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Notable reports: Incentives (WHO, AMR Hub); Strategy (BARDA); Capacity Building (UK Fleming Fund, US CDC)

Dear All, Four big reports have recently been released and are very much worth reviewing.

First, the Global AMR R&D Hub and the WHO AMR Team have written a report entitled “Incentivising the development of new antibacterial treatments“. This report is a response to a 2021 request by the G7 Finance Ministers for a report on the state of play for AMR. The 18-page report is an excellent read and covers:

  • The current antibacterial treatment and vaccine pipelines;
  • The financial landscape for developing new antimicrobials, and
  • Recommendations for future action.

In particular, the report’s discussion of the need for Pull Incentives is very detailed and useful. It includes a good review of the general problem that references the BCG’s recent “The Case for a Subscription Model to Tackle Antimicrobial Resistance” as well as the Milken Institute’s “Models for Financing Antibiotic Development to Address Antimicrobial Resistance“. The model-by-model commentary of various incentives on page 16 is especially noteworthy for its balanced critique of the various approaches currently being tested around the world.

Related to this report, you should review the call for Pull in the 2022 G7 Health Ministers communication. Also note that the G7 Finance Ministers 20 May 2022 statement reiterates their support for addressing AMR in paragraph 11: “We reaffirm our commitments of December 2021 on actions to support antibiotic development and support the ongoing work of the G7 Health, Agriculture and Climate Environment and Energy Tracks on antimicrobial resistance (AMR). We welcome the AMR progress report by the World Health Organisation and the Global AMR R&D Hub and request a further detailed update on the progress made for G7 Finance and Health Ministers in 2023.”

It is VERY encouraging to see this sustained interest by the G7 Health and Finance Ministers … this is what it will take to create those Pull incentives!


___

Secondly, BARDA have released their 2022-2026 Strategic Plan. There’s a lot to take in here, but I’ll excerpt from some of their objectives to give you a feel for the breadth and depth of their impressive AMR-related goals:

  • OBJECTIVE 1.2 Expand commitment to combat antimicrobial resistance through:
    • Establishment of the follow-on to the CARB-X program and continue support of the CARB Accelerator resulting in the transition of at least two antibacterial candidates from the Accelerator into the BARDA advanced research and development portfolio,
    • FDA approval of at least three novel antibacterials,
    • Procurement of approved novel antibacterials through Project BioShield, and
    • Development of at least one new diagnostic to inform appropriate antibiotic use.
  • OBJECTIVE 2.1: Revitalize the armamentarium of antibiotics that could be stockpiled to address antimicrobial resistant threats that could complicate any public health emergency.
  • OBJECTIVE 2.2: Work with antibiotic development and manufacturing companies to generate domestic production of critically needed antibacterial products and expand U.S.-based manufacturing capabilities.

Go Team BARDA! Yow!

—
Finally, we come to reports 3 and 4. Resolving the problem of AMR will require well-trained colleagues around the world … and those people have to be cultivated! To that end, the UK’s Fleming Fund was created in 2015 as a £265 million UK aid program focused on building knowledge, AMR surveillance, and workforce capacity for addressing AMR in Africa and Asia. The Fund recently released a major report on its progress to date. I can summarize it in one word: Impressive! Here are a few highlights:

  • Support for more than 240 laboratories across 22 countries
  • Funding for over 25,000 training attendances and and 170 Fleming Fellows
  • Growth from 6 to 14 in the number of countries providing data to GLASS, WHO’s Global Antimicrobial Resistance and Use Surveillance System

Also very active in the capacity-building game is the AMR group at US CDC. In a recent announcement, CDC reports having awarded more than $36 million for innovative research on AMR topics to diverse partners during Fiscal Year 2021 both within the United States and globally: 

Above: Global investment by US CDC in AMR during FY21


Fabulous! It’s hard work, but this kind of capacity- and knowledge-building creates a powerful momentum. I stand in awe!

With thanks to our colleagues around the world who made these amazing things happen, –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)

  • The AMR Industry Alliance has announced their 2022 Stewardship Prize! The program offers 10,000 CHF to recognize established, innovative approaches to AMR stewardship in low- and middle-income countries (LMICs). The 2021 prize went to the Infectious Diseases Institute (IDI) in Kampala, Uganda for their best practices in diagnostic stewardship and for their patient awareness campaigns dedicated to decreasing inappropriate use of antibiotics in their specialist HIV clinic in Kampala. Applications for the 2022 prize are due August 31, 2022. Thinking in terms of stewardship, WHO have recently released a pair of courses through the OpenWHO platform:
  • 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 a newly launched early-stage funding vehicle. Details are still coming into focus, but per comments on 25 Aug 2021 at the BIOCOM conference, their goal is to support ~4 companies per year with about $250k/company. Contact details are on their website (https://www.incate.net/).
  • New funding rounds from CARB-X are expected soon now that funding for the next 10 years has been announced! [NEW] There is a 9 June 2022 webinar (9-9.30a ET) that will “discuss the global health issues of AMR, and how CARB-X and its partners are working together to address them.” Go here to register.
  • It’s not a funder, but 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.
  • 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):

  • [Not to be missed!] 8 Dec 2021: “The New Winds Pushing and Pulling Antibacterial Development.” This FABULOUS program featured talks from the UK team behind the NHS “Netflix” pilot, Kevin Outterson’s recently released report documenting the need for global Pull incentives to have a value of $2.2 – 4.8b, and speakers covering PASTEUR and work in the EU on pull incentives. The video is here — please make time to listen to this program!
  • [Required reading!] The stunning 4 Feb 2022 webinar for the GRAM report (Global Research on Antimicrobial Resistance “1.27 million deaths per year are directly attributable to AMR”) is now available for replay. #AMRSOS! 
  • 7 Jun 2022 (virtual, 9-10.30a East Coast). CDC-sponsored webinar entitled “Antifungal Resistance: Understanding this Growing Global Threat.” Hosted by the team at CDC’s Mycotic Diseases Division, this looks to be an excellent conversation. Go here to register.
  • 8-9 Jun 2022 (virtual, 15.00-18.00 CEST / 9.00-12.00 EDT on both days): “Expert Workshop on Monoclonal Antibodies for AMR Pathogens” sponsored by the Paul-Ehrlich-Institut, on behalf of the COMBINE project. Day 1 focuses on preclinical development and translation (register here); Day 2 focuses on recurring problems and mitigation strategies in the clinical development (register here).
  • [NEW] 9 Jun 2022 (virtual, 9-9.30a ET). CARB-X-sponsored webinar at which CARB-X, BARDA, Wellcome and NIAID to discuss the global health issues of AMR, and how CARB-X and its partners are working together to address them.” Go here to register.
  • [NEW] 13 or 14 Jun 2022 (virtual,  14.00-17.00 (CEST) on 13 Jun, 09.00-12.00 (CEST) on 14 Jun, same agenda both days): “Supporting measures to mitigate AMR in One Health settings,” webinars sponsored by JPIAMR and ICARS that will consider at length the ‘Prevention and Intervention’ pillar of the JPIAMR’s Strategic Research and Innovation Agenda. Go here for details and to register.
  • 16-18 June 2022 (Perth, Australia): Australasian Society for Infectious Diseases Annual Scientific Meeting is a hybrid event for adult and pediatric infectious disease and clinical microbiology specialists. Go here for details.
  • 21 Jun 2022 (virtual, 10:00-11:00 ET | 15:00-16:00 BST): Launch of the AMR Register. Sponsored by Vivli with funding from many partners, this is the launch of an open-access repository for industry-generated surveillance data. Looks interesting! Go here to register.
  • 22-23 Jun 2022 (virtual, 10a to approx. 2.30p ET on both days): Workshop entitled “Strategies for Early-Stage Programs Developing Novel Antibacterial and Antifungal Drugs.” Sponsored by NIAID’s Bacteriology and Mycology Branch (BMB), this 2-day webinar features a very strong faculty (including speakers from FDA) discussing tips and insights for early product discovery including in-depth discussions of funding opportunities. The timing is US-centered but video replay will be available. Do not miss this! Go here to register.
  • [NEW] 23 Jun 2022 (Virtual, 2-4p CEST): “Tackling the emerging threat of fungal drug resistance,” a webinar sponsored by JPIAMR, the Israeli MoH, and the UK MRC. Go here to register. Yes, that’s the Israeli Ministry of Health getting into AMR … perhaps in part stimulated by a 2015 report on the significant burden of fungal infections in Israel.
  • 11-14 July 2022 (Sydney): Australian Society for Microbiology Annual National Meeting is a hybrid event that will feature a range of lectures and symposium sessions, as well as extensive opportunities for networking. Go here for details.
  • 24-27 July 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
  • 28-31 July 2022 (Singapore): 10th International Congress of Asia Pacific Society of Infection Control is a hybrid event for professionals in the Asia Pacific region. Go here for details and to register.
  • 12-13 Sep 2022 (virtual, 9a-5p ET): This meeting of PACCARB is going to “identify key issues and critical policy gaps through a series of facilitated discussions examining a hypothetical large-scale disease outbreak scenario based on historic examples and estimates of future AMR outbreaks.” Sounds like pandemic wargaming (Center for Health Security; pre-COVID 19 May 2020 NPR article) to me! Go here for details.
  • 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
  • 4-7 Oct 2022 (Dublin, Ireland): The 2022 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent meeting, especially for developers … and if you’ve missed it, the recordings from the 2021 meeting are online. Go here for details on the 2022 meeting.
  • 19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
  • 15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6th edition of Patrice Courvalin’s fabulous ICARe residential training course covering all things AMR is on for 2022! This is a soup-to-nuts training in AMR: it is very intense, very detailed, and always gets rave reviews from attendees. Registration is open 21 Mar 2022 to 21 June 2022 and is limited, so book your slot as soon as you can. Go here for details.
  • 19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
  • 25-28 Oct 2022 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.
  • 17-20 Nov 2022 (Kuala Lumpur, Malaysia): The International Congress on Infectious Diseases will take place for the first time as a hybrid event. Go here for details. 
  • 27-30 Nov 2022 (Perth, Australia): 32nd International Congress of Antimicrobial Chemotherapy is the biennial congress of the International Society of Antimicrobial Chemotherapy (ISAC). Go here for details.
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