Opportunity Information: Apply for W81XWH 22 TBDRP TDRA
The DoD Tick-Borne Disease, Therapeutic/Diagnostic Research Award (FY22 TBDRP TDRA) is a Department of Defense funding opportunity aimed at moving practical, product-oriented solutions for Lyme disease and other tick-borne diseases closer to real-world use. The program is designed for hypothesis-driven research that has clear translational potential, meaning the work should be positioned to improve patient care and/or quality of life for military Service Members, Veterans, their beneficiaries, and the broader public. The emphasis is on empirical, development-focused studies that push a therapeutic candidate or diagnostic approach forward rather than purely exploratory or basic research.
Applicants can apply under one of two main focus areas. The Treatment Focus Area supports therapeutic evaluation studies intended to advance early-stage or preclinical drug and treatment discovery. This includes work that helps identify, refine, evaluate, or select promising therapeutic candidates before they reach human testing. The Diagnosis Focus Area supports development of diagnostic approaches that are likely to be adopted in routine clinical settings, with attention to practical implementation and performance characteristics that matter to clinicians and patients (for example, improving sensitivity, specificity, and usability). Across both tracks, the program expects projects to be product-driven, with a line of sight to eventual transition, including partnerships that can help move an approach toward deployment.
The types of activities encouraged under this award cover a broad but clearly applied range of preclinical and translational development tasks. Examples include evaluating and down-selecting therapeutic candidates using in vitro and/or in vivo studies; building and testing proof-of-concept diagnostic assays or devices with in vitro or ex vivo samples; running high-throughput screening and confirming hits; testing new therapeutic modalities or delivery mechanisms in established preclinical models; and conducting early formulation, stability, and safety studies that prepare a product for more advanced development. The announcement also explicitly supports studies that generate the kind of data needed for regulatory pathways, such as Investigational New Drug (IND)-enabling work for pharmacologic agents (including compound characterization, ADME studies, dose-response studies, and toxicology) and Investigational Device Exemption (IDE)-enabling work for devices (including prototype development and device characterization) to demonstrate safety and performance in relevant models or samples. In addition, it encourages work that improves the practicality of evidence-based treatments, such as making therapies easier to administer outside of traditional clinical environments.
Human subjects research and the use of human anatomical substances are allowed, but clinical trials are not permitted under this specific opportunity. In other words, applicants can work with human samples and human-derived data, but they cannot run interventional clinical trials as part of the proposed project. To strengthen applications, the program encourages applicants to leverage existing resources when possible, including validated specimens and data from Lyme and tick-borne disease biorepositories and databases, and to design studies that maximize statistical power. Strong study design expectations are highlighted, including authentication of proposed cell lines, statistical rigor for in vitro and animal experiments, and validation using well-characterized cohorts of uniformly documented patients. The announcement also welcomes projects that use large patient datasets with long-term health records and biospecimen repositories, and projects that apply state-of-the-art genomics, proteomics, bioinformatics, or mathematical modeling, as long as applicants clearly describe inclusion/exclusion criteria for curated specimens or datasets to justify their validity.
Collaboration is treated as a major success factor. Investigators who are new to tick-borne disease research are strongly encouraged to team up with established tick-borne disease researchers to ensure disease-area depth and appropriate models, samples, and interpretation. Conversely, investigators who already have substantial tick-borne disease expertise are strongly encouraged to partner with experts in therapeutic development, diagnostic assay development, and especially transition and commercialization, including collaborators from the commercial sector. The underlying message is that the program is not just looking for interesting science; it is looking for science that is organized to become something usable.
A dedicated Career Development Option is also available for early-career investigators, and it is reviewed separately using career development-specific criteria by a dedicated peer review panel. This option is designed for researchers within 10 years of completing their terminal degree (with residency time and family medical leave excluded from the calculation) who will conduct impactful work under the mentorship of an experienced tick-borne disease investigator. The applicant institution is expected to show a strong commitment to the candidate by providing at least 75 percent protected research time for the PI (with more protected time viewed favorably). Mentorship requirements are specific: the mentor should have a recent track record (past 5 years) of tick-borne disease funding and publications, ideally with prior mentoring experience, and must hold at least an Associate Professor-level position or equivalent. A formal Career Development Plan is required and should explain how the PI will gain needed skills, build expertise in tick-borne diseases, and engage with relevant scientific and (when applicable) advocacy communities, along with a concrete plan for ongoing mentor involvement even if the mentor and PI are at different institutions. A key difference is that preliminary data are not required for the Career Development Option, whereas preliminary data are required for the standard Therapeutic/Diagnostic Research Award mechanism.
From a funding and administrative standpoint, awards are issued as assistance agreements, meaning they may be structured as either a grant or a cooperative agreement depending on anticipated DoD involvement during the project. If the agency expects no substantial involvement, the award is typically a grant; if substantial involvement is anticipated (such as collaboration, participation, or intervention in the research), the mechanism becomes a cooperative agreement and the specific involvement is spelled out in the award. Budget-wise, the maximum anticipated direct costs for the standard Therapeutic/Diagnostic Research Award are capped at $825,000 for the entire period of performance. The Career Development Option has a lower direct cost cap of $495,000. The opportunity was run under the USAMRAA/CDMRP framework (CFDA 12.420) and was broadly eligible (unrestricted eligibility, subject to any clarifications in the full announcement).
In terms of scale and timing, CDMRP planned to allocate about $4.2 million total, with an expectation of funding roughly four awards in total: approximately two standard Therapeutic/Diagnostic Research Awards and two Career Development Option awards. As with most federal competitions, actual funding depended on federal fund availability, the volume of applications received, and the scientific and programmatic merit determined through peer and programmatic review. The notice anticipated making awards no later than September 30, 2023, and noted that FY22 funds supporting awards would expire for use on September 30, 2028, which effectively sets the window in which the obligated funds must be spent according to federal fiscal rules.Apply for W81XWH 22 TBDRP TDRA
- The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Tick-Borne Disease, Therapeutic/Diagnostic Research Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Apr 11, 2022.
- Applicants must submit their applications by Aug 25, 2022. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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FAQs: DoD Tick-Borne Disease, Therapeutic/Diagnostic Research Award (FY22 TBDRP TDRA)
1) What is the FY22 TBDRP Therapeutic/Diagnostic Research Award (TDRA)?
This is a Department of Defense (DoD) funding opportunity under the Tick-Borne Disease Research Program (TBDRP) focused on moving practical, product-oriented solutions for Lyme disease and other tick-borne diseases closer to real-world use. It supports hypothesis-driven research with clear translational potential, meaning the proposed work should be positioned to improve patient care and/or quality of life.
2) What types of diseases are in scope?
The opportunity targets Lyme disease and other tick-borne diseases.
3) What is the main goal of the program?
The program emphasizes empirical, development-focused studies intended to push a therapeutic candidate or diagnostic approach forward toward eventual use. The work should have a clear line of sight to transition, deployment, and/or adoption in real-world settings.
4) Is this opportunity aimed at basic science or applied development?
It is aimed at applied, translational development rather than purely exploratory or basic research. The expectation is that projects are product-driven and positioned to advance a therapeutic or diagnostic toward practical use.
5) What are the two main focus areas applicants can choose from?
Applicants can apply under one of two focus areas: (1) Treatment Focus Area (therapeutics) or (2) Diagnosis Focus Area (diagnostics).
6) What kinds of projects fit under the Treatment Focus Area?
The Treatment Focus Area supports therapeutic evaluation studies intended to advance early-stage or preclinical drug and treatment discovery. This includes work to identify, refine, evaluate, or down-select promising therapeutic candidates before they reach human testing.
7) What kinds of projects fit under the Diagnosis Focus Area?
The Diagnosis Focus Area supports development of diagnostic approaches that are likely to be adopted in routine clinical settings. Proposals should consider practical implementation and clinically meaningful performance characteristics such as sensitivity, specificity, and usability.
8) What does "translational potential" mean in this announcement?
In this context, translational potential means the research is structured to produce development-ready evidence and move an intervention (therapeutic) or tool (diagnostic) closer to real-world use, with an emphasis on improving care and outcomes.
9) Who is the program intended to benefit?
The program highlights improving patient care and/or quality of life for military Service Members, Veterans, their beneficiaries, and the broader public.
10) Are partnerships and transition planning expected?
Yes. The program expects projects to be product-driven with a line of sight to transition. Partnerships that can help move an approach toward deployment are emphasized across both therapeutic and diagnostic tracks.
11) What types of preclinical or translational activities are encouraged?
Examples of encouraged activities include: in vitro and/or in vivo evaluation and down-selection of therapeutic candidates; proof-of-concept diagnostic assay or device development and testing using in vitro or ex vivo samples; high-throughput screening and hit confirmation; testing new therapeutic modalities or delivery mechanisms in established preclinical models; and early formulation, stability, and safety studies to support more advanced development.
12) Does the award support regulatory-enabling studies?
Yes. The announcement explicitly supports generating data that align with regulatory pathways, including IND-enabling work for pharmacologic agents and IDE-enabling work for devices, to demonstrate safety and performance in relevant models or samples.
13) What are examples of IND-enabling activities mentioned?
Examples include compound characterization, ADME studies, dose-response studies, and toxicology studies intended to prepare for an Investigational New Drug (IND) pathway.
14) What are examples of IDE-enabling activities mentioned?
Examples include prototype development and device characterization work intended to support an Investigational Device Exemption (IDE) pathway and demonstrate safety and performance in relevant models or samples.
15) Does the opportunity encourage improving how therapies are delivered in real life?
Yes. The announcement encourages work that improves the practicality of evidence-based treatments, including making therapies easier to administer outside of traditional clinical environments.
16) Are human subjects research and human anatomical substances allowed?
Yes. Human subjects research and the use of human anatomical substances are allowed under this opportunity.
17) Are clinical trials allowed?
No. Clinical trials are not permitted for this specific opportunity. Applicants may work with human samples and human-derived data, but they cannot conduct interventional clinical trials as part of the proposed project.
18) Can projects use existing biorepositories and datasets?
Yes. The program encourages leveraging existing resources such as validated specimens and data from Lyme and tick-borne disease biorepositories and databases, where possible.
19) What study design expectations are highlighted?
The announcement emphasizes strong study design, including authentication of proposed cell lines, statistical rigor for in vitro and animal experiments, and validation using well-characterized cohorts of uniformly documented patients.
20) Does the opportunity welcome the use of large patient datasets and long-term records?
Yes. Projects using large patient datasets with long-term health records and biospecimen repositories are welcomed, as long as the validity of curated specimens or datasets is justified.
21) Are advanced computational or "omics" approaches allowed?
Yes. The announcement welcomes state-of-the-art genomics, proteomics, bioinformatics, and mathematical modeling, provided applicants clearly describe inclusion and exclusion criteria for curated specimens or datasets to justify validity.
22) How important is collaboration to competitiveness?
Collaboration is treated as a major success factor. The program is looking for teams organized to produce something usable, not just interesting science.
23) What if an investigator is new to tick-borne disease research?
Investigators who are new to tick-borne disease research are strongly encouraged to team up with established tick-borne disease researchers to ensure appropriate disease expertise, models, samples, and interpretation.
24) What if an investigator already has tick-borne disease expertise?
Investigators with substantial tick-borne disease expertise are strongly encouraged to partner with experts in therapeutic development, diagnostic assay development, and especially transition and commercialization, including commercial sector collaborators.
25) What is the Career Development Option?
The Career Development Option is a dedicated option for early-career investigators. It is reviewed separately using career-development-specific criteria by a dedicated peer review panel.
26) Who is eligible for the Career Development Option based on career stage?
It is intended for researchers within 10 years of completing their terminal degree. Residency time and family medical leave are excluded from the 10-year calculation.
27) What mentorship is required for the Career Development Option?
The early-career PI is expected to conduct impactful work under the mentorship of an experienced tick-borne disease investigator. The mentor should have a recent (past 5 years) track record of tick-borne disease funding and publications, ideally with prior mentoring experience, and must be at least Associate Professor-level or equivalent.
28) What is required regarding protected research time for the Career Development Option PI?
The applicant institution is expected to provide at least 75% protected research time for the PI, and providing more protected time is viewed favorably.
29) Is a formal Career Development Plan required?
Yes. A Career Development Plan is required and should explain how the PI will gain needed skills, build expertise in tick-borne diseases, engage relevant scientific and (when applicable) advocacy communities, and maintain ongoing mentor involvement even if the mentor and PI are at different institutions.
30) Is preliminary data required?
Preliminary data are required for the standard Therapeutic/Diagnostic Research Award mechanism. Preliminary data are not required for the Career Development Option.
31) What type of award mechanism will be used?
Awards are issued as assistance agreements and may be structured as either a grant or a cooperative agreement, depending on anticipated DoD involvement during the project.
32) What determines whether it will be a grant versus a cooperative agreement?
If the DoD expects no substantial involvement, the award is typically a grant. If substantial involvement is anticipated (such as collaboration, participation, or intervention in the research), it becomes a cooperative agreement, and the involvement is described in the award terms.
33) What is the maximum budget for the standard TDRA?
The maximum anticipated direct costs for the standard Therapeutic/Diagnostic Research Award are capped at $825,000 for the entire period of performance.
34) What is the maximum budget for the Career Development Option?
The Career Development Option has a lower direct cost cap of $495,000 for the entire period of performance.
35) What program framework and CFDA number are associated with this opportunity?
The opportunity was run under the USAMRAA/CDMRP framework and is associated with CFDA 12.420.
36) Is eligibility restricted?
Eligibility was described as unrestricted, subject to any clarifications in the full announcement.
37) How much total funding was planned, and how many awards were expected?
CDMRP planned to allocate about $4.2 million total and expected to fund roughly four awards in total: approximately two standard TDRA awards and two Career Development Option awards.
38) Is funding guaranteed if an application is submitted?
No. Actual funding depended on federal funds availability, application volume, and scientific and programmatic merit as determined through peer and programmatic review.
39) When were awards anticipated to be made?
The notice anticipated making awards no later than September 30, 2023.
40) What is the significance of the September 30, 2028 date mentioned?
The notice stated that FY22 funds supporting awards would expire for use on September 30, 2028, which effectively sets the window in which obligated funds must be spent under federal fiscal rules.
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