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Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development of Disorders of the Nervous System (UG3/UH3) - Clinical Trial Optional

PAR
Thursday, December 21, 2017
Friday, May 8, 2020
UG3/UH3
PAR-18-546

Funding Opportunity Purpose

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, or at the Development stage, to advance a development candidate 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 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.

BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3 - Clinical Trial Required)

RFA
Thursday, December 21, 2017
Thursday, October 22, 2020
UH3
RFA-NS-18-023

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/.

BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 - Clinical Trial Required)

RFA
Thursday, December 21, 2017
Thursday, October 22, 2020
UG3/UH3
RFA-NS-18-021

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical trial (e.g., Early Feasibility Study). The small clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical trial. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/.

BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44 Clinical Trial Required)

RFA
Thursday, December 21, 2017
Translational Research, Clinical Trials Research
Thursday, October 22, 2020
U44
RFA-NS-18-022

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain. The program will utilize a cooperative agreement mechanism to support the non-clinical studies necessary for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and the subsequent small clinical trial (e.g., Early Feasibility Study). Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical trial. The small clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.

NeuroNEXT Clinical Trials (U01 - Clinical Trial Optional)

PAR
Thursday, December 21, 2017
Friday, January 8, 2021
U01
PAR-18-528

Funding Opportunity Purpose

This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

Research on the Mechanisms and/or Behavioral Outcomes of Multisensory Processing (R01 - Clinical Trial Optional)

PA
Thursday, December 21, 2017
Tuesday, January 8, 2019
R01
PA-18-545

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications that elucidate the mechanisms and/or behavioral outcomes of multisensory processing, the integration or processing of at least two distinct types of sensory input as defined by distinct receptor-type transduction, neural pathways and cognate perceptual quality. Specifically, multiple sensory inputs may include the major traditional modalities of hearing, vision, taste, smell, balance, and touch. Additional submodalities of body senses include but are not restricted to thermosensation, body position and proprioception, pain, itch, and general visceral sensation. This FOA encourages research grant applications investigating multisensory processing in perception or other behavioral and social outcomes and/or the mechanisms underlying multisensory processing in the context of the described specific areas of research interests from the participating NIH Institutes, Centers, and Offices (ICOs). The FOA is intended to encourage basic, behavioral, and/or clinical research projects examining the interactions between other neural systems, such as cognitive, affective, or motor processes, and multiple sensory modalities. Multisensory research applications that do not align with the specific areas of research interests described below by the participating NIH ICOs should be submitted to the relevant parent R01 FOA.

Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01)

PAR
Wednesday, December 20, 2017
Saturday, August 18, 2018
U01
PAR-18-534

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support clinical studies that will fill gaps in the design of upcoming clinical trials in rare neurological or neuromuscular diseases by validating clinical outcome measures or biomarkers, or by characterizing cohorts of relevant patients. Through the support of trial readiness studies, NINDS expects to accelerate the initiation of clinical trials for rare diseases and to increase the likelihood of success in those trials.

CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR- Clinical Trial Optional)

PAR
Wednesday, December 20, 2017
Translational Research, Clinical Trials Research
Tuesday, September 8, 2020
U44
PAR-18-543
Chris Boshoff

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with 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 this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 - Clinical Trial Optional)

PAR
Wednesday, December 20, 2017
Tuesday, September 8, 2020
U01
PAR-18-542
Chris Boshoff

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with 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 this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

Innovation Corps (I-Corps) at NIH Program for NIH and CDC Translational Research (Admin Supp - Clinical Trial Not Allowed)

PA
Tuesday, December 19, 2017
Tuesday, March 6, 2018
333
PA-18-517

Funding Opportunity Purpose

This funding opportunity announcement (FOA) seeks to develop and nurture a national innovation ecosystem that builds upon biomedical research to develop technologies, products and services that benefit society. Toward meeting this objective, the I-Corps program is being offered. The I-Corps at NIH program is focused on educating researchers and technologists on how to translate technologies from the lab into the marketplace. Under this FOA, participating NIH and CDC Institutes and Centers will continue providing administrative supplement awards to currently-funded SBIR and STTR Phase I grantees. The program is designed to provide three-member project teams with access to instruction and mentoring in order to accelerate the translation of technologies currently being developed with NIH and CDC SBIR and STTR funding. It is anticipated that outcomes for the I-Corps teams participating in this program will include significantly refined commercialization plans and well-informed pivots in their overall commercialization strategies. Prospective applicants are strongly encouraged to contact NIH or CDC Scientific/Research staff for more information about the program before applying.

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