SPECIAL NOTICE
A -- NCI OA Special Notice of Subcontract Opportunity at the Frederick National Laboratory for Cancer Research
- Notice Date
- 2/12/2018
- Notice Type
- Special Notice
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- S18-023
- Archive Date
- 4/24/2018
- Point of Contact
- SBO Help Desk, , Kimberly A. Iman,
- E-Mail Address
-
NCIOASupport@centeva.com, Kimberly.Iman@nih.gov
(NCIOASupport@centeva.com, Kimberly.Iman@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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: 1) publicize the requirements of the Frederick National Laboratory for Cancer Research (FNLCR); and 2) increase participation by qualified HUBZone small business, small, small disadvantaged, women-owned small business, veteran-owned small business and service-disabled veteran-owned small business concerns, as applicable. The FNLCR is a Government-Owned Contractor-Operated (GOCO) 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. for the National Cancer Institute (NCI) under Prime Contract No. HHSN261201500003I, which provides Operations and Technical Support (OTS) for the Frederick National Lab. 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 notice as no information is being requested. Please be advised that any submissions provided despite the aforementioned notice that no information is requested become Government property and will not be returned, nor will there be any ensuing discussions or debriefings of any responses. Responses submitted to this 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. Title: National Clinical Laboratory Network (NLCN) for Precision Oncology - Pharmacodynamic Assays Project Background and Objectives:As a follow-up to the success of its initial precision oncology trials (NCI-MATCH and NCI-COG Pediatric MATCH), The Division of Cancer Treatment and Diagnosis (DCTD) is developing a portfolio of clinical trials in the Experimental Therapeutics - Clinical Trial Network (ET-CTN) that will systematically identify new drugs to treat newly discovered molecular abnormalities of clinical significance. The product of this clinical trial portfolio is expected to be an increased number of molecular abnormalities that can be matched to targeted therapies. An additional goal of these ET-CTN trials is to assess drug molecular mechanism of action (mMOA) and reveal if the pharmacodynamics (PD) of each drug varies when matched to particular variants of the molecular abnormality. To conduct the ET-CTN portfolio trials, a precision oncology clinical trial laboratory network is needed to provide robust, specialized fit-for-purpose analyses of patient specimens with a reliability that will assure reproducible assay performance when the assays are incorporated into the next generation MATCH trial both to assign patients to therapy and to assess PD response. The Clinical Pharmacodynamic Program (CPP) and the Molecular Characterization Program (MoCha) have been tasked with supporting a National Clinical Laboratory Network (NCLN) for Precision Oncology by establishing, participating in, leading and assuring the quality of a national network of clinical laboratories capable of providing robust, reliable and relevant clinical assays that are harmonized across laboratories. The NCLN will provide complete assays services covering all required aspects of molecular characterization, diagnostic protein assays and pharmacodynamic assays of patient specimens in the ET-CTN. The NCLN must also have flexibility to add newly developed assays and technologies. This new work request is to establish subcontractors for the support of multiple pharmacodynamic assays on two platforms, (1) multiplex immunoassays on the Luminex platform for fresh flash frozen biopsy and cellular extracts, and (2) multiplex immunofluorescence assays for formalin fixed paraffin embedded (FFPE) tumor biopsies using both multi-channel fluorescent whole slide scanner and confocal microscopy. The goal of the solicitation is to select two laboratories, one for each platform, or possibly one laboratory that could reliably handle both platforms and related validated pharmacodynamic assays. After selection of an appropriate laboratory for performing multiplex immunoassays on the Luminex platform for biopsy and cellular extracts and multiplex immunofluorescence assays for formalin fixed paraffin embedded (FFPE) tumor biopsies using both multi-channel fluorescent whole slide scanner and confocal microscopy, CPP will work with the selected laboratories to harmonize validated pharmacodynamic assay performance using established standard operating procedures. Appropriate personnel from the selected laboratories will participate in a training class to gain a thorough understanding of the assays and supporting methods. The selected laboratories will be equipped with critical equipment and assay critical reagents and control materials to perform familiarization and assay transfer test runs and will provide assay data to CPP to demonstrate acceptable assay performance for all relevant transferred assays to their site. Standard operating procedures will then be harmonized with the established site and the Leidos Biomed CPP clinical hub, NCTVL. The sites will then provide pharmacodynamic assay support for ET-CTN and other clinical studies as directed by LBR CPP. The sites will receive qualified reagents for all relevant assays from the CPP's IQC laboratory. The site will provide appropriate handling, storage, tracking, analysis and data reporting of all incoming clinical specimens. The sites will be monitored to ensure satisfactory performance and timely reporting of the assay data. The site will provide regular updates including clinical sample data reports and QC sample results. All assay failures will be reported to LBR CPP with an explanation of the cause of the failure and any corrective and preventive action (CAPA) that was necessitated. Additionally, the site will participate in periodic proficiency sample testing and will host periodic site visits from a representative from LBR's CPP QA program. The external laboratory may also propose additional assays that they develop and validate internally that may be incorporated into the pharmacodynamic assay list in which this laboratory may conduct for designated trials through this subcontracting mechanism. The site may also periodically conduct preclinical specimen testing support as directed by LBR CPP, such as fit for purpose preclinical evaluations to support planned new drug evaluations, and may support the validation of new assays in development. Leidos Biomedical Research, Inc. POC:For a copy of RFP S18-023 and Draft Leidos Biomedical Research, Inc. Agreement, please contact: Kimberly A. Iman, Senior Subcontracts Administrator at Kimberly.Iman@nih.gov. For additional information regarding Experimental Therapeutics - Clinical Trial Network, please visit: https://ctep.cancer.gov/initiativesPrograms/etctn.htm#sites For information concerning other opportunities with the FNLCR, please refer to: https://frederick.cancer.gov/workwithus/solicitations
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/S18-023/listing.html)
- Record
- SN04819972-W 20180214/180212231447-6380e742af6abcb4fc5f660a9ee7eb29 (fbodaily.com)
- Source
-
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