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FY13 PROGRAM UPDATE

Released: February 1, 2013

DEPARTMENT OF DEFENSE TUBEROUS SCLEROSIS COMPLEX RESEARCH PROGRAM
FISCAL YEAR 2013 STRATEGIC PLAN

The Department of Defense Tuberous Sclerosis Complex (TSCRP) is administered by the US Army Medical Research and Materiel Command through the Office of the Congressionally Directed Medical Research Programs (CDMRP).

To allow investigators time to plan and develop applications, the TSCRP is providing its strategic plan for award mechanisms to be offered in 2013 should funding become available. Congressional funds for the FY13 TSCRP have not yet been appropriated, and this document is not to be construed as an obligation by the government; there is no guarantee of funding for these planned mechanisms.

Areas of Focus: The FY13 TSCRP encourages research projects applications that specifically address the critical needs of theTSC community in the following areas of focus:

  • Genetic, epigenetic, and non-genetic modifiers of TSC.
  • Identification and development of preclinical models and therapeutic strategies (e.g., cytotoxic agents, combination therapies).
  • Identifying biomarkers for early detection, prognosis, and prediction of treatment outcomes (such as serum markers, imaging, electrophysiology, prenatal testing, and pharmacogenetics).
  • Impact of TSC manifestations in adults (e.g., care management, age-specific pathogenesis, epidemiology, renal, reproductive issues, and lymphangioleiomyomatosis [LAM])).
  • Long-term benefits and effects of mTOR inhibitors or other agents.
  • Novel strategies for diagnosis, treatment, and prevention of TSC manifestations including those geared toward early identification and intervention.
  • Understanding the cellular and molecular mechanisms of TSC and LAM pathogenesis.
  • Understanding the mechanism and improving the treatment of epilepsy in TSC.
  • Understanding the mechanism and improving treatment of TSC-associated neurocognitive disorders (TAND) including cognitive impairment, and psychiatric, behavioral, and sleep disorders.

Award Mechanism PI Eligibility Key Mechanism Elements
Pilot Clinical Trial Award Must be an independent investigator at or above the level of Assistant Professor (or equivalent)
  • Fund pilot clinical trials, especially observational or feasibility studies.
  • Supports collection of preliminary data that will lead to a successful phase I/II clinical trial.
  • Preliminary or preclinical data is required
Exploration -Hypothesis Development Award Investigators at all academic levels (or equivalent)
  • Fund the initial exploration of innovative, untested research, and pursue serendipitous observations
  • Projects involving human subjects or human biological substances must be exempt under 32 CFR 219.101(b)(4)
  • Preliminary data is encouraged but not required
  • Clinical trials not allowed
Idea Development Award Independent investigators with a documented faculty appointment (or equivalent)
  • Encourage high-impact, innovative research that will drive the field forward
  • Optional Feature: Applications that include either a Qualified Collaborator or Postdoctoral Fellow who meet criteria identified in the announcement may apply for a higher level of funding
  • Preliminary data required
  • Clinical trials not allowed

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 upon official announcement of funding opportunity release. Submission deadlines will not be available until the program announcements are released. Requests for email notification of the program announcements release may be sent to help@cdmrp.org. For more information about the TSCRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

Point of Contact:

CDMRP Public Affairs
301-619-9783
CDMRP.PublicAffairs@amedd.army.mil