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 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 Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-292.htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-292.htm The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN receive funding for activities to be conducted in their own laboratories and the opportunity to collaborate with NIH-funded consultants and contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize well-validated hit compounds through medicinal chemistry, or at the Development stage, to advance development candidates through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN participants receive intellectual property rights to drug candidates developed through the program. Tue, 22 Jul 2014 00:00:00 EDT Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (UH2/UH3) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-293 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-293 .htm The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN receive funding for activities to be conducted in their own laboratories and the opportunity to collaborate with NIH-funded consultants and contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize well-validated hit compounds through medicinal chemistry, or at the Development stage, to advance development candidates through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN participants receive intellectual property rights to drug candidates developed through the program. Tue, 22 Jul 2014 00:00:00 EDT NINDS CREATE Bio Development Track: Preclinical and Early-phase Clinical Development for Biotechnology Products and Biologics (UH2/UH3) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-288 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-288 .htm This Funding Opportunity Announcement (FOA) is dedicated to the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, and cell therapies) for disorders that fall under the NINDS mission. An identified candidate, which has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to the CREATE Bio Development Track. The FOA supports Investigational New Drug (IND)-enabling studies for the candidate and early-phase clinical trials. At the end of the funding period, a successful project should have an IND application submitted to the U.S. Food and Drug Administration (FDA), at a minimum. The program supports early-phase clinical trials, although these are not required. Fri, 18 Jul 2014 00:00:00 EDT NINDS CREATE Bio Development Track: Preclinical and Early-phase Clinical Development for Biotechnology Products and Biologics (U44) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-289.htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-289.htm This Funding Opportunity Announcement (FOA) is dedicated to the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, and cell therapies) for disorders that fall under the NINDS mission. An identified candidate, which has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to the CREATE Bio Development Track. The FOA supports Investigational New Drug (IND)-enabling studies for the candidate and early-phase clinical trials. At the end of the funding period, a successful project should have an IND application submitted to the U.S. Food and Drug Administration (FDA), at a minimum. The program supports early-phase clinical trials, although these are not required. Fri, 18 Jul 2014 00:00:00 EDT NINDS CREATE Bio Discovery Track: Optimization in Preparation for Development of Biotechnology Products and Biologics (U44) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-287 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-287 .htm This Funding Opportunity Announcement (FOA) is dedicated to the discovery of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, and cell therapies) for disorders that fall under the NINDS mission. It supports the optimization of therapeutic lead(s) showing convincing proof-of-concept. At the end of the funding period, projects that successfully advance through support from this program will have identified an optimized candidate, which has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, and will be ready for entry into the CREATE Bio Development track for further development to enable filing for an Investigational New Drug (IND). Fri, 18 Jul 2014 00:00:00 EDT NINDS CREATE Bio Discovery Track: Optimization in Preparation for Development of Biotechnology Products and Biologics (U01) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-286 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-286 .htm This Funding Opportunity Announcement (FOA) is dedicated to the discovery of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, and cell therapies) for disorders that fall under the NINDS mission. It supports the optimization of therapeutic lead(s) showing convincing proof-of-concept. At the end of the funding period, projects that successfully advance through support from this program will have identified a optimized candidate, which has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, and will be ready for entry into the CREATE Bio Development track for further development to enable filing for an Investigational New Drug (IND). Fri, 18 Jul 2014 00:00:00 EDT Career Transition Award for NINDS Intramural Clinician-Scientists (K22) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-282 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-282 .htm The objective of the NIH Career Transition Award (K22) is to provide support to outstanding basic or clinical investigators to develop their independent research skills through a two phase program: an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. This NINDS K22 is specifically designed to facilitate the transition of NINDS intramural neurologist- and neurosurgeon-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities. Tue, 15 Jul 2014 00:00:00 EDT