Pharmacodynamic and Tolerability studies of candidate AD drugs in a transgenic AD mouse model

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: 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. Through ongoing contracts for - Phenotypic screening of candidate drugs to treat Alzheimer's Disease, - In vivo efficacy studies of a candidate Alzheimer treatment in a transgenic mouse model, and - Tolerability studies of candidate AD drugs and efficacy of Poly(L-lysine succinylated)-hydroxychloroquine (PLS-HCQ) in a transgenic AD mouse model, the NIA IRP is testing a subset of `candidate AD treatments in cell culture-based phenotypic screening models and in a well characterized transgenic AD mouse model. Through the recently funded PREVENT-AD study (Experimental validation of candidate Alzheimer's disease treatments identified by multi-omics analyses), the NIA IRP will be testing 11 drugs in in vivo efficacy studies in a transgenic AD mouse model and 45 drugs in cell culture models. This acquisition has two objectives: 1) NIA IRP proposes to test the tolerability of 2 candidate drugs. These tolerability studies will determine the optimal dose to be used in the in vivo efficacy studies. 2) Based on the results of the tolerability studies, NIA IRPs propose to test the efficacy of 2 drugs in a well-characterized transgenic AD mouse model. 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 one complete study called the Drug Repurposing for Effective Alzheimer's Medicines (DREAM) study, one ongoing study called the Experimental Validation of candidate Alzheimer's disease treatments identified by multi-omics analyses (PREVENT-AD) study, in addition to three ongoing contracts, the NIA IRP is testing the utility of commonly prescribed, FDA-approved drugs that may be repurposed as `candidate AD treatments. The proposed acquisition will build on this work to test 1) tolerability of two candidate AD drugs in the 5x-FAD transgenic mouse model of AD to determine their optimal dosing in efficacy studies; and 2) efficacy of two candidate AD drugs in this transgenic AD mouse model. Project 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 attached to this Sources Sought notice. Anticipated period of performance: September 30, 2023 - September 29, 2025 Capability statement /information sought. Small business concerns that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Small businesses must also provide their Company Name, Unique Entity ID number from SAM.gov, Physical Address, and Point of Contact Information. Interested small businesses are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The respondent must also provide their Unique Entity ID number from SAM.gov, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2 x 11 paper size, with 1 top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Rashiid Cummins, Contract Specialist at e-mail address contact@example.gov. The response must be received on or before July 19, 2023 at 9:00 am, Eastern Time. - Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).