NCI Justification_and_Approval_UMD Final_oalm_Redacted.pdf

analysis. The database platform can then be utilized by CCR investigators for hypothesis verification or generating new hypotheses as well as providing ongoing research support for the Laboratory of Human Carcinogenesis’ continuing research goals as approved in the last site visit. The access to the database with de-identified patient data by CCR approved staff will also have to be incorporated in the database development with proper security and specific user roles.

The second is to preserve the current Internal Review Board (IRB) approvals for patient tissue, blood, biofluids and epidemiologic profiles. The continuity of data collection and database restructuring for case and control volunteer enrollees as well as patient follow up as needed will require that an IRB is in place and renewed annually as two medical institutions ( University of Maryland Medical Center and the Veteran’s Affairs Hospital).

b) Project background. The Laboratory of Human Carcinogenesis (LHC), with assays that are designed for clinical application, uses integrative epidemiology and translational research strategies to investigate the molecular epidemiology of human cancer. To address key scientific questions concerning the initiation and progression of cancer in humans and their potential translational significance in improving patient outcome, a resource is needed to identify and recruit cancer patients from the city of Baltimore and surrounding areas, individuals identified as high-risk for cancer, and healthy population-based controls matched by socio-economic and environmental factors to the cases. In addition to collecting and processing biological specimens, the contractor collects, merges, cleans and stores participant interview data to send to the LHC. One of the unique and cost-effective features of this approach to date has been the sharing of biological materials and epidemiological data from the healthy controls with each of the distinct primary cancer groups among the Principal Investigators (PIs) within the

LHC.

The longevity of the contract has culminated in almost 30 years of patient enrollment. As a result, many of the projects at LHC culminated in analysis of patient DNA, RNA, proteomics, metabolomics, viral load and more, and all of the published data can be curated and linked to the patient data. The proposed modification to add two option periods will ensure continuation of the existing requirement in which the contractor provides human bio-specimens and questionnaire data for research as well as linking EPA pollution data and survival follow-up. The collection of these specimens and data has been consistent in its quality for analysis and the laboratory results have been reproducible. Using IRB-approved protocols designed by the PIs in the LHC, the accrual of subjects for cases, high-risk and population controls (shared between the studies) and case-series studies are a critical component of the contract design and critical for research conducted in LHC.

The project has progressed successively through six competitive contract cycles with the same vendor, the University of Maryland Medical Center (UMD). The longevity of the current studies allows for long-term follow-up with cancer specific mortality. Detailed in-person questionnaires facilitate the integration of tumor biology and risk factors for precision medicine and precision prevention.

Collection of demographically and clinically annotated biospecimens (blood, Collection of patient survival rates through the Center for Disease Control.

Identification of factors driving excess mortality in sub-populations and studies of health disparity and population differences in tumor biology.

Exploration of the microbiome, virome, metabolome, and proteome of cancer patients and those at high-risk of cancer or aggressive subtypes.

The discovery of molecular subtypes.

Translational studies with ‘bench to bed-side” applications of new discoveries.

Sharing materials and data intra and extramurally through collaborations and consortia.

Building a comprehensive shared resource for NCI of patient data with their genetic and molecular analysis from patient tissue or biofluids for use as a validation cohort and/or for generating hypothesis for future initiatives.

c) Requirement type.

Research & development (R&D) R & D support services

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a) Name and address of the proposed contractor(s).

STATE OF MARYLAND: UNIVERSITY OF MARYLAND BALTIMORE

220 ARCH STREET RM 02148

BALTIMORE MD 21201-1531

b) Nature of the acquisition and proposed unique qualifications of the contractor(s).

The University of Maryland initially began a contract agreement with the National Cancer Institute in 1998 as a pilot program to obtain tissues for the experimental development of conditions to culture human specimens as organ and cellular tissues for the study of invitro molecular carcinogenesis covering five lethal human cancers.

The University’s expertise in patient recruitment and in maintaining detailed longitudinal records with follow-up data makes it unique, not only in sustaining the viability and relevance of studies for decades, but also as the only institution that developed a dedicated mechanism to support these clinical research studies. This includes IRB approved access to patients and medical records for NCI approved studies. Some medical records dated back more than 39 years, and participating populations continue to be followed as part of a natural history study. This unique design and resource are vital to maintaining a robust and healthy database.

The continuation and maintenance of records for these studies with the development of an epidemiologically based questionnaire have created an invaluable resource.

With improvements to the database structure, this resource has the potential to serve as a dynamic and unique cohort of patient information for molecular carcinogenesis as well as a powerful tool for AI-driven models for early diagnosis and predictive outcomes.

Other sources do not demonstrate having an expertise in exporting the antiquated file type, InfoPath, which has been used by the existing database to house patient epidemiological data and therefore would not be qualified to make necessary improvement to the database while maintaining patient record integrity. Also, they do not demonstrate having surgical connections essential to collecting samples or getting permission for access to the Veteran’s Affairs Hospital or UMD medical records from which the data is collected. This is essential for follow-up on enrolled patients and for verification of patient data in the restructured database. There is also a requirement to continue with the existing protocol for consistent sample storage of all biospecimens so that quality research can be done with samples collected.

Accurate and specific sample preparation is also critical. There would be significant delays/duplicated costs due to the need for access to the VA hospital and medical record data, rebuilding an infrastructure capable of managing multiple locations, seamlessly moving between changing hospital staff, having trained nurses to be back up staff on an as needed basis, hiring qualified pathologist to verify cancer types and obtaining the IRB approvals, which can take years.

Today, the resource supports integrative molecular epidemiological methods, systems biology and the analysis of biospecimens that informs both precision medicine and precision prevention. Importantly, the design of the study and resource specifically allows the PIs to address key questions related to the health disparities in the Baltimore region of Maryland. The loss of this resource would be detrimental to ongoing studies that rely on receiving accurate and relevant patient information consistent with the currently used data. A lapse in funding will void the IRB approvals for two hospitals and waste considerable amount of time (more than six months) and funding to renew.

The continuity of the quality and precision in data collection that the UMD resource provides, allows studies that have been ongoing for more than 30 years to produce data that can be published and verified at the highest level supported by custom designed software. Using another vendor would mean that NCI would have to have test cases to prove that the new collections would be at the highest quality and would require further explanation in published manuscripts. This would cause unnecessary delays and might compromise research integrity.

The co-operative agreements that are established at the UMD grant them access to medical records to all the patients in our studies (including the VA hospital), pathology, and epidemiology, make them uniquely qualified to fulfill this service for CCR. UMD also hold all the data rights to the survival information and the IRB approvals to continue to collect data. The custodianship of this survival information is a key factor for many of LHC/CCR hypothesis generation.

Furthermore, there has not been another hospital source that is willing to give NCI access to medical records or allow an IRB for patient enrollment into our studies.

The UMD Pathology department has given NCI the permission and renews the IRB to allow continued sample collection and patient recruitment. The signed informed consent of recruited volunteers is with UMD. It would be difficult to replicate this consent with another vendor. Another vendor that is not a hospital affiliated department cannot guarantee this kind of access.

Description of the efforts made to ensure that offers are solicited from as many potential sources as possible, including whether a notice was or will be publicized as required by part 5 and, if not, which exception under part 5 applies.

A sources sought notice (75N91024R00018) was posted on SAM.gov on January 16, 2025, and remained open for 30 days. Two vendors responded to the notice, Vendor 1 and Vendor 2, but only Vendor 2 provided a capability statement. The COR reviewed both responses and determined that neither source proved to have the appropriate qualifications to fulfill the project goals.

A pre-solicitation notice was posted to SAM.gov on July 1, 2025, and remained open for 15 days. No responses/capability statements were received.

Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

An Independent Government Cost Estimate (IGCE) was developed using historical data on costs incurred on the current, active contract with the University of Maryland, as well as the COR’s knowledge of the salary information for the clinical research personnel. There are also costs for FISMA and NDI requests that are included in this IGCE which are other direct costs.

The Contracting Officer will obtain certified cost and pricing data as necessary to establish a fair and reasonable price for the services being acquired, if required by FAR 15.403-4. After receipt of a cost proposal for this work, if FAR 15.403-4 does not require certified cost and pricing data (e.g. if the dollar threshold for certified cost and pricing data is not met), the Contracting Officer will require Data Other Than Certified Cost or Pricing Data to support all proposed costs. The Contracting Officer will conduct a cost analysis and cost realism analysis as part of the award decision. The cost analysis will include comparing separate individual cost elements in the proposal to costs incurred on the current, active contract.

8. Description of the market research conducted (see part 10) and the results, or a statement of the reason market research was not conducted.

A sources sought notice (75N91024R00018) was posted on SAM.gov on January 16, 2025 and remained open for 30 days. Two vendors responded to the notice, Vendor 1 and Vendor 2, but only Vendor 2 provided a capability statement. Vendor 1 is not being considered because they offer consulting and quotation services and are not capable of providing a cost-effective solution for replacing the current contractor with clinical and biospecimen expertise. The current established contract has clinical connections, IRB approval and epidemiological data that is vital to our current studies. Any start up delays or increase in costs would not be acceptable. The patient accrual would also have to be from residents of Baltimore and vendor 1 is based in Oklahoma City, so unless they have clinical staff in place in Baltimore, which they did not attest to, they could not provide the same level of patient enrollment as the current contractor.

Vendor 2 has also replied in writing. They do not meet our criteria either. They do not provide information about being able to navigate the complexity of a hospital administration or the lengthy processes of obtaining an IRB for sample collection.

The minimum time requirement would be 6-12 months to obtain an IRB approval for both the VA and UMD. With a 2-year extension, this would delay an already short timeline.

No qualified sources responded.

The specificity of the patient collection for socio-economic and environmental demographics requires that an IRB be obtainable through a major University or hospital in the Baltimore Metro area. No source, comparable to UMD answered the sources sought notice, nor have they in the past which is why this contract has stayed with the UMD for so long. Other Universities and hospitals in the area are not willing to share resources through a NIH contract. Even the subcontract that is in place with the neighboring Veteran’s Affairs Hospital has been notoriously difficult and slow and is not interested in bidding to be the prime on the contract.

Any other facts supporting the use of other than full and open competition.

None

Listing of sources, if any, that expressed an interest in the acquisition in writing.