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The National Center for Advancing Translational Sciences (NCATS) seeks to expand the therapeutics discovery program piloted in 2012, to explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program allows investigators to propose new therapeutic uses for Agents from pharmaceutical company partners. A strong application will be supported by scientific evidence that modulation of the Agents target will have a positive impact on the disease/condition. PAR-14-213 encourages X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules.The X02 pre-application is the first step in the application process for PAR-14-212, PAR-14-210, PAR-14-211; applicants must read all of the companion FOAs.The X02 pre-applications will be evaluated by outside experts. Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH2/UH3 application under this FOA or PAR-14-212, or a UH3 application under PAR-14-211. The UH2/UH3 is a two stage application. 1. The UH2 (Stage 1) for this FOA may be used to support milestone-driven preclinical studies to perform juvenile toxicity testing and verify target engagement in a disease model and Phase 1a and 1b trials for a period that may vary from one to two years.UH2 projects that have met the scientific milestones and feasibility requirements will be eligible for rapid transition to the second UH3 stage after NIH administrative review. 2. The UH3 (Stage 2) will support milestone-driven Phase 2a trials to demonstrate that the Agent, made available for this program by the pharmaceutical partners, modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population.The project period for the UH3 stage is up to two years.

The National Center for Advancing Translational Sciences (NCATS) seeks to expand the therapeutics discovery program piloted in 2012, to explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program allows investigators to propose new therapeutic uses for Agents from pharmaceutical company partners. A strong application will be supported by scientific evidence that modulation of the Agents target will have a positive impact on the disease/condition. PAR-14-213 encourages X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules.The X02 pre-application is the first step in the application process for PAR-14-212, PAR-14-210, and PAR-14-211; applicants must read all of the companion FOAs.The X02 pre-applications will be evaluated by outside experts. Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH3 application under this FOA or a UH2/UH3 under PAR-14-212 or a UH2/UH3 application under PAR-14-210 in the case of a pediatric indication. The UH3 will support milestone-driven Phase 2a trials to demonstrate that the Agent, made available for this program by the pharmaceutical partners, modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population.

The National Center for Advancing Translational Sciences (NCATS) seeks to expand the therapeutics discovery program piloted in 2012 to explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program allows investigators to propose new therapeutic uses for Agents from pharmaceutical company partners. A strong application will be supported by scientific evidence that modulation of the Agents target will have a positive impact on the disease/condition. PAR-14-213 encourages X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules.The X02 pre-application is the first step in the application process for PAR-14-212, PAR-14-210, and PAR-14-211; applicants must read all of the companion FOAs.The X02 pre-applications will be evaluated by outside experts. Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH2/UH3 application under this FOA or a UH3 under PAR-14-211 or a UH2/UH3 application under PAR-14-210 in the case of a pediatric indication. The UH2/UH3 is a two stage application. 1. The UH2 (Stage 1) may be used to support milestone-driven preclinical studies to verify target engagement in a disease model and/or Phase 1b clinical trials using the selected Agent in its existing formulation/route of administration to identify the dose or exposure of the Agent in the proposed patient group, and inform patient selection. Support for the UH2 may be requested for a period that may vary from six months up to one year.UH2 projects that have met the scientific milestones and feasibility requirements will be eligible for rapid transition to the second UH3 stage after NIH administrative review. 2. The UH3 (Stage 2) will support milestone-driven Phase 2a trials to demonstrate that the Agent, made available for this program by the pharmaceutical partners, modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population.The project period for the UH3 stage is up to two years.

The National Center for Advancing Translational Sciences (NCATS) seeks to expand the therapeutics discovery program piloted in 2012, to explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program allows investigators to propose new therapeutic uses for Agents from pharmaceutical company partners. A strong application will be supported by scientific evidence that modulation of the Agents target will have a positive impact on the disease/condition. PAR-14-213 encourages X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules.The X02 pre-application is the first step in the application process for PAR-14-212, PAR-14-211 and PAR-14-210; applicants must read all of the companion FOAs. The X02 pre-applications will be evaluated by outside experts. Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH2/UH3 under PAR-14-212 or a UH3 application under PAR-14-211 or a UH2/UH3 application under PAR-14-210 in the case of a pediatric indication.

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support exploratory 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 NIHs 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.

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support the next stage of development for projects requiring approval from a Federal regulatory agency or for those projects developing complex research tools. The FOA aims to facilitate the transition of previously funded SBIR and STTR Phase II projects to the commercialization stage by promoting partnerships between NIHs 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.

This Funding Opportunity Announcement (FOA) invites applications for the Morris K. Udall Centers of Excellence for Parkinsons Disease Research program. The overarching goal of the specialized Udall Centers program is to establish a network of Centers that work collaboratively as well as independently to define the causes of and discover improved treatments for Parkinsons disease (PD). A more immediate goal for each Center is to rapidly advance synergistic, interdisciplinary research programs while serving as local resources and national leaders in PD research. The overall theme, proposed research projects, and associated cores must inform the etiology, pathogenesis or treatment of PD. Investigations on related synucleinopathies may be included, to the extent that these directly inform PD research.

The NIH Research Evaluation and Commercialization Hub (REACH) program will support proof-of-concept centers (Hubs) that facilitate and accelerate the translation of biomedical innovations into commercial products that improve patient care and enhance health. The REACH Hubs will provide qualified institutions with the initial investment and resources to nurture innovators to develop high priority early-stage technologies within the NIHs mission by providing: (1) infrastructure for identifying the most promising technologies, (2) funding for product definition studies (e.g. feasibility studies, prototype development, or proof-of-concept studies), (3) coordinated access to expertise in areas required for early stage technology development (including scientific, regulatory, reimbursement, business, legal, and project management), and (4) skills development and hands-on experience in entrepreneurism. Establishing public-private partnerships and providing additional non-federal funds will be critical for success.

This FOA solicits applications for the Lasker Clinical Research Scholars Program for the purpose of supporting the research activities during the early stage careers of independent clinical researchers.

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for graduate training programs in Big Data Science, for the expressed purpose of training the next generation of scientists who will develop computational and quantitative approaches and tools needed by the biomedical research community to work with biomedical Big Data in the biomedical sciences (see definition under Funding Opportunity Description). This proposed training initiative should prepare qualified individuals for careers in developing new technologies and methods that will allow biomedical researchers to maximize the value of the growing volume and complexity of biomedical data.