AMR.Solutions

EMA: “Regulatory sandboxes” to explore approval pathways

Dear All,

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

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

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

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

Sandboxes: A shift from static regulation to dynamic learning

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


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

The sandbox is temporary, the resulting adapted framework is permanent



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

Sandboxes: Phage break the "defined active substance" rule



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

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


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

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

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

All best wishes, –jr

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


For reference, note as well these prior newsletters regarding phage

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!

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

  Upcoming meetings of interest to the AMR community:

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

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

Current funding opportunities

  • [UPDATED] CARB-X have announced a funding round that will be open 8-22 April 2026 (there will also be a round during 4Q 2026). There are 4 funding themes as below. Informational webinars have been announced for 9 and 10 April 2026.
    • Direct-acting therapeutics for infections caused by Gram-negative bacteria
    • Novel Chemistry for AMR Challenge – target-based therapeutics.
    • Non-vaccine approaches to prevent neonatal sepsis
    • Diagnostics for neonatal sepsis
  • The Horizon Europe Work Programme 2026-2027 includes at least 3 calls of interest within its Cluster 1 — see the list below.  The application window starts 10 Feb 2026 and closes on 16 Apr 2026. See also the 12 Dec 2025 newsletter about the call. Note as well that there calls for agents to prevent and/or treat viral infections.
    • HORIZON-HLTH-2027-01-DISEASE-08: Development of innovative antimicrobials against pathogens resistant to antimicrobials
    • HORIZON-HLTH-2027-02-IND-02: Portable point-of-care diagnostics
    • HORIZON-HLTH-2026-01-DISEASE-03:Advancing research on the prevention, diagnosis, and management of post-infection long-term conditions. 
  • ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews. 
  • BARDA’s long-running BAA (Broad Agency Announcement) for medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases is now BAA-23-100-SOL-00004 and offers support for both antibacterial and antifungal agents (as well as antivirals, antitoxins, diagnostics, and more). Note especially these Areas of Interest: Area 3.1 (MDR Bacteria and Biothreat Pathogens), Area 3.2 (MDR Fungal Infections), and Area 7.2 (Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens). Although prior BAAs used a rolling cycle of 4 deadlines/year, the updated BAA released 26 Sep 2023 has a 5-year application period that ends 25 Sep 2028 and is open to applicants regardless of location: BARDA seeks the best science from anywhere in the world! See also this newsletter for further comments on the BAA and its areas of interest.
  • HERA Invest was launched August 2023 with €100 million to support innovative EU-based SMEs in the early and late phases of clinical trials. Part of the InvestEU program supporting sustainable investment, innovation, and job creation in Europe, HERA Invest is open for application to companies developing medical countermeasures that address one of the following cross-border health threats: (i) Pathogens with pandemic or epidemic potential, (ii) Chemical, biological, radiological and nuclear (CBRN) threats originating from accidental or deliberate release, and (iii) Antimicrobial resistance (AMR). Non-dilutive venture loans covering up to 50% of investment costs are available. A closing date is not posted insofar as I can see — applications are accepted on a rolling basis; go here for more details.
  • The AMR Action Fund is open on an ongoing basis to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to contact@amractionfund.com.
  • INCATE (Incubator for Antibacterial Therapies in Europe) is an early-stage funding vehicle supporting innovation vs. drug-resistant bacterial infections. The fund provides advice, community, and non-dilutive funding (€10k in Stage I and up to €250k in Stage II) to support early-stage ventures in creating the evidence and building the team needed to get next-level funding. Details and contacts on their website (https://www.incate.net/).
  • These things aren’t sources of funds but would help you develop funding applications
    • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D. See also the 7 Feb 2026 newsletter (“The global funding pipeline, 2017-2023: A review”) about an excellent deep dive by the Hub team into patterns of funding over time.
    • Antimicrobial Resistance Research and Innovation in Australia is an actively updated summary that covers Australia’s AMR research and patent landscape. It is provided via collaboration between The Lens (an ambitious project seeking to discover, analyse, and map global innovation knowledge) and CSIRO (Commonwealth Scientific and Industrial Research Organisation, an Australian Government agency responsible for scientific research). Lots to explore here!
    • Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-X, C-CAMP, and FIND, it pulls together real-life insights into a succinct set of tutorials.
  • In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).
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