A02-JA_Clinical_Research_Trials_Services_4.29.2019Posted_to_FBO.pdf

Control No. JA-19-04-094

FOR OFFICIAL USE ONLY

Justification and Approval for Other Than Full and Open Competition

1. Contracting Activity: The contracting activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702 on behalf of the U.S. Army Research Institute of Environmental Medicine (USARIEM).

2. Description of Action: Approval is requested for a new sole source, Firm Fixed Price (FFP) contract for Louisiana State University (LSU)/Pennington Biomedical Research Center (PBRC) to conduct a Clinical Trial for “Testosterone Undecanoate for Optimizing Physical and Cognitive performance during military operations (OPSII)”. The contract will be incrementally funded with RDT&E funds from Fiscal Years (FY) 2019, 2020, and 2021. Estimated total dollar value including the base year and two option years is $3,932,128.24.

3. Description of Supplies/Services: The Government has a follow-on contract to Cooperative Agreements (W81XWH-14-1-0335 and W81XWH-17-2-0026) for a Clinical Trial to provide a comprehensive clinical study of the effects of supplemental testosterone during sustained military operational stress on gonadal status, body composition, skeletal muscle and whole-body protein anabolism, health biomarkers, and measures of muscle and cognitive function.

LSU/PBRC will assist with research design, screen and enroll study participants, and conduct the research, including the execution of all experimental testing and data collection and the provision of a technical report. The Contractor will be responsible for providing staff, inpatient and outpatient clinic services with licensed medical personnel. Additionally the clinical trial include a preparation of meals by the metabolic kitchen. The study will be staffed by medical doctors, physician's assistants, nurse practitioners, registered nurses, licensed practical nurses, exercise physiologists, registered dietitians, project managers, and study coordinators. The contractor shall submit the clinical study protocol to their local Institutional Review Board as well as U.S.

Army Medical Research and Materiel Command Human Research Protections Office.

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation (FAR) 6.302-1(a)(2)(iii)(B), services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in unacceptable delays in fulfilling the agency’s requirements.

5. Reason for Authority Cited: The LSU/PBRC is the only laboratory capable of meeting this requirement. The LSU/PBRC successfully executed the OPS 1 clinical trial for Optimizing Performance for Soldiers. The OPS I study was a US Army funded (W81XWH-14-1-0335 and W81XWH-17-2-0026) collaborative effort with the USARIEM Military Nutrition Division, that required the LSU/PBRC to develop standard operating procedures to reproduce highly controlled simulated military operational stress in a laboratory setting in order to mimic the complex stressors Warfighters are exposed to during training and combat in austere environments. This was a substantial, integrated, multi-disciplinary effort that allowed USARIEM to test the efficacy, safety, and mechanisms by which supplemental testosterone modulates muscle mass, metabolism, physical and cognitive function under simulated military operational stress. To execute a competitive contract and bring in a new contractor would result in unacceptable delays in fulfilling the USARIEM Military Nutrition Division’s requirement. Approximately one year would be required for a new contractor to demonstrate their ability to recreate the multi-layered simulated military-relevant operational stressors that are critical to degrade eugonadal status, accelerate muscle catabolism, diminish muscle function and performance, and impair cognition.

The LSU/PBRC required two years to execute the OPS 1 clinical trial and demonstrate that ability. Without previous demonstrated ability to quantitatively simulate the degradative effects of military operational stress in a controlled laboratory setting, the USARIEM Military Nutrition Division will not be able to reliably test the viability of supplemental testosterone as a safe and effective Warfighter performance enhancing strategy. A delay in the continuation of the next phase of this research would result in failure of the USARIEM Military Nutrition Division to meet the U.S. Army Medical Research and Materiel Comment Military Operational Medicine Research Program’s FY21 Milestone to identify one effective androgen replacement therapy that enhances Warfighter physical and cognitive performance during simulated, multi-stressor military operations by FY21.

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted on Federal Business Opportunities (FBO) from 24 January 2019 – 7 February 2019. Potential sources were given the opportunity to provide capability statements. Two vendors submitted capability statements, the LSU/PBRC and Research Centers of America (RCA). The Government’s subject matter expert conducted a review and their response to the RFI is below:

Evaluation of the LSU/PBRC’s Capability statement – Acceptable

The LSU/PBRC has provided sufficient information to demonstrate their ability to a provide Clinical Research Trial for a comprehensive clinical study of the effects of supplemental testosterone during sustained military operational stress to include the effects of testosterone on gonadal status, body composition, skeletal muscle and whole-body protein balance, health biomarkers, and measures of muscle and cognitive function. The response from the LSU/PBRC addresses how all of the specific tasks in the RFI will be performed and how it will be monitored. The facilities and equipment match or exceed the requirements of the RFI.

Evaluation of RCA’s Capability statement – Unacceptable

The RCA provided insufficient information to demonstrate their ability to provide a Clinical Research Trial for a comprehensive clinical study of the effects of supplemental testosterone during sustained military operational stress to include the effects of testosterone on gonadal status, body composition, skeletal muscle and whole-body protein balance, health biomarkers, and measures of muscle and cognitive function. The response from RCA addresses how most of the specific tasks in the RFI would be performed in minor detail and how it will be monitored and the personnel responsible. The facilities and equipment described appear adequate to conduct the study. However, at no point, does their response specifically demonstrate their ability to recreate the multi-layered simulated military-relevant operational stressors that are critical to degrade eugonadal status, accelerate muscle catabolism, diminish muscle function and performance, and impair cognition. Without the demonstrated ability to quantitatively simulate the degradative effects of military operational stress in a controlled laboratory setting, the USARIEM Military Nutrition Division will not be able to reliably test the viability of supplemental testosterone as a safe and effective Warfighter performance enhancing strategy.

Further consideration of their response comes at a substantial duplication of costs and risk of lost scientific validity of that cannot be recouped by the Government. The USARIEM recently completed a collaborative study to develop standardized methodologies to simulate extreme military stress in a controlled laboratory setting in order to test pharmacological performance enhancement. The findings derived from that study serve as the foundational basis for the follow-up study for the services requested in the RFI. Based on this capability gap, the RCA is not capable in providing Clinical Trial Services for a comprehensive, militarily-relevant clinical study.

Although this notice was an effort to ensure market research was conducted from as many potential sources as practicable, there was no expectation that effective competition would be the result.

a. Effective competition. No effective competition is anticipated for this requirement. No other vendors are capable of performing the requirement.

b. Subcontracting competition. There are no subcontracting possibilities with this requirement.

7. Actions to Increase Competition: Competition of the requirement is not possible due to the established research and the capability to do direct comparisons of prior findings using the same methodology with current required upcoming studies. Using alternative performers would hamper comparisons of scientific results across studies potentially leading to erroneous conclusions, and would incur unnecessary costs to repeat previously completed experiments.

8. Market Research: The USARIEM conducted market research activities from 1 October 2018 to 30 December 2018 using: SAM, FedBizOpps, and GSAAdvantage.gov – searching for clinical research trial services which resulted in no viable source aligning to this requirement. As such, it was determined that only the LSU/PBRC has the capabilities to support the requirement.

Through an RFI, Notice of Intent (NOI), internet searches, literature review and discussion with colleagues. No other Clinical Research Trial Services vendor was identified to have the capabilities to support this requirement.

9. Interested Sources: A Notice of Intent to Sole Source to LSU/PBRC was posted on FBO on 6 March 2019 for 45 days. As a result of the intent, no responses were received.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements: W81XWH-14-1-0335 and W81XWH-17-2-0026

(2) Competitive status of these actions: Competitively reviewed and awarded in response to the W81XWH-BAA-11-1 and W81XWH-16 Military Operational Medicine Research Program Broad Agency Announcements (BAA).

(3) Authority previously used for less than full and open competition: Not Applicable

(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: Not Applicable

(5) If any prior award was accomplished by full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources:

During the OPS I study, the LSU/PBRC and USARIEM discovered that a relative high dose of testosterone, administered weekly by intramuscular injection during a 28-d exercise- and diet-induced simulated military operational stress, safely enhanced nutritional status, muscle mass and type 1 muscle fiber cross-sectional area, but did not alter lower-body muscle function deterioration. These data provide the foundation for OPS II, which will leverage the militarily-relevant clinical trial capabilities so clearly demonstrated by the LSU/PBRC in OPS 1, to further refine our scientific design in order to assess a more field expedient, clinically standardized dose of testosterone, administered only once before exposure (e.g., pre-deployment) to a more demanding, multi-stressor (high energy flux, limited dietary intake, sleep deprivation, and psychological stress), simulated military operation on military-specific metrics of physical and cognitive function. OPS II is expected to deliver evidence-based guidance for supplemental testosterone use for performance enhancement in Warfighters by FY21. Guidance will be transitioned to the United States Special Operations Command (USSOCOM), including the Army, Naval, Marine Corps Forces, Air Force, and Joint Special Operations Commands.

(6) An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive, urgent buys: Not Applicable

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes: Not Applicable

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