This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on January 15, 2025. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Biological Therapeutics Product Development Subject Matter Expert Consultants

Closed

NIH-NINDS-CSS-75N95025Q00109Federal

Submission Closed01/27/2025, 06:00:00 AM UTC

Contract Overview

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

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NAICS: 541690

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Frimley Health NHS Foundation Trust

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Archaeology Consulting Services

Solicitation # 26-122

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R--Technical Services Support

Solicitation # 89243126RSC000172

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Solicitation # 1070-30/FH27FHQ131

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Region of Halton

POSTED

1 day ago

DEADLINE

in 24 days

AI Contract Overview

The NINDS is seeking expert consultants in biological therapeutics to support the translational development of innovative biologic drugs, including cell and gene therapies, for NIH drug discovery initiatives. The scope of support encompasses all phases up to Phase 1 clinical trials, covering critical areas such as chemistry, manufacturing, and controls (CMC), assay development, pharmacokinetics and pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME), toxicology, regulatory affairs, medical writing, biostatistics, and quality assurance/quality control. The contract aims to leverage a diverse pool of subject matter experts across various modalities to provide technical recommendations and strategic guidance throughout the development process. The contract, issued by the NIH NINDS under the Department of Health and Human Services, is posted with a response deadline of January 27, 2025. It is a combined type procurement under NAICS code 541690, targeting vendors capable of delivering comprehensive expertise in biologics development. Interested parties can contact designated points of contact, Shayna Simpson and Kelly Dempsey, for further details. The work will be performed primarily in Bethesda, Maryland, and the contract aims to facilitate the advancement of novel biologic therapeutics from discovery through initial human testing.

General Info

NIH seeks consultants for biological therapeutics development; proposals due January 27, 2025.

Agency

Department Of Health And Human Services → National Institutes Of Health Nida

NAICS

541690 - Other Scientific and Technical Consulting Services

Place of Performance

Bethesda, MD, USA

Set-Aside

NONE

Documents

Additional Terms and Conditions

specifications

High

Information and Physical Access Security Requirements - Bioactivity Assay Development

specifications

High

NIH Invoicing Instructions w-IPP

specifications

High

NIH-NINDS-CSS-75N95025Q00109 - Biological Therapeutics SME Consulting Services

rfq

High

NIH-NINDS-CSS-75N95025Q00109 Technical Evaluation Criteria

specifications

High

RFQ 75N95025Q00109 - Attachment 4 Price Template

specifications

High

RFQ NIH-NINDS-CSS-75N95025Q00109 - Representations and Certification

representations-and-certifications

High

SOW for Biological Therapeutics Product Development SME Consultants

sow

High

Q&A - Biological Therapeutics Product Development SME Consultants (75N95025Q00109)

q-and-a

Low

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

CLEATUS splits the solicitation into Uniform Contract Format (UCF) sections: scope, pricing, deliverables, and evaluation criteria.

Timeline

1 update

PhaseClosed

PostedJan 2

Combined Synopsis

Notice updatedJan 15

The notice description changed.

Response DeadlineJan 27

Deadline has passed

Submission Closed

01/27/2025, 06:00:00 AM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health Nida

Contacts2 people available

OfficeBethesda, MD, 20892, USA

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Nida

Office AddressBethesda, MD, 20892, USA

Contacts

Shayna Simpson

contact@example.gov

Kelly Dempsey

contact@example.gov

Full Description

Attachment 01 Amend 1_CSS 75N95025Q00109 has been added on 1/15/25 to address questions related to this solicitation. 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 all aspects of drug discovery and development through the Phase 1 clinical trial, including but not limited to chemistry, manufacturing, and controls (CMC), assay development, pharmacokinetics and pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME), toxicology, regulatory affairs, regulatory operations, medical writing, biostatistics, and quality assurance/quality control (QA/QC), and first-in-human trial planning and design. The NINDS is seeking vendors who can supply a broad array of Biologics subject matter experts, including all modalities and cell and gene therapies.