Pulling for Pandemic Preparedness

Dear All,

This evening I’d like to bring together several relatively recent reports and note how all of them focus in one way or another on Pulling for Pandemic Preparedness … perhaps we can call this the Rule of 3 Ps. And as an aside, I’ll note that I learned the Rule of 4 Ps (Penicillin Penetrates Pus Poorly) and the Rule of 6 Ps (Proper Prior Preparation Prevents Poor Performance) many years ago when I was a medical student … and both have stood the test of time as valuable ideas!

With that out of my system (just had to say it, but we’ll also come back to these rules in a moment), we’re off to a 3-part tour. To follow along, here are the links you’ll need:

  • A 21 Sep 2023 report from CGD (Center for Global Development) entitled “A New Grand Bargain to Improve the Antimicrobial Market for Human Health.
  • A report entitled “A Shared Dialog on Pull Incentives” from the Global AMR R&D Hub of 27 April 2023 discussion by a diverse stakeholder group (NGO, civil society, Academia, Industry, global funders) on the approach to pull incentives for incentivizing the development of and access to new antimicrobials.
  • A 23 Oct 2023 report from the Duke-Margolis Center for Health Policy entitled “Bolstering Public Health Preparedness by Investing in Post-Market Incentives for Novel Antibiotics.
  • And relatedly, you might also want to review the 11 May 2023 newsletter discussing reports from the AMR R&D Hub to the G7 Finance & Health Minister as well as a recent reprise of a 2020 report from the US GAO (Government Accounting Office).

Let’s start with the report from CGD. As shown in the graphic below, this report proposes a global Grand Bargain based on answering the question “Why would any given group take action to support an antibiotic ecosystem?”:

The answer? Well, both high- and low-/middle-income countries (HICs, LMICs) would gain a system that ensures sustainable access to effective antimicrobials while the pharmaceutical industry gains a system that both adequately remunerates research and that removes barriers to selling antimicrobials in LMICs. 

This perspective has often been present in prior reports in the discussion of the access-innovation-stewardship triangle but CGD’s contribution is in calling out the idea of “How do I / we benefit?” so explicitly. And this is an interesting change from the inverse perspective of (to paraphrase) “How do I / we avoid providing support for products that don’t work very well?” that was a central theme of the 2021 EU-JAMRAI policy brief entitled “Incentivizing Antibiotic Access and Innovation”  (for a deep dive on this angle, see the 25 April 2021 newsletter on the report as well as the related Fireside Chat with Christine Ardal).

There’s a lot more in CGD’s report, but let’s now follow a thread from their recommendation that we “… ensure that innovation is properly valued and meets the needs of LMICs” to the Global AMR R&D Hub’s report on Shared Values that notes:

  • “For any pull incentive, it is critical that a global perspective is pursued.”
  • “Although countries have their own priority needs & burden, alignment across countries will help support predictability.”
  • Building stewardship & access into pull incentives at an early stage is helpful.”

OK, but what exactly does it mean to have a global perspective? Well, I think this figure from CDC answers that question rather neatly. Yes, there are resistant pathogens that are more common in some parts of the world today than in others (e.g., Neisseria gonorrhea; and congratulations here to GARDP for delivering a successful Phase 3 study of zoliflodacin, a new antibiotic for same) but with 1 billion people crossing international borders each year, resistance that was remote last week can suddenly be present in your hospital system:

As CDC’s figure shows, there is no place to hide from AMR! And this brings us to our 3rd stop on this tour, the excellent report from Duke-Margolis on pandemic preparedness. I thought the essential theme was well captured in this quote from Jose Fernandez (Acting Director, Pandemics and Emerging Threats, HHS) who says, “Our investments in combating AMR can be foundations for preparedness. We know that the infrastructure and capacities that we need to address AMR align well with the capacities that we need to address pandemics.” Exactly so … it’s all connected!

And so with that, we loop back to the Rules of 3 and 6 Ps: By Pulling for Pandemic Preparedness, we will ensure that Proper Prior Preparation Prevents Poor Performance. I like the idea of linking all this to the goal of Pandemic Preparedness as this is now such a well and widely understood idea … it is the kind of theme that creates opportunities for alignment across policymakers from different parts of the political spectrum … everybody can get behind not dying from an infection!

And I would link all of this to the recurring call to pass the PASTEUR Act in the United States (and of course, the corresponding projects in Canada, the EU, and Japan)! To be prepared for those pandemics, we need both to fix the global pipeline and then (critically!) ensure that drugs reaching approval both stay on the market and are widely available

Preparedly 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: 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-XC-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!
  • 7-9 Nov 2023 (Atlanta, USA): 13th Annual Antibiotics Symposium hosted by the National Institute for Animal Agriculture. Go here for details. 
  • 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.
  • [NEW] 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.
  • [NEW, with multiple events] 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.
  • 6-7 Feb 2024 (online): 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,[NEW]  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.an


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