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 here. 26 Feb 2021 deadline.
• FDA Fellowship #2: A study of the discordance between symptoms and microbiology in cUTI trials. Application details here. 26 Feb 2021 deadline.
• RFP #1: Up to 4 contracts ($250k each) to update breakpoints, especially for older drugs. Details here. 28 Jan 2021 deadline.
• RFP #2: Research on the impact of extended duration infusion of beta-lactams on resistance and outcome. Details here. 28 Jan 2021 deadline.
• RFP #3: Development of PROs (Patient-Reported Outcomes) tools for these 3 infections. Details here, 28 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://web.archive.org/web/20210513093758/https://web.archive.org/web/20210513093758/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