Dear All,
The US Government is now building its budget for FY23 (Federal Year 2023, really runs 1 Oct 22 to 30 Sep 23). We had proposals from the House for the Department of Health and Human Services (DHHS) budget in late June; and the proposal from Senate was released on 28 Jul 2022. Each budget is presented as both a proposed bill and a report; I am going to quote from the reports. Extended excerpts from the Senate report and a brief excerpt from the House report are found below my signature but here are the key excerpts related to pull incentives:
FY23 Senate report, pg. 214: Antibiotic Resistant Infections. “The Committee supports the Administration’s proposal to combat antibiotic-resistant infections by encouraging the development of innovative antimicrobial drugs, which is in alignment with the United States’ obligations made at the December 2021 G7 Summit. The Committee believes that it is essential to delink revenue of antimicrobials from volume of sales and provide a robust contracting mechanism to incentivize the commercial availability of new and novel antimicrobials in order to protect Americans against highly dangerous drug-resistant microbes. …”
FY23 House report, page 239: Antimicrobial Resistance. “… The Committee requests within 180 days of the date of enactment of this Act a professional judgement budget estimate to support a comprehensive, long-term program for the development and procurement of novel antibiotics.”
Although the House text is brief and neither report specifically mentions the PASTEUR Act, my reading is that this is a clear call for Pull incentives via PASTEUR. It’s really hard to see how else you could read the Senate text as “delink revenue of antimicrobials from volume of sales” and “robust contracting mechanism to incentivize the commercial availability” are the backbone of PASTEUR.
It is also interesting to see the shout-out to the G7’s calls for action with “in alignment with the United States’ obligations made at the December 2021 G7 Summit.” On this, I refer you to the 28 June 2022 newsletter about AMR-related language from the 2022 G7 process. The fact that AMR has risen to the level of being a discussion item at the G7 Head of State level is extraordinary! As an expansion on why this is so important, see this 5-minute video explainer:
Fabulous stuff, and fingers crossed that we’ll see PASTEUR folded into an appropriate piece of legislation in the near future!
—
And as a real-life example of how any of us could suddenly find we need a good antibiotic (and hence good motivation for getting to done with PASTEUR!), I’m going to drop in a video from our ongoing series of Movies to Discovery Antibiotics By. In this edition, we consider a real-life twist involving the filming of Cast Away, starring Tom Hanks. Check it out!
Cheers!
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.
Extended text excerpts
FY23 Senate report, pg. 214: Antibiotic Resistant Infections.—The Committee supports the Administration’s proposal to combat antibiotic-resistant infections by encouraging the development of innovative antimicrobial drugs, which is in alignment with the United States’ obligations made at the December 2021 G7 Summit. The Committee believes that it is essential to delink revenue of antimicrobials from volume of sales and provide a robust contracting mechanism to incentivize the commercial availability of new and novel antimicrobials in order to protect Americans against highly dangerous drug-resistant microbes. The success of similar creative funding initiatives, such as Project BioShield, show the need for pursuing unique approaches to preparing for and countering serious threats to human health. The Committee requests the Department provide a briefing to the Committees on Appropriations within 60 days of enactment of this act that details the budgetary requirements for implementation of this proposal. In addition, the Committee directs OASH, NIH, ASPR/ BARDA, CDC, ASPE and AHRQ to jointly update the Committees on Appropriations no later than 60 days after the enactment of this act and each succeeding annual Appropriations bill detailing how HHS and its agencies are coordinating their AMR-related efforts, as well as domestic and international AMR trends. The briefing should include a comparison of actual performance for the most recent years available against the National targets established in the current National Action Plan for Combatting Antibiotic-Resistant Bacteria and whether those goals were achieved in the last fiscal year. Building on these results, agencies are directed to outline in briefings the focus of their plans for the next two fiscal years and how these are connected to longer-term objectives included in the current National Action Plan.
FY23 Senate report, pg. 224 (repeats language from page 214): Antimicrobial Resistance [AMR].—The Committee is encouraged by the Administration’s proposal to combat antibiotic-resistant infections by encouraging the development of innovative antimicrobial drugs, which is in alignment with the United States’ obligations made at the December 2021 G7 Summit. The Committee requests the Department provide a briefing to the Committees on Appropriations within 60 days of enactment of this act that details the budgetary requirements for implementation of this proposal. The Committee directs the Office of the Assistant Secretary for Health, NIH, ASPR/BARDA, CDC and AHRQ to jointly brief the Committees on Appropriations no later than 30 days after the enactment of this act and each succeeding annual Appropriations bill detailing how HHS and its agencies are coordinating their AMR related efforts. The briefing should include a comparison of actual performance for the most recent years available against the National targets established in the current National Action Plan for Combatting Antibiotic-Resistant Bacteria and whether those goals were sustained in the last fiscal year. Building on these results, agencies are directed to outline the focus of their plans for the next two fiscal years and how these are connected to longer-term objectives included in the applicable National Action Plan.
Other related AMR language in the Senate draft
Research on Antimicrobial Resistance [AMR] (page 119).—The Committee supports NIAID’s efforts to continue responding to the COVID–19 pandemic and prepare for future outbreaks while carrying out its broader role in infectious diseases research, including research on AMR. To that end, the Committee provides no less than $565,000,000, an increase of $25,000,000, to fund NIAID research to combat antimicrobial resistance. The Committee directs the Office of the Assistant Secretary for Health, NIH, ASPR/BARDA, CDC and AHRQ to jointly brief the Committees on Appropriations no later than 30 days after the enactment of this act and each succeeding annual Appropriations bill detailing how HHS and its agencies are coordinating their AMR-related efforts. The briefing should include a comparison of actual performance for the most recent years available against the National targets established in the current National Action Plan for Combatting Antibiotic-Resistant Bacteria and whether those goals were sustained in the last fiscal year. Building on these results, agencies are directed to outline the focus of their plans for the next two fiscal years and how these are connected to longer-term objectives included in the current National Action Plan.
Antimicrobial Resistance (page 178).—The Committee directs the Office of the Assistant Secretary for Health, NIH, ASPR/BARDA, CDC, and AHRQ to jointly brief the Committees on Appropriations no later than 30 days after the enactment of this act and each succeeding annual Appropriations bill detailing how HHS and its agencies are coordinating their AMR-related efforts. The briefing should include a comparison of actual performance for the most recent years available against the National targets established in the current National Action Plan for Combatting Antibiotic-Resistant Bacteria and whether those goals were sustained in the last fiscal year. Building on these results, agencies are directed to outline the focus of their plans for the next two fiscal years and how these are connected to longer-term objectives included in the applicable National Action Plan.
FY23 House Language, page 239
Antimicrobial Resistance.—The Committee provides an increase for efforts to combat antimicrobial resistance, recognizing the importance and challenges of this threat. BARDA’s Advanced Research and Development program support will be critical to support new products. The Committee requests within 180 days of the date of enactment of this Act a professional judgement budget estimate to support a comprehensive, long-term program for the development and procurement of novel antibiotics.
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:
- Course 1 provides training on the WHO Policy Guidance on Integrated Antimicrobial Stewardship Activities
- Course 2 focuses on the WHO practical toolkit for antimicrobial stewardship programmes in health-care facilities in low- and middle-income countries
- The online training courses can be found on the dedicated channel: https://openwho.org/channels/amr
- 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! For the most current update, watch this 30-minute video from the June 2022 kick-off webinar.
- 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):
- 10 Aug 2022 (virtual, 11a-12.30p ET): REVIVE webinar entitled “Animal models to study the activity of antibiotics.” Go here for details.
- 10 Aug 2022 (virtual, 10a-4.30p ET): USDA ‘s APHIS (Animal and Plant Health Inspection Service) will host a public meeting on Antimicrobial Resistance. Co-hosted with USDA’s FSIS (Food Safety Inspection Service) and REE (Research, Education and Economics) mission area, the webinar will review lessons learned since the first AMR workshop 2012 as well as discuss plans for the future. Go here to register.
- 23 August 2022 (virtual, 11a-12.30p ET): REVIVE webinar entitled “The Challenges and options in developing antibiotic combinations.” Go here for details.
- 30 August 2022 (virtual, 8.30a-5.00p ET): Webinar sponsored by CDC and FDA entitled “Drug Development Considerations for the Prevention of Healthcare-Associated Infections.” This is very timely as developing products for prevention is surprisingly hard. As just one example, see this 20 Dec 2018 newsletter about a valiant (but failed, sadly) effort to develop a S. aureus vaccine. Go here for additional 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.
- IDWeek has opened pipeline sessions for antibacterials, antifungals, and non-HIV, non-COVID antivirals as well as for diagnostics (no limitations). Go here to submit your abstract; this 14 July 2022 newsletter contains some additional 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.
- 23 Oct 2022 (Cape Town, South Africa): Symposium entitled “Tackling AMR: How implementation research is vital in a One Health approach” that is sponsored by the AMR knowledge hub of TGHN (The Global Health Network). 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.
- 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.
