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Reissue PAR-21-122. This NOFO provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological or neuromuscular disorders that fall under the NINDS mission. Therapeutic agents include small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network or other translational programs.

Reissue PAR-21-122. This NOFO provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological or neuromuscular disorders that fall under the NINDS mission. Therapeutic agents include small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network or other translational programs.

Some projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR/STTR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap (known as the Valley of Death) between the end of the SBIR/STTR Phase II award and the commercialization stage. The goal of this FOA is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product/technology that requires Federal regulatory approval or to bring a complex research tool to market. This opportunity aims to facilitate the transition of previously funded SBIR and STTR Phase II projects to the commercialization stage by promoting partnerships between NINDS SBIR or STTR awardees and third-party investors and/or strategic partners in the Phase IIB competing renewal. Applicants are strongly encouraged to secure independent third-party funding throughout the Phase IIB project period.

(Reissue of PAR-18-665) This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support clinical trials for projects that were previously funded by NIH SBIR and STTR Phase II awards. The projects must focus on products related to the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS) and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Since conducting the clinical trials needed for commercialization may be capital-intensive, the FOA aims to facilitate the transition of SBIR Phase II projects to the commercialization stage by promoting partnerships between NIH's SBIR/STTR awardees and third-party investors and/or strategic partners. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all SBIR Phase II applications, applicants must submit a Commercialization Plan, which should include details on any independent third-party investor funding that has already been secured or is anticipated during the project period. It is expected that the level of this independent third-party funding will equal or exceed the NINDS funds being requested throughout the SBIR Phase IIB project period.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NINDS R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs.

The purpose of this FOA is to provide support for institutional research training programs in areas relevant to the NINDS mission. These institutional research training programs should produce well-trained neuroscientists who leave the program with the research skills and scientific knowledge to make a significant contribution to neuroscience research. Programs should be designed to enhance the breadth and depth of training in NINDS mission areas by incorporating didactic, research and career development components in the context of a defined scientific theme. Programs may support basic, clinical and/or translational research. Critical components of programs supported by this FOA include mechanisms to ensure a thorough understanding of experimental design, strong statistics and analytical skills, and skills for communicating science, both orally and in writing, to a wide variety of audiences. Regardless of theme, programs should provide opportunities and activities that will foster the development of quantitative literacy and the application of quantitative approaches to the trainees' research. NINDS institutional training programs are intended to be 1-2 years in duration and support training of one or more of the following groups: dissertation stage predoctoral students in their 3rd and/or 4th year of graduate school, postdoctoral fellows and fellowship-stage clinicians. (NINDS does not support first or second year graduate students under this PAR).

The purpose of the NINDS Institutional Translational Research Training Program is to equip trainees with the knowledge and skills needed to advance basic research toward clinical application. These programs will support, students and/or postdocs conducting basic, disease-relevant research in an environment that includes 1) basic neuroscientists and clinicians who are actively engaged in collaborative research projects, 2) neuroscience researchers with expertise in translational processes who are conducting research designed to move basic discoveries toward clinical application and 3) relationships with industry and government regulatory agencies. Programs will have a cohesive educational approach to translational training in areas relevant to the NINDS mission, and in which students and postdocs learn the processes involved in translational research in the context of their individual projects. Programs supported by this FOA must include activities that ensure a thorough understanding of experimental design, strong statistical and analytical skills, and skills for communicating science with a wide variety of audiences. These programs are intended to be 2 years in duration and support training of one or more of the following groups: advanced predoctoral students, postdoctoral fellows and fellowship-stage clinicians. Upon completion of the program, trainees will be prepared to address basic research problems with an understanding of the requirements for translating discoveries into viable therapies.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this National Insitute of Neurological Disorders and Stroke R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs.To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on research experiences, designed to foster the development of physicians as research scientists in areas relevant to the NINDS mission. The research experiences will prepare clinicians to successfully compete for individual NIH mentored career development awards, or where appropriate, independent research awards. This FOA will also support educational activities such that participants of the R25 are expected to attend and participate in an annual workshop specific to this FOA to present their work, discuss progress and plans towards transitioning to the next career stage and to network with other researchers and leaders in their fields. Such success will facilitate their transition from resident/fellow to physician-scientist, and will thus foster retention of a cadre of physician-scientists who will conduct research into the mechanisms of, etiology, and treatment of neurological diseases.

This NOFO encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions; biomarker or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery; and ancillary studies designed to add scientific aims to active studies being conducted within StrokeNet. Successful applicants will collaborate and conduct the study within the NIH StrokeNet. Following peer review, NINDS will prioritize studies among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

(Reissue of PAR-21-266) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only SBIR Phase II and Fast-Track applications are supported under this program. SBIR Phase I applications are only accepted as part of a Fast-track application.