75N94025Q00023.Combined Synopsis Solicitation.pdf

COMBINED SYNOPSIS / SOLICITATION WORKFORM

(1) Action Code: Combined Synopsis/Solicitation

(2) Date: 12/4/2024

(3) Year: 2024

(4) Contracting Office Zip Code: 20892

(5) Project Service Code: R499 – SUPPORT PROFESSIONAL:

OTHER

(6) Contracting Office Address:

6710B Rockledge Drive Bethesda, MD 20892

(7) Subject/Title: Acquisition of Services of a Contract Immunology and Hereditary Autoinflammatory Diseases Scientist

(8) Proposed Solicitation Number: 75N94025Q00023

(9) Closing Response Date: 12/19/2024

(10) Contact Point: Amber Harris

(11) Contract Award and Solicitation Number: TBD

(12) Contract Award Dollar Amount: TBD

(13) Contract Line Item Number(s): TBD

(14) Contractor Award Date: TBD

(15) Contractor Name: TBD

(16) Description: (Background)

(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; quotes are being requested and a written solicitation will not be issued.”

(ii) The solicitation number is 75N94025Q00023 and the solicitation is issued as a Request for Quote (RFQ).

(iii) The solicitation document, the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-01 Effective November 12, 2024.

(iv) The associated NAICS code is 541690, Other Scientific and Technical Consulting

Services, and the small business size standard is $19.0. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13.

(v) The Contractor Requirements are listed below:

1.0 PURCHASE ORDER TITLE

Acquisition of Services of a Contract Immunology and Hereditary Autoinflammatory Diseases Scientist

2.0 BACKGROUND

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.

In recent years, the scientific community has turned its attention towards the intricate role of exosomes in patients grappling with Cushing syndrome and metabolic syndrome, conditions often characterized by significant metabolic and immunological dysregulations.

These nano-sized vesicles have emerged as pivotal players in the complex network of interactions that underpin multi-organ diseases, including atherogenesis, a condition frequently encountered in these patients. Notably, individuals with rare genetic mutations such as hyper immunoglobulin E (Job's) syndrome, Turner's syndrome, lipodystrophy, or HIV infection exhibit a spectrum of dysregulations that mirror those seen in obesity, particularly affecting leptin metabolism and T-cell function. As these subjects are known to acquire accelerated atherosclerosis, a deeper understanding of the early signaling events mediated by exosomes could pave the way for innovative therapeutic strategies.

The goal, therefore, is to isolate and scrutinize these defects, fostering a new frontier in the battle against the devastating cardiovascular consequences associated with these syndromes.

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 necessitates an in-depth understanding of the molecular basis of inflammatory diseases and studying their associated pro-inflammatory cytokines.

In this complex landscape, the role of extracellular vesicles and their diverse subpopulations emerges as a focal point of research. These vesicles, including exosomes, are instrumental in mediating the intricate communications between various cellular entities, significantly influencing the dysregulation of metabolism and inflammation seen in these conditions. Particularly, their cargo of microRNAs serves as molecular messengers, modulating pathways that are central to the inflammatory response and metabolic homeostasis. By dissecting the nuanced interactions of these microRNAs and their target molecules, researchers can unravel the complex molecular bases underlying the accelerated progression of atherosclerosis. Consequently, a deeper exploration into the world of extracellular vesicles and their microRNA cargos not only sheds light on the mechanistic intricacies of metabolic and immunological dysregulations but also paves the way for the development of targeted therapeutic strategies, offering a beacon of hope in the comprehensive management of these debilitating conditions.

The novel role of microRNA within the mitochondrial and vascular domains has been spotlighted as a critical factor in the pathogenesis of autoinflammatory diseases, including those with significant mitochondrial dysfunction such as Type 2 diabetes and obesity. These microRNAs are pivotal in orchestrating complex cellular dialogues, influencing both mitochondrial dynamics and vascular function, thereby playing a substantial role in the progression of these diseases. Consequently, a deeper comprehension of the intricate relationships between microRNAs and mitochondrial as well as vascular dysfunctions could significantly propel the development of novel therapeutic strategies to combat inflammatory diseases. To this end, research endeavors are increasingly leveraging cutting-edge techniques such as induced pluripotent stem cells (iPSC) technology, microarray analyses, and single-cell RNA sequencing. These approaches, coupled with the study of various subpopulations of extracellular vesicles, aim to pinpoint the precise origins of these vesicles, thereby providing a more granular understanding of their roles in disease progression. By employing a synergistic combination of these advanced methodologies, researchers aspire to unveil the nuanced mechanisms that govern the mitochondrial regulation of inflammatory diseases, paving the way for a new era of targeted and effective treatments.

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 and siRNA transfection, and processing of induced pluripotent stem cells (iPSCs), 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 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.

3.0 OBJECTIVE

The objective of this requirement is to procure the services of scientist with specialized skills beyond what our current resources can provide in order to accomplish the goals of this program. The contractor will work 40 hours per week, Monday through Friday, totaling 2080 hours per year.

4.0 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

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 microRNA analysis, western blotting, quantitative PCR, and multiplex ELISA, 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 cellular signaling pathways, and their potential as biomarkers and therapeutic targets, with a focus on their involvement in mitochondrial and vascular dysfunction.

• Expertise in nucleic acid isolation techniques, 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.

• 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 microRNA analysis, facilitating detailed insights into cellular heterogeneity, 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 and established 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 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. The candidate’s progress will be parodically evaluated and the candidate will be provided with feedback and directions.

Task Area 3 – 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 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, microRNA, qPCR, 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. The data will be reviewed and evaluated by the principal investigator.

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.

5.0 PURCHASE ORDER TYPE

This Purchase Order is to be a firm fixed price.

6.0 PERIOD OF PERFORMANCE AND PAYMENT BREAKDOWN

Period of Performance:

Base Year 1/20/2025 – 1/19/2026 Option Year 1 1/20/2026 – 1/19/2027

Payment will be made Monthly in Arrears.

7.0 INSPECTION AND ACCEPTANCE

The Project Officer or the Project Officer Supervisor will perform inspection and acceptance of materials and services to be provided. For equipment orders, inspection and acceptance will be done AFTER All materials are unpacked, installed, and test run for operation. Receiving will be completed no later than 7 days following date of Delivery.

Acceptance and Delivery will be complete once the signed packing slip is provided to the Vendor.

Inspection and acceptance will be performed at the place of installation –

The National Institutes of Health, NIDDK, Bldg. 10, Room 3-5340, 9000 Rockville Pike, Bethesda, Maryland 20892.

For services, invoices will be approved by the Project officer and or COR according to payment terms in the resultant purchase order.

(vi) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

(vii) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, is applicable.

Award will be made to the contractor providing the most advantageous quote to the Government. Technical factors and price considered with technical factors outweighing price.

Specifically, the following technical factors will be evaluated:

i. The vendor will be evaluated on their quoted product meeting the specifications under section 4.0 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS.

ii. The Offeror should note that the evaluation criteria listed in order of importance are:

A. Technical – The services proposed by the vendor meets the requirements in the SOW

B. Cost/Price

The technical factors are as follows:

The evaluation will be based on the demonstrated capabilities of the prospective Offeror in relation to the needs of the project as set forth in the Statement of Work. The merits of the proposal will be evaluated carefully and will be deemed Acceptable or Unacceptable. The proposal must document the feasibility of successful implementation of the requirements of the Statement of Work. The Offeror must submit information sufficient to evaluate the proposal based on the detailed factors listed in section 4.0 SALIENT / REQUIRED FEATURES AND

SPECIFICATIONS.

Evaluation Criteria Acceptable Unacceptable

Technical The services proposed by the vendor meet the requirements in the SOW

Summary Overall Rating (Overall Risk)

Cost/Price Offerors will be evaluated based upon cost/price completeness and accuracy to determine the validity of the price, realism, reasonableness, and risk.

Technical Evaluation Rating Definitions

(viii) FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

(x) FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

(xi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. Including the following clauses and Prohibitions:

i. 52.204-10, Reporting Executive Compensation and First-Tier

Subcontract Awards

ii. 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

iii. 52.209-9, Updates of Publicly Available Information Regarding

Responsibility Matters

iv. 52.219-4, Notice of Price Evaluation Preference for HUBZone Small

Business Concerns

v. 52.219-8, Utilization of Small Business Concerns

vi. 52.219-28, Post Award Small Business Program Representation

vii. 52.222-3, Convict Labor

viii. 52.222-21, Prohibition of Segregated Facilities

ix. 52.222-26, Equal Opportunity

x. 52.222-36, Equal Opportunity for Workers with Disabilities

xi. 52.222-50 Combating Trafficking in Persons

xii. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving

xiii. 52.225-13, Restrictions on Certain Foreign Purchases xiv.

Rating Definition Acceptable Proposal meets requirements and indicates an adequate approach and understanding of the requirements, and risk of unsuccessful performance is no worse than moderate.

Unacceptable Proposal does not meet requirements of the solicitation, and thus, contains one or more deficiencies, and/or risk of unsuccessful performance is unacceptable.

http://www.acquisition.gov/

Additional Clauses:

i. 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (OCT 2018) (31 U.S.C. 3332).

ii. 52.232-39, Unenforceability of Unauthorized Obligations

(xii) Additional Contract Requirements:

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.

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 response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.

Vendor/Contractor Must be able to accept payments via IPP (Invoice Processing

Platform) The contractor may submit a request for an exception. See below for IPP, IPP helpdesk information and applicable Health and Human Services addendum clause.

INVOICING PROCESSING PLATFORM (IPP) In compliance with the Office of

Management and Budget (OMB) M-15-19 memorandum "Improving Government Efficiency and Saving Taxpayer Dollars through Electronic Invoicing" directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award resulting from this solicitation will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests" IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury's Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date. The IPP website address is:

https://www.ipp.gov If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973-3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov Note: Should an Offeror feel that use of the IPP would be unduly burdensome, the response to this solicitation should include an explanation of this position for a determination by the contracting officer.

HHSAR 352.232-71 Electronic Submission of Invoice Payment Requests (Feb 2022) will apply when this requirement is solicited and awarded. As stated: (a) Definitions.

As used in this clause, Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. (END OF CLAUSE)

(xiii) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable.

(xiv) Offers shall be submitted via email to amber.harris@nih.gov and must reference 75N94025Q00023 in the subject line.

(17) Place of Contract Performance:

National Institute of Health, NIDDK 10 Center Drive Bethesda MD 20892

(18) Set-aside Status: This requirement is not set aside for small business.

mailto:amber.harris@nih.gov