A03-JA_18-99_19C0028_Redacted.pdf

Control Number JA-18-99

FOR OFFICIAL USE ONLY

Justification Review Document for Other Than Full and Open Competition

Program/Equipment: Technical and Administrative Support to the NMC Clinical Trial Study in Cebu, Philippines at the Armed Forces Research Institute of Medical Sciences (AFRIMS)

Authority: FAR 6.302-1 Only One Responsible Source

Amount:

Prepared by:

Typed Name: DSN: N/A

Title: Date:

E-Mail:

Contracting Officer:

Typed Name: DSN:

E-Mail: Date Reviewed

Requirements Representative:

Typed Name: DSN: N/A

Title: Date:

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

COR

Typed Name: DSN: N/A

Signature Date:

Legal Counsel

Typed Nam DSN:

Signature: Date:

Control Number JA-18-99

Justification and Approval for Other Than Full and Open Competition

1. Contracting Activity: The Contracting Activity responsible for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, Maryland on behalf of the Walter Reed Army Institute of Research (WRAIR), Armed Forces Research Institute of Medical Sciences(AFRIMS).

2. Description of Action: Approval is requested for a sole source, firm-fixed price contract for a period of performance of one (1) 12-month base and four (4) 12-month options to BioPath Clinical Diagnostics, Inc. (hereby referred to as BioPath). Fiscal year 2018, two-year Research, Development, Test and Evaluation funds will be used for this requirement.

3. Description of Supplies/Services: This is a follow-on contract for the continuation of support for an ongoing clinical trial study (Immunological Correlates of Clinical Outcomes in a Tetravalent Dengue Vaccine Cohort, an Ancillary Study to the CYD14 Dengue Vaccine Trial, also known as the National Institute of Health, Military Infectious Diseases Research Program, Cohort Study or the “NMC Study”). Specifically, the Contractor is responsible for providing technical and administrative support necessary for the maintenance of the established clinical study site(s) and execution of clinical study-related activities for the conduct the NMC Study to take place within (or near) Cebu, Philippines. The Contractor is responsible for hiring, maintaining and managinga qualified and experienced Principal Investigator(s) and study support personnel at adequate levels, procurement of clinical research support services, supplies and equipment, laboratory testing, transportation and communications services, and quality control for all activities related to the preparation and execution of the NMC Study. The costs for these services for a base and four one-year options is Incremental funding has been provided in the amount of erformance will be 19 May 2018 through 18 May 2023.

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 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: This proposed action is for a follow-on contract for the continued technical and administrative support of an ongoing clinical trial. BioPath Clinical Diagnostics, Inc. (herein referred to as BioPath) has been provisioned to provide these services under contract W81XWH-12-C-0104. BioPath is a diverse company that specializes in providing clinical laboratory and diagnostic services.

While the services provided by BioPath may not be unique, the services thatBioPath

Control Number JA-18-99 provides, in tandem with their ability and experience to provide oversight and management of advanced stage clinical vaccine trials, providing experienced staff, providing physical locations ideally suited for execution of studies within the space of the same building as the AFRIMS laboratory, and the their possession of required laboratory permits to allow work to be executed on the premises, is exceptionally unique. In addition, the Government would be substantially harmed in terms of sunk cost and a significant schedule delay in the performance of this clinical trial. Failure to award this follow-on, sole-source contract to BioPath would compromise the integrity of the study and cause a loss to the Government that has already been disbursed through the previous two contracts that could not be recovered through competition. BioPath has already provided the principle investigator, staff and several subordinate investigators to this study for many years. If these key study staff were removed and needed to be replaced, this study would need to undergo four Institutional Review Board reviews with respect to regulatory approval which would suspend the study for several months. This is not acceptable as this continued, ongoing study requires intense follow-up with the subjects for fever and potential cases of dengue, who received a vaccine product previously against the dengue virus. Should there be a prolonged break in follow-up with these subjects, which would be unavoidable if attempting to work around not having BioPath as the Vendor, the complete reason for the study would be completely lost and the sunk costs into the work thus far would be rendered largely a waste. At the very least, there would be no scientific reason to resume the study after several months of lost follow-up. Furthermore, the principal investigator on an advanced clinical trial such as this signs a Statement of Investigator Form 1572 with the Food and Drug Administration which obligates them to the protection of subjects throughout the course of the study (this Form is required for clinical trials involving investigational drugs and biologics and is required to be completed before the principal investigator may participate in the study). The regulatory bodies have already approved the study to move forward and continue and if the Vendor were to change midstream, the study would be suspended which violates AFRIMS obligation to the ethical committees, of which there are four, to do the work that they have promised to do. In order to conduct this study, AFRIMS and BioPath required regulatory approval from the ethical bodies of WRAIR, The Research Institute of Tropical Medicine (the research arm of the Department of Health in the Philippines) and two local ethical bodies of Chong Hua Hospital and Vicente Sotto Memorial Medical Center. Each of these ethical committees are approved and licensed by a governing body assigned by the Department of Health in the Philippines, except for the WRAIR IRB that is part of the US Army. Furthermore, BioPath possesses a laboratory permit at the study site which allows them and AFRIMS/Philippines- AFRIMS Virology Research Unit (PAVRU) to conduct laboratory work at this particular site and also allows them to dispose of medical waste. Granting this contract to a different Vendor would again, cause a significant delay in executing the study which would, in turn, break AFRIM’s regulatory and contractual obligations with the ethical bodies and the study sponsor and render the study useless if not able to continuously follow-up with the subjects as described above.

Control Number JA-18-99

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted to Federal Business Opportunities (FBO) on 16 March 2018 to announce the Government’s requirement for these services. An amendment to the RFI was posted on 19 March 2018 adding the original attachment providing further description of the requirement. Responses to the announcement were due on 27 March 2018 by 1000 hours Eastern Standard Time. Two Vendors submitted capabilities statements, BioPath Clinical Diagnostics, Inc. and Protac Fitness. ative (COR) reviewed both capabilities statements

a. Effective Competition. No effective competition is anticipated.

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

7. Actions to Increase Competition: Actions to increase competition is not possible since the proposed Vendor, BioPath is the only one capable of meeting the requirement. Any other source would delay and disrupt the continuation of the clinical trial.

8. Market Research: The AFRIMS Project Manager conducted an internet search, assessed potential vendors located in and around Cebu, Philippines and relied upon the experience of local study staff in consultation with clinicians and scientists with local collaborators. No other Vendors were identified to have the capabilities to support this requirement as needed without creating an unacceptable and unnecessary delay with the ongoing study.

9. Interested Sources: In accordance with FAR 5.201, a notice was published on 29 March 2018 on FBO announcing the Government’s intent to award a sole source contract to BioPath Clinical Diagnostics, Inc. on a non-competitive basis for 15 calendar days. At the closing of the synopsis on 13 April 2018, no other potential sources were obtained.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements.

Control Number JA-18-99

W81XWH-10-C-0216: 5/30/2010 –12/16/2011

W81XWH-12-C-0104: 1/16/2012 –5/18/2017

(2) Competitive status of these actions.

Both of the previous contracts were completed on a sole-sourcebasis.

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

W81XWH-10-C-0216: FAR6.302-1(a)(2)(i) W81XWH-12-C-0104: FAR 6.302-1(a)(2)(iii)(A) and(B)

(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.

In the most recent previously-referenced contract, Justification and Approval (J&A) 12-009 was approved as other than full and open competition with the justification stating that the Government wouldbe substantially harmed in terms of sunk cost and a significant schedule delay in the performance of clinical trials; therefore, full and open competition was not possible.

(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.

Not applicable

(6) An explanation of any unusual patterns that may be revealed by thehistory, e.g., several consecutive, urgentbuys.

Not applicable

(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.

In the previous J&A 12-009, the United States Army Medical Materiel Development Activity Project Manager and the Integrated Product Team stated they would continue to monitor for possible sources to perform Clinical Studies specific to Outside the Continental United States areas.

They stated that should sources be identified, they would be extended the opportunity to compete for subsequent acquisitions of this kind. Since then, no other possible sources have been identified as transitioning this study to a different vendor would compromise the integrity of the study as

Control Number JA-18-99 outlined in paragraph five above. The AFRIMS continues to be responsible for conducting dengue surveillance activities and is responsible for the oversight of the NMC Study in Cebu, Philippines.

There have been no significant changes to the study or to the support provided by BioPath.

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

Not applicable

Control Number JA-18-99

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Typed Name: Date:

Title:

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Typed Name: Date:

Title: ignatu

13. Fair and Reasonable CostDetermination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for determination: In accordance with FAR 15.404-1(b)(2)(v), the Government will use the Independent Government Cost Estimate in combination with FAR 15.404- 1(b)(2)(ii) comparisons of proposed prices to historical prices paid, in order to determine the proposed cost/price is fair and reasonable. Certified cost and pricing data is not required as this is determined to be a commercial item and meets the exception at FAR 15.403-1(b)(3).

Typed Name: Date:

TTitiltele: : r Sign e:

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

TTitiltel : Sign e:

Control Number JA-18-99

15. Legal SufficiencyReview:

Based on the information provided in this document, I hereby determine this justification for other than full and open competition to be legally sufficient.

Title: Signature:

Control Number JA-18-99

Approval Special Advocate for Competition

Based on the foregoing justification, I hereby approve the procurement of a contract to provide Technical and Administrative support the AFRIMS on the CYD14 Dengue Vaccine Trial (NMC Study) on an other than full and open competition basis pursuant to the authority of 10 U.S.C.2304(c) and FAR 6.302-1(a)(2)(iii)(B) only one responsible source, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Name:

Title: Special Advocate for Competition

Date: Signature: