Department of Defense – FY19 Pre-announcement of the Tuberous Sclerosis Complex Research Program (TSCRP)

February 7, 2019 by kjt5j@virginia.edu

If  you wish to speak with The Conafay Group about developing a proposal for this program, please contact Dr. David Driscoll (dld5dt).

The Department of Defense recently released a pre-announcement for its Tuberous Sclerosis Complex (TSC) Research Program, which is managed by the office of Congressionally Directed Medical Research Programs (CDMRP) https://cdmrp.army.mil/pubs/press/press, to allow investigators time to plan and develop ideas for submission to the anticipated FY19 funding opportunities.

Anticipated award types for FY19:

  • 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.
  • 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.
  • Idea Development Award
    • Established Investigators:
      • Independent investigators at or above the level of Assistant Professor [or equivalent])
    • New 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.)
    • 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.

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

Descriptions of each of the anticipated funding opportunities, eligibility, key mechanism elements, and funding can be found in the Program pre-announcement.  FY19 pre-announcements can be found in the CDMRP home page features at https://cdmrp.army.mil.

Filed Under: Featured, Funding Opportunities