Inactive Total Small Business Set-Aside (FAR 19.5)

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institu... INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to award a purchase order without providing for full and open competition to Exonova Biosciences for Inflammatory and Vascular Diseases Scientific Support for NIDDK Biomedical and Metabolic Imaging Branch. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541690 with a Size Standard of $19.0 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2025-06 effective October 1, 2025. This acquisition is conducted under the procedures as prescribed in FAR Subpart 13.106-1(b). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 1901 – Simplified Acquisition Procedures. DESCRIPTION OF REQUIREMENT BACKGROUND In order to accomplish the goals of this program, The National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Biomedical and Metabolic Imaging Branch has a requirement to obtain services of a scientist with extensive expertise in innate immunology and hereditary autoinflammatory diseases. This scientist should have a demonstrated understanding of, and ability to apply principles, concepts, practices, and standards associated with patient sample testing in a laboratory setting. Moreover, the scientist must be proficient in a range of advanced techniques including cloning, exosome engineering, microRNA transfection, and processing of induced pluripotent stem cells (iPSCs), along with single-cell RNA sequencing, which are directly applicable to the research conducted by the Biomedical and Metabolic Imaging Branch. Their skill set should also encompass traditional molecular and cellular biological techniques such as Polymerase chain reaction (PCR), flow cytometry, and immunohistochemistry (IHC). The candidate must be self-motivated and driven, capable of achieving milestones and exceeding goals with minimal direction. Furthermore, they must possess a PhD with 15+ years of demonstrated expertise in immunology and/or inflammation research, showcasing a deep and comprehensive understanding of the complex dynamics involved in these fields. OBJECTIVE The objective of this request is to procure Inflammatory and Vascular Diseases Scientific Support for NIDDK. CONTRACTOR REQUIREMENTS The contractor must have: Doctorate degree with over 15 years of specialized experience in the realms of immunology or inflammation research, with a proven track record of leading innovative studies. Expertise in the isolation and characterization of various subpopulations of extracellular vesicles, including a deep understanding of their biogenesis, secretion mechanisms, and functional roles in intercellular communication and disease progression. Mastery in cellular culture techniques, particularly focusing on the cultivation and manipulation of human cells, including primary cells, stem cells, and immune cells, to facilitate in-depth studies on disease mechanisms and potential therapeutic interventions. Proficiency in advanced molecular biology techniques, including RNA sequencing, western blotting, quantitative PCR (polyamerase chain reaction), and multiplex ELISA (enzyme linked immunosorbent assay), complemented by hands-on experience in microarray analyses and proteomics to facilitate comprehensive molecular studies. In-depth knowledge of microRNA biology, including their functional roles in regulating gene expression, cellular signaling pathways, and their potential as biomarkers and therapeutic targets, with a focus on their involvement in mitochondrial and vascular dysfunction. DNA (Deoxyribonucleic Acid), along with adeptness in T-cell isolation and the development of innovative cell assays. Hands-on experience with animal models, including mouse and rabbit handling and organ isolation, particularly within the context of autoimmune and inflammatory disease research. Advanced skills in lentiviral production and vector design, complemented by a background in synthetic biology and cloning techniques, facilitating the development of novel gene therapy approaches. Comprehensive knowledge in exosome research, including purification, characterization, and engineering, with a focus on understanding the role of microRNA cargos and their implications in intercellular communication and disease progression. Proficiency in cutting-edge technologies such as single-cell RNA sequencing, facilitating detailed insights into cellular heterogeneity and gene expression patterns, and enabling the identification and study of rare cell populations. A keen interest in metabolomics, with the ability to integrate findings into a broader understanding of immune responses and inflammatory processes, complemented by a strong foundation in proteomics for detailed protein expression analyses. Demonstrated ability to contribute both creatively and strategically to the design and optimization of in vitro assays, with a focus on deriving actionable biological insights and developing novel therapeutic strategies. Experience with induced pluripotent stem cell (iPSC) technology, including cloning and processing, to support groundbreaking research initiatives and develop disease models for studying complex biological systems. Capacity to conceptualize and implement critical studies that bolster hypothesis-driven research, with a focus on innovative approaches in the field of exosome research and microRNA biology. Proficiency in drafting protocols and study reports, coupled with the ability to maintain accurate and detailed records, facilitating transparent and reproducible research. Expertise in data analysis using software platforms such as Excel and GraphPad Prism, along with skills in analyzing high-throughput sequencing data, facilitating the integration of large datasets into coherent research findings. Exceptional verbal and written communication skills, with the ability to articulate complex scientific concepts in a clear and concise manner, facilitating effective collaboration and knowledge dissemination. Strategic thinking abilities, with the capacity to distill complex scientific challenges into coherent strategies and tactics, fostering innovation and advancing the field of immunology and inflammation research. Familiarity with various operating systems including Microsoft and Mac, and proficiency in software applications such as PowerPoint, Excel, Word, Adobe Photoshop, and Access, facilitating effective data presentation and report generation. Outstanding interpersonal skills, complemented by analytical, organizational, and time management abilities, with a proven track record in managing complex research projects and leading multidisciplinary teams. The contractor is expected to spearhead and deliver groundbreaking scientific data and results, fulfilling the following responsibilities: Tissue processing and purification of immune cells, alongside the development of in vitro cell-based bioassays, encompassing tissue cell culture techniques with primary mouse and human cells, established cell lines, and genetically engineered cell lines. Establishing induced pluripotent stem cell (iPSC) models and co-culture systems to facilitate the comprehensive study of vascular function, leveraging imaging techniques such as Magnetic Resonance Imaging (MRI) to glean detailed insights into the underlying mechanisms. Multicolor flow cytometry (FACS), and ELISA assays, complemented by advanced techniques to study the role and implications of exosomes and exosomal microRNAs in disease progression and therapy. Implementation of basic and advanced molecular biology techniques, including cloning, viral transductions, and the development of novel approaches to study exosomal cargo, particularly focusing on microRNA functionalities. Analyzing biological data utilizing a range of software platforms including FlowJo, Microsoft Excel, and GraphPad Prism, with the ability to integrate data from various sources to derive coherent insights. Interpreting, analyzing, and presenting data in a dynamic, fast-paced, and result-oriented research environment, fostering collaboration and knowledge exchange. Contributing to project advancement by developing new methods or technologies, troubleshooting existing protocols, and spearheading translational research initiatives to bridge the gap between laboratory findings and clinical applications. Writing detailed protocols and study reports, producing and maintaining accurate records to ensure transparency and reproducibility in research endeavors. Preparing manuscripts for journal publications, with a focus on disseminating findings related to the role of exosomes and microRNAs in disease mechanisms and potential therapeutic interventions. TASK AREAS Task Area 1 – Drive discovery and translational research aimed at identifying, characterizing, and interpreting results for novel diagnosis for inflammatory diseases. The candidate must be able to create their own research plans with minimum support from the principal investigator. The candidate must be able to run research plans independently. Weekly/as needed meetings will be held to evaluate the work and provide directions for next steps. Task Area 2 – Define and implement critical studies needed to support hypothesis-based research. Task Area 3 – Make contributions to scientific literature and conferences through publication and presentation of research results. Task Area 4 – Identify and evaluate a wide variety of in vitro assays to test immunological, inflammatory , metabolic, and various disease mechanisms. Task Area 5 – Contribute creatively and strategically to in vitro assay design, optimization, and derive actionable biological conclusions. Task Area 6 – Perform assay development, qualification and validations as needed. Task Area 7 – Conduct cell-based assays including, but not limited to, single cell RNA, ELISA and Flow Cytometry. Task Area 8 – Separate, isolate and cryopreserve primary cells peripheral blood mononuclear cells (PBMCs). Task Area 9 – Organize data prior to scientific publication submission. Task Area 10 – Ensure lab maintenance activities and equipment calibration are performed according to schedule. Task Area 11 – Ensure lab maintenance activities and maintain a clean and safe lab environment. ORDER TYPE The anticipated purchase order will be a Firm Fixed Price. PERIOD OF PERFORMANCE January 1, 2026 – December 31, 2026 CLOSING STATEMENT The recommended Contractor possesses extensive expertise in vascular biology, extracellular vesicles, immunology and hereditary autoinflammatory diseases, which is vital to study the relationship between atherosclerosis and obesity and other metabolic disorders at NIDDK. There have been no other known Contractors identified with the expertise and knowledge required. In addition, this ongoing project requires specific knowledge of the history of the development of each experiment and the thought process that led to each conclusion. Thus, these unique capabilities can’t be easily replicated. The Contractor/incumbent is currently providing the support that is conducting all of these experiments, changing personnel will introduce a variable that could compromise the integrity of NIDDK’s ongoing experiments. This is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. 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 Identifier (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. 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. 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. All responses must be received by Monday, December 15, 2025 at 10:00 AM EST. Responses must be submitted via email to Kimesha Leake, Contracting Officer at Kimesha.leake@nih.gov All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.