“NCI OA Special Notice of Subcontract Opportunity at the Frederick National Laboratory for Cancer Research”

This Special Notice is not a formal Invitation for Bid (IFB), Request for Proposal (RFP), Request for Quotation (RFQ) nor any type of Solicitation for offers. In accordance with FAR 15.201(d), this Special Notice is intended FOR INFORMATIONAL PURPOSES ONLY in order to publicize the requirements of the Frederick National Laboratory for Cancer Research (FNLCR).

The FNLCR is a Government-Owned Contractor-Operated Federally Funded Research and Development Center (FFRDC) located at Fort Detrick, Maryland. The FNLCR partners with university, Government, and corporate scientists to speed the translation of laboratory research into new diagnostic tests and treatments for cancer and AIDS. FNLCR is a multi-program laboratory currently operated by Leidos Biomedical Research, Inc. (Leidos Biomed) for the National Cancer Institute (NCI) under Prime Contract No. 75N91019D00024 & HHSN261201500003I, which provides Operations and Technical Support (OTS) for the FNLCR.

The Government assumes no liability for reimbursement for any effort or associated costs to respond, nor for any information provided as a result of this Special Notice as no information is being requested. Please be advised that any submissions provided, despite that no information is requested, become Government property and will not be returned, nor will there be any ensuing discussions or debriefings.

Responses submitted to this Special Notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. It is the responsibility of the interested parties to monitor this site and any sites referenced herein for additional information pertaining to business opportunities with the FNLCR, if any.

Description of Work: NIAID DMID's objective is to initiate and execute the clinical trial provisionally entitled A Platform Trial to Evaluate Next Generation COVID-19 Vaccines , and referred to as NextGen, which is a series of standardized phase 1 and phase 2 trials on next-generation vaccines to generate data to inform decisions on which candidates to support for advanced development.

In support of the NIAID DMID NextGen clinical trials, Leidos Biomed is tasked with the management, oversight, and conduct of activities to support customized gap-filling for the vaccine candidate. This includes completion of reports and documentation that will enable regulatory filing, and evaluation of the vaccine candidate in a phase 1 clinical trial. In support of one vaccine candidate, Leidos Biomed seeks to contract with a Contract Development and Manufacturing Organization (CDMO) with the capabilities to perform nanofiltration processing followed by fill and finish of a recombinant protein vaccine for the prevention of SARS-CoV-2 generated from the 1c-SApNP platform (CHO Expression System). The filled, finished, and tested drug product is intended for use in a US-based Phase 1 clinical trial. The Offerors shall provide nanofiltration, fill and finish, and release testing.

Offerors shall be a US-based CDMO to provide nanofiltration, fill/finish, and release testing services for a 1c-SApNP platform recombinant protein vaccine candidate for use in a US-based Phase 1 clinical trial. Services shall be conducted in accordance with current Good Manufacturing Practices (cGMP) and all applicable US Pharmacopeia (USP) standards.

Leidos Biomedical Research, Inc. Point of Contact for a copy of Solicitation/RFP No: S26-125:

KIMBERLY IMAN AT kimberly.iman@nih.gov

For information concerning other opportunities with the FNLCR, please refer to:

https://frederick.cancer.gov/workwithus/solicitations