Promoting Partnerships To Improve Veterans’ Health

The FY19 Defense Appropriation provides $6 million (M) to the Department of Defense Tuberous Sclerosis Complex Research Program (TSCRP) to support innovative, high-impact TSC research.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency, J9 Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation.  The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Materiel Command (USAMRMC).

The TSCRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications.  FY19 TSCRP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in February 2019.  Pre-application and application deadlines will be available when the Program Announcements are released.  This pre-announcement should not be construed as an obligation by the government.

Focus Areas:  The goal of the FY19 TSCRP is to fund exploratory, pioneering, and transformative science that promotes discoveries in tuberous sclerosis complex (TSC), from mechanistic insights to clinical application, by supporting new ideas and investigators for the benefit of Service members, their beneficiaries, and the American public.  Within this context, the FY19 TSCRP encourages applications that address the critical needs of the TSC community in one or more of the following FY19 Focus Areas:

• Eradicating tumors associated with TSC and TSC-associated lymphangioleiomyomatosis (LAM), including gaining a deeper mechanistic understanding of TSC signaling pathways
• Preventing epilepsy, improving treatment, and mitigating comorbidities associated with TSC-related seizures
• Understanding the features of TSC-Associated Neuropsychiatric Disorders (TAND) and reducing their impact through pharmacological or nonpharmacological interventions
• Advancing clinical trial readiness through development of biomarkers, clinical endpoints, clinical pharmacokinetic/pharmacodynamic (PK/PD), patient selection and sample size determination, novel drug delivery, and treatment optimization

https://cdmrp.army.mil/pubs/press/2019/19tscrppreann

Exploration – Hypothesis Development Award

• Investigators at or above postdoctoral fellow (or equivalent)
• Supports the initial exploration of innovative, high-risk, high gain, and potentially groundbreaking concepts in the TSC research field.
• Projects involving human subjects or human biological substances must be exempt under 32 CFR 219.101(b)(4) or eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110.
• Preliminary data are not required.
• Research projects must be innovative, feasible, and supported by a strong rationale.
• Innovation is an important review criterion.
• Clinical trials are not allowed.
• Maximum funding of
• $150,000 for direct costs (plus indirect costs)
• Maximum period of performance is 2 year

Idea Development Award

Established Investigators:  Independent investigators at or above the level of Assistant Professor (or equivalent);

OrNew Investigators:  

• Independent investigator at or below the level of Assistant Professor (or equivalent); or
• Established independent investigator in an area other than TSC at or above the level of Assistant Professor seeking to transition to a career in TSC, thereby bringing his/her expertise to the field.
• Must not have received more than $300,000 in total direct costs for previous or concurrent TSC research as a Principal Investigator of one or more Federally funded, non-mentored peer-reviewed grants. (National Institutes of Health K/R00 Awardees are eligible to apply.)
• Must not have received a New Investigator Award previously from any program within the CDMRP.
• Supports new ideas that have the potential to yield high-impact findings and new avenues of investigation.
• Preliminary data are expected.
• Impact and Innovation are important review criteria.
• Clinical trials are not allowed.
• New Investigator Option supports the continued development of promising independent investigators that are early in their faculty appointments and/or the transition of established investigators from other research fields into a career in TSC research.
• Applications from New Investigators and Established Investigators will be peer and programmatically reviewed separately
• Maximum funding of $450,000 for direct costs (plus indirect costs)
• Maximum period of performance is 3 years

Clinical Translational Research Award

• Independent investigators at or above the level of Assistant Professor (or equivalent)
• Supports studies that will move promising, well-founded preclinical and/or clinical research findings closer to clinical application, including, diagnosis, prognosis, or treatment of TSC.
• Studies advancing clinical trial readiness through development of biomarkers, clinical endpoints, and validation of PK/PD are of particular interest.
• Preference will be given to studies that involve human samples, patients, or leverage existing clinical data and/or ongoing clinical studies. 
• Preclinical studies may be appropriate but must include a clinical component.
• Projects that are exploratory and/or strictly animal research will not be considered for funding.
• Applications may include a small, pilot clinical trial intended to inform the next step in the continuum of translational research.
• Clinical Translational Potential is an important review criterion.
• Preliminary data are required.
• Maximum funding of $600,000 for direct costs (plus indirect costs)
• Maximum period of performance is 3 years

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website.  The application package containing the required forms for each award mechanism will also be found on Grants.gov.  A listing of all CDMRP and other USAMRMC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

Submission deadlines are not available until the Program Announcements are released.  For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the TSCRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil