Five FDA RFPs! Antifungal animal models, MIC breakpoints, and more!

Dear All, I just today learned that FDA have posted their FY 2023 funding opportunities. All the details are on this webpage and I’m just going to reproduce the text below my signature for your reference. I’ll also add a few details in italics. Lots of good opportunities here! –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 FY23 FDA Funding Opportunities

“The FDA funds research proposals through FDA’s Broad Agency Announcements for the Advanced Research and Development of Regulatory Science. This is a competitive announcement where research proposals to facilitate antibacterial drug development and address antibacterial drug resistance are evaluated on an ongoing basis throughout the fiscal year. The BAA is currently open for submissions.

“Below is a list of current FY23 Research Funding Opportunities. Quad Charts and White Papers are due by January 23, 2023.

  1. Request for Proposals: Research Funding Opportunity to Facilitate Systemic and Inhaled Antifungal Drug Development and Address Antifungal Drug Resistance (PDF – 143 KB): From the RFP: Specifically, research proposals focused on advancing the development of animal models of serious infections caused by rare, emerging, and drug-resistant fungal pathogens associated with invasive systemic disease will be prioritized.
  2. Request for Proposals: Research Funding Opportunity to Evaluate the Useability and Impact of Antimicrobial Drug Labeling for Healthcare Providers (PDF – 149 KB): From the RFP: Specifically, research proposals focused on methods to evaluate and enhance the functionality and utility of product labeling of antimicrobial drugs to better communicate scientific information to healthcare providers on the optimal use of these drugs (including those that are active against bacteria and fungi resistant to many currently available therapies) will be sought. 
  3. Request for Proposals: Research Funding Opportunity to Evaluate the Utility of In Vitro Models to Characterize the Urine-Specific Antibacterial Pharmacokinetics and Pharmacodynamics (PDF – 157 KB): From the RFP: Specifically, research proposals focused on evaluating the utility of in vitro models to derive urine-specific antibacterial pharmacokinetic/pharmacodynamic parameters in support of drug development for uncomplicated urinary tract infections will be prioritized. 
  4. Request for Proposals: Research Funding Opportunity to Facilitate the Development of Urine-Specific Susceptibility Test Interpretive Criteria (Breakpoints) (PDF – 180 KB): From the RFP: Specifically, research proposals focused on evaluating microbiologic and pharmacokinetic data that could be utilized by standards development organizations and the FDA to update urine-specific susceptibility testing criteria (breakpoints) will be prioritized. 
  5. Request for Proposals: Research Funding Opportunity to Facilitate Updating Susceptibility Test Interpretive Criteria (Breakpoints) (PDF – 224 KB): From the RFP: Specifically, research proposals focused on evaluating microbiologic and pharmacokinetic data that could be utilized by standards development organizations and the FDA to update susceptibility testing criteria (breakpoints) will be prioritized. Yes, this is exactly the same short summary as for #4!

Current funding opportunities (most current list is here)

  • Current funding rounds from CARB-X are 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):

  • 27-30 Nov 2022 (Perth, Australia): 32nd International Congress of Antimicrobial Chemotherapy is the biennial congress of the International Society of Antimicrobial Chemotherapy (ISAC). Go here for details.
  • [NEW] 2 Dec 2022 (Harvard, Boston, 9a-6p with reception to follow): BAARN, the Boston Area Antimicrobial Resistance Network. A full day of networking and lectures, including a keynote by Gerry Wright. Go here for details and here to register.
  • 3-7 Dec 2022 (Banff, Canada): Novel Approaches Against Emerging Antimicrobial Resistance by Keystone Symposia. Go here for details. 
  • [NEW] 1-2 Feb 2023 (virtual): Antimicrobial Chemotherapy Conference by GARDP and BSAC in collaboration with ReAct Africa and Africa CDC. Go here for details.
  • 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.
  • 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.
  • [NEW] 14-22 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.

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