AMR.Solutions

Transferable exclusivity vouchers (TEV) in EU: Coming soon!

Dear All:

EMA today hosted an exciting stakeholder webinar in which they gave a heads-up on the work they have done to create concrete requirements for the upcoming TEVs (TDEVs, Transferrable Data Exclusivity Vouchers) for novel antibacterial agents.

The recording and slides from the webinar will be released soon (within a few days, we were told); I will provide just some highlights from today. If you need a deep dive into TEVs, see the 12 Dec 2025 newsletter entitled “Pull incentives in Europe: TEVs to be included in legislative update”.

  1. The key to accessing a voucher will be to show that your new agent is a priority antimicrobial per the new Reform of the EU pharmaceutical legislation
  2. Here’s the definition of a priority antimicrobial from Article 41(3) of the new legislation:
    1. An antimicrobial shall be considered a ‘priority antimicrobial’ if it addresses a multi-drug resistant organism, if the preclinical and clinical data demonstrate a significant clinical benefit with respect to antimicrobial resistance and if it has at least one of the following characteristics:
      1. its mechanism of action (MOA) is distinctly different from that of any authorised antimicrobial in the Union;
      2. it contains a new active substance that, when used either alone or in combination with other active substances, addresses a serious or life-threatening infection.
    2. In the scientific assessment of the criteria referred to in the first subparagraph, the Agency shall take into account the ‘WHO bacterial priority pathogens list’, or an equivalent list of priority pathogens established at Union level.
  3. The webinar walked through all the pieces of the rule – let me comment on these topics:
    1. What is “a multi-drug resistant organism”? The organism is not susceptible to available agents in 3 or more categories.
    2. What is meant by “the preclinical and clinical data demonstrate a significant clinical benefit with respect to antimicrobial resistance”? Lots of debate on this that reduces to the idea that you need to present a clear reason to believe that compound will have impact. At least some clinical data will be needed but a statistical demonstration of superiority is not required.
    3. How are “novel MOA” and “new active substance” defined? Standard existing EMA rules for determining if a product has a novel mechanism (by analogy with the rules used for orphan products) or is a new active substance (NAS).
    4. What is a priority pathogen? Right now, it’s the WHO list. The EU could create its own list but that seems unlikely to me. For a summary of all the current priority pathogen lists (PPLs), see the AMR.Solutions Bugs and Drugs page.
  4. There are also requirements for supply chain that focus on having adequate capacity for EU needs
  5. EMA’s formal documents on its thinking will be available soon for consultation:
    1. Expected release is the week of 23 Nov 2026
    2. Consultation will run through the end of January 2027
  6. My understanding is that the vouchers go into force when the Reform Legislation is published later this year in the Official Journal of the European Union.

Exciting stuff! I’ll amend this blog post when the webinar recording/slides are posted and will send a note around when the consultation goes live. Many thanks to Team EMA!

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!

  • 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! The program for the 2027 conference is now live; abstract submissions begin Nov 2026 and close January 15, 2027.
  • 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!)..
  • 7-9 Sep 2027 (Bengaluru [Bangalore], India): The 3nd GAMRIC, the Global AMR Innovators Conference. Formerly the ESCMID-ASM (or ASM-ESCMID depending on location) Joint Conference on Drug Development for AMR, 2027 will be the 12th year for this series that is now under the joint sponsorship of CARB-X, ESCMID, LifeArc,GARDP, BEAM Alliance, Boston University, and AMR.Solutions. The 2026 meeting in Lisbon was superb and included substantial networking time (drinks on the lawn!), a keynote lecture by Karen Bush on the threat to beta-lactams due to the emergence of PBP3 mutations and sessions on program design for phage, development for pediatrics, and more! Check out the 2.5-minute YouTube video summary — and you can expect similar quality in 2027 in Bengaluru! Mark your calendar — details will follow in the spring of 2027.
  • 6-9 Oct 2027 (Boston, MA, USA): IDWeek 2026, the annual meeting of the Infectious Diseases Society of America, has just closed. As always, the program provided 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. Details will follow in due course about IDWeek 2027.

  Upcoming meetings of interest to the AMR community:

  • 16-18 Nov 2026 (FAO Headquarters, Viale delle Terme di Caracalla, 00153 Rome, Italy): The 4th Annual Plenary Assembly of the AMR Multi-Stakeholder Partnership Platform, of the Quadripartite organizations (FAO, UNEP, WHO, and WOAH). “Organized ahead of the Fifth High-Level Ministerial Conference on AMR, the Plenary Assembly will bring together MSPP members and observers, partners and external stakeholders from across regions and One Health sectors. The Plenary Assembly will focus on moving from political commitments to practical delivery, with particular attention to supporting countries in implementing their AMR NAPs.” Go here for additional details to register.
  • [NEW] 18 Nov 2026 (virtual, 9am to ??; end time not stated): Vivli are holding a webinar to review the winners of their 2026 data-mining challenge (14 Apr 2026 newsletter, “AMR Surveillance Data Challenge – Vivli 2026 Call for Projects!” Go here to register.
  • 18-24 Nov 2026 (everywhere, but not quite all at once): World AMR Awareness Week is happening! Here are some links to active partners: WHO, US CDC, UK Government; I’m sure I’ve not found them all!
  • 23 Nov 2026 (virtual, 1-2.30p CET): WHO will host a webinar entitled: “TrACSS at 10 years: Tracking Global Progress on Antimicrobial Resistance.” TrACSS (Tracking AMR Country Self-Assessment Survey) has now being running for 10 years (!!) and this webinar will discuss its progress. Go here to register. 
  • 27-29 Jan 2027 (Las Vegas, USA): IMARI (Interdisciplinary Meeting on Antimicrobial Resistance and Innovation) sponsored by IDSA and ASM. Abstract submissions are open through 19 Aug; registration and housing will open later this summer.
  • 4 Feb 2027 (in person, Liverpool, UK): Bionow‘s Bioinfect 2027 Conference on AMR. Good networking! Go here for details and to register.
  • 9-11 Feb 2027 (virtual, 1-5p GMT each day): ACC2027 (Antimicrobial Chemotherapy Conference 2027), sponsored by GARDP and BSAC (British Society for Antimicrobial Chemotherapy) in collaboration with EUP OHAMR (European Partnership on One Health Antimicrobial Resistance). This 3-day online conference includes both symposia and poster presentations. Go here for details and to register. Note that the abstract submission deadline is 16 Nov 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.
  • 27 Jun – 1 Jul 2027 (Ascona, Switzerland): NCCR-AntiResist will host the 3rd edition of its multi-day conference on antibiotic R&D. This biennial meeting has a similar structure to a Gordon Research Conference and its timing has been adjusted to be 1-year off-sync with the actual GRC (next edition of which is March 2028 — see below). Attendance requires an application; details on how to do this as well as the preliminary program are now available at the conference website. 
  • 7-9 Sep 2027 (Bangalore, India): GAMRIC  the Global AMR Innovators Conference. See list of Top Recurring meetings, above..
  • 6-9 Oct 2027 (Boston, MA, USA): IDWeek 2027. See list of Top Recurring meetings, above.
  • [Dates for 2027 are now announced] 16-24 Oct 2027 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance). This will be year 11 for this course. 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 will open during the spring of 2027, so for now just mark your calendar with the dates and keep an eye on the course website for updates.
  • [Placeholder] ??? 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

  • [Application window is open!!] CARB-X have announced their second 2026 funding round. The 4 funding themes are as below. The application window runs 10-23 Nov 2026; see the 2 Sep 2026 newsletter for more details:.
    • 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
  • OHAMR (European Partnership on One Health AMR) have announced the 2nd call in their plan to fund €253 million of AMR research over 10 years. This call is constructed around the theme of “Transmission” and opens on 18 Nov 2026. See the 8 Nov 2026 newsletter for details. 
  • The India AMR Co-Development Programme (I-AMR-CDP) is a collaboration between Venus Remedies Limited, the Indian Government, GARDP, ADVANCE-ID, and Singapore’s Experimental Drug Development Centre that seeks to support antibacterial R&D based in India. The website that is now open for applications until 31 Dec 2026; you might want to also review this LinkedIn post.
  • 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).

Last Updated on November 12, 2026 by John Rex

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