LC-MS/MS Analysis of Human Plasma Samples for ManNAc and Neu5Ac

Agency: Department of Health and Human Services
State: Maryland
Type of Government: Federal
  • Q - Medical Services
Posted Date: Oct 11, 2017
Due Date: Nov 3, 2017
Solicitation No: NICHD-18-001
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Solicitation Number :
Notice Type :
Synopsis :
Added: Oct 11, 2017 4:48 pm
The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to award a purchase order toAlliance Pharma Inc. for Sample analysis of 48 total samples to quantify ManNAc and Neu5Ac.

The Nationall Institute of Diabetes, Digestive, & Kidney Diseases is currently conducting a clinical trial entitled "A Phase 1 Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ManNAc in Subjects with Primary Podocyte Diseases " (16-DK-0036 ; identifier NTC02639260). ManNAc is converted inside cells to sialic acid (Neu5Ac). The basis for this clinical trial is that there is evidence that some subjects with primary glomerular diseases do not put enough sialic acids on glomerular proteins and so ManNAc therapy may increase sialic acid production and sialylation of glomerular proteins in these subjects. For this clinical trial, it is important that concentrations of ManNAc and sialic acid (Neu5Ac) will be measured in plasma at various times before and after oral dosing of ManNAc. These results will inform about the absorption of ManNAc by the GI tract/cells and the subsequent production of sialic acid in subjects with primary glomerular diseases.

Alliance Pharma developed validated (per FDA guidelines) LC/MSMS assays to measure ManNAc and Neu5Ac in plasma. We have been working with this company since the start of this trial and they have already performed these assays for 4 subjects under a different contract. The purpose of this project is to provide analysis of the compounds ManNAc and Neu5Ac.

In compliance with Federal Acquisition Regulation (FAR) 13.106-1(b) Soliciting from a single source. This notice of intent is not a request for competitive proposals, however; all responses received, before the closing date, of this announcement will be considered by the Government. A determination by the Government not to compete this proposed acquisition is based upon responses to this notice and is solely within the discretion of the Government. It is anticipated that the RFQ NIH-NICHD-18-001 will be available fifteen (15 days after the publication date of this synopsis. Receipt of quotations will be due ten (10) days after the release of the RFQ. All interested parties to this solicitation may request a copy of the RFQ package in writing to the attention of Ms. Verne Griffin at Eunice Kennedy Shriver National Institute Child Health and Human Development (NICHD), 6710B Rockledge Drive, Room 1155A, Bethesda, MD 20892 or via email . All requests must contain offerors name, address, telephone number and fax number. Email addresses are encouraged but not mandatory

Contracting Office Address :
Contracts Management Branch
6710B Rockledge Dr., Suite 1124, MSC7000
Bethesda, Maryland 20892-7510
United States
Primary Point of Contact. :
Lynn Griffin
Phone: 301-594-7730

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