Inactive

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH20004968 TITLE: Pharmacokinetic study and drug evaluation of Niemann-Pick disease type C1 in cats CLASSIFICATION CODE: Q -- Medical services NA... NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH20004968 TITLE: Pharmacokinetic study and drug evaluation of Niemann-Pick disease type C1 in cats CLASSIFICATION CODE: Q -- Medical services NAICS CODE: 541690 – Other Scientific and Technical Consulting Services RESPONSE DATE: September 13, 2020 at 5:00 PM EST PRIMARY POINT OF CONTACT: Michael Horn michael.horn@nih.gov Phone: (301) 827-5871 DESCRIPTION: INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with PennVet Clinical Sciences & Advanced Medicine of the University of Pennsylvania for Pharmacokinetic study and drug evaluation of Niemann-Pick disease type C1 in cats. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541690 – Other Scientific and Technical Consulting Services with a Size Standard of $15M. 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, Contracting officers 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) 2020-09 dated August 27, 2020. DESCRIPTION OF REQUIREMENT Niemann-Pick type C1 (NPC1) disease is an incurable lysosomal storage disorder characterized by the intralysosomal accumulation of unesterified cholesterol, hepatosplenomegaly, progressive neurological dysfunction, and early death. NIH found 2-hydroxypropyl-beta-cyclodextrin and delta tocopherol exhibited a synergistic effect to reduce the disease phenotype in our in vitro assay. Additionally, our studies in the activation of AMP-activated protein kinase (AMPK) have shown to modify the disease phenotype in a favorable way. In order to explore and understand therapeutic effects of the combination and some of our AMPK associated lead compounds,NIH need to assess their efficacy in a truly relevant animal model of the disease that will provide the best data to guide the translation of our pre-clinical candidates. Researchers at the University of Pennsylvania School of Veterinary Medicine have shown that cats with NPC mirror the human version of the disease quite well, making this animal model a unique and effective way to truly assess efficacy of potential therapeutic interventions against this devastating disease. With this in mind, NCATS is seeking to obtain the results of following studies. Study 1: NCATS is seeking to evaluate 1 compound in a Cat pharmacokinetic study. This fee for service will entail the production of 4 experimental cats at approximately 6 month of age and will evaluate the pharmacokinetic distribution of NCATS’ experimental compound. The obtained data will be used to guide advancement towards pre-clinical compound selection. NIH is working with the University of Pennsylvania School of Veterinary Medicine in other efficacy and combination drug studies related to the cat model of Niemann-Pick disease type C1. Study 2: NCATS is seeking to evaluate a combination of 2-hydroxypropyl-beta-cyclodextrin and delta tocopherol at two doses in cats with Niemann-Pick disease type C1. This fee for service will entail the production of 10 experimental cats from 7 breeding females and will evaluate the combination agents’ efficacy over 6 months.The obtained data will be used to guide advancement towards pre-clinical compound development. The researchers at the University of Pennsylvania School of Veterinary Medicine are pioneers and experts in the development of the NPC disease cat model, there are no commercial vendors that have the expertise or infrastructure to develop this animal model and carry out the specific efficacy experiments required by NCATS. • Study 3: NCATS is seeking to evaluate one small molecule agent in cats with Niemann-Pick disease type C1. This fee for service will entail the production of 5 experimental cats from 4 breeding females and will evaluate the compound’s efficacy over 6 months. The obtained data will be used to guide advancement towards pre-clinical compound selection. 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. During market research, it was determined that none of the CROs had the experience or capability to develop the disease cat model Specifically, the researchers at the University of Pennsylvania School of Veterinary Medicine are pioneers and experts in the development of the NPC disease cat model; there are no commercial vendors that have the expertise or infrastructure to develop this animal model and carry out the specific efficacy experiments required by NCATS. There are no substitutes available; there is only one responsible source and no other service providers will satisfy agency requirements The intended source is: PennVet Clinical Sciences & Advanced Medicine University of Pennsylvania School of Veterinary Medicine 3900 Delancey St Philadelphia, PA 19104-6018 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 services included in this notice, including: unit price, list price, shipping and handling costs, the delivery period after contract award (if applicable), 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, NIMH20004698. Responses must be submitted electronically to Michael Horn, Contracting Officer, at michael.horn@nih.gov. U.S. Mail and fax responses will not be accepted.