Assay Service for assessing ADME properties and in vivo PK properties with the selected vendor.
Closed Pre-Solicitation Posted
- Solicitation number
- 75N98026Q01083ENAMINEYSINC
- Agency
-
Office of Logisitics and Acquisition Operations
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 424690 Other Chemical and Allied Products Merchant Wholesalers
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to procure assay services for assessing absorption, distribution, metabolism, and excretion (ADME) properties and in vivo pharmacokinetic (PK) properties in support of novel molecular entity development, with responses due by September 3, 2026. This procurement is anticipated as a non-competitive award to a single vendor.
Work will be performed by the Section on Medicinal Chemistry (SMC) at NIAAA to support evaluation of compounds under development for metabolic and alcohol-associated disease therapeutics. The scope includes grouped ADME assays and a pharmacokinetic study in C57BL6 mice, with specific testing methodologies: Caco-2 permeability assays to predict oral absorption potential and assess passive diffusion, active transport, and efflux processes; CACO and MDCKR assays to evaluate brain penetrance; hERG assays to assess cardiac toxicity risk; plasma stability and binding analysis; and oral bioavailability testing in mice to determine translational potential for human testing.
The procurement is classified under NAICS 424690 (Other Chemical and Allied Products Merchant Wholesalers) and PSC 6505 (Drugs and Biologicals). Contract value does not exceed the simplified acquisition threshold of $350,000 and will be conducted under FAR Part 13 Simplified Acquisition Procedures. Responses should include technical proposals, cost-price proposals, period of performance, UEI, TIN, business size certification, and proof of active SAM registration, submitted electronically to vishnuh@mail.nih.gov.
Notice text
Assay Service for assessing ADME properties and in vivo PK properties with the selected vendor.
- 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 with 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. CACO and MDCKR assays allow to know the brain penetrance of the compounds. hERG assays allow to know if the compounds will show cardiac toxicity. The plasma stability and binding show how the compounds behave in bodily fluids. Finally, the best compounds then undergo testing in mice to know if they can be given orally and thus have translational potential in human testing. These assays are integral to the work of section on medicinal chemistry at NIAAA as these enable to progress compounds for further development as therapeutics in metabolic and alcohol use disorders.
Files
| File | Type | Posted |
|---|---|---|
| Notice of Intent - VISHNU ENAMINE NIAAA 08396.docx | DOCX document |
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