Attachment_7,_TO_0003_SOO_-_Foundational_Chemistry_and_Molecular_Sensing.pdf

STATEMENT OF OBJECTIVES

FOUNDATIONAL CHEMISTRY & MOLECULAR SENSING

TASK ORDER 0003

1.0 BACKGROUND

The variety and scope of occupations and potential duty locations within the military require trained operators with unique skill sets. However, improved knowledge of the factors contributing to the operating environments of specific career fields are required to develop tools to assess potential risk and protect the health and performance of those who serve. To put this in perspective, over 1,000 factors are measured related to the performance of next-generation high-performance aircraft during flight, yet no sensors are currently considered standard to measure the breathing air quality or the performance of the pilot. This work will focus on the human aspect of military operations to improve safety, training, and overall confidence in mission success.

2.0 OBJECTIVE

The objective is to research, develop, investigate and advance molecular signature discovery and mechanisms of action in a variety of media, further advance applications of sensing technologies for assessment and augmentation of human performance, as well as the impact of environmental, and air quality to human health and performance. Also, to address environmental monitoring for chemical and biological surrogates during aircraft decontamination. Finally, using the data collected during field and laboratory studies, understand molecular pathways and develop bioinformatics tools for statistical analysis and predictive modeling to understand or optimize human health and physiological performance.

3.0 SCOPE

To provide basic, applied and advanced technology development research, development and demonstration for understanding and/or sensing within the context of environmental air quality monitoring, biomarker discovery, and molecular mechanisms. The present research may include both laboratory and field research.

4.0 TASKS/TECHNICAL REQUIREMENTS

4.1 BIOMARKER DISCOVERY FOR PHYSIOLOGICAL STATE ASSESSMENT: Investigate and optimize sampling methods, perform sample collection, discovery, and identification of molecular compounds from biological and environmental samples. Establish baselines and develop methodologies to determine if the identified molecular compounds correspond to enhancements and/or degradations of physiological performance, indicate exposure, or predict training performance or susceptibility.

4.2 MOLECULAR MECHANISMS OF PERFORMANCE: Investigate and optimize approaches to understand the biochemical mechanism of potential biomarkers to determine whether they are endogenous/exogenous, and how regulation/manipulation of the markers or their influenced chemical pathway may potentially aid in enhancement of performance.

Understand the biochemical mechanisms generally contributing to human performance states to inform engineering approaches or build models to enhance physiological performance, indicate exposure, or predict training performance or susceptibility.

4.3 ENVIRONMENTAL AND AIR QUALITY ASSESSMENT: Investigate and optimize sampling and analytical methods, perform sample collection, discovery, and identification of molecular compounds, volatile organic compounds (VOCs), proteins/metabolites, or chemical contaminants. Comparison to standards and sample quantitation may be required depending on the needs of the study. This may include either baseline data gathering, or a comparative study design. In addition to investigate and optimize sampling & analysis methods, perform sample collection, discovery, and identification of molecular compounds, volatile organic compounds (VOCs), or chemical contaminants from aircraft and/or pilot breathing air.

4.4 DEVELOP NOVEL SENSOR TECHNOLOGIES: Research and develop novel sensing technologies for gases, VOCs, metabolites/proteins, and biological samples. In addition to, compare and validate sensor performance against current commercially available technologies using industry gold standard methods. Sensing technologies, and the supporting sensor software developed, should be able to either function as a stand-alone sensor or be easily integrated into a sensor package. May require the development of accompanying electronics, data logging/analysis, packaging, and graphical user interface for field demonstration.

4.5 TEST AND EVALUATION OF AFRL-DEVELOPED AND COMMERCIAL-OFF-THE-SHELF

(COTS) DEVICES: Perform test and evaluation of COTS devices and devices developed through AFRL partners that are designed for sampling and/or detection of chemical compounds from environmental samples or various biological matrices. Evaluate performance of the devices to detect a set of recognized standards for each sensing application. In addition to characterize the background and general chemical content (VOCs, proteins, metabolites, etc.) from various settings and determine the devices’ abilities to qualitatively identify target compounds, as compared to gold standard analytical methods. Known chemical standards can be characterized using device and gold standard methodologies to identify potential device deficiencies and to enable future study and remediation as needed. Devices may be compared to alternative portable technologies of similar gas chromatography – mass spectrometry (GC-MS) detection principles, or entirely different techniques (such as ion mobility spectrometry (IMS), etc.). Provide recommendations on the benefits and limitations related to the types of compounds each technology is suitable for under different conditions and relevant use-case scenarios. Evaluate the ability of the devices to quantify Chemical Warfare Agent (CWA) simulants during all phases of flight operations given the variety of environmental conditions that may affect their accuracy and precision.

4.6 OPERATIONAL FIELD SAMPLING: Develop a thorough understanding of the field sampling process and complications that can arise with field testing, and the proper procedures for collecting, transporting, storing, and analyzing samples. Strict adherence to quality control (QC) standards in the field will ensure the resulting data is of the highest quality and maximize confidence in any differential signatures found between sites/conditions. In consultation with the Air Force Monitor, a comprehensive sampling plan will be formulated. The goal of the plan is to formalize a set of steps that preserve the original physical form and chemical composition of the sample in a manner that facilitates all downstream analytical steps with sufficient QC measures incorporated to be legally defensible. The sampling devices will include, but not be limited to, SUMMA® canisters, Signature Science Less-P, sorbent tubes, badge style passive samplers and custom fabricated novel sampling devices.

4.7 BIOINFORMATICS TOOLS: Research and develop exploratory statistics toolkits with basic multivariate, univariate, as well as more complex statistics such as exploratory methods and confirmatory methods. The statistical analysis methods will allow the user to display and view the data in various forms highlighting the implicit relationships between data points. The use of statistical methods will reduce dimensionality and then identify patterns. The statistical analysis methods will provide information on differences between sample groups within study and across multiple relevant studies, and/or will indicate biomarkers or predictive markers of human physiological performance, exposure, or infection. The statistical analysis methods will also enable linking biomarkers/predictive markers with larger datasets including, but not limited to:

cognitive, physical performance/physiological monitoring, epidemiological, environmental, genetics, & in vitro/vivo models when additional data is available.

Provide assessment on which statistical methods were chosen, and the benefits/limitations compared to appropriate alternatives for each study. Evaluate different COTS software to analyze datasets, and determine mechanisms of action from statistically significant biomarker candidates using pathway analysis. Populate databases with record specific information, sample information, sensor and analytical chemistry information, mass spectral data, mass spectral peak data and coincident physiological responses. Research and develop a database with stored molecular signatures and an application programming interface (API) for user retrieval and experiment storage. The database will design a system to transfer and store experimental data collected from instrumentation for later retrieval. Develop tools to allow the User to sync data from multiple sources and rapidly visualize data to provide a first-pass analysis of data quality and experimental design without complex statistical analysis.

5.0 OTHER REQUIREMENTS

5.1 MANAGEMENT OF EFFORT: The contractor shall manage technical schedule and cost satisfaction of the task order; plan, prepare, conduct and document reviews; track CDRL satisfaction; and interface with the customer to assess performance satisfaction and re-plan the project as needed. Contractor shall comply with all applicable human use and animal use regulations.

5.2 CONTRACT HOLIDAYS: The prices/costs in Section B of the contract include holiday observances; accordingly, the Government shall not be billed for such holidays, except when services are required by the Government and are actually performed on a holiday.

The following days are contract holidays: New Year’s Day, Martin Luther King Jr. Day, Presidents Day, Memorial Day,4th of July, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

5.3 PROTECTION OF HUMAN SUBJECTS: The Contractor shall perform research using subjects in various laboratory experiments. The Contractor shall provide screening, scheduling, and training of subjects in order to accomplish this task order research, and will provide technical information required by the USAF IRB to approve the study design. The Contractor shall comply with the provisions of the following directives/regulations:

(i) Department of Defense (DoD), Title 32, Code of Federal Regulations, Part 219 (32 CFR 219), ”Protection of Human Subjects,” July 2004;

(ii) Department of Health and Human Services Regulations, 45 CFR 46, “Protection of Human Subjects,” 14 July 2009;

(iii) DoD Directive 3216.2, “Protection of Human Subjects and Adherence to Ethical Standards in DoD Supported Research,” 8 Nov 2011;

(iv) Air Force Instruction (AFI) 40-402, “Protection of Human Subjects and Adherence to Ethical Standards in Air Force Supported Research,” 10 Sep 2014.;” and

(v) AFRL Instruction 40-402 “Protection of Human Subjects in Research,” 9 Jul 2014.

Human testing shall not commence until approval from the Air Force Internal Review Board (IRB) has been obtained. If an exemption to the above is granted by the IRB, the provisions above are no longer applicable.

5.4 WORKING WITH HAZARDOUS MATERIALS: The Contractor shall adhere to all safety requirements regarding working with hazardous materials, including the Chemical Hygiene Plan and/or Material Information Sheets. The Contractor shall execute hazardous materials responsibilities in accordance with all applicable federal and military procurement policies and requirements, to include, but not limited to AFI 32-7086 “Hazardous Materials Management”, AFI 32-7086 WPAFB Supplement, and the Wright-Patterson AFB (WPAFB) Installation HAZMAT Management Program (IHMP) Plan. This documents will be provided by the Program Manager upon award.

5.5 OPERATIONS SECURITY: The Contractor shall provide Operations Security (OPSEC) protection for all sensitive/critical information as defined by AFI 10-701 (Operations Security), the 711 HPW OPSEC Plan, and critical information list. The Contractor shall participate in the 711 HPW sustained OPSEC awareness training or include OPSEC training as part of their ongoing security program. The 711 HPW OPSEC Coordinator shall evaluate the OPSEC posture of Air Force contract activities and operations.

5.6 INFORMATION SECURITY AND FORCE PROTECTION: The Contractor shall provide information security and force protection training as defined by AFI 16-1404 (Air Force Information Security Program) and AFI 10-245 (Antiterrorism (AT)). The Contractor shall participate in the 711 HPW sustained information security and force protection/antiterrorism training or include this training as part of their on-going security program. The 711 HPW Security Managers will evaluate the training posture of Air Force contract activities and operations. This requirement is set forth in AFI 16-1404, AFI 10-245 and applicable Air Force Materiel Command (AFMC) and local supplements.

5.7 USE OF LIVE ANIMALS SUBJECTS: The Contractor shall comply, as appropriate, with the provisions of the following directives/regulations: (i) Air Force Manual 40-401(I), "The Care and Use of Laboratory Animals in DoD Programs", (July 2006); (ii) DoD Directive 3216.1, "Use of Laboratory Animals in DoD Programs" (13 September 2010).

The use of live animals shall not commence until:

a. The Air Force Institutional Animal Care and Use Committee (IACUC) has approved the animal protocol.

b. The appropriate DoD/service veterinarian has reviewed and approved the animal protocol.

c. The appropriate DoD/service veterinarian has conducted, if necessary, a site visit to the Contractor's facilities.

5.8 SECURITY REQUIREMENTS: This effort is unclassified.

5.9 PERIOD OF PERFORMANCE: 39 months total; 36 months of technical effort and 3 months for final reporting.

5.10 DELIVERABLES:

5.10.1 CDRLs:

5.10.2 SOFTWARE: Software deliverables include specialized data software, modeling software, algorithms, and source code.

5.10.3 HARDWARE: Hardware deliverables include sensor prototypes, integrated system prototypes, and custom environmental chambers.