Testing the efficacy of novel candidate Alzheimer’s disease drugs in rescuing impaired hippocampal synaptic plasticity in the APP/PSI transgenic mouse model

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: 75N95024Q00403
2. TITLE:  Testing the efficacy of novel candidate Alzheimer’s disease drugs in rescuing impaired hippocampal synaptic plasticity in the APP/PSI transgenic mouse model
3. CLASSIFICATION CODE: B504 - SPECIAL STUDIES/ANALYSIS- CHEMICAL/BIOLOGICAL
4. NAICS CODE: 621511 – Medical Laboratories
5. RESPONSE DATE: July 15, 2024, 1 pm EST
6. PRIMARY POINT OF CONTACT: Giuliana C. Faller, Giuliana.faller@nih.gov Phone: 301-480-9789
7. 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 purpose of this acquisition is to procure Testing the efficacy of novel candidate Alzheimer’s disease drugs in rescuing impaired hippocampal synaptic plasticity in the APP/PSI transgenic mouse model services for the National Institute on Aging (NIA).

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS

The intended procurement is classified under NAICS code 621511 – Medical Laboratories with a Size Standard of $41.5 million  

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) 2023-04 dated June 2, 2023.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

There is currently a pressing need to identify effective treatments for Alzheimer’s disease (AD). With the repeated failures of multiple pivotal phase-III clinical trials in patients with AD, it is critical to test novel methods of discovering disease-modifying AD treatments. As part of a recently completed study called the Drug Repurposing for Effective Alzheimer’s Medicines (DREAM) study, the National Institute on Aging (NIA) Intramural Research Program (IRP) is testing whether exposure to commonly prescribed, Food and and Drug Administraton (FDA)-approved drugs will be associated with protection against AD. DREAM has tested approximately 20 drugs that NIA  have nominated as ‘candidate AD treatments.’ NIA has selected the most promising drugs from the DREAM study to test in the recently funded Experimental Validation of candidate Alzheimer’s disease treatments identified by multi-omics analyses (PREVENT-AD) study.  The NIA is additionally testing additional FDA approved and experimental drugs in ongoing contracts including phenotypic screening in cell culture.  In the proposed acquisition, NIA will test the efficacy of a promising drug (emerging from the DREAM study, the PREVENT-AD study, ongoing contracts and proteomic/ metabolomic studies in the NIA IRP) to determine whether it rescues impaired hippocampal synaptic plasticity. This will be accomplished by studying their effects on late long term potentiation (LTP) in hippocampal slices obtained from the APP/PS1 transgenic AD mouse model.

Research in the NIA IRP has identified several FDA approved drugs through the DREAM study that may target metabolic abnormalities associated with AD and be of utility as effective disease-modifying AD treatments. Repurposing of approved drugs is a promising approach that can accelerate the development of novel AD treatments.

Research in the NIA IRP has identified several FDA approved drugs that may target metabolic abnormalities associated with AD and be of utility as effective disease-modifying treatments. Repurposing of approved drugs for AD is a promising approach that can accelerate the development of novel AD treatments. Through two ongoing contracts, the NIA is currently testing 9 candidate AD drugs on LTP.

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

The electrophysiological studies in the proposed acquisition will characterize the ability of candidate AD drugs (nominated by the NIA IRP) to rescue a form of hippocampal synaptic plasticity called late long-term potentiation (L-LTP) which is believed to be important for the brain to store and retrieve remote memories. Impaired L-LTP is thought to be responsible for cognitive impairment in AD as well as age-associated cognitive impairment. This fundamental biological phenomenon is dependent on the synthesis of synaptic proteins through a mechanism called synaptic tagging and capture (STC). Characterization of L-LTP and STC in hippocampal slice preparations from transgenic AD mouse models requires sophisticated equipment and highly skilled personnel to generate these data. Their interpretation must be performed by an experienced scientist with highly specialized expertise in synaptic physiology.

It is critical that the study in the proposed acquisition is performed in the same laboratory and with the same methods and protocols used in prior studies for accurate results.

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, National University Of Singapore, is the only vendor in the marketplace that can provide the services required by NCATS in the interest of continuity of science.

The intended source is: National University of Singapore

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 75N95024Q00403 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.