Inactive

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The Nat... INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to EDWAN LLC for lab work and research services for the 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 $16.50. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2022-08 Effective October 28, 2022. This acquisition is conducted under the procedures as prescribed in FAR subpart 13—Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). PERIOD OF PERFORMANCE Base Year: 1/20/2023 - 1/19/2024 Option Year 1: 1/20/2024 - 1/19/2025 Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 10 Center Drive Bethesda, MD 20892 ? DESCRIPTION OF REQUIREMENT Much of the work carried out in the Biomedical and Metabolic Imaging Branch focuses on developing noninvasive imaging approaches with high spatial (micro-millimeter) and temporal (milliseconds) resolution that allow multi-organ evaluation and analysis to better understand the interplay between atherogenesis and metabolic syndrome in humans. This is being achieved through new chemical spectroscopic techniques of involved organs (e.g. liver, heart and muscles) and improved imaging methodologies such as the development of free breathing methods (important for kids and adolescents) and high contrast techniques without the use of contrast agents. The Biomedical and Metabolic Imaging Branch has championed the creation of a multidisciplinary team of imaging physicists, spectroscopists, and biologists. Patients with rare genetic mutations such as hyper immunoglobulin E (Job's) syndrome (immune system and coronary arteries), Turner's syndrome (genetics and vascular disease), lipodystrophy (metabolic dysfunction and cardiovascular disease), or HIV infection (inflammation and coronary disease), share many of the metabolic and immunological dysregulations encountered in multi-organ disease subjects inclusive of atherogenesis. T-cell dysfunction mirrors that seen in obesity affecting leptin metabolism. Finally, it is well established that such subjects acquire accelerated atherosclerosis. Therefore, a goal has been to isolate and understand the effects of these defects and the early events that signal atherosclerosis. Taking advantage of the effects of deregulation of metabolism, inflammation and immunity that play a key role in multi-organ disease progression of atherosclerosis in obesity and metabolic syndrome requires an in-depth understanding of the molecular basis of inflammatory diseases and studying their associated pro-inflammatory cytokines. Specifically, understanding the initiating pathways of the immune system, such as the Toll-Like Receptors (TLRs) and the inflammasome, to determine effective therapies involved in the dysregulation of these inflammatory signals as a treatment approach to ameliorate atherosclerosis and obesity, diabetes and hereditary autoinflammatory diseases. Novel role for mitochondrial STAT3 has been implicated in autoinflammatory diseases with an underlying component of mitochondrial dysfunction, such as Type 2 diabetes and obesity among many other diseases. Therefore, a deeper understanding of the interplay between STAT3 and mitochondria creates a great advantage to developing therapeutic approaches to treat inflammatory diseases. Research endeavors will employ a combination of flow cytometry, cell imaging, proteomic and bioinformatic approaches to further dissect mechanisms involved in mitochondrial regulation of inflammatory diseases. 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 with demonstrated understanding of, and ability to apply principles, concepts, practices and standards associated with patient sample testing in a laboratory setting. _________________________ PURPOSE AND OBJECTIVES 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), and BMIB have a requirement to obtain services of a scientist with extensive expertise in innate immunology and hereditary autoinflammatory diseases with demonstrated understanding of, and ability to apply principles, concepts, practices and standards associated with patient sample testing in a laboratory setting. The scientist must demonstrate experience and understanding of techniques directly applicable to the BMIB research (tissue culture, molecular and cellular biological techniques such as PCR, flow cytometry, IHC, etc.) and must be self-motivated and driven to achieve milestones and exceed goals with minimal direction. Furthermore, they must possess a PhD with 15+ years of demonstrated expertise in immunology and/or inflammation research. The objective of this request is to procure the services of a scientist with specialized skills beyond what our current resources can provide in order to accomplish the goals of this program. The contractor shall work 40 hours per week, Monday through Friday, totaling 2080 hours per year. SALIENT / REQUIRED FEATURES AND SPECIFICATIONS Specifically, the NIDDK requires the following of the candidate: • PhD with 15 +years of directly relevant experience in immunology, or inflammation. • Proficiency in T cell culture, multicolor Flow Cytometry, RNA-seq, western blotting, q-PCR, multiplex ELISA, RNA/DNA isolation, T cell isolation, cell assay development, mouse handling/ organ isolation is highly desired. • Expertise with lentiviral production, synthetic biology, lentiviral vector design desired. • Human T cell isolation & in vitro culture- The candidate must be able to isolate T cells from buffy of peripheral blood mononuclear cells (PBMCs). Starting with PBMC cells, the candidate must be able to isolate T cells by either positive or negative selection strategies, using antibody-based capturing techniques, such as magnetic beads coated with different antibody cocktails. Short- and long-term culturing of the T cells for research or clinical purposes rely on continuous expansion of these cells. The candidate must be able to use Anti-CD3- and anti-CD28-based activation techniques to expand these cells. The candidate must be able to perform genetic and epigenetic manipulation of T cells cultures to enable efficient ways of studying phenomena at a cellular level. • Possess experience using autoimmune and inflammatory disease mouse models- The candidate must possess hands-on experience using autoimmune and inflammatory disease mouse models to study inflammatory cell recruitment and immune function using techniques that have been validated to support inflammatory disease drug discovery research. The candidate must be able to utilize these models combined with the appropriate biomarkers, including flow cytometry and histologic analysis, in a study design tailored to meet the strategic goals of our programs. • Must have experience in the NLRP3 inflammasome and mitochondrial STAT3. • Good understanding of immune signaling pathways and interest in metabolomics. Metabolic choices in cells enforce fate and function. Metabolic commitment is influenced not only by substrate availability but also by signaling pathways elicited by metabolites. Transitions between quiescent and activated states require the apportioning of nutrients into different pathways. The candidate must have a good understanding demonstrated by previous publications in how metabolic pathways are regulated to support or direct functional changes. • Expertise with data analysis software such as Excel and Graphpad Prism. The candidate must have hands-on experience using statistical data analysis software package in Excel and/or Graphpad Prism. The candidate must have hands-on experience creating graphs for presentations/publications using statistical software demonstrated by previous publications referencing the use of statistical data analysis software. • Strong verbal and written communication skills. The candidate must demonstrate on their CV strong communication skills, this will be evaluated by several podium presentations in major international scientific symposia. The candidate must possess strong English skills, the candidate English skills will be evaluated by providing samples of scientific writings e.g. a draft manuscript. • Ability to synthesize complex scientific problems into a strategy and tactics. • History and ability to prepare manuscripts for high impact journals. Must have prior publications I high impact journals such as Nature, or Science or Cell • Familiarity with both Microsoft and Mac operating systems, including PowerPoint, Excel, Word, Adobe Photoshop and Access. • Excellent interpersonal, analytical, organizational and time management skills. The contractor is expected to deliver scientific data results and implement the following: • Tissue processing and purification of immune cells, in vitro cell based bioassay development, tissue cell culture (primary mouse and human cells, cell lines and genetically engineered cell lines) • Multicolor flow cytometry (FACS), and ELISA assays • Basic molecular biology techniques (cloning, viral tranductions, etc.) • Analyze biological data using FlowJo, Microsoft Excel, and GraphPad Prism • Interpret, analyze and present data; work in fast-paced, result oriented research environment • Contribute to project advancement by developing new methods or technologies and troubleshooting existing protocol • Write protocols and study reports, produce and maintain accurate records • Prepare manuscripts for journal publications TASKS AREAS Independently, and not as an agent of the Government, the contractor shall perform all of the detailed Task Areas listed below: Task Area 1 – Scientific Research Support – Contractor shall 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 – Scientific Research Implementation – Contractor shall define and implement critical studies needed to support hypothesis-based research. The candidate’s progress will be parodically evaluated and the candidate will be provided with feedback and directions. Task Area 3 – Scientific Publication Support – Contractor shall make contributions to scientific literature and conferences through publication and presentation of research results. The candidate will be evaluated based on preparing manuscripts and abstracts for scientific publications. Task Area 4 – Identify/Design/Develop In-Vitro Assays – Contractor shall identify and evaluate a wide variety of in vitro assays to test immunological, metabolic, and various disease mechanisms. Contractor shall contribute to in-vitro assay design, optimization, and derive actionable biological conclusions. Contractor shall perform assay development, qualification and validations as needed. Task Area 5 – Cell-Based Assays – Contractor shall conduct cell-based assays including, but not limited to, ELISA and Flow Cytometry. Task Area 6 – Blood Cell Services – Contractor shall separate, isolate and cryopreserve primary cells peripheral blood mononuclear cells (PBMCs). Task Area 7 – Data Organization – Contractor shall organize data prior to scientific publication submission. The data will be reviewed and evaluated by the principal investigator. Task Area 8 – Lab Maintenance/Safety – Contractor shall ensure lab maintenance activities and equipment calibration are performed according to schedule (to be determined by PO). Contractor shall ensure lab maintenance activities and maintain a clean and safe lab environment. Task Area 9 – Location of Service(s) – The Contractor shall perform the services for BMIB located in Building 10, Room 1C334, Bethesda MD, 20892 at NIH’s Biomedical and Metabolic Imaging Branch (BMIB). CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10—Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined EDWAN LLC to be the only reasonable available source to provide lab work and research services for the NIDDK Biomedical and Metabolic Imaging Branch. This acquisition was pursued on a sole source basis centered on the fact that this is ongoing project that requires specific knowledge of the history of the development of each experiment and the thought process that led to each conclusion. Jehad Edwan of Edwan LLC possesses extensive expertise in innate immunology and hereditary autoinflammatory diseases, which is vital to our study of the relationship between atherosclerosis and obesity and other metabolic disorders. CLOSING STATEMENT This synopsis 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: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), 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 to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Tuesday, December 27, 2022 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov . Assessment of Capability Lowest Price Technically Acceptable

Inactive

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