75N94024Q00020.SOURCES SOUGHT NOTICE.pdf

SOURCES SOUGHT NOTICE

(Acquisition of Services of a Contract Biomedical Imaging and Medical

Image Analysis Scientist)

AGENCY: The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)

TITLE: Acquisition of Services of a Contract Biomedical Imaging and Medical Image Analysis Scientist

PROPOSED SOLICITATION NUMBER: 75N94024Q00020

PROJECT SERVICE CODE: R499 – SUPPORTPROFESSIONAL:

OTHER

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of all qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification according to the North American Industry Classification System, (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set- aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

BACKGROUND:

Chronic liver disease (from fatty infiltration or infections), with accompanying hepatic inflammation and subsequent fibrosis, affects over 4 million Americans and often progresses to cirrhosis and primary liver cancer with approximately 51,000 deaths per year in the US. Early assessment of inflammation is of the utmost importance for improved liver treatment and recovery. However, inflammation is difficult to diagnose and the progression of inflammation to fibrosis and cirrhosis in chronic liver diseases is a continuous process that requires invasive biopsy to quantify for appropriate medical management.

Invasive biopsy provides subjective histopathologic ranked scoring systems that attempt to classify fibrosis and inflammation. Even though biopsy is considered to be the gold standard for quantifying liver fibrosis and inflammation, it suffers from sampling errors that may not reflects the true extent of pathology in addition to being an invasive technique that causes pain and potential complications to patients.

As the liver becomes fibrotic, nodules and abnormal spherical areas of cells form as dying liver cells are replaced by regenerating cells. This regeneration of cells causes the liver to become stiffer. Recent radiological advances allow bedside assessment of liver stiffness with various vibrator-assisted imaging techniques such as Fibroscan, acoustic radiation force impulse (ARFI) and magnetic resonance elastography (MRE). Yet none of these methods has been shown to accurately detect and clinically quantify the amount of inflammation. Furthermore, they neglect the potential effect of tissue inflammation on liver stiffness measurement accuracy.

The accurate non-invasive assessment of liver inflammation in addition to fibrosis assessment has become increasingly important as it allows for individualized early treatment management. The lack of accuracy and reproducibility, and challenges in assessment has been a major limitation for both clinical management and in liver disease research.

Liver damage can be prevented and, in many cases, reversed if liver disease is treated in its early stages in which inflammation precedes fibrosis. Biopsy, while the gold standard is also hardly justifiable in early stages. Biomedical and Metabolic Imaging Branch proposes a project to target this dilemma by offering to develop a safe, non-invasive, and affordable alternative to biopsy to assess liver inflammation and provide adjusted quantification of liver stiffness. Tens of millions of liver disease patients may benefit from these techniques either for early disease assessment and treatment or following up treatment effects, or in longitudinal clinical pharmacological studies in which the effect of new medication can be followed in patients without intervention.

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 a scientist with extensive expertise in biomedical imaging and medical image analysis with demonstrated understanding of, and ability to apply principles, concepts, practices and standards associated with biomedical imaging and medical image analysis. The scientist must 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 20+ years of demonstrated expertise in biomedical imaging and medical image analysis research.

OBJECTIVE:

The objective of this requirement 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 project. Specialized skills include extensive expertise in biomedical imaging and medical image analysis with demonstrated understanding of, and ability to apply principles, concepts, practices and standards associated with biomedical imaging and medical image analysis.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS:

The contractor will be performing translational research aimed at developing advanced medical imaging and medical image analysis techniques for cardiac Computed Topography Angiograph (CCTA) and liver Magnetic Resonance Imaging (MRI) to detect and assess the coronary atherosclerosis and the liver fibrosis and inflammation at the early asymptomatic stage.

The contractor must have:

• PhD degree in Biomedical Engineering or any related field with 20+ years of directly relevant experience in medical imaging, or medical image analysis.

• 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 deep learning methodologies: RNN, CNN, LSTM, DNN, etc

• Proven experience working with Python, Keras, TensorFlow and/or PyTorch.

• Expertise in image processing, computer vision and machine learning theory.

• Proven experience working with OpenCV, ITK, and VTK.

• Excellent analytical and problem-solving skills.

• Excellent knowledge in OOP concepts.

• Experience with Unix/Linux.

The contractor is expected to deliver scientific data and results and implement the following:

• Develop and implement a 3D MRE technique and algorithms to analyze 3D

MRE liver.

• Develop and implement analysis algorithms optimized for liver tissue deformation imaging driven by inherent cardiac motion to measure liver tissue biomechanical properties.

• Develop and implement machine learning algorithms to estimate the levels of inflammation and accordingly correct the fibrosis stage using liver tissue biomechanical properties.

• Write well-designed, testable, efficient code

• 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.

TASK AREAS:

Task Area 1 – Drive discovery and translational research aimed at developing and implementing a 3D MRE technique and algorithms to analyze 3D MRE liver.

The Contractor shall create their own research plans with minimum support from the principal investigator. The Contractor shall 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 develop analysis algorithms optimized for liver tissue deformation imaging driven by inherent cardiac motion to measure liver tissue biomechanical properties. The Contractor’s progress will be parodically evaluated and the Contractor will be provided with feedback and directions.

Task Area 3 – The Contractor shall develop and implement machine learning algorithms to estimate the levels of inflammation and accordingly correct the fibrosis stage using liver tissue biomechanical properties.

Task Area 4 – The Contractor shall make contributions to scientific literature and conferences through publication and presentation of research results. The Contractor shall be evaluated based on preparing manuscripts and abstracts for scientific publications.

Task Area 5 – The Contractor shall organize data prior to scientific publication submission. The data will be reviewed and evaluated by the principal investigator.

Task Area 6 – The Contractor shall work 40 hours per week, Monday through Friday, totaling 2080 hours per year.

PERIOD OF PERFORMANCE:

Period of Performance: 2/2/2024 – 2/1/2025

INVOICE PROCESSING PLATFORM (IPP):

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)

SPECIAL INSTRUCTIONS:

This Sources Sought is for an organization or institution to provide the NIDDK with the Services of a Contract Biomedical Imaging and Medical Image Analysis Scientist.

All qualified small businesses, whether they are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses;

or small disadvantaged businesses; interested in submitting a corporate capability statement should demonstrate their capability to provide equipment that meets the characteristics above.

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

If you or your firm/business has an interest and possess the required expertise, we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502- 2(b) whether or not this procurement will be set-aside for any of the programs described above. The associated NAICS code is 541690, with the small business size standard of $19.0. All respondents are requested to identify their firm's size and type of business.

Interested firms responding to this Sources Sought Notice should adhere to the following:

(a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 15 pages using a font size 10 or larger.

(b) Small business concerns that possess the capabilities necessary to undertake the efforts should submit complete documentation of their capabilities to the Contracting Officer. This capability statement should include: 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as they relate to the requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented.

Further, Past Performance documentation, which should include, but not be limited to, a minimum of two (2) contracts performed for either Government or commercial organizations shall be provided. References shall include for each contract: names, titles, contract number, total price or cost, telephone numbers of government Contracting Officer Representative and Contracting Officers.

(c) All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Point of Contact below in MS Word or Adobe Portable Document Format (PDF). The subject line must specify 75N94024Q00019. Facsimile responses will not be accepted.

Electronically submitted capability statements are due no later than 9:00 AM (Eastern Prevailing Time) seven (7) calendar days (including date of submission to https://sam.gov) after posting of the Small Business Sources Sought Notice.

CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL

NOT BE CONSIDERED

https://sam.gov/

This notice is for information and planning purposes only and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.