Tab_A15_JA_Univ__of_Miami_FBO.docx

J&A Number: 15-10008

JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity.

This Justification and Approval (J&A) is executed by the Naval Medical Logistics Command (NMLC), 693 Neiman Street, Fort Detrick, MD, on behalf of the requesting agency, Naval Medical Research Center, 503 Robert Grant Avenue, Silver Spring, MD 20910-7500.

2. Description of the Action Being Approved.

Award of a contract on a sole source basis will be made to extend the existing capability of physicians to treat patients with life threatening traumatic brain injury (TBI) and possibly increase the threshold for the safe cerebral perfusion pressure. The proposed source is Kenneth G. Proctor, University of Miami Miller School of Medicine; Daughtry Department of Surgery; 1800 NW 10th Ave Ryder Trauma Center Miami, FL 33136.

3. Description of Supplies/Services.

The Advanced Medical Development Program has a critical need to manage the cerebral perfusion pressure in patients with traumatic brain injury through administration of arginine vasopressin. This proposed requirement needs to be sole sourced to the University of Miami, because they conducted the prior clinical study at a major trauma hospital and have the data to support advancement of this research effort into clinical practice. Biochemical data generated from protein analysis of blood samples were collected on nearly 100 subjects. Clinical results and statistical analyses were conducted by the University of Miami to support an application for the clinical trial to the Food and Drug Administration (FDA). These results show that low dose vasopressin infusion maintains elevated serum vasopressin levels and decreases fluid administration following injury. This study suggests an early survival advantage with the use of vasopressin after severe trauma.

The University of Miami is the only entity to have conducted the prior, Office of Naval Research funded effort, which will be leveraged to pursue a new Food and Drug Administration indication that will support the treatment of Marines and Sailors wounded in the field.

The follow-on effort will involve an initial two-year clinical trial for the administration of vasopressin to a greater number of patients suffering severe traumatic brain injuries and the data to support submission of a package to the FDA. Data will be submitted to the FDA according to the Code of Federal Regulations (CFR) Title 21 201.56, for revising the labeled indication for an already approved drug (arginine vasopressin) to include traumatic brain injury patients with refractory intracranial hypertension.

The third year will result in the revision of traumatic brain injury clinical guidelines through an evidence-based proposal that will be submitted to the Brain Trauma Foundation for the purpose of revising the current in-hospital practice for hyperosmolar therapy, intracranial pressure thresholds, and/or cerebral perfusion pressure (CPP) thresholds based on the comprehensive evidence reviewed for the FDA.

4. Statutory Authority Permitting Other Than Full and Open Competition.

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.

5. Rationale Justifying Use of Cited Statutory Authority.

This “Management of Cerebral Perfusion Pressure in Patients with Traumatic Brain Injury Using Arginine Vasopressin” clinical study is a follow on effort to a previous study, performed by the University of Miami and funded by the Office of Naval Research (ONR). Patients with traumatic brain injury (TBI) and intracranial pressure monitors were eligible for the study; of those, patients were consented and randomized. All TBI patients requiring intracranial pressure (ICP) monitoring at the University of Miami level 1 trauma center were consented and randomized to receive either catecholamines (CA) or arginine vasopressin (AVP) if vasopressors were required to maintain an acceptable level of cerebral perfusion pressure. Results suggested that arginine vasopressin is a safe and effective alternative to catecholamines for the management of Cerebral Perfusion Pressure (CPP) after TBI and support the continued investigation and use of AVP when vasopressors are required for CPP management in TBI patients.

Specifically, the preliminary data from a randomized controlled trial in patients with TBI and polytrauma suggest that AVP is a safe and effective alternative to catecholamines in normotensive patients with refractory intracranial hypertension. This is an off-label use in an especially vulnerable patient population. The Principal Investigator intends to review large prospective and retrospective clinical experience on the safety and efficacy with AVP in polytrauma patients, in accordance with new FDA requirements, and submit detailed information to revise the current labeled indication for AVP. This will potentially extend the existing capability to treat patients with life threatening TBI, and possibly increase the CPP threshold.

To award to another contractor would require the rewriting and re-approval of all IRB review/determination documents. This adds additional costs to the study and delays the start of the study.

Cost: By leveraging the prospective data already collected by the University of Miami, the United States Navy reduces its costs in multiple ways. First, for another group to replicate the work required would necessitate the creation of a new study. Second, the University of Miami has already assembled an extensive team of trained scientists and technical staff to undergo the clinical study, and has developed the protocol, human use approval, enrollment criteria, and clinical study research team that would take extensive funding to recreate by another group.

Feasibility: Due to the University of Miami already conducted an earlier, smaller scale trial, the leadership and staff require no training time, very little hiring time and already have the critical contacts for recruitment and assessment to complete the project. The feasibility of another group being able to complete this project from implementation, assessment, analysis and reporting in the time given (3 years) is extremely unlikely.

Data collection and management experience: In conducting the initial clinical trial, the University of Miami has already learned how to overcome the challenges in collecting quality data from large numbers of subjects, managing enrollment criteria, and working with the multiple regulatory agencies overseeing human subject rights and proper handling of sensitive information, and hiring, training, and managing the technical and clinical staff required to implement the study.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

A sources sought notice was synopsized on the Federal Business Opportunities (FEDBIZOPS) website on 09 December 2014 and only the University of Miami expressed an interest in this requirement. No additional market research was conducted because it is not practicable for the reasons discussed in paragraph 5 above, for any company other than the University of Miami to provide the required supplies and services. Additionally, upon approval of this J&A, a notice of intent to award to the University of Miami will also be issued on the FEDBIZOPS website for a period of no less than 15 days. At that time, companies will also be given the opportunity to provide capability statements. All capability statements received by the due date of this notice will be considered by the Government.

7. Determination of Fair and Reasonable Cost.

The contracting officer will perform a price analysis in order to determine that the anticipated price of the product procured by the Government under this J&A will be fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contacts for the type of product covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.

9. Contracting Point Of Contact.

The point of contact at NMLC is Mr. Ronnie Sanford, Code 05, 301-619-9330 or by e-mail at Ronald.sanford@med.navy.mil.