The purpose of this requirement is o determine the single dose Pharmacokinetics of two compounds in non-naïve cynomolgus monkeys, using both oral (PO) and intravenous (IV) routes of administration, with bioanalyses in plasma conducted in triplicate to determine the toxicokinetics of the test compound following single and multiple administrations.

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The Early Translational Branch  (ETB) is tasked with identifying and developing novel small molecule leads for improving human health. 

In pursuit of this goal, the Center has a strong internal trans-disciplinary team of scientists who continually discover novel small molecules to modulate molecular targets to identify novel treatment strategies.  As such, discovering lead molecules that could serve as starting points for therapeutic development for patients is a key part of discovery. At ETB we have developed a small molecule inhibitor to combine with immunotherapy for treating advanced hepatocellular carcinoma. It is essential to identify drug exposure in a higher animal species in an earlier stage before filing IND enabling studies. Therefore we would like to determine plasma PK for test compounds.

This service should provide the following deliverables: 

Animal: Non-Naïve Cyno monkey Compound: TBD Route of administration: IV, PO Subjects per collection: 3 males, total 6 Dose: TBD Plasma:0.083, 0.25, 0.5, 1, 2, 4, 8, 24h Bioanalysis and PK calculation

The vendor must submit documentation of an approved OLAW Assurance (such as an Assurance number) (OLAW, IACUC) from PHS Policy on Humane Care and Use of Laboratory Animals, of IACUC approval within the prior 36 months (such as the approval letter), and AAALAC Accreditation.

ESTIMATED PERIOD OF PERFORMANCE:

The Period of Performance (PoP) is 8 weeks from the contract award and receipt of the materials.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Pharmaron, Inc. is the only vendor in the marketplace that can provide the services required by NCATS.

The intended source is:

Pharmaron, Inc.

201 E JEFFERSON ST STE 304

LOUISVILLE, KY 40202-1249

CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. 

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. 

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95023Q00198. Responses must be submitted electronically to Giuliana Faller, Contract Specialist, at giuliana.faller@nih.gov.  U.S. Mail and fax responses will not be accepted.