Contact Points
Primary Contract Specialist
THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.
The National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with University of Kansas BIO Center McCollum Laboratories for the Formulation of compound NCGC00413972.
NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS
The intended procurement is classified under NAICS code - 541714 Research and Development in Biotechnology (except Nanobiotechnology) with a Size Standard of 1000 employees.
REGULATORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, the contracting officer may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization).
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) No. 2021-06, dated June 10, 2021.
Background / Purpose / Objective:
The National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS) develops novel approaches to improve the process of joining basic science discoveries with initial testing of therapies in humans. The NCATS preclinical programs and resources focus on key obstacles and inefficiencies in the translational process, overcoming bottlenecks that slow the development of new treatments for patients.
NCATS is in need of developing an orally viable formulation for the advanced lead in our RP182 project, compound NCGC00413972. This formulation should be a tablet form that will be used in preclinical long-term efficacy studies in a dog sarcoma model. The results will help confirm the current project lead molecule, NCGC00413972, as the preclinical candidate for advancement into future use in human clinical trials.
Anticipated period of performance / delivery date:
September 22, 2021 – November 21, 2021.
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, University of Kansas BIO Center McCollum Laboratories is the only source that can provide Formulation of compound NCGC00413972.
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 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 the closing date and time of this announcement and must reference the solicitation number, NIMH-NOI-21-006506. Responses must be submitted electronically to kim.stapleton@nih.gov.
Lawrence, KS 66047
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 requirements below:
The design and development of manufacturable tablet formulations of NCGC00413972, including its analysis, tablet formation, processing and stability testing.
Specific Requirements:
1. Development of analytical method for drug product (NCGC00413972) testing.
2. Development of dissolution method for NCGC00413972.
3. Establishment of the parameters for milling NCGC00413972.
4. The design of the tablet formulation and processing parameters.
5. Design and execution of accelerated stability testing of tablets of formulated NGC00413972.
GOVERNMENT RESPONSIBILITIES:
NCATS will provide the experimental compound NCGC00413972.
DELIVERY OR DELIVERABLES:
The contractor is responsible for providing the following deliverables:
1. Full report for experimental formulation of compound along with formulation characterization details according to Specific Requirements..
2. Final detailed report to be provided to Raul Calvo (Raul.Calvo@nih.gov) or Juan Marugan (maruganj@mail.nih.gov) at NCATS via email.
REPORTING REQUIREMENTS:
Upon submitting an invoice for payment, the vendor shall include a detailed summary of all work completed under the terms of this order. No payments shall be authorized until such work is inspected and accepted.
Data Rights:
The NIMH shall have unlimited rights to and ownership of all deliverables provided under this contract, including reports, recommendations, briefings, work plans and all other deliverables. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” is hereby incorporated by reference and made a part of this contract/order.
Publications and Publicity:
Publications are expected to be prepared after use of each or some of these precursors. The data obtained by all experiments performed on the chemicals received are exclusively the property of the National Center for Advancing Translational Sciences within the United States Government.
Macrophages are intimately linked to many human diseases. Targeting surface molecules and endogenous signaling processes in macrophage subtypes driving disease states may provide a strategic advantage over unselective systemic inhibition. RP-182 is a synthetic 10mer striapathic host defense peptide (HDP) with immunomodulatory function which was derived from a biophysical homology screen of naturally occurring HDPs and mediators of innate defense processes. RP-182 selectively induces a conformational switch of the mannose receptor MRC1/CD206 expressed on tumor-associated macrophages displaying a M2-like phenotype (M2 TAMs), and activates in human and murine M2-like macrophages a program of endocytosis, phagosome-lysosome formation, and apoptosis. In syngeneic murine and autochthonous murine cancer models RP-182 suppressed tumor growth and extended survival and was an effective combination partner with chemo- or immune checkpoint therapy. Anti-tumor activity of RP-182 was also observed in MRC1/CD206high patient-derived xenotransplantation models. Mechanistically, via selective reduction of immune suppressive M2-like TAMs, RP-182 improved adaptive and innate anti-tumor immune responses including increased cancer cell phagocytosis by reprogrammed TAM. Collectively, peptide-based innate defense regulators (IDRs) like RP-182 derived from biophysical homology studies can effectively target innate immune cell subpopulations with therapeutic merit across cancer models suggesting a new anti-tumor immunotherapeutic modality for cancer histologies with MRC1/CD206high TAM populations.
In line with these findings, we are persuing preclinical efficacy studies in a dog sarcoma model. For this purpose, NCATS requires the development of an orally viable formulation for the advanced lead in our RP182 project, compound NCGC00413972. This formulation should be a tablet form that will be used in preclinical long-term efficacy studies in a dog sarcoma model. The results will help confirm the current project lead molecule, NCGC00413972, as the preclinical candidate for advancement into future use in human clinical trials.
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.