Biological Therapeutics Product Development Consultant Support Services

Closed Pre-Solicitation Posted

Solicitation number
NIH-NINDS-SBSS-75N95025Q00003
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
Not on record
PSC
Not on record
Place of performance
Bethesda, Maryland, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) is seeking small business sources capable of providing subject matter expert consulting services to support NIH drug discovery and development programs involving biologics, particularly in the areas of chemistry, manufacturing, and controls (CMC) for gene therapies. The consultants will be expected to provide technical recommendations and advice to support the translational development of novel biological therapeutics, including participation on lead development teams and multi-disciplinary project teams. Key requirements include expertise in the drug discovery and development process for biologics, the ability to analyze and evaluate development milestones, and strong communication skills. Responses to the Sources Sought Notice must address the specific requirements outlined and are limited to 10 pages. This is not a solicitation for proposals, and no award will be made as a result of this notice.

This opportunity is not set-aside for any particular business size or type. The pre-solicitation notice does not provide information on potential incumbents, award values, or budget ranges. The only key numerical detail provided is the due date of October 15, 2024 for responses to the Sources Sought Notice.

Notice text

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and apply that knowledge to enhance health, lengthen life, reduce illness and disability, and conduct, support, and make medical discoveries that improve people’s health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is an institute within the NIH that conducts research into the causes, treatments, and preventions of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and use that knowledge to reduce the burden of neurological disease.

The NINDS has a need for biological therapeutics development subject matter expert (SME) consultants to provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs. The support included in this contract will cover chemistry, manufacturing, and controls (CMC) for gene therapies.

Files

File Type Posted
Sources Sought Notice.pdf PDF

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