Dear All,
You can’t actually submit your application until ~4 April 2025, but I’ve learned that EU’s HERA (Health Emergency Preparedness and Response Agency) has posted a notice about an intriguing planned call for tenders. Here’s the brief summary currently available online:
- “This call for tenders aims to speed up the 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.
- “Diagnostic tests that allow for pathogen identification (in addition to AST) should aim at identifying at least one of the bacteria listed in the 2024 WHO bacterial pathogen priority list and/or the fungi Candida spp., and/or Aspergillus fumigatus.
- “The call aims to speed up the development of rapid, point-of-care AST devices currently in the pipeline.
- “The proposed product shall be at minimum technology readiness level (TRL) 3 onwards with a clear pathway for CE marking in the EU.
- “By the end of the contract, the product developed should aim at reaching system complete and qualified (TRL 8). Tenders aiming at early TRLs will be considered, as long as the product is working towards certification.”
According to the website, this will be procedure HADEA/2025/CPN/0006-PIN with a TED (Tenders Electronic Daily) reference of 28/2025 90073-2025.
The anticipated total funds available are 12,860,000 EUR, the contracts will be up to 4 years long, and the website will publish the call on approximately 4 April 2025. A closing date is not posted but it would be typical for letters of intent to be required within a month and full applications due a few months later.
Exciting! Ambitious! A 1-h POC device? Yow!
It’s great to have the planned call posted now so that those who are interested can start spinning their brains!
And while we’re at it, let me remind you of HERA Invest and its goal of promoting advanced research and development of medical countermeasures via its EUR 100m fund supporting innovative EU-based SMEs with loans in the early and late phases of clinical trials (see also the 5 Sep 2023 newsletter for a brief discussion of HERA Invest as well as a great AMR-related movie).
Good work, Team HERA! Sharpen your pencils!
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.
- 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.
- The 2026 NIAID DMID Omnibus Broad Agency Announcement (HHS-NIH-NIAID-BAA2025-1) seeks applications in its Research Area 001 for (i) therapeutics for bacterial and fungal infections, (ii) vaccines for bacterial infections, and in vitro diagnostics for fungal pathogens. Applications are due by 21 Feb 2025. See also the 26 Nov 2024 newsletter discussing the BAA.
- 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!
- 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.
- (September-ish, no date as yet) 2025 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. 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.
Upcoming meetings of interest to the AMR community:
- 20-22 Feb 2025 (Melbourne, Australia): 12th Annual Meeting of the Australian Society for Antimicrobials. Go here for details and to register.
- 25-26 Feb 2025 (Basel, Switzerland): The 9th AMR Conference 2025. See list of Top Recurring meetings, above.
- 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.
- [NEW] 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.
- 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.
- OpenWHO: “Antimicrobial Resistance in the environment: key concepts and interventions.” Per the webpage for the course, it will teach you “…why addressing AMR in the environment is essential and gain insights into how action can be taken to prevent and control AMR in the environment at the national level.” This course builds on WHO’s 2024 Guidance on wastewater and solid waste management for manufacturing of antibiotics. For further reading, see also the 25 Sep 2023 newsletter entitled “Manufacturing underpins both access and stewardship: Cefiderocol as a case study” and the 28 Jan 2024 newsletter entitled “EMA Concept Paper: Guidance on manufacturing of phage products”.