FDA offers 2 fellowships and 3 RFPs! Endpoints, breakpoints, PROs & more!

Dear All,

Our colleagues at FDA are planning some serious AMR-related research during 2021-22 with the following fellowships and RFPs. Extended details are available via the links — you can also find brief summaries below my signature or via FDA’s research webpage. Wow!

  • FDA Fellowship #1: A study of ordinal endpoints for antibiotic trials using the desirability of outcome ranking (DOOR) concept. Application details here26 Feb 2021 deadline.
  • FDA Fellowship #2: A study of the discordance between symptoms and microbiology in cUTI trials. Application details here26 Feb 2021 deadline.
  • RFP #1: Up to 4 contracts ($250k each) to update breakpoints, especially for older drugs. Details here28 Jan 2021 deadline.
  • RFP #2: Research on the impact of extended duration infusion of beta-lactams on resistance and outcome. Details here28 Jan 2021 deadline.
  • RFP #3: Development of PROs (Patient-Reported Outcomes) tools for these 3 infections. Details here28 Jan 2021 deadline:
    • Non-tuberculous mycobacterial infections
    • Allergic bronchopulmonary aspergillosis (ABPA)
    • Coccidioidomycosis.


The fellowships run for at least a year (extensions may be possible) and are for early stage researchers at the Masters or Doctoral level (including MDs). The RFPs are standard US government RFPs under the currently open FY21 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science FDABAA-21-00123.

There are some impressive opportunities here … could one of these be for you? I hope so! 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.


  • FDA Antibacterial Drug Resistance (DOOR) Fellowship
    • “The project will evaluate ordinal endpoints using the desirability of outcome ranking (DOOR) approach for anti-infective clinical trials for indications such as hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP), complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI) and acute bacterial skin and skin structure infections (ABSSSI).  Under the guidance of a mentor, the selected candidate will perform analysis of the existing database of recently completed antibacterial drug trials to validate ordinal endpoints using the DOOR approach.”
    • 26 Feb 2021 deadline to apply, anticipated start date June 2021
      • The initial appointment is for a year; an extension may be possible.
      • FDA are currently working remotely but participants will be required to report on-site when a return to facilities does occur.
    • Further details are here: https://www.zintellect.com/Opportunity/Details/FDA-CDER-2021-0617

 

  • FDA Antibacterial Drug Resistance (cUTI) Fellowship
    • “Currently, the primary endpoint for complicated urinary tract infection (cUTI) trials is a composite of clinical and microbiologic outcomes assessed at a fixed time point after completing therapy. In recent clinical trials, it has been noted that while some patients are classified as microbiologic failures due to persistently positive urine culture, however they are doing well clinically such that no further antibacterial therapy is needed. The reasons for this discordance are unclear and need further evaluation. For this project, data from recently completed cUTI trials will be reviewed to assess the degree of discordance between the clinical and microbiologic endpoints, the reasons for the discordance and, based on the data, consideration will be given to revising the endpoint if needed.”
    • 26 Feb 2021 deadline to apply, anticipated start date June 2021
      • The initial appointment is for a year; an extension may be possible.
      • FDA are currently working remotely but participants will be required to report on-site when a return to facilities does occur.
    • Further details are here: https://www.zintellect.com/Opportunity/Details/FDA-CDER-2021-0618

 

  • FDA RFP #1: Updating Susceptibility Test Interpretive Criteria (breakpoints)
    • “FDA is interested in advancing the science of antibacterial drug susceptibility testing to ensure that up-to- date breakpoints are available for patient care and antimicrobial stewardship by supporting high quality proposals to obtain needed microbiologic and pharmacologic data needed to consider updating breakpoints for high priority drug-bacteria combinations.
    • “FDA will prioritize White Papers submitted in response to the FDA Broad Agency Announcement by the January 28, 2021 deadline that provide a rationale for why data to support updating of breakpoints for a particular drug-bacteria combination is a high priority, 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.
    • “Proposals also must include a plan to make research findings publicly available for consideration by the FDA and standards development organizations.”
    • 28 Jan 2021 deadline for initial Quad Chart and White Paper; anticipated funding by 30 Sep 2021
      • Four contracts of up to $250k are possible
    • For more details, download this pdf: https://www.fda.gov/media/133769/download

 

  • FDA RFP #2: Impact of Extended-Infusion of Beta-lactam Antibacterial Drugs on Resistance and Outcomes
    • “FDA is interested in advancing the understanding of the impact of dosing strategies of beta-lactam antibacterial drugs on development of antimicrobial resistance and patient outcomes.
    • “FDA will prioritize White Papers submitted in response to the FDA Broad Agency Announcement by the January 28, 2021 deadline that provide a rationale and study design to assess the association between extending the infusion time of beta-lactam antibacterial drugs and development of beta-lactam resistance and improvement in patient outcomes.
    • “Proposals also must include a plan to make research findings publicly available for consideration by the FDA and standards development organizations.”
    • 28 Jan 2021 deadline for initial Quad Chart and White Paper; anticipated funding by 30 Sep 2021
      • 1-2 contracts, total funding combined of up to $500k
    • For more details, download this pdf: https://www.fda.gov/media/144162/download

 

  • FDA RFP #3: 
    • “FDA is interested in the development, evaluation and qualification of PRO instruments for use in trials in patients with pulmonary NTM infections (including MAC and M. abscessus infections), coccidioidomycosis, and ABPA to facilitate evaluation of new therapies for these conditions.
    • “The studies to develop and assess a candidate PRO instrument should be well-designed to include plans for the qualitative phase of instrument development including: 1) hypothesize the conceptual framework, 2) adjust the conceptual framework and draft the instrument, and 3) confirm the conceptual framework and assess other measurement properties.
    • “No intervention studies involving the use of an investigational drug product will be funded through this RFP.
    • Studies to evaluate the PRO instrument under development in patients longitudinally would generally not be expected to be proposed under these research contracts but may be requested in a future funding opportunity.
    • “FDA will prioritize White Papers submitted in response to the FDA Broad Agency Announcement by the January 28, 2021 deadline that provide a rationale for why development of a PRO for pulmonary NTM infections, coccidioidomycosis, or ABPA is a high priority.
      “Proposals also must include a plan to make research findings publicly available for consideration by the FDA and standards development organizations.”
    • 28 Jan 2021 deadline for initial Quad Chart and White Paper; anticipated funding by 30 Sep 2021
      • Looks like different contracts for each PRO, each for up to $430k
    • For more details, download this pdf: https://www.fda.gov/media/144163/download

Current funding opportunities (most current list is here):

  • CDC has released a Broad Agency Announcement with that includes multiple opportunities for AMR-related work. See this newsletter for details. The deadline is 13 Jan 2021.
  • The US Department of Defense is funding pre-clinical research on small molecules vs. P. aeruginosa. See this newsletter for details. The deadline is 18 Feb 2021.
  • CDC has released an RFP entitled “Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD)” that seeks support for a broad range of healthcare epidemiology projects. See this newsletter for details. The deadline is 3 Mar 2021.
  • The National Institute of Allergy and Infectious Diseases (NIAID) Applicant Assistance Program (AAP) provides no cost support for companies planning to apply for a Phase II, Fast Track, or Direct-to-Phase II SBIR or STTR Award. Go here for details.
  • Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
  • CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (75 total awards, and counting and they conclude contracting on prior rounds), including future options on those awards. New rounds from CARB-X will occur only after new funding is obtained in 2021.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.
  • It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
  • Finally, you might also be interested in the 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 Jan 2021 (online, 11a-6p EST): Sponsored by UCSF-Stanford, the 2nd Innovations in Regulatory Science Summit. Featuring talks by three FDA Center directors (Peter Marks of CBER, Jeffrey Shugren of CDRH, Janet Woodcock of CDER), the program includes panel discussions on infectious disease and pandemic preparedness. It’s heavily virus oriented, but I anticipate useful perspectives that could be relevant to antibacterials. Its free — go here for details and to register.
  • 14 Jan 2021 (online, 5-6.30p CET): GARDP-sponsored webinar entitled “Manipulating the host response to treat infections,” moderated by Neeloffer Mookherjee. Go here to register.
  • 18-20 Jan 2021 (online, 10.00a EST to ???): A pair of virtual Keystone Symposia entitled “Harnessing the Microbiome for Disease Prevention and Therapy” and “The Microbiome: From Mother to Child”. Not a lot specifically on infection, but the deep biology typical of Keystone’s programs looks fascinating. Go here and here to register. 
  • [NEW] 25 Jan 2021 (online, 4-6 UK): Update webinar by the NHS England and NHS Improvement team who are running the UK Antibiotic Subscription pilot. Please mark your calendar now; the link for the webinar will be posted to https://amr.solutions/meetings/ when I have it.
  • 26-28 Jan 2021 (online, runs ~7.30a-5.00p Central each day): 4th Annual Texas Medical Center Antimicrobial Resistance and Stewardship Conference. Sponsored by McGovern Medical School, ARLG, and the Gulf Coast Consortia, the agenda includes both poster sessions and keynotes. The call for abstracts closes 18 Dec 2020. Go here for more details.
  • 2-3 Feb 2021 (online, 1-5p GMT): Antimicrobial Chemotherapy Conference 2021 sponsored by BSAC and GARDP in collaboration with the Helmholtz Institute for Pharmaceutical Sciences (HIPS), the German Center for Infection Research (DZIF) and the International Research Alliance for Antibiotic Discovery and Development (IRAADD, a JPIAMR-funded network). Go here for details and to register.
  • 10-11 Feb 2021 (online, 10a-4p EST): Virtual public meeting of PACCARB (US Presidential Advisory Council on Combatting Antimicrobial Resistant Bacteria). Go here for details.
  • [TITLE AMENDED] 25 Feb 2021 (online, 5-6.30p CET): GARDP-sponsored webinar entitled “From discovery to the pre-clinical antimicrobial candidate,” moderated by Michael Mourez. Go here to register.
  • 10-12 Mar 2021 (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; abstract deadline is 15 Nov 2020.
  • 9-12 Jul 2021 (Vienna): Annual ECCMID meeting (#31)
  • 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 24-29 May 2021 (online and in Geneva): ESPID 2021, the 39th Annual Meeting of the European Society for Paediatric Infectious Diseases. Save-the-date announcement is here, details to follow. 
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
  • 27 Jun-2 Jul 2021 (Ventura, CA): Gordon Research Conference entitled “Antimicrobial Peptides”. Go here for details, go here for the linked 26-27 Jun Gordon Research Seminar that precedes it.
  • 5-21 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
  • 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
  • 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students. Bonus feature: For obvious reasons, the course didn’t happen in 2020! But as a celebration of the course’s 5th year, a webinar version was held on 29 Oct 2020: go here to stream it. 
  • 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.

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