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The 6 meanings of “Lack of Access”

Dear All,

We often talk about the problem of lack of access to new antibiotics. In late 2021, for example, we explored data showing that multi-year delays in access to new antibiotics were common even in high income countries (19 Aug 2021 newsletter with YouTube discussion). 

But as we’ll learn today, that analysis considers only one possible facet of “lack of access.” In an instructive new paper, Baraldi, Ardal, Aho, Popescu, and Melaku have given us a powerful new analytical framework showing that there are at least six (6!) possible meanings of “Lack of Access” to antibiotics. Here are the links you need:


So, what are the 6 variations on the idea of “Lack of Access”? The paper by Baraldi et al. focuses on 4 ways that “Lack of Access” is grounded in lack of supply of the antibiotic itself:

  1. Short-term shortages (< 3 months)
    1. Example causes: Supply chain disruption, issues with forecasting demand
  2. Long-term shortages (> 3 months)
    1. Example causes: As for short-term and also weak procurement systems, hoarding
  3. Deregistration (withdrawal of a product from a given market)
    1. Example causes: Low profitability, small markets
  4. Lack of registration (product never registered in a given market)
    1. Example causes: Low profitability, regulatory complexity

Baraldi et al. also point us in a footnote to two further aspects of access that were noted as part of Indicator 46 in the Millennium Development Goals (link above, page 97; SDG 3.8 picks up these same themes albeit with less detailed wording). The MDG indicator was entitled “proportion of population with access to affordable essential drugs on a sustainable basis” and its definition gives us the 5th and 6th variations on “Lack of Access”:

  1. Financial access: Drugs are affordable.
  2. Physical access: Drugs are available “at public or private health facilities or drug outlets that are within one hour’s walk of the population.”


For the first 4 types of “lack of access”, the paper offers specific examples of each variation from recent history. The paper’s Table 1 then summarizes possible consequences (e.g., increased mortality due to use of less than effective drugs, more rapid progression to resistance due to repeated use of a limited range of antibiotics). The 5th and 6th types of “lack of access” are not considered in detail but their consequences are logical extrapolations of the first four variants.

Finally, Baraldi et al. consider possible solutions to each variant of “lack of access”:

  • For short- and long-term shortages, example solutions include improved communication, improved purchasing practices, pooled procurement, and stockpiling
  • For deregistration and lack of registration, example solutions include revenue guarantees (pull incentives), mutual recognition of marketing authorizations, and pooled procurement 


And finally, the authors conclude that this framework is a jumping off point for further research that would explore specific consequences, “… including actual calculations of their costs for patients and society and comparing these with the investments in various policy interventions. Future studies may also perform more fine-grained analyses of unavailability based on WHO’s AWaRe (Access, Watch, Reserve) categorization, specific countries and patient groups.”

Well done to the authors! Now we just need an acronym: SLDLAA is simple-minded but unpronounceable. Converting Deregistration and Lack of Registration to Unregistration and Non-registration would give SLUNAA or AASLUN — not lovely but an improvement. Hmmm … let me know if you think of something better!

Happy December! –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

  • NIAID’s RFA-AI-24-069 is a notice of funding opportunity (NOFO) soliciting applications to establish Centers for Accelerating Phage Therapy to Combat ESKAPE Pathogens (CAPT-CEP). The CAPT-CEPs will focus on developing preclinical assays, tools, and models for robust phage therapy research and development (R&D) and advancing phage clinical research. Applications are due by 28 Jan 2025; letters of intent must be received 30 days prior to the due date. See also the 23 Oct 2024 newsletter about the RFA for a discussion of issues with developing phage-based products.
  • 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
    • 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!

  • 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. 
  • (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:

  • [NEW] 3 Dec 2024 (virtual, 1700-1830 CET / 1100-1230 EST): GARDP REVIVE webinar entitled “Implementation research for the appropriate use of, and access to, antimicrobials.” Go here to register.
  • [NEW] 4 Dec 2024 (virtual, 1200-1300 CET): WHO (Quadripartite on AMR) sponsored webinar entitled “Launch of a Quadripartite toolkit: Engaging young people meaningfully for greater reach and impact in AMR.” The aim to equip youth-led networks and youth-serving organizations with the resources to engage young people in AMR communication, education, and advocacy. Go here to register.
  • 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.
  • 12 Dec 2024 (virtual, 11am ET): A CDC AMR Exchange webinar entitled “It’s Time for Action: Working Together to Achieve the Targets of the 2024 UNGA High-level Meeting on AMR Political Declaration.” With a focus on actionable next steps, the agenda includes discussants from CDC, Gallup, and the WHO Task Force of AMR Survivors. Go here to register.
  • [NEW] 23 Jan 2025 (virtual, 1700-1830 CET / 1100-1230 EST): GARDP REVIVE webinar entitled “The importance of chemical synthesis for antimicrobial R&D.” Go here to register.
  • 28-29 Jan 2025 (online and in-person, Washington, DC): PACCARB (US Presidential Advisory Council on Combatting Antimicrobial Resistant Bacteria): This particular meeting of PACCARB is unusually important as it will seek (i) public input into NAP for CARB 2025-2030 and (ii) work to sustain the momentum regarding the commitments at the High-Level Meeting on AMR at the 2024 UN General Assembly (UNGA HLM AMR). Go to http://hhs.gov/paccarb for details and to register.
  • 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.
  • 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. See list of Top Recurring meetings, above.
  • [NEW] 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.
  • 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.
  • 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.
  • [2025 dates now posted] 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.

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

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