FDA posts 4 RFPs! MIC breakpoints, PRO for ABPA, dosing in obesity/CRRT!

Dear All,

Whew … still catching up after all the activities of World Antimicrobial Awareness Week (WAAW)!  More to follow on some of that great content, but for today we have the news that FDA has posted 4 RFPs! All have due dates of 21 Jan 2022:

  • Optimizing dosing strategies for obese patients and in continuous renal replacement therapy (link)
    • Up to three contracts for proposals that “provide a rationale and study design to assess methods to optimize dosing strategies for antimicrobial drugs to treat populations at high risk for treatment failure or adverse events, specifically obese patients and patients who are receiving CRRT.”
  • Developing a PRO instrument for ABPA (link)
    • One contract for a proposal “focused on developing patient reported outcome (PRO) instruments for evaluating results of clinical trials in allergic bronchopulmonary aspergillosis (ABPA).”
  • Updating urine-specific interpretive (MIC) breakpoints (link)
    • One contract for work that will “provide a rationale for the proposed approach to evaluate urine-specific breakpoints and selection of particular drug-bacteria combinations, propose to synthesize or obtain relevant microbiologic data, propose to generate urinary drug pharmacokinetics data and bactericidal activity data in patients with uUTI or healthy adults using state-of-the-art methodologies (e.g., population PK modeling), propose to utilize relevant human pharmacokinetic data and animal model studies to conduct probability of target attainment analyses, incorporate any clinical response data available in the public literature or other sources to justify any proposal for using urine-specific breakpoints based on the research findings.”
  • Updating interpretive (MIC) breakpoints for important bug-drug combinations (link)
    • Up to two contracts that “provide a rationale for why data to support updating of breakpoints for a particular drug-bacteria combination is a high priority including the specific data gap, propose to synthesize or obtain relevant microbiologic data, propose to utilize relevant human pharmacokinetic data and animal model studies to conduct probability of target attainment analyses, incorporate any clinical response data available in the public literature or other sources to justify any proposal for updating of breakpoints based on the research findings. Proposals to obtain data for older antibacterial drugs are encouraged.”

Also know that the RFPs can also be found on the Office of Infectious Diseases (OID) research webpage:  www.fda.gov/oidresearch

Wow! These look like fun projects! And please note that these opportunities are open to everybody no matter where located in the world. Please sharpen your pencils and submit those proposals!

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.
  • 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):

  • 3 Dec 2021 (Boston, in person, 9a-6.30p, COVID vaccination required): 8th annual BAARN (Boston Area Antimicrobial Research Network) meeting. Go here for details; registration link is here.
  • 3 Dec 2021 (virtual, US daytime timings): Symposium entitled “Advances in Antibacterial Discovery” sponsored by the St. Jude Department of Chemical Biology and Therapeutics, is a part of the broader Bringing Chemistry to Medicine series and is supported by the St. Jude T32 Infectious Disease Therapeutics training program. Go here for details and to register.
  • 8-9 Dec 2021 (virtual, 9a-noon East Coast US): ASM-ESCMID-sponsored joint conference on antimicrobial drug development. This is the 2021 online version of one of my favorite meetings and I strongly encourage attendance on both days to gain a perspective on how new reimbursement models are going to change the R&D landscape. Online agenda is here, registration link is pending so just mark your calendar for now.
    • 8 Dec: “The New Winds Pushing and Pulling Antibacterial Development.” DO NOT MISS THIS ONE! Featuring 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, this promises to be a key update for the whole community.
    • 9 Dec: CARB-X – GARDP Boot Camp: What Makes a Good Project Succeed? Featuring speakers with many years of R&D experience, this session makes a good companion to the 8 Dec talk and will leave you well informed on best ways to guide your search for new antibiotics.
  • 14 Dec 2021 (virtual, 9a-1030a EST): CDC webinar entitled “Hooves, Paws, or Feet: A Multispecies Examination of Antimicrobial Use and Stewardship Practices”. This event is the third installment of the AMR Exchange webinar series. Click here for details.
  • 2-3 Feb 2022 (virtual): 10th Advances Against Aspergillosis and Mucormycocosis. 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.
  • 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.
  • 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.

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