NINDS Division Translational Research – Rodent Pharmacokinetic (PK) Studies

See PDF Attachment below.

Sources Sought Notice

Solicitation Number: 75N95024R00062

Title:  NINDS Division Translational Research – Rodent Pharmacokinetic (PK) Studies

Classification Code:  Q301 Medical – Laboratory Testing

NAICS Code:  541380 Testing Laboratories and Services

Size Standard: $19M

DESCRIPTION:

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; and (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.

The Government is also considering NAICS 325414 Biological Product (except Diagnostic) Manufacturing, Size Standard 1,250 employees.

Background:  The National Institutes of Health (NIH) Blueprint Neurotherapeutics Network (BPN) has a series of collaborative drug discovery and development projects focused on supporting preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to support their eventual use as therapeutics for nervous system disorders. These projects will be developing therapeutic candidates through an iterative process of lead optimization, in vitro and in vivo testing. A component of this process will be the conduct of in vivo pharmacokinetic (PK) assessment of small molecules and biologics (e.g, peptides, etc). The contractor shall conduct rodent PK studies to assess blood and tissue (primarily brain) levels of a novel test article supplied by the PI or the Project Team in order to support lead optimization and preclinical pharmacokinetic efforts under the NIH BPN program.

Purpose and Objectives: The National Institute of Neurological Disorders and Stroke (NINDS) requires plasma and brain sample analysis and rodent pharmacokinetic (PK) testing for the purposes of new therapeutics developments.

Scope of Work:

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 following PK studies under this purchase order:

Base Task:

• Mouse Plasma and brain samples analysis for 2 compounds
• One mouse pharmacokinetic study
• One rat pharmacokinetic study

Optional Task 1:

• One rat pharmacokinetic study

Optional Task 2:

• One rat pharmacokinetic study

Requirements:

The Government will initiate a study with the submission of a study request form which will include available information on the test article to be evaluated. After completion of the in-life portion of the study, the contractor shall estimate Pharmacokinetic parameters of the test articles or samples using WinNonlin (Phoenix software, Pharsight). The Contractor shall prepare an excel file and submit it as a data report for each study requested by the Contracting Officer’s Representative (COR) within 4 weeks or less of receiving of compounds or samples for bioanalysis.

1. Mouse Plasma and Brain Samples Analysis for 2 Compounds

The contractor shall conduct studies to analyze plasma and tissue samples supplied by the BPN to measure levels of two test articles being studied to support pharmacokinetic assessment.  Each compound has 16 plasma samples and 13 brain samples.  Samples will be collected off-site, as a component of in vivo activity studies conducted by the Project Teams.

For budget development purposes assume no analytical method exist and a total of 32 plasma samples and 26 brain samples will be analyzed.

1. Rodent Pharmacokinetic Studies

The contractor shall conduct pharmacokinetic studies, administering BPN - supplied test articles to rodents (e.g., rat or mouse) and assessing blood concentrations of test article at various time points and calculating standard PK parameters.

Designs for a basic mouse or rat PK study is presented below. 

2.a Mouse Pharmacokinetic Study Design

Group

Test Compound

Dose

Route

Subgroup

No. of Animals

Plasma Collection

(hr.)

1

Compound A

TBD

iv

A

3

0.083, 0.5

iv

B

3

0.25, 1

iv

C

3

2, 4

iv

D

3

6, 8

2

Compound A

TBD

po

A

3

0.25, 0.5

po

B

3

0.75, 1

po

C

3

2, 4

po

D

3

6, 8

Blood (plasma) collected via retro orbital sinus stick and/or cardiac puncture last time point (prefer volume of 50-60 ul if possible since C57 mouse is smaller than CD1 mouse or other strains)

Dose levels will be determined at the time of protocol development based on available information on the test article.

For the purposes of proposal development, assume that C57/BL6 mice will be used and a bioanalytic method is not available. The expected LLOQ is 1ng/mL for plasma (or value applicable to biologic test article).

2.b. Rat Pharmacokinetic Study

Group

Test

Article

Dose (mg/kg)

Route

No. of Animals

Plasma Collection

1

Compound  B

TBD

iv

3

10 time points

2

Compound B

TBD

po

3

10 time points

Blood (plasma) collected via jugular catheters.  Blood will not be collected from the catheter used to administer the dose formulation.

Route of administration will be iv/po.

Dose levels will be determined at the time of protocol development based on available information on the test article.

Plasma will be collected on after dose administration for 10 time points (e.g., pre-dose, 0.083, 0.25, 0.5,1, 2, 4, 6, 8 and 24).

For the purposes of proposal development, assume that a bioanalytic method is not available and must be developed. The expected LLOQ is 1ng/mL for plasma and 5ng/mL for brain.

CAPABILITY STATEMENT:

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, DUNS number, 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 DUNS number, 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.

The response must be submitted electronically to the Contract Specialist, Sneha Singh, at sneha.singh@nih.gov.  Facsimile responses are NOT accepted.

The response must be received on or before July 1, 2024 at 11:00 A.M., 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 www.sam.gov. 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).