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Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)

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Grant

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The National Institutes of Health, through the National Institutes of Neurological Disorders and Stroke, is forecasting a program to support the optimization and translational development of genomic and biologic therapies for Alzheimer’s Disease-Related Dementias. This initiative targets the challenges associated with delivery, safety, and manufacturability to move therapeutic candidates from preclinical evidence toward clinical testing. The program focuses on disease-modifying developments for frontotemporal degeneration, Lewy body dementia, and vascular contributions to cognitive impairment and dementia. Eligible projects may span the translational pipeline, including the refinement of therapeutic design, the establishment of pharmacology and toxicology, and the generation of data necessary for IND submissions and first-in-human clinical studies. While applications are not currently being solicited, this notice serves to allow potential applicants to establish collaborations. The opportunity is categorized under NAICS code 325414 and is managed by the NINDS ADRD Program.

General Info

NINDS supports developing, optimizing genomic and biologic therapies targeting Alzheimer’s-related dementias.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

325414 - Biological Product (except Diagnostic) Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

forecast

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUSA
Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health
Office AddressUSA
Contacts
NINDS ADRD Program
contact@example.gov

Full Description

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The National Institutes of Neurological Disorders and Stroke (NINDS) is interested in supporting research projects proposing the optimization and translational development of genomic and biologic therapeutic candidates for Alzheimer’s Disease-Related Dementias (ADRD). Breakthroughs in genomic and biologic therapies are creating new opportunities to treat, prevent, and potentially modify the course of dementias; however, progress is limited by challenges in delivery, safety, manufacturability, and readiness for clinical testing.

This program is intended to support projects across the translational pipeline, from optimization through IND development and early clinical evaluation, for genomic and biologic therapeutic candidates with compelling preclinical evidence. Eligible projects may include activities to refine therapeutic design and manufacturability; establish pharmacology, toxicology, biodistribution, and in vivo efficacy; to generate the full body of data required to support regulatory interactions and IND submissions, and, when appropriate, first-in-human (FIH) clinical studies.

The program is aligned with priorities from the ADRD Summits, including acceleration of disease-modifying therapeutic development in frontotemporal degeneration (FTD), Lewy body dementia (LBD), and vascular contributions to cognitive impairment and dementia (VCID). Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

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