3D liver spheroid assays for pharmacogenomics-based prediction of DILI

Maryland

08/14/2024 06:28 PM EDT

08/19/2024 04:00 PM EDT

HEALTH AND HUMAN SERVICES, DEPARTMENT OF - NATIONAL INSTITUTES OF HEALTH - NATIONAL INSTITUTES OF HEALTH NIDA

The National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) Early Translation Branch (ETB) is seeking Capability Statements from Other Than Small Business organizations under the North American Industry Classification System (NAICS) code 325414, that are manufacturers of Primary Human Hepatocytes vials to be used in the evaluation of the impact of patient variability on the development of drug induced liver injury. This Primary Human Hepatocytes vials are necessary to build an accurate in vitro model of the liver for evaluation a panel of drugs for drug induced liver injury.

This is a 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 business sources; and (2) 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. The established NAICS code is 325414, Biological Product (except Diagnostic) Manufacturing. The U.S. Small Business Administration establishes a size standard for 325414 as 1,250 employees or less.

BACKGROUND INFORMATION AND OBJECTIVE:

NCATS mission is to turn research observations into health solutions through translational science. The DPI plans and conducts collaborative research projects across the preclinical phases of the translational science spectrum. The specific mission of NCATS DPI ETB is to uncover small-molecule probes for disease targets and advance the process of therapeutic development through a collaborative research model. To support this mission, NCATS seeks to harness 3D tissue engineered models to evaluate a 240-drug panel for toxicity in the form of drug induced liver injury. Current in vitro models are failing to predict injury in a clinical setting. Therefore, NCATS aims to harness spheroid models formed from a wide variety of donors, male and female of different ethnic backgrounds, to increase model accuracy. As the primary functional cell type of the liver, human hepatocytes must be procured to form this model.

REQUIREMENT: Sixteen primary human hepatocytes. It shall consist of the following items:

1. 1. 1. 1. Hepatocyte-Adult-Pltabl-Mid Term
         2. Hep-Ad-Plt-MT
         3. Availability of a minimum of 100 different donors
         4. Specific donor types required:
            1. Female donor aged 35, Asian, with a BMI between 19-32, fibrosis score of 0, NAS of 0
            2. Female donor aged 25, Caucasian, with a BMI between 19-32, fibrosis score of 0, NAS of 0
            3. Male donor aged 50, Asian, with a BMI between 19-32, fibrosis score of 0, NAS of 0
            4. Male donor aged 51, Caucasian, with a BMI between 19-32, fibrosis score of 0, NAS of 0
            5. Female donor aged 63, Black, with a BMI between 19-32, fibrosis score of 0, NAS of 0
            6. Male donor aged 44, Black, with a BMI between 19-32, fibrosis score of 0, NAS of 0
            7. Female donor aged 41, Hispanic, with a BMI between 19-32, fibrosis score of 0, NAS of 0
            8. Male donor aged 52, Hispanic, with a BMI between 19-32, fibrosis score of 0, NAS of 0

This product shall include shipping.

Salient Characteristics:

The following features/characteristics are required for this requirement:

1. The hepatocyte inventory list must have a minimum of 100 available donors with over 30 available vials per donor;
2. There must be a viability of at least 80% upon thaw;
3. The hepatocyte inventory must have a minimum of four different racial backgrounds, with both male and female availability;
4. Hepatocyte inventory must have variability with regards to BMI, age, and drug/alcohol history; and
5. Specific donor types set forth in the Purchase Description are required.

Anticipated Delivery Date:

Within 30 days after contractor receipt of Purchase Order.

INSTRUCTIONS:

Companies that believe they possess the capabilities to provide the required product should submit documentation of their ability to meet each of the requirements to the Contracting Officer. The capability statement must specifically address each of the 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. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

Interested companies 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 established NAICS code is 325414. Respondents must provide clear and convincing documentation of their capability of providing the products and support services specified in this notice. Also, information must be provided in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) capability to perform the work; (c) prior completed projects of similar nature; (d) compliance with requirements: Vendors must identify and demonstrate specifically how they will meet the requirements listed above.

Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc.

The information submitted must be in an outline format that addresses each of the elements of the requirement and in the capability statement paragraphs stated herein.  A cover page and an executive summary may be included but is not required.

Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Rob Bailey at Rob.Bailey@nih.gov, NO LATER THAN 4:00 p.m. EST on August 19, 2024. The Subject line for the submission should include this Sources Sought Number and organization name. NIDA will not accept paper or faxed capability statements.

THIS NOTICE IS NOT A REQUEST FOR PROPOSALS.  This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. 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 pre-solicitation synopsis and solicitation may be published on 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).