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NIAID announces the availability of funds for administrative supplement awards to promote the development of pediatric chemical research models and medical countermeasures (MCM) discovery under the Chemical Countermeasures Research Program (CCRP). There is currently an unmet need in understanding the natural history, pathophysiology, and treatment of critical illness in infants, children, adolescents, and young adults after exposure to highly toxic DHS-designated Chemicals of Concern (CoCs). The administrative supplement funds are intended to support pilot preclinical projects by CCRP-supported researchers that focus on 1) Basic research to elucidate mechanistic differences in susceptibility to CoCs between pediatric and adult populations and/or 2) Applied research towards the discovery and early development of pediatric-safe MCMs.

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.

(Reissue PAR-21-056) The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

(Reissue PAR-21-058). The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

(Reissue PAR-21-057) The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

Reissue of PAR-18-546. 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 are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. BPN awardee Institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

Reissue of PAR-18-541. The Blueprint Neurotherapeutics Network (BPN) encourages applications from small businesses seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to 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 awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

The Center for Inherited Disease Research (CIDR) high-throughput genotyping, sequencing and supporting statistical genetics services are designed to aid the identification of genes or genetic modifications that contribute to human health and disease or to enhance existing collections of well-phenotyped specimens in biorepositories by the addition of genotype or next-generation sequence data. The laboratory specializes in genomic services that cannot be efficiently carried out in individual investigator laboratories. CIDR provides the most up-to-date platforms, services and statistical genetic support. This is an NIH-wide initiative that is managed by NHGRI. Information about current services offered can be accessed via: http://www.cidr.jhmi.edu.