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Description of Modification
Modification provides the name of the award mechanism.
Modification to Previous
Funding Opportunity Number:
Jul 10, 2009
Jul 16, 2009
Original Closing Date for Applications:
Oct 28, 2009
Current Closing Date for Applications:
Oct 28, 2009
Nov 27, 2009
Funding Instrument Type:
Category of Funding Activity:
Science and Technology and other Research and Development
Expected Number of Awards:
Estimated Total Program Funding:
Military Medical Research and Development
Cost Sharing or Matching Requirement:
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Additional Information on Eligibility:
Dept. of the Army -- USAMRAA
The PH/TBI Research Program Advanced Technology/Therapeutic Development Award is intended to support the assessment of scientific and/or military field deployment feasibility for promising new products, pharmacologic agents (drugs or biologics), behavioral interventions, devices, clinical guidance, and/or emerging approaches and technologies. These awards are expected to yield potential products, approaches, or technologies for the treatment, prevention, detection, and/or diagnosis of PH issues and/or TBI. The products developed may be pharmacologic agents (drugs, biological), cognitive/behavioral interventions, devices, or clinical guidance.
Military relevance is a key feature of this award. All applications must specifically and clearly address the military relevance of the proposed research. Each PI must provide a transition plan (including funding and resources) showing how the product will progress to clinical trials and/or delivery to the military market after the successful completion of this PH/TBI Research Program award.
The overall goal of this award mechanism is to accelerate the introduction of improved therapies, treatments, devices, or technologies for PH/TBI into the clinical setting. Examples of the types of research that may be supported include, but are not limited to:
Collection and analysis of data for developing and validating clinical guidance.
Developing new behavioral or cognitive interventions.
DOD PH/TBI Research Program Advanced Technology/Therapeutic Development Award 6
Testing new therapeutic modalities (agents, delivery systems, chemical modification of lead compounds) using established or validated novel preclinical systems.
Comparative activity/efficacy testing to define a single lead agent from a limited library of candidates.
Designing and implementing full-scale, pilot Good Manufacturing Practice (GMP) production of therapeutics and/or delivery systems for use in advanced preclinical and initial clinical trials.
Developing pharmacologic agents through the elements of adsorption, distribution, metabolism, excretion, and toxicity (ADMET).
Developing pharmacologic agents to Investigational New Drug (IND) stage for initiation of Phase I clinical trials.
Developing prototype devices for diagnosis or treatment to Investigational Device Exemption (IDE) stage for initiation of Phase I clinical trials.
Generation of safety and/or efficacy data (e.g., Phase I or Phase I/II clinical studies) on therapeutics and devices in clinical trials.
Development and validation of assays and reagents required to measure biological responses and molecular endpoints.
Developing and validating computational models.
Optimizing diagnostic or treatment devices for field deployment.
Preference will be given to proposals that include preliminary and/or published data relevant to the PH/TBI topic area and the proposed project, but omission of these will not be a disqualifying factor.
Partnering PI Option: As a method to support an accelerated assessment of scientific and/or military market feasibility for promising new products, devices, and/or emerging technologies, the FY09 PH/TBI Research Program is offering a Partnering PI option for this award mechanism. Development of the research plan should involve a reciprocal flow of ideas and information with equal intellectual input from all partners into the design of a single research project. For example, a proposed project in which a partner merely supplies support services, tissue samples, or access to patients will not meet the intent of this option.
This award option is structured to accommodate up to three PIs. One member of the team will be identified as the Initiating PI, who will be responsible for the majority of the administrative tasks associated with application submission. The other members will be identified as the Partnering PI(s) and will need to complete administrative tasks associated with application submission. Separate awards will be made to each PIs institution. One Initiating and up to two Partnering PIs may be designated. Additional collaborators may be included, but they will not be designated as PIs. Multidisciplinary and multi-institutional projects are allowed. If the project is multi-institutional, PIs should include plans for communication between investigators at each institution. Additionally, participating institutions must be willing to resolve potential intellectual and material property issues, and to remove any barriers that might interfere with achieving high levels of cooperation to ensure successful completion of this award.
DOD PH/TBI Research Program Advanced Technology/Therapeutic Development Award 7
Submissions that include clinical research involving humans should:
Describe clearly defined and appropriate endpoints for the proposed clinical research
Clearly articulate the statistical analysis plan
Discuss the potential impact of the study results for patients with the specified disease/condition
Include a named study coordinator who will guide the clinical protocol through Institutional Review Board (IRB), Human Subjects Research Review Board (HSRRB), and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual
Multi-institutional research: If the proposed research is multi-institutional, plans for communication and data transfer between the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the Project Narrative. A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional research.
Encouraged DOD collaboration and alignment: Military relevance is a key feature of this award. Therefore, PIs are strongly encouraged to collaborate, integrate, and/or align their research projects with military and/or VA research laboratories and programs. The following websites may be useful in identifying information about ongoing DOD areas of research interest within the FY09 PH/TBI Research Program topic areas:
Defense Technical Information Center
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
Defense and Veterans Brain Injury Center
Center For Deployment Psychology
Deployment Health Clinical Center
Center For The Study of Traumatic Stress
National Center for Telehealth and Technology
Congressionally Directed Medical Research Programs
U.S. Army Medical Research and Materiel Command
Air Force Research Laboratory
Navy and Marine Corps Public Health Center
U.S. Department of Veterans Affairs, Office of Research and Development www.research.va.gov
Office of Naval Research
U.S. Army Research Laboratory
DOD PH/TBI Research Program Advanced Technology/Therapeutic Development Award 8
U.S. Naval Research Laboratory
Defense Advanced Research Projects Agency: http://www.darpa.mil/
U.S. Army Medical Research Acquisition Activity
Naval Health Research Center
U.S. Department of Defense Blast Injury Research Program
Office of the Under Secretary of Defense for Acquisition, Technology and Logistics
Use of Military Populations: Describe the military population(s) to be used for the proposed study, if applicable. Coordination of access to various military populations is described below.
1. Active Duty, National Guard, Reserve troops, and/or military patient populations (not CENTCOM Area of Responsibility): Unless the PI has an already established Service member population, access to Active Duty, National Guard, or Reserve troops must be coordinated through the CDMRP. PIs who do not have a previously established study population should not contact unit Commanders at this time or during preparation of the proposal submission. If selected for funding, the PI will be provided guidance on how to obtain access to the appropriate population.
2. CENTCOM Area of Responsibility military populations: Access to military populations in these areas is very limited and will be coordinated through the CDMRP as described above.
Research conducted using military populations in Iraq is conducted with oversight by the Multi-National Force-Iraq (MNF-I). PIs that are outside of this system and submit a research proposal designed to recruit patients within MNF-I must coordinate with the in-theater Deployed Combat Casualty Research Team charged with facilitating an in-theater review, and be approved by the MNF-I Command and the MNF-I designated Institutional Review Board (IRB). The same is true for research conducted in Afghanistan in the US Forces-Afghanistan (USFOR-A) Area of Responsibility. PIs who are outside of this system and submit a research proposal designed to recruit patients within USFOR-A must coordinate with the in-theatre Deployed Combat Casualty Research Team charged with facilitating an in-theatre review, and be approved by the USFOR-A Command and the USFOR-A designated IRB. If selected for funding, CDMRP will assist with guidance on how to obtain the required in-theater approvals.
Given the constraints of wartime operations, investigators without an ongoing collaboration with an appropriate military investigator should strongly consider alternatives to conducting in-theater research. DOD-supported human subjects research can only be conducted by institutions (including those in-theater) with approved Federal Assurances of Compliance from the Human Research Protection Office (HRPO). It is strongly suggested that proposals necessitating the use of this population involve civilian and non-deployed military populations as an alternative.
DOD PH/TBI Research Program Advanced Technology/Therapeutic Development Award 9
3. Department of Veterans Affairs (VA) Medical Centers patient populations: Access to patient populations from VA Medical Centers or use of information from VA data systems must be coordinated by the PI. PIs who submit a research proposal designed to recruit patients from a VA Medical Center or use information from VA data systems, and who do not have an appointment at one of the VA Medical Centers, must include a collaborator with a VA appointment. This collaborator must be willing to assume the role of PI for the VA component of the research.
Use of human subjects and human biological substances: All Department of Defense (DOD)-funded research involving human subjects and human biological substances must be reviewed and approved by the USAMRMC Office of Research Protections (ORP), HRPO, in addition to local IRBs. The HRPO is mandated to comply with specific laws and directives governing all research involving human subjects that is conducted or supported by the DOD. These laws and directives are rigorous and detailed, and will require information in addition to that supplied to the local review board. Allow a minimum of 6 months for regulatory review and approval processes for studies involving human subjects. Refer to the Application Instructions & General Information, Appendix 6, for detailed information.
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Synopsis Modification History
The following files represent the modifications to this synopsis
with the changes noted within the documents. The list of files is
arranged from newest to oldest with the newest file representing the
current synopsis. Changed sections from the previous document are shown
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