SAM #36C24526Q0669

VA Seeks Preclinical Toxicology and PK Studies for Experimental Rheumatoid Arthritis Treatment

This opportunity seeks vendors to perform preclinical toxicology and pharmacokinetic (PK) studies for an experimental rheumatoid arthritis treatment developed by the Department of Veterans Affairs (VA). - Government Buyer: - Department of Veterans Affairs, VA Maryland Health Care System, Network Contracting Office (NCO) 05 - Products/Services Requested: - Preclinical toxicology studies (GLP-compliant) on peptide-displaying liposomes containing dexamethasone - Includes single-dose intravenous (IV) administration in adult rats - Clinical observation, weight and food intake monitoring, blood chemistry, necropsy, and histopathology - Pharmacokinetic (PK) studies (GLP or non-GLP) in adult rats - IV dosing, timed blood collection, plasma processing, LC-MS/MS quantification of dexamethasone and 6-hydroxydexamethasone, PK parameter calculation - Comprehensive final written report summarizing all findings - Unique/Notable Requirements: - All toxicology work must be performed under Good Laboratory Practice (GLP) standards - PK studies may be GLP or non-GLP - Vendor must have demonstrated technical capability in GLP toxicology, rodent PK studies, and advanced LC-MS/MS analytical techniques - All work to be performed in the vendor's laboratory - No specific OEMs or commercial products are named; the focus is on specialized laboratory services and technical expertise

Description

PRE SOLICITATION NOTICE

Department of Veterans Affairs Network Contracting Office (NCO) 05 Title: A Joint Targeted Drug Delivery Approach for Arthritis Therapy Toxicity and Pharmacokinetics

The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 05, intends to issue a solicitation for preclinical toxicology and pharmacokinetic (PK) studies to support advancement of an experimental joint targeted liposomal delivery system for Rheumatoid Arthritis therapy. This requirement involves GLP compliant toxicity studies and GLP or non GLP PK studies in adult rats.

The forthcoming solicitation will seek a contractor capable of performing:

GLP single dose IV toxicity studies including clinical observations, weight/food intake monitoring, blood chemistry assessments, necropsy, and histopathology. GLP or non GLP pharmacokinetic studies including IV dosing, timed blood collection, plasma processing and storage, LC MS/MS analysis of dexamethasone and 6 hydroxydexamethasone, and calculation of PK parameters. A comprehensive final written report covering toxicity results, PK data, and analytical findings.

Place of performance will be the contractor s laboratory. The anticipated period of performance is one year, approximately September 15, 2026 through September 14, 2027.

This notice is issued solely for informational purposes. A formal solicitation and the Government s acquisition strategy will be issued after completion of market research.

This notice does not constitute a solicitation and does not commit the Government to award a contract.

Point of Contact: Robert O Keefe Jr., Contract Specialist Email: robert.okeefejr@va.gov

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