JA_W81XWH20C0122_Redacted_Final.pdf

Control No: JA-20-06-0354

Contractor: Westat, Inc.

Program/Equipment: Navy Medical Research

Version – September 2018 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: Naval Medical Research Center (NMRC) seeks to procure services of an Investigational New Drug (IND) sponsor for the performance of Good Clinical Practice (GCP) compliant clinical trials leading to a new indication for Valproic Acid (VPA) for the treatment of patients with significant hemorrhage.

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: $13.2M

Prepared by: Jeanette Wolfe DSN: 343-7140

Contract Specialist Email: jeanette.m.wolfe.civ@mail.mil

Date: 16 JUL 20

Contracting Officer: Wayne Medina Contracting Officer Email: wayne.a.medina.civ@mail.mil

DSN: 343-9204

Date: 20 JUL 20

Technical: Thomas Dunn Acting Program Manager, NMRC Email: thomas.a.dunn.civ@mail.mil

DSN: 285-6458

Date: 16 JUL 20

Requirements: Thomas Dunn Acting Program Manager, NMRC Email: thomas.a.dunn.civ@mail.mil

DSN: 285-6458

Date: 16 JUL 20 mailto:jeanette.m.wolfe.civ@mail.mil mailto:wayne.a.medina.civ@mail.mil mailto:thomas.a.dunn.civ@mail.mil mailto:thomas.a.dunn.civ@mail.mil

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

Program Manager:

Typed Name: Mr. Thomas Dunn

DSN: 285-6458

Signature:

Legal Counsel:

Typed Name: Dmitri G. Goubarkov

DSN: 343-0283

Chief, Services Group Name: Cheryl R. MILES.CHERYL.R.

DSN: 343-7148

Date: 2020.07.27 18:38:12 -04'00'

FAR Part 6 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), Fort Detrick, MD, in support of the Naval Medical Research Center (NMRC).

2. Description of Action: The government intends to establish a research and development (R&D) cost-type contract with Westat, Inc., 1600 Research Blvd, Rockville, MD 20850, for the research and development to procure services of an Investigational New Drug (IND) sponsor for the performance of Good Clinical Practice (GCP) compliant clinical trials leading to a new indication for Valproic Acid (VPA) for the treatment of patients with significant hemorrhage. The Government projects award for September 2020 and fiscal year 2020, Defense Health Agency (DHA) funds will be used.

This proposed new contract is a follow-on to contract W81XWH15C0128 and includes execution of GCP compliant clinical trials which were not competed under the previous contract since the U.S Food and Drug Administration (FDA) recommended additional safety studies that needed to be conducted prior to the clinical trials. The pre-clinical studies are anticipated to be completed before the new contract is awarded.

3. Description of Supplies/Services: NMRC seeks to contract with an entity to manage the planning and execution of a placebo controlled randomized multicenter phase 2 clinical trial in a variety of patients possibly using an adaptive design for the clinical studies. The study will require subjects with high risk of significant hemorrhage using VPA as an adjunct to resuscitation to obtain indication approval from the FDA. The Contractor will be the regulatory sponsor for the product development effort including everything until New Drug Application (NDA) filing with the FDA. Accordingly the Contractor bears the legal responsibilities of sponsor under 21 Code of Federal Regulations (CFR) 312 Subpart D and retains control over the product development effort. As the sponsor, the contractor’s regulatory monitor will conduct site visits of the selected clinical trial sites to ensure GCP compliance.

Period of Performance: September 2020 to September 2023 Value: $13,163,104

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304 (c)(1) as implemented by FAR Part 6.302-1, only one responsible source and no other services will satisfy agency requirements.

5. Reason for Authority Cited: As described at FAR 6.302-1(a)(2), “when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for.” As required, the government issued a sources sought announcement and a notice of intent on beta.sam.gov with few responses and with no viable sources to award a contract. The paragraph below provides additional information related to the interested sources (see paragraph titled “9. Interested Sources”). It is noted that hemorrhage is the leading cause of preventable death on the battlefield and currently, forward medical support cannot consistently provide blood products at Role of Care (ROC) 2 and ROC 1 due to logistics constraints. Therefore, prolonged field care remains the #1 gap in the military.

VPA for the treatment of hemorrhagic shock at point of injury has the ability to reduce morbidity, and mortalityby up to 25% overall in battlefield deaths thus extending the “Golden Hour” and saving warfighter lives. Development of a VPAproduct is an extremely high priorityfor the DoD since it is the most viable candidate with potential manufacturer identified and communicating. The manufacturer of VPA, Fresenius Kabi, is not interested in pursuing a new indication to satisfy the DoD requirement and has agreed for Westat to obtain generic VPA via its suppliers to pursue studies related to this indication.

Westat, Inc. is the Sponsor for the IND application (IND #142565) filed with the FDA for this VPA product. Under a preceding DoD Award #: W81XWH15C0128 from September 2015 to September 2020, Westat established a VPA development program, completed the requisite pre-clinical studies to support an IND and conducted a pre-IND meeting with the FDA. They have also undertaken the additional pre-clinical studies requested by the FDA at the pre-IND meeting and completion is anticipated by August 2020. During this same period, Westat conducted extensive exercises with DoD and academic experts to design and develop clinical protocols that are most suitable to address the DoD requirements. These along with results from the completing pre-clinical studies will be included in their IND submission to the FDA in August 2020. Conduct of the proposed clinical study is on the critical path leading to FDA approval and since Westat is the IND holder for VPA, contracting with them for this clinical trial is the most viable option for potential mitigation of this #1 capability gap for the military.

Thus far, the IND enabling work completed by Westat has cost the government approximately$10M. If another contractor is selected it would need to establish a full new program including establishing agreements with a VPA provider and subcontractors for pre-clinical testing. They would then have to repeat the pre-clinical studies and filings with the FDA for pre-IND and subsequent IND. It is estimated that repeating this work would cost the government another $10M and lead to a significant delay in FDA approval and fielding of VPA, thereby prolonging the#1 capability gap.

(b) Alternatives available to the government were considered. Specifically, the alternatives included Arginine-Vasopressin (AVP), 17αethynylestradial-3-sulfate (EE-3- SO4), and Adenosine Lidocaine Magnesium (ALM), but three alternatives were not acceptable.AVP showed that low-doseAVP during the resuscitation of trauma patients in hemorrhagic shock decreased blood product requirements but did not increase survival time. A pharmaceutical company,American Reagent, Inc., received tentative approval (NDA 212593) from FDA for the use ofvasopressin injection to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; however, FDA approval is contingent upon resulting patent infringement investigations. Another alternative product is 17aethynylestradial-3-sulfate (EE-3-SO4), but it still in the early stages with no manufacturer identified. Finally, recent studies of Adenosine Lidocaine Magnesium (ALM) have failed to replicate any promising results and past funders have discontinued investment inALM.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered. To obtain as many potential sources as is practicable, a sources sought announcement was posted to the government point of entry on 12 May 2020 and made available with a response date of 26 May 2020. Additionally, a notice of intent to sole source was posted to the government point of entry on 28 May 2020 with a response date of 12 June 2020.

a. Effective Competition: Effective competition is not feasible at this time.

b. Subcontracting Competition: Subcontracting competition will be achieved by requiring the contractor to agree in the contract that small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns will have the maximum practicable opportunity to participate in contract performance consistent with its efficient performance. If applicable, a subcontracting plan will be required in accordance with FAR 19.704.

7. Actions to Increase Competition: No additional efforts are anticipated to increase competition. Any subsequent acquisition would also post a sources sought announcement or request for information, as applicable.

8. Market Research: In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a sources sought was posted to beta.sam.gov on 12 May 2020 for 15 days. As a result of the sources sought announcement, one response/capability statement was received from LBR Regulatory & Clinical Consulting Services, Inc. The statement was sent to NMRC for review and it was determined that the company was not capable of providing the necessary research and development; there was noevidence of experience as a regulatory sponsor. Moreover, LBR Regulatory & Clinical Consulting Services, Inc. had no association with VPA in terms ofscientific background, business arrangement with manufacturer, orregulatory sponsorship. IfLBR Regulatory & Clinical Consulting Services, Inc. were selected, the company would need to serve as a regulatory sponsor and establish a full new program including establishing agreements with a VPA provider for pre-clinical testing, repeating the pre-clinical studies and filings with the FDA for the pre-IND and subsequent IND (duplicative research creating delays and additional costs).

In addition, a notice of intent to sole sources the requirement was posted to beta.sam.gov on 28 May 2020 for 16 days. As a result of the posting, one interested source (Zen Pharmatech, LLC) provided a response/capability statement before the response date. The statement was sent to NMRC for review and it was determined that the company was not capable of providing the necessary research and development. It appeared as though the company’sskills were more suited to manufacturing aspects of product development than regulatory sponsorship and conducting clinical trial. Moreover, Zen Pharmatech, LLC has no association with VPA in terms of scientific background, business arrangement with manufacturer, or regulatory sponsorship. Therefore, if the company were willing to serve as a regulatory sponsor and establish a new program, including establishing agreements with a VPA provider for pre-clinical testing, it would require a repeat of the pre-clinical studies and filing with the FDA for the pre-IND and subsequent IND. The repetition of this work would create duplicative research, delays, and additional costs.

It is noted that an Analysis of Alternatives (AoA) was submitted to the Combat Casualty Care Research Program in Oct 2014 (Booz Allen and Hamilton) for the Management of Hemorrhagic Shock Products – Damage Control Resuscitation. VPA was one of 3 top scoring alternatives, along withAVPand 17αethynylestradial-3- sulfate (EE-3-SO4).AVP and VPA both scored highest, respectively, in Measures of Effectiveness (MOEs) in performance, safety, development status, logistics, and usability compared to other cardiovascular modulators and cell protectives, and also compared to blood component replacements, colloids, and crystalloids. Subsequently, NMRC commissioned a Market Analysis from Air Force Medical Evaluation Support Activity (AFMESA) to reflect the state of the science and technology as it pertains to Stabilizing Adjunct for Resuscitation and Trauma (StART) products. The Market Research Report (MRR) was accepted and published in Dec 2018. Further, market researchers identified a number of government-funded studies on Adenosine Lidocaine Magnesium (ALM), EE- 3-SO4, and VPA.

Additional initiatives on alternative products were also identified, including four Small Business Innovation Research (SBIR) programs. The findings revealed that studies of the candidate products are still on-going and need to be monitored for resuscitation adjunct viability. Regarding manufacturing, the current researchers were unable to find partner manufacturers for AVP, ALM and EE-3-SO4, which was anticipated at the early stages of the research (TRL 4/5).

In February 2020, NMRC conducted additional follow-up on the above mentioned candidates to determine progress since the last market research in 2018. This revealed that there are still no other viable partners for the development of VPA other than

Westat. Published results of a phase 2 clinical study of alternative candidate AVP showed that low-dose AVP during the resuscitation of trauma patients in hemorrhagic shock decreased blood product requirements but did not increase survival time. A pharmaceutical company American Reagent, Inc. received tentative approval (NDA 212593) from FDA for the useof vasopressin injection to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. However, FDA approval is contingent upon resolving patent infringement investigations. Another candidate EE-3-SO4 remains in the pre-clinical stage with no identified transition partner. ALMstudies have also not replicated any promising results and past funders have discontinued investment in it.

Additional market research related to internet and government wide database information resulted in no viable sources.

9. Interested Sources: Information submitted by LBR Regulatory & Clinical Consulting Services, Inc. (LBR) in response to the sources sought announcement has been reviewed by the requiring activity who have advised that LBR does not appear to meet the requirements. In the information provided by LBR, there was no evidence of experience as a regulatory sponsor. Moreover, LBR had no association with VPA in terms of scientific background, business arrangement with manufacturer, or regulatory sponsorship. If LBR were selected, the company would need to service as a regulatory sponsor and establish a full new program including establishing agreements with a VPA provider for pre-clinical testing, repeating the pre-clinical studies and filings with the FDA for the pre-IND and subsequent IND (duplicative research creating delays and additional costs).

Additionally, information submitted by Zen Pharmatech, LLC in response to the notice of intent has been reviewed by the requiring activity who have advised the company was not capable of providing the necessary research and development. It appeared as though the company’s skills were more suited to manufacturing aspects of product development than regulatory sponsorship and conducting clinical trial. Moreover, Zen Pharmatech, LLC has no association with VPA in terms of scientific background, business arrangement with manufacturer, or regulatory sponsorship. Therefore, if the company were willing to serve as a regulatory sponsor and establish a new program, including establishing agreements with a VPA provider for pre-clinical testing, it would require a repeat of the pre-clinical studies and filing with the FDA for the pre-IND and subsequent IND. The repetition of this work would create duplicative research, delays, and additional costs.

10. Other Facts:

a. Procurement History:

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

Contract W81XWH15C0128, awarded to Westat, Inc., expires September 2020.

(2) The competitive status of these actions.

Full and open competition.

(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.

The proposed new contract is a follow-on to contract W81XWH15C0128 and includes execution of a GCP compliant clinical trial which was not completed under the previous contract since the U.S Food and Drug Administration (FDA) recommended additional safety studies that needed to be conducted prior to the clinical trials.

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: Thomas Dunn Date: 20 JUL 20

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:Thomas Dunn Date: 20 JUL 20 Title: Acting Program Manger Signature:

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. Cost analysis will be completed to determine the fair and reasonable cost determination.

Pricing will be compared to the independent government estimate (IGE). Certified cost or pricing data will be required in accordance with FAR 15.403.

This determination will be made using the following: ☒ cost analysis ☐ price analysis

☐ should cost ☒ IGCE ☐ audit: ☐ other:

As a part of this basis, certified cost or pricing data:

☒ will be required.

☐ will not be required and the following exception applies (FAR 15.403):

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☐ A commercial item is being acquired.

☐ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☐ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Typed Name:Wayne A. Medina Date:

Title: Contracting Officer Signature:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name:Wayne A. Medina Date:

Title: Contracting Officer Signature: MEDINA.WAYN

Approval

Based on the foregoing justification, I hereby approve the procurement of VPA research and development for the estimated amount of $13.2M on an other than full and open competition basis pursuant to the authority of 10 U.S.C.2304(c)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.

ERIN K. CROSS Date:

Command Advocate for Competition Signature: