D JEFO Redacted.pdf

1. Requisition Organization:

a. Contracting Activity:

NIDA Office of Acquisitions, NCATS Section National Institutes of Health Department of Health and Human Services

b. Requesting Office:

National Center for Advancing Translational Sciences (NCATS) 9800 Medical Center Drive Rockville, MD 20850

c. Project Officer:

2. Nature and/or description of the action being approved.

This action is to obtain cloud-based electronic data capture (EDC) software and provide services to provision it in accordance with NCATS data environment standards to support clinical data management and analysis requirements of the Bespoke Gene Therapy Consortium (BGTC).

3. Description of the Requirement:

a. Project title.

Bespoke Gene Therapy Consortium Coordination Center (BGTC CC) Electronic Data Capture (EDC) Platform Support

b. Acquisition purpose and objectives.

The objective of this acquisition is to obtain cloud platform services to support data collection, dissemination, analysis, integration, reporting, and management of the BGTC.

The BGTC is part of the Accelerating Medicines Partnership (AMP) program, a public–private partnership among NIH, the U.S. Food and Drug Administration (FDA), multiple pharmaceutical and life sciences companies, and nonprofit and other organizations. The AMP program, which is managed by the Foundation for the NIH (FNIH), aims to improve current models for developing diagnostics and therapies. NCATS is the lead NIH IC for BGTC, one of several NCATS-led programs aligned with

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

the NCATS’ mission to re-engineer the translational research process so new treatments and cures for diseases can be delivered to patients faster. The BGTC is establishing platforms and standards to speed the development and delivery of customized or “bespoke” gene therapies (GT) that could treat millions of people affected by rare diseases, including diseases too rare to be of commercial interest.

c. Project background.

BGTC program management is performed through the BGTC Coordination Center (BGTC CC). The BGTC CC coordinates consortium development of early-stage gene therapy drug candidates (currently 7 candidates) to treat selected rare diseases. Gene therapy development includes early-stage drug development, pre-clinical evaluation, regulatory preparation, and program platform operations in advance of initiating clinical trials.

To meet the data management requirements for this gene therapy effort, the BGTC CC is developing a centralized regulatory and Quality Management System (QMS)-compliant Electronic Data Capture (EDC) and electronic Clinical Outcome Assessment (eCOA) platform. Data management requirements include data collection, dissemination, analysis, integration, reporting, and program/project management. This EDC/eCOA is being configured under a task order under the NIH-wide Project, Program, and Portfolio (P3) Support Services Contract, contract

no. 75N98022D00019, task order no. 75N98023F00006.

The P3 parent award, single award IDIQ, 75N98022D00019 was awarded from solicitation 75N98022R00003 dated 4/4/2022. It was solicited as a set-aside for Women Owned Small Businesses. There were 4 offers received. Black Canyon Consulting, LLC was selected as the awardee. The estimated order value is and the period of performance is from 5/26/22 to the last date to order of 5/25/26. The task orders from this parent award are awarded non-competitively to the sole parent award contractor, Black Canyon Consulting, LLC.

P3 support for the BGTC is provided under three task orders, all to Black Canyon Consulting, which provides program management support.

The P3 contractor, Black Canyon Consulting, LLC subcontracted with IQVIA Government Solutions, Inc. for comprehensive program and project support for BGTC, including partnering with Medidata to provide Medidata Rave as the standard commercial EDC for use across all gene therapy trials sponsored by BGTC. Development of the EDC/eCOA system on that cloud platform will continue under the P3 task order. The period of performance of contract no. 75N98022D00019, task order no.

75N98023F00006 is 09/01/23 through 08/31/26. The task order is not complete and will be completed on 08/31/26. The contract 75N98022D00019 task order 75N98023F00006 is currently valued at , and was awarded to Black Canyon Consulting, LLC, as they are the single award contractor for the parent award.

To meet the requirements for privacy, security, and long-term sustainability (estimated at 8 to 11 years) of all data collected in support of the BGTC, in February 2024 the Government decided that it would take responsibility for the cloud-based platform itself, while the development of the EDC/eCOA system would continue under the already-established P3 contract. The first natural history study under the BGTC required prompt access to the EDC, and the Government placed a NITAAC order, as required by the HHS Category Management directive, to IQVIA to obtain and configure an initial instance of Medidata Rave to support development of the EDC under the P3 contract, while a long-term NITAAC order for secure clinical trial data cloud platform services (i.e. the subject of this action) could be awarded. The sole-source short-term order is no. HHSN316201500008W-75N95C24F30001, value , period of performance 5/1/2024 – 10/31/2024.

d. Project description.

The contractor shall provide secure cloud-based clinical trial data software services and provide professional services to provision the software services in accordance with NCATS data environment standards.

e. Requirement type.

Information technology (IT).

f. Type of action.

Follow-on.

g. Proposed order type.

Firm-fixed-price, with options.

h. Acquisition identification number.

24-005328

i. Total estimated dollar value and performance/delivery period.

Base year (11/01/24-10/31/25):

Option Period 1 (11/01/25-10/31/26):

Option Period 2 (11/01/26-10/31/27):

Option Period 3 (11/01/27-10/31/28):

Option Period 4 (11/01/28-10/31/29):

Base and all options:

4. Market Research.

Market research shows that the services to be provided are commercial in nature and are available through NITAAC.

A Sources Sought Notice- Notice ID- 24-005328 was published in SAM on July 18, 2024, and closed on August 1, 2024 at 4:00 pm. Six vendors replied to the Sources Sought Notice with a capability statement. The NCATS program office reviewed the responses, and determined that the only vendor that was capable of performance is IQVIA Government Solutions, Inc. The following table captures the program’s review of the capability statements.

Respondent Review Determination

IQVIA

Government Solutions, Inc.

IQVIA is the incumbent already providing services in accordance with the SOW.

Capable.

Respondent offers full clinical trial support, which is beyond the scope of this requirement.

While respondent cites relevant expertise and experience, the proposed capabilities would fundamentally interrupt the work already underway under the other contracts supporting BGTC and involve complete duplication of the work already accomplished, estimated at

Respondent offers full clinical trial support, which is beyond the scope of this requirement.

While respondent cites relevant expertise and experience, the proposed capabilities would fundamentally interrupt the work already underway under the other contracts supporting BGTC and involve complete duplication of the work already accomplished, estimated at

Respondent does not cite any experience with clinical trial support, including electronic data capture (EDC), a fundamental concept in clinical trial data management.

Not capable.

Respondent does not cite any experience with clinical trial support, including electronic data capture (EDC), a fundamental concept in clinical trial data management.

Not capable.

Respondent does not cite any experience with clinical trials support, including electronic data capture (EDC), a fundamental concept in clinical trial data management.

Not capable.

A search of GSA identified the Alliant 2 vehicle as a potential source for acquiring the cloud platform services to support data collection, dissemination, analysis, integration, reporting, and management of the BGTC. However, this vehicle was not considered due to the fact its use would fundamentally interrupt the work already underway under the other contracts supporting BGTC and involve complete duplication of the work already accomplished, estimated at

5. Identification of the justification rationale [see 16.505(b)(2)] for exceptions to the fair opportunity process:

FAR 16.505(b)(2)(B), Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

6. Demonstration that the nature of this acquisition requires the use of this authority.

a. Name and address of the proposed contractor:

IQVIA Government Solutions Inc.

3110 Fairview Park Drive, Suite 400 Falls Church, VA 22041

b. Nature of the acquisition and unique qualifications of the contractor.

IQVIA is currently providing comprehensive program and project support for the entire BGTC CC under subcontract to the P3 contractor, Black Canyon Consulting. This support requires extensive, continuous coordination with all parties involved in the BGTC effort, including FNIH, ten NIH institutes and centers, the FDA, multiple pharmaceutical and life sciences companies, and nonprofit and other organizations.

The BGTC requires IQVIA, as an integral and non-severable function of its comprehensive program support for the BGTC CC, to develop an EDC/eCOA platform that will support the data requirements of BGTC. The BGTC has standardized on Medidata Rave, a widely used commercial platform for clinical trial data management, as the technical environment within which IQVIA will develop the EDC/eCOA. The Government has determined that to ensure privacy, security, and long-term sustainability of all data, the Government must provide this environment as a Government responsibility under any contracts or task orders for BGTC support.

The Government is ultimately responsible for security and sustainment of the EDC/eCOA platform, as the studies may require data management for 8-11 years or longer. Any system deployed is determined to be a government system, independent of the commercial nature of the service hosting the system, with the government as the official responsible party.

The Government shall provide direct technical guidance and coordination to the Contractor related to NCATS data environment standards, including security, standardization, and sustainment.

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

The contracting officer will evaluate proposed costs against previous contract prices available through FPDS and USASpending.gov and prices found for comparable services on pre-negotiated vehicles, including NITAAC CIO-CS and GSA Advantage.

8. Any other facts supporting the justification.

Duplication of cost and effort. The software platform requirement is one element of comprehensive program execution, with platform operations integrated with all aspects of development of early-stage gene therapy drug candidates (i.e. early-stage drug development, pre-clinical evaluation, and regulatory preparation in advance of initiating clinical trials). The BGTC engaged IQVIA, subcontracted through the NIH P3 contractor, for integral and non-severable subject-matter expertise in managing the entire drug development effort, including the clinical trials. IQVIA’s support includes development of the EDC/eCOA within the Medidata platform. However, the Government determined that it must be responsible for the sustainability and security of the platform itself.

Therefore, the Government will engage directly with IQVIA to provide the Medidata platform, and the BGTC will continue to work with IQVIA for data management within that platform.

The BGTC is a public-private partnership, with the Government, using appropriated funds provided by 10 NIH institutes and centers, providing program management, most pre-clinical operations, and study sponsorship, and the FNIH coordinating manufacturing and clinical operations among two dozen non-profit and private sector participants. As noted above, IQVIA’s services are integral to the BGTC, funded by the Government via the P3 and NITAAC contracts. Use of any other contractor to meet this requirement would require duplication of effort from the ground up, since implementation of the data management platform is fully intertwined with the execution of the bespoke gene therapy initiative itself.

The contractor would have to reinvent the entire program merely to develop the specifications for the EDC/eCOA.

Regulation. The platform must meet Federal privacy and security requirements applicable to clinical data, protected health information, and personally identifiable information. The Government is ultimately responsible for ensuring compliance.

Sustainability. Within the individual gene therapy trials, dosing may take place over three years with follow up for five years. The Government must maintain direct control of data to ensure long term security and sustainability of this effort.

Security. The Government maintains the appropriate security posture for its data environment.

No legal review has been conducted.

9. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

a. Removal of barriers to competition.

The Government will ensure that it maintains unlimited rights in data (to include all custom software code) first developed in the performance of this contract so that it can engage follow-on contractors as appropriate. All custom software code shall be deposited in a Government controlled repository (currently GitHub) and is subject to unlimited rights in the Government.

NCATS anticipates this will be a continuing requirement to support development of gene therapies. At the end of each contract period, NCATS will reassess contractor services and performance, support for BGTC, the EDC/eCOA landscape, and Federal regulations to determine whether to exercise the next option period, and whether the commercial landscape has evolved to provide viable competition for these services.

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

A Sources Sought Notice- Notice ID- 24-005328 was published in SAM on July 18, 2024, and closed on August 1, 2024, at 4:00 pm. Six vendors replied to the Sources Sought Notice with a capability statement. See the Market Research section of this document for the specific assessment of each capability statement received. The NCATS program office reviewed the responses, and determined that the only vendor that was capable of performance is IQVIA Government Solutions, Inc.

10. Program office certification.

CERTIFICATION: This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs or requirements, or other rationale for an exception to fair opportunity, are accurate and complete.

Official Name & Title Signature Date

Program Official

Program Officials’ Immediate Supervisor

11. Contracting Officer Certification and Approval Signature(s).

CERTIFICATION: This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Action Official Name & Title Signature Date

Review Contracting Officer & Section Head

Concur Branch Chief

Concur Director, NIDA Office of Acquisition

Concur Head of the Contracting Activity

Concur Competition Advocate