Dear All,
Following hard on the heels of the very successful call for signatories of a letter in support of PASTEUR (2 Mar 2023 newsletter; copy of final signed letter with > 230 signatories!), we now have two more calls for letters supporting key AMR funding initiatives. And importantly, you do not have to be US citizen or a US-based company to sign or submit comments … the US government appreciates the global nature of this problem and highlighting global interconnections would be valuable!
First (and easy to do), IDSA (Infectious Diseases Society of America), AdvaMedDx, American Society for Microbiology (ASM), BIO, Food Animals Concerns Trust (FACT), and the Society for Healthcare Epidemiology of America (SHEA) invite you to sign this letter (.docx, .pdf) to congressional appropriations leaders urging robust funding for federal AMR programs at CDC, ASPR/BARDA, NIAID, FDA, USDA, USAID, and the State Department. Sign by using this form! The official deadline is end of the day on Thu 25 Mar, but I’m told that your signature will be recorded if you sign by noon ET on Friday, March 24.
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Second (and a bit more work, but worthwhile!!), a process to again re-authorize PAHPA (the Pandemic and All-Hazards Preparedness Reauthorization Act) and there is an RFI underway for topics to include. The AMR community believe that inclusion of PASTEUR in PAHPA is great opportunity to bring PASTEUR into being … and this is the point of the letter discussed in the first paragraph of newsletter. As you may recall, that letter began with “On behalf of the undersigned organizations representing health care providers, public health professionals, scientists, patients, and the pharmaceutical and diagnostics industries, we urge you to include the PASTEUR Act in any moving legislative vehicle this year, including the reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA).“
During the BEAM-AMR Conference last week in Basel, Sen. Todd Young gave comments by Zoom and noted that The Senate Health, Education, Labor, and Pensions (HELP) Committee now seeks your input on policies that the Committee should consider during the reauthorization process The full list of topics Committee outlined topics/questions that stakeholders could respond to is found below my signature. This is only a suggestion, and a letter on PASTEUR only will also be recorded.
Comments are to be sent to the Committee by email at PAHPA2023Comments@help.senate.gov no later than close of business on Wednesday, March 29, 2023. Your comments should be in the form of letter urging the inclusion of the PASTEUR Act in the PAHPA reauthorization. Given the nature/focus of the legislative vehicle, you should explain how AMR impacts preparedness for outbreaks and pandemics, natural disasters like hurricanes, and bioterror events.
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And as inspiration for the importance of writing that letter to the Senate and for having the right antimicrobial fire extinguisher to hand, I close with a link to a 19 Mar 2023 Op-Ed by Bill Gates entitled “I Worry We’re Making the Same Mistakes Again”. As he says, “We need to prepare to fight disease outbreaks just as we prepare to fight fires. If a fire is left to burn out of control, it poses a threat not only to one home but to an entire community. The same is true for infectious diseases, except on a much bigger scale.” Love it!
Antibiotics are the #FireExtinguishersOfMedicine!
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.
PAHPA Request for Information
Send comments to at PAHPA2023Comments@help.senate.gov no later than close of business on Wednesday, March 29, 2023.
Program Effectiveness
What specific changes could Congress make to improve the efficiency and effectiveness of current HHS programs and activities? Specifically:
Public Health Emergency Coordination and Policy
- The responsibilities and authorities of the Secretary of Health and Human Services (HHS) prior to or during a public health emergency (PHE)
- The authorities, duties, and functions of the Assistant Secretary for Preparedness and Response (ASPR)
- The National Health Security Strategy (NHSS)
- The National Advisory Committees on Children and Disasters, Seniors and Disasters and Individuals with Disabilities and Disasters
Medical Countermeasures Development and Deployment
- The Strategic National Stockpile (SNS)
- The Biomedical Advanced Research and Development Authority (BARDA)
- Project BioShield
- The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and related strategy, implementation plan, and budget plan
- Emergency Use Authorizations and related authorities
- The Public Readiness and Emergency Preparedness (PREP) Act
- The Material Threat Medical Countermeasures Priority Review Voucher Program
Support for Jurisdictional Preparedness and Response Capacity
- The Public Health Emergency Preparedness (PHEP) Cooperative Agreements
- The Hospital Preparedness Program (HPP) Cooperative Agreements
- Other ASPR activities financed through the general HPP budget, such as the Regional Disaster Health Response System (RDHRS) demonstration projects
- The National Disaster Medical System (NDMS)
- The Medical Reserve Corps (MRC)
- The Emergency System for Advanced Registration of Volunteer Health Professionals (ESAR-VHP)
- Epidemic Intelligence Service (EIS) Loan Repayment Program
- The Epidemiology and Laboratory Capacity Cooperative Agreement Program and related activities, including mosquito abatement
- Biosurveillance and Public Health Situational Awareness
- Vaccine tracking and distribution
- Policies for the inclusion of at-risk individuals in public health emergency preparedness and response activities
Gaps in Current Activities & Capabilities
- What gaps do you see in the PAHPA framework, or how it has been implemented to date? (These gaps could be related to any of the programs noted above, or other aspects of the public health and medical preparedness and response ecosystem that are otherwise currently unaddressed.)
- Additionally, aside from currently authorized programs and activities, what gaps exist in HHS’ capabilities, and what types of activities or authorities are necessary for HHS to fulfill the intent of PAHPA and related laws?
Partnerships
What specific steps could Congress take to improve partnerships with states and localities, community-based organizations, and private sector and non-government stakeholders, such as hospitals and health care providers, on preparedness and response activities? For example:
- How can these entities be better supported in appropriately engaging with the federal government to understand available resources, capabilities, and expectations prior to, during, and following a public health emergency?
- How can foundational programs, such as the public health emergency preparedness cooperative agreements and the hospital preparedness program, be improved to ensure state, local, and health system readiness to mount effective responses?
Current funding opportunities (most current list is here)
- NIAID BAA with a biodefense focus: Vaccines, Therapeutics, and Diagnostics are all in scope. See this newsletter for details; various due dates through 11 April 2023.
- [UPDATED – New application round] CARB-X again has an open-round for funding applications with a deadline of 1 May 2023. Applications are sought for any of 3 themes (oral products, vaccines for neonatal sepsis, gonorrhea products) as described in this newsletter!
- 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.
- BARDA’s long-running BAA-18-100-SOL-00003 offers support for both antibacterial and antifungal agents. This BAA has offered 4 deadlines/year since 2018 … check the most current amendment for details.
- 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/).
- 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):
- 23-24 March 2023 (virtual, 10a-4p ET): 23rd Meeting of the Presidential Advisory Council on Combating Antibiotic Resistance (PACCARB). The PACCARB will vote on the report from the Pandemic Preparedness Working Group (PPWG) on how to strengthen defenses against AMR pathogens in the face of a potential future, large-scale disease event. Go here for details and to register.
- 14 Apr 2023 (Copenhagen, Denmark; 3-6.30p CEST): ECCMID and the Global Leaders Group on AMR will jointly sponsor a symposium entitled “Forging partnerships between science and policy in Antimicrobial Resistance (AMR).” Go here to register.
- 15-18 Apr 2023 (Copenhagen, Denmark): 33rd ECCMID. Go here for details and to register.
- 26 Apr 2023 (virtual, noon-1.30p CET): Webinar entitled “WHO Human health AMR research agenda” from WHO’s series entitled “WHO Global Webinar Series to Support Implementation of National Action Plans on Antimicrobial Resistance (AMR).” Go here to register.
- 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.
- [NEW] 3-5 Jul 2023 (Tours, France): 9th Symposium on Antimicrobial Resistance in Animals and the Environment (ARAE). Sponsored by INRAE (French National Research Institute for Agriculture, Food, and Environment, itself a merger of merger of INRA, the French National Institute for Agricultural Research, and IRSTEA, the French National Research Institute of Science and Technology for the Environment and Agriculture), this conference has been running since 2005. Go here for details.
- [NOW OPEN FOR APPLICATIONS!] 7-15 Oct 2023 (residential, Annecy, France): ICARe, the Interdisciplinary Course on Antibiotics and Resistance. Now in its 7th year, this course is a deep-dive into the world of antibiotic development. Intense, rigorous, and HIGHLY recommended. Seats are always limited … apply sooner rather than later! Go here for details.
- 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.
