CARB-X – AMR.Solutions https://webdisk.amr.solutions Antimicrobial Resistance Solutions with Dr. John H. Rex Thu, 28 May 2026 00:38:07 +0000 en-US hourly 1 https://webdisk.amr.solutions/wp-content/uploads/2022/04/Fire-Extinguisher-icon-70x70.png CARB-X – AMR.Solutions https://webdisk.amr.solutions 32 32 CARB-X seeks two Assistant Directors of External Affairs https://webdisk.amr.solutions/2026/05/18/carb-x-seeks-two-assistant-directors-of-external-affairs/ Mon, 18 May 2026 11:11:46 +0000 https://amr.solutions/?p=25484

Dear All:

Starting to get caught up after some time on vacation! For today, we have announcement by CARB-X of the posting of two openings for the role of Assistant Directors of External Affairs. Here are the links:


A few excerpts from the job description:

  • “The Assistant Director of External Affairs will play a pivotal role in strengthening CARB-X’s financial sustainability and elevating its partnerships and impact across the global antimicrobial innovation ecosystem.”
  • “Reporting to the Director of External Affairs (Will Hall), these positions offer the opportunity to help shape and execute CARB-X’s engagement strategy with funders, policy-makers and innovation partners worldwide.”
  • Required skill set: “8+ years of experience demonstrating strong fundraising capability and relationship cultivation.”
  • Location: The position “can be entirely virtual but must be able to work (at least partially) in ET and CET time zones.”
  • The deadline to apply for these positions is Wednesday, 3 June 2026.

These are great opportunities for the right folks! Could you be one of the two people appointed to these exciting roles? 

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers, 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!

  • 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 2025 meeting is here and the videos from the sessions are now available here. Registration for the 2026 meeting is now open and you can view the preliminary program here. Abstract submissions are open through Fri 10 Apr at noon CET; note as well that travel grants are available for attendees with accepted abstracts. A late-breaker window be announced for July.
  • 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. Mark your calendars for next year’s 11th AMR Conference!
  • 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:

  • 28 Apr 2026 (9:30-11:00 CET, virtual): REVIVE (GARDP)-sponsored webinar: “Natural product-inspired antibiotics: Successes and future prospects.” Go here for details and to register.
  • [NEW] 21 May 2026 (11a-noon EDT): AMR Exchange webinar entitled “CDC’s Antimicrobial Resistance Solutions Initiative: A Decade of Action Against Drug-Resistant Infections.” that will review the work done over the first 10 years of CDC’s Antimicrobial Resistance Initiative. Go here to register.
  • 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:

Current funding opportunities

  • 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).
]]> Stewardship & Access Guide from CARB-X, Wellcome, and partners: Analysis, video chat https://webdisk.amr.solutions/2021/03/22/stewardship-access-guide-from-carb-x-wellcome-and-partners-analysis-video-chat/ Mon, 22 Mar 2021 14:00:55 +0000 https://13.43.35.2/?p=4719

Dear All,

Novel antibacterial agents, vaccines, and diagnostics will do little if they are not widely available and used responsibly. CDDEP’s recent report entitled “The State of the World’s Antibiotics in 2021” makes this very clear: “… more people in LMICs (low-middle-income countries) die from lack of access to antimicrobials than from resistant infection.”

Hence, CARB-X has required from the very start that all grant recipients commit to creating a Stewardship & Access Plan (SAP) within 90 days of their product entering pivotal (Phase III or the equivalent for diagnostics) clinical development. 

Although this is easy to articulate at a high level (“Please have a plan!”), the best approach to balancing access, stewardship, and innovation has long been a source of debate within the community.

As the SAP would be shared publicly once the product has obtained regulatory approval and would need to cover both Stewardship (appropriate use) and Access (Accessibility, Availability, Affordability, and Acceptability), it’s obviously an ambitious document. But, providing stewardship and access is also not something that the developer can do alone — others also have a role to play.

To support CARB-X grantees as they seek to address this task, a SAP Development Guide has been published today (press release) that provides guidance on meeting the SAP requirement. It is an impressive and thoughtful document that has been created by Wellcome Trust in collaboration with CARB-X, its funding partners, and other interested parties: US Dept of Health and Human Services Office of Global Affairs (DHHS OGA), BARDA, the Global AMR Innovation Fund (GAMRIF), UK Department of Health and Social Care (DHSC), the Bill & Melinda Gates Foundation (BMGF), Wellcome Trust, GARDP, and the Access to Medicine Foundation (ATMF).

The Guide suggests a structure for a SAP and supports this with a detailed list of points to consider (Annex B), a starter list for possible strategies (Annex C) and links to organizations that can provide support and partnering opportunities (Annex D). It is obvious that a lot of thought has gone into this! In particular, the list of plausible strategies in Annex C make this document a strong starting point on what can reasonably be expected of product developers, whether part of the CARB-X system or not.

Tim Jinks, Head of the Drug-resistant Infections Programme at Wellcome Trust said, “The SAP Development Guide represents a new benchmark for what can be expected from companies preparing to market innovative antibiotics, as they should proactively develop robust plans enabling worldwide stewardship and equitable access alongside market entry plans. We hope that these insights inform the wider pharmaceutical, scientific and global health community, as well as CARB-X awardees.”

Impressive! But it is critical to note that responsibility for implementing a SAP does not lie solely with product developers. This point is not explicitly covered in the SAP guide, but many of the actions required can only be suggested by the product sponsor and greater action is also needed from governments, donors and civil society, working with industry, to develop innovative solutions that both accelerate equitable access to new products and slow the spread of bacterial drug resistance.

In particular, delinked Pull incentives are needed both to attract R&D investment and to support the pipeline and the newly approved antibiotics to which the SAP will be applied. On this theme, Thomas Cueni, Director General and key architect of the recently announced AMR Action Fund (see this newsletter for more) said, “With the recent commitment by Industry of ~$1b for the AMR Action Fund that will support Phase 2-3 development and bring 2-4 important new antibiotics to approval by 2030, the pharmaceutical industry is definitely stepping up to meet the challenge of AMR! But, the recent market failures of newly launched antibiotics show clearly that governments need to take action now to implement the delinked incentive models that will sustain these new agents after they are approved.” 

While reviewing SAP Development Guide, you should also review the recent report from ATM entitled 2021 Access to Medicine Index. ATMF contributed to the SAP Development Guide and it is exciting to see the momentum that is building. Here is a summary provided by ATMF:

  • “The most notable progress is in planning ahead during R&D to make future products accessible: eight companies are developing approaches for systematically ensuring all R&D projects are paired with plans to increase access in poorer countries soon after launch (these have yet to be applied across late-stage projects).
  • “The industry has stepped up efforts to understand the outcomes of their access-related activities, and more companies are evaluating initiatives to build local capacity and strengthen health systems than in 2018.
  • “All 20 companies have now set specific goals and targets for improving access, and more companies are deploying business models that explicitly include people at the base of the income pyramid.
  • “There is also movement in responsible promotional practices, with three additional companies adopting rewards schemes that decouple sales agents’ incentives from sales targets only (now 12 companies).”

Hooray for CARB-X, Wellcome Trust, and their partners! The SAP requirement is a reminder that none of us are safe from AMR until we are all safe! As stated by the IACG AMR (Interagency Coordination Group on Antimicrobial Resistance) in their 2019 report to the UN Secretary-General, “Antimicrobial resistance is a global crisis that threatens a century of progress in health and achievement of the Sustainable Development Goals.”


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 (most current list is here):

  • [IMPORTANT UPDATE] Novo REPAIR Impact Fund will open its next global call on 1 April 2021. Go here for current details.
  • [NEW] NIAID’s 2021 Broad Agency Announcement for product development is entitled “Development of Medical Countermeasures for Biothreat Agents, Antimicrobial-Resistant Infections an Emerging Infectious Diseases” and is now live with a 24 May 2021 deadline. Research areas include Vaccines, Therapeutics, and Sequencing-Based Diagnostics.
  • 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):

  • 24 Mar 2021 (online, 2.30-4p CET): GARDP-sponsored webinar entitled “Discovering and developing new treatments for tuberculosis,” moderated by Lydia Nakiyingi. Go here to register.
  • [NEW] 25 Mar 2021 (online, 8.30-9.30a EST, 2.30-3.30p CET, 7-8p IST): CDDEP- and WHO-sponsored webinar entitled Vaccines and AMR. The impressive speaker lineup includes Hanan Balkhy (Assistant Director General for AMR at WHO). Go here to register.
  • 20-22 April 2021 (online, 1-5p CET): JPIAMR-sponsored workshop entitled “Feeding the Antimicrobial Therapeutics Pipeline.” JPIAMR, the collaborative global effort of 28 countries (much of the EU and also Argentina, Canada, Egypt, Israel, Japan, Korea, South Africa, and Turkey), is organizing a mixture of keynote talks, abstract presentations, and discussion panels designed to encourage collaborative antibiotic R&D. Go here for more details and registration. Abstract deadline is March 17th 2021; no previous JPIAMR funding required.
  • 9-12 Jul 2021 (virtual): Annual ECCMID meeting (#31)
  • 10-12 May 2021 (virtual): UK-focused Virtual AMR Innovation Mission sponsored by Innovate UK in collaboration with AMR Insights and Oxford innovation. This free 3-day virtual event seeks to connect AMR-focused start-ups, SMEs and Multinationals, Academia, Research Institutes, Regional Development Companies and other interested stakeholders in the UK, Europe and other parts of the world. It will be followed (COVID-willing!) by a face-to-face mission scheduled for 11-15 Oct 2021. Go here for more details.
  • 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 24-29 May 2021 (online and in Geneva): ESPID 2021, the 39th Annual Meeting of the European Society for Paediatric Infectious Diseases. Save-the-date announcement is here, details to follow. 
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • 20-24 Jun 2021 (virtual, various times): World Microbe Forum sponsored by the American Society for Microbiology (ASM) and the Federation of European Microbiological Societies (FEMS). Go here for more details and to register.
  • 27 Jun-2 Jul 2021 (Ventura, CA): Gordon Research Conference entitled “Antimicrobial Peptides”. Go here for details, go here for the linked 26-27 Jun Gordon Research Seminar that precedes it.
  • 14-29 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
  • 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
  • 11-15 Oct 2021 (physical, somewhere in the UK): UK-focused Innovation Mission sponsored by Innovate UK in collaboration with AMR Insights and Oxford innovation. This free event seeks to connect AMR-focused start-ups, SMEs and Multinationals, Academia, Research Institutes, Regional Development Companies and other interested stakeholders in the UK, Europe and other parts of the world. Go here for more details.
  • 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students. Bonus feature: For obvious reasons, the course didn’t happen in 2020! But as a celebration of the course’s 5th year, a webinar version was held on 29 Oct 2020: go here to stream it. 
  • 25-28 Oct 2021 (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.
  • 6-11 Mar 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.
]]> CARB-X announces its 2025 funding round https://webdisk.amr.solutions/2025/02/26/carb-x-announces-its-2025-funding-round/ Wed, 26 Feb 2025 12:51:21 +0000 https://amr.solutions/?p=17799

Dear All,

At BEAM’s AMR Conference in Basel, Team CARB-X have today announced their 2025 funding round. Key points:

And, don’t forget about HERA’s call for rapid diagnostics with the application portal opening around that same time.

Lots to do! Good luck! 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

  • The first RFP for Gr-ADI, the Gram-Negative Antibiotic Discovery Innovator, announced on 11 Feb 2025 by the Novo Nordisk Foundation (NNF), Wellcome, and the Gates Foundation (GF) is open until 25 Mar 2025. This initial RFP seeks proposals to (i) genome-scale tools that find new chemical start points, (ii) find technologies that would select/targets leads with propensity for resistance, (iii) better understand how/why compounds penetrate the bacterial cell, and (iv) develop approaches to finding new chemical leads vs. validated targets for which there is no current Phase 3 development program. It’s clear that additional RFPs will follow … it’s quite a project! See the 11 Feb 2025 newsletter for details.
  • [NEW] The Trinity Challenge on Community Access to Effective Antibiotics is a £1 million innovation competition that seeks applications to answer the question: “How can data and technology improve stock control and/or reduce the use of substandard and falsified oral antibiotics for community use in low- and middle-income countries?” Applications are open at this website until 24 April 2025.
  • EMA have posted a call for tenders under which they will provide up to 16m EUR for project that would “perform studies on the quality, safety and efficacy of human and veterinary medicines that would provide complementary evidence to support regulatory decision-making.” The deadline to apply is 30 April 2025. See this 17 Feb 2025 newsletter for details.
  • HERA plans to post a call on 4 April 2025 in which they will call for tenders under which they will provide up to 13m EUR for development of a point-of-care diagnostic medical device that can provide antimicrobial susceptibility results on the bacteria or fungi causing an infection in humans, within one hour or less from subject sample collection, and ideally, to also allow for pathogen identification. See the 19 Feb 2025 newsletter 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
    • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
    • Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-X, C-CAMP, and FIND, it pulls together real-life insights into a succinct set of tutorials.
  • In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).

John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 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. 
  • [UPDATED] 30 Sep-2 Oct 2025 GAMRIC, the Global AMR Innovators Conference (Washington, DC). Formerly the ESCMID-ASM Joint Conference on Drug Development for AMR, this meeting series is being continued under the joint sponsorship of CARB-X, ESCMID, BEAM, GARDP, LifeArc, WHO, and AMR.Solutions. You can’t yet register for this meeting but please mark your calendar now. The ongoing series is expected to continue that successful format of prior meetings with a (mostly) single-track meeting and you can also go here to see details of the outstanding 2024 meeting.
  • 19-22 Oct 2025 (Georgia, USA): IDWeek 2025, the annual meeting of the Infectious Diseases Society of America. Details pending; go here for the general meeting website.
  • [UPDATED] 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! 

  Upcoming meetings of interest to the AMR community:

  • [NEW] 27 Feb 2025 (virtual, 6-7am PDT): Webinar with Q&A about the initial RFP from Gr-ADI, the Gram-Negative Antibiotic Discovery Innovator sponsored by Novo Nordisk Foundation, Wellcome, and the Gates Foundation. See this 11 Feb 2025 newsletter, the Gr-ADI home webpage, and this webinar registration page. If you miss it, I understand that a post-webinar video will be available for replay.
  • 27 Feb 2025 (virtual, 1700-1830 CET / 1100-1230 EST): GARDP REVIVE webinar entitled “In vitro and in vivo correlations for prediction of human pharmacokinetics and dose of antimicrobials.” Go here to register.
  • 3 Mar 2025 (Virtual, 12-1p CET / 6-7a ET): WHO-GARDP webinar entitled “Policy and regulatory interventions to address antibiotic shortages in low and middle-income countries.” Go here to register. This webinar will be the official launch of the WHO-GARDP report of the same name with a discussion of measures being undertaken to address antibiotic shortages. For background on this, see the 1 Dec 2024 newsletter for a discussion of the paper by Baraldi et al. on possible meanings of Lack of Access and as well the 13 Dec 2024 newsletter about WHO-GARDP report.
  • 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.
    • During ESCMID, mark your calendar for the Science Policy forum during which we’ll have follow-up from UNGA 2024  (11 April, 3-8p CEST) and Pipeline Monday (14 April) during which we’ll have a variety of sessions on the antimicrobial pipeline. See also the 13 Feb 2025 newsletter for details and commentary.
    • I’ve also learned of a 14 April (12.15-1.15p, Hall 8) symposium on mechanisms to expand access to antibiotics. To find this one, you have to go the general program and navigate to Hall 8 at 12.15p. Awkward, but a direct link is not possible due the design of the ESCMID webpage.
  • 30 June – 1 July (in person and virtual, Grand Hyatt, Washington DC): BARDA Industry Days 2025 (BID2025) with the theme “Enhancing Health Security With a Sustainable Future.” This is a major annual opportunity to interact with BARDA and ASPR teams and thereby identify potential areas of collaboration in the field of MCM (medical countermeasure) research and development. Go here for details.
  • 19-22 Oct 2025 (Georgia, USA): IDWeek 2025, the annual meeting of the Infectious Diseases Society 
  • 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025. See list of Top Recurring meetings, above.
  • 30 June-1 July 2025 (virtual and in Washington, DC): BID2025: BARDA Industry Days — Enhancing Health Security With a Sustainable Future.  BID provides the opportunity to discuss U.S. government medical countermeasure (MCM) priorities, provide the private sector an informal opportunity to interact with BARDA and ASPR teams, and identify potential areas of collaboration in the field of MCM research and development. Go here for details.
  • 30 Sep-2 Oct 2025 GAMRIC, the Global AMR Innovators Conference (Washington, DC; formerly the ESCMID-ASM Joint Conference on Drug Development for AMR). See list of Top Recurring meetings, above..
  • 19-22 Oct 2025 (Georgia, USA): IDWeek 2025. See list of Top Recurring meetings, above.
  • 11-19 Oct 2025 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance) … and 2025 will be the 9th 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! Seating is limited, so mark your calendars now if you are interested. Applications should open ~March 2025 — go here for more details.
  • 3-4 Mar 2026 (Basel, Switzerland): The 10th AMR Conference sponsored by the BEAM Alliance. See list of Top Recurring meetings, above.

 Noteworthy self-paced courses and training materials (this is a new section — comments or builds would be appreciated!):

]]> Notable reports: Incentives (WHO, AMR Hub); Strategy (BARDA); Capacity Building (UK Fleming Fund, US CDC) https://webdisk.amr.solutions/2022/06/04/notable-reports-incentives-who-amr-hub-strategy-barda-capacity-building-fleming-fund/ Sat, 04 Jun 2022 20:41:35 +0000 https://13.43.35.2/?p=7738

Dear All, Four big reports have recently been released and are very much worth reviewing.

First, the Global AMR R&D Hub and the WHO AMR Team have written a report entitled “Incentivising the development of new antibacterial treatments“. This report is a response to a 2021 request by the G7 Finance Ministers for a report on the state of play for AMR. The 18-page report is an excellent read and covers:

  • The current antibacterial treatment and vaccine pipelines;
  • The financial landscape for developing new antimicrobials, and
  • Recommendations for future action.

In particular, the report’s discussion of the need for Pull Incentives is very detailed and useful. It includes a good review of the general problem that references the BCG’s recent “The Case for a Subscription Model to Tackle Antimicrobial Resistance” as well as the Milken Institute’s “Models for Financing Antibiotic Development to Address Antimicrobial Resistance“. The model-by-model commentary of various incentives on page 16 is especially noteworthy for its balanced critique of the various approaches currently being tested around the world.

Related to this report, you should review the call for Pull in the 2022 G7 Health Ministers communication. Also note that the G7 Finance Ministers 20 May 2022 statement reiterates their support for addressing AMR in paragraph 11: “We reaffirm our commitments of December 2021 on actions to support antibiotic development and support the ongoing work of the G7 Health, Agriculture and Climate Environment and Energy Tracks on antimicrobial resistance (AMR). We welcome the AMR progress report by the World Health Organisation and the Global AMR R&D Hub and request a further detailed update on the progress made for G7 Finance and Health Ministers in 2023.”

It is VERY encouraging to see this sustained interest by the G7 Health and Finance Ministers … this is what it will take to create those Pull incentives!


___

Secondly, BARDA have released their 2022-2026 Strategic Plan. There’s a lot to take in here, but I’ll excerpt from some of their objectives to give you a feel for the breadth and depth of their impressive AMR-related goals:

  • OBJECTIVE 1.2 Expand commitment to combat antimicrobial resistance through:
    • Establishment of the follow-on to the CARB-X program and continue support of the CARB Accelerator resulting in the transition of at least two antibacterial candidates from the Accelerator into the BARDA advanced research and development portfolio,
    • FDA approval of at least three novel antibacterials,
    • Procurement of approved novel antibacterials through Project BioShield, and
    • Development of at least one new diagnostic to inform appropriate antibiotic use.
  • OBJECTIVE 2.1: Revitalize the armamentarium of antibiotics that could be stockpiled to address antimicrobial resistant threats that could complicate any public health emergency.
  • OBJECTIVE 2.2: Work with antibiotic development and manufacturing companies to generate domestic production of critically needed antibacterial products and expand U.S.-based manufacturing capabilities.

Go Team BARDA! Yow!

—
Finally, we come to reports 3 and 4. Resolving the problem of AMR will require well-trained colleagues around the world … and those people have to be cultivated! To that end, the UK’s Fleming Fund was created in 2015 as a £265 million UK aid program focused on building knowledge, AMR surveillance, and workforce capacity for addressing AMR in Africa and Asia. The Fund recently released a major report on its progress to date. I can summarize it in one word: Impressive! Here are a few highlights:

  • Support for more than 240 laboratories across 22 countries
  • Funding for over 25,000 training attendances and and 170 Fleming Fellows
  • Growth from 6 to 14 in the number of countries providing data to GLASS, WHO’s Global Antimicrobial Resistance and Use Surveillance System

Also very active in the capacity-building game is the AMR group at US CDC. In a recent announcement, CDC reports having awarded more than $36 million for innovative research on AMR topics to diverse partners during Fiscal Year 2021 both within the United States and globally: 

Above: Global investment by US CDC in AMR during FY21


Fabulous! It’s hard work, but this kind of capacity- and knowledge-building creates a powerful momentum. I stand in awe!

With thanks to our colleagues around the world who made these amazing things happen, –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)

  • The AMR Industry Alliance has announced their 2022 Stewardship Prize! The program offers 10,000 CHF to recognize established, innovative approaches to AMR stewardship in low- and middle-income countries (LMICs). The 2021 prize went to the Infectious Diseases Institute (IDI) in Kampala, Uganda for their best practices in diagnostic stewardship and for their patient awareness campaigns dedicated to decreasing inappropriate use of antibiotics in their specialist HIV clinic in Kampala. Applications for the 2022 prize are due August 31, 2022. Thinking in terms of stewardship, WHO have recently released a pair of courses through the OpenWHO platform:
  • 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/).
  • New funding rounds from CARB-X are expected soon now that funding for the next 10 years has been announced! [NEW] There is a 9 June 2022 webinar (9-9.30a ET) that will “discuss the global health issues of AMR, and how CARB-X and its partners are working together to address them.” Go here to register.
  • 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):

  • [Not to be missed!] 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!
  • [Required reading!] 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! 
  • 7 Jun 2022 (virtual, 9-10.30a East Coast). CDC-sponsored webinar entitled “Antifungal Resistance: Understanding this Growing Global Threat.” Hosted by the team at CDC’s Mycotic Diseases Division, this looks to be an excellent conversation. Go here to register.
  • 8-9 Jun 2022 (virtual, 15.00-18.00 CEST / 9.00-12.00 EDT on both days): “Expert Workshop on Monoclonal Antibodies for AMR Pathogens” sponsored by the Paul-Ehrlich-Institut, on behalf of the COMBINE project. Day 1 focuses on preclinical development and translation (register here); Day 2 focuses on recurring problems and mitigation strategies in the clinical development (register here).
  • [NEW] 9 Jun 2022 (virtual, 9-9.30a ET). CARB-X-sponsored webinar at which CARB-X, BARDA, Wellcome and NIAID to discuss the global health issues of AMR, and how CARB-X and its partners are working together to address them.” Go here to register.
  • [NEW] 13 or 14 Jun 2022 (virtual,  14.00-17.00 (CEST) on 13 Jun, 09.00-12.00 (CEST) on 14 Jun, same agenda both days): “Supporting measures to mitigate AMR in One Health settings,” webinars sponsored by JPIAMR and ICARS that will consider at length the ‘Prevention and Intervention’ pillar of the JPIAMR’s Strategic Research and Innovation Agenda. Go here for details and to register.
  • 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.
  • 21 Jun 2022 (virtual, 10:00-11:00 ET | 15:00-16:00 BST): Launch of the AMR Register. Sponsored by Vivli with funding from many partners, this is the launch of an open-access repository for industry-generated surveillance data. Looks interesting! Go here to register.
  • 22-23 Jun 2022 (virtual, 10a to approx. 2.30p ET on both days): Workshop entitled “Strategies for Early-Stage Programs Developing Novel Antibacterial and Antifungal Drugs.” Sponsored by NIAID’s Bacteriology and Mycology Branch (BMB), this 2-day webinar features a very strong faculty (including speakers from FDA) discussing tips and insights for early product discovery including in-depth discussions of funding opportunities. The timing is US-centered but video replay will be available. Do not miss this! Go here to register.
  • [NEW] 23 Jun 2022 (Virtual, 2-4p CEST): “Tackling the emerging threat of fungal drug resistance,” a webinar sponsored by JPIAMR, the Israeli MoH, and the UK MRC. Go here to register. Yes, that’s the Israeli Ministry of Health getting into AMR … perhaps in part stimulated by a 2015 report on the significant burden of fungal infections in Israel.
  • 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 and to register.
  • 12-13 Sep 2022 (virtual, 9a-5p ET): This meeting of PACCARB is going to “identify key issues and critical policy gaps through a series of facilitated discussions examining a hypothetical large-scale disease outbreak scenario based on historic examples and estimates of future AMR outbreaks.” Sounds like pandemic wargaming (Center for Health Security; pre-COVID 19 May 2020 NPR article) to me! 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.
  • 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 6th 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 details.
  • 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.
  • 17-20 Nov 2022 (Kuala Lumpur, Malaysia): The International Congress on Infectious Diseases will take place for the first time as a hybrid event. Go here for details. 
  • 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.
]]> Italy funds CARB-X and announces pull incentive! https://webdisk.amr.solutions/2024/10/17/italy-funds-carb-x-and-announces-pull-incentive/ Thu, 17 Oct 2024 20:55:47 +0000 https://amr.solutions/?p=17179

Dear All (and with thanks to Damiano for co-authoring),
 
We have exciting news from the G7 Health Ministers’ Meeting, which was held in person in Ancona on 9-11 October 2024, and the accompanying G7 Joint Finance and Health Ministers’ Meeting, which took place in a hybrid format on 10 October 2024. At the press conference closing both ministerial events, the Italian Minister of Health, Orazio Schillaci, made two announcements that mark a major step forward in global coordination to PUSH and PULL antibacterial R&D!
 
PUSH: Italy funds CARB-X

  • Italy will contribute USD 21 million to CARB-X over the next three years.
  • This funding will enhance CARB-X’s efforts to support, accelerate and coordinate the early-stage development of innovative products aimed at preventing, diagnosing, and treating drug-resistant bacterial infections.
  • As a quick reminder, CARB-X is already supported by five other G7 governments (United States, Germany, United Kingdom, Canada, Japan) and the three largest private foundations focusing on global health (Wellcome, Bill & Melinda Gates Foundation, and Novo Nordisk Foundation).
  • If you need a single figure to understand the impact and relevance of CARB-X, consider this: half of all therapeutic R&D projects in Phase 1 worldwide that target bacteria in the Critical group of the 2024 WHO Bacterial Priority Pathogens List (excluding tuberculosis) and meet at least one WHO innovation criterion come from CARB-X portfolio (!).
  • While we celebrate this significant step forward from the Italian government, it’s important to note that recent reports still concluded that “there is relative consensus on the need to provide additional push funding, in a range between USD 250 and USD 400 million on an annual basis at a global level.”

 
PULL: Italy announces new initiative to sustain revenues for high-priority antibacterial products

  • Italy’s Health Minister Orazio Schillaci announced that the Italian Ministry of Health, together with the Italian Ministry of Finance and the Italian Medicines Agency, is working on a new pull incentive to accelerate innovation and access to much-needed antibiotics.
  • More in details, the Ministry of Health has proposed a legislative measure within the Italian Budget Law for 2025 (to be discussed and approved in the coming months) which aims to grant new and recently-approved antibiotics direct access to the national Fund for Innovative Oncological and Non-Oncological Medicines. Benefits of direct access to this Fund include immediate access to regional markets and exemption from the payback mechanism if the national pharmaceutical expense cap is exceeded.
  • This is positive news because, while details are not available publicly at this moment, the new initiative appears to be a healthy top-up with respect to current market revenues in the country, leading Italy to potentially become the second G7 government in the world (after the United Kingdom) to meet its fair share of a global pull incentive.
  • You can find more information about similar initiatives from other G7 governments in the newsletters here below:

 
On top of the new incentives for antibacterial R&D, these announcements from the Italian Government are crucial to maintain political momentum to support antibacterial R&D and access globally. We look forward to seeing the positive impacts of these measures on global health!
 
Push! Pull! Onward! It’s time to #PassPASTEUR!
 
John & Damiano
 
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.
 
Damiano de Felice, PhD, Chief of External Affairs, CARB-X (these views are personal and do not necessarily reflect the views of CARB-X or any of its funders). Follow me on Twitter and LinkedIn: https://x.com/damidefelice and https://www.linkedin.com/in/damianodefelice.

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 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).

John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 17-20 Sep 2024 (Porto, Portugal; virtual attendance is possible): 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:

  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above. 
  • 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.
  • 22-24 Oct 2024 (Belgrade, Serbia): Ecraid/ESCMID postgraduate course “Better methods for clinical studies in infectious diseases and clinical microbiology”. Go here to register by 29 Sep 2024.
  • 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.
  • 4-5 Feb 2025 (online, 1-5p GMT timing on both days): Antimicrobial Chemotherapy Conference by GARDP and BSAC in collaboration with CEPID-ARIES and Fiocruz. Now in its 6th year, the free program offers a good review of antimicrobial R&D, ranging from drug discovery to preclinical and clinical activities. Go here to register; the abstract deadline is 15 Nov 2024.
  • 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.

Noteworthy self-paced courses and training materials (this is a new section — comments on it would be appreciated!):

]]> New CARB-X round with expanded TPPs (enteric infection, S. aureus, E. coli) https://webdisk.amr.solutions/2024/09/23/new-carb-x-round-with-expanded-tpps-enteric-infection-s-aureus-e-coli/ Mon, 23 Sep 2024 22:07:30 +0000 https://amr.solutions/?p=16926

Dear All,

CARB-X have opened their 2nd funding round for 2024! The Expression of Interest (EoI) deadline is 4 Oct 2024, so time is short! The 2nd round has the same 4 basic areas as the first round (see 6 Mar 2024 newsletter for reference):

  • Therapeutics for Infections Caused by Gram-Negative Pathogens (WHO and CDC threat list pathogens; see this webpage for the threat lists, including a comparative summary)
  • Prevention for Invasive Disease (focused on S. aureus and E. coli)
  • Diagnostics for Neonatal Sepsis
  • Proof-Of-Concept for Novel Sample Types for Diagnosing Lower-Respiratory-Tract Infections

But new on this round is a TPP (Target Product Profile) for enteric infections caused by Shigella, Salmonella, Campylobacter, and E. coli. There are also additional TPPs for prevention of invasive diseases caused by S. aureus and E. coli.

Here are the links you need:


The addition of the TPP for enteric infections is really interesting. This was the subject of an excellent session at the recent (17-20 Sep 2024) ESCMID-ASM developer’s meeting. Listening to that discussion made me wonder if this could be an alternative to the typical pathway of using uUTI or cUTI as a gateway indication for a Gram-negative therapy. Hmm!

Many thanks to all who are working so hard in this space! 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

  • 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).

John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 17-20 Sep 2024 (Porto, Portugal; virtual attendance is possible): 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:

  • [ONGOING – 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!
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above. 
  • 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.
  • [Short timeline on registration] 22-24 Oct 2024 (Belgrade, Serbia): Ecraid/ESCMID postgraduate course “Better methods for clinical studies in infectious diseases and clinical microbiology”. Go here to register by 29 Sep 2024.
  • 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.
  • 4-5 Feb 2025 (online, 1-5p GMT timing on both days): Antimicrobial Chemotherapy Conference by GARDP and BSAC in collaboration with CEPID-ARIES and Fiocruz. Now in its 6th year, the free program offers a good review of antimicrobial R&D, ranging from drug discovery to preclinical and clinical activities. Go here to register; the abstract deadline is 15 Nov 2024.
  • 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.
]]> CARB-X receives $50m from UK & Gates; Session at BIO on antibiotic reimbursement; PLOS opens an AMR Channel; CDD-sponsored SAR webinar https://webdisk.amr.solutions/2018/05/23/carb-x-receives-50m-from-uk-session-at-bio-on-antibiotic-reimbursement-plos-opens-an-amr-channel-cdd-sponsored-sar-webinar/ https://webdisk.amr.solutions/2018/05/23/carb-x-receives-50m-from-uk-session-at-bio-on-antibiotic-reimbursement-plos-opens-an-amr-channel-cdd-sponsored-sar-webinar/#respond Wed, 23 May 2018 16:37:15 +0000 https://13.43.35.2/?p=261 Dear All: There has been tremendously exciting activity in parallel with this week’s World Health Assembly! Here’s the list…

  • CARB-X has announced this week that the Bill & Melinda Gates Foundation and the UK government will contribute $25 million and £20 million ($26.9 million), respectively, over the next 3 years. With this new inflow of $50m in committed funds, CARB-X has raised more than $500 million. And the money is being applied at a furious pace: from its launch 21 months ago on 28 July 2016, CARB-X has funded 36 companies!! Showing that the projects are moving swiftly and the portfolio is being actively managed, 33 are still being funded and 3 have reached a project endpoint.
  • Antibiotic economics at BIO: The anti-infective track at the BIO meeting shows sessions that cover bacteria, fungi, and viruses. Note in particular these two:
    • The session at 11a on 6 June entitled “The value of addressing AMR” appears especially relevant to the entire community as its speakers include Colm Leonard of NICE and Mark Sculpher of the Economic Evaluation Policy Research Unit (EEPRU) at the University of York. Dr. Leonard gave an excellent talk assessing the value of antibiotics at the 6-8 Sep 2017 ASM-ESCMID developer’s conference and I would expect Dr. Sculpher to present results from the U of York EEPRU’s work on de-linking antibiotic reimbursement from usage.
    • The AMR Industry Alliance is sponsoring a session entitled “Forging antimicrobial R&D pacts” from 4-5p on 4 June that looks like a good panel discussion on challenges in the AMR space and ways to use partnership(s) to make progress.
  • PLOS announced that it has collaborated with GARDP to launch an AMR channel. Described as a global forum for AMR research, the press release says that the channel will provide research, commentaries, blogs, news, and discussions that span science, research and development, public health, and policy.
  • CDD (Collaborative Drug Discovery) will host a webinar on at 11a EST on 26 June on “SAR data in Drug Discovery”. Andrew Leach (ChEMBL) and Evan Bolton (PubChem) will discuss drug discovery informatics and ways to use the freely available PubChem and ChEMBL SAR data. This webinar is not specifically focused on AMR but rather looks like a good broad tour of tools that make SAR information more accessible.

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://13.43.35.2/blog/

Upcoming meetings of interest to the AMR community:

]]> https://webdisk.amr.solutions/2018/05/23/carb-x-receives-50m-from-uk-session-at-bio-on-antibiotic-reimbursement-plos-opens-an-amr-channel-cdd-sponsored-sar-webinar/feed/ 0 2024 CARB-X funding rounds: Treatment, Prevention, and Diagnostics https://webdisk.amr.solutions/2024/03/06/2024-carb-x-funding-rounds-treatment-prevention-and-diagnostics/ Wed, 06 Mar 2024 20:19:46 +0000 https://13.43.35.2/?p=11525

Dear All,

Heads up! Having just yesterday announced funding of its 100th project, CARB-X have today announced two funding rounds for 2024. With application dates of 18-29 Mar 2024 and 23 Sep-4 Oct 2024, applications are sought on 4 major areas (see extended details below my signature):

  • Therapeutics for Infections Caused by Gram-Negative Pathogens (WHO and CDC threat list pathogens)
  • Prevention for Invasive Disease (focused on S. aureus and E. coli)
  • Diagnostics for Neonatal Sepsis
  • Proof-Of-Concept for Novel Sample Types for Diagnosing Lower-Respiratory-Tract Infections

I like this spread of topics … the first 2 areas represent ongoing major gaps with global impact; the latter two would have special value in low- and middle-income countries with high(er) disease burden.

Per the press release, public webinars will be held on 21 Mar (7:00pm ET) and 22 Mar (8:00am ET) to discuss the scope of the funding rounds, application process, and to answer questions — you can register for the webinars at https://carb-x.org/apply/apply-here/.

I’ll also give a specific shout-out to the funders who have made this possible either through funding or provision of services in kind:

  • U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (HHS-ASPR-BARDA)
  • Wellcome
  • Germany’s Federal Ministry of Education and Research (BMBF)
  • UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF)
  • Bill & Melinda Gates Foundation
  • Public Health Agency of Canada (PHAC, new funder since 2023)
  • Novo Nordisk Foundation (new funder since 2024)
  • U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS (in-kind services through access to a suite of preclinical services for product development)

It is amazing to see how far we’ve come! Seeing CARB-X with 100 funded projects and 8 funders, including 4 governments (US, Germany, UK, Canada) is simply stunning! MANY THANKS (again) to all the funders and also to Team CARB-X! Now, please get busy and submit those brilliant, innovative ideas!

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.

Copied straight from the press release, here is a bit more detail on the topic areas:

  • THERAPEUTICS FOR INFECTIONS CAUSED BY GRAM-NEGATIVE PATHOGENS
    The scope is restricted to direct-acting small-molecule therapeutics. Molecules with properties that will deliver an IV route with an oral stepdown are preferred. In all cases, activity against both susceptible and multidrug-resistant organisms on the WHO and CDC bacterial threat lists is essential.
  • PREVENTION FOR INVASIVE DISEASE 
    Novel approaches to prevention of invasive disease caused by Staphylococcus aureus or Escherichia coli are sought. Given the history of challenges in drug development in this arena, modalities other than vaccines are preferred; however, if a vaccine is proposed, a novel aspect (e.g. adjuvant strategy or vaccine composition) that makes a compelling case must be underscored.
  • DIAGNOSTICS FOR NEONATAL SEPSIS
    Consistent with our “Aligned by Design” strategy, we seek diagnostics to support the growing portfolio of potential maternal vaccines to prevent neonatal sepsis. Products focused on rapid triage, bacterial identification and/or automated susceptibility testing are sought. Time-to-result and cost-of-goods are key criteria, and small-sample volumes are critical for this patient population. Pathogen ID and AST Products must focus on priority pathogens, including Klebsiella pneumoniae, Escherichia coli, Staphylococcus aureus and Acinetobacter baumannii.
  • PROOF-OF-CONCEPT FOR NOVEL SAMPLE TYPES FOR DIAGNOSING LOWER-RESPIRATORY-TRACT INFECTIONS
    Consistent with our “Aligned by Design” strategy, we seek diagnostics to support the many therapeutic projects focused on lower-respiratory-tract infections (LRTI). Owing to the challenges with BAL samples, as a first step, projects that can demonstrate proof-of-concept data with novel sample types are sought. 

John’s Top Recurring Meetings

Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 6-7 Mar 2024 (Basel, Switzerland): The 8th AMR Conference 2024. Go here to register!
  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details. 
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here for the meeting’s general website. You can’t register (yet) for the 2024 event, but save the date!
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Save the date! More details to come!

Upcoming meetings of interest to the AMR community:

  • 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.
  • 25-26 Mar 2024 (In person, London): “Novel Diagnostics for Infectious Diseases,” a 2-day workshop co-organised and funded by Imperial College London’s Institute of Infection, JPIAMR-funded B2B2B Network, London In Vitro Diagnostics Co-operative, NIHR Imperial Biomedical Research Centre, and DIAMONDS consortium. Go here for details and to register.
  • 10-11 Apr 2024 (virtual): Sepsis Alliance AMR Conference, a 2-day conference focused on “practical technologies to manage sepsis and counteract the expanding challenge of antimicrobial resistance.” Go here for details and to register.
  • 26 Apr 2024 (Barcelona, Spain): ESCMID workshop entitled “Using Data Science and Machine Learning for Infection Science: A Hands-on Introduction.” Click here to register or here for more details. 
  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
  • 26-31 May 2024 (Montreal, Canada): EDAR7, the McGill AMR Centre’s 7th edition of their Environmental Dimension of Antimicrobial Resistance conference. Go here for details; final abstract deadline is 21 Dec 2023.
  • [NEW] 28-29 May 2024 (in person, Uppsala, Sweden): Uppsala Antibiotic Days, a broad-ranging 2-day program hosted by the Uppsala Antibiotic Center. Go here for details and to register.
  • 9-13 June 2024 (in person, Ascona, Switzerland): “New Approaches to Combat Antibiotic-Resistant Bacteria, 2nd Edition” is a Sunday-Thursday residential workshop focused on the deep biology of AMR. Sponsored by NCCR AntiResist (a Swiss National Science Foundation consortium), the scientific program has the feel of a Gordon Conference. Space is limited, so you are encouraged to apply promptly — go here for details.
  • 13-17 June 2024 (Atlanta, Georgia): ASM Microbe, the annual meeting of the American Society for Microbiology. You can’t register yet, but you can go here for general details.
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. See Recurring Meetings list, above.
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above. 
  • 19-27 Oct 2024 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance). Now in its 8th year, Patrice Courvalin directs the program with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Seating is limited, so mark your calendars now if you are interested. Applications open in March 2024 — go here for more details.
  • 4-5 Dec 2024 (in person, Washington, DC): “Fungal Dx 2024: Fungal Diagnostics in Clinical Practice” is a 2-day in-person workshop organized by ISHAM‘s Fungal Diagnostics Working Group. The program and registration links are available at https://fungaldx.com/; the agenda is comprehensive and features an all-star global list of speakers.
]]> Novo Nordisk Foundation joins CARB-X! https://webdisk.amr.solutions/2024/01/19/novo-nordisk-foundation-joins-carb-x/ Fri, 19 Jan 2024 19:53:38 +0000 https://13.43.35.2/?p=11170

Dear All (and with thanks to Damiano, Peter and Aleks for co-authoring),
 
Some great news to start off 2024 on the right foot: the Novo Nordisk Foundation has announced that it will fund CARB-X with a three-year grant of USD 25 million!
 
The Novo Nordisk Foundation joins four governments (Canada, Germany, the United Kingdom, and the United States) and two private foundations (the Bill & Melinda Gates Foundation and the Wellcome Trust) in supporting the work of CARB-X to accelerate the early-stage development of innovative tools to prevent, diagnose and treat the most dangerous drug-resistant bacterial infections. Since 2016, CARB-X has funded 93 projects in 12 countries. Nineteen projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market.
 
The press release offers a good summary of why we need push incentives such as CARB-X and pull incentives such as the PASTEUR Act: “Private investments in innovative antibiotics are poor partly because doctors use them only when older and cheaper drugs fail. This is important to prolong their effectiveness, but it also limits their sales. This broken market has created a huge funding gap in antibacterial product development. A report for the European Commission has recently estimated that an additional global investment of USD 250 to 400 million from public and philanthropic sources is needed every year for the R&D of products that counter drug resistance, and that this investment should focus in the early phase of development, which is where CARB-X operates.”
 
As a recap for those who are new to the area, Novo Holdings – the Novo Nordisk Foundation’s wholly owned subsidiary – established the REPAIR (Replenishing and Enabling the Pipeline for Anti-Infective Resistance) Impact Fund in 2018 to address this early-stage funding gap and a strong collaboration between REPAIR and CARB-X dates back to the very beginning of the two initiatives. REPAIR has invested in 12 product developers with antibacterial R&D pipeline projects, several of which also received support from CARB-X. This shows the catalytic role of push funding and the crucial role of impact investing in antibacterial product development.
 
Due to market conditions, REPAIR has recently gone on pause for new investments while continuing to support the existing portfolio with capital held in reserve. Despite this, Novo Holdings and the Novo Nordisk Foundation are more committed to the strategic mission of combatting antimicrobial resistance than ever. The philanthropic grant from the Novo Nordisk Foundation to CARB-X for advancing R&D projects at a similar (early) stage of development highlights the critical importance of this pipeline, while also acknowledging the difficult financial prospects – in essence calling a spade a spade (and if any of this is new to you, see our introductory discussion of #TheFireExtinguishersOfMedicine).
 
The Novo Nordisk Foundation is also increasing their public policy activities on AMR – this includes proposing payment models for antibiotics based on access and value, rather than volume. Other exciting news coming from the Novo Nordisk Foundation is the funding of a major new initiative – the Novo Nordisk Foundation Initiative for Vaccines and Immunity – that will develop vaccines against respiratory infections, thus reducing the use of antibiotics and the spread of AMR.
 
For its part, Novo Holdings is one of the founders of the AMR Action Fund and also recently acquired Paratek Pharmaceuticals together with Gurnet Point Capital, subsequently delisting the company.
 
We hope that this positive news is just the start of a monumental year to address AMR, and we look forward to more progress on both push and pull incentives in the coming 12 months!
 
All best wishes,
 
John, Damiano, Peter, & Aleks
 
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://13.43.35.2/blog/. All opinions are my own.
 
Damiano de Felice, PhD, Director of Development and External Engagement, CARB-X (these views are personal and do not necessarily reflect the views of CARB-X or any of this funders) @damidefelice
 
Peter Lawætz Andersen, DVM, DSc, Professor | Senior Vice President, Infectious Diseases, Novo Nordisk Foundation. Follow me on LinkedIn: @Peter L. Andersen
 
Aleks Engel, PhD | Partner, Novo Holdings A/S | Director, REPAIR Impact Fund. Follow me on Twitter: @AleksEngel.

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).


John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 6-7 Mar 2024 (Basel, Switzerland): The 8th AMR Conference 2024. Go here to register!
  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details. 
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here for the meeting’s general website. You can’t register (yet) for the 2024 event, but save the date!
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Save the date! More details to come!

Upcoming meetings of interest to the AMR community:

  • [Post-meeting video available] 12 Dec 2023 (virtual, 1-2.15p ET): Duke-Margolis held the third and final installment of their webinar series for policymakers combating AMR with a webinar entitled “Improving Regulatory Practices to Sustain Antibiotic Innovation.” The webinar featured perspectives from experts affiliated with the FDA, Industry, GARDP, CARB-X, and the Center for Global Development. The webinar was excellent and is available for streaming; prior webinars occurred on 9 May 2023 on the Need for New Antibiotics, and on 29 Aug 2023 on Preparedness for AMR Threats (also see their related October 2023 report on Preparedness and Post-Market Incentives for Novel Antibiotics).
  • 22 Jan 2024 (virtual, 5p-6.30p CET): ‘What do the various non-commercial actors in the antibiotics R&D ecosystem do?’ with Erin Duffy (CARB-X), Peter Beyer (GARDP) and Laura Marin (JPIAMR). Click here to register.
  • 24 Jan 2024 (online, 9a-1p London): Webinar entitled “Priorities and next steps for tackling antimicrobial resistance in the UK”, sponsored by the Westminster Health Forum. Featured speakers include Dame Sally Davies and the focus is on the UK’s 20-year vision and 5-year action plan for AMR. Go here for details and to register.
  • [NEW] 24 Jan 2024 (virtual, 3-4.30p CET): WHO’s “The role of vaccines to reduce antimicrobial resistance” webinar. Click 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). 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.
  • [NEW] 14 Feb 2024 (virtual, 8-9a EST): GARDP’s “SECURE: Improving access to antibiotics through new economic models” webinar about the SECURE project. Click here to register.
  • [NEW and HIGHLY RECOMMENDED] 15 Feb 2024 (virtual, 8.30a-10.00a EST, 2.30-4p CET, 10.30p-12.00a JST): Entitled “AMR Preparedness Index: 2024 Progress Report”, this will be the launch of a major report by the Global Coalition on Aging (GCOA) and IDSA, and sponsored by IFPMA. Speakers are global (US, EU, Brazil) and feature Dame Sally Davies (UK Special Envoy for AMR) plus a panel moderated by Andrew Jack (Financial Times, creator of a marvelous 5-minute AMR video explainer); the discussion will to cover the new report (it updates the 2021 AMR Preparedness Index), including high-level policy insights from the report in advance of the eagerly anticipated High-Level Meeting on AMR at UNGA 2024 (see 15 Apr 2023 newsletter for background on the HLM). Go here to register.
  • [NEW] 27 Feb 2024 (virtual, 8.30a-9.30a EST): GARDP’s “What does the future look like if pull incentives to support antibiotic R&D are insufficient?” webinar. Go here for details. 
  • 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.
]]> AMR Hearing in Congress, PASTEUR re-introduced … and more! https://webdisk.amr.solutions/2023/04/28/amr-hearing-in-congress-pasteur-re-introduced-and-more/ Sat, 29 Apr 2023 02:17:07 +0000 https://13.43.35.2/?p=9446

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

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

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

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

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

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

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

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

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

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

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

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

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

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

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

Now, to the Q&A  —

Current funding opportunities (most current list is here)

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


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

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