SOLICITATION NOTICE
R -- Procurement is to analyze induced pluripotent stem cells (iPSCs)
- Notice Date
- 5/15/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 813212
— Voluntary Health Organizations
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- 75N92018Q0162
- Archive Date
- 6/6/2018
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- COMBINED SYNOPSIS / SOLICITATION SOLICITATION NUMBER: 75N92018Q0162 (i) "This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued." (ii) The solicitation number is 75N92018Q0162 and the solicitation is being posted as a request for proposal (RFP) to (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-97, January 24, 2018. (iv) This is not a set-aside, the associated NAICS Codes: 813212, Voluntary Health Organizations and small business size standard is $27.5M. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13. All responsible offerors may submit a proposal, which if timely received, shall be considered by the agency. Offers are due by 7:30 A.M. Eastern Time (EST) on May 22, 2018. Responses must be submitted via the FedConnect webportal (www.fedconnect.net). Potential Offerors do not need to register to view a notice; however, in order to submit questions and/or response to this Notice, an account will need to be established. (v) Background: The National Institutes of Health (NIH) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Human Genome Research Institute (NHGRI), mission has expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. The Medical Genomics and Metabolic Genetics Branch/Molecular Genetics Section Investigators use a broad range of tools to understand how health and disease are related to genetic, genomic and metabolic variation. Investigators study a broad spectrum of disorders, from common diseases associated with common variants to the rarest diseases associated with uncommon, sometimes unique variants. Scientific Investigators sometimes study disorders that are not inherited at all, which are due to somatic mosaicism-a difference in genetic composition among cells in an individual. Additionally, also study how the genome influences normal metabolic processes. MGMGB investigators apply tools ranging from high-throughput biology to clinical and animal research. A unifying theme in research is that the human is the most complex, fascinating and important system in which one can study the effects of heritable variation. For twenty years, NHGRI have been engaged in a large collaborative study entitled FUSION (Finland United States Investigation of NIDDM), in which more than 30,000 individuals with type 2 diabetes (T2D) (and suitable controls) from Finland are being studied. To achieve the objectives of the diabetes research the National Institute of Human Genome Research (NHGRI), Medical Genomics and Metabolic Genetics Branch (MGMGB) are initiating a translational research program extending the genetic association of T2D related genes to the functional analysis of these genes and the effects of the genetic background of normal vs. T2D subjects in tissues relevant to T2D. Towards this goal the FUSION project has collected skeletal muscle and adipose samples from ~100 normal glucose tolerant, ~100 impaired glucose response and 78 newly diagnosed T2D subject prior to medication. This allows the functional analysis of gene expression correlation with disease state and genetic background of the subjects. Purpose and Objectives: The purpose of this procurement is to analyze induced pluripotent stem cells (iPSCs) throughout the differentiation stages to mature beta cells and functionally characterize the mature beta cell product insulin response to glucose to advance the study of the functional basis of genetic variants associated with type 2 diabetes (T2D). Also, to investigate differential genetic influence on pancreatic beta cell on the genetic background of our Finnish T2D cohort we aim to differentiate iPSC cell lines derived from the FUSION Tissue Biopsy Study subject fibroblasts into mature beta cell lineages to assess the glucose stimulated insulin secretion response of normal glucose tolerant versus T2D subjects. The foresight towards the advent of induced pluripotent stem cell (iPSC) technology the FUSION Study also collected skin biopsies with which generated epidermal fibroblast cell cultures as a resource. Implementation of iPSC protocols allows for the dedifferentiation of fibroblasts into a pluripotent state of cells which in turn can be differentiated into different lineages of tissues of interest in T2D otherwise unobtainable from human subjects, such as, such as but not restricted to pancreatic beta cells, representing pancreatic islets; adipocytes, representing fat tissue; hepatocytes, representing liver tissue, myocytes, representing skeletal muscle, and neuronal cells. The capability of differentiating iPSCs into T2D relevant tissue types FUSION investigators can perform functional analysis of genes associated with T2D that are characteristic of the tissues involved in the disease examining the differential effect of the genetic make-up of the original subjects on the function of the associated gene in that particular tissue type. This allows for the functional analysis of genes responsible for T2D in the context of gene networks and tissue environment that was not achievable prior to iPSC differentiation. In addition, this valuable resource enables the generation of important resources for the evaluation of potential therapeutics in model cell lines of relevant tissues to the treatment of T2D. Procurement: 1. To provide Beta Cell Differentiation and Cell Assay, Twelve (12) Lines. Anticipated Period of Performance: Base Year: May 2018 to May 2019 Option 1: May 2019 to May 2020 Contractor' Requirement: • The Contractor shall present sufficient capacity to differentiate 12 iPSC cell lines to pancreatic beta cell lineage in a reproducible automated protocol according to prescribed study with one year. • The Contractor shall be proficient in differentiation of iPSC to beta cells in order to complete differentiation in 40 days or less generating ≥ 400,000 cells per time point. • The Contractor shall monitor the differentiation process with sufficient biomarker analyses to verify interim stage identity throughout the seven stages to mature beta cells and provide 400,000 cells at no less than 4-time points throughout the differentiation time course for assessment of differentiation efficiency by single cell RNA sequencing (scRNA-Seq). • The Contractor shall be proficient in performing automated glucose stimulated insulin secretion (GSIS) assay upon mature beta cell differentiation providing ≥400,000 cells at each of four-time points (0, 30, 60, and 120 minutes) including collection of experimental supernatant for appropriate insulin measurement. • The Contractor shall be proficient at dissociation of mature beta cell organoids at each time point of collection and capable of single cell cryopreservation for transfer to the laboratory at NIH for comprehensive genomic and epigenomic analyses. • The Contractor shall generate multiple pools of mature beta cells for each differentiated cell line to achieve the number of cells required for analysis in a robust reproducible process for analysis. • The Contractor shall provide documentation of the process of generating the mature beta cell lines as well as the raw data supporting the process upon request. • The Contractor shall provide monthly written reports and quarterly Conference call updates throughout the generation of the mature beta cells from iPSC lines and performance of the GSIS assay. Deliverables: The Contractor shall deliver the following: • The Contractor shall deliver Cells within ~6-8 months post execution of agreement and delivery of starting material. • The Contractor shall deliver iPS cell lines with master bank from up to 2 polyclonal pools (6 vials per pool). Expansion to larger working banks possible. • Shall deliver Protocol for iPS cell line recovery; • Shall deliver Certificate of Analysis which will be made available and will include results from mycoplasma and sterility tests, identity and karyotype data, plutipotency expression profile and differentiation capacity. Raw data can be made available upon request; • Shall deliver monthly written progress report; and • Shall deliver quarterly phone updates. EVALUATION OF PROPOSALS: The Government will evaluate proposals that are determined technically acceptable in accordance with the Technical Evaluation factors. The Government intends to award a single contract from this solicitation. The Government reserves the right not to award a contract. Evaluation of Proposals: The Government reserves the right to make an award without discussions based solely upon initial proposals. Price (This will be Firm-Fixed Price): An evaluation of the offeror's price proposal will be made to determine if proposed prices are realistic for the work to be performed, reflect a clear understanding of the requirements, and are consistent with the technical proposal. Reasonableness determinations will be made by determining if competition exists, by comparing proposed prices with established commercial or GSA price schedules (if applicable), and/or by comparing proposed prices with the Independent Government Cost Estimate (IGCE). EVALUATION FACTORS: The evaluation will be based on the following: 1. Must be able to present sufficient capacity to differentiate 12 iPSC cell lines to pancreatic beta cell lineage in a reproducible automated protocol according to prescribed study with one year. 2. Lowest price technically acceptable (LPTA). vi. The FAR Provision 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and is hereby incorporated by reference. All Federal Acquisition Regulations (FAR) clauses may be viewed at http://acquisition.gov/comp/far/index.html. The proposal must reference the RFP Number: 75N92018Q0162. All responsible offerors may submit a proposal, which if timely received, shall be considered by the agency. All proposals shall contain the following: 1. Name of Contracting Organization; 2. Solicitation number; 3. Contract Type; 4. Total Contract Value and Discounts; 5. Description of Requirement; 6. North American Industry Classification System (NAICS) Code; and 7. DUNS, TIN or EIN Number. ix. In accordance to FAR clause 52.212-2, Evaluation - Commercial Items x. In accordance with FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items, offerors must complete annual representations and certifications on- line at https://www.sam.gov/portal/public/SAM/. xi. FAR clause 52.212-4, Contract Terms and Conditions - Commercial Items applies to this acquisition. xii. FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this Acquisition. Additional FAR Clauses include: FAR clause 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUL2013) (Pub.L. 109-282) (31 U.S.C. 6101 note). FAR clause 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (AUG2011). FAR clause 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). FAR clause 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (JUL2013) (31 U.S.C. 3332). xiii. All responses must be received by May 22, 2018, 7:30 a.m. Eastern time. Responses must be submitted via the FedConnect webportal (www.fedconnect.net). Potential Offerors do not need to register to view a notice; however, in order to submit questions and/or response to this Notice, an account will need to be established. Should you require a waiver not to use FedConnect, please contact the Contracting Office: National, Heart, Lung and Blood Institute, Section 3, Branch B, Office of Acquisitions, Office of Management, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell, Contracting Officer (maxwelld@nih.gov). Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency and include the following: 1. Name of Contracting Organization; 2. Solicitation number; 3. Contract Type; 4. Total Contract Value and Discounts; 5. Description of Requirement; 6. North American Industry Classification System (NAICS) Code; and 7. DUNS, TIN or EIN Number. xv. All responsible offerors may submit a proposal, which if timely received, shall be considered by the agency. Offers are due by 7:30 A.M. Eastern Time (EST) on May 22, 2018. Dorothy Maxwell, Contracting Officer can be reached at (301) 827-7729 regarding any questions regarding Solicitation Number: 75N92018Q0162. Quotations shall not be deemed received by the Government until the quotation is entered into the e-mail address inbox set forth above. Faxed proposals will NOT be accepted. Offerors must complete annual representations and certifications on-line at https://www.sam.gov/portal/public/SAM/.
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