PERFORMANCE_WORK_STATEMENT_update12282016.docx

PERFORMANCE WORK STATEMENT (PWS)

1. INTRODUCTION

Since 1969, the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) has served as the Department of Defense's (DoD) lead laboratory for medical biological defense research. While its core mission is to protect the warfighter from biological threats, USAMRIID also investigates disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions—therapeutics, vaccines, diagnostics, and information—that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command at Fort Detrick, located in Frederick, MD.

2. BACKGROUND.

The Virology division is developing the non-human primate (NHP) model to evaluate potential therapeutic and vaccines against encephalitic alphaviruses eastern equine encephalitis virus (EEEV), western equine encephalitis virus (WEEV), and Venezuelan equine encephalitis viruses (VEEV). In humans, the initial encephalitic alphavirus infection diagnosis can be aided by the utilization of brain imaging via MRI and CT scans and monitoring of brain electrical activity via EEG. Additionally, the combination of MRI, CT, and EEG has been utilized to follow brain pathology and abnormal activity associated with alphavirus induced encephalitis (4-16). However, the published data is limited, and the available imaging data is exclusively from EEEV infections (4-12). MRI and CT imaging of EEEV infection have shown the presence of cerebral edema, intracranial hypertension, as well as lesions in the thalamus, basal ganglia, and brain stem. In contrast to MRI and CT scans, an EEG enables continuous monitoring of the brain’s electrical activity and has been used to monitor EEEV, WEEV, and VEEV infections (8-15). The EEG data show a general decreased and/or altered electrical activity, particularly the alpha and delta wave patterns, indicative of seizures and encephalopathy (8-15). These findings have not been investigated in the NHP models. In addition, the telemetry technology has advanced to the point that additional physiological parameters, such as an EEG, can be investigated using new implants and analysis tools. By incorporating implants that can measure an EEG, respiratory rate, activity, along with body temperature and heart rate into the cynomolgus macaque model, a more comprehensive picture of the disease process can be discerned and compared to human cases.

3. PURPOSE AND OBJECTIVE OF THE PROCUREMENT

The objective of these studies is to further define animal models of encephalitic alphavirus disease by investigating alterations of brain electrical activity via electroencephalography (EEG) in non-human primates (NHPs) following infection. This will be the first investigation into the alteration of EEG activity in NHPs infected with encephalitic alphaviruses. The purpose of this procurement is to obtain expert EEG analysis following the conclusion of the studies. These data will provide critical insights into kinetics and dynamics of alphavirus-induced encephalitis in NHP modeling. These studies are the initial steps necessary for preclinical evaluation that will lead to advanced development efforts.

To accomplish this work within scope of this requirement, the contractor shall have access to USAMRIID telemetry data files from NHPs studies including but not limited to raw physiological and video data. Due to the sensitive nature of the data, all copies of this data must be safely stored in a secured (locked) container when not in used and subject to inventory procedures. Video analysis will need to be done at USAMRIID. The contractor shall not copy the data nor disclose any information from this library to outside parties. The contractor shall not use this information for any purpose other than the performance of this contract. USAMRIID will retain all proprietary rights and privileges to all Government-furnished information. Once the final report is completed on a set of data, all copies will be returned to USAMRIID.

4. CONTRACTOR REQUIREMENTS

Phase 1: Data Analysis of Electroencephalography

Objective: The contractor shall analyze the electroencephalogram (EEG) signals for one (1) group of four (4) animals with approximately 15 days (5 days pre-infection through 10 days post infection) of EEG and video data recording.

· Task 1: Analysis will include quantitative EEG analysis with 3D graphical representation, and characterization of EEG morphologies, circadian cycles, paroxysmal and ictal activity.

· Task 2: Interpret EEG signals using the NeuroScore software, or equivalent.

· Task 3: Video will be used as a complement for interpretation of EEG and this analysis will need to be done at USAMRIID.

· Task 4: Evaluation of EEG by a Board Certified Veterinary Neurologist (American College of Veterinary Internal Medicine Neurology) or equivalent is important. An established, documented track record of video-EEG analysis, especially with seizure detection and characterization is a plus.

Quantity: One (1) group (of 4 animals)

Compliance: non-GLP

Timeframe: 4 months

Deliverable: Presentation of preliminary interpretation within 4 weeks. Draft Phase Report within 12 weeks after reception of the video-EEG data. Final Phase Report within 4 weeks after reception of the comments from USAMRIID on the Draft Phase Report.

Phase 2 (optional): Data Analysis of Electroencephalography

Objective: The contractor shall analyze the electroencephalogram (EEG) signals for two (2) additional groups of four (4) animals with approximately 15 days (5 days pre-infection through 10 days post infection) of EEG and video data recording.

· Task 1: Analysis will include quantitative EEG analysis with 3D graphical representation, and characterization of EEG morphologies, circadian cycles, paroxysmal and ictal activity.

· Task 2: Interpret EEG signals using the NeuroScore software, or equivalent.

· Task 3: Video will be used as a complement for interpretation of EEG and this analysis will need to be done at USAMRIID.

· Task 4: Evaluation of EEG by a Board Certified Veterinary Neurologist (American College of Veterinary Internal Medicine Neurology) or equivalent is important. An established, documented track record of video-EEG analysis, especially with seizure detection and characterization is a plus.

Quantity: Up to two (2) groups (of 4 animals)

Timeframe: 4 months per group

Compliance: non-GLP

Deliverable: Presentation of preliminary interpretation within 4 weeks. Draft Phase Report within 12 weeks after reception of the video-EEG data (Neuroscore compatible). Final Phase Report within 4 weeks after reception of the comments from USAMRIID on the Draft Phase Report.

Phase 3 (optional): Data Analysis of Electroencephalography

Objective: In the event that animals survive challenge past 10 days, the contractor shall analyze the electroencephalogram (EEG) signals for the additional days (up to 50 days) of EEG and video data recording.

· Task 1: Analysis will include quantitative EEG analysis with 3D graphical representation, and characterization of EEG morphologies, circadian cycles, paroxysmal and ictal activity.

· Task 2: Interpret EEG signals using the NeuroScore software, or equivalent.

· Task 3: Video will be used as a complement for interpretation of EEG and this analysis will need to be done at USAMRIID.

· Task 4: Evaluation of EEG by a Board Certified Veterinary Neurologist (American College of Veterinary Internal Medicine Neurology) or equivalent is important. An established, documented track record of video-EEG analysis, especially with seizure detection and characterization is a plus.

Quantity: Up to fifty (50) additional days

Deliverable: Add preliminary/final interpretations with Draft and Final Phase Reports.

5. DELIVERABLES

1. The Contractor shall submit monthly technical progress reports in accordance with REPORTING REQUIREMENTS (OCT 2009) (USAMRAA).

2. The Contractor shall provide all electronic and hard copy data and material(s) to the COR on an annual basis no later than fifteen (15) calendar days from the end date of the period of performance

3. The COR is required to submit to the Contract Specialist and Contracting Officer a monthly report concerning performance of services rendered under this contract. See Paragraph 8: Quality Assurance Surveillance Plan for details

4. The Contractor shall report contract‐related information in accordance with the Contractor Manpower Reporting (CMR) clause by 31 October of each year to the CMR website at: https://cmra.army.mil

6. GOVERNMENT-FURNISHED PROPERTY

The Government shall ship, at no cost to the Contractor, all required data (with the exception of video data) for analysis in order to facilitate the performance of this contract. The Government shall provide the Contractor with access to the video data on site at USAMRIID.

7. SECURITY AND SAFEGUARD METHODS

1. The contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The contractor shall ensure the confidentiality, integrity, and availability of Government data is in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFARS Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management.

2. The Contractor must provide analyzed data within the established timeframe.

8. QUALITY ASSURANCE SURVEILLANCE PLAN

The QASP is a tool used by the Government (i.e. COR) as a way to assess contractor performance. The following performance based service acquisition items will be monitored under this QASP and shall be uploaded to the Virtual Contractor Enterprise (VCE) at https://cor.army.mil on a monthly basis by the COR:

See attachment 2 – Quality Assurance Surveillance Plan

9. TRAVEL

Travel to USAMRIID (Fort Detrick) in Frederick, MD will be required for video review, which must take place at USAMRIID. All Contractor personnel must be a U.S. citizen or provide documentation of clearance to enter USAMRIID (i.e. Passport and/or VISA information, citizenship, etc.).

10. PERIOD OF PERFORMANCE

The anticipated period of performance (PoP) is:

Phase One: 16 Jan 2017 -15 Jan 2018 Phase Two (Option Qty): 16 Jan 2018 – 15 Jan 2019 Phase Three (Option Qty): 16 Jan 2018 - 15 Jan 2019 Disposal or Shipping: 16 Jan 2017 – 15 Jan 2019

Because the Contractor’s Period of Performance is dependent on receiving EEG and video data from USAMRIID, this timeframe may slip due to circumstances out of the Contractor’s control.

11. ANTITERRORISM/ OPERATIONS SECURITY REQUIREMENT – None required based on the approved Contact Requirements Package Antiterrorism/ Operations Security Review Sheet.

REFERENCES

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7. Hirsch MS, et al. N Engl J Med, 359(3):294-303.

8. Lury KM, et al. Emerg Radiol, 11(1):46-8.

9. Deresiewicz RL, et al. N Engl J Med, 336(26):1867-74.

10. Badar Z, et al. Ped Inf Dis, 6:66-71.

11. Wendell L, et al. Neuro Care, 19:111-115.

12. Morse RP, et al. Ped Neuro, 8:473-475.

13. Silverman MA, et al. EID, 19:194-201.

14. Anderson BA, et al. Can Med Assoc J, 131:186-188.

15. Delfraro A, et al. EID, 17:952-954.

16. Ehrenkranz NJ, et al. Annu Rev Med, 25:9-14.