Posted on:

Type

Reference Number

#### W81XWH-22-TBDRP-TDRA

The FY22 TBDRP Therapeutic/Diagnostic Research Award is intended to support hypothesis-driven therapeutic and diagnostic development research. Projects submitted under a Treatment Focus Area should be therapeutic evaluation studies designed to promote new ideas aimed at drug or treatment discovery that are still in the early/preclinical stages of development. Projects submitted under a Diagnosis Focus Area should propose diagnostic approaches that will be readily integrated into clinical settings. All research projects should have a translational potential and aim to improve patient care and/or the quality of life for military Service Members, Veterans, and their beneficiaries, as well as the American public living with Lyme disease and/or other tick-borne diseases.The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited tick-borne disease experience are strongly encouraged to collaborate with experienced tick-borne disease investigators. Applicants with substantial tick-borne disease experience are strongly encouraged to partner with experts in therapeutic and diagnostic assay development and transition, particularly those from the commercial sector. Examples of the types of research that may be supported by this award include, but are not limited to:• Evaluation, maturation, and/or down-selection of potential therapeutic candidates in vitro and/or in vivo• Design, development, and evaluation of proof-of-concept diagnostic assays or devices using in vitro or ex vivo samples• High throughput screening and confirmation of candidate therapeutics obtained from screening or by other means• Testing new therapeutic modalities (agents, delivery mechanisms) using established and accepted preclinical models• Preliminary studies on formulation, stability and safety prior to Good Manufacturing Practice production methods and evaluation in advanced preclinical studies• Investigational New Drug application-enabling studies leading to the development of pharmacologic agents, including compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies to demonstrate safety and efficacy in relevant model systems• Investigational Device Exemption application-enabling studies leading to the development of devices, including prototype development and device characterization, to demonstrate safety and efficacy using relevant model systems or samples• Optimization and improvement of potential evidence-based treatments or therapeutics for easy administration outside of a clinical setting• Studies aimed at improving diagnostic assay sensitivity, specificity and/or implementation in standard clinical settingsResearch involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this program announcement.Leveraging existing resources, maximizing statistical power, and using validated specimens from Lyme and other tick-borne disease biorepositories and databases are encouraged, but not required. Investigators are strongly encouraged to incorporate the following components into their study design where appropriate: authentication of proposed cell lines; statistical rigor of in vitro cellular studies and preclinical animal experiments; and validation in well-pedigreed cohorts of uniformly documented patients. Studies utilizing data derived from large patient studies that include long-term health records, biospecimen repositories, pre-existing research, and/or studies that apply state-of-the art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are also encouraged. The criteria defining the inclusion/exclusion of curated biospecimens or data in biorepositories or databases must be described to demonstrate the validity of their use in the proposed studies.A Career Development Option is available to eligible early-career investigators who propose to conduct impactful research under the mentorship of an experienced tick-borne disease researcher. The Therapeutic/Diagnostic Research Award – Career Development Option has a lower direct cost limit than the Therapeutic/Diagnostic Research Award; however, preliminary data are not required. Applications submitted under the Therapeutic/Diagnostic Research Award – Career Development Option will be reviewed via separate, career development-specific evaluation criteria by a separate, dedicated peer review panel. The following are key aspects of the Career Development Option:• Principal Investigator (PI): The PI must be an early-career research scientist, physician scientist, or other qualified clinical scientist within 10 years of completing their terminal degree (excluding time spent in residency or on family medical leave). The PI’s record of accomplishments and the proposed research will be evaluated regarding their potential for contributing to the field of tick-borne disease research. Because career development is the focus of this award, the PI’s institution should demonstrate a commitment to the PI through a minimum of 75% protected research time for all tick-borne disease research projects by the PI, although more protected time is highly desirable.• Mentorship: The mentor must be an experienced tick-borne disease researcher, as demonstrated by a recent (last 5 years) history of funding and publications in tick-borne disease research, and should ideally have experience mentoring other independent scientists. Collectively, the PI/mentorship team should have demonstrated experience in the field (pathogen/disease and associated methods) of the proposed studies. The mentor must hold a position at or above the level of Associate Professor (or equivalent). In addition, the mentor must demonstrate a commitment to developing the PI’s career in tick-borne disease research and should remain engaged for the entire duration of the project. The mentor and PI may be at different organizations; however, a clear indication of how the mentor will communicate with and facilitate the PI’s career development should be provided in the Career Development Plan, as described below.• Career Development Plan and Environment: A Career Development Plan is required and should be prepared by the PI with appropriate guidance from the mentor. The plan should outline how the PI will gain experience in tick-borne disease research and engage with the tick-borne disease scientific and advocacy communities (as applicable). A clearly articulated strategy for acquiring the necessary skills, competence, and expertise to establish a career at the forefront of tick-borne disease research should be included, as well as a plan for how the mentor will engage with the PI to contribute to the PI’s career development as a tick-borne disease researcher and to the success of the proposed research for the duration of the project.Preliminary Data: Inclusion of preliminary data relevant to the proposed studies are required for this mechanism unless applying under the Therapeutic/Diagnostic Research Award – Career Development Option.The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.The anticipated direct costs budgeted for the entire period of performance for an FY22 TBDRP Therapeutic/Diagnostic Research Award will not exceed $825,000.The anticipated direct costs budgeted for the entire period of performance for an FY22 TBDRP Therapeutic/Diagnostic Idea Award – Career Development Option will not exceed$495,000.Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2023. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately \$4.2M to fund approximately two Therapeutic/Diagnostic Research Award and two Therapeutic/Diagnostic Research Award – Career Development Option applications. Funding of applications received is contingent upon the availability of federal funds for this program, as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY22 funding opportunity will be funded with FY22 funds, which will expire for use on September 30, 2028.
Categories: Science and Technology and other Research and Development.
Posted on: