The FY22 TBDRP Therapeutic/Diagnostic Research Award is intended to support hypothesisdriven 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 and conditions.
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.
Deadlines:
• Pre-Application Submission Deadline: May 25, 2023
• Invitation to Submit an Application: July 2023
• Application Submission Deadline: August 24, 2023
Applications submitted to the FY23 TBDRP should be focused on Lyme disease and/or other tick-borne diseases/conditions with emphasis on reducing public health burden. Particularly encouraged are applications focused on persistent Lyme disease, and other tick-borne diseases and conditions endemic to the United States (https://www.cdc.gov/ticks/datasummary/index.html). Proposed research must focus on directly impacting the health of the U.S. military (active-duty or Veteran), their beneficiaries, and/or the American public. Therapeutic/Diagnostic Research Award applications must respond to at least one of the following specific FY23 TBDRP Focus Areas:
• Treatment ○ Novel preclinical therapeutic strategies for tick-borne diseases, with priority given to Lyme disease and other tick-borne diseases endemic to the U.S. that have a documented need for additional therapeutic options ○ Pre-clinical evaluation of Food and Drug Administration (FDA)-approved or -cleared drugs to support additional intended use(s) in the treatment of tick-borne diseases
• Diagnosis ○ Innovative approaches that provide diagnosis for a single or for multiple tick-borne pathogens in human samples, with priority given to direct detection assays ○ Novel diagnostics capable of distinguishing active Lyme disease infection from previous exposure ○ Approaches focused on the detection/diagnosis of maternal-to-fetal transmission of Lyme disease and/or other tick-borne infections, including the development of relevant animal models
For the Therapeutic/Diagnostic Research Award: Independent investigators at or above the level of Assistant Professor (or equivalent) may be named by the organization as the PI on the application.
For the Therapeutic/Diagnostic Research Award – Career Development Option:
• 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 at the time of application submission deadline (excluding time spent in residency or on family medical leave) and exhibit a strong desire to pursue a career in tick-borne disease research. Time spent as a postdoctoral fellow is not excluded. ○ Institutional commitment to the PI’s independent career must be demonstrated, including confirmation of laboratory space and a minimum of 50% level of time and effort during the period of performance for the PI to conduct tick-borne disease research under this award.
• Mentor ○ The mentor(s) must hold a position at or above the level of Associate Professor (or equivalent). ○ The mentor(s) must be experienced researcher(s), 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/technologies) of the proposed studies. The mentor(s) must demonstrate a commitment to developing the PI’s career in tick-borne disease research.
The PI and the mentor do not need to be located within the same organization.
The anticipated direct costs budgeted for the entire period of performance for an FY23 TBDRP Therapeutic/Diagnostic Research Award should not exceed $825,000.
The anticipated direct costs budgeted for the entire period of performance for an FY23 TBDRP Therapeutic/Diagnostic Research Award – Career Development Option will not exceed $495,000.
