A02 JA FAR Part 6 AI (AI-ML) Design PTSD 7-11-22_Redacted.pdf

CUI//SP-SSEL

Control Number: JA-22-04-1147

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

MAR 2022

Continuity of Research:

The Surgeon’s General of Army, Navy and Air Force instructed the Systems Biology Consortium to determine an objective signature of PTSD which could be used as a diagnostic tool; primarily focused on military PTSD. As a result, a Cooperative Research and Development Agreement (CRADA) titled “PTSD Systems Biology Consortium” was created in 2009.

The Consortium is a collaboration of 7 institutes in the pursuit of identifying key biomarkers linked to the diagnosis of PTSD in members of the military who have been exposed to traumatic events through combat and combat related events. Harvard participation in the Consortium began in 2015 to aid in moving the project to advanced development through a mathematical model that it developed to support the mission.

Harvard has been supporting the consortium PTSD research efforts using this mathematical model since 2016 through Cooperative Agreements (CA) awarded by the U.S. Army Contracting Command (ACC) Aberdeen Proving Ground under W911NF-16-2-0015 and W911NF-17-2- 0086.

The effort under this follow-on requirement will be executed under a Contract vehicle as the research has advanced through the medical product development lifecycle, and as such, does not fit the criteria of a CA.

Harvard is the only member of the Consortium that is capable of continuing the efforts that it established through previous CA’s totaling Awarding to any other source is not in the best interest of the Government as it would require duplication of effort in an attempt to capture all of the institutional knowledge specific to the mathematical modeling developed by Harvard.

Data derived from the efforts under the Consortium is retained under a common site and deposited by members of the Consortium and periodically used to meet the collective effort.

Harvard, as a Consortium member, has the ability to access, analyze, and deposit the large and complicated datasets as needed. Sources outside of the Consortium do not have access to the datasets.

For scientific and programmatic integrity of the ongoing research, project analysis of this new cohort needs to be analyzed using the similar system and settings as completed before.

Unique Capability:

Harvard has a unique capability as it initiated the AI/ML Design PTSD Objective Indicators study for the Consortium. More specifically, Harvard has constructed a mathematical model for the cortisol dynamics in the hypothalamic-pituitary-adrenal (HPA axis) that supports the hypothesis that high stress intensity and strong negative feedback loop may cause hypersensitive neuro-endocrine axis that results in hypocortisolemia in PTSD. Additionally, it has modeled the effect of acute and chronic stress on the dynamics of the Heat Shock protein 90 (HSP90) network and extended this to the human model to make predictions about the occurrence of depression, CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

PTSD and the comorbidity. The team postulated that depending on the stress intensity and the concentrations of HSP90 and Heat shock factors monomeric or oligomeric proteins, PTSD and its cormorbidities can be distinguished.

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted on SAM.GOV on 31 March 2022 to obtain competition. Responses to the announcement were reviewed by the Government and determined this requirement cannot be competed due to the nature of the existing CRADA and the unique capability required to perform the study as noted section 5 of this document. A notice required by FAR 5.201 has been published on SAM.GOV.

a. Effective competition. Effective competition cannot be met as this research effort is limited to Harvard who constructed a mathematical model specific for AI/ML Design PTSD Objective Indicators study. A notice of intent was posted for 45 days and resulted in no responses to the requirement.

b. Subcontracting competition. Subcontracting is not possible for this applied extramural

R&D contract.

7. Actions to Increase Competition: Action to increase competition of the requirement is not possible as Harvard is a Consortium member that developed the mathematical model specific to the AI/ML Design PTSD Objective Indicators study.

Competing this effort would require Contractors to be accepted into the Consortium through a CRADA amendment to obtain access to the datasets, gain knowledge and lead the effort of AI/ML Design PTSD Objective Indicators study designed by Harvard.

8. Market Research: Market Research was conducting by the requiring activity and documented on 22 February 2022 and included a search for contractors to perform data analysis to assist on designing an objective screening tool to identify early comorbidities associated with ASR and PTSD. Market research revealed that Harvard is the only source capable of providing the necessary data analysis requirements taking to consideration of the Consortium and the unique capability provided by Harvard. Harvard initiated the AI/ML Design PTSD Objective Indicators study using its self-developed mathematical model through CA’s and utilizing datasets through the Consortium and is the only source that can continue the research efforts.

9. Interested Sources: An RFI was posted on SAM.GOV on 31 March 2022. Responses to the announcement were due 8 April 2022. Six capability responses were received: Soar Technology, Vista Defense Technologies, LLC, 640-Acres, Cogitativo Inc, RTI International, and Hewlett Packard Enterprise. The Government reviewed the capability statements of each and determined that all were unacceptable as none of the Contractors are members of the Consortium, do not have access to the datasets to keep integrity of the research, and do not have the knowledge of the mathematical model developed by Harvard to continue the AI/ML Design PTSD Objective Indicators study.

10. Other Facts:

a. Procurement history.

(1) The following CA’s were executed by ACC – Aberdeen Proving Ground. These CA”s are not identical to the new requirement as efforts are dependent on the samples received.

• W911NF-16-2-0015 / 15 December 2015 -14 December 2016

• W911NF-17-2-0086 / 04 May 2017- 4 May 2022 (extension was executed until

4 November 2022 to complete the study of the existing samples)

(2) The competitive status of these actions.

CA's were awarded by ACC – Aberdeen Proving Ground using PTSD Systems Biology

Consortium Agreement as basis and were initially competed through the Military

Operational Medicine Research Program (MOMRP) and evaluated by a private organization, American Institute of Biological Sciences (AIBS), used by Medical

Research Development Command (MRDC).

(3) Authority previously cited if less than full and open competition was used.

N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

N/A

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated.

N/A

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

Approval

Based on the foregoing justification, I hereby approve the procurement of Artificial Intelligence/ Machine Learning (AI/ML) Design PTSD Objective Indicators on an other than full and open competition basis pursuant to the authority of 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(i)(A), Demonstrates a unique and innovative concept or demonstrates a unique capability of the source to provide the particular research services proposed, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

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