readyone industries, el paso, tx
TRANSCRIPT
ReadyOne Industries,El Paso, TX
2 Apr - Jun 2009
Chem-Bio Defense Quarterly
U.S. Air Force Capt. Robert Wilson scans the area for threats during a proficiency exercise on Joint Base Balad, Iraq, April 10, 2009. Wilson is a combat rescue officer assigned to the 64th Expeditionary Rescue Squadron. U.S. Air Force photo by Staff Sgt. James L. Harper Jr.
On the cover: Arcy Noriega instructs Carmen Acosta, a new hire participating in the Phase One Training Program at ReadyOne Industries, El Paso, TX. ReadyOne Industries is a proud member of the Ability One Program with a mission to provide employment opportunities for people who are blind or have other severe disabilities.
Back cover: Brig. Gen. Scarbrough receives and passes the JPEO-CBD flag signifying the assumption of responsibilities of the Joint Program Executive Officer for Chemical and Biological Defense.
Back cover photo lower: Lt. Gen. N. Ross Thompson III, presents Maj. Gen. Stephen Reeves his retirement flag at the Change of Charter and Retirement Ceremony.
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CONTENTS 5 The Chemical Biological Medical Systems: Countering Current
and Emerging CBRN Threats
10 Time-Temperature Indicators, Increasing Warfighter Confidence, Decreasing Medical Logistics Load
14 Data Model Compliance: What it is and How to Achieve it
16 JSLIST: Saving Lives from Iraq to Afghanistan to El Paso
22 The “Human Immune System in a Test Tube”
26 An Introduction to Sensor Data Fusion
30 The Reason For Our Success Is Our People
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Col. Kyle BurkeUSA
Col. Mark MalatestaUSA
Mr. Will HartzellUSMC
Mr. Scott WhiteUSN
Col. David WilliamsUSA
Mr. Rudolf OlszykUSMC
Mr. Michael AbaieUSN
Col. Alan BurketUSAF
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Chem-Bio Defense Quarterly
The Chemical Biological Medical Systems Joint Project Management Office (CBMS) leads the Department of Defense (DoD) in the advanced development of
transformational Chemical, Biological, Radiological, and Nuclear (CBRN) medical countermeasures (MC) for the Warfighter. This edition of the Chem-Bio Defense Quarterly provides an overview of several key areas of interest within CBMS that reflect our proactive approach to mission accomplishment. Chartered in 2003, CBMS has achieved an unprecedented seven FDA CBRN MC approvals, licensures, and clearances; completed 13 Investigational New Drug (IND) submissions to the FDA, including the first two electronic IND submissions by any DoD organization; and completed 12 drug and safety trials. Building upon this impressive record, three additional INDs will be submitted within the next 23 months. For current and emerging threats, CBMS focuses on four thrust themes:• Partnering: Proactive inter-agency, intra-agency, industry, and
international / allied country partnering with a focus on unity of purpose and effort
• Regulatory compliance: Ensuring full compliance with the corollary DoD Defense Acquisition System and FDA regulatory guidance
• Life cycle management: Use of government and commercial best business practices for program life cycle management
• Planning for the future: Through the management of evolutionary acquisition increments, ensuring the deliv-ery of military useful and supportable capability enhancements
As an illustrative example of one of these key themes, strategic partnering, CBMS participates on the Inte-grated National Biodefense Medical Countermeasure Portfolio Initiative. This initiative provides a structured organization and process that coordinates the U.S. Government’s efforts with respect to biodefense MC devel-opment and procurement for the nation. Core Working Group members driving this cooperative inter-agency effort include the Biomedical Advanced Research and Development Authority (BARDA), the National Institute of Allergy and Infectious Diseases (NIAID), the DoD Chemical and Biological Defense Program (CBDP), the DoD Defense Threat Reduction Agency (DTRA) and the Joint Program Executive Office for Chemical and Bio-logical Defense (JPEO-CBD). CBMS serves as the seated JPEO-CBD representative. Our expertise with both the DoD Defense Acquisition System and FDA advanced development regulatory process, e.g. the “Animal Rule,” makes us uniquely qualified to assist in the Initiative’s risk assessment and cost and schedule modeling. In addition to the Core Working Group, there are also a variety of Integrated Product Development teams that review the portfolios for each countermeasure and make portfolio recommendations. These recommendations are provided to advisory committees that make final decisions on portfolio composition, with the intent of mini-mizing duplication of effort across agencies and exploiting its members’ technological breakthroughs. Chemical Biological Medical Systems (CBMS) has greater than 1,170 person years of experience related to the advanced development of CBRN MC, spanning functional areas and core competencies, such as Acquisi-tion/Program Management, Biological Sciences, Regulatory Affairs/Quality Assurance, Contracting/Legal, Lifecycle Logistics, Operations, and Finance. This team of dedicated professionals is further enhanced through its diverse and cross-functional experiences as the team is comprised of active duty military, DoD civilians, and DoD contractors, many of whom bring direct commercial experience to the team. In many cases the profes-sionals on staff are subject matter experts in their respective career fields, possessing an invaluable wealth of directly relevant technical knowledge. In this regard, the sum of the CBMS whole provides for a robust, experi-enced and technically creative workforce. Additionally, CBMS has been able to structure itself so that all supporting functional areas are collocated. Of particular note, CBMS enjoys full-time, on-site dedicated support from a team of contracting professionals from the U.S. Army Space and Missile Defense Command and legal support from the U.S. Army Medical Research and Materiel Command. Chemical Biological Medical Systems has achieved unprecedented success and continues to overcome the evolving challenges of pharmaceutical advanced development through the fully integrated and parallel execu-tion of the Defense Acquisition System and the FDA regulatory process. Our extensive organizational experi-ence in this unique niche and our mission focus on CBRN MC places CBMS at the forefront of protecting the Warfighter and nation. In the CBMS articles that follow, you will learn more about the innovative products and technologies JPMO-CBMS has in advanced development to meet the Warfighter’s needs. From the use of Time Temperature Indicators that will be placed on individual product units to help confirm product safety and effectiveness to the development of an “immune system in a test tube” that will reduce the time it takes to identify vaccine candi-dates, JPMO-CBMS is on the cutting edge of technology. Our skilled professionals proactively work to develop the best CBRN MC possible in our efforts to combat current and emerging threats. Please visit the JPEO-CBD website for further details regarding the innovative work underway at CBMS and to view a multimedia presentation of our organization in action.
Brig. Gen. Jess A. Scarbrough Joint Program Executive Officer
Mr. Douglas Bryce Deputy Joint Program Executive Officer
Mr. Scott Paris Chief of Staff
Col. Jonathan Newmark Deputy JPEO-CBD for Medical Affairs
Ms. Brenda Besore Director, Knowledge Management
Ms. Karan Williams Director, Resource Management
Mr. Gary Olejniczak Director, Current Acquisition
Ms. Camille Schumacher Director, Future Acquisition
Mr. Darrell McCarthy Director, Human Resources
Ms. Patricia Estep Webmaster
Editor, Chem-Bio Defense Magazine
Mr. Julius L. Evans [email protected]
Contractor Support Provided by Kalman & Co., Inc. and Camber Corporation
Mr. Stephen Gude Assistant Editor
Mr. Steven Lusher Senior Graphic Designer
Ms. Tonya Maust Graphic Designer
Ms. Ashlee Burns Graphic Designer
Ms. Jacqueline Grosser Distribution
Chem-Bio Defense Quarterly magazine is published quarterly by the Joint Program Executive
Office for Chemical and Biological Defense. Articles reflect the views of the authors and do
not necessarily represent the views of Chem-Bio Defense Quarterly, the Department of the Army or
the Department of Defense.
To contact the editorial office:
Call: (703) 681-0701 DSN: 761-9600
Fax: (703) 681-3439 Email: [email protected]
Articles should be submitted to:
Chem-Bio Defense Quarterly 5203 Leesburg Pike
Skyline 2, Suite 1609 Falls Church, VA 22041
www.jpeocbd.osd.mil
Guest Columnist: Col. Dave Williams Joint Program Executive Office
Col. Dave WilliamsJoint Project Manager
Chem Bio Medical Systems
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The Joint Project Management Office (JPMO) Chemical Biological Medical Systems (CBMS) rapidly provides the Warfighter with safe, robust, and affordable medical
countermeasures (MC) against a broad spectrum of Chemical, Biological, Radiological, and Nuclear (CBRN) threats. Char-
tered in April, 2003, CBMS remains a critical component in the Department of Defense’s (DoD) comprehensive national
strategy to counter the threat of CBRN weapons of mass destruction. Led by Joint Project Manager (JPM) Col. David
Williams, CBMS is composed of two subordinate organizations: the Joint Vaccine Acquisition Program
(CBMS-JVAP) and the Medical Identification and Treatment Systems (CBMS-MITS) Product
Management Offices. Together, these product offices deliver CBRN MC spanning the
continuum of medical care from prevention and diagnosis to treatment.
The advanced development of CBRN vaccines and drugs starts with the identi-
fication of Warfighter requirements and capability gaps identified through the use
of the needs-driven Joint Capabilities Integration and Development System
(JCIDS). Based on the capabil-ity gaps identified by JCIDS,
the Joint Requirements Office (JRO) documents these require-
ments. CBMS then marshals its resources to develop and
license CBRN MC to meet
Organization and Mission these requirements. In so doing, CBMS complies with Food and Drug Administration (FDA) regulations (21 Code of Federal Regulation) regarding product development and testing to ensure the safety and effectiveness of CBRN MC for the Warfighter. A critical and unique component of the CBMS mission is, therefore, the integration of the DoD Defense Acquisition System, detailed in Department of Defense Instruction (DoDI) 5000.02, with man-dated FDA regulatory processes.
CBMS is comprised of two subordinate organizations: The Joint Vaccine Acquisition Program (JVAP) and the Medical Identification and Treatment Systems (MITS). CBMS meets Warfighter needs through the development of FDA-approved CBRN MC.
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The FDA serves as the developmental and operational test and evaluation authority for the development of CBRN MC. The flexibility inherent in the DoDI 5000.02 makes it possible for CBMS to tailor its processes to meet both DoD and FDA requirements. CBMS collaborated with the Department of Health and Human Services (HHS) to standardize the separate Technology Readiness Levels (TRL) formerly used by both organizations. This synchronization of TRL helped establish a unified measurement of technology maturity within the medi-cal community. CBMS focuses on improving current industry standard development times for the advanced development portion of the acquisition process. This development timeframe is largely due to complex and phased animal and human testing associated with medical product development and the chal-lenges unique to the development and manufacturing of vaccines and drugs. Despite these challenges, CBMS exceeds industry standard metrics by exploring ways to shorten our development schedules and total life cycle costs while continuing to provide
the finest medical capabilities to the Warfighter as cost effec-tively as possible. In its short six year history, CBMS has emerged as the world leader in innovative CBRN MC advanced development. In particular, CBMS has achieved seven FDA approvals, com-pleted 13 submissions for Investigational New Drugs (IND), and developed two enabling technologies. Key to these accom-plishments are partnerships with other U.S. agencies and allied governments, compliance with DoD and FDA guidelines, use of both commercial and government best practices, and situational awareness of technology when planning for current and emerg-ing threats. Additionally, CBMS has been able to structure itself so that all supporting functional areas are collocated. CBMS enjoys full-time, on-site support from a team of contracting pro-fessionals from the U.S. Army Space and Missile Defense Com-mand and legal support from the U.S. Army Medical Research and Materiel Command.
The flexibility of the DoD acquisition process as described in the DoDI5000.02 makes it possible for CBMS to tailor its processes to meet both DoD and FDA requirements while partnering with other agencies and governments for CBRN MC advanced devel-opment. CBMS led the collaboration with HHS in standardizing the TRL now used by both organization.
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The CBMS product office chartered to develop, acquire, and stockpile FDA-licensed vaccine products is responsible for the Joint Vaccine Acquisition Program (CBMS-JVAP). Lieutenant Col. Philip Smith serves as the Joint Product Manager and leads the CBMS-JVAP team efforts. The CBMS-JVAP mission is the advanced development of vaccines to protect DoD personnel from the effects of Biological Warfare Agents (BWA). In addition to acquiring FDA-licensed vaccines, CBMS-JVAP is engaged in the development of second-generation anthrax vaccine, tularemia vaccine, Venezu-elan Equine Encephalitis vaccine, plague vaccine, and botulinum vaccine. CBMS-JVAP, in fulfilling defense needs of our Warf-ighters and the nation, meets or exceeds the quality standards established in current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Clinical Practices
(GCP) and FDA requirements for safety and efficacy. Vaccines fill a vital need in the full spectrum of Warfighter CBRN MC protection. Vaccines help to maintain combat force effectiveness by preventing illness and death resulting from exposure to biological agents. Once a Warfighter is vaccinated, this “biological body armor” can protect him/her for periods ranging from 18 months to decades. Without vaccines, the abil-ity to sustain combat power would rely solely on physical pro-tection, detection of exposure to agents, a long medical logistics tail, and treatment of exposed people/worried well. All of these degrade the fighting force and add significant burden to theater medical resources. Use of commercial and DoD best practices to minimize life cycle costs is a vital factor in the CBMS-JVAP equation for vac-cine development success. Leveraging these practices acceler-ates schedules and minimizes risk. Additionally, CBMS-JVAP partners with other U.S. agencies and allied governments in product development. Our agreements with the Department of Health and Human Services (HHS) Strategic National Stock-pile for the procurement of Anthrax Vaccine Adsorbed and the
The Joint Vaccine Acquisition Program (CBMS-JVAP)
CBMS has accomplished seven FDA approvals, completed 13 IND Submissions, and developed two enabling technologies in its six year history.
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Smallpox vaccine save the federal government more than $60M annually. Agreements with the National Institute of Allergy and Infectious Diseases (NIAID) allow CBMS-JVAP access to technical expertise in animal model and assay development resulting in decreased program cost, schedule, and risk. CBMS drives to increase product quality, decrease cost, and accelerate program schedule by aggressively transitioning technologies from Defense Advanced Research Projects Agency (DARPA) to reduce the time a vaccine remains in clinical trials. The CBMS-JVAP’s impressive portfolio of products fielded to the Warfighter include the Anthrax Vaccine Adsorbed (AVA;Biothrax ®), the Smallpox vaccine (ACAM2000®), and the Vaccinia Immune Globulin, a treatment for rare adverse reactions to the smallpox vaccine. The CBMS-JVAP advanced development portfolio includes a plague vaccine, a botulinum toxin vaccine, and a filovirus vaccine. CBMS continues to aggressively explore opportunities to partner with allied coun-tries for all CBRN vaccine advanced development efforts.
The DoD requires the capability to provide lifesaving MC against CBRN threats through drugs, biological products, and diagnostic system capabilities. In response, the Medical Identi-fication and Treatment Systems (CBMS-MITS) was charted to develop, stockpile, and field systems of FDA approved drugs and devices to protect Warfighters and the nation from CBRN threats. In so doing, three individual programs were unified under CBMS in 2003 to form CBMS-MITS:
• The Medical Chemical Defense Advanced Development Program, which was formerly managed by the U.S. Army
Medical Materiel Development Activity (USAMMDA) of the U.S. Army Medical Research and Materiel Command (USAMRMC)• The Joint Biological Agent Identification and Diagnostics Systems Program, formerly managed by the Joint Program Office for Biological Defense (JPOBD)• The Critical Reagents Program, also formerly managed by the JPOBD The CBMS-MITS faces a herculean challenge in rapidly providing the Warfighter and the nation with robust, affordable, FDA-approved, life-saving CBRN MC drug and diagnostic system capabilities. Lt. Col. Brian Gentile, CBMS-MITS Joint Product Manager, spearheads the CBMS-MITS team in the advanced development and acquisition management of FDA approved products. The CBMS-MITS serves as the lifecycle product manager for a number of FDA-approved fielded CBRN MC products to include:
• Convulsant Antidote for Nerve Agents (CANA) for the treatment of nerve agent-induced seizures• Antidote Treatment Nerve Agent Autoinjector (ATNAA) containing atropine and 2-PAM for the rapid treatment of nerve agent poisoning • Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP) to enhance the effects of other nerve agent antidotes
The CBMS-MITS system-of-systems approach to CBRN MC development requires both pre and post-exposure treatments. For example, the pretreatment drug SNAPP is only effective when given prior to nerve agent exposure while other fielded chemical agent countermeasures require administration immedi-ately after nerve agent exposure. Advanced development efforts include bioscavenger, which fulfills an urgent capability gap in the Warfighter’s defense against current nerve agents, non-traditional agents (NTA’s), and emerging threats by serving as a prophylactic that inhibits the toxicity of nerve agents in the blood. Other advanced devel-opment efforts include the Advanced Anticonvulsant System (AAS), the Improved Nerve Agent Treatment System (INATS), Dry Powder Inhaler Atropine (DPIA), and Medical Radiation (MEDRAD) countermeasures. The AAS, a developmental effort conducted in partnership with HHS, is anticipated to replace the currently fielded CANA. The INATS, which will protect against a broad spectrum of nerve agents, is anticipated to replace the ATNAA. The INATS project will expand label indica-tions for SNAPP beyond Soman to include additional nerve agents, NTA’s, and emerging threats. CBMS-MITS coordinates with members of an international working group, the Medical Countermeasures Coordinating Team (MCCT), on the INATS developmental effort for the purposes of interoperability, burden sharing, decrease in schedule, and risk reduction. Through the use of the CBMS Broad Agency Announcement, the DPIA effort advances the state of the art by assisting industry’s advance development efforts directed toward a dry powder atropine inhaler for the treatment of nerve agent exposure. The Medical Radiation (MEDRAD) advanced development effort, less than 2 years in existence, is relatively new. There are
CBMS partners with other U.S. agencies, academia industry, and allied governments in the advanced development of CBRN MC. Examples of our partners include membership on the international Medical Countermeasures Coordinating Work-ing Group (some members pictured above) and the U.S. Army Institute of Chemical Defense.
The Medical Identification and Treatment Systems (CBMS-MITS)
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no current FDA-approved products to treat the acute radiation syndrome resulting from radiological or nuclear events. CBMS-MITS bases its system of systems approach on three pillars: pre-vention, diagnosis, and treatment. In close collaboration with other federal agencies, CBMS-MITS is developing MEDRAD countermeasures through integration of complementary tech-nologies which act by minimizing radiation injury and promot-ing tissue repair in order to fill the MEDRAD capability gap. CBMS-MITS is well poised to overcome the obstacles of tech-nology integration and cost in the development of MEDRAD countermeasures.
The CBMS-MITS also manages DoD’s Critical Reagents Program (CRP) whose mission is to develop, validate, and field critically needed specialty biodefense reagents and assays. These activities and products support biological environmental detection and biological human diagnostic systems that identify a variety of threat agents which cause deadly diseases such as anthrax and plague. The CRP assays and reagents are essen-tial components of multiple fielded, front-line diagnostic and detection platforms and serves as a foundation for our national biological defense capabilities. The CRP was organized by the Joint Program Executive Office for Chemical and Biological Defense in 1998 and has been supplying assays and reagents for identifying biological threats since 1999.
CBMS is the leader in developing and acquiring innova-tive CBRN MC for the Warfighter on time and on target. Our aggressive forward leaning approach to product development requires that we work with partners worldwide and capitalize on the benefits of “unity-of-effort” when there is “unity-of-purpose.” Using government and industry best practices, we tailor our processes to meet FDA and DoD Defense Acquisition System requirements while continuously planning for current
and emerging threats. The future of CBMS includes the development of novel countermeasures to fulfill Warfighter requirements as well as innovative ways to improve currently fielded ones. Key future Evolutionary Acquisition Increments, in the form of product improvements, currently under way at CBMS will decrease pro-gram cost while increas-ing product performance. These efforts include:
• Time/Temperature Indicators (TTI’s): TTI’s are small devices placed on individual product units that experience the same thermal history as the product vial or packet. These indicators will aid the supply chain and Warfighter to deter mine, at a glance, whether or not a product remains safe and effective.
• Multi-dose Formulation: Multi-dose formulation changes involve the inclusion of more than one dose of vaccine within each vial versus the current one dose per one vial production method. This change will decrease the logistics footprint in terms of storage as well as decrease production costs.
• Increased Formulation Stability: The development of thermo stable products will reduce cold chain, or temperature- controlled supply chain, requirements; thereby, resulting in decreased logistical burden and cost savings.
• Item Unique Identification (IUID) Application: The IUID is an asset management system that will facilitate documentation in electronic health records, assist in product recalls and adverse event reporting, improve supply chain management and reduce inventory management costs.
• Alternate Drug Delivery Technology: CBMS is researching new drug delivery technologies that will provide alternatives to intramuscular injections of drugs and vaccines. Examples include skin patches and inhalation devices.
The JPMO-CBMS has a diverse product line of CBRN MC under advanced development by a world class team of military, government civilian, and contract personnel. Through our use of DoD and commercial best practices, we expertly combine FDA regulations with DoD acquisition policies to rapidly provide transformational CBRN MC materiel solutions for current and emerging threats to our Warfighters, our nation, and the world.
CBMS-MITS system-of-systems approach to CBRN MC development requires both pre and post-exposure treatments such as the Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP)
CBMS has numerous product improvement efforts under way such as Time Temperature indicators that will be placed on individual products.
Critical Reagents Reagents Program (CRP)
The Future for CBRN MC
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Chem-Bio Defense Quarterly
The Chemical Biological Medical Systems (CBMS) Joint Project Management Office is responsible
for developing Medical Countermeasures (MC) through the implementation of the Defense Acquisition Management System to protect and treat Warfighters against the incapacitating and/or lethal effects of chemical, biological, radiological and nuclear (CBRN) threats. Many of these MC are carried by individual Warfighters for immediate, emergency use. Most of these MC, by their very nature, are sensi-tive to temperature extremes. Exposure to these temperature extremes can decrease the stability of the product, yet the War-fighter in possession of these products has no way to know if his or her product is
still usable. In the past, product life cycle managers provided conservative opera-tional use guidance for these products, resulting in the disposal of CBRN MC that were still usable. For example, the Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP) product is stable for 10 years in refrigeration, yet operational guidance for SNAPP states that the product must be used or discarded within 3 months once issued to an individual Warfighter. The Medical Identification and Treat-ment Systems Joint Product Management Office of the Chemical Biological Medical Systems (CBMS-MITS) are tackling this challenge by field testing the use of Time-Temperature Indicators (TTIs) on CBRN MC. TTIs are self adhesive devices
placed on individual CBRN MC vials or packets. TTIs contain temperature sensi-tive materials that undergo a predictable color change based on heat exposure over time. This technology is already in use by the World Health Organization (WHO) on their vaccines and by the Department of Defense (DoD) on cartons of Meals Ready to Eat (MREs). CBMS-MITS is identifying TTIs that closely model the thermal sensitivity of each CBMS CBRN MC to provide a visual warning of potentially heat-dam-aged products in the global theater. TTIs will:• Increase the Warfighter’s confidence
that his or her CBRN MC is ready when needed
By Tim Belski, Pharmaceutical Manager, Medical Identification and Treatment Systems
Figure 1: Medical Countermeasures such as Reactive Skin Decontamination Lotion (RSDL) are carried by individual Warfighters for immediate, emergency use.
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• Reduce wastage and maximize the re-use of heat-sensitive products by preventing the disposal of products not compromised by heat
The TTIs will also assist in the supply chain management of these CBRN MC by providing information on product quality at the basis of issue level. This informa-tion will be used to determine when to order more CBRN MC. The need for temperature monitors on vaccine vials was first identified by WHO in 1979 to address the problems with ship-ping heat sensitive vaccines to many areas of the world where temperatures regu-larly exceed 100°F. By 1999, WHO had identified an appropriate TTI technology and released specifications for TTIs for
all vaccines used in developing-country immunization programs. Since implementing TTIs on vaccine vials, WHO has been able to:• Prevent delivery of heat-damaged vac-
cines • Reduce the discard of usable vaccines
when heat exposure occurs• Allow vaccines to be safely transported
beyond the cold chain without ice, minimizing logistics and increasing outreach capabilities
• Better manage vaccine stocks by deter-mining which vials have experienced some heat exposure (but are still good and should be used first).
Since 1995, The DoD has used TTIs on the cartons of MRE’s to link the quality
of the ration to the time and temperature since packaging. Boxes of rations are often stored for long periods of time in hot storage facilities, waiting for shipment to troops around the world. TTIs have provided a cost effective tool to assist in managing the quality of rations. The CBMS-MITS is bringing the same TTI technology used on WHO vaccines and DoD MRE’s to Warfighter carried CBRN MC. These types of TTI use a heat sensitive polymer-based ink that irrevers-ibly darkens over time due to temperature exposure. The rate of chemical reaction, or polymerization, can be predicted by the Arrhenius equation. This equation defines the combined effects of time and tempera-ture which cause a gradual, predictable,
Figure 2: CBMS Pharmaceutical Managers, Dr. Renae Malek (left) and Mr. Tim Belski (right) discuss the inherent advantages of TTI with Major Nizamettin Gul.
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cumulative and irreversible color change from clear to dark. The rate of polym-erization of the TTIs can be tailored to closely follow the temperature profile of a CBRN MC. In selecting TTIs for CBRN MC, CBMS-MITS is following ASTM F
1416-96 Standard Guide for Selection of Time-Temperature Indicators. This guide states that visually readable indicators should reach end point before the product shelf life at all temperatures within the reasonable and abusive storage ranges. CBMS-MITS’ challenge is to select TTIs
for each CBRN MC that signals product failure before actual product failure, but not too soon as to cause an excessive amount of product to be unnecessarily discarded. Operational life guidance for products with a TTI will be based on validation
Figure 4: TTIs will assist supply chain management of CBRN Medical Countermeasures by providing information on product quality at the basis of issue level. This information can be used for more efficient medical logistics management.
Figure 3: Warfighter inspects Soman Nerve Agent Pyridostigmine Bromide Tablets to determine when to order more CBRN Medical Countermeasures.
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testing that determines CBRN MC condi-tion at different stages of TTI darkening. Each TTI consists of an outer reference ring and an inner circle. The inner circle darkens with time, and darkens more quickly as the temperature increases. When the inner circle matches the outer ring, this indicates that the CBRN MC is approaching the end of its usable life and a new product must be ordered. When the inner circle is darker than the outer ring, the CBRN MC must not be used. Mr. Tim Belski, Pharmaceutical Man-ager with CBMS-MITS, is collaborating with Mr. Rudy Olszyk, the Joint Proj-ect Manager-Decontamination and his team to field a TTI on the Reactive Skin Decontamination Lotion (RSDL). This Evolutionary Acquisition Incremental effort, in the form of a Preplanned Product Improvement (P3I), resulted in the selec-tion of a TTI from available commercial systems with sound chemical kinetic data for further validation. A field test at Camp Bullis, Texas to assess the rugged-ness and durability of the attached TTI to the RSDL packet began in March 2009
and will finish in May 2009. The selected TTI will be validated against the RSDL stability specifications and will be incor-porated into the product packaging by the RSDL manufacturer by the first quarter of fiscal year 2010. The CBMS-MITS shall apply the les-sons learned from the RSDL TTI effort to other CBRN MC in advanced devel-opment. The Advanced Anticonvulsant System (AAS) program is in the Post Milestone B Engineering and Manufactur-ing Development phase and is planning the product stability studies necessary to select an appropriate TTI. Other CBMS-MITS programs, the Improved Nerve Agent Treatment System (INATS), Med-ical Radiation Countermeasure (MRC), and Bioscavenger, are in the Technology Development phase and will also include TTIs in their acquisition plans. CBMS-MITS is also investigating the use of TTIs on legacy products such as Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP) and the atropine autoinjector. The use of TTIs will result in signifi-cant cost savings to the DoD by retaining
product exposed to unknown environ-mental conditions that would otherwise be discarded. WHO estimates the use of TTIs on vaccines has saved the global health community $5 million (US) every year. More importantly, TTIs will identify products that are no longer effective as the result of exposure to extreme environmen-tal conditions and alert the Warfighter of the need for a replacement. The TTI will provide to Warfighters the assurance that their lifesaving CBRN MC are safe and effective when needed.
REFERENCES:HealthTech Historical Profile: Vaccine Vial Monitors June 2005 http://www.path.org/files/TS_htiv_vvms.pdf“Bull’s Eye” Time Temperature Indica-tor Labels: A Cost Effective Approach to Monitoring the Quality of Rations http://www.ssc.army.mil/about/pao/pubs/war-rior/96/mar/labels.htm
ASTM Designation: F 1416 – 96 (Reap-proved 2008) Standard Guide for Selec-tion of Time-Temperature Indicators.
Figure 5: TTI increases the Warfighter confidence that their CBRN Medical Countermeasures are effective and ready to use when needed.
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Chem-Bio Defense Quarterly
George Bernard Shaw once said that the problem with com-munication is the illusion that it has been accomplished. He was no doubt speaking in the literary realm where an
illusion of communication would be little more than an irritant. However, in the realm of Department of Defense information technology, an illusion of communication could well result in loss of life and mission failure. To address the critical issue of ensuring true communication among the Chemical, Biological, Radiological, and Nuclear (CBRN) Family of Systems, the Joint Program Execu-tive Office for Chemical and Biological Defense (JPEO-CBD) has, through the SSA Data Management team, implemented the CBRN Data Model. Systems that exchange data that is compliant with the CBRN Data Model will be conducting true and accurate communi-cation with interoperable data. Although the CBRN Data Model has been around for several years, the concept of what specifically makes a program data model compliant or non-compliant is not commonly understood. This may result in part from the fact that when the JPEO-CBD Net-Centric Policy (Figure 1) was put into place last year, the definition of data model compliance changed. In the early days of the CBRN Data Model, the focus was on database implementations, so data model compliance meant implementing the data model as a database. Alternately, for those programs that were not using database solu-tions, data model compliance meant ensuring that all of your data items and valid values were supported in the CBRN Data Model and using the CBRN Data Model definitions for those data items. Although exact matching of physical datatypes and names was encouraged, it was not required. At the same time as developing the Net-Centric Policy for JPEO-CBD, the SSA defined a Net-Centric Assessment process as a tool for measuring a program’s progress toward net-centricity. In
putting together the Net-Centric Assessment process, the SSA held a series of discussions on how data model compliance should be defined. The first question was specifically what type of data would be required to be compliant—data that is exchanged or data that is stored, or both. Since the underlying reason for requiring data model compliance is to promote data interoperability among programs, it was agreed that data model compliance would apply only to data that is to be exchanged, and not to internal data storage. This is particu-larly appropriate because most programs are implementing XML-based solutions, rather than database solutions. The second question that the SSA addressed was how to measure data model compliance. The exact measure that was agreed upon and incorporated into the Net-Centric Assessment process was “Program has created and registered Data Exchange XML Schema Definitions (XSDs) that Use CBRN XML Schema Types.” In other words, the program’s XML Schema should use the “types” defined in the CBRN XML Schema, which corresponds to the CBRN Data Model. The use of the CBRN “types” means that the program’s definitions, datatypes, enumerations, valid ranges, and units of measure will automatically be compliant because these are all carried with the “type.” Thus, if program A and program B are both using the same CBRN “type,” their data will be compatible. The program’s element names are not required to match the CBRN XML Schema element names; this allows the program the flexibility to use names that are meaningful for their program. See an example in Figure 2. It is assumed that few, if any, programs will need to use everything that is in the CBRN Data Model and XML Schema. The CBRN XML Schema should be viewed as a set of building blocks that the programs use to build their own program schemas. These program schemas are sometimes referred to as CBRN XML Schema subsets because they use only a subset of the elements in the CBRN XML Schema. Note that programs may not make extensions to the CBRN XML
Data Model Compliance
What it is and How to Achieve itBy Sheila Vachher, JPEO-CBD Software Support Activity (SSA) Data Management Lead
The JPEO-CBD Net-Centric Policy implements the DoD requirement for Net-Centric Software Systems.
Figure 1 - The JPEO-CBD Net-Centric Policy, signed April 2008
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Types unilaterally. If they need to have something added or modi-fied, the procedure is to work with the SSA Data Management Team to get it incorporated into the next release of the XML Schema. If the next scheduled release of the CBRN XML Schema will not come out soon enough for a program’s needs, an interim release can be provided to the program. However, programs are allowed to further restrict a type from the CBRN XML Schema when they use it. For example, if the CBRN XML Schema allows for 10 possible enumerations and the program
Figure 2 - Example of a program schema using the CBRN “Types” to be data model compliant. Note that the program uses its own name for the element (TypeOfIncident), while using the CBRN Type (CBRNEventTypeCode).
only needs to use five of them, then the program can restrict the CBRN Type to allow just those five values. When a Net-Centric Assessment is performed for a program, the SSA Data Management Team evaluates the program’s XML Schema and web service(s) to determine whether they are compli-ant, i.e. whether they use the CBRN XML “types.” The program is given one of the following assessments for the net-centricity of its data structures: Complete, Compliant, In Progress-Satisfactory, In Progress-Challenges, or Non-compliant, and comments are provided as appropriate. The results of the assessment are reported to the program and to JPEO-CBD. The SSA strongly recommends that programs begin working with the Data Management Team early in their design and development phases. This allows the program to make course corrections early in the process so that when it comes time to perform the Net-Centric Assessment, there are no unneces-sary surprises. It is the SSA’s goal to begin Net-Centric Assessments early in a program’s acquisition timeline in order to partner with the program in achieving data model compliance and net-centricity, to the ultimate end of reliable and trustworthy communication with all interfacing systems.
As additional aspects of data are required to be compliant, imprementation become increasingly complex and brittle, i.e. subject to “breaking” when changes are made. The key is to require compliance for those aspects which are necessary for data interoper-ability, while allowing flexibility with other aspects.
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Chem-Bio Defense Quarterly
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During the Presidential election of 2008, Senator Barack Obama coined
a phrase that has taken on the meaning of hope and prosperity, and now appears on bumper stickers around the nation. However, one manufacturing company in Texas has characterized the phrase Yes We Can through its employees for years, encouraging them to always strive to achieve superior production results in everything they make because in many cases, lives depend on their products -- and in more ways than one.
By Julius L. Evans, Editor, Chem-Bio Defense Quarterly Magazine Photos by Steve Lusher, Camber Corporation
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At some facilities, company slogans tend to become mun-dane and take up wall space, but for ReadyOne Industries of El Paso, TX, that very popular phrase has a unique parallel that resonates with each employee. A member of the Ability-One Program, a federal initiative to help people who are blind or severely disabled find employment with non-profit agen-cies that sell products or services to the U.S. government, 75 percent of the direct labor at ReadyOne is performed by people with severe disabilities. “Our organization has two important qualities. One, is that we put a great deal of careful consideration into everything we do from the beginning of the process to packaging the end product,” explained Geronimo Medina, ReadyOne’s Plant Manager. “The second part pertains to the people who work here. Having the opportunity to work in a safe, conscien-tious environment, where management is aware of the special needs of our workforce, one could say, saves their lives and their livelihood -- and we understand that – all of us do. Our staff appreciates very much the opportunity to work in a nice environment, on a product for which they really care. It truly makes a difference for everyone involved.” That product is the Joint Service Lightweight Integrated Suit Technology (JSLIST) chemical/biological (CB) protec-tive overgarment, developed and procured by the Joint Proj-ect Manager for Individual Protection (JPM-IP), Stafford,
VA. JPM IP is one of eight joint project managers under the leadership of Brig. Gen. Jess A. Scarbrough, the Joint Pro-gram Executive Officer for Chemical and Biological Defense, JPM-IP is responsible for providing skin, eye, and inhalation protection against CB threats to Warfighters. The JSLIST is a state-of-the-art ensemble that provides increased durability, reduced weight, improved fit, enhanced suit closures and a reduction in heat stress for the wearer when compared to previous protective garments. Each JSLIST com-ponent is state-of-the-art material technologies that have under-gone extensive user evaluation and field and laboratory testing. The JSLIST ensemble includes the overgarment (coat and trousers), protective overboots and, gloves. A single base-garment design is produced in two configurations (Type II and Type VII) to meet Service requirements. The Type II JSLIST has a hood and is used for most applications; Type VII elimi-nates the hood, adds a stand-up collar and is used by Special Operations Personnel. The JSLIST garment is launderable up to six times. For complete percutaneous and respiratory protection, the JSLIST ensemble is intended for use with the Joint Service General Purpose Mask or remaining in-use legacy mask sys-tems such as the M40, M42 or MCU-2/P. The JSLIST replaces earlier protective systems including the Battledress Overgar-ment (BDO), the U.S. Navy Chemical Protective Overgarment
“We don’t let anything leave here that knowingly would not meet or exceed the highest quality. We built our reputation on being the best of the best of the best and that is what sets us apart from, we think, everyone else in this industry.”
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(CPOG), the U.S. Marine Corps Saratoga, and other prior systems. The JSLIST is an all-Service pro-gram that provides both vapor and liquid protection from the damaging effects of all known biological and chemical agents and radiological particles. It is specified for use in Mission-Oriented Protective Posture conditions. The specifications for JSLIST do not stop there. When it comes to manufacturing CB protective overgarments, ReadyOne Industries endeavors to maintain the highest standards via use of a unique meth-odology. “We call it the four M’s: Manpower, Machinery, Method, and Material. By identifying where there may be a problem amongst the four M’s, we are able to identify a root-cause and fix it before it gets any bigger,” explained Juan Bezanilla, ReadyOne’s Engineering Manager. “There are very structured ways of finding a root-cause on an issue. There are statistical ways and there are empirical ways, but root-cause analysis is – if we do find a problem on the floor, we’ll barrel down, get to the root-cause, and try to fix it with each department’s help before it impacts an entire production line.” In-line quality reports to the line managers who report to the Direc-tor of Manufacturing, who oversees the 350,000 square foot facility that employs a workforce of about 1,200 people. End of line auditor’s report to the Quality Control Manager, who reports directly to the Chief Execu-tive Officer. “It is our intent that in-line quality personnel detect and correct any quality issues before the finished product gets to final audit. To make absolute certain that in-line produc-tion does not miss any potential quality issues, we have a differ-ent reporting structure for in-line quality vs. quality audit,” said Tom Ahmann, Chief Executive Officer and President of ReadyOne Indus-tries. “The Quality Control Manager (QCM) is responsible for reviewing all quality issues with production on a daily basis. The QCM and her team works with production man-agement and in-line quality inspec-
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tors throughout the day to insure any minor quality issues are caught before they become big issues. The team meets with me each Tuesday to review the quality results by product for production from the preceding week,” Ahmann said. ReadyOne uses this same type of checks and balances system in everything they do, including many activities performed by members of the board of directors such as holding compliance committees for AbilityOne requirements, financial audit com-mittees, and board governance committees that reviews their corporate policies and procedures with legal counsel. “We don’t let anything leave here that knowingly would not meet or exceed the highest quality. People at other companies might say, ‘the customer won’t be able to see it, so let it go.’ That’s the cheap way to do business, but that’s not what we built our reputation on,” stated Ahmann. “We built our reputa-tion on being the best of the best of the best and that’s what sets us apart from, we think, everyone else in this industry.” In manufacturing the JSLIST, ReadyOne Industries fol-lows one of the most rigorous quality control standards in the sewing industry today. “I have been in this industry for more than 35 years. Previ-ously, I worked for a company that had what I felt was the strictest quality control program and requirement procedures in place. But I was in for a rude awakening when I came to work here on the JSLIST ensemble,” said Maria Elena Jimenez, Quality Control Manager. “The quality control program there does not come close to comparing with the checks we perform
on the JSLIST.” The Director of Manufacturing agreed with those sentiments and explained the importance of each step in the process, and why ReadyOne stresses quality. “If you purchase a garment at the mall that doesn’t fit well or the zipper is busted, you can always take it back. Our Soldier cannot do that. It has to be perfect each time,” Cynthia Dearo exclaimed. “Even with packing, we put a specific focus there because if the package says a coat is in the bag, there has to be a coat in it. If there is a pair of trousers inside a coat bag, where will the Soldier exchange the product? There is nowhere for the Warfighter to turn.” Since becoming ReadyOne Industries in 2005, the organiza-tion strived to become the leader in JSLIST manufacturing and has been extremely successful in doing just that. “What we see from ReadyOne is always quality first. They have become not just the leading manufacturer for JSLIST, but also an integral part of the team, providing input and recommendations to improve processes not just there but in all JSLIST manufactur-ing facilities,” explained Danielle Fleming, Protective Clothing Program Manager at JPM IP. During those years, the Yes We Can, slogan has helped build the belief that superior products are not only determined by the workforce that stand behind it, but also by the culture that espouses those beliefs. ReadyOne remains committed to living up to those standards.
Vocational training offered by ReadyOne Industries covers a wide range of skills in such positions as sewing operations, cut-ting, corrugated operations, corner board operations, packaging, warehousing, clerical and administrative. These positions are all designed to creatively and innovatively accommodate the special needs of disabled workers.
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Geronimo Medina (left) ReadyOne’s Plant Manager and Juan Bezanilla, the Engineering Manager, explain the precision incor-porated into the manufacturing processes at ReadyOne Industries.
ReadyOne has rallied around the ‘Yes We Can’ slogan for years encouraging its workforce to always strive to achieve superiorproduction results in everything they make.
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Details of the MIMIC System
CBMS Builds on DARPA Investments
C
During the post-licensure phase of vaccine development (after Milestone C), the MIMIC technologies should: • facilitate product improvements such as improved thermal stability or formulation for multi-dose vialing to improve safety and efficacy and reduce life cycle costs • be a cost-effective way of assessing the potency of stockpiled vaccines The MIMIC technologies can assess two or more competing prototype vaccines and thereby facilitate informed decision making, either before or after acquisition Milestone A. In this way, the use of the MIMIC system could accelerate fielding of vaccines by at least three years and save millions of dollars. The MIMIC system could also be used in additional ways by CBMS. For example, it could be applied to immunotoxicology evaluation of drugs, or biologics other than vaccines, in development. The drug or biologics developer needs to know whether a new drug or biologic, not being purposely developed to affect the immune system, may nonetheless do so, resulting in unwanted immunosuppression, immunogenicity, or hypersensitivity. The MIMIC system could be used to supplement or replace immunotoxicology studies conventionally done with animals, as part of an effort to reduce cost, save schedule, and minimize risk.
Details of the MIMIC System The MIMIC technologies exploit the explosion in knowledge of immunology that has taken place over the last 30 years, as well as advances in automation and information technology. Now, specific types of white blood cells can be identified, counted, and characterized and brought together so that their interactions can be documented. White blood cells can be kept alive and functional for weeks outside the body, enough time for immune responses to develop to a reasonable degree of maturity. Molecules of interest on cell surfaces, within cells, and released by cells can be quantitated, and interpreted within the context of knowledge accumulated by immunologists working in laboratories throughout the world. The MIMIC system uses white blood cells from volunteer donors. Since the donors never come into contact with the vaccine, it need not have been tested for safety in animals prior to use in the MIMIC system, and there are no requirements to
Chemical Biological Medical Systems (CBMS) is on the cutting edge in applying new technologies to vaccine development. In state of the art vaccine development, there has been a multi-year period
between the time that the research lab, in pre-Milestone A work, learns that a vaccine candidate protects a lab animal against a biological agent and the time that the advanced developer, in post-Milestone A work, gets information about human immune responses to that vaccine candidate. During that period, the research lab and the advanced developer have traditionally spent millions of dollars on the basis of an inference that immune responses seen in lab animals are predictive of protective human immune responses. The Milestone Decision Authority uses information about human immune responses to help decide whether to continue the development of a vaccine candidate or to re-plan development efforts. In order to accelerate the vaccine development process, CBMS has been evaluating the utility of a new technology – an immune system in a test tube – to see whether it could quickly yield human immune response information about a vaccine in development. The answer is “Yes” – Within six months of a cold start, CBMS acquired information about human immune responses to a plague vaccine candidate, helping to validate the utility of the new technology in the context of advanced development. The “human immune system in a test tube” is just one example of the innovative technologies used by CBMS to move products of the highest quality out to the Warfighter as soon as possible and at the lowest cost.
CBMS Builds on DARPA Investments The Defense Advanced Research Projects Agency (DARPA) funded research into, and early development of, a set of technologies for rapid vaccine assessment. Through interactions with Dr. Michael Callahan, DARPA Rapid Vaccine Assessment program manager, CBMS learned about VaxDesign Corporation’s MIMIC™ (Modular IMmune In vitro Construct) system. In view of progress made with DARPA funding, there was, in early 2008, reason to believe that MIMIC technologies could accelerate vaccine development. The CBMS experience, now about one year with the MIMIC system, confirms the value of DARPA and CBMS investment. The use of MIMIC should significantly improve the cost and schedule of vaccine development and reduce risk as follows: During the preclinical phase of vaccine development (well before Milestone B), the MIMIC technologies should:
• reduce the risks of adverse events in a first time-in-humans clinical trial
• help develop vaccine formulations that minimize health risks, maximize beneficial immune responses, and decrease life cycle costs
During the clinical phase of vaccine development (late Technology Development and between Milestones B and C), the MIMIC technologies should:
• help explain the information obtained from immunization of people, e.g., why a vaccine worked in a group of individuals and did not in others • help address possible safety and immunogenicity issues
VaxDesign: The “human immune system in a test tube.”
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inform the blood center staff, the cell donors, or the Food and Drug Administration about the characteristics of the vaccine. Since there are relatively few regulatory requirements, immune response information can be obtained quickly and at relatively low cost, compared to information obtained through clinical trials. This means cost and schedule savings, since ineffective vaccine candidates can be weeded out and promising vaccines can be advanced in development more quickly than would be possible using phase 1 clinical trials as the first source of human immune response data. The MIMIC system is comprised of the Peripheral Tissue Equivalent Module (PTE) and the Lymphoid Tissue Equivalent Module (LTE). The PTE models events at a vaccination site, such as the skin (or point of attack by a microbial invader), and provides information about the innate immune system’s response to a vaccine or microbe. Within our bodies, the innate immune system responds in a short time (minutes to hours) to the presence of certain molecular patterns; the response is often inflammation, which we experience as redness, heat, swelling, and pain. While
the PTE readouts do not include measurements of redness, heat, swelling, or pain, they do include measurements of specific immunomodulatory molecules (cytokines) which correlate with inflammatory responses to vaccines or microbes. In addition, the PTE assesses the maturation of antigen presenting cells (APCs), such as dendritic cells, which are vital to development of adaptive immunity. Adaptive immunity is the exquisitely specific immunity that arises days to weeks after administration of vaccines or exposure to agents of infectious diseases. Adaptive immunity is modeled by the LTE, which is more complex than the PTE. The LTE models events in lymph nodes, which are sites within the body that bring several types of cells together, including cells such as APCs that have traveled from peripheral tissues. The APC can be thought of as the Paul Revere of the immune system, sounding the alarm of invasion, and the lymph node can be viewed as the immunological command center that sends out T and B cell warfighters to destroy the invading pathogen. The LTE allows assessments of activities of B cells and T cells, including the production of specific antibodies.
Through the use of the MIMIC system (comprised of the Lymphoid Tissue Equivalent Module and Peripheral Tissue Equivalent Module), Vax Design simulates the human lymph nodes and vaccination site to provide information on human responses to vaccines.
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Initial Results of Application of MIMIC to Plague Vaccine DevelopmentInitial Results of Application of MIMIC to Plague Vaccine Development CBMS contracted with VaxDesign Corporation in April 2008. The initial effort investigated the application of MIMIC technolo-gies to the advanced development of plague vaccine, which is being performed by DynPort Vaccine Company under a contract managed by CBMS. The plague vaccine entered clinical trials in early 2005. By April 2008, immune response data from about 200 people had been accumulated from phase 1 and early phase 2 clinical studies, but manufacturing process validation and studies critical to demonstrating vaccine efficacy remained as required pre-Milestone C activities. Thus, application of MIMIC came at a time ripe for exploitation of new information about human immune responses. The plague vaccine in advanced development is a purified protein vaccine; it contains the F1 and V proteins encoded by Yersinia pestis but expressed in Escherichia coli as a fusion protein, as well as aluminum hydroxide (an adjuvant, a substance that enhances the immune response). In the MIMIC system, PTE analysis showed that plague vaccine enhances the maturation of antigen presenting cells and LTE analysis showed that plague vaccine elicits the production of specific antibodies. These initial results are compatible with information obtained in clini-cal studies. The MIMIC results to date are also consistent with
the prime-boost strategy (an initial dose of vaccine to prime the immune system, followed by booster doses to improve immune responses) that guided the early development of the plague vac-cine by Drs. David Heath, George Anderson, J. Matthew Mauro, Susan Welkos, Gerard Andrews, Jeffrey Adamovicz, and Arthur Friedlander at the U.S. Army Medical Research Institute of Infec-tious Diseases. CBMS intends to investigate the utility of the MIMIC system in assessing the comparability of various batches of plague vac-cine; such assessments are traditionally done with a combination of biochemical analyses, studies with experimental animals, and clinical studies. The use of MIMIC could eventually eliminate some of these studies, minimize their costs, or provide additional information that would reduce risks. CBMS and its develop-ment partners will publish the results of investigations of utility of MIMIC in the scientific literature and thus advance the state of the art of vaccine development. By so doing, improvements in quality and savings in cost and schedule could be extended beyond the boundaries of CBMS.
The “human immune system in a test tube” is just one example of the innovative technologies used within CBMS to provide CBRN MC to the Warfighter
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Chem-Bio Defense Quarterly
As technology continues to evolve, the Department of Defense (DoD) is able to provide an ever-increasing amount of data to military forces. We continue to
develop sensors that are able to provide more data about the operational environment at higher fidelity than previous hard-ware. We have developed new technology capable of detecting chemical and biological agents, particular types of ammunition as it impacts its target and intelligent video surveillance sys-tems. Our scientists have been able to identify what happens to chemical and biological agents over time on various surfaces. As individual data sources the information provided by these sensors and data sets is useful. As fused data, these data sources provide the foundation for the Joint Program Executive Office for Chemi-cal and Biological Defense (JPEO-CBD) goal of Chemical and Biological information superiority.
As we begin to develop the needed decision support and decision management tools to support tomorrow’s Warfighter, advanced sensor data fusion techniques are required to adequately transform the large amounts of data available in today’s technical world into usable information. In order to understand sensor data fusion and its usefulness, it is first necessary to define the various terms used when discussing the subject. Given the relevant level if import applied to sensor data fusion within the community, terms are often used in general with multiple meanings and it is easy to confuse what the Chemi-cal and Biological Defense Program needs and what Industry is offering. Data fusion is generally defined as the use of techniques that
By Joshua Pressnell, JPEO-CBD Software Support Activity (SSA), Technical Director
Accurate information provided through fused data from multiple sources provides Warfighters with the best situational awareness avail-able on the battlefield.
SENSOR DATA FUSION OVERVIEW
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combine data from multiple sources and gather that information in order to achieve inferences or “educated guesses,” which will be more efficient and potentially more accurate than if they were achieved by means of a single source. The expectation is that fused data is more informative than the original inputs. Sensor fusion is also known as sensor data fusion or multi-sensor data fusion. It describes the combining of sensor data from dispa-rate sources such that the resulting information is in some sense “better” than would be possible when these sources were used individually. The term “better” in this case may mean more accu-rate, more complete, more dependable, or refer to the result of emergent information, such as an assured chemical and biological attack derived from the combination of a chemical sensor alert, an acoustic sensor’s report that a shell capable of carrying chemi-cal weapons landed in the area and confirmed radar reports of a cloud moving from the location of detonation. As seen in Figure 1, the data sources for a fusion process are not required to originate from identical sensors. In addition, one can distinguish between direct fusion and indirect fusion. Direct fusion is the fusion of direct sensor input data, while indirect fusion uses information sources like a priori knowledge about the environment and human input. A large number of processes are associated with sensor data
fusion, such as disparate data normalization, event tracking, situational assessment, and situational planning. Each of these processes is both collectively and separately referred to as sensor data fusion. The most common model to describe these processes is developed by a DoD committee, the Joint Directors of Labo-ratories (JDL) Data Fusion Group. The most recent JDL model defines five data fusion processes, as outlined in Figure 1. The JDL model was originally defined to describe signals intelligence fusion applications, but as the model has been refined it has been utilized more generically to help frame discussion of all data fusion processes. The JDL model describes automated data fusion processes and is not typically applied to manual fusion processes which support the automated system. In addition to the five levels of fusion defined by JDL, industry often defines a sixth level or “Level 5” data fusion called “User Refinement” to capture and discuss these manual or “human in the loop” processes.
In order to understand how data fusion principles can be applied within the Chemical and Biological Defense Program (CBDP)
DATA FUSION LEVELS APPLIED to CHEMICAL and BIOLOGICAL SYSTEMS
Figure 1. Revised JDL Fusion Model
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it may be helpful to further explore the definition of each level within the JDL fusion model and briefly describe the level’s potential use within our community. Level 0, or preprocessing, fusion was added to the model during the 1998 revision and was originally intended to describe processes performed directly on sensor data in order to estab-lish or quantify a signal within the individual sensor. As it is applied more generically to sensor systems, preprocessing fusion describes the steps necessary to gather and refine sensor data and to put that data into a common usable format. An example of preprocessing fusion steps would be the processes required to identify particular chemicals out of the plasmagrams within the LCD chemical sensor and to output those readings in the Common CBRN Sensor Interface (CCSI) protocol. Level 1, or object refinement, fusion describes the processes necessary to identify unique entities, or “tracks.” Within the signal intelligence world, these processes are used to associ-ate potentially multiple radar returns with a single airborne platform. Within the CBDP, these processes might be used to associate multiple sensor alerts received from several different disparate chemical detectors with the same chemical attack or cloud. Level 1 fusion may also be used to support source term estimation and prediction of the historical location and future movement of the cloud. Level 2, or situation refinement, fusion describes processes necessary to assess identified entities and the relationships between them. In the classic signal intelligence world, these processes are used to estimate whether or not identified entities are friends or enemies and whether or not those entities are in attack or peaceful posture. Within the CBDP, these processes may be used to determine if a particular sensor report or set of sensor reports represents a “real” attack. For instance, these
processes may determine, given the location, threat posture, known likelihood of attack, and other environmental factors, what the probability is that the identified cloud is a chemical weapons attack rather than a stimulant or alert caused by natural environmental factors. Level 3, or threat refinement, fusion represents processes used to determine the cost or operational effectiveness impact given probable situational states, including the cost and operational effectiveness impacts associated with alternative courses of action. As applied to the CBDP, threat refinement fusion could be utilized to assess the relative impact to the military force and mission effectiveness of sheltering forces in-place versus moving to avoid the cloud. Level 4, or process refinement, fusion describes processes used by the system to determine whether or not the answers provided within the complete fusion process were satisfactory and refine the fusion processing system as necessary to achieve optimum goals. A large portion of sensor data fusion is based on statistical calculations and estimation based on a priori knowledge. Process refinement fusion is used to allow the system to learn from the environment over time and refine the a priori knowledge base to provide more accurate future answers.
There are many challenges associated with sensor data fusion, particularly as systems attempt to utilize higher fusion levels. Most current development in data fusion and decision support systems within the community today centers on preprocess-ing and object refinement fusion or “How do I get my sensors talking the same language?” and “How can I identify a single
event using all my available sensors?” The evident results of this type of fusion work are “cooperative sensor systems” where one sensor may queue or command another sensor to take a closer look at an event and provide more information or systems-on-target in the event area. While this level of fusion is certainly useful and efforts to normalize sensor data and develop cooperative systems are necessary, it is not overly challenging. The biggest challenge to realizing fusion at levels two or greater is in the lack of good a priori input. One of the key features of statistical processes is that small changes in early inputs yield extremely large differences in the resul-tant decision. Since current sensors were developed with warfighter support rather than data fusion requirements in mind, they most often output a red/amber/green alert system or a basic alert/no alert notification system. This data is exactly what the warfighter needs to determine the course of action against an immedi-ate threat, but it is insufficient resolution to support advanced statistical decision support through automated data fusion
SENSOR DATA FUSION CHALLENGES
Successful level 1 fusion allows accurate plume pictures which group sensor network alerts into a single “event”
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processes. This type of validated statistical data is the founda-tion of level 2 fusion processes. In addition to the direct sensor data issue, indirect sources are also lacking within the Chemical and Biological Defense Community. The signals intelligence community has developed extensive databases which provide the likelihood of encounter-ing particular airborne platforms in given locations around the world at particular times. This allows their systems to make intelligent predictions about whether or not particular radar tracks are actually specific platforms and what the platform’s threat posture is. There is no analog available to decision sup-port systems within the CBDP which defines the likelihood that a particular agent will be used in a particular area of the world given particular military posture and environmental conditions. These a priori databases are critical inputs to level 2 situational assessment processes and support some forms of level 3 threat refinement processes.
Sensor data fusion and automated fusion-based decision sup-port is a complex field which can be approached from many angles. It is important for program managers to understand what their specific data fusion requirements are and what their potential vendors are capable of offering. For additional read-
Successful level 3 fusion tells decision makers when it is less impactful to mission success parameters to protect-in-place than to avoid the cloud
SUMMARY
ing on data fusion processes and techniques, including classical inference, Bayesian inference, Dempster-Shafer theory, neural networks, voting logic, and fuzzy logic, Sensor Data Fusion: A Tool for Information Assessment and Decision Making by Lawrence Klein is an excellent, although heavily math-focused, resource. For more information about information contained in this article, please contact the JPEO-CBD SSA Technical direc-tor (Joshua Pressnell – [email protected]).
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