NIH-NCATS-NOI-21-006505

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Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Manufacture and Supply non-GMP Tablet Dosage Forms of RXFP1 Compound NCGC00250135 for Use in Dog Sarcoma Studies
Contracting Office
National Institute on Drug Abuse (NIDA)

Contact Points

Primary Contract Specialist

Samson
Shifaraw
samson.shifaraw@nih.gov
NAICS Code Number
32541
Pharmaceutical and Medicine Manufacturing
Small Business Size Standard
1,000
Estimated Period of Performance
10/1/2021-09/30/2022
Set-Aside Status
Not Set Aside
Competition Status
Non-Competitive
Vendor Name
KU Biopharmaceutical Innovation & Optimization Center
Vendor Address
McCollum Laboratories, 2097 Constant Avenue, Lawrence, KS 66047
Single-Sole Source Determination
This notice of proposed acquisition is posted as an intent to award a purchase order on a non-competitive basis. Using this vendor will help to avoid the introduction of new variables into the experimental results and to avoid long delays resulting from retesting of products from other potential vendors.
Background/Description of Requirement

Background Information and Objective

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), whose 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.

NCATS needs formulating 1 compound for the advancement towards preclinical development.

This acquisition is restricted to University of Kansas Institute for Advanced Medical Innovation. The National Center for Advancing Translational Sciences (NCATS) has worked with the University of Kansas Biomedical facility over the past 10 years. This vendor is uniquely positioned to advance the capabilities of NCATS to advance RXFP1 lead compound ML290 in further animal efficacy studies.

The University of Kansas Institute for Advanced Medical Innovation have worked on the NCATS projects of metarestin (which they successfully formulated and is now in clinical trials), glucocerebrosidase, hepatitis C and CD206, and we now need their expertise to successfully formulate ML290, a first in class RXFP1 agonist molecule discovered at NCATS.

Statement of Need and Purpose

Given the previously screened physicochemical properties of the ML290 drug candidate, investigate the feasibility of generating a progressable formulation strategy for clinical evaluation. The very high lipophilicity and poor water solubility will drive the feasibility testing toward solubilization in a safe cosolvent system, a self-emulsifying lipid-based system, or an amorphous solid dispersion.

Specific Requirements

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

NCATS needs a formulating 1 compound and screen potential counterions (at least 10) for salt formation of RXFP1 agonist ML290 Candidate. This service should provide the following deliverables: 

  1. Develop and Implement Analytical Methods Screen potential liquid 
  2. Screen potential liquid formulation vehicles including SEDDS (self-emulsifying drug delivery system)
  3. Supplies for Task 1 and 2
  4. Screen Potential for spray- dried ASD formulation
  5. Supplies for Task 3

Interested parties may identify in writing their interest and capability in response to this requirement. 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 Dun & Bradstreet Number (DUNS), 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 closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.