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In Vivo Efficacy and Toxicology Studies

Active

Grant

Response Deadline10/10/2028, 04:00:00 AM UTC

Contract Overview

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

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This subcontract, titled In Vivo Efficacy and Toxicology Studies, supports the National Institutes of Health and the Department of Health and Human Services by providing preclinical validation of biologic therapies for prime contractors on NIH/NINDS ADRD projects. The scope of work involves executing in vivo efficacy, safety pharmacology, and toxicology studies utilizing translationally appropriate animal models specifically for Alzheimer's and Frontotemporal Dementia. To fulfill the requirements, the contractor must utilize GLP-compliant toxicology lab facilities to ensure regulatory standards are met. The primary deliverables include comprehensive preclinical validation reports and detailed toxicology data packages necessary for Investigational New Drug submission. The project is categorized under NAICS code 541714, with a response deadline set for October 10, 2028.

General Info

Preclinical efficacy and toxicology studies for NIH biologic therapies targeting Alzheimer's and dementia.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of RFA-NS-28-012.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

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

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Timeline

PostedNov 3

subcontract

Response DeadlineOct 10

Submission deadline

Response Deadline

10/10/2028, 04:00:00 AM UTCin almost 2 years

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health

Office AddressN/A

ContactsNo contact information available

Full Description

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Performs preclinical validation of biologic therapies for prime contractors on NIH/NINDS ADRD projects. Executes in vivo efficacy, safety pharmacology, and toxicology studies using translationally appropriate animal models for Alzheimer's and Frontotemporal Dementia. Requires GLP-compliant toxicology lab facilities. Delivers preclinical validation reports and toxicology data packages for IND submission.

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