Dear All,
Greetings from Porto (Portugal) where we’ve just ended the 2024 edition of the ESCMID-ASM Developer’s Meeting .. a superb congress with contributions from EMA, FDA, young investigators, older investigators, and points between. I enjoyed meeting so many of you this week!
Three items today, all on the path to next week’s United Nations General Assembly High-Level Meeting on AMR.
First up is the political declaration that will be ratified at the HLM. At 15 pages, it is a lot to absorb — you’ll want to page through it a couple of times to grasp the whole.
As an orientation, its 106 paragraphs are divided across 7 chapters: (I) Governance; (II) Financing; (III) Access; (IV) Co-ordinated Multisectoral Response (Human Health, Agriculture & Human Health, Environment); (V) Research and Development, Training, Innovation and Manufacturing; (VI) Surveillance and Monitoring, (VII) Follow-up.
As you go along, watch for these paragraphs (screenshots of all are below my signature):
- Paragraphs 5 and 6 are good summaries of the cost(s) of AMR:
- “… in 2019, 4.95 million deaths were associated with drug-resistant bacterial infections, including 1.27 million deaths directly attributable to bacterial antimicrobial resistance, …”
- “… globally, antimicrobial resistance could result in US$ 1 trillion of additional health-care costs per year by 2050 …”
- Paragraph 24 calls for national action plans to be in place globally by 2030
- “Ensure, by 2030, that all countries have developed or updated and are implementing multisectoral national action plans …”
- This timing would align with an update of the current SDGs (Sustainable Development Goals) at the end of the 2030 Agenda for Sustainable Development
- Paragraph 30 re-iterates the important call for an independent panel on evidence: “Invite the Quadripartite organizations to establish an independent panel for evidence for action against antimicrobial resistance in 2025 …”
- Paragraph 53 reinforces the value of diagnostics and laboratory systems: “Enhance the appropriate, prudent and responsible use of antimicrobials across sectors through better valuation of and investment in innovative, rapid, effective, validated and affordable diagnostics and laboratory systems …”
- Towards the end, paragraph 89 calls for delinked mechanisms: “Recognize the important role played by the private sector in research and development of innovative medicines and continue to support voluntary initiatives and incentive mechanisms that separate the cost of investment in research and development from the price and volume of sales …”
- Finally, the closing para 106 calls for another HLM in 5 years (2029); as noted above, an SDG update would be needed in 2030
In short, comprehensive coverage of everything we’d expect. I do wish the call for delinked mechanisms was a bit crisper, but I can only imagine the wrangling that went into this language.
And on the theme of delinked mechanism (drum roll, please!), we have some exciting news for the 2nd and 3rd stops on today’s tour … both Australia and Canada are both going to push towards incentive models!
- Tour Stop #2: As I hope you’ll recall, Canada commissioned a major review of the issue of Pull incentives
- See this 8 Sep 2023 newsletter entitled “Canada says, ‘Let’s pull together!’ in a major new report”
- Following on from this, we now have a “Pilot project to make more antimicrobials available in Canada”
- The available details are limited, but we are told
- “Canada’s Antimicrobial Economic Incentives Pilot Project will run for 3 years. It will start in the 2024 to 2025 fiscal year and end in the 2026 to 2027 fiscal year.
- “The pilot project will use an incentive program to help secure access for antimicrobials in Canada that address priority unmet public health needs for people in Canada.
- “To create a more attractive marketplace for antimicrobials, incentives could, for example, change the revenue model for antimicrobials and help support applications for market authorization.
- “This new incentive model also aims to encourage antimicrobial stewardship practices.”
- Hopefully, this is going to look a lot like the UK subscription model with scaling appropriate to Canada’s size and situation.
Tour Stop #3: In parallel, Australia have released an updated Health Technology Assessment (HTA) plan entitled “Accelerating Access to the Best Medicines for Australians Now and Into the Future.”
- In the summary of its recommendations (page 18 of the .pdf), we find Recommendation 21: Approaches to incentivise the development of health technologies that address antimicrobial resistance (AMR) which …
- Recommends that the Australian Government develop an HTA policy that would lead to the design of “a flexible reimbursement policy for antimicrobial products.“
- And recommends that the Australian Government should in the “short term, develop, implement and assess the effectiveness of a pilot subscription fund for novel antimicrobials. The model should be guided by international examples but tailored for the Australian setting.”
- Net, this feels like an earlier stage of the process than in Canada … some analysis will be done but the direction of travel is towards delinked Pull.
Exciting! We could wish for more details and more certainty, but even having this conversation is SUCH a big step forward. With thanks to all for their work and with 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.
Selected paragraphs from the draft political declaration:
- 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:
- [ONGOING – DON’T MISS IT] 28 Aug to 28 Sep (Off-Broadway, New York City, the Alice Griffin Jewel Box Theatre): Lifeline, the musical story of Sir Alexander Fleming’s discovery of penicillin. Previously entitled The Mould that Changed the World, the musical is a two-time Edinburgh Festival Fringe sell-out (2018 and 2022) and has toured to London, Glasgow, Atlanta and Washington DC (2022). This 5-week run in NYC is timed to be in support of the High-Level Meeting on AMR (HLM AMR) during UNGA 2024. Go here for a blurb and here to book your tickets!
- 19 Sep 2024 (virtual, 10-11.30a CEST / 18.00–19.30 AEST): GARDP’s REVIVE webinar entitled “An introduction to antibiotic research and development (R&D).” Go here to register.
- 24 Sep 2024 (in person, 7.45-10a ET, New York City): Breakfast meeting entitled “Advancing Together: Securing the Global AMR Agenda by Harnessing the Collective Strength of Multi-Sector Partnerships”, sponsored by bioMèrieux, The Wellcome Trust, The American Society of Microbiology, and the Republic of Malawi. This occurs two days before the 26 Sep 2024 UNGA HLM on AMR. Go here to register.
- 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.
- [NEW — short timeline on registration] 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.
- [NEW] 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.