MRI PHYSICS AND ENGINEERING CONSULTANTS.NOTICE OF INTENT.75N94025Q00049.pdf

RFQ# 75N94025Q00049

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 MRI PHYSICS AND ENGINEERING CONSULTANTS for the Acquisition of Support Services of an MRI Physicist.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541690 with a Size Standard of $19.0.

PRIMARY PRODUCT/SERVICE CODE

Q522 - MEDICAL- RADIOLOGY

PURCHASE ORDER TYPE

This purchase order will be Firm Fixed Price, with payment terms per the vendor allowance being a large business (net 30).

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular FAC 2025-03 Effective January 17, 2025.

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: 3/30/2025 – 3/29/2026

Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

8 Central Drive Bethesda, MD 20892

DESCRIPTION OF REQUIREMENT

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

The lack of reliable, noninvasive methods to diagnose early Non-Alcoholic Steatohepatitis (NASH) / Metabolic- Associated Steatohepatitis (MASH) is still a major unmet need. Most cases of hepatic simple steatosis remain free of inflammation, however 10%-20% of patients develop inflammation and fibrosis (NASH/MASH). It is still unknown why some patients progress toward inflammation and fibrosis and why others do not. This is significant and relevant because inflammation and/or fibrosis are what determine the long-term prognosis of this disease and are central to proper clinical management of patients with non-alcoholic fatty liver disease (NAFLD) / metabolic dysfunction-associated fatty liver disease (MAFLD). One of the major gaps in clinical practice is the lack of safe and accurate non-invasive methods that distinguish between patients with NASH/MASH who are at risk of progression to advanced disease and those who have simple steatosis and are less likely to develop liver-related complications.

Several biomarkers of inflammation have been evaluated (e.g. biochemical and blood test markers), but they lack the accuracy and reliability that are necessary to eliminate the need for invasive liver biopsies.

Conventional imaging modalities, as well as clinical blood tests, are still limited by their inability to distinguish between patients with simple steatosis and those with histological NASH/MASH. These approaches can also not determine disease activity (i.e. the degree of inflammatory change) and hepatic fibrosis severity. The histological criteria for the diagnosis of NASH include the presence of inflammatory cellular infiltrates and hepatocyte ballooning. To detect and quantify these changes, multiple MRI data acquisition techniques of quantitative magnetic resonace imaging (MRI) parameters can be explored to determine their potential as biomarkers for the onset of inflammation and its progression/increase. The histological changes of increased inflammatory infiltrates in the extracellular spaces accompanied by hepatocyte ballooning may also lead to changes in intrinsic quantifiable magnatic resonance (MR) parameters such as T1, T2, T2*, T1rho, and free water diffusion. These quantitative MR biomarkers should correlate with the standard blood test markers that are currently used to detect and quantify inflammation in the liver, e.g. C-reactive protein (CRP). An additional aspect of exploration is the bio-mechanical or visco-elastic property changes as a result of inflammation in hepatic tissue. Magnetic resonance elastography (MRE) is a technique used to estimate tissue bio-mechanical and visco-elastic properties, i.e. tissue elasticity and stiffness. It is now accepted as the standard non-invasive MR technique for detecting and staging liver fibrosis in clinical practice. Liver fibrosis is not the sole contributor to increases in liver stiffness however, there is also confounding interplay from hepatic inflammation.

A comprehensive investigation of the various quantitative MRI-derived biomarker parameters affected by and sensitive to changes in hepatic inflammation is lacking. Several previous studies have suggested that a combination of MR-derived parameters is needed to provide good diagnostic discrimination of inflammation from simple steatosis and that a more complete picture of hepatic inflammation that provides information on different aspects of the condition is possible using a combination of techniques than with each technique alone.

A long-term goal would be to identify specific quantitative biomarkers that are specifically and exclusively sensitive to tissue inflammation that distinguishes hepatic necroinflammation from hepatic fibrosis and to develop efficient MR acquisition techniques that would quantify a multitude of these biomarkers in as few acquisitions as possible.

In order to accomplish the goals of this project, 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 an MR physicist and scientist with extensive expertise in MRI data acquisition and MRI scanner pulse sequence programming with demonstrated understanding of, and ability to apply principles, concepts, practices and standards associated with MRI data acquisition and scanner pulse sequence programming.

PURPOSE AND OBJECTIVES

The objective of the order is to procure the services of an MRI physicist and scientist with specialized skills beyond what our current resources can provide to accomplish the project's goals.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The MR physicist and scientist shall investigate and identify specific and sensitive non-invasive quantitative MRI biomarkers for the early detection and longitudinal follow-up of hepatic inflammation in non-alcoholic steatohepatitis (NASH)/ MASH in humans. The scientist must also demonstrate experience and understanding of techniques directly applicable to the Biomedical and Metabolic Imaging Branch research (medical imaging, image processing, machine learning, 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 MR imaging and data acquisition.

The Contractor must have:

• PhD degree in Bioengineering or any related field with 15+ years of directly relevant experience in MRI data acquisition and pulse sequence programming.

• Strong research and presentation skills.

• Ability to define and implement critical studies needed to support hypothesis-based research.

• Ability to write protocols and study reports, produce and maintain accurate records.

• Expert in MR data acquisition and pulse sequence programming environments on MRI scanner platforms

• Proven experience working with object oriented programming software (e.g. C++,etc.), python, Matlab, and other statistical analysis software packages.

• Experience in image processing, computer vision, and artificial intelligence and machine learning applications.

• Excellent analytical and problem-solving skills.

The Contractor shall deliver scientific data and results and implement the following:

• Develop and implement a novel 3D multi-parametric MR pulse sequence to acquire multiple quantitative MRI biomarker parameters sensitive to changes in hepatic inflammation in a single to a few breath-holds.

• Support, develop and implement analysis algorithms for Phosphorous-31 NMR and test sensitivity to changes in hepatic inflammation.

• Support with MR elastography and MR spectroscopy data acquisition and analysis.

• Write well-designed, testable, and efficient code.

• Interpret, analyze and present data; work in fast-paced, result oriented research environment.

• 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 – Drive discovery and translational research aimed at developing and implementing a novel 3D multi-parametric MR pulse sequence to acquire multiple quantitative MRI biomarker parameters. 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 – Drive discovery, support and aid with development and implementation of Phosphorous-31 NMR pulse sequences and data analysis accompanying software. Progress will be perodically evaluated and feedback and directions will be provided.

Task Area 3 – Support clinical collaboration teams with MR elastography and MR spectroscopy data acquisition and analysis.

Task Area 4 – Organize data prior to scientific publication submission. The data will be reviewed and evaluated by the principal investigator.

Task Area 5 – Make contributions to scientific literature and conferences through publication and presentation of research results. The contractor will be evaluated based on preparing manuscripts and abstracts for scientific publications.

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 MRI PHYSICS AND ENGINEERING CONSULTANTS to be the only reasonable available source to provide the support services of an MRI Physicist and Scientist.

This acquisition was pursued on a sole source basis centered on the following. 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 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 requirement to obtain services of a MR physicist and scientist with extensive expertise in MRI data acquisition and MRI scanner pulse sequence programming with demonstrated understanding of, and ability to apply principles, concepts, practices and standards associated with MRI data acquisition and scanner pulse sequence programming. The MR physicist and scientist shall investigate and identify specific and sensitive non-invasive quantitative MRI biomarkers for the early detection and longitudinal follow-up of hepatic inflammation in non-alcoholic steatohepatitis (NASH)/ MASH in humans. The scientist must also demonstrate experience and understanding of techniques directly applicable to the Biomedical and Metabolic Imaging Branch research (medical imaging, image processing, machine learning, 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 MR imaging and data acquisition.

The suggested vendor has extensive expertise in MRI data acquisition and MRI scanner pulse sequence programming and development of novel medical imaging technologies for the early diagnosis, assessment, and treatment of several chronic diseases related to metabolic disorders and obesity. This is an ongoing project with several ongoing design and development of multiple MRI data acquisition techniques for quantitative MRI parameters. These processes are highly complex in nature and require great attention to technical details. In addition, this is an ongoing project that requires specific knowledge of the history of the development of each technique and the thought process that led to each conclusion. Thus, these unique capabilities of the suggested vendor cannot be easily replicated in other vendors without adding cost and delaying vital ongoing research.

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 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 to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Monday, March 24, 2024 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov .

Assessment of Capability Lowest Price Technically Acceptable http://www.sam.gov/ mailto:amber.harris@nih.gov