Dear All,
As we discussed in the 5 Nov 2023 “Pulling for Pandemic Preparedness” newsletter, AMR is a global threat: resistance in one part of the world can suddenly appear in your hospital. As an example of that sort of threat, Jason Gale’s 30 Oct 2023 newsletter entitled “Untreatable Typhoid Should Make You Worry About Poop” points out how very serious some of these AMR threats are right now. Not next year, not next month, not next week … right now there are circulating strains of Gram-negative bacteria that are close to untreatable.
On the theme of global preparedness for this type of resistant pathogen (and Pull for AMR … just keep reading!), I was thrilled to have the opportunity to attend the 10th Nikkei FT Communicable Diseases Conference (16-18 Oct 2023, Tokyo).
This fascinating conference series actually got its start in July 2000 at the Kyushu–Okinawa Group of Eight summit in 2000 during which Japan called out for global cooperation in action against communicable diseases such as AIDS, tuberculosis, malaria, polio. Making clear its own commitment, Japan announced at that time the Okinawa Infectious Diseases Initiative (IDI) with a pledge to spend US$3 billion over five years to combat infectious and parasitic diseases in developing countries (for more on the Okinawa IDI, see this summary white paper from 2004 and manuscript from 2007).
Moving forward 14 years, this momentum for global action against communicable diseases was crystallized 14-15 Feb 2014 as the “Nikkei Asian Conference.” This, in turn, became an annual series that has gained broad sponsorship and is now the annual Nikkei FT Communicable Diseases Conference (to see more on the history of the conference, check out these archives).
The conference advocates for action versus communicable diseases both domestically and internationally by bringing together technical experts, private sector, academia and government officials responsible for health from both inside and outside Japan. In particular, it has very high-level support from within the government of Japan: Sponsors include the Cabinet Office; the Office of the Hideyo Noguchi Africa Prize; the Ministry of Foreign Affairs; the Ministry of Health, Labour and Welfare; the Ministry of Economy, Trade and Industry; the Ministry of Education, Culture, Sports, Science and Technology; and the Cabinet Agency for Infectious Disease Crisis Management. Corporate sponsorship is also extensive — see the full list on the meeting’s home page. Wow!
And what about Pull for AMR? Well, I was delighted to have the opportunity to attend and present as part of a Shionogi-sponsored 3-person panel in a session entitled “Importance of Novel Antibacterial Drugs, and Global Collaboration for Expansion of Necessary Pull-type Incentives.”
I opened the session with a scene-setting talk on the challenges of antimicrobial R&D, Hideki Araoka (MD, PhD, an ID physician at Toranomon Hospital, Tokyo) spoke on the global threat of resistance, and then Nozomi Takeshita (MD, PhD, Director of the Office of Pandemic Preparedness and Response within MHLW) spoke on Japan’s progress towards creating a Pull incentive in Japan.
A copy of my talk can be found here and covered (no surprise!) the idea that Antibiotics are the #FireExtinguishersOfMedicine (and it also includes a new approach to comparing the probability of success for building/inventing a fire department vs. a novel antibiotic that you might enjoy). The talks by Drs. Araoka and Takeshita were in Japanese and I could follow them on the day with the help of the excellent translators, but I won’t try to reproduce them here.
I will, however, say that Dr. Takeshita’s talk covered the MHLW’s work towards a Japanese Pull incentive with content essentially identical to the materials I reviewed in this 19 Aug 2023 newsletter and its 22 Aug 2023 follow-on newsletter. In brief, Japan continues to progress towards a pilot Pull project with initial implementation expected in the coming months. In addition, it is encouraging to see that Japan plans to expand its support for push incentives by joining CARB-X (see the bottom of numbered page 69 [but actually document page 71] of the FY 2024-2025 budget proposal from MHLW).
Of interest, the Q&A both after the panel and during a subsequent roundtable had a strong (and welcome, to my ear) focus on encouraging young people to choose careers in the broad anti-infective space. Very forward thinking — hooray for our Japanese colleagues for calling this out!
Exciting! Yes, I know that the pace of progress towards Pull initiatives can seem terribly slow but it is overall amazing progress from IDSA’s original “Bad Bugs, No Drugs” clarion call of 2004 and our start-from-scratch towards pull incentives in 2009.
The Nikkei FT conference and its review of the diverse efforts by our colleagues in Japan to address the full range of microbial threats was indeed inspiring. I am especially glad to see such high-level government support — Japan is setting a great example!
Onward towards global Pull incentives! Hopefully yours, –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 (most current list is here)
- 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.
- FDA have released a BAA covering a wide variety of regulatory topics. See this newsletter for general details; also note in particular an RFP for work on urine-specific breakpoints for uUTI. Early concept papers are due 6 Nov 2023; full proposals are due 19 Feb 2024.
- PACE (Pathways to Antimicrobial Clinical Efficacy), a £30 million initiative supporting early-stage innovation, has been created by jointly by Innovate UK, LifeArc, and Medicines Discovery Catapult (MDC). An initial round of up to £10 million in grant funding is available to support up to 12 projects focused on developing new treatments for the most threatening microbes and resistance mechanisms. Applications are welcomed from any part of the world for projects expected to last up to two years and with total funding of up to £1 million per project. Expressions of interest are invited by 24 November, and an informational webinar will be held on 31 October.
- [NEW] The GHIT (Global Health Innovative Technology) Fund has opened two calls for proposals. Both require an Intent to Apply form no later than 10am JST on November 28, 2023 and then a Full Proposal by 10am JST on January 12, 2024.
- 16th Request for Proposals for the Target Research Platform to support the early-stage discovery and development of novel technologies and approaches for new drugs, vaccines, or diagnostics for malaria, tuberculosis, and Neglected Tropical Diseases. Details are found in RFP-TRP-2024-001 and the Intent to Apply form.
- 23rd Request for Proposals for the Product Development Platform to support the development of new drugs, vaccines, or diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects will need to be between eligible Japanese and non-Japanese organizations. Details are found in RFP-PD-2024-001 and the related Intent to Apply form.
- ARPA-H have an Open BAA that is accepting applications through 14 March 2024. It is quite wide-ranging in its scope and definitely includes AMR-related projects. See this newsletter for discussion of the BAA and an AMR project that it now supports.
- 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. Applications are accepted on a rolling basis; go here for all the details.
- The ENABLE-2 consortium has announced a call to support hit-to-lead compound development by researchers at publicly-funded European universities. The call is focused on molecules with the potential to be direct-acting therapies for one or more of the following priority pathogens: ESBL-producing/carbapenem-resistant Enterobacteriaceae (E. coli, K. pneumoniae), P. aeruginosa, A. baumannii, methicillin-resistant S. aureus, or vancomycin-resistant E. faecium. The Call is open continuously, applications are reviewed at intervals, and funding is non-dilutive. Expressions of interest received before 30 Sep 2023 would be considered in November 2023. Applications received after this date will be evaluated in the spring of 2024 (date to be decided). Go to https://www.ilk.uu.se/enable2/apply/ for further details.
- The AMR Action Fund is now open 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).
Upcoming meetings of interest to the AMR community (most current list is here):
- General note: Virtual meetings are easy to attend, but regular attendance at in-person events is the key to networking and deeper insight. My personal favorites for such in-person meetings are marked below as PERSONAL FAVORITE and are the BEAM Alliance’s AMR Conference (March, Europe), ECCMID (April, Europe), the ASM-ESCMID Developer’s meeting (September, alternates sides of the Atlantic), and ID Week (October, USA). Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!
- 13-14 Nov 2023 (virtual and Washington DC, USA): BARDA Industry Day 2023. Go here for more details.
- 14-15 Nov 2023 (Rockville, Maryland, USA and virtual): NIAID workshop entitled “Systematic Approaches for ESKAPE Bacteria Antigen Discovery”. Go here for details.
- 16 Nov 2023 (online, noon-1.30p CET): WHO quadripartite webinar entitled “Results from the Tracking Antimicrobial Resistance Country Self- Assessment Survey (TrACSS).” Go here to register.
- [WAAW!] 18-24 Nov 2023 (multiple events online and globally): World Antibiotic Awareness Week (WAAW) with the One Health theme “Preventing antimicrobial resistance together” (same as for 2022). The WHO’s main webpage is here; both the US CDC and the EU ECDC have a webpage for WAAW. The WHO home page provides an events calendar; events posted thus far are wide-ranging: HIV, AMR, youth engagement, pediatrics, and equitable access, just to name a few.
- [WAAW!] 21 Nov 2023 (virtual, 10-11a ET, 4-5p CET): “The Voice of AMR Survivors in Awareness and Advocacy,” a webinar organized as part of WAAW by the WHO Taskforce of AMR Survivors. I am very pleased to see the emergence of active AMR patient advocacy groups — we have been missing this! Go here to register for this webinar!
- [NEW & HIGHLY RECOMMENDED] 12 Dec 2023 (virtual, 1-2.15p ET): Duke-Margolis presents the third and final installment of their webinar series for policymakers combating AMR with a webinar entitled “Improving Regulatory Practices to Sustain Antibiotic Innovation.” The webinar will feature perspectives from experts affiliated with the FDA, Industry, GARDP, CARB-X, and the Center for Global Development. HIGHLY RECOMMENDED! Go here to register; prior webinars occurred on 9 May 2023 on the Need for New Antibiotics, and on 29 Aug 2023 on Preparedness for AMR Threats (also see their related October 2023 report on Preparedness and Post-Market Incentives for Novel Antibiotics).
- [NEW] 24 Jan 2024 (online, 9a-1p London): Webinar entitled “Priorities and next steps for tackling antimicrobial resistance in the UK”, sponsored by the Westminster Health Forum. Featured speakers include Dame Sally Davies and the focus is on the UK’s 20-year vision and 5-year action plan for AMR. Go here for details and to register.
- 6-7 Feb 2024 (virtual): Antimicrobial Chemotherapy Conference. This is an annual, free of charge conference that is co-organized by GARDP and the British Society for Antimicrobial Chemotherapy (BSAC). Details to follow — for now, just mark your calendar.
- 6-7 Mar 2024 (Basel, 6-7 Mar 2024): Sponsored by the BEAM Alliance, the AMR Conference is now in its 8th year and is consistently an excellent meeting for developers. You can’t register yet but you can mark your calendar and signup for notifications about the meeting. PERSONAL FAVORITE.
- 17-22 Mar 2024 (Ventura Beach, CA, in person): Gordon Research Conference (GRC) entitled “New Antibacterial Discovery and Development” with a 16-17 Mar 2024 pre-conference Gordon Research Seminar (GRS) for young doctoral and post-doctoral researchers. An intensive residential meeting, GRCs are highly recommended for networking and deep research insights. Apply here for the GRC and here for the GRS.
- 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details. PERSONAL FAVORITE.
- 26-31 May 2024 (Montreal, Canada): EDAR7, the McGill AMR Centre’s 7th edition of their Environmental Dimension of Antimicrobial Resistance conference. Go here for details; final abstract deadline is 21 Dec 2023.
- 13-17 June 2024 (Atlanta, Georgia): ASM Microbe, the annual meeting of the American Society for Microbiology. You can’t register yet, but you can go here for general details.
- 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here for the meeting’s general website. You can’t register (yet) for the 2024 event, but you can mark your calendar. PERSONAL FAVORITE.
- 16-24 Oct 2023 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Limited details as yet on line, watch https://idweek.org/ for updates. PERSONAL FAVORITE.
