Click for next page ( 36


The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 35
3 Core Science and Technology Capabilities for the Chemical and Biological Defense Program The committee explored the various science and technology capa- bilities that are relevant to the Chemical and Biological Defense Program (CBDP). In order to address its task, the committee utilized the six science and technology (S&T) capability categories defined in the previous chap- ter: Enabling CBRN Intelligence, Surveillance, and Reconnaissance; Chemical and Biological Agent Detection; Individual and Collective Protection; Medical Countermeasures; Hazard Assessment, Manage- ment, and Decontamination; and Cross-Cutting Science and Technol- ogy. In addressing the first five areas, excluding Cross-Cutting Science and Technology, the committee identified four to eight S&T capabilities for each category that "must be available to support Chemical and Bio- logical Defense (CBD) research, development, test and evaluation, and operational activities."1 Table 3.1 shows the S&T capabilities identified by the committee under the six S&T capability categories. Except where otherwise noted, each of the identified S&T capabilities is of sufficient importance to the CBDP that it should provide support to further the activity. To that end, this chapter describes the committee's views on which capabilities can and should be obtained in Department of Defense (DoD) laboratories and which are better suited to be obtained outside of the DoD or outside of the government altogether. To reach these conclusions, a decision tree was developed with several elements 1 Statement of Task. 35

OCR for page 35
36 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE TABLE 3.1 Committee Identified S&T Capabilities 1. ENABLING CBRN 2. CHEMICAL AND 3. INDIVIDUAL INTELLIGENCE, BIOLOGICAL AGENT AND COLLECTIVE SURVEILLANCE, AND DETECTION PROTECTION RECONNAISSANCE Controlled Molecular Information Acquisition Analytical Methods Transport Materials and Analysis Discovery Discovery Instrumentation Barrier Materials Health Monitoring Development Engineering Environmental Sensor Systems Personal Protective Monitoring Development Systems Development Unknown Agent Collective Protection Identification and Agent Transport Analysis Systems Development Characterization Physiology 5. HAZARD 6. CROSS-CUTTING 4. MEDICAL ASSESSMENT, SCIENCE AND COUNTERMEASURES MANAGEMENT, AND TECHNOLOGY DECONTAMINATION Acquisition, Maintenance Decontamination Methods and Transport of Critical Target Discovery Discovery Chemical and Biological Reagents Decontaminant Regulatory Science Agent Simulation Development Mechanisms of Delivery Decontamination Resilient Informatics and Delivery Systems Materials Development Decontamination Systems Statistical Measurement Animal Models Engineering Design Agent Transport and Host Response Forensics Viability Analysis Pre-Clinical Studies Education and Training Clinical Trials (GLP and Behavioral Analysis GMP) Medical Product Systems Analysis and Development Engineering Repurposing Commercial Technologies Systems Biology Synthetic Chemistry and Biology Materials Science Test and Evaluation

OCR for page 35
CORE SCIENCES AND TECHNOLOGY CAPABILITIES 37 to consider at each node in order to help address the necessity of DoD to maintaining certain capabilities in-house (see Figure 3.1). For the S&T capabilities listed, which the committee has already determined to be core to the CBDP, the committee asked the following questions: (1) Should the CBDP be providing funding to support this core S&T capability? The obvious answer may well be yes, but the committee explored some possible reasons that the CBDP should avoid using its limited resources in a specific area. For example, if another part of DoD or the government, which is viewed as reliable and com- petent, is already funding this area, maybe the CBDP should not invest heavily in this area, provided the two government units involved communicate with one another and make shared use of the findings. (2) Assuming the CBDP does decide to support and fund a specific S&T capability, the committee looked at whether this capability can be found outside of the government. As defined previously, capability is having both competence and capacity to accomplish a goal. Do the extra-governmental sources have the competence and capacity, the ability to ensure safety, security and scale to a given problem? If not, should DoD, as opposed to another governmental agency, be focusing on the S&T capability (see step 4)? (3) If it can be found outside, should the government do it anyway? In addressing this question, the committee considered a variety of factors that are of high importance to the program. What is the cost differential? Is there both long- and short-term domes- tic availability2 in the private sector? Does industry provide the necessary staying power for CBDP? Are there safety and security considerations that would require the program to maintain con- trol? If these issues can be satisfactorily addressed, then perhaps CBDP should obtain this capability primarily from the private sector. (4) If the above questions direct the government to maintain an inter- nal capability, the CBDP should then consider whether it should maintain the capability itself, within DoD, or obtain it from other 2 The meaning of availability will be different for each S&T capability. Considerations for intellectual property rights are important in making this determination. Procedural barriers, such as contracting, should be considered in the short term, but care must be taken not to ascribe all problems to "procedural barriers" to avoid finding a solution.

OCR for page 35
38 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE Is the End. Do not capability No core to consider the CBDP? capability Yes End. This 1) Should CBDP No capability is fund the not under the capability? control of CBDP Yes 2) Can the capability be No found outside the government? Yes 3) Should 4) Should the capability be the capability be maintained Yes maintained inside the primarily government within the DoD anyway? service labs? Yes No No The capability The capability The capability should be obtained should be obtained should be obtained primarily from primarily from primarily from DoD academia and other government service industry laboratories laboratories FIGURE 3.1 The decision tree for determining if capabilities should be housed within DoD or leveraged from external sources. Figure 3-1 replaced editable

OCR for page 35
CORE SCIENCES AND TECHNOLOGY CAPABILITIES 39 government laboratories3 (e.g., Centers for Disease Control and Prevention, National Institutes of Health, Department of Energy National Laboratories). Items to consider when making this assessment include agency mission, agency resources, and pos- sible public health overlap. While the committee does not necessarily believe that it should be a high bar for the CBDP to maintain in-house, DoD-controlled capabilities, there are some important questions to consider when discussing the loca- tion of the various S&T capabilities. The committee used the decision tree (Figure 3.1) to determine whether individual capabilities should be maintained by the program and where. Many of the metrics used to address each decision node on the tree are subjective and the committee's consensus view is described in this chapter. If the CBDP does not agree with an individual assessment of an S&T capability, they are encouraged to undertake a de novo analysis of that capability, using the decision tree above,4 to reach their own conclusion. ENABLING CBRN INTELLIGENCE, SURVEILLANCE, AND RECONNAISSANCE The CBDP must have a natural and fundamental role in the pre- vention of and strategic warning against threats to global and national security through the use of or exposure to priority biological and chemi- cal agents. No other program is better positioned to project capability forward or contribute to global strategic, operational, and tactical warning and prevention. From the force health protection perspective, CBDP plans and provides resources for the research, development, test and evalu- ation (RDT&E) and delivery of vaccine, prophylaxis, and therapeutic technologies that protect US military personnel and civilians, as required when exposure is determined or suspected. Further, the CBDP supports and directs funding for detection, diagnosis, and biosurveillance, which simultaneously aids in advancing forensic capabilities that inform deci- 3 We make a distinction between non-DoD government labs and non-government per- formers. This is based on an assumption that government labs meet security and surety standards (e.g., ability to work with classified samples, materials, and information) and are designed to be an enduring capability that will be available when needed. Non-government labs have no such assumption of guaranteed continuity, even if security and surety stan- dards are currently met. 4 The real intent of the committee's approach is to illustrate how to apply a structured, systematic, and consistent process to decision making that allows for a common under- standing of priorities and how they were developed. The results also provide a basis for continuity of support.

OCR for page 35
40 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE sions related to medical protection and treatment as well as those that inform intelligence, operations planning, medical intelligence, and attri- bution. Just as S&T contributes considerably to medical decisions, it also contributes to military and policy decisions related to possibly nefarious activities involving biological and chemical agents. The committee has identified four S&T capabilities that are required to provide technolo- gies needed for chemical, biological, radiological, and nuclear (CBRN) intelligence, surveillance, and reconnaissance (CBRN ISR): information acquisition and analysis, health monitoring, environmental monitoring, and unknown agent identification and characterization. Information Acquisition and Analysis The core concept for this capability is that multiple dense sources of information pertinent to CBRN ISR exist and need to be properly mined, managed, integrated, distilled, and efficiently queried. A few examples of information sources in the biological domain include ProMed Mail (outbreak reports), ARGUS (a system that searches World Wide Web news media for signs of social unrest that could be due to pathogen outbreaks), Global Public Health Information Network, social media such as Facebook or Twitter,5 and global weather forecasts and reports. To be fully effective, an information acquisition and analysis system needs to be capable of extracting pertinent facts from a large number of languages and informa- tion source types. This involves numerous difficult and largely unsolved problems in natural language processing and information fusion. DoD needs to be well informed of potential and actual biological and chemical outbreaks and incidents as they relate to both existing and potentially needed detection capabilities. There are multiple government and non-government sources of relevant information for enabling CBRN ISR. Additionally, there are multiple government-funded groups that already attempt various levels of information integration in the chemical and biological domain. It is likely that no existing systems individually meet all current DoD needs. However, DoD should strive to leverage as much as possible from collaborations with existing systems, rather than launching any de novo efforts at developing such capabilities. The committee noted that the current program plans to search social media for outbreak-relevant information did not appear to have a plan for inte- grating with other available information sources. CBDP should be better aligned with other relevant government information acquisition and anal- ysis efforts in the biological and chemical domains. 5 We note that legal issues involving the Privacy Act are faced by any information systems that mine information about US citizens, even if such information is in the public domain.

OCR for page 35
CORE SCIENCES AND TECHNOLOGY CAPABILITIES 41 Health Monitoring US forces and civilian personnel are projected and mobilized in and out of a diverse array of operational settings and environments. The DoD must be aware of, and be able to protect and respond to, threats to health and readiness. Not only should the DoD support protection and prevention against routine diseases common within the continental United States,6 it must also be able to provide agile medical and S&T responses to "surprise" in any location worldwide. Thus, programs to address those diseases that are intentionally caused, endemic or present- ing elsewhere in the world where DoD operates, need to be incorporated into CBDP planning, resourcing, and delivery. While every new disease cannot be anticipated, a system and capabilities must be in place for CBDP to respond effectively and in a timely manner. This applies to medical treatment approaches as well as diagnostics, biomarkers to exposure, and biosurveillance. One aspect of this is to consider health monitoring in the context of "One Health,"7 which considers human health in the global context of animals (domestic and wild) and includes all reservoirs and vectors (e.g., mammals, birds, ticks, mosquitoes, etc.). This implies increased global biosurveillance of both human and animal baselines to determine what is currently endemic so that new pathogens with pandemic potential can be more rapidly detected and characterized, ideally before they are spread widely via global air transportation. Effective health monitoring implies the development and use of a broad hierarchy of diagnostics that includes not only inexpensive point-of-care presumptive diagnostic kits (akin to home pregnancy tests), but also sensitive and precise multiplex confirmatory diagnostics (symptomatic panels such as respiratory, fever, enteric, encephalitis, etc.; also panels for food-borne pathogens, zoonotic pathogens, etc.), broad-spectrum microarray diagnostics (as a safety net to cover unusual/unexpected known single pathogens or combinations), and finally, sequencing to detect and begin to characterize unknown pathogens. It is important to note that global biosurveillance cannot con- sist of merely the high-consequence pathogens that the United States is most concerned with. It should offer real benefit to both the local com- munities and the US warfighters who may be serving there, in terms of diagnosing endemic pathogens of local concern. To be effective, the 6 Traditionally, force protection against natural health threats was primarily addressed by WRAIR, and force protection against biological weapons was the main focus of USAMRIID; recently, however, biothreat agent funding has been approved for use in addressing pan- demic threats, such as H1N1. The committee recognizes that this decision has broad im- plications, but believes that an examination of this issue is beyond the scope of this report. 7 Also called "species-neutral."

OCR for page 35
42 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE United States cannot expect to merely "cherry-pick" samples of potential pandemic or bioterror cases. Another aspect of health monitoring is that it requires the ability to be adaptive in order to respond to unknown pathogens as they appear. There may be a truly novel heretofore undiscovered/unrecognized pathogen, or bio-engineered pathogen. New "signals" must be identified and the proper responses provided for. "Signals in noise" must be discerned and put in context with and measured against routine disease outbreaks. A robust system of integrated biosurveillance, through the proper "kits" of low-, medium-, and high-resolution diagnostics, best position the CBDP to provide agile and comprehensive support to the warfighter. This is true whether the focus required is force health protection, humanitarian assistance, global biosurveillance, or intelligence to support operational or policy decisions. Despite the fact that other government agencies have been involved with pathogen detection for many years, the CBDP does not currently have the required completed hierarchy of Food and Drug Administration (FDA)-approved diagnostics outlined above. Nor does it appear that there is any defined path through other government agencies to achieve this goal, for reasons that are beyond the scope of this committee.8 Thus, it appears to be imperative for CBDP to take up the charge of ensuring that the warfighters are provided optimal protection by ensuring that appro- priate FDA-approved diagnostics are available to global biosurveillance efforts, as well as available for use in DoD medical facilities in theaters of operation worldwide. To the extent that US regulatory policies and procedures impede the timely delivery of modern diagnostics and effec- tive countermeasures to the warfighter, CBDP should continue to actively engage with the FDA to provide needed improvements. The responsibility to ensure that the DoD health monitoring needs9 are achieved clearly lies within the DoD. Ideally, more diagnostics could be leveraged from the Department of Health and Human Services (HHS) via the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), and/or the United States Department of Agriculture (USDA) for animal or other host/vector diagnostics, but it does not appear likely that timely completion of the required hierarchy of 8 As discussed in Chapter 5, research-development-acquisition of medical products face unique challenges, including obtaining FDA approval. FDA-approved diagnostics may be an unrealistic goal, especially for diseases endemic to developing countries, as funding to support the development of FDA-approved diagnostics is not supported by the eventual potential market for those tests. 9 DoD health monitoring needs for the warfighter and civilian personnel are to be aware of, and be able to protect and respond to, threats to health and readiness, including those diseases that are endemic or presenting wherever DoD operates.

OCR for page 35
CORE SCIENCES AND TECHNOLOGY CAPABILITIES 43 diagnostics will be achieved via these routes.10 Much of the work to create and test pathogen diagnostics could be performed outside of DoD and other government agencies (under appropriate government contracting methods). However, live-agent testing for many high-consequence patho- gens may need to continue to be performed within government facilities to ensure the ability to do so. Environmental Monitoring The DoD desires to operate in a "detect to warn" mode, which trans- lates most broadly into "detect an approaching cloud of chemical or biological agent swiftly enough to issue a warning for the warfighters to don their protective gear." Thus, the committee's operational definition of environmental monitoring is what is known as "standoff detection," and typically would be utilized in the event of either a deliberate attack (chemical or biological) or an industrial accident (most likely chemical, but potentially biological). Standoff detection is a perennial high-priority request for CBDP for base protection. Standoff detection of potentially dangerous chemical or biological materials is a difficult goal to achieve considering the relation- ship of distance and agent concentration upon signal detection. Achieving acceptable false positive and negative rates, considering the enormous confounding background of potential aerosolized materials, also adds to the challenge. The high concentrations of agent that are likely required for standoff detection to provide a clear signal requires the dispersion of large quantities of material--something that is less likely to be the case in an asymmetric warfare situation.11 In light of these challenges, it is clear that expertise must be obtained via collaborations between experts out- side of the government with expertise and testing facilities within DoD and potentially other government agencies. Unexplored, but of potential promise, is adapting the multimodal architecture which evolved in coun- tering improvised explosive devices to the chemical or biological detec- tion problem (i.e., using more conventional ISR techniques that identify and track suspicious activities to queue forward deployment of chemical or biological detection systems). 10 While it may be possible for DoD to acquire existing diagnostics from other government agencies, assay inadequacies due to age and issues related to the particular platforms used by other agencies make adoption difficult. No other agency is currently funding the range and hierarchy of modern diagnostics that the DoD requires for its worldwide missions. 11 The committee is in general agreement that active point detection (e.g., sensors in a drone) may be more likely to achieve desired results within reasonable time/cost/error constraints.

OCR for page 35
44 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE Unknown Agent Identification and Characterization Continuing human encroachment upon remaining wild lands world- wide, particularly in tropical or subtropical climatic regions, has con- tributed to a continuing stream of "novel" pathogen outbreaks in recent decades. Severe acute respiratory syndrome (SARS), Ebola, and Nipah are three biological examples of novel pathogens. Non-traditional agents are similarly unpredictable in the chemical domain. DoD requires that there be a robust (available, timely, and skilled) capability to identify and char- acterize unknown agents, both biological and chemical. This capability can be generalized as a hierarchy of detection approaches: [low resolution] presumptive field assays (rapid and inexpensive) that can rule dangerous agents in or out; [medium resolution] sensitive laboratory confirmatory tests for all known dangerous agents (biological or chemical); and [high resolution] robust suite of broad-spectrum analysis technologies to detect and characterize new, mutated, or engineered dangerous agents. In this area today, DoD collaborates with many of the best researchers outside of government. However, it may well be necessary that DoD have an in-house capability so that classified samples can be processed. It is important that a robust identification and characterization capability for unknown agents be maintained. DoD has facilities and competent staff who should certainly be part of this capability. There are other non-DoD gov- ernment agencies such as the Department of Homeland Security's (DHS) National Biodefense Analysis and Countermeasures Center (NBACC) facilities that have competence with unknown agent identification and characterization that can be considered part of the overall capability. CBDP is currently sponsoring strong collaborations outside DoD for unknown biological agent identification and characterization. This collab- oration involves scientists at DoD laboratories and is providing valuable training and technology transfer to their facilities. This successful model should be sustained and enlarged to include other key US participants as part of a robust US response to novel biothreats. CHEMICAL AND BIOLOGICAL AGENT DETECTION Detection of relevant chemical and biological agents is an important capability that underpins the CBDP. Sensors are needed that not only detect and identify agents over a wide range of concentrations, but also quan- tify airborne, waterborne, and surface contamination levels with adequate specificity to minimize false positives while responding as near to real time (seconds) as possible. The program has developed a wide range of point detectors with varying levels of sensitivity, specificity, and response times for a variety of relevant agents. In many cases improvements in sensitivity, specificity, response time, automation, robustness, size, weight, power consumption, and consumable reagent use would be beneficial. The

OCR for page 35
CORE SCIENCES AND TECHNOLOGY CAPABILITIES 45 development of standoff detection instruments with adequate sensitivity, specificity, response times, and multiagent capability has been difficult. Systems that substitute real-time point agent detection deployed on unmanned air or ground vehicles may supplement or replace traditional remote sensing systems. Agent detection instrumentation systems that include automated sample collection, instrument control, data acquisition, and analysis and handling must be engineered for both laboratory and field use; and suites of instruments may need to be integrated with either static or mobile platforms for field deployment. Accurate agent transport analysis models to predict future agent distributions based on current agent distributions are also required. The committee has identified four primary S&T capabilities that are required for the CBDP to achieve their Chemical and Biological Agent Detection objectives. The S&T capabilities are Analytical Methods Dis- covery, Instrumentation Development, Sensor Systems Development, and Agent Transport Analysis. Analytical Methods Discovery Current and anticipated chemical and biological agents must be characterized to identify and assess unique molecular and/or biologi- cal features that can be exploited to allow detection at acceptable levels of sensitivity and specificity in as near real time as possible. Chemical agent detection might be based on spectroscopic, mass spectrometric and/or chromatographic or mobility properties of the molecular agent or a derivative agent reaction product. For biological agents, detection may be based on DNA or other biomarker identification (e.g., protein, RNA). The capability to determine which structural and/or reactive agent prop- erties can be exploited for reliable agent detection is the critical first step in developing reliable analytical agent detection methods. Subsequent experimental work can determine which identified analytical methods are reproducible, robust, and inexpensive enough that they could be developed into reliable laboratory and field agent detection technologies. Analytical methods discovery is primarily a basic science endeavor in molecular recognition. This capability can be obtained in DoD labora- tories, other government laboratories and in academic and private-sector laboratories. However, the ability to provide and safely handle the chemi- cal and biological agents12 necessary to test and assess analytical methods is reliably found in DoD facilities (including test ranges). 12 The committee recognizes that there are many laboratories throughout the United States with the capability to work with up to Biosafety Level 4 (BSL-4) pathogens. These private laboratories, however, can be closed at any time for any reason (e.g., an accident at a pri- vately owned BSL-4 laboratory may lead to immediate, and possibly permanent, closure).

OCR for page 35
62 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE Forensics An important goal of CBDP is detecting and mitigating chemical and biological threats to the warfighter. A secondary goal, however, is to develop answers to key intelligence questions related to the perpetra- tors, origin of the source materials, and how the biological or chemical weapon was produced and disseminated. For example: How did a food poisoning event transpire? Was anthrax used on US or allied forces from a natural exposure in contaminated soil or was it engineered in some fashion to be more lethal? Was it a strain one would expect to find in that location of the world? Could it be associated with a strain that has been or could be identified as having originated from a known facility? Could any chemical signatures in the agent used on US or allied forces indicate what production process was used, who might have the capacity and competency to produce or disseminate agent, and who might have aided the perpetrators? Chemical and biological weapons forensics may leverage many of the techniques and technologies used for detection diagnostics, plus other techniques that examine orthogonal dimensions (e.g., isotopes in the water used in manufacturing might provide a clue to origin). CBDP has invested in some of these activities. For example, DNA sequence analysis may drive both the development of detection diagnostics and supply evidence of potential genetic engineering, which is of forensic value. For several reasons, the DoD chemical and biological laboratories may be involved in attempts to augment other US government capabilities to perform forensic analysis of incidents affecting US forces in order to inform attribution decisions and mission planning and decision making. The committee is aware that chemical and biological forensics is not currently in the purview of CBDP, but is handled by other DoD and DOE elements. Chemical forensics is handled primarily at two sites (ECBC and LLNL). Bioforensics is presently in a more nascent form. Greater synergy between the CBDP, DHS, and intelligence community programs, including the Defense Intelligence Agency, could prove useful to improve overall DoD diagnostics and forensics capabilities. Education and Training Implementation of capability in CBD will usually have components in both technology and training in use of the technology: the latter may be the more difficult, but depends on the former. Ease of use is a key concern in the development of most CBD programs. The development of aids for education and training has been a long- standing interest in the DoD, with programs such as SIMNET and the Medical Management of Biological Casualties "Blue Book" being pioneer-

OCR for page 35
CORE SCIENCES AND TECHNOLOGY CAPABILITIES 63 ing efforts. Adapting computer-aided programs from a wide variety of apparently unrelated activities (e.g., for sonar operators, helicopter pilots, and sniper detection) could provide useful methodology at relatively low cost. The development of realistic training protocols, with long-lasting impact, is a more complex subject. Since technology for CBD cannot be tested and learned in a "real" environment (as in live-fire exercises), and since a serious CB attack, or even a threat of one, produces great confusion and misuse of technology (as judged from experiences in the early days of the Iraq wars), the development of adaptable, durable, robust training protocols for users is an important issue, but one from which there is little established technology. Behavioral Analysis Earlier we discussed how physiology was important to study the impact of chemical and biological protection on the physical ability of the warfighter to function in protective gear. Similarly, behavioral analysis is important to understand the mental state of those required to perform their missions under the added mental and physical stress of an impend- ing or actual chemical or biological attack. Even if individual and collective protection gear functions perfectly as designed, there may be individuals who increase their risk of exposure due to behavioral factors (e.g., claustrophobia, extreme irritability due to discomfort, etc.). It is important for CBDP to learn as early as possible in the design, development, and test cycle whether new equipment has any characteristics that may increase the likelihood of such behaviors. A thorough understanding of behavioral factors may also provide useful design requirements. Most human behavioral expertise resides in academia. Close collabo- ration between academia and DoD researchers, product developers, and operators will be needed to effectively translate this expertise into a useful outcome for the DoD. Systems Analysis and Engineering System analysis refers to an overall analysis of the various alterna- tive means of meeting the mission requirements. Cost/benefit, threats, CONOPs, manufacturability, human factors, and behavioral analysis are all capabilities needed to conduct an appropriate systems analysis. Sys- tems engineering refers to the detailed examination of how the totality of an individual system is likely to perform in its operational environ- ment. Computer simulations are a critical part of systems engineering and include many factors of informatics.

OCR for page 35
64 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE A system analysis performed early in the R&D process can often eliminate technically interesting but operationally inadequate solutions. Integrating end-user expertise into a system analysis can lead to discovery of entirely new solutions to mission requirements. Without systems engineering, the performed solution at best may be overly expensive, and at worst will fail to meet operational requirements. System analysis and engineering are critical to CBDP, especially when incorporated into the process at early stages and updated throughout the RDT&E process. High-quality system engineering and analysis capability exists both inside and outside the government, although it does not seem to be resident throughout the CBDP. Repurposing Commercial Technologies The committee encourages the entire CBD community to take an active approach to following scientifically related fields of R&D and prod- uct development in an effort to identify non-CBDP projects, products, and personnel that may aid the CBDP meet its mission without direct, or with reduced, investment and shorten time to solution. Most of the activities involved (literature and public press tracking, active engagements in societal meetings, and engagement of fellow US government colleagues) are likely performed already by nearly every CBDP scientist and manager. Additionally, actively engaging pre-competitive alliances (particularly in the pharmaceutical industry) could provide the CBDP with sufficient direct awareness of the research-of-interest and partnership connectivity to justify the relatively modest membership fees. In the procurement-type strategy much of the innovation for the required DoD capability or product is developed during the early stages of research and then subsequently transitioned into a scale that is needed. In some cases however, due to the rapidity of technology development, such as the materials sector and medical research, there can be a sig- nificant breakthrough that could rapidly be incorporated to provide a needed product.18 The procurement mechanism lends itself toward the development of "blinders" that may mask the incorporation of concurrent innovative solutions to ongoing needs by limiting the ability of incor- porating new concepts or emerging technologies into the process. The incorporation of a "tech watch" concept into the existing practice would have two elements, (1) mechanisms for searching and identifying relevant breakthroughs in the literature and private sector and (2) mechanisms 18 As an example, the National Cancer Institute (NCI) has recently issued a solicitation for testing their older and unused drug candidates for new purposes. In this case, AZT was in the NCI drug archive and later found new use as the best therapeutic for HIV/AIDS.

OCR for page 35
CORE SCIENCES AND TECHNOLOGY CAPABILITIES 65 and processes in place for incorporating the innovation into a T&E for the capability needed. The DoD researchers might help focus the off-label requirement and specify the need for detectors with new assay capabilities (and contrib- ute to the new assay development itself). It is not clear that a major role exists for the DoD laboratories to run large-scale repurposing panels or to perform detector repurposing development. The culture of program man- agers and scientists within the DoD should dictate that they are "smart buyers" first before a major RDT&E investment is made. Systems Biology Systems biology studies how the many different networks or systems within one or more living organisms interact. One example might be how proteins from some viral pathogens spoof their way past human immune defenses and hijack human proteins in order to accomplish replication of the attacking virus, with a byproduct being human illness. By defini- tion, systems biology requires a complex collaborative interconnection and integration of diverse sets of knowledge and expertise. One hope for systems biology is the future ability to automatically analyze pathways in multiple pathogens (and their corresponding responses in hosts) to deter- mine potential broad-spectrum medical countermeasures. (Note that this was a goal of the former Transformational Medical Technologies program.) Systems biology is still very early in development, and most systems biology efforts in the pharmaceutical companies are conventional drug development programs that have been extended to include understand- ing of pathways rather than knowledge of single protein targets. Systems biology requires a strong base in fundamental science to be useful; it is not a silver bullet. Since chemical agents--especially nerve agents--attack multiple pathways, the topic is an ideal candidate for study in a systems biology program. Systems biology is being performed worldwide throughout the vari- ous biology communities. CBDP should be able to leverage much of this work. However, it appears probable that not all of the desired aspects of systems biology related to pathogenesis will be supplied by the academic research community or other government agencies. Thus, it is likely that CBDP will need to be selective in supporting necessary systems biology efforts related to key mission needs. Synthetic Chemistry and Biology Synthetic chemistry is now capable of synthesizing almost any small- to medium-sized molecule. Chemical synthesis is no longer rate limiting for chemical and biological defense.

OCR for page 35
66 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE "Synthetic biology" is a name given to the rational, biology-based synthesis of compounds (small molecules or large) that requires manipu- lation of synthetic pathways using metabolic and genomic tools. The abil- ity to use synthetic biology to recreate viruses and to create novel bacterial platforms should indicate to DoD that a useful fundamental capability is to be able to detect and characterize the application of synthetic biol- ogy applied for both beneficial and nefarious purposes. The timeline of when full mastery of synthetic biology will be achieved is unclear, but recent rapid advances in other aspects of biotechnology make it appear imprudent to suggest that massively engineered organisms will not be a potential threat in the near future, whether due to design or unintended consequences of a beneficial intention. Materials Science Materials science has a role to play in many of CBDP's R&D endeav- ors. Areas as diverse as temporary building construction materials to nanomaterials for targeted drug delivery and agent-surface transport modeling to studies on the degradation effects of decontamination meth- ods on textiles draw on the field. As a result, it is important that the DoD maintain at least a limited in-house infrastructure to perform research in materials science and to be available to consult and collaborate with scientists as needed across the program. This is also an area, however, where its very ubiquity has resulted in a great deal of expertise within the government and commercial sectors. Many examples can be found in the field of nanotechnology, which has received heavy investment over the past decade. To leverage these resources effectively, it will be necessary for CBDP to encourage collaboration and engagement with those broad communities. Test and Evaluation The materials and space required, access to live agents, and knowl- edge of the operational realities and environments in which the warfight- ers function make test and evaluation a core S&T capability for CBDP. However, based on limited exposure to the program, the committee infers that T&E is an area that requires serious strengthening in areas relevant to CBD. Upon examination of the T&E structures in place, a number of questions emerge as difficult to answer: (1) Under what conditions of actual use (a combat soldier, in MOP gear, with weapons, pack, ammo, comms, under fire, in an environment with mud, thorns, rocks, sweat, and water) are the suits protective, and against what agents? (2) How, exactly, are these evaluations carried out (and they must incorporate simulants or

OCR for page 35
CORE SCIENCES AND TECHNOLOGY CAPABILITIES 67 "hazards" that are already environmentally common, e.g., diesel smoke as a particulate, poison oak/ivy as ground cover, fluorescent particles in dirt in an alley, and food dye in the wet sand of a landing zone). Test and eval- uation protocols should be designed with consideration of the CONOPs the gear is intended to support. Data collected under controlled test con- ditions (and even the test conditions themselves) must be evaluated to aid in estimates of real world mission consequences and effectiveness. The point of urging much more realistic and demanding T&E is to encourage development of a culture in which T&E produces accurate evaluations of how protective equipment, detectors, and operational doc- trine function under conditions of use in conflict. This applies not just to the development of new equipment or materials, but also to currently fielded equipment that may have to protect against new threats. For example, established CONOPs may need to be revised if fielded equip- ment does not provide the same level of protection against an emerging agent as against the traditional agents. In order for a commander to plan and execute operations, it is important that test results can be collected, evaluated, and presented in a way that provides accurate information regarding possible casualties under a variety of conditions (lightly or heavily contaminated, damp or dry environment, etc.) and any restric- tions or limitations on mission-critical activities that protective gear may introduce. SUMMARY OF CBDP CORE CAPABILITIES The committee identified 39 core chemical and biological defense S&T capabilities and created a framework that groups them in six categories. Using the decision framework discussed above the committee found that almost all of the capabilities can be found outside of the service labora- tories. For each capability, R&D and T&E are discussed separately and typically were not best suited to the same organization. The committee considered four types of institutions with laboratories that may be suited to provide CBDP core capabilities and organized them from typically having the most fundamental-science-focused to the most product-focused research. These institutions are (1) academia, (2) other governmental facilities (e.g., NIH, CDC, DOE National Labs, NIST), (3) DoD laboratories and facilities, and (4) industry (e.g., pharmaceutical companies). For some capabilities, T&E requires use of actual agent;19 19 Actual agent testing refers to the actual chemical or biological agent the capability is being tested against (e.g., Vx, Sarin, sulfur mustard, anthrax, tularemia, botulinum toxin), as opposed to testing with simulants.

OCR for page 35
68 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE institutions other than DoD laboratories may be well suited to do the work but would need to do so in close collaboration with DoD. Table 3.2, which summarizes the committee's judgments about how well suited the types of institutions are for R&D and for T&E with respect to 26 of the core capabilities, is reproduced below. Dark shades indicate an institutional category that the committee views as well suited to main- tain a given capability for the CBDP, while the lighter shade indicates less well-suited locales. The white boxes indicate that the institutional category is, in the committee's view, not well suited to maintain the capa- bility. The other 13 capabilities are cross-cutting science and technology that the committee views as necessary for effective RDT&E for any of the capabilities defined in the preceding capability categories. Discussion of the potential locales for the cross-cutting science and technology capabili- ties were discussed previously in this chapter. The committee does not intend to imply that each of the thirteen cross-cutting capabilities be maintained exclusively, or indeed at all, within DoD. When considering the various locales for obtaining S&T capabilities, it is important to recognize that 1. the analysis of the various laboratory locales is general, and indi- vidual performers within a category may be exceptions; 2. the color coding of each category represents the aggregate of rea- sons considered, including but not limited to a. reputation and experience at providing the given capability, b. the extent to which the capability requires work with classified information, c. limitations on the locale of the capability resulting from inter- national treaties or other laws, and d. the need to maintain important capabilities, at least in part, at government facilities to ensure availability (e.g., BSL-4 facilities). FINDINGS AND RECOMMENDATIONS In identifying the science and technology capabilities necessary to support the Chemical and Biological Defense Program, the committee identified the following principle findings and recommendations. Scientific Collaboration Finding 3.1: Little of the fundamental science required for CBD lies pri- marily in the DoD. The vast majority of the scientific research performed in the United States occurs in academic and industrial laboratories. This is

OCR for page 35
Table 3.2: Science & Technology Core Capabilities R&D T&E OGF DoD Industry OGF DoD Industry Academia Academia 1. Enabling CBRN ISR 6. Cross Cutting Science and Technology Information Acquisition & Analysis Acquisition, Maintenance and Transport of Health Monitoring Critical Chemical and Biological Reagents Environmental Monitoring Simulation Unknown Agent Identification and Characterization Informatics 2. Chemical & Biological Agent Detection Forensics Analytical Methods Discovery A Education and Training Instrumentation Development A Behavioral Analysis Sensor Systems Development A Systems Analysis and Engineering Agent Transport Analysis A Repurposing Commercial Technologies 3. Individual & Collective Protection Systems Biology A Table 3-1 Controlled Molecular Transport Materials Discovery Synthetic Chemistry and Biology Barrier Materials Engineering A Materials Science Personal Protective Systems Development A Statistical Measurement Design Collective Protective Systems Development A Test & Evaluation Physiology A 4. Medical Countermeasures Target Discovery In the committee's view, this category is: Broadside no caption Regulatory Science not well suited Mechanisms of Delivery & Delivery Systems less well suited Animal Models N/A well suited Host Response very well suited Pre-Clinical Studies N/A to provide this capability to CBDP Clinical Trials (GLP and GMP) Medical Product Development R&D: research and development 5. Hazard Assessment, Mgmt and Decon T&E: test and evaluation Decontamination Methods Discovery A OGF: other govenment facilities Decontaminant Development A A: the actual chemical or biological agent is Decontamination Resilient Materials Development A important for T&E Decontamination Systems Engineering A N/A: the capability does not have a major Agent Transport & Viability Analysis A R&D or T&E component 69

OCR for page 35
70 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE particularly true for the biological and chemical sciences which lie at the nexus of the S&T requirements of the CBDP. Finding 3.2: The military laboratory community is not as strongly part- nered with key external research institutions and programs as it could and should be. As the United States has a robust S&T sector, the CBDP can and does engage with individuals and organizations external to DoD and the US government, but this typically occurs at the individual proj- ect or principal investigator level, and not necessarily on a sustained basis. The CBDP has not systematically promoted institutional ties with academic, industrial (especially pharmaceutical companies), and other non-DoD laboratories or related federal programs. Recommendation 3.1: The Director, JSTO-CBD, should ensure that the development of a Culture of Collaboration is a high priority for all elements of the chemical and biological defense enterprise. Although information control requirements and contracting concerns have been stated as barriers on both sides to collaboration, these are issues that can and should be addressed. To ensure that the program delivers products based on the best S&T available, the CBDP needs to find ways to partner with the broader scientific community and other federal agencies in areas relevant to chemical and biological defense. Tech Watch and Adopt Finding 3.3: There is the potential to significantly improve chemical and biological defense capabilities by using existing technology. Despite the nation's superb biomedical research establishment and the explosive growth of biological and biomedical science that is relevant to DoD as well as the public health community, relatively little of this broad compe- tency has been applied to problems relevant to chemical and biological defense. Recommendation 3.2: The DASD(CBD) should establish an effective "tech watch and adopt" component within the CBDP to bring innovative solutions to ongoing needs. Program managers and scientists within the CBDP should recognize the importance of technology watch and adoption before a major new RDT&E investment is made. The incorporation of a "tech watch and adopt" concept would have at least the following three elements: (1) mechanisms for searching and identifying relevant break- throughs in the literature and from the private sector; (2) mechanisms and processes in place for incorporating innovation into the ongoing program

OCR for page 35
CORE SCIENCES AND TECHNOLOGY CAPABILITIES 71 for the capability needed; and (3) processes for rapid adoption of "tweaks" that would significantly improve existing capabilities. An adjunct objective would be to get the external performers interested in CBD problems such that they might be recruited to work on the problem. Linking R&D Community to Operators Finding 3.4: Separation of S&T performers from the end user is imped- ing their ability to meet the user's needs. Individuals in the military laboratories noted that understanding more fully the context of their work could assist S&T personnel in developing operationally relevant products, identifying variables or factors that would otherwise be overlooked, and possibly shortening development time. In addition, a stronger relation- ship between operators and R&D performers could support innovation by enabling informed, collaborative "blue sky thinking." Recommendation 3.3: The DASD(CBD) should survey the military laboratories and associated facilities to identify strong relationships between S&T performers and the warfighters, and support replication of such interactions across the program. Simulants for Test and Evaluation Finding 3.5: Broadly speaking, the capacity for test and evaluation to support the needs of the CBDP exists within DoD. Test and evaluation is a core component of the program and important to maintain within DoD at a high level of competency and responsiveness. Finding 3.6: Much of the current T&E is based on unrealistic expecta- tions of how the material or equipment being tested would actually be used. The threat, although long-standing, is uncertain. In addition, the lack of connection with the military operators often leads to the omission of realistic simulation of deployment and use environments. Recommendation 3.4: Because of the economic, logistical, and environ- mental concerns with actual agent testing, DASD(CBD) should give priority to the active development and production of realistic and rel- evant threat agent simulants for both outdoor and large-chamber tests. A single simulant, especially for chemical agents, is unlikely to possess all of the same physical, chemical, and/or transport properties of an actual agent; therefore, multiple simulants may be required to fully stress critical design parameters during T&E.

OCR for page 35
72 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE Review of Test and Evaluation Plans Finding 3.7: Test and evaluation plans apparently are not subject to independent external review. These plans are created internally, and the committee observed little evidence of the use of external expertise to review testing plans. Recommendation 3.5: For CBD products to be viable for fielding, the Deputy Under Secretary of the Army for Test and Evaluation should require that (1) T&E activities be based on testing protocols that accu- rately emulate actual operating environments (both threat properties and operator employment) and (2) independent reviews of testing pro- tocols be conducted.