FORWARD Act, PREVENT Act, new NIAID RFP!

Dear All, Our US government colleagues have been busy! Three things back-to-back:

First, the FORWARD Act (Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2022”) was introduced in the US Senate on 13 Jan 2021 as S.3498 by Sens. Kelly, Sinema, and Feinstein. You’ve got to admire the acronymics! The Senate bill is the companion bill to the House version (H.R.5566) introduced on Oct 2021 by Reps. McCarthy, Schweikert, Bass, and O’Halleran. Rep. McCarthy is steadily pushing this along: A version of this Act was introduced in the previous session of congress as H.R. 2858 (116th): FORWARD Act of 2019. In brief, this Act encourages research in to treatment of endemic fungal diseases with a particular focus on coccidioidomycosis.

Second, Senators Murray and Burr released a discussion draft of the PREVENT Pandemics Act (Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act). This legislation is focused on strengthening US public health and medical preparedness and response systems in the wake of COVID-19. There’s a lot in this one on the broad theme of enhanced infrastructure and the discussion draft is meant as a step towards a final bill.

It’s not clear how far either of these Acts this will ultimately go — and that’s true of all legislation at these early stages — but every bit of conversation about the need for preparedness is one more opportunity to broaden the conversation to include all the stakeholders necessary for progress. It’s also not a stretch to see how FORWARD and PREVENT could be connected to PASTEUR and Cures 2.0. Many thanks to the Senators, Representatives, and their staffers who have worked to advance the conversation!


Third, we have an interesting NIAID RFP. Entitled “Preclinical Services for Biopharmaceutical Product Development”, the RFP seeks to create a “multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) type contract.” Read that one slowly (IDIQ is not in my everyday lexicon!!) and then read this text from the solicitation:

  • “The development and introduction of new therapeutic products against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority.
  • “To assist in filling these public health gaps, the NIAID requires a nontraditional, proactive, and product development-oriented program to provide preclinical product development support for promising biopharmaceutical therapeutic candidates for human infectious diseases or diseases caused by infectious agents.
  • “The suite of services included in this IDIQ contract will encompass those activities commonly associated with the development of biopharmaceutical products for treating or diagnosing infectious disease that are required for Investigational New Drug (IND) application and/or Biologic License Application (BLA) and/or other FDA submissions including 510(k) application and Investigational Device Exemption (IDE) application.
  • “These services are available for therapeutic candidates arising from academia, the private sector or other sources.”

Digging a bit deeper, the RFP is for up to $30m over a contract period of 5 Jan 2023 through 5 Jan 2030 for a contractor who can provide a broad range of support services at the discretion of NIAID. I’ll leave to those who think they might be able to respond to dig more deeply, but it’s really interesting to see how NIAID uses a multiple award IDIQ (say that quickly 3 times!) to provide services to product developers … good work, Team NIAID!

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 PAR Foundation has two open calls. First, are early career grants (students at bachelor and masters level, PhD students, and individuals graduating during 2020-2022) of up to ~€30k to support 1-year projects on prevention of antibiotic resistance. Second, grants up to ~€1000k to support projects with the potential to prevent infections and antibiotic resistance among elderly. Go here for details; the deadline for both is 10 Mar 2022.
  • NIAID has released a four-pronged BAA (Broad Agency Announcement (HHS-NIH-NIAID-BAA2022-1) that covers therapeutics (antibacterial, antifungal, antiviral), vaccines (again, all 3 areas), and diagnostics. Lots of possibilities! The due date is 18 Mar 2022.
  • BARDA’s RFP to support new antibiotics for Yersinia pestis, Francisella tularensis, Burkholderia pseudomallei is open through 6 April 2022. The RFP offers from funding from LO to Phase 2. Go here for the details.
  • JPIAMR’s 14th call is now open. Entitled “Disrupting drug resistance using innovative design”, the call seeks consortia that would seek to “improve the treatment of bacterial and fungal infections (including co-infection) and/or the prevention of the emergence/spread of resistance in humans, animals or plants through the improvement of the efficacy, specificity, delivery, combinations and/or repurposing of drugs and plant protection agents.” Bacteria, fungi, human health, animal health, and plant health are all in scope! Pre-proposals are due 8 Mar 2022; full proposals would be due 5 July 2022. Go here for 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 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/).
  • CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (more than 80 total awards, and counting, as they include contracting from prior rounds). New rounds from CARB-X will occur only after new funding is obtained in 2021.
  • 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):

  • [If you missed it, you can now watch the video] 8 Dec: “The New Winds Pushing and Pulling Antibacterial Development.” This was a GREAT program that 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!
  • 26 Jan 2022 (virtual, 2-3.30p CET): REVIVE (GARDP) Webinar: New technologies and strategies to overcome the challenges of sexually transmitted infections. Moderated by Amir Schroufi and Remco Peters, the program will covers strategies for managing STDs with a particular focus on the developing world. Go here to register.
  • 2-3 Feb 2022 (virtual): 10th Advances Against Aspergillosis and Mucormycosis. Registration closes on 30 Jan 2022. Go here for details.
  • 2-3 Feb 2022 (virtual): Antimicrobial Chemotherapy Virtual Conference jointly organised by GARDP with the British Society for Antimicrobial Chemotherapy (BSAC), Center for Disease Dynamics, Economics & Policy (CDDEP) and the Indian Council of Medical Research (ICMR). Click here for details.
  • [NEW] 4 Feb 2022 (virtual, 5-6.30p GMT): Launch of the GRAM (Global Research on Antimicrobial Resistance) report. Sponsored by the Institute for Health Metrics and Evaluation, the University of Oxford, the Fleming Fund, the Bill & Melinda Gates Foundation and Wellcome Trust, this report by Murray et al. is based on 471 million individual records or isolates and 7585 study-location-years’ worth of data and shows that at least 1.27 million deaths per year are directly attributable to AMR. Amazing stuff! #AMRSOS! Go here to register. If you miss it, a post-event recording will be available.
  • 7 Feb 2022 (virtual, 10a-11.30a and 3:30p-5p CET): 2-part webinar entitled Antimicrobial Consumption & Use – Data for Action as part of the WHO Global Webinar Series. Be sure to register for both session 1 and session 2
  • [NEW] 3 Mar 2022 (virtual, 2p GMT): The Longitude Prize (run by Nesta Challenges), CARB-X and FIND, have joined forces for a virtual event in March, AMR& Diagnostic Frontiers: Developing and increasing access to innovative diagnostics in and for low-and-middle-income countries (LMICs). Full agenda details and registration can be found here, including an invitation for diagnostic companies to pitch to a panel of global health representatives.
  • 3-6 Mar 2022 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Details are here.
  • 6-11 Mar 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.
  • 9 Mar 2022 (virtual, and in-person): BioInfect Conference, Alderley Park, UK (near Manchester). This long-running Bionow-sponsored annual conference draws a very strong audience. Go here for details.
  • 7-8 Apr 2022 (Basel and in person, we hope): The 6th edition of the annual AMR conference sponsored by the BEAM AllianceCARB-X, the Novo REPAIR Impact Fund, the IMI Accelerator, and the European Biotechnology Network. Go here for the hold-the-date page and a way to be kept informed about the meeting. 
  • 9-13 May 2022 (Athens and online): 40th Annual Meeting of the European Society for Paediatric Infectious Diseases, 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.
  • 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.

Dear All,
 
The IDWeek 2024 program committee is again seeking programs on novel antimicrobial agents and novel diagnostics for presentation in pipeline sessions! Here’s what is sought:

  • “Industry partners are invited to submit antimicrobials that are in preclinical stages of development (Phase II and III preferred) or recently approved after January 2024.
  • “The pipeline sessions will include antibacterials, antifungals, and antivirals (excluding COVID-19 and HIV).
  • “The committee also invites companies developing novel diagnostic technologies with a minimum of some preliminary proof of concept data to submit.” 

This is a great opportunity to tell the story of your development project! The deadline to submit is Wednesday, June 26 via the application portal. Any questions should be directed to program@idsociety.org. Please share this email with anyone you think might be interested in applying!
 
In addition, I’ll also note that those with a more general story to tell should look at the BugHub Stage (and the Global BugHub stage). Both BugHub variants seek “presentations that touch on your experience of working in infectious diseases and presentations that ultimately lead to a greater understanding of our diverse field” via a TED Talk-esque speech about your work. The deadline for applications is 26 June, the same as for the pipeline sessions.

I look forward to seeing you there! 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.

John’s Top Recurring Meetings

Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 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. 
  • 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 save the date!
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Save the date! More details to come!
  • 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. Go here to register

Upcoming meetings of interest to the AMR community:

  • [NEW]  9 Apr 2024 (virtual, 830a-10a ET): GARDP’s next REVIVE webinar entitled “Progressing a discovery project – Criteria and challenges.” Register here.
  • [NEW] 9 Apr 2024 (virtual, 10a-1130a ET): CDC webinar “Impacts of Antimicrobial Resistance on Cancer Care.” Click here for details and to register.
  • 10-11 Apr 2024 (virtual): Sepsis Alliance AMR Conference, a 2-day conference focused on “Practical technologies to manage sepsis and counteract the expanding challenge of antimicrobial resistance.” Go here for details and to register.
  • 26 Apr 2024 (Barcelona, Spain): ESCMID workshop entitled “Using Data Science and Machine Learning for Infection Science: A Hands-on Introduction.” Click here to register or here for more details. 
  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
  • 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.
  • 28-29 May 2024 (in person, Uppsala, Sweden): Uppsala Antibiotic Days, a broad-ranging 2-day program hosted by the Uppsala Antibiotic Center. Go here for details and to register.
  • [NEW] 30-31 May 2024 (face-to-face in Rockville, Maryland as well as online, 8.30-5.30p ET on 30 May, 9-2.40p on 31 May): NIAID-sponsored workshop entitled “Towards realizing the promise of adjunctive immune therapy for invasive fungal infections”. The agenda covers host immunity to invasive fungal infections, immune modulators in the context of fungal infections; and strategies for testing immune modulators as adjunctive therapy. Go here for more details and to register.
  • 9-13 June 2024 (in person, Ascona, Switzerland): “New Approaches to Combat Antibiotic-Resistant Bacteria, 2nd Edition” is a Sunday-Thursday residential workshop focused on the deep biology of AMR. Sponsored by NCCR AntiResist (a Swiss National Science Foundation consortium), the scientific program has the feel of a Gordon Conference. Space is limited, so you are encouraged to apply promptly — go here for details.
  • 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. See Recurring Meetings list, above.
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above. 
  • 19-27 Oct 2024 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance). Now in its 8th year, Patrice Courvalin directs the program with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Seating is limited, so mark your calendars now if you are interested. Applications open in March 2024 — go here for more details.
  • 4-5 Dec 2024 (in person, Washington, DC): “Fungal Dx 2024: Fungal Diagnostics in Clinical Practice” is a 2-day in-person workshop organized by ISHAM‘s Fungal Diagnostics Working Group. The program and registration links are available at https://fungaldx.com/; the agenda is comprehensive and features an all-star global list of speakers.

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