Assay Service for assessing ADME properties and in vivo PK properties with the selected vendor. ENAMINE US INC

Cancelled Solicitation Posted

Solicitation number
75N98026Q01193ENAMINEUSINCPCANIAAA08396
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Bethesda, Maryland 20892, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institute on Alcohol Abuse and Alcoholism (NIAAA), within the Department of Health and Human Services National Institutes of Health, is procuring assay services to assess ADME properties and in vivo pharmacokinetic properties of novel molecular entities, with proposals due September 19, 2026. This is a firm fixed-price purchase order with no set-aside.

Place of performance is Bethesda, Maryland. The vendor must deliver a grouped ADME assay panel and pharmacokinetic study in male C57BL/6 mice. The ADME assays include Caco-2 Permeability Assay (A to B, B to A with P-glycoprotein test using verapamil), MDCK/MDR1 Permeability Assay (A to B, B to A with P-glycoprotein test using cyclosporine A), Hepatic Microsomal Stability (human), Plasma Protein Binding Assay (human and mouse equilibrium dialysis), Plasma Stability Assay (human and mouse), FluxOR hERG inhibition Assay (10 compounds, 7-point IC50 curve in quadruplicates), and MDR1-MDCKII Assay. The pharmacokinetic study involves intraperitoneal or peroral administration routes with eight timepoints and control groups totaling approximately 25 animals. Deliverables include detailed study reports with full methodological descriptions, calculations, and PK parameters derived using Phoenix WinNonlin software. Services must be initiated within three to nine months of award and completed within one year. Payment is one lump sum within 30 days of acceptance by the Receiving Official. The NAICS code is 424690, Other Chemical and Allied Products Merchant Wholesalers, and the PSC code is 6505, Drugs and Biologicals.

Notice text

The Section on Medicinal Chemistry (SMC) develops new molecular entities with implications in improving health and treatment for various metabolic and alcohol associated diseases. To assess the translational potential of novel molecular entities, which would allow us to make decisions to proceed the compounds for further development we utilize multiple derisking assays. These assays comprise of both cell-based (in vitro) testing and then eventually in mice to assess pharmacokinetic parameters to see if the drug is orally available. 

Request to procure Chemical Reagent (Assay) Development & Laboratory Testing Service SMC to produce grouped ADME assays and perform a Pharmacokinetic study in C57BL6 mice. By including the Caco-2 Permeability Assay in our ADME evaluation it'll accurately predict the oral absorption potential of our compounds. This well-established in vitro model closely mimics the human intestinal epithelium, providing critical insights into a compound’s passive diffusion, active transport, and efflux processes, such as those mediated by P-glycoprotein (P-gp). The data generated from this assay are vital for informing structure-activity relationship (SAR) optimization, improving compound permeability, and reducing transporter-related liabilities that could hinder bioavailability

Files

File Type Posted
SOW ENAMINE US INC.pdf PDF

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