Funding Announcements: National Institute of Neurological Disorders and Stroke (NINDS) Copyright 2014, National Institute of Neurological Disorders and Stroke http://www.ninds.nih.gov/funding/funding_announcements/RSS_Funding.htm en Funding Announcements Saturday Sunday http://blogs.law.harvard.edu/tech/rss High Throughput Screening (HTS) to Discover Chemical Probes (R01) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-284 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-284 .htm Technological innovations in high throughput screening (HTS), chemical synthesis, and cheminformatics have allowed rapid discovery of novel, small-molecule probes for the study of disease related biological processes and mechanisms in academic environments (see Academic Screening Facilities Directory, http://www.slas.org/screeningFacilities/facilityList.cfm). This provides an unprecedented opportunity for investigators to translate knowledge about diseases into tangible tools for translational research. This Funding Opportunity Announcement (FOA) aims to support investigators to form collaborations with an academic, nonprofit, or commercial HTS screening facility that has the requisite expertise and experience to implement an HTS-ready assay for the discovery and development of small molecule chemical probes. Through this FOA, NIH wishes to stimulate research in 1) discovery and development of novel, small molecules for their potential use in studying disease treatments relevant to the missions of the participating NIH Institutes, and 2) discovery and/or validation of novel, biological targets that will inform studies of disease mechanisms. Emphasis will be placed on projects that provide new insight into important disease targets and processes. For example, applications may involve emerging therapeutic targets and mechanisms for the discovery of chemical probes that may lead to further development of therapeutics or provide insight into the biology of relevant diseases and health. Wed, 17 Sep 2014 00:00:00 EDT Centers Without Walls for Collaborative Research in the Epilepsies: Developing Disease Modifying or Prevention Therapies (U54) http://www.ninds.nih.gov/funding/funding_announcements/rfa/RFA-NS-15-001.htm http://www.ninds.nih.gov/funding/funding_announcements/rfa/RFA-NS-15-001.htm Centers Without Walls for Collaborative Research in the Epilepsies: Developing Disease Modifying or Prevention Therapies (U54). The purpose of this FOA is to solicit applications for an Epilepsy Center without Walls (CWOW) focused on multidisciplinary, collaborative research to further the development of disease modifying or prevention therapies for epilepsy. Thu, 21 Aug 2014 00:00:00 EDT Detect, Define and Measure the Progression of Chronic Traumatic Encephalopathy (U01) http://www.ninds.nih.gov/funding/funding_announcements/rfa/RFA-NS-14-012 .htm http://www.ninds.nih.gov/funding/funding_announcements/rfa/RFA-NS-14-012 .htm The purpose of this initiative is to detect, characterize and measure the progression of neurodegeneration in individuals with a probable or possible diagnosis of chronic traumatic encephalopathy (CTE) using brain imaging and other biomarkers. The overall goals are increased knowledge concerning the neurological mechanisms and ways to detect CTE as it evolves over a 3 - 5 year period and the development of a consensus diagnosis to inform clinical trials aimed at preventing or slowing disease progression in the future. Tue, 29 Jul 2014 00:00:00 EDT NINDS CREATE Devices: Translational and Clinical Studies on the Path to 510(k) (UH2/UH3) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-295.htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-295.htm The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and clinical studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) or IRB approval for a Non-Significant Risk (NSR) study and the following clinical study. It is expected the immediate next steps upon completion of the clinical study will be a 510(k)/510(k) De Novo submission or a larger clinical trial that will lead directly to a 510(k)/510(k) De Novo submission. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a small clinical study. Tue, 29 Jul 2014 00:00:00 EDT NINDS CREATE Devices: Translational and Clinical Studies on the Path to 510(k) (U44) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-296 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-296 .htm The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and clinical studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) or IRB approval for a Non-Significant Risk (NSR) study and the following clinical study. It is expected the immediate next steps upon completion of the clinical study will be a 510(k)/510(k) De Novo submission or a larger clinical trial that will lead directly to a 510(k)/510(k) De Novo submission. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a small clinical study. Tue, 29 Jul 2014 00:00:00 EDT NINDS CREATE Devices: Translational and Clinical Studies to Inform Final Device Design (UH2/UH3) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-297 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-297 .htm The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and clinical studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) or IRB approval for a Non-Significant Risk (NSR) study and the following clinical study. It is expected that the clinical study will inform a final device design that would have to go through most, if not all, of the preclinical testing on the path to more advanced clinical trials and market approval. This program also supports development of a device to test scientific hypotheses that are not feasible or practical to conduct in animal models, but are critical to enable next-generation devices. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a small clinical study. Tue, 29 Jul 2014 00:00:00 EDT NINDS CREATE Devices: Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) (UH2/UH3) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-298.htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-298.htm The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and Early Feasibility Studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE), with the option of also supporting the following Early Feasibility Study. It is expected the immediate next steps upon completion of the Early Feasibility Study will be a full Feasibility Study and a Pivotal Trial in support of a PMA (Pre-Market Approval) or HDE (Humanitarian Device Exemption). Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and an Early Feasibility Study. Tue, 29 Jul 2014 00:00:00 EDT NINDS CREATE Devices: Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) (U44) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-299.htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-299.htm The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and Early Feasibility Studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE), with the option of also supporting the following Early Feasibility Study. It is expected the immediate next steps upon completion of the Early Feasibility Study will be a full Feasibility Study and a Pivotal Trial in support of a PMA (Pre-Market Approval) or HDE (Humanitarian Device Exemption). Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and an Early Feasibility Study. Tue, 29 Jul 2014 00:00:00 EDT NINDS CREATE Devices: Translational and Clinical Studies to Inform Final Device Design (U44) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-300 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-300 .htm The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and clinical studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) or IRB approval for a Non-Significant Risk (NSR) study and the following clinical study. It is expected that the clinical study will inform a final device design that would have to go through most, if not all, of the preclinical testing on the path to more advanced clinical trials and market approval. This program also supports development of a device to test scientific hypotheses that are not feasible or practical to conduct in animal models, but are critical to enable next-generation devices. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a small clinical study. Tue, 29 Jul 2014 00:00:00 EDT