health, ASM Applied and Environmental Microbiology, and ASM Mechanism Discovery) into one event. Go here for details.
11-12 Jun 2026 (Washington, DC): The Second Annual Unite for Sepsis Symposium, presented by the Sepsis Alliance. The event seeks to accelerate progress in sepsis research and care. Go here for details and to register.
22-24 Sep 2026 GAMRIC (Lisbon, Portugal), the Global AMR Innovators Conference (London, UK; formerly the ESCMID-ASM Joint Conference on Drug Development for AMR). See list of Top Recurring meetings, above..
[REGISTRATION IS OPEN] 10-18 Oct 2026 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance) … and 2026 will be the 10th year for this program. Patrice Courvalin orchestrates content 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! Registration for 2026 is now open and runs through June 21, 2026. Go here to register!
21-24 Oct 2026 (Washington, DC, USA): IDWeek 2026. See list of Top Recurring meetings, above.
10-13 November 2026 (Madrid, Spain): The International Society for Infectious Diseases (ISID) has announced its 21st International Congress on Infectious Diseases (ICID). Register and view the preliminary program here (Early bird closes 30 July 2026); abstract deadline is 28 April 2026.
23-24 Mar 2027 (Basel, Switzerland): The 11th AMR Conference sponsored by the BEAM Alliance. See list of Top Recurring meetings, above.
9-13 April 2027 (Stockholm, Sweden): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
??? Mar 2028 (yes, that’s 2028, with location TBD): The 2028 Gordon Research Conference (GRC, https://www.grc.org/) entitled “Antibacterials of Tomorrow to Combat the Global Threat of Antimicrobial Resistance” and its related Gordon Research Seminar (GRS) for young doctoral and post-doctoral researchers will be sometime in March 2028. The organizers hope to coordinate dates and location with the 2028 BEAM-AMR meeting. Details to follow — mark your calendar!

Self-paced courses, online training materials, and other reference materials:

OpenWHO: “Antimicrobial Resistance in the environment: key concepts and interventions.” Per the webpage for the course, it will teach you “…why addressing AMR in the environment is essential and gain insights into how action can be taken to prevent and control AMR in the environment at the national level.” This course builds on WHO’s 2024 Guidance on wastewater and solid waste management for manufacturing of antibiotics. For further reading, see also the 25 Sep 2023 newsletter entitled “Manufacturing underpins both access and stewardship: Cefiderocol as a case study” and the 28 Jan 2024 newsletter entitled “EMA Concept Paper: Guidance on manufacturing of phage products”.
GARDP’s REVIVE website provides an encyclopedia covering a range of R&D terms, recordings of prior GARDP webinars, a variety of viewpoint articles, and more! Check it out!
GARDP’s https://antibioticdb.com/ is an open-access database of antibacterial agents.
The CARB-X website provides a range of recordings from its webinars, bootcamps, and more. A bit of browsing would be time well spent!
British Society for Antimicrobial Chemotherapy offers an eLearning section: Education – The British Society for Antimicrobial Chemotherapy.

Current funding opportunities

CARB-X have had one funding round (8-22 April 2026); a further round is expected during 4Q 2026. There are 4 funding themes for these rounds as below.
- Direct-acting therapeutics for infections caused by Gram-negative bacteria
- Novel Chemistry for AMR Challenge – target-based therapeutics.
- Non-vaccine approaches to prevent neonatal sepsis
- Diagnostics for neonatal sepsis
The Horizon Europe Work Programme 2026-2027 includes at least 3 calls of interest within its Cluster 1 — see the list below. The application window starts 10 Feb 2026 and closes on 16 Apr 2026. See also the 12 Dec 2025 newsletter about the call. Note as well that there calls for agents to prevent and/or treat viral infections.
- HORIZON-HLTH-2027-01-DISEASE-08: Development of innovative antimicrobials against pathogens resistant to antimicrobials
- HORIZON-HLTH-2027-02-IND-02: Portable point-of-care diagnostics
- HORIZON-HLTH-2026-01-DISEASE-03:Advancing research on the prevention, diagnosis, and management of post-infection long-term conditions.
ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews.
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.
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 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
- 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. See also the 7 Feb 2026 newsletter (“The global funding pipeline, 2017-2023: A review”) about an excellent deep dive by the Hub team into patterns of funding over time.
- Antimicrobial Resistance Research and Innovation in Australia is an actively updated summary that covers Australia’s AMR research and patent landscape. It is provided via collaboration between The Lens (an ambitious project seeking to discover, analyse, and map global innovation knowledge) and CSIRO (Commonwealth Scientific and Industrial Research Organisation, an Australian Government agency responsible for scientific research). Lots to explore here!
- 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).

EMA: “Regulatory sandboxes” to explore approval pathways

John Rex — Thu, 12 Mar 2026 15:25:46 +0000

Dear All,

No, EMA has not decided to set up shop on the beach! Rather, the point of this newsletter is that I heard a fascinating talk on the idea of “regulatory sandboxes” during the recent BEAM-AMR meeting. I had not previously heard of this idea, but it turns out that the concept of regulatory sandbox has been around for some years in the financial world with the idea being that of “a ‘safe space’ in which businesses can test innovative products, services, business models and delivery mechanisms without immediately incurring all the normal regulatory consequences of engaging in the activity in question.”

So, it then turns out that the European Commission (EC) began a few years ago to consider the idea of using regulatory sandboxes to explore areas where scientific advances were struggling to progress due to a mismatch between the science and the current regulatory frameworks. The online information on this is currently somewhat scattered, but here are some links to get you started:

9 Dec 2025: https://gdprlocal.com/eu-regulatory-sandbox/: An excellent introductory blog
16 Dec 2025: A Q&A document regarding the European Biotech Act that alludes to sandboxes as as controlled environments for companies to experiment and trial innovative solutions, regulatory procedures and technologies
July 2025: A technical paper developed by OECD in collaboration with the EC that provides guidance for regulators on managing sandboxes
August 2025: A commentary in Drug Discovery Today on the use of sandboxes for gene therapy regulation
22 May 2023: An even earlier commentary on the sandbox idea
15 Mar 2026 addendum: It turns out that MHRA has been exploring the idea of a sandbox for phage since 2024! The initial steps appear focused on manufacturing — it will be interesting to see where this goes!

Helpfully, EMA’s Radu Botgros, MD, gave a talk at the recent BEAM-AMR Conference on the use of regulatory sandboxes. He has very kindly given permission to reproduce a few of his slides as a way to further spread the word about this emerging idea. Here we go!

—
Slide excerpt #1: A sandbox is a means to an end. During a pilot, a sandbox provides a controlled environment in which current rules can be broken. The ultimate goal is to find a way to convert lessons learned into permanent rules:

As you can see, this slide hints at a regulatory sandbox to address the problem of the variable composition of phage. Although this issue may have already been addressed by the recently released draft EU General Pharmaceutical Legislation (see below), it’s still useful to review the ideas.

Slide excerpt #2: Reinforcing the first slide, we have this tagline: We do not just want exception; we want a new permanent ecosystem!

And now we come to the heart of the example of a regulatory sandbox offered by Dr. Botgros — what is (or was, see below) the problem with phage? Well, phage break the requirement that medicinals must contain a “defined active substance.” Phage (or phage cocktails), on the other hand, are going to be different for each patient … and might even be different from dose to dose for any given patient (see below my signature if you want more background on phage):

Summarizing, Dr. Botgros stated at the time of his talk that EMA had discussed the potential use of sandboxes in 4 areas:

Personalized medicines (n = 1 therapies)
Non-routine advanced therapy medicinal products (ATMPs)
AI and Digital health
Phage therapy (anti-infectives with variable compositions)

But the breaking news (I think) for this community is that the phage therapy sandbox is no longer needed! Why? Well, the draft EU GPL (General Pharmaceutical Legislation) has been announced and seems to have dealt with phage composition. Specifically, paragraph 92 of the GPL’s associated directive states that (emphasis added) “In order to increase the preparedness and responsiveness against health threats, in particular the emergence of antimicrobial resistance, adapted frameworks may be relevant to facilitate the rapid change of antimicrobials composition to maintain their efficacy. The use of established platforms would allow efficient and timely adaptation of those medicinal products to the clinical context.”

Aside: Note separately that I am still studying the content of the draft GPL. For now, know that transferable exclusivity vouchers for priority antimicrobials are included (!!) … more to follow in a future newsletter!

—–
So, that’s the story for this newsletter. Whether it was ultimately needed for phage is not the point … rather the core concept is the forward-looking way that EC/EMA is thinking about evolving our regulatory tools for things such as n-of-1 clinical trials. Kudos to all involved for finding a way to explore these challenging areas! Happy sandcastling!

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.

For reference, note as well these prior newsletters regarding phage

11 Dec 2025 newsletter: “Phage therapy: Further notes related to the recent TATFAR paper” (this one builds on an 8 Dec 2025 newsletter)
6 Jun 2025 newsletter: “MHRA compilation of regulatory guidance on phage products”
12 May 2024 newsletter: “Environmental, Animal, and Human Uses of Phage: WHO webinars”
28 Jan 2024 newsletter: “EMA Concept Paper: Guidance on manufacturing of phage products”

17-21 April 2026 (Munich, Germany): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. You can go here to register and view the preliminary program; the abstract submission window for 2026 will run 15 October to 26 Nov 2025. For those who would like a substantial opportunity to present a product to a large audience (see also adjacent note about IDWeek), I know that the meeting schedule will again include Pipeline Monday.
[REGISTRATION IS NOW OPEN!] 22-24 Sep 2026 (Lisbon, Portugal): The 2nd GAMRIC, the Global AMR Innovators Conference (London, UK). Formerly the ESCMID-ASM (or ASM-ESCMID depending on location) Joint Conference on Drug Development for AMR, 2026 will be the 11th year for this series that is now under the joint sponsorship of CARB-X, ESCMID, BEAM Alliance, GARDP, LifeArc, Boston University, and AMR.Solutions. The ongoing series employs the successful format of prior meetings with a single-track meeting and substantial networking time. The 2025 meeting was a sell-out success! A written summary of the meeting is here and the video from the sessions is now available here. Registration opens 1 March 2026; the abstract submission window will be 10-31 March 2026 with a late-breaker window in July.
21-24 Oct 2026 (Washington, DC, USA): IDWeek 2026, the annual meeting of the Infectious Diseases Society of America. Details are not yet available but I would expect the program to continue to provide a substantial opportunity to present a product to a large audience (see also adjacent note about ESCMID) as well as opportunities to present at an IDWeek Pipeline Session.
23-24 Mar 2027 (Basel, Switzerland): The 10th AMR Conference (3-4 Mar 2026) is now over and offered a rich program that included a 10-year retrospective (we’ve done a lot!), regulatory updates, discussions of how to pursue development in China, and much more … in addition to being a superb opportunity for networking! I am told the session videos will soon be available on the conference website. Mark your calendars for next year’s 11th AMR Conference!

Upcoming meetings of interest to the AMR community:

13 Mar 2026 (12.00-13.30 ET, virtual): REVIVE (GARDP)-sponsored webinar: “Current developments in Clostridioides difficile prevention, therapy and R&D.” Go here for details and to register.
24 Mar 2026 (1-2p ET, virtual): CDC webinar entitled “Tools to Tell the Story: New Resources for Communicating about Antimicrobial Resistance.” Go here for additional details to register,
26 Mar 2026 (12.00-13.30 ET, virtual): REVIVE (GARDP)-sponsored webinar: “Journal Club: Key findings from recent publications in antimicrobial R&D.” Go here for details and to register.
17-21 April 2026 (Munich, Germany): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
4-8 June 2026 (Washington, DC): ASM Microbe, the annual meeting of the American Society for Microbiology. The meeting format is evolving and next year will combine 3 meetings (ASM Health, ASM Applied and Environmental Microbiology, and ASM Mechanism Discovery) into one event. Go here for details.
11-12 Jun 2026 (Washington, DC): The Second Annual Unite for Sepsis Symposium, presented by the Sepsis Alliance. The event seeks to accelerate progress in sepsis research and care. Go here for details and to register.
22-24 Sep 2026 GAMRIC (Lisbon, Portugal), the Global AMR Innovators Conference (London, UK; formerly the ESCMID-ASM Joint Conference on Drug Development for AMR). See list of Top Recurring meetings, above..
[REGISTRATION DATES ANNOUNCED] 10-18 Oct 2026 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance) … and 2026 will be the 10th year for this program. Patrice Courvalin orchestrates content 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! Registration for 2026 will be during March 16–July 3, 2026. You can go here for more details and you should put a reminder in your calendar register on / after 16 March.
21-24 Oct 2026 (Washington, DC, USA): IDWeek 2026. See list of Top Recurring meetings, above.
10-13 November 2026 (Madrid, Spain): The International Society for Infectious Diseases (ISID) has announced its 21st International Congress on Infectious Diseases (ICID). Register and view the preliminary program here (Early bird closes 30 July 2026); abstract deadline is 28 April 2026.
23-24 Mar 2027 (Basel, Switzerland): The 11th AMR Conference sponsored by the BEAM Alliance. See list of Top Recurring meetings, above.
??? Mar 2028 (yes, that’s 2028, with location TBD): The 2028 Gordon Research Conference (GRC, https://www.grc.org/) entitled “Antibacterials of Tomorrow to Combat the Global Threat of Antimicrobial Resistance” and its related Gordon Research Seminar (GRS) for young doctoral and post-doctoral researchers will be sometime in March 2028. The organizers hope to coordinate dates and location with the 2028 BEAM-AMR meeting. Details to follow — mark your calendar!

Self-paced courses, online training materials, and other reference materials:

OpenWHO: “Antimicrobial Resistance in the environment: key concepts and interventions.” Per the webpage for the course, it will teach you “…why addressing AMR in the environment is essential and gain insights into how action can be taken to prevent and control AMR in the environment at the national level.” This course builds on WHO’s 2024 Guidance on wastewater and solid waste management for manufacturing of antibiotics. For further reading, see also the 25 Sep 2023 newsletter entitled “Manufacturing underpins both access and stewardship: Cefiderocol as a case study” and the 28 Jan 2024 newsletter entitled “EMA Concept Paper: Guidance on manufacturing of phage products”.
GARDP’s REVIVE website provides an encyclopedia covering a range of R&D terms, recordings of prior GARDP webinars, a variety of viewpoint articles, and more! Check it out!
GARDP’s https://antibioticdb.com/ is an open-access database of antibacterial agents.
The CARB-X website provides a range of recordings from its webinars, bootcamps, and more. A bit of browsing would be time well spent!
British Society for Antimicrobial Chemotherapy offers an eLearning section: Education – The British Society for Antimicrobial Chemotherapy.

Current funding opportunities

[UPDATED] CARB-X have announced a funding round that will be open 8-22 April 2026 (there will also be a round during 4Q 2026). There are 4 funding themes as below. Informational webinars have been announced for 9 and 10 April 2026.
- Direct-acting therapeutics for infections caused by Gram-negative bacteria
- Novel Chemistry for AMR Challenge – target-based therapeutics.
- Non-vaccine approaches to prevent neonatal sepsis
- Diagnostics for neonatal sepsis
The Horizon Europe Work Programme 2026-2027 includes at least 3 calls of interest within its Cluster 1 — see the list below. The application window starts 10 Feb 2026 and closes on 16 Apr 2026. See also the 12 Dec 2025 newsletter about the call. Note as well that there calls for agents to prevent and/or treat viral infections.
- HORIZON-HLTH-2027-01-DISEASE-08: Development of innovative antimicrobials against pathogens resistant to antimicrobials
- HORIZON-HLTH-2027-02-IND-02: Portable point-of-care diagnostics
- HORIZON-HLTH-2026-01-DISEASE-03:Advancing research on the prevention, diagnosis, and management of post-infection long-term conditions.
ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews.
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.
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 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
- 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. See also the 7 Feb 2026 newsletter (“The global funding pipeline, 2017-2023: A review”) about an excellent deep dive by the Hub team into patterns of funding over time.
- Antimicrobial Resistance Research and Innovation in Australia is an actively updated summary that covers Australia’s AMR research and patent landscape. It is provided via collaboration between The Lens (an ambitious project seeking to discover, analyse, and map global innovation knowledge) and CSIRO (Commonwealth Scientific and Industrial Research Organisation, an Australian Government agency responsible for scientific research). Lots to explore here!
- 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).

PASTEUR (v2.0) reintroduced in the US Congress!

John Rex — Thu, 12 Feb 2026 15:49:58 +0000

Dear All,

I’m delighted to be able to say that PASTEUR 2026 was (re)introduced into the US Congress this week! It’s an improved version relative to the version introduced into the prior 3 sessions of the US Congress (see below for discussion of that), so I think we can safely call it “PASTEUR v2.0” as well as by its more official name of PASTEUR 2026. Here are the links you need:

PASTEUR 2026 (v2.0)
- On congress.gov, it is “H.R.7352 – To amend the Public Health Service Act to establish a program to develop innovative antimicrobial drugs targeting the most challenging pathogens and most threatening infections, and for other purposes.”
- But, you can’t (yet) download from congress.gov … instead, use this text (.pdf) of the newly introduced version
- A section-by-section analysis of the Act
Press releases and commentary
- One-pager about the newly introduced version of PASTEUR
- Press release by the five house representatives who are sponsoring the bill
  - And excitingly, six additional representatives have joined the bill as of today (to follow this, look at the “Date Cosponsored” column on that webpage)
- Press releases from IDSA and BIO
Background and context on the ideas behind PASTEUR as well as its potential value
- 16 June 2021 newsletter (“PASTEUR Act re-introduced and levels up antimicrobial economics for strong innovation!”). This newsletter gives a good tour of the ideas behind PASTEUR v1.0.
  - There is also an excellent op-ed by Sen. Todd Young on the ideas of PASTEUR
- 29 Nov 2022 newsletter (“Impact of PASTEUR: 9.9m lives saved, ROI of 125:1”). This is a deep discussion of the value of PASTEUR to the US and the rest of the world. The data discussed are as close to a slam dunk economic analysis as you will ever see.
  - There is an 8 Dec 2022 follow-up on value for Canada, EU, Japan, and the UK.
- Newsletters on 28 Feb 2024 and 19 Mar 2024: This pair of newsletters discusses the way(s) that economists think about the problem of AMR. There are great discussions here of the key concepts of market failure and the “Tragedy of the (Antibiotic) Commons.”

So what’s in the new Act? Importantly, the key elements are unchanged: PASTEUR creates a volume-delinked payment model (a Pull incentive) under which:

The federal government would sign a subscription-style contract with pharmaceutical companies that develop critically needed new antibiotics and antifungals AND
The companies would receive fixed annual payments from the government, ranging from $75 million to $300 million per year, based on measures such as innovation, contribution to patient care, and public health benefits.

What’s changed relative to prior version? In addition to some process simplification, the big change is clarity on how antibiotics would be scored for purposes of the contract mechanism. Rather than the relatively vague language in PASTEUR 1.0, the new Act specifies the creation of a consistent, transparent, scoring methodology based on a set of defined elements. Not surprisingly, these look a lot like the criteria in the UK’s Pull incentive in which value comes from measures of innovation (novelty, etc.), patient benefit (better outcomes, less toxicity, etc.), and public health benefit. See below my signature for the full text of the proposed scoring methodology.

Overall, it’s felt that these changes have retained the best parts of PASTEUR v1.0 while creating a v2.0 that will be more likely to move forward through Congress.

Woot, woot! Oh, so very exciting! Many thanks here to the bipartisan team of Reps. Earl L. “Buddy” Carter (R-GA), Scott Peters (D-CA), Nick Langworthy (R-NY), Mike Levin (D-CA), and Mike Carey (R-OH) who introduced this bill!

And, also, we all owe a great debt of thanks to the AMR stakeholders who have been working to update PASTEUR based on feedback received from policymakers. This is largely the same group who sponsored a day of advocacy for an earlier effort to advance PASTEUR (15 Sep 2023 newsletter: “How the sausage is made: A day of advocacy for PASTEUR”) … and to them I can only say “Well done! THANK YOU!”

Such great news! I’m sure there will be ways for all us to pitch in to support the Act at at various points along the way. Stay tuned!

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.

Text from PASTEUR 2026 on the numerical scoring methodology:
“METHODOLOGY: An eligible antimicrobial shall receive a score, calculated by points awarded based on criteria developed in consultation with the Advisory Group established under section 399PP-1 within the following three categories, with a weighting assigned to each criterion established under such categories and a greater number of points resulting in a higher score:

CATEGORY I.- The eligible antimicrobial’s major contributions to patient care, including-
1. improving clinical outcomes for patients with multi-drug-resistant infections;
2. improved dose frequency;
3. reduced toxicity;
4. reductions in adverse events; and
5. benefits from the eligible antimicrobial’s route of administration, especially through oral administration or more than one administration method.
CATEGORY II.- The innovative characteristics of the eligible antimicrobial, including-
1. being a first-approved antimicrobial drug that has the potential to address, or has the evidence of addressing, unmet medical needs for the treatment of a serious or life-threatening infection, or, to a lesser extent, second and third drugs that treat such infection;
2. containing no active moiety (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in any other application under section 505(b) of the Federal Food, Drug) and Cosmetic Act and containing no active ingredient licensed in any other biological product license application under section 35l(a) ofthis Act;
3. being a member of a new class of drugs with a novel target or novel mode of action that are distinctly different from the target or mode of any antimicrobial drug approved under such section 505(b) or licensed under such section 351(a); and
4. addressing a multi-drug resistant infection through a novel chemical scaffold or mode of action.
CATEGORY III.- The benefit of the eligible antimicrobial to health systems and public health, including-
1. not being affected by cross-resistance to one or more antimicrobials approved under such section 505(b) or licensed under such section 351(a);
2. manufacturing capabilities within the United States;
3. improved product stability and storage;
4. increased activity against resistance mechanisms; and
5. reduction of the economic or population burden of antimicrobial resistance in the United States.”

3-4 Mar 2026 (Basel, Switzerland): The 10th AMR Conference. Sponsored by the BEAM Alliance, the 9th AMR Conference was an excellent meeting! A draft program has been posted and registration is now open. Please plan to attend!
17-21 April 2026 (Munich, Germany): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. You can go here to register and view the preliminary program; the abstract submission window for 2026 will run 15 October to 26 Nov 2025. For those who would like a substantial opportunity to present a product to a large audience (see also adjacent note about IDWeek), I know that the meeting schedule will again include Pipeline Monday.
22-24 Sep 2026 (Lisbon, Portugal): The 2nd GAMRIC, the Global AMR Innovators Conference (London, UK). Formerly the ESCMID-ASM (or ASM-ESCMID depending on location) Joint Conference on Drug Development for AMR, 2026 will be the 11th year for this series that is now under the joint sponsorship of CARB-X, ESCMID, BEAM Alliance, GARDP, LifeArc, Boston University, and AMR.Solutions. The ongoing series employs the successful format of prior meetings with a single-track meeting and substantial networking time. The 2025 meeting was a sell-out success! A written summary of the meeting is here and the video from the sessions is now available here. Registration will open March 2026; the abstract submission window will be 10-31 March 2026.
21-24 Oct 2026 (Washington, DC, USA): IDWeek 2026, the annual meeting of the Infectious Diseases Society of America. Details are not yet available but I would expect the program to continue to provide a substantial opportunity to present a product to a large audience (see also adjacent note about ESCMID) as well as opportunities to present at an IDWeek Pipeline Session.

Upcoming meetings of interest to the AMR community:

18-20 Feb 2026 (Sydney, Australia, in person): The “AMR 2026 Summit”, hosted by the Fleming Initiative and Australia’s Science Agency, CSIRO. This event (website) will spotlight evidence-informed One Health approaches, practical solutions to implementation barriers, and strategies for public engagement, education, and advocacy. Space is limited, so (and sort of like applying to attend a Gordon Conference), please register your interest to attend here.
[NEW] 19 Feb 2026 (virtual, 9.30-11a ET): REVIVE-sponsored webinar entitled “Innovating for impact: Tackling chronic lung infections in cystic fibrosis through new antimicrobials.” Go here to register. If this webinar interests you, you might also want to review the discussions at FDA’s 2020 workshop on inhaled therapies that is discussed in the 18 Oct 2020 newsletter (“FDA workshop: Insights on inhaled antifungals and antibacterials”).
3-4 Mar 2026 (Basel, Switzerland): The 10th AMR Conference sponsored by the BEAM Alliance. See list of Top Recurring meetings, above.
8-13 Mar 2026 (Renaissance Tuscany Il Ciocco, Italy): 2026 Gordon Research Conference (GRC) entitled “Antibacterials of Tomorrow to Combat the Global Threat of Antimicrobial Resistance.” A Gordon Research Seminar (GRS) will be held the weekend before (7-8 Mar) for young doctoral and post-doctoral researchers. Space for the GRS and the GRC is limited; for details and to apply, go here for the GRC and here for the GRS.
17-21 April 2026 (Munich, Germany): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
4-8 June 2026 (Washington, DC): ASM Microbe, the annual meeting of the American Society for Microbiology. The meeting format is evolving and next year will combine 3 meetings (ASM Health, ASM Applied and Environmental Microbiology, and ASM Mechanism Discovery) into one event. Go here for details.
22-24 Sep 2026 GAMRIC (Lisbon, Portugal), the Global AMR Innovators Conference (London, UK; formerly the ESCMID-ASM Joint Conference on Drug Development for AMR). See list of Top Recurring meetings, above..
10-18 Oct 2026 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance) … and 2026 will be the 10th year for this program. Patrice Courvalin orchestrates content 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! Registration for 2026 will not open for some time; go here for more details and put a reminder in your calendar to check back in the Spring if you are interested.
21-24 Oct 2026 (Washington, DC, USA): IDWeek 2026. See list of Top Recurring meetings, above.
[Updates to abstract and registration details] 10-13 November 2026 (Madrid, Spain): The International Society for Infectious Diseases (ISID) has announced its 21st International Congress on Infectious Diseases (ICID). Register and view the preliminary program here (Early bird closes 30 July 2026); abstract deadline is 28 April 2026.

Self-paced courses, online training materials, and other reference materials:

OpenWHO: “Antimicrobial Resistance in the environment: key concepts and interventions.” Per the webpage for the course, it will teach you “…why addressing AMR in the environment is essential and gain insights into how action can be taken to prevent and control AMR in the environment at the national level.” This course builds on WHO’s 2024 Guidance on wastewater and solid waste management for manufacturing of antibiotics. For further reading, see also the 25 Sep 2023 newsletter entitled “Manufacturing underpins both access and stewardship: Cefiderocol as a case study” and the 28 Jan 2024 newsletter entitled “EMA Concept Paper: Guidance on manufacturing of phage products”.
GARDP’s REVIVE website provides an encyclopedia covering a range of R&D terms, recordings of prior GARDP webinars, a variety of viewpoint articles, and more! Check it out!
GARDP’s https://antibioticdb.com/ is an open-access database of antibacterial agents.
The CARB-X website provides a range of recordings from its webinars, bootcamps, and more. A bit of browsing would be time well spent!
British Society for Antimicrobial Chemotherapy offers an eLearning section: Education – The British Society for Antimicrobial Chemotherapy.

Current funding opportunities

FDA have issued two AMR-related RFPs: One for interpretive criteria for in vitro activity vs. Candida auris and one for ideas on using large public datasets to generate control data for invasive fungal infections. The submission deadline for both is 24 Feb 2026. See the 5 Feb 2026 newsletter for details (“FDA RFPs: Susceptibility breakpoints and external controls for invasive fungal infections”).
The Horizon Europe Work Programme 2026-2027 includes at least 3 calls of interest within its Cluster 1 — see the list below. The application window starts 10 Feb 2026 and closes on 16 Apr 2026. See also the 12 Dec 2025 newsletter about the call. Note as well that there calls for agents to prevent and/or treat viral infections.
- HORIZON-HLTH-2027-01-DISEASE-08: Development of innovative antimicrobials against pathogens resistant to antimicrobials
- HORIZON-HLTH-2027-02-IND-02: Portable point-of-care diagnostics
- HORIZON-HLTH-2026-01-DISEASE-03:Advancing research on the prevention, diagnosis, and management of post-infection long-term conditions.
ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews.
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.
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 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/).
CARB-X will have calls during April 2026 and 4Q 2026. The team have announced that at least one of the themes of both calls will be novel chemistry scaffolds.
These things aren’t sources of funds but would help you develop funding applications
- 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. See also the 7 Feb 2026 newsletter (“The global funding pipeline, 2017-2023: A review”) about an excellent deep dive by the Hub team into patterns of funding over time.
- Antimicrobial Resistance Research and Innovation in Australia is an actively updated summary that covers Australia’s AMR research and patent landscape. It is provided via collaboration between The Lens (an ambitious project seeking to discover, analyse, and map global innovation knowledge) and CSIRO (Commonwealth Scientific and Industrial Research Organisation, an Australian Government agency responsible for scientific research). Lots to explore here!
- 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).

UK Pull (“Netflix-like”) pilot: STEDI-based QALY value of new antibiotics implies societal value > 10m GBP/year!

Kevin Outterson — Tue, 12 Apr 2022 01:40:21 +0000

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter),

We’ve written before about the UK’s “Netflix” pilot antibiotic Pull incentive in which England leads the way on showing how it plans to provide its fair share of a global antibacterial Pull incentive (for background on Pull incentives, see this superb 5-minute video explainer).

In an exciting update, NICE has now published the draft guidance for the first two pilot drugs: cefiderocol and ceftazidime-avibactam! Both documents are well worth your time to download and read. In addition, NICE have published this commentary and there’s a also good summary posted by FT.

You may remember that these two drugs were chosen competitively to receive subscriptions of up to £10M each every year for up to 10 years, pending the outcome of economic assessments and a Committee review calculating the societal value of these fire extinguishers of medicine using the STEDI principles (Spectrum, Transmission, Enablement, Diversity, Insurance; for a refresher on STEDI, see this newsletter or this YouTube explainer).

The initial numbers are now in and while there remains work to do, it’s also a moment to celebrate: We don’t (yet) have a specific $/£ value but NICE has stated each drug has a QALY-based value to the NHS in England: for ceftazidime-avibactam it is 530 QALYs/year x 10 years; for cefiderocol, the value is 970 QALYs/year x 10 years. As NICE typically uses £20,000 and £30,000 per QALY as a threshold for the idea of good value (that is, things that cost more than this per QALY are too expensive), a simple scaling of these QALYs/year x £20k/QALY = £11-19M/year. We can see that contract negotiations need to be completed to determine the actual £ figure for each drug (and the actual award will be limited by the £10m/year cap in the pilot program), but it’s evident that the math shows that major new antibiotics have a real social value that can be estimated and should be rewarded!

Pop a cork and raise a glass: we are witnessing the successful maiden voyage of the first antibacterial pull incentive! When the rest of the G7 and (at least some of the) G20 follow suit to bring the global Pull reward into the target range of ~$3b for a substantial new antibiotic, we will have a sustainable solution. Thank you to the entire Team UK! This is what leadership looks like! Woot, woot!

Note that the economists didn’t quite have all of the data they wanted to calculate some of the STEDI values of antibiotics, so the UK government committee for the project stepped up and made some reasonable estimates. This was precisely the sort of courage needed in the face of some uncertainty, and shines a light on the need to continue to improve both data and methods.

And, that’s why we run Pilot projects: to work out the kinks and to prepare the way to do better next time. Who wants to go next? The PASTEUR ACT in the US is poised to happen in 2022 … as an early sign, the 2023 US budget recently proposed by the White House includes a proposal that “… would provide annual payments from a contract valued between $750 million and $3 billion to the developers of newly approved antimicrobial drugs” — this is, of course, exactly the PASTEUR concept! With Canada, Europe, and Japan also taking steps, we are seeing the momentum build.

it’s just stunning to contemplate how far we’ve come since the 17 Sep 2009 conference hosted by Sweden on Innovative Incentives for Effective Antibacterials. IDSA had sounded the Bad Bugs, No Drugs call in 2004, but there was really zero momentum on global solutions until the meeting in 2009 triggered a cascading series of actions by multiple stakeholders: New Drugs for Bad Bugs (ND4BB)! CARB-X! DRIVE-AB! UK AMR Review! Novo REPAIR Impact Fund! GARDP! The Global AMR R&D Hub! The IACG on AMR! The $1b AMR Action Fund!

And now we see the creation of the first true Pull incentive that would make it possible for new #FireExtinguishersOfMedicine to reach registration, stay on the market, and be available to the many who will desperately need them! As stated in the NICE commentary: “The NHS will now use its commercial power to secure deals that will enable NHS patients to benefit from these treatments, delivering on its Long Term Plan commitment and paving the way for a pipeline of future treatment options.”

Our world is beset with many vexing problems; the broken economics of antibiotics is a problem we can truly start to fix in 2022.

We’ll say it again: Woot, woot! WELL DONE, TEAM UK!

All best wishes, Kevin and John

Kevin Outterson, JD, Professor of Law, Boston University & Executive Director, CARB-X (these views are personal and do not necessarily reflect the views of CARB-X or any of its funders) @koutterson

Current funding opportunities (most current list is here):

JPIAMR’s 14th call is now open. Entitled “Disrupting drug resistance using innovative design”, the call seeks consortia that would seek to “improve the treatment of bacterial and fungal infections (including co-infection) and/or the prevention of the emergence/spread of resistance in humans, animals or plants through the improvement of the efficacy, specificity, delivery, combinations and/or repurposing of drugs and plant protection agents.” Bacteria, fungi, human health, animal health, and plant health are all in scope! Pre-proposals are due 8 Mar 2022; full proposals would be due 5 July 2022. Go here for 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.
INCATE (Incubator for Antibacterial Therapies in Europe) is a newly launched early-stage funding vehicle. Details are still coming into focus, but per comments on 25 Aug 2021 at the BIOCOM conference, their goal is to support ~4 companies per year with about $250k/company. Contact details are on their website (https://www.incate.net/).
CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (more than 80 total awards, and counting, as they include contracting from prior rounds). New rounds from CARB-X will occur only after new funding is obtained in 2021.
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 Dec 2021: “The New Winds Pushing and Pulling Antibacterial Development.” This FABULOUS program featured talks from the UK team behind the NHS “Netflix” pilot, Kevin Outterson’s recently released report documenting the need for global Pull incentives to have a value of $2.2 – 4.8b, and speakers covering PASTEUR and work in the EU on pull incentives. The video is here — please make time to listen to this program!
The stunning 4 Feb 2022 webinar for the GRAM report (Global Research on Antimicrobial Resistance “1.27 million deaths per year are directly attributable to AMR”) is now available for replay. #AMRSOS!
23-26 Apr 2022 (Lisbon): 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). Go here for details.
9-13 May 2022 (Athens and online): 40th Annual Meeting of the European Society for Paediatric Infectious Diseases, Go here for details.
16-18 June 2022 (Perth, Australia): Australasian Society for Infectious Diseases Annual Scientific Meeting is a hybrid event for adult and pediatric infectious disease and clinical microbiology specialists. Go here for details.
11-14 July 2022 (Sydney): Australian Society for Microbiology Annual National Meeting is a hybrid event that will feature a range of lectures and symposium sessions, as well as extensive opportunities for networking. Go here for details.
24-27 July 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
28-31 July 2022 (Singapore): 10th International Congress of Asia Pacific Society of Infection Control is a hybrid event for professionals in the Asia Pacific region. Go here for details.
20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
[NEW] 4-7 Oct 2022 (Dublin, Ireland): The 2022 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent meeting, especially for developers … and if you’ve missed it, the recordings from the 2021 meeting are online. Go here for details on the 2022 meeting.
19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6^th edition of Patrice Courvalin’s fabulous ICARe residential training course covering all things AMR is on for 2022! This is a soup-to-nuts training in AMR: it is very intense, very detailed, and always gets rave reviews from attendees. Registration is open 21 Mar 2022 to 21 June 2022 and is limited, so book your slot as soon as you can. Go here for more: https://www.icarecourse.org/
19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
25-28 Oct 2022 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.
27-30 Nov 2022 (Perth, Australia): 32nd International Congress of Antimicrobial Chemotherapy is the biennial congress of the International Society of Antimicrobial Chemotherapy (ISAC). Go here for details.

UK Subscription model goes live! Value bands cover entire UK!

Kevin Outterson — Mon, 19 Aug 2024 14:52:44 +0000

Dear All (with thanks to Kevin for leading on this newsletter and with a wonkish / long-read alert on this email … settle in for the ride!),

Great news from TEAM UK! As of 12 August, the UK Subscription Program is no longer a pilot but is fully operational with an initial application deadline of 12 Sep 2024. Here are the links you need to follow along:

The 12 Aug 2024 NHS England webpage that provides the basic announcement
The Find-A-Tender legal notice: https://www.find-tender.service.gov.uk/Notice/025397-2024
The detailed procurement documents
- Master website: https://atamis-1928.my.site.com/s/Welcome
- If you click on “View Live Opportunities”, you can search to find the webpage entitled “NHS Antimicrobial Resistance Subscription Model”
- And from here click on the View Documents tab to access the full set of documents starting with Document #1: “Invitation to Tender”
- Rather a bit of digging required here: if you get stuck, there are contact emails readily evident for help
For context
- The 8 May 2024 NHS England “long read” summary entitled “Antimicrobial products subscription model: guidance on commercial arrangements”
- The 8 May 2024 AMR.Solutions newsletter entitled “New UK 5-year AMR plan: Subscription model details!”

There’s a fair bit to digest if you are going apply, but the key points that everyone needs to know are briefly summarized here with extended details below our signatures:

The subscription process now covers the entire UK (England, Scotland, Wales, and Northern Ireland) and with this the value bands are higher.
The payments can be made for up to 16 years, until the UK exclusivity expires (including patents, SPCs, or regulatory data protection).
The Clinical Technical Evaluation has been thoughtfully updated, giving best-in-world clarity on what will qualify for an antibacterial pull incentive.
Eligible products include existing and upcoming products.
This year’s tender has an application deadline of 12 Sep 2024.
And a few constructive critiques
1. The financial stability criteria should better consider both the circumstances and importance of small companies in providing critical antibiotics
2. Provisions are needed regarding global stewardship and access
3. Provision are needed for increasing value with label expansion [see addendum, below]

27 Aug 2024 addendum: Per a discussion with staff at NICE, products could be moved to a higher (or lower) band if new evidence emerges. The sponsor could submit new efficacy data at/after 3 years in the subscription model; NICE could trigger a review sooner if safety issues arise.

Woot, woot! Wow! Our critiques not withstanding, it is marvelous to see this process become business as usual! MANY THANKS TO TEAM UK for their WORLD-LEADING WORK on Pull Incentives!

It truly is the case that we’ve pushed as hard as we can and and now we need to start pulling via the PASTEUR Act in the US, the different (and potentially complementary) proposals of pull incentives from the European Commission, as well as the ideas/pilots from Japan, Canada, Italy, and Switzerland.

Onward! All best wishes, Kevin and John

Kevin Outterson, JD, Professor of Law, Boston University & Executive Director, CARB-X (these views are personal and do not necessarily reflect the views of CARB-X or any of its funders) @koutterson

EXTENDED DETAILS, POINT-BY-POINT
1. The subscription process now covers the entire UK (England, Scotland, Wales, and Northern Ireland) and with this the value bands are higher:

As you can see, the highest possible value is GBP 23.7m ($30.6m at current exchange rates). As the total budget allocated for the entire program is up to £100 million per year, the UK is certainly paying its “fair share” for antibacterial innovation (see also our 2023 article on “fair share”).

2. The payments can be made for up to 16 years, until the UK exclusivity expires (including patents, SPCs, or regulatory data protection).

3. The Clinical Technical Evaluation has been thoughtfully updated, giving best-in-world clarity on what will qualify for an antibacterial pull incentive. The details are found in Document 6 (“Clinical_Technical_Evaluation criteria”) and we highlight 2 key elements:

3.a. The Product will be scored against the criteria below, with the weights shown below. The criteria are in 3 groups: (1A-D) Relative effectiveness and unmet clinical need (45%) of the overall value, (2A-F) pharmacological benefit (25%), and (3A-G) Health system benefit (30%):

3.b. Each of these factors is explained in the text of Document 6, including the types of evidence that will be accepted. For example, the extended rules for Criteria 1A show how the awarded points follow the WHO Priority Bacterial Pathogen List to vary by pathogen (and these rules also make clear the focus on bacterial pathogens; the pathogens from the fungal PPL are not in scope for this tender):

The technical criteria in document 6 are required reading for anyone developing an antibiotic which might want a UK subscription.

4. Eligible products include existing and upcoming products. Here are the eligibility rules:

“an antimicrobial with a license for the UK and a UK launch where the marketing authorisation has already been granted or is likely to be granted before 31 July 2025 and
- “the Licensed Indication(s) include one or more pathogens on the WHO critical priority pathogen list 2024 against which the antimicrobial is active.
“The product should also be within the period of the exclusivity defined either by the patent, supplementary protection certificate or regulatory data protection and
- “have a minimum remaining twelve (12) months before the date of loss of exclusivity from the date of commencement of the contract”

5. Don’t miss the bus! The application timeline for the next round of subscriptions is very short: 12 September (one month from publication, see time table below). The expectation is that the tender will be repeated annually with the proviso that its terms might be updated (from the long read webpage, we have this: “The documentation will include the eligibility and the award criteria. These will be reviewed each year before notice of the tender is given.”)

CONSTRUCTIVE CRITIQUES, POINT-BY-POINT

We would like to see the UK modify Document 3, “Guide for assessing financial standing.”
1. In a normal procurement process, governments want to ensure that the counterparty is financially sound.
  1. For antibiotics, especially in small companies, pull incentives like the Subscription are also designed to rescue financially struggling companies. It make little sense to apply the standard financial scoring methodology to small antibacterial biotechs.
  2. It would be akin to requiring proof of financial solvency prior to receiving disaster assistance after a storm.
  3. This issue was raised in the comment process on the program: In the pilot stage of the Subscriptions, some small company applicants found this to be a formidable barrier.
  4. This might force small companies to partner with larger, more solvent, companies in order to apply to UK. That might be a good thing, but the decision should be made on business grounds, not the standard language of a procurement agreement.
2. Further, the company gets a lower score if this contract is a substantial portion of their global revenue and if they have a bad D&B score.
  1. Rather than this, we think that we want small companies with no other revenue yet to apply to G7 pull incentives. They need 22 points to pass this financial check.
  2. We want to hear from any small companies who have a product UK might want, but who miss this pass/fail financial hurdle.
We would like to see provisions added regarding global stewardship & access.
1. The UK has a clear opportunity to lead here by imposing reasonable contractual conditions that support global stewardship and access.
2. Shionogi’s license of cefiderocol to GARDP is a good model for this (25 Sep 2023 newsletter).
3. This would be a great opportunity to reinforce the ideas from the Stewardship & Access Guide created by CARB-X, Wellcome, and partners (22 March 2021 newsletter).
No provisions were found allowing the selected drug to be rescored upward after a label expansion or other evidence of greater clinical utility.
1. We would like to see processes that support label expansions.

Current funding opportunities

The GHIT Fund has announced its 21st Request for Proposals for its Hit-to-Lead Platform to support drug discovery and development process to address Malaria, Tuberculosis, Chagas disease, and Visceral leishmaniasis. Go here for the RFP: GHIT-RFP-HTLP-2024-002. The deadline is 30 Aug 2024.
The AMR Industry Alliance have announced the 2024 edition of their ongoing annual series of stewardship prizes. Applications for innovative approaches to AMR stewardship are sought from public, private or not-for-profit health care organization or institution operating in an LMIC. This year’s deadline is 1 Sep 2024. Go here for details.
ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews.
CARB-X has open calls at intervals that span four areas: (i) Therapeutics for Gram-Negatives, (ii) Prevention for Invasive Disease, (iii) Diagnostics for Neonatal Sepsis, and (iv) Proof-Of-Concept for Diagnosing Lower-Respiratory-Tract Infections. See this 6 Mar 2024 newsletter for a discussion of the call and go here for the CARB-X webpage on the call. There are multiple opportunities to submit — see the CARB-X webpage for details.
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.
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 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).

17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here to register!
16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Go here for details.
25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. Go here to register!
11-15 April 2025 (Vienna, Austria): ESCMID Global 2025, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details.

Upcoming meetings of interest to the AMR community:

[HAS HAPPENED; NOTEWORTHY VIDEO]: 22-23 May 2024 meeting of PACCARB. If you were intrigued by the 23 July 2024 newsletter entitled “Conflict-Borne XDR Superbugs”, you should note that PACCARB devoted its 23 May 2024 morning session to the topic of combat-related drug resistance. See page 3 of the agenda and then follow along in the video on YouTube.
22 Aug 2024 (virtual, 11a-12.30p EDT, 5p-630p CEST): GARDP REVIVE Webinar entitled “Exploring non-traditional antimicrobials: Insights from three cases.” Go here for details and to register. If non-traditional approaches interest you, please do be sure to review the challenges that are raised in the papers discussed in the 6 Aug 2019 newsletter entitled “Non-Traditional Antibiotics: A Pipeline Review And An Analysis Of Key Development Challenges.” Developing non-traditional products is MUCH harder than you might expect … it is important to know the issues!
[NEW – DON’T MISS IT] 28 Aug to 28 Sep (Off-Broadway, New York City, the Alice Griffin Jewel Box Theatre): Lifeline, the musical story of Sir Alexander Fleming’s discovery of penicillin. Previously entitled The Mould that Changed the World, the musical is a two-time Edinburgh Festival Fringe sell-out (2018 and 2022) and has toured to London, Glasgow, Atlanta and Washington DC (2022). This 5-week run in NYC is timed to be in support of the High-Level Meeting on AMR (HLM AMR) during UNGA 2024. Go here for a blurb and here to book your tickets!
[NEW – DON’T MISS IT] 9 Sep 2024 (9a-4p ET, in-person or virtual): FDA have announced an AMDAC (Antimicrobial Drugs Advisory Committee) meeting that will discuss “new drug application 213972, for oral sulopenem etzadroxil/probenecid tablets consisting of 500 milligrams (mg) sulopenem etzadroxil and 500 mg probenecid, submitted by Iterum Therapeutics US Ltd., for the proposed indication of treatment of uncomplicated urinary tract infections caused by designated susceptible bacteria in adult women 18 years of age and older.” Try to make time to listen to this … every FDA Advisory Committee is a master class in regulatory thinking! Go here for the Federal Register notice and here for the meeting’s webpage: materials are typically posted 2 days before the meeting.
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.
[NEW] 24 Sep 2024 (in person, 7.45-10a ET, New York City): Breakfast meeting entitled “Advancing Together: Securing the Global AMR Agenda by Harnessing the Collective Strength of Multi-Sector Partnerships”, sponsored by bioMèrieux, The Wellcome Trust, The American Society of Microbiology, and the Republic of Malawi. This occurs two days before the 26 Sep 2024 UNGA HLM on AMR. Go here to register.
16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above.
[NEW] 16 Oct 2024 (virtual and in-person, 10a-1p ET): FDA’s Rare Disease Innovation Hub, in collaboration with the Reagan-Udall Foundation will discuss how the recently announced Rare Disease Innovation Hub can engage and prioritize its work. This may seem somewhat remote, but could this have implications for rare infections? Hmm! Attend if you can! Go here for the meeting’s webpage.
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.
11-15 April 2025 (Vienna, Austria): ESCMID Global 2025, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.

Antibiotic supply chains: Challenges & Opportunities

John Rex — Thu, 05 May 2022 00:20:58 +0000

Dear All,

In a report entitled Understanding the Antibiotic Manufacturing Ecosystem: A view of global supply chains, pressure points, and implications for antimicrobial resistance response, the Boston Consulting Group and Wellcome Trust have examined at length the questions of (i) how the #FireExtinguishersOfMedicine are made and (ii) how they can be made with the least impact on the environment.

To see all this in context, there are are two parallel threads to consider. First, COVID has taught us about the fragile nature of supply chains in general. Antibiotics definitely have fragile supply chains and you can get a flavor of this by scanning this 2018 article in Forbes, this 2021 paper in BMJ Global Health, and FDA’s Drug Shortage webpage. Second, manufacturing discharges can themselves drive antibiotic resistance — ATMF’s 2021 review is a good summary of the problem. The need for responsible approaches to manufacturing was also clearly called out in proposals to establish environmental discharge from the AMR Industry Alliance. Notably, the AMR Industry Alliance (AMRIA) will publish an industry standard next month which, together with an independent certification scheme (expected in early 2023), could provide a mechanism to drive adoption of risk based, cost effective controls to minimize antibiotic emissions across the global supply chain and provide means by which manufacturers can give assurance of responsibly made antibiotics.

Addendum: the AMRIA published its Antibiotic Manufacturing Standard on 14 June 2022. See https://www.amrindustryalliance.org/shared-goals/common-antibiotic-manufacturing-framework/ for details, including research-based Predicted No-Effect Concentrations (PNECs). In collaboration with BSI (British Standards Institution), there is also an industry certification scheme. See also the 25 Sep 2023 newsletter for a further discussion of this scheme.

So, this new report analyzes the impact of possible environmental regulatory changes on antibiotic supply. The report starts from a very practical concern — it regulatory changes increase manufacturing costs, will manufacturing decline?

There are some excellent figures throughout the report but I wanted to share these two in particular. Production of antibiotics is not simple and, unfortunately, antibiotic discharge does happen. Note in particular (2nd figure) that most of the manufacturing happens in two of the most densely populated countries in the world:

In terms of the impact of environmental regulation to curb this issue, it really boils down to someone paying more and at what scale. If it is the developers, we all know how tough it is to just keep the lights on once you’ve made a new antibiotic. If it is the consumers, no one ever wants to pay more if they can help it. And, none of us will be happy if we break the supply chains for critical antibiotics! But how likely is this if new environmental regulation was introduced?

I encourage you to read the report yourself, but findings suggest environmental regulation can be compatible with strong antibiotic supply chains. However, policies should be developed in a supply chain-sensitive way and complimented with supportive measures for at-risk supply chains. The key being (no surprise!) to take a number of pragmatic steps in parallel. These include:

Evidence-based discharge limits
Standardized methods for monitoring discharge
Cost-efficient processes for meeting and monitoring compliance with the targets
Ambitious but feasible timelines for implementation
Consideration of the fragility of individual supply chains with an eye to ensuring that supply chains for critical antibiotics are not broken
International coordination on all the above, including actions by net-importers

The report suggests that the WHO and G7/G20 need to take the lead: global government action will be needed to change the way we develop and use antibiotics. Now is the time to include changing the way we manufacture them as part of this global effort!

Well done, BCG and Wellcome Trust! –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.

Current funding opportunities (most current list is here):

JPIAMR’s 14th call is now open. Entitled “Disrupting drug resistance using innovative design”, the call seeks consortia that would seek to “improve the treatment of bacterial and fungal infections (including co-infection) and/or the prevention of the emergence/spread of resistance in humans, animals or plants through the improvement of the efficacy, specificity, delivery, combinations and/or repurposing of drugs and plant protection agents.” Bacteria, fungi, human health, animal health, and plant health are all in scope! Pre-proposals are due 8 Mar 2022; full proposals would be due 5 July 2022. Go here for 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.
INCATE (Incubator for Antibacterial Therapies in Europe) is a newly launched early-stage funding vehicle. Details are still coming into focus, but per comments on 25 Aug 2021 at the BIOCOM conference, their goal is to support ~4 companies per year with about $250k/company. Contact details are on their website (https://www.incate.net/).
CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (more than 80 total awards, and counting, as they include contracting from prior rounds). New rounds from CARB-X will occur only after new funding is obtained in 2021.
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 Dec 2021: “The New Winds Pushing and Pulling Antibacterial Development.” This FABULOUS program featured talks from the UK team behind the NHS “Netflix” pilot, Kevin Outterson’s recently released report documenting the need for global Pull incentives to have a value of $2.2 – 4.8b, and speakers covering PASTEUR and work in the EU on pull incentives. The video is here — please make time to listen to this program!
The stunning 4 Feb 2022 webinar for the GRAM report (Global Research on Antimicrobial Resistance “1.27 million deaths per year are directly attributable to AMR”) is now available for replay. #AMRSOS!
[NEW] 13 May 2022 (Strasbourg, France): AC21 Workshop: “Pre-clinical development of antimicrobial peptides”, with contributions from the AC21 member universities in Stellenbosch, South Africa, Minneapolis, USA, Freiburg, Germany and Strasbourg, France as well as from other institutions. Participation is free and open to non-member institutions but registration is required. Supported by Academic Consortium 21. Go here for details.
16-18 June 2022 (Perth, Australia): Australasian Society for Infectious Diseases Annual Scientific Meeting is a hybrid event for adult and pediatric infectious disease and clinical microbiology specialists. Go here for details.
11-14 July 2022 (Sydney): Australian Society for Microbiology Annual National Meeting is a hybrid event that will feature a range of lectures and symposium sessions, as well as extensive opportunities for networking. Go here for details.
24-27 July 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
28-31 July 2022 (Singapore): 10th International Congress of Asia Pacific Society of Infection Control is a hybrid event for professionals in the Asia Pacific region. Go here for details.
20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
[NEW] 4-7 Oct 2022 (Dublin, Ireland): The 2022 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent meeting, especially for developers … and if you’ve missed it, the recordings from the 2021 meeting are online. Go here for details on the 2022 meeting.
19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6^th edition of Patrice Courvalin’s fabulous ICARe residential training course covering all things AMR is on for 2022! This is a soup-to-nuts training in AMR: it is very intense, very detailed, and always gets rave reviews from attendees. Registration is open 21 Mar 2022 to 21 June 2022 and is limited, so book your slot as soon as you can. Go here for more: https://www.icarecourse.org/
19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
25-28 Oct 2022 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.
27-30 Nov 2022 (Perth, Australia): 32nd International Congress of Antimicrobial Chemotherapy is the biennial congress of the International Society of Antimicrobial Chemotherapy (ISAC). Go here for details.

EPA Concept Note (Part 1): AMR risks of antibacterial or antifungal pesticides

John Rex — Wed, 27 Sep 2023 12:34:26 +0000

This is the first of a 5-part newsletter series. There is a second (28 Sep 2023) newsletter that expands on the EPA concept note, a third (12 Jan 2024) newsletter about ending the use of streptomycin spray on citrus crops, 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,

What a week … and I certainly was not expecting this one! … a 4th newsletter in as many days is needed for this Federal Register notice that was published yesterday:

“Pesticides; Concept for a Framework To Assess the Risk to the Effectiveness of Human and Animal Drugs Posed by Certain Antibacterial or Antifungal Pesticides; Notice of Availability and Request for Comment”: Yes, that’s quite a mouthful … read it slowly!
The FR notice regarding the “Concept for a Framework”: https://www.federalregister.gov/documents/2023/09/26/2023-20929/pesticides-concept-for-a-framework-to-assess-the-risk-to-the-effectiveness-of-human-and-animal-drugs
The concept paper describing the approach to developing a framework: https://www.regulations.gov/document/EPA-HQ-OPP-2023-0445-0001

I can hear you thinking: Pesticides? Did you really say pesticides? What do these have to do with AMR? Copying freely from the text in the FR notice, we can take it step by step:

First, the term “pesticide” in this usage means “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest…”.
- This definition for pesticide is found in FIFRA, the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. §136 et seq, 1996).
- So, this definition would include (for example) use of an azole to control fungal growth on plants.
Next, a pesticide must be registered with the EPA under FIFRA before it can be legally sold or distributed in the United States.
During the registration process, EPA considers whether the pesticide will cause unreasonable adverse effects on people or the environment.
Because resistance is considered an adverse effect under FIFRA, the U.S. government is working to develop a structured and coordinated approach to assess and manage these risks.

So, this is really the agricultural equivalent of all the work that has been done to date on reducing veterinary usage (see this 26 Sep 2023 newsletter for any entry point on the veterinary conversation). And, it’s more than agricultural … what about non-agricultural uses such as paint or wood preservation?

With that understanding, the ideas in the FR notice and the concept note become compelling. Here are some excerpts (I’ve drawn variously from the two documents with some light editing for ease of reading):

“We currently have an incomplete understanding of the factors that contribute to AMR in various settings, including their use in agriculture.
- “Best practices continue to evolve for evaluating the risks to human and animal health posed by pesticides that select for antimicrobial-resistant bacteria or fungi, and substantial uncertainties exist related to this issue.
  - “Further, optimal approaches to risk mitigation may be unknown or vary substantially depending on the characteristics of a pesticide and its proposed use.
“Through a U.S. government interagency process, the U.S. Environmental Protection Agency (EPA), the U.S. Department of Health and Human Services (HHS), and the U.S. Department of Agriculture (USDA), under the oversight of the White House Executive Office of the President, have developed this concept note.
- The concept note is the first step in creating a framework to improve assessments of potential risks to human and animal health where the use of certain pesticides could potentially result in antimicrobial resistance (AMR) that compromises the effectiveness of medically importanti antibacterial and antifungal drugs.
- “This concept note solicits stakeholder input on the proposed structure for the framework and on potential solutions, research, or mitigation approaches to reduce the spread of AMR.
  - “Feedback will then be incorporated, as appropriate, into the draft framework and the final framework, which will be issued at a later date.
“In particular, input is sought on:
- Ensuring that the framework (see figure below) is appropriately defined and clear to stakeholders,
- The types of pesticides that should be evaluated under the framework, either by class or function,
- The factors that should be considered in determining if a proposed pesticide use constitutes a potential risk to human or animal health due to AMR,
- How to determine which human and animal antimicrobial drugs should be considered ‘medically important’ and how this term should be defined, and
- Mitigation strategies that are currently available to address the risk of AMR developing because of pesticide use.”

Here’s the conceptual framework. It’s drawn from a framework in CVM GFI #152 (“Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern”) and it has three sections: (i) resistance characterization, (ii) risk assessment, and (iii)risk management (including risk mitigation).

The concept note does not give any specific ideas on the details of such a framework — that’s all for the future. But, the background section of the concept note give an example of how recent evidence indicates that use of azole antifungals in plant agriculture selects for azole-resistant strains of Aspergillus and the note cites Verweij et al. “Dual use of antifungals in medicine and agriculture: How do we help prevent resistance developing in human pathogens?” Drug Resist Updates 2022, https://doi.org/10.1016/j.drup.2022.10088). (Disclaimer: please also know that Verweij et al. discuss two novel mechanism antifungals currently in clinical development as human therapeutics, both of which have agricultural equivalents in development or in use. I am employed by the company that is developing one of these two potential new human medicines.)

The FR notice further expands on the concerns regarding prior examples of the impact of agricultural use in a section entitled “Why is the Agency taking this action?”:

In the United States, more than 2.8 million antimicrobial-resistant infections occur each year, resulting in more than 35,000 annual deaths.
Some antibacterial and antifungal pesticides used in agriculture as well as some pesticides used in other settings, belong to the same class as or share mechanisms of action with medically important antimicrobial drugs used in human and veterinary medicine.
Recent evidence indicates that the use of some antifungal pesticides can select for resistant organisms that pose a potential risk to human and animal health.
As new pesticides and uses are proposed, the potential exists for these pesticides to select for pathogenic bacteria or fungi that are resistant to medically important antimicrobial drugs, including both FDA-approved drugs and those still undergoing clinical trials.

Wow! It feels like the beginning of a very important conversation. It’s impressive to see the coordination across USG (US Government): EPA + USDA + HHS under the oversight of the White House … wow, again! It may take some time to get to an answer, but well begun is half done.

Your comments on the concept note are sought! Comments should be provided in writing and submitted to EPA Docket ID No. EPA-HQ-OPP-2023-0445 no later than 5:00 pm ET on November 10, 2023.

And (in a news flash that is your reward for reading all the way to the end of this newsletter), I just now learned that President Biden will today announce a $100 million research drive to support the Advanced Research Projects Agency for Health (ARPA-H) in developing new antibacterial agents! Exciting! Addendum: There is a follow-up newsletter that expands on the ARPA-H award

All best wishes, –jr

Current funding opportunities (most current list is here)

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 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.
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.
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).

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

General note: Virtual meetings are easy to attend, but regular attendance at in-person events is the key to networking and deeper insight. My personal favorites for such in-person meetings are marked below as HIGHLY RECOMMENDED and are the BEAM Alliance’s AMR Conference (March, Europe), ECCMID (April, Europe), the ASM-ESCMID Developer’s meeting (September, alternates sides of the Atlantic), and ID Week (October, USA). Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!
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. HIGHLY RECOMMENDED.
12 Oct 2023 (virtual, 2-3p CET) GARDP-sponsored webinar entitled “Market interventions to improve access to antibiotics for resistant infections.” Go here 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.
6-7 Mar 2024 (Basel,[NEW] 6-7 Mar 2024): Sponsored by the BEAM Alliance, the AMR Conference is now in its 8th year and is consistently an excellent meeting for developers. You can’t register yet but you can mark your calendar and signup for notifications about the meeting. HIGHLY RECOMMENDED.
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.
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. HIGHLY RECOMMENDED.
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.
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. Go here for the meeting’s general website. You can’t register (yet) for the 2024 event, but you can mark your calendar. HIGHLY RECOMMENDED.

EPA (part 3): Streptomycin spray on citrus? Not any more!

John Rex — Fri, 12 Jan 2024 02:50:02 +0000

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.

Current funding opportunities

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).

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.

Pull incentives in Europe: TEVs to be included in legislative update

John Rex — Fri, 12 Dec 2025 08:03:45 +0000

Dear All,

There are more details yet to come, but the EU Council (“the Council”) and the EU Parliament (EP) yesterday announced an agreement on the update to the EU General Pharmaceutical Legislation that includes transferable exclusivity vouchers (TEVs or TEEVs, depending on your preferred abbreviation). Here’s the key text from the EP’s press release:

Stepping up the fight against antimicrobial resistance (AMR)

Negotiators agreed to introduce a “transferable data exclusivity voucher” for priority antimicrobials, giving the right to 12 additional months of data protection for one authorised product. The 12-month extension may be used once, for the priority antimicrobial or for another centrally authorised medicinal product of the same or different marketing authorisation holder.

Among new measures to promote the prudent use of antimicrobials, the deal introduces stricter requirements, such as compulsory medical prescriptions for all antimicrobials, specific information requirements to be provided with the package leaflet, and an “awareness card” in paper format in case the leaflet is made available only electronically.

When applying for marketing authorisation for antimicrobials, companies would also need to provide an “antimicrobial stewardship plan” and include an evaluation of the risk for antimicrobial resistance as part of the compulsory environmental risk assessment.

As further background, here are the links you need:

The 11 Dec 2025 press release from the EP (same press release as linked above)
The corresponding 11 Dec 2025 press release from the Council
A 20 Jun 2025 newsletter (“Pull incentives in Europe: Next legislative steps”) in which Deepali Patel (Director of International Policy at the AMR Action Fund) decodes the EU legislative process
A 21 Oct 2025 newsletter (“Technical Briefing on Pull Incentives for the European Parliament”) in which Frédéric Peyrane (General Secretary, BEAM Alliance) and I take you through the details of a technical briefing on TEVs that was provided to the EP by BEAM Alliance, AMR Action Fund, and Novo Nordisk Foundation
(23 Jan 2026 addendum): A 2 May 2023 newsletter (“European Commission: Proposed Pull incentives!”) that discusses the idea of TEVs as a temporary bridge to more permanent solutions. This idea has not been prominent in more recent conversations but it should be in the back of everyone’s mind.

Woot, woot! We have been working towards this for so very long (since at least 2009 depending on how you look at it; see the summary at https://amr.solutions/incentives/) … how exciting to see this next step become real! What a lovely present for the holidays! 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.

3-4 Mar 2026 (Basel, Switzerland): The 10th AMR Conference. Sponsored by the BEAM Alliance, the 9th AMR Conference was an excellent meeting! A draft program has been posted and registration is now open. Please plan to attend!
17-21 April 2026 (Munich, Germany): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. You can go here to register and view the preliminary program; the abstract submission window for 2026 will run 15 October to 26 Nov 2025. For those who would like a substantial opportunity to present a product to a large audience (see also adjacent note about IDWeek), I know that the meeting schedule will again include Pipeline Monday.
22-24 Sep 2026 (Lisbon, Portugal): The 2nd GAMRIC, the Global AMR Innovators Conference (London, UK). Formerly the ESCMID-ASM Joint Conference on Drug Development for AMR, 2026 will be the 11th year for this series that is now under the joint sponsorship of CARB-X, ESCMID, BEAM Alliance, GARDP, LifeArc, Boston University, and AMR.Solutions.
- The ongoing series employs the successful format of prior meetings with a single-track meeting and substantial networking time. The 2025 meeting was a sell-out success! A written summary of the meeting is here and the video from the sessions is now available here.
- [Don’t miss this: 16 Dec 2025 update webinar] The GAMRIC program committee is hosting an update webinar on 16 Dec 2025 (8-9a ET, 2-3 CET) that will include a review of the 2025 content and brainstorming on content for 2026. Go here to register! Don’t miss it!
21-24 Oct 2026 (Washington, DC, USA): IDWeek 2026, the annual meeting of the Infectious Diseases Society of America. Details are not yet available but I would expect the program to continue to provide a substantial opportunity to present a product to a large audience (see also adjacent note about ESCMID) as well as opportunities to present at an IDWeek Pipeline Session.

Upcoming meetings of interest to the AMR community:

15 Dec 2025 (virtual, 13.00-14.30 CET): WHO sponsored webinar entitled “AMU Surveillance Data for Action” and will focus on using AMU surveillance data to inform policy making, stewardship, and access strategies. Go here to register. This webinar is part of a WHO series support implementation of national action plans — go here to see past webinars.
21 Jan to 15 April 2026 (every Wednesday, 11a-12.30p MST / 1p-2.30p EST / 6-7.30p GMT / 7-8.30p CET): CAN-AMR-Net (Canadian Antimicrobial Resistance Network) is running a 12-lecture in-depth training course entitled “Antibiotic Drug Discovery: From AI-Enabled Discovery to Successful Commercialization Comprehensive Training.”
- The course will span the entirety of antibiotic development from early discovery to clinical, regulatory, and marketing stages. Go here for more details on the planned lectures and to register.
- To best enable interaction, seating is limited – please register promptly if you are interested. The course fee ranges from $100 to $500 CAD based on geography and background.
- CAN-AMR-Net is a Health Research Training Platform (HRTP) funded by the Canadian Institutes of Health Research (CIHR) from 2024 to 2030 and this course is part of their goal to train the next generation of researchers, practitioners, and leaders in the application of transdisciplinary methodologies and communication skills across One Health sectors to tackle the problem of AMR. For questions or suggestions on the course contents, contact Sameeh Salama at: ssalama@fedorapharma.com
28-30 Jan 2026 (Las Vegas, NV, USA): IDSA and ASM have announced a new US-based meeting series entitled IMARI (Interdisciplinary Meeting on Antimicrobial Resistance and Innovation) that is described as a “forum for collaboration and exploration around the latest advances in antimicrobial drug discovery and development.” Go here for to register.
4-5 Feb 2026 (virtual, 8a-noon GMT on both days): Antimicrobial Chemotherapy Conference 2026, sponsored by BSAC and GARDP. Registration here: acc-conference.com. Abstracts are welcomed and can be submitted here; abstract deadline is Friday, 14 November 2025, 17:00 GMT.
5 Feb 2026 (in person, Alderley Park, UK): BioInfect, the annual AMR-focused networking conference delivered by BioNow. Go here for details and to register.
5-6 Feb 2026 (virtual or in person [FDA White Oak campus, 1.30-5p ET on 5 Feb; 8.30-4p ET on 6 Feb): FDA hosted public workshop #10 in their series entitled Advancing the Development of Pediatric Therapeutics (ADEPT). The goal is to discuss challenges seen in neonatal and rare disease product development and to identify ways to leverage rare disease product development tools and regulatory frameworks. Go here for more details and here to register. The challenges of pediatric development run deep … and we need to find ways to protect children by including them in research rather than excluding them. On this theme, you might enjoy reviewing the related 7 Apr 2021 newsletter (“Developing antibiotics for children: There are no easy answers”) and the 27 May 2022 newsletter (“Antibacterial guidance (including pediatrics): Parallel EMA+FDA updates”).
18-20 Feb 2026 (Sydney, Australia, in person): The “AMR 2026 Summit”, hosted by the Fleming Initiative and Australia’s Science Agency, CSIRO. This event (website) will spotlight evidence-informed One Health approaches, practical solutions to implementation barriers, and strategies for public engagement, education, and advocacy. Space is limited, so (and sort of like applying to attend a Gordon Conference), please register your interest to attend here.
3-4 Mar 2026 (Basel, Switzerland): The 10th AMR Conference sponsored by the BEAM Alliance. See list of Top Recurring meetings, above.
8-13 Mar 2026 (Renaissance Tuscany Il Ciocco, Italy): 2026 Gordon Research Conference (GRC) entitled “Antibacterials of Tomorrow to Combat the Global Threat of Antimicrobial Resistance.” A Gordon Research Seminar (GRS) will be held the weekend before (7-8 Mar) for young doctoral and post-doctoral researchers. Space for the GRS and the GRC is limited; for details and to apply, go here for the GRC and here for the GRS.
17-21 April 2026 (Munich, Germany): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
4-8 June 2026 (Washington, DC): ASM Microbe, the annual meeting of the American Society for Microbiology. The meeting format is evolving and next year will combine 3 meetings (ASM Health, ASM Applied and Environmental Microbiology, and ASM Mechanism Discovery) into one event. Go here for details.
22-24 Sep 2026 GAMRIC (Lisbon, Portugal), the Global AMR Innovators Conference (London, UK; formerly the ESCMID-ASM Joint Conference on Drug Development for AMR). See list of Top Recurring meetings, above..
10-18 Oct 2026 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance) … and 2026 will be the 10th year for this program. Patrice Courvalin orchestrates content 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! Registration for 2026 will not open for some time; go here for more details and put a reminder in your calendar to check back in the Spring if you are interested.
21-24 Oct 2026 (Washington, DC, USA): IDWeek 2026. See list of Top Recurring meetings, above.

Self-paced courses, online training materials, and other reference materials:

OpenWHO: “Antimicrobial Resistance in the environment: key concepts and interventions.” Per the webpage for the course, it will teach you “…why addressing AMR in the environment is essential and gain insights into how action can be taken to prevent and control AMR in the environment at the national level.” This course builds on WHO’s 2024 Guidance on wastewater and solid waste management for manufacturing of antibiotics. For further reading, see also the 25 Sep 2023 newsletter entitled “Manufacturing underpins both access and stewardship: Cefiderocol as a case study” and the 28 Jan 2024 newsletter entitled “EMA Concept Paper: Guidance on manufacturing of phage products”.
GARDP’s REVIVE website provides an encyclopedia covering a range of R&D terms, recordings of prior GARDP webinars, a variety of viewpoint articles, and more! Check it out!
GARDP’s https://antibioticdb.com/ is an open-access database of antibacterial agents.
The CARB-X website provides a range of recordings from its webinars, bootcamps, and more. A bit of browsing would be time well spent!
British Society for Antimicrobial Chemotherapy offers an eLearning section: Education – The British Society for Antimicrobial Chemotherapy.

Current funding opportunities

[CALL IS NOW OPEN] CARB-X has now opened its 2nd call for 2025. The call is focused on (i) Small molecules for Gram-negatives (the focus is on Pseudomonas aeruginosa) and (ii) Diagnostics for typhoid (the focus is diagnosis of acute infections in 60 minutes or less). See this 26 Feb 2025 newsletter for a discussion of the call and go here for the CARB-X webpage on the call. This 2nd round is open 1-12 Dec 2025. Informational webinars are being held on Thu 4 Dec at 19:00 ET and Fri 5 Dec at 9:00 ET.
EU OHAMR (One Health AMR) has opened its first call with a request for consortia to propose projects on (i) combination therapies, (ii) ways to improve adherence to protocols, and (iii) ways to assess/inform regarding the impact of antimicrobials used in veterinary medicine and food agriculture. The window for pre-proposals runs 18 Nov 2025 to 2 Feb 2026. See also the 22 Oct 2025 newsletter about the call.
ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews.
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.
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 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
- 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.
- Antimicrobial Resistance Research and Innovation in Australia is an actively updated summary that covers Australia’s AMR research and patent landscape. It is provided via collaboration between The Lens (an ambitious project seeking to discover, analyse, and map global innovation knowledge) and CSIRO (Commonwealth Scientific and Industrial Research Organisation, an Australian Government agency responsible for scientific research). Lots to explore here!
- 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).

Technical Briefing on Pull Incentives for the European Parliament (26 Sep 2025)

John Rex — Tue, 21 Oct 2025 21:42:10 +0000

Dear All (and with thanks to Frédéric Peyrane for leading on this newsletter):

You will know that we eagerly watching the work in the EU on implementing a set of pull incentives based on use of ‘transferable data exclusivity voucher’ (TEV), also referred to as a ‘transferable exclusivity extension voucher’ (TEEV). In brief, the concept is that a TEEV would be granted upon approval of a new, important antibiotic. The TEEV could generate income to compensate the developer of the antibiotic by being applied to extend the period of marketing protection of another drug (it could also be sold).

For a more detailed update on the state of legislative play, see the 20 Jun 2025 newsletter (“Pull incentives in Europe: Next legislative steps”) in which Deepali Patel and I have a Q&A on the current state of play.
For a wonkish dive into the economic logic behind a TEV/TEEV, see the 2 Oct 2022 newsletter (“How hard (and how) to Pull? Net value of Pull via a TEEV”) which reviews at length a report on the economics of this approach using the lens of the STEDI values of new antibiotics.

Excitingly, the BEAM Alliance, AMR Action Fund, and Novo Nordisk Foundation convened a technical briefing on pull incentives and the TEV/TEEV concept at the European Parliament on 26 Sep 2025. The briefing consisted of 5 segments, each 30-40 minutes in length; a copy of the agenda is here. The videos from the five sessions are now posted:

Defining “Priority Antimicrobials”: The Missing Link for Effective PULL Incentives (Video)
1. Speakers: Marco Cavalieri (EMA) and Sophie (Cooper (UK NICE)
The Future of the TEE Voucher in EU Pharma Package (Video)
1. Speakers: Pierre Dubois (Toulouse School of Economics), Tim Wilsdon (Charles River Associates), and Henry Skinner (AMR Action Fund)
The Milestone Prize: A Smart Way to Boost AMR Innovation—or a Gamble? (Video)
1. Speakers: Enrico Baraldi (Uppsala University) and Marc Gitzinger (BEAM Alliance, BioVersys)
Can a Subscription Model Fix Europe’s Antimicrobial Crisis? (Video)
1. Christine Ardal (NIPH, EU-JAMRAI 2), Jean-Baptiste Perrin (EC DG HERA), and David Glover (NHS England)
Could Transferable Priority Review Vouchers (TPRV) Work in Europe? (Video)
1. David Ridley (Duke University) and Stefan Schulz (MSD)

Expanded notes on each session are found below our signatures, but the (lightly paraphrased) titles of the sessions are a clear guide to their content and you will also note the leading roles of the speakers.

Well done to the organizers of the event … seeing this conversation more forward is very exciting!

All best wishes, Frédéric and John

Frédéric Peyrane | General Secretary | BEAM Alliance. frederic.peyrane@beam-alliance.eu. All opinions are my own.

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.

=== Extended details on the content of the videos ===

1. Defining “Priority Antimicrobials”: The Missing Link for Effective PULL Incentives (Video)

The success of PULL incentives—designed to drive new antimicrobial development—depends on one critical, often overlooked step: clearly defining eligibility for “priority antimicrobials.” Yet, the conversation around what qualifies as meaningful innovation remains surprisingly limited. Below are the key takeaways from a discussion with Marco Cavalieri (EMA) and Sophie (Cooper (UK NICE):

Expert-Led Criteria: The EMA is ready to help, as criteria must go beyond the WHO Priority Pathogens List. Factors like safety, ease of use, and clinical impact are essential.
Lessons from the UK: The UK’s subscription model uses a scoring system that balances unmet needs, drug profile, and health system impact. A comprehensive list of criteria is required for the score to better reflect the drug’s full value.
Pan-EU Potential: A unified EU framework is possible, and it must provide early clarity to attract investment.

Summary: Even a multi-billion-dollar incentive will fail if it rewards the wrong products or is inaccessible. Getting eligibility right requires collaboration among clinicians, researchers, and policymakers—with the EMA playing a central role.

—
2. The Future of the TEE Voucher in EU Pharma Package (Video)

As trilogue negotiations on the EU’s General Pharmaceutical Legislation (GPL) progress, the Transferable Exclusivity Extension Voucher (TEEV) remains a focal point—but its effectiveness hangs in the balance. Below are the key points shared by Pierre Dubois (Toulouse School of Economics), Tim Wilsdon (Charles River Associates), and Henry Skinner (AMR Action Fund):

Predictable & Cost-Effective: Unlike cash prizes, TEEV avoids free riding and delivers value, especially in imperfect generic markets.
Investor-Friendly: Aligns with typical 5–10 year investment cycles, offering a clear path to returns.
Broad Support: Backed by SMEs, industry, and investors for its ability to spur innovation, particularly in antimicrobials and oncology.
Challenges Ahead: New constraints—like the “blockbuster” clause (€490M turnover cap) and “EU-first” registration rule—risk diluting its impact. These add complexity without addressing core needs, and may even penalize valid projects facing development hurdles.

Summary: TEEV isn’t perfect, but its predictability makes it a powerful tool for driving R&D. To keep it effective, policymakers should minimize constraints and pair it with complementary incentives to meet the EU’s fair share goals.

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3. The Milestone Prize: A Smart Way to Boost AMR Innovation—or a Gamble? (Video)

Most AMR breakthroughs today come from SMEs, but bringing new antibiotics to market is risky and expensive. Enter the milestone prize. a financial reward for hitting key R&D milestones such as completing Phase 1 trials. The prize is designed to encourage early progress early but it does not ensure funding will be adequate for later phases. The strengths and risks of prizes were discussed by Enrico Baraldi (Uppsala University) and Marc Gitzinger (BEAM Alliance, BioVersys):

Products may never reach the market: Setting up target product profiles and a pipeline coordinator could help anticipate which products have the best chance (provided the latter can thoroughly monitor any drug development in the world).
To be part of EU fair share, the milestone prize must be accessible to any developer: which source of EU funding could be used?
It is tempting to require the developer to use the prize for further development: but then, that’s PUSH funding and the impact on the size of the PULL at market entry is limited.

Summary: We need more evidence before writing this into EU law. The idea is compelling, but the details are tricky.

—
4. Can a Subscription Model Fix Europe’s Antimicrobial Crisis? (Video)

The subscription (or revenue guarantee) model is the most talked-about “pull” incentive for antimicrobial innovation. But scaling it up in the EU is a major challenge as health policy remains a national competence and the bloc lacks the authority to enforce a unified approach. Critical insights were shared by Christine Ardal (NIPH, EU-JAMRAI 2), Jean-Baptiste Perrin (EC DG HERA), and David Glover (NHS England), including:

Impactful incentive mechanisms are needed to attract investment in truly impactful antimicrobials.
DG HERA’s incentive pilot aimed to procure new antibiotics with 24-hour antimicrobial availability across EU member states, but hit roadblocks that led to closure of the tender with no awardee. Although the process received generally favorable feedback, concerns that frustrated the process arose from procedural complexity, budget, and confidentiality. Possible solutions include simplified methods for hospital-level access and budgeting to fully cover the cost of launching in all EU member states.
The UK’s success started with political agreement, then a Memorandum of Understanding. England leads evaluations, and other UK nations opt in based on the results.

Summary: An EU-funded revenue guarantee could work if incentives are strong enough to justify the registration effort in Europe’s fragmented market. It could also complement the Transferable Exclusivity Extension (TEE) voucher, ensuring fairer benefits.

—
5. Could Transferable Priority Review Vouchers (TPRV) Work in Europe? (Video)

The US introduced TPRV in 2007 to spur innovation in neglected and rare paediatric diseases. To date, over 80 vouchers have been issued and prices around $100M. TPRV have been considered as a pull incentive to reward new antimicrobials in the revision of the EU pharmaceutical package. David Ridley (Duke University) and Stefan Schulz (MSD) discussed the question of the applicability of the TPRV to antibiotics:

TPRVs could be implemented at EU level—just like TEEVs.
The EU is not the US: Regulatory hurdles, national HTAs, and existing schemes like PRIME may limit their impact.

Summary: While TPRVs have driven progress in the US, their success in Europe is not guaranteed. Overall, TEEVs would offer less uncertainty and a more predictable value.

19-22 Oct 2025 (Georgia, USA): IDWeek 2025, the annual meeting of the Infectious Diseases Society of America. Go here to register. For those who would like a substantial opportunity to present a product to a large audience (see also adjacent note about ESCMID), note the call for applications to present at an IDWeek Pipeline Session; go here to submit an application for your compound or diagnostic.
3-4 Mar 2026 (Basel, Switzerland): The 10th AMR Conference. Sponsored by the BEAM Alliance, the 9th AMR Conference has just concluded and it’s again been an excellent meeting! Please mark your calendar for next year. You can’t register yet, but details will appear here!
17-21 April 2026 (Munich, Germany): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. You can’t register yet, but you can go here for details on the outstanding 2025 meeting. The abstract submission window for 2026 will run 15 October to 26 Nov 2025. For those who would like a substantial opportunity to present a product to a large audience (see also adjacent note about IDWeek), I know that the meeting schedule will again include Pipeline Monday; go here to see details from 2025.
22-24 Sep 2026 (Lisbon, Portugal): The 2nd GAMRIC, the Global AMR Innovators Conference (London, UK). Formerly the ESCMID-ASM Joint Conference on Drug Development for AMR, 2026 will be the 11th year for this series under the joint sponsorship of CARB-X, ESCMID, BEAM Alliance, GARDP, LifeArc, Boston University, and AMR.Solutions. The ongoing series employs the successful format of prior meetings with a single-track meeting and substantial networking time. The 2025 meeting was a sell-out success — be sure to mark your calendar for 2026!

Upcoming meetings of interest to the AMR community:

23 Oct 2025 (8.30a-3.30p ET, In person at the Loeb House, Harvard campus, Boston or virtual): Annual meeting for the Vivli AMR challenge. Vivli 2025 challenge award winners will be featured at 11am ET. Go here to register.
[NEW] 30-31 Oct 2025 (in person, Addis Ababa, Ethiopia): Africa CDC (Africa Centres for Disease Control and Prevention) is convening a 2-day meeting on access to antimicrobials, diagnostics and vaccines as countermeasures to AMR. Go here for a concept note regarding the meeting and go here to register.
4 Nov 2025 (London, in person): ADVANCE-ID are holding a workshop entitled “Framing JUST solutions for access to treatment against AMR.” Space is limited; go here for details and to register.
9-13 Nov 2025 (Portland, OR, USA): ASM Conference on Biofilms. Go here for details and to register.
[NEW media toolkits] 18-24 Nov 2025 (global, multiple locations): World Antibiotic Awareness Week (WAAW) is convened annually on 18-24 Nov by WHO with national events (e.g., CDC’s US Antibiotic Awareness Week (USAAW); ECDC’s 18 Nov European Antibiotic Awareness Day) occurring around the globe. Details will follow as events become visible. Media toolkits are being released
- The Health Diplomacy Alliance offers a media toolkit with the theme “7 Days, 7 Actions, 7 Stakeholders.”
- CDC offers a Be Antibiotics Aware Toolkit
- ECDC offers a range of tools: key messages, infographics. and factsheets.
20 Nov 2025 (Washington, DC, 9a-5p ET): BARDA Innovation Symposium. BARDA will be showcasing early-stage health security innovations supported by BARDA, including through DRIVe, BARDA Accelerator Network, BARDA Ventures, Blue Knight, and CARB-X. The symposium (see also the 20 Sep 2025 newsletter: “20 Nov 2025: BARDA Innovation Symposium”) convenes “a diverse network of early stage companies, government agencies, non dilutive funders, investors, and strategic partners all interested in developing the next generation of medical countermeasures (MCMs).” BARDA has consistently been a very creative funder seeking very diverse types of products … could this be you? Go here for details and to register.
19-22 Oct 2025 (Georgia, USA): IDWeek 2025. See list of Top Recurring meetings, above.
29-31 Oct 2025 (Bengalaru, India): ASM Global Research Symposium on the One Health Approach to Antimicrobial Resistance (AMR), hosted in partnership with the Centre for Infectious Disease Research (CIDR) at the Indian Institute of Science (IISc). Go here for details and to register.
28-30 Jan 2026 (Las Vegas, NV, USA): IDSA and ASM have announced a new US-based meeting series entitled IAMRI (Interdisciplinary Meeting on Antimicrobial Resistance and Innovation) and described as a “forum for collaboration and exploration around the latest advances in antimicrobial drug discovery and development.” Go here for more details, to register, and to submit an abstract (deadline for abstracts is 1 Oct 2025).
4-5 Feb 2026 (virtual, 8a-noon GMT on both days): Antimicrobial Chemotherapy Conference 2026, sponsored by BSAC and GARDP. Registration here: acc-conference.com. Abstracts are welcomed and can be submitted here; abstract deadline is Friday, 14 November 2025, 17:00 GMT.
18-20 Feb 2026 (Sydney, Australia, in person): The “AMR 2026 Summit”, hosted by the Fleming Initiative and Australia’s Science Agency, CSIRO. This event (website) will spotlight evidence-informed One Health approaches, practical solutions to implementation barriers, and strategies for public engagement, education, and advocacy. Space is limited, so (and sort of like applying to attend a Gordon Conference), please register your interest to attend here.
3-4 Mar 2026 (Basel, Switzerland): The 10th AMR Conference sponsored by the BEAM Alliance. See list of Top Recurring meetings, above.
8-13 Mar 2026 (Renaissance Tuscany Il Ciocco, Italy): 2026 Gordon Research Conference (GRC) entitled “Antibacterials of Tomorrow to Combat the Global Threat of Antimicrobial Resistance.” A Gordon Research Seminar (GRS) will be held the weekend before (7-8 Mar) for young doctoral and post-doctoral researchers. Space for the GRS and the GRC is limited; for details and to apply, go here for the GRC and here for the GRS.
17-21 April 2026 (Munich, Germany): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
4-8 June 2026 (Washington, DC): ASM Microbe, the annual meeting of the American Society for Microbiology. The meeting format is evolving and next year will combine 3 meetings (ASM Health, ASM Applied and Environmental Microbiology, and ASM Mechanism Discovery) into one event. Go here for details.
22-24 Sep 2026 GAMRIC (Lisbon, Portugal), the Global AMR Innovators Conference (London, UK; formerly the ESCMID-ASM Joint Conference on Drug Development for AMR). See list of Top Recurring meetings, above..
[placeholder] ??-?? Oct 2026 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance) … and 2026 will be the 10th year for this program. Patrice Courvalin orchestrates content 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! Dates for next year will not be posted for some time, but go here for more details and put a reminder in your calendar to check back in the Spring if you are interested.

Self-paced courses, online training materials, and other reference materials:

OpenWHO: “Antimicrobial Resistance in the environment: key concepts and interventions.” Per the webpage for the course, it will teach you “…why addressing AMR in the environment is essential and gain insights into how action can be taken to prevent and control AMR in the environment at the national level.” This course builds on WHO’s 2024 Guidance on wastewater and solid waste management for manufacturing of antibiotics. For further reading, see also the 25 Sep 2023 newsletter entitled “Manufacturing underpins both access and stewardship: Cefiderocol as a case study” and the 28 Jan 2024 newsletter entitled “EMA Concept Paper: Guidance on manufacturing of phage products”.
GARDP’s REVIVE website provides an encyclopedia covering a range of R&D terms, recordings of prior GARDP webinars, a variety of viewpoint articles, and more! Check it out!
GARDP’s https://antibioticdb.com/ is an open-access database of antibacterial agents.
The CARB-X website provides a range of recordings from its webinars, bootcamps, and more. A bit of browsing would be time well spent!
British Society for Antimicrobial Chemotherapy offers an eLearning section: Education – The British Society for Antimicrobial Chemotherapy.

Current funding opportunities

ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews.
CARB-X will have two calls during 2025 that span two areas: (i) Small molecules for Gram-negatives (the focus is on Pseudomonas aeruginosa) and (ii) Diagnostics for typhoid (the focus is diagnosis of acute infections in 60 minutes or less). See this 26 Feb 2025 newsletter for a discussion of the call and go here for the CARB-X webpage on the call. The first cycle is now closed (it ran16-30 April 2025); the 2nd round will be open 1-12 Dec 2025.
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.
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 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
- 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.
- Antimicrobial Resistance Research and Innovation in Australia is an actively updated summary that covers Australia’s AMR research and patent landscape. It is provided via collaboration between The Lens (an ambitious project seeking to discover, analyse, and map global innovation knowledge) and CSIRO (Commonwealth Scientific and Industrial Research Organisation, an Australian Government agency responsible for scientific research). Lots to explore here!
- 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).