Biological Therapeutics Product Development Subject Matter Expert Consulting Services to Support the Development of Therapeutic Biotechnology Products (Biologics)
Closed Solicitation Posted
This opportunity was awarded. See its 3 award notices in the notice history.
- Solicitation number
- NIH-NINDS-CSS-22-000015
- Agency
-
National Institute on Drug Abuse
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- R499 Support- Professional: Other
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Neurological Disorders and Stroke seeks to procure biological therapeutics product development subject matter expert consulting services through December 2024 to provide technical recommendations and advice supporting novel biologics development programs at the National Institutes of Health. Consultants are required across eight subject matter areas including biologics development, manufacturing, and clinical trials to assist initiatives such as the Blueprint Neurotherapeutics Network Biologics program. Proposals will be evaluated in two phases on personnel qualifications, technical approach, and pricing, with quotes due by November 12, 2021 for the labor-hour contract.
The solicitation is a total small business set-aside under NAICS code 541690 with a size standard of $16.5 million average annual receipts. Evaluation will utilize criteria on key personnel experience and technical presentations, with the agency seeking up to three experts annually in each area for estimated 20 hours each up to a maximum of 800 hours per expert. Potential award value depends on the number of subject matter experts proposed across the defined areas to support candidate biologics development, cGMP manufacturing, and clinical trials advice for conditions of the nervous system through December 2024. Place of performance is the contractor's site and various NIH locations.
Notice text
3 versions
Update #3 · Latest ·
Amendment 2: Two questions and answers added to Q&A document; two-page limit removed for Key Personnel Narrative, and minor adjustment made to Information/Physical Access Security document.
Amendment 1: Consolidated Q&A document posted in response to questions submitted by 11/5 deadline. Revised documents also posted for Combined Synopsis/Solicitation (pgs 3-4), Statement of Work (pgs 9-10), Tech Eval Criteria (pgs 4-5), and Information/Physical Access Security (pgs 8-12).
Description: The National Institute of Neurological Disorders and Stroke (NINDS) has a need for biological therapeutics development subject matter expert (SME) consulting services. SME consultants will be required to provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs.
Several such programs are being launched or expanded to provide support for investigators developing medical interventions for neurological disorders. These include the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH programs. The SMEs will support these biologics development programs by providing consulting services related to candidate biologics therapeutics development, current Good Manufacturing Practices (cGMP) manufacturing, and evaluation of the biologics in Phase 1 clinical trials.
Please review the attachments for additional information.
Update #2 ·
Amendment 1: Consolidated Q&A document posted in response to questions submitted by 11/5 deadline. Revised documents also posted for Combined Synopsis/Solicitation (pgs 3-4), Statement of Work (pgs 9-10), Tech Eval Criteria (pgs 4-5), and Information/Physical Access Security (pgs 8-12).
The National Institute of Neurological Disorders and Stroke (NINDS) has a need for biological therapeutics development subject matter expert (SME) consulting services. SME consultants will be required to provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs.
Several such programs are being launched or expanded to provide support for investigators developing medical interventions for neurological disorders. These include the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH programs. The SMEs will support these biologics development programs by providing consulting services related to candidate biologics therapeutics development, current Good Manufacturing Practices (cGMP) manufacturing, and evaluation of the biologics in Phase 1 clinical trials.
Please review the attachments for additional information.
Update #1 ·
The National Institute of Neurological Disorders and Stroke (NINDS) has a need for biological therapeutics development subject matter expert (SME) consulting services. SME consultants will be required to provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs.
Several such programs are being launched or expanded to provide support for investigators developing medical interventions for neurological disorders. These include the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH programs. The SMEs will support these biologics development programs by providing consulting services related to candidate biologics therapeutics development, current Good Manufacturing Practices (cGMP) manufacturing, and evaluation of the biologics in Phase 1 clinical trials.
Please review the attachments for additional information.
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Notice history
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