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.
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 26, 2022
• Invitation to Submit an Application: July 2022
• Application Submission Deadline: August 25, 2022
Applications submitted to the FY22 TBDRP should be focused on Lyme disease and/or other tick-borne diseases/conditions with emphasis on reducing public health burden. Therapeutic/Diagnostic Research Award applications must respond to at least one of the following specific FY22 TBDRP Focus Areas:
• Treatment ○ Novel preclinical therapeutic strategies for tick-borne pathogens, Lyme disease, and/or other tick-borne diseases with priority given to those in the U.S. ○ Potential treatments designed to mitigate development of long-term sequelae following infection ○ Repurposing Food and Drug Administration (FDA)-approved drugs for off-label indication in preclinical evaluation for use in tick-borne diseases
• Diagnosis ○ Priority given to direct detection diagnostic assays for agents of Lyme disease and/or other tick-borne diseases ○ Diagnostic biomarker panel for Lyme disease and/or other tick-borne diseases that distinguishes tick-borne infection from other febrile illnesses ○ Approaches capable of distinguishing active infection and previous exposure and/or monitoring response to treatment ○ Innovative approaches that provide diagnosis for a single or multiple tick-borne infections
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 completion of 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 diseases research. Time spent as a postdoctoral fellow is not excluded. ○ Institutional commitment to the PI’s independent career should be demonstrated, including a minimum of 75% protected research time for all tick-borne disease research projects by the PI and a confirmation of the laboratory space
• Mentor ○ The mentor must hold a position at or above the level of Associate Professor (or equivalent). ○ The mentor must be an experienced 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 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 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.
