PASTEUR action; Wellcome convenes Global R&D discussion!

Dear All,

Two items for your attention today: an immediate action for you to take to support PASTEUR plus a launch event for a major Wellcome Trust project for your calendar. 

First, as you may recall, the Oversights & Investigations Subcommittee of the US House Energy & Commerce Committee recently held a hearing about the impact of AMR. Now the Health Subcommittee is holding a hearing on 13 June 2023 to consider a list of bills as part of the Pandemic and All Hazards Preparedness Act (PAHPA) reauthorization.

At the time of writing, the PASTEUR Act has not been included on this list but it isn’t too late. Our community needs to reach out to the Committee in order to get PASTEUR as part of the stack of bills to be considered for PAPHA. There was a previous newsletter about including PASTEUR in PAPHA and you can reference it for the content of your message to the subcommittee. Even a simple email to your local congressional representative could help get PASTEUR onto the list to be considered! For the simplest way to take action, you can use the IDSA’s online action center to connect directly with your representative and provide a pre-written message on PASTEUR that you can then modify at your own discretion. Action on this TODAY would be ideal!
 
Second, the Wellcome Trust is hosting a 3-month long discussion entitled “Reforming the R&D ecosystem for infectious disease: A Global Conversation” with the launch event happening on 13 June 2022! This specific event will be focused on Wellcome’s recent discussion paper “Towards a reformed R&D ecosystem for infectious disease” and will run for approximately 2 hours. After the presentation of the paper and a Q&A, participants will then be asked to work in small groups to begin defining the scope of the work that needs to be done. This is not your typical webinar series; active webinar participation is vital and expected!

This will be the beginning of their Global Conversation events and the overall goal is to hear from stakeholders globally about what needs to be done to improve the R&D status quo. There will also be other events throughout June, July, and August so check out the detailed scheduleIf you can’t attend but still want to be provide feedback on Wellcome’s report, fill out this form after reading the discussion paper.

In brief, Wellcome proposes that we need to envision broad changes to the infectious disease R&D ecosystem by recognizing that there are systemic challenges affecting both R&D and access across multiple areas (including antibiotics), as well as cross-cutting opportunities for change to improve how and where R&D is done. Wellcome’s key areas for this work are (i) priority-setting, (ii) clinical trials and regulation, (iii) globally diverse manufacturing, and (iv) aligning innovation and equitable access. You will readily spot the elements most relevant to the R&D community but please read the paper and see if other elements strike a chord for you: it’s an exciting set of ideas that come at a good time relative to the overall arc of the global policy conversation.

To gather global input during discussions, Wellcome has partnered with CoLab International to produce an independent report capturing the issues, challenges, questions, debates and solutions proposed by participants, including those which might not fall within the scope of Wellcome’s remit for action. The summary of the feedback will be shared publicly by Wellcome later this year.

Yow! Reach out to the subcommittee and signup for Wellcome’s webinar! 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.

Current funding opportunities (most current list is here)

  • 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/).
  • 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):

  • 10 Jun 2023 (Virtual, 3-5.30p India Standard Time): Sponsored by the AMR Declaration Trust, a webinar entitled “Engaging the Pharmaceutical Industry in Joint Efforts to Tackle Antimicrobial Resistance.” Thinking globally and acting locally, this webinar will be a conversation about the global pipeline with a focus on ideas for action in India. Go here to register.
  • [NEW] 13 Jun 2023 (Virtual, 8a-10a ET): Wellcome Trust’s “Reforming the R&D ecosystem for infectious disease: A Global Conversation” launch event as detailed in this newsletter. Go here to register and read about the entire event series here.
  • 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.
  • 4-6 Aug 2023 (Bangkok, Thailand): The regional Medical Mycology Training Network Conference by ISHAM’s Asia Fungal Working Group is set to feature both hands-on workshops and clinical sessions for all those managing and working with invasive fungal infections. Go here for details. 
  • 19-22 Sep 2023 (Boston, USA): ASM-ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent development focused meeting … highly recommended! Go here for details and to register. 
  • 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.
  • 11-15 Oct 2023 (Boston, USA): IDWeek 2023, the annual meeting of the Infectious Diseases Society of America. Go here for details and to register. 
  • 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.
  • 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.
  • 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.
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