Aside: Please refer to our UNGA 2024 webpage for additional post-HLM notes and updates.
Dear All (and with thanks to Damiano for co-authoring),
Last week in NYC, the UN General Assembly (UNGA) and all its surrounding activities created a lot of energy (not to mention a giant traffic jam)! After a series of side meetings designed to build momentum, we reached the Thursday 26 Sep High-Level Meeting (HLM) on AMR (video replay, HLM website, HLM agenda). To appreciate the significance of the event, we’re going to try to sketch the breadth of support that was evident during the day.
The HLM was opened by H.E. Mr. Philemon Yang (Cameroon), President of the General Assembly. He quickly led the meeting to vote to approve the draft political declaration, made a statement about the need to address AMR, and then invited a series of high-level comments from VERY senior leaders:
- H.E. Mr. Robert Rae (Canada), President of the Economic and Social Council
- Recall that Canada has generated a very valuable report on AMR (8 Sep 2023 newsletter) and also recently committed to implement a Pull model (20 Sep 2024 newsletter)
- Ms. Amina J. Mohammed (Nigeria), Deputy Secretary-General of the United Nations
- “Without science, we will surely lose the battle,” she said!
- The 4 organizations behind the Quadripartite Joint Secretariat on AMR (QJS-AMR)
- WHO: Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, who expressed serious concern about “the alarmingly dry pipeline for new antibiotics.”
- UNEP: Ms. Inger Andersen, Executive Director of the UN Environment Programme
- WOAH: Dr. Emmanuelle Soubeyran, Director-General of the World Organization for Animal Health
- FAO: Mr. Thanawat Tiensin, Assistant Director-General of the Food and Agriculture Organization
- Mr. Axel van Trotsenburg, Senior Managing Director for Development Policy and Partnerships of the World Bank
- H.E. Ms. Mia Amor Mottley, Prime Minister of Barbados, Chair of the Global Leaders Group on Antimicrobial Resistance
- In a very compelling statement, she said “The big big heavy lift is what must be raised in order to encourage research; we have gone from 20 companies at the year 2000 doing antibiotic research to four, and the world cannot depend only on the efforts of four because the economics of antibiotics do not work.”
- Ms. Gabriella Balasa, one of the founding members of the WHO AMR Survivor Task Force
After these heavy-hitting opening statements, we had nearly 7 hours (!!) of brief (~3-5 minute) statements from governments around the world. These statements discussed the need for collaboration, highlighted the importance of equity in terms of access, and expressed support for creation of the Independent Panel on Evidence for Action Against AMR.
This steady drumbeat of support is/was significant in that each of these speeches (both short and long) resulted from months of work in national capitals — teams worked to build a report, reports were reviewed, and ministers were briefed. All of this effort means that a knowledge base to implement action now exists at political levels!
And on the theme of data that drive action, we’ve talked before about the powerful idea of creating that independent panel on evidence (see paper #4 from the 10-20-30 Lancet series, 23 May 2024 newsletter). Excitingly, Stella Kyriakides, European Commissioner for Health and Food Safety, announced the European Union’s €2.5 million commitment to facilitate the establishment of the panel in 2025 (and this is on top of previous commitments of GBP 10 million each from the United Kingdom and Saudi Arabia for the independent panel).
Finally, the meeting concluded with statements from
- H.E. Mr. Philemon Yang, President of the General Assembly
- H.E. Ms. Beatrice Atim Odwong Anywar, Minister of State for Environment of Uganda, Member of the Global Leaders Group on Antimicrobial Resistance
- “A public health emergency anywhere is a public health emergency everywhere,” she said!
- Mr. John Kariuki Muhia, WHO AMR Survivor Taskforce
- And … drumroll … a 10-minutes popup performance by the team behind Lifeline, the musical story of penicillin (4 Sep 2024 newsletter). To see their performance, jump to 7h, 47m, 30 s in the UN TV replay
Wow! Wow! Such energy! Such commitment!
What’s next? Well, the HLM is a big step but not the last one. Borrowing from Winston Churchill, it really feels appropriate to repeat his words: “Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”
Next up, we must continue to build on this momentum to ensure that every country is doing its part to implement the ideas from the political declaration:
- Adoption of the Political Declaration by the full General Assembly
- Meetings during October and November of the G7 and G20 Health and Finance Ministers
- And continued action at national levels globally (The PASTEUR Act in the US! Pull models from Canada, Australia, Japan, and Switzerland! Pull incentives from the European Commission!)
And for those of you working to find new therapies, preventatives, and diagnostics … get busy! The world is counting on you!
All best wishes, 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, 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
The billboard in Times Square from the Fleming Initiative was so cool!
Every 11 seconds, someone in the USA gets an antibiotic resistant infection.
- 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.