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The Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) provides support for biologic-based therapeutic discovery and development, from lead optimization through phase I clinical testing. This Funding Opportunity Announcement (FOA) supports preclinical discovery and development of potential therapeutic Biotechnology Products and Biologics including, but not limited to, large biologic macromolecules, (e.g., proteins, antibodies, and peptides), gene-based therapies (i.e., oligonucleotide- and viral-based), cell therapies, and novel emerging therapies (e.g., microbial and microbiome therapies). Applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in manufacturing, scaling, pharmacokinetics, toxicology, and Phase I clinical testing. BPN-Biologics awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN-Biologics contractors (and thereby control the patent prosecution and licensing negotiations) for biotherapeutic candidates developed in this program.

The purpose of the NIH Research Conference Grant (R13) is to support high quality conferences that are relevant to the public health and to the scientific mission of the participating Institutes and Centers.

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.

A central goal of the BRAIN Initiative is to understand how electrical and chemical signals code information in neural circuits and give rise to sensations, thoughts, emotions and actions. While currently available technologies can provide some understanding, they may not be sufficient to accomplish this goal. For example, non-invasive technologies are low resolution and/or provide indirect measures such as blood flow, which are imprecise; invasive technologies can provide information at the level of single neurons producing the fundamental biophysical signals, but they can only be applied to tens or hundreds of neurons, out of a total number in the human brain estimated at 85 billion. Other BRAIN FOAs seek to develop novel technology (RFA-NS-17-003) or to optimize existing technology ready for in-vivo proof-of-concept testing and collection of preliminary data (RFA-NS-17-004) for recording or manipulating neural activity on a scale that is beyond what is currently possible. This FOA seeks applications for unique and innovative technologies that are in an even earlier stage of development than that sought in other FOAs, including new and untested ideas that are in the initial stages of conceptualization. In addition to experimental approaches, the support provided under this FOA might enable calculations, simulations, computational models, or other mathematical techniques for demonstrating that the signal sources and/or measurement technologies are theoretically capable of meeting the demands of large-scale recording or manipulation of circuit activity in humans or in animal models. The support might also be used for building and testing phantoms, prototypes, in-vitro or other bench-top models in order to validate underlying theoretical assumptions in preparation for future FOAs aimed at testing in animal models.

This FOA encourages applications at the intersection of HIV and aging by addressing two overarching objectives: 1) to improve understanding of biological, clinical, and socio-behavioral aspects of aging through the lens of HIV infection and its treatment; and 2) to improve approaches for testing, prevention, and treatment of HIV infection, and management of HIV-related comorbidities, co-infections, and complications in different populations and cultural settings by applying our current understanding of aging science. Applications appropriate to this FOA should be consistent with the scientific priorities outlined by the NIH Office of AIDS Research (OAR) as described in NOT-OD-20-018.

This FOA encourages applications at the intersection of HIV and aging by addressing two overarching objectives: 1) to improve understanding of biological, clinical, and socio-behavioral aspects of aging through the lens of HIV infection and its treatment; and 2) to improve approaches for testing, prevention, and treatment of HIV infection, and management of HIV-related comorbidities, co-infections, and complications in different populations and cultural settings by applying our current understanding of aging science. Studies that move the science of HIV and aging into new directions with little or no preliminary data are appropriate for this activity code.

The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this Funding Opportunity Announcement (FOA) may not include preliminary data. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. This Funding Opportunity Announcement is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the appropriate Clinical Trial Required or Clinical Trial Not Allowed" FOA

The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this Funding Opportunity Announcement (FOA) may not include preliminary data. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. This Funding Opportunity Announcement does not accept applications proposing clinical trials.

This Funding Opportunity Announcement (FOA) will support students at institutions without NIH-funded institutional predoctoral dual-degree training programs. The purpose of the Kirschstein-NRSA, dual-doctoral degree, predoctoral fellowship (F30) is to enhance the integrated research and clinical training of promising predoctoral students, who are matriculated in a combined MD/PhD or other dual-doctoral degree training program (e.g. DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), and who intend careers as physician/clinician-scientists. Candidates must propose an integrated research and clinical training plan and a dissertation research project in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The fellowship experience is expected to clearly enhance the individual's potential to develop into a productive, independent physician/clinician-scientist. This Funding Opportunity Announcement (FOA) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

(Reissue of PAR-20-021) The purpose of this award is to support outstanding scientific training of highly promising postdoctoral candidates with outstanding mentors. Candidates are eligible to apply for support from this program from ~12 months prior to the start of the proposed postdoctoral position to within 12 months after starting in postdoctoral position. Based on the early timeframe of eligibility, and the discouragement of inclusion of preliminary data, this NINDS F32 seeks to foster early, goal-directed planning and to encourage applications for bold and/or innovative projects by the candidate that have the potential for significant impact. Applications are expected to incorporate strong training in quantitative reasoning and the quantitative principles of experimental design and analysis. Support by this program is limited to the first 3 years of a candidate's activity in a specific laboratory or research environment, so as to further encourage early fellowship application and timely completion of mentored training of the postdoctoral candidate in a single environment.