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Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

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Grant

Contract Overview

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

AI Contract Overview

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The National Institute of Neurological Disorders and Stroke (NINDS) is seeking to support scientific research using data from intermediate-size patient population expanded access protocols for Amyotrophic Lateral Sclerosis (ALS). To be eligible, protocols must provide access to an investigational drug or biological product for individuals with ALS and generate data that supports research into the prevention, diagnosis, mitigation, treatment, or cure of the disease. Research goals may include analyzing the effects of products on biomarkers, target engagement, safety and outcome information such as survival and hospitalization, or general patient experience data. This opportunity is currently listed as a forecast by the National Institutes of Health under the Department of Health and Human Services, and applications are not being solicited at this time. The notice serves as a preliminary announcement to allow potential applicants sufficient time to develop responsive projects. Interested parties can contact the ALS Program for further information.

General Info

NINDS forecast for scientific research using ALS patient expanded access protocol data.

Agency

Department Of Health And Human Services → National Institutes Of HealthView Agency

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)View NAICS

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 / Agency
Department Of Health And Human Services → National Institutes Of Health
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Office AddressUSA
Contacts
ALS Program
contact@example.gov

Full Description

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The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS ("intermediate expanded access protocol for ALS", see Expanded Access Categories for Drugs (Including Biologics)). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. The scientific research goal(s) informed by these data could include the investigational drug's or biological product's effect on biomarkers related to the pathophysiology of ALS or target engagement, the collection of safety or outcome information, such as survival or other significant medical events (e.g., hospitalization or need for ventilatory support), or patient experience data that are not specifically tied to assessing efficacy. 

Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects.

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