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 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 NINDS Direct Phase II SBIR Grants to Support Exploratory Clinical Trials (R44) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-265 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-265 .htm The purpose of this funding opportunity announcement (FOA) is to support Direct-to-Phase II exploratory clinical trials at the NINDS. For this FOA, the small business has demonstrated the scientific and technical merit and feasibility of the prototype stage of developing a biomedical technology that has commercial potential. The goal of this FOA is to enable a small business that has accomplished the objectives of a Phase I SBIR grant through non-SBIR funds to initiate the Phase II SBIR stage of development, without needing to perform more early stage, Phase-I-SBIR-type research. Fri, 20 Jun 2014 00:00:00 EDT Parkinson's Disease Biomarker Program (PDBP) Discovery Projects (U01) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-259 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-259 .htm The NINDS Parkinson's Disease Biomarkers Program (PDBP) was established to advance discovery of biomarkers that will improve the efficiency and outcome of Phase II clinical trials for Parkinson's Disease (PD) and advance therapeutic development for PD. The PDBP was setup to cover the spectrum of Parkinson's disease from first diagnosis to more advance stages of the disease and includes the longitudinal collection of clinical data and biospecimens. Since the program began in November of 2012, six clinical sites have enrolled more than 800 participants in the study, and over 12,000 clinical forms are available through the PDBP data management resource (DMR). Each participating clinical site follows a standardized schedule for patient visits and clinical data collection. Also, through a standardized set of procedures, biospecimens are collected and stored at the NINDS Repository. There are currently over 200 cerebropinal fluid samples (CSF) and more than 500 RNA, plasma and serum samples available for analysis. These biospecimens and associated quality control data on the biospecimens are available through the NINDS Repository catalog in the PDBP DMR. Requests for biospecimens are handled through the PDBP Biospecimen Resource Access Committee (BRAC). The relationship of clinical data with the biospecimen is initially blinded to investigators using these samples. Upon completion of biomarker measurements and disposition of the associated data with the PDBP DMR, biospecimens used in the study will be unblinded. Access to this data by other investigators is embargoed for one year post sample identification. Fri, 20 Jun 2014 00:00:00 EDT Notice of Intent to Publish a Funding Opportunity Announcement for Institutional Center Core Grants to Support Neuroscience Research (P30) http://www.ninds.nih.gov/funding/funding_announcements/notice/NOT-NS-14-037.htm http://www.ninds.nih.gov/funding/funding_announcements/notice/NOT-NS-14-037.htm NINDS intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for Institutional Center Core Grants to Support Neuroscience Research. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in summer of 2014 with an expected application due date in fall of 2014. Fri, 20 Jun 2014 00:00:00 EDT Request for Information: Phase 1 Clinical Trial Services for Neurotherapeutics http://www.ninds.nih.gov/funding/funding_announcements/notice/NOT-NS-14-035.htm http://www.ninds.nih.gov/funding/funding_announcements/notice/NOT-NS-14-035.htm The National Institute of Neurological Disorders and Stroke (NINDS), NIH is considering establishing a Phase 1 clinical trials contract program to support advancement of neurotherapeutics. The services provided under this contract program will support that part of NINDS's mission for the development of neurotherapeutics. The design, study population and procedures to be performed will vary from project to project; therefore NINDS would like to determine whether it is possible for a single vendor to provide the full range of services potentially required. NINDS is seeking feedback from potential sources regarding interest, availability, and costs for the desired resources and services. This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes. Fri, 20 Jun 2014 00:00:00 EDT Notice of the Change in the Expiration Date for PAR-14-253 "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention Infrastructure Resource Access (X01)" http://www.ninds.nih.gov/funding/funding_announcements/notice/NOT-NS-14-036.htm http://www.ninds.nih.gov/funding/funding_announcements/notice/NOT-NS-14-036.htm The purpose of this Notice is to inform applicants of the change in the expiration date for PAR-14-253 "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention Infrastructure Resource Access (X01)". The previous expiration date was September 8, 2017. The new expiration date will be July 13, 2017. Fri, 13 Jun 2014 00:00:00 EDT NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-252 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-252 .htm This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects. Successful applicants may be given access to the NIH StrokeNet infrastructure. Following peer review, NINDS will prioritize trials among the highest scoring to be given access to the StrokeNet infrastructure. The StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently. The StrokeNet National Data Management Center (NDMC) will provide statistical and data management support. The Regional Coordinating Centers (RCCs) of the StrokeNet and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. The StrokeNet network will also be uniquely poised to collaborate with the NINDS Neurological Emergencies Treatment Trials Network (NETT) and/or other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery. Fri, 06 Jun 2014 00:00:00 EDT NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention Infrastructure Resource Access (X01) http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-253.htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PAR-14-253.htm Fri, 06 Jun 2014 00:00:00 EDT Administrative Supplements for the U.S.-Japan Brain Research Cooperative Program (BRCP) - U.S. Entity (Administrative Supplement) http://www.ninds.nih.gov/funding/funding_announcements/pa/PA-14-249.htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PA-14-249.htm The National Institutes of Health (NIH) announces the continuation of the U.S. entity of the U.S.-Japan Brain Research Cooperative Program (BRCP). This administrative supplement program will provide funds to research projects that are currently supported by the participating NIH Institutes and Centers. The purpose of the BRCP is to promote scientist exchange, training, and collaborations in basic, translational and clinical research between neuroscientists from the U.S. and Japan. The U.S. entity of the BRCP supports the following activities: 1) Visit of U.S. scientists to conduct collaborative research and/or to acquire advanced research skills in Japanese institutions. 2) Joint workshops to exchange scientific information and to foster collaborations. Fri, 06 Jun 2014 00:00:00 EDT Research on Chronic Overlapping Pain Conditions (R01) http://www.ninds.nih.gov/funding/funding_announcements/pa/PA-14-244.htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PA-14-244.htm The purpose of this FOA is to encourage epidemiological, clinical and translational research that will increase our understanding of the presence of multiple chronic pain conditions in subjects with pain. Recent findings suggest substantial overlap may exist between chronic pain conditions. Individuals diagnosed with one disorder often exhibit characteristics of additional chronic painful conditions or transition to other diagnostic categories. A better understanding is needed of the prevalence of overlapping pain conditions, their underlying etiologies, the evolution of these overlaps, and the therapeutic approaches best suited for treating subjects with these conditions. The main objective of this FOA is the formation of research groups with research interests bridging expertise in pain mechanisms and translational and clinical expertise to address important unresolved questions about overlapping pain conditions. Thu, 05 Jun 2014 00:00:00 EDT Research on Chronic Overlapping Pain Conditions (R21) http://www.ninds.nih.gov/funding/funding_announcements/pa/PA-14-243 .htm http://www.ninds.nih.gov/funding/funding_announcements/pa/PA-14-243 .htm The purpose of this FOA is to encourage epidemiological, clinical and translational research that will increase our understanding of the presence of multiple chronic pain conditions in subjects with pain. Recent findings suggest substantial overlap may exist between chronic pain conditions. Individuals diagnosed with one disorder often exhibit characteristics of additional chronic painful conditions or transition to other diagnostic categories. A better understanding is needed of the prevalence of overlapping pain conditions, their underlying etiologies, the evolution of these overlaps, and the therapeutic approaches best suited for treating subjects with these conditions. The main objective of this FOA is the formation of research groups with research interests bridging expertise in pain mechanisms and translational and clinical expertise to address important unresolved questions about overlapping pain conditions. Thu, 05 Jun 2014 00:00:00 EDT