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A -- Development, Testing and Evaluation of a Live Attenuated Tularemia Vaccine Candidate

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Reference-Number-HHSN266200400002CFederal

Contract Overview

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

AI Contract Overview

The National Institute of Allergy and Infectious Diseases (NIAID), specifically its Division of Microbiology and Infectious Diseases, plans to modify its existing contract with DynPort Vaccine Company (DVC) to advance the development of a clinical grade Tularemia vaccine candidate. This modification is authorized under federal regulations that allow non-competitive contracting due to the specialized nature and prior investment in the vaccine's manufacturing process. Originally established through a collaborative research agreement with the Department of Defense in 2003, the contract supports preclinical testing and preparation for an Investigational New Drug (IND) application, aiming to enable phase 1 clinical trials. The scope of the contract modification includes the manufacturing of an additional cGMP-compliant clinical lot of the vaccine, along with its release and stability testing to ensure suitability for further clinical investigations. The unique challenges and costs associated with developing this vaccine candidate render competition impractical. The contract involves ongoing collaboration among federal agencies and relies on DVC’s established expertise in vaccine production, emphasizing continuity in the development process. Key contacts for this effort include Elizabeth D Osinski, the Lead Contract Specialist, and Jacqueline D Holden, Chief of the NICHD Contracts Management Branch.

General Info

NIAID modifies contract with DynPort to produce clinical-grade Tularemia vaccine for phase 1 trials.

Agency

N/A

NAICS

325414 - Biological Product (except Diagnostic) Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

No documents available

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AI Contract Breakdown

Uniform Contract Format

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Timeline

PostedJul 15

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Organization & Contact Information

AgencyN/A

Contacts2 people available

OfficeN/A

Organization / Agency

N/A

Office AddressN/A

Contacts

Elizabeth D OsinskiLead Contract Specialist

contact@example.gov

+1 (555) 000-0000

Jacqueline D HoldenChief, NICHD Contracts Management Branch

contact@example.gov

+1 (555) 000-0000

Full Description

The Division of Microbiology and Infectious Diseases, (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) intends to negotiate, under the authority of 41 U.S.C. 253(c)(1) and FAR 6.302-1, a modification to its current contract with DynPort Vaccine Company (DVC) for additional current Good Manufacturing Practice (cGMP) of a clinical grade Tularemia vaccine candidate. In October of 2003, NIAID entered into a collaborative research agreement with the US Department of Defense to complete ongoing preclinical and product testing of this vaccine and file an Investigational New Drug, (IND), with the goal of conducting a phase 1 clinical trial. As part of this interagency collaboration, NIAID awarded a non-competitive contract to DVC as the developer of the manufacturing process. Work currently includes preclinical testing and support for compilation of an Investigational New Drug (IND) submission. This modification will provide for continued development of the vaccine candidate. Tasks include manufacture of an additional cGMP clinical lot and its release and stability testing, suitable to support the use of this product in continuing clinical investigations. Inherent duplication of cost to the government and the difficulty in developing a new product make competition unfeasible for this project. See Numbered Note 22. No collect calls will be accepted.