OpportunityTitle: Spinal Cord Injury Research Program Advanced Technology Therapeutic Development Award
Description: The Advanced Technology/Therapeutic Development Award (AT/TDA) is intended to support demonstration studies of pharmaceuticals (drugs, biologics, and vaccines) and medical devices in preclinical systems and/or the testing of therapeutics and devices in clinical studies. The intent of the Advanced Technology/Therapeutic Development Award is to assess therapeutics and devices for the treatment, prevention, detection, and diagnosis of SCI. The overall goal of this award mechanism is to accelerate the introduction of improved therapies, treatments, devices, or technologies for SCI into the clinical setting by supporting (1) cognitive/behavioral clinical studies, (2) clinical interventions, (3) the generation of the preclinical data (e.g., Good Laboratory Practice [GLP] animal safety and toxicity, identifying endpoints of clinical efficacy or its surrogate in animal models, and data collection sufficient to support an Investigational New Drug [IND] or Investigational Device Exemption [IDE] application) necessary to conduct clinical trials after completion of the proposed research. The proposed studies are expected to be empirical in nature and product-driven and are expected to be at or beyond Biomedical Technology Readiness Level (TRL) 4 (for descriptions of TRL(s) please see pages 126-138 of the document located at http://www.darpa.mil/STO/solicitations/sn07-44/pdf/TRA_Desktop.pdf). All applications must specifically and clearly address the military relevance of the proposed research. Therefore, Principal Investigators (PIs) are strongly encouraged to collaborate and integrate their projects with military and/or VA research laboratories and programs. 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 award. Applications must include relevant data to support the rationale for the proposed study. These data may be unpublished and/or from the published literature. DOD Spinal Cord Injury Advanced Technology/Therapeutic Development Award 4 Awards may support human studies but may not be used to support clinical trials of medical products to support regulatory submissions for new or expanded indications (i.e., Phase I-IV clinical trials). Awards may not be used to support fundamental basic research. Proposals must include preliminary and/or published data relevant to the hypothesis/aims of the proposed research project. Awards may support human studies but may not be used to support clinical trials of medical products to support regulatory submissions for new or expanded indications (i.e., Phase 1&#150;4 clinical trials). Awards may not be used to support fundamental basic research. Proposals must include preliminary and/or published data relevant to the hypothesis/aims of the proposed research project. Refer to the Application Instructions &amp; General Information, Appendix 6, for helpful information about distinguishing clinical trials and clinical research. PIs seeking funding for a clinical trial should apply to the FY09 SCIRP Clinical Trial Award &#150;Rehabilitation mechanism (for information about this mechanism, see http://cdmrp.army.mil). Partnering PI Option: To foster collaboration and facilitate progress in the SCI research field by combined effort, the FY09 SCIRP 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 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 member(s) 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 PI&#146;s institution. One Initiating and up to two Partnering PIs may be designated. Additional collaborators may be included, but they will not be designated 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. Use of Human Subjects and Human Biological Substances: All DOD-funded research involving human subjects and human biological substances must be reviewed and approved by the USAMRMC Office of Research Protections (ORP), Human Research Protection Office (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 by 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 &amp; General Information, Appendix 6, for additional information. Encouraged Department of Defense (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 DOD Spinal Cord Injury Advanced Technology/Therapeutic Development Award 5 programs. The following websites may be useful in identifying information about ongoing DOD areas of research interest within the FY09 SCIRP topic areas: Defense Technical Information Center http://www.dtic.mil Congressionally Directed Medical Research Programs http://cdmrp.army.mil U.S. Army Medical Research and Materiel Command https://mrmc.amedd.army.mil Air Force Research Laboratory http://www.wpafb.af.mil/afrl Navy and Marine Corps Public Health Center http://www-nehc.med.navy.mil/ U.S. Department of Veterans Affairs, Office of Research and Development www.research.va.gov Office of Naval Research http://www.onr.navy.mil/ U.S. Army Research Laboratory http://www.arl.army.mil U.S. Naval Research Laboratory www.nrl.navy.mil Defense Advanced Research Projects Agency http://www.darpa.mil/ U.S. Army Medical Research Acquisition Activity http://www.usamraa.army.mil Naval Health Research Center http://www.nhrc.navy.mil/ Office of the Under Secretary of Defense for Acquisition, Technology and Logistics http://www.acq.osd.mil/
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: PA HELP: 301-619-7079; cdmrp.pa@amedd.army.mil  &lt;br/&gt;eReceipt HELP: 301-682-5507; help@cdmrp.org &lt;br/&gt;