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8

Conclusions and Recommendations

This chapter presents the committee’s conclusions and recommendations. It begins with a discussion of overarching issues, continues with specific recommendations for Army investment, and concludes with other findings on topics encountered during the study. The committee considered opportunities afforded by biotechnology in application categories relevant to soldier operations in the present and foreseeable future through 2025. In keeping with national policy, the study did not consider offensive biological weapons; however, the committee believes that all biotechnology development should be undertaken with defenses against such weapons in mind.

As requested in the Statement of Task, the committee considered technologies likely to be important to the Army in the next 25 years. As a framework for its evaluation of prospective and applicable biotechnologies, the committee developed a list of enduring Army applications, with topics listed in alphabetical order ( Table 8-1).

BIOTECHNOLOGY DEVELOPMENT AREAS

The committee evaluated biotechnology developments in five broad application categories: sensors; electronics and computing; materials; logistics; and therapeutics. The following areas in each category were then identified as providing significant opportunities for the Army:

  • sensors: assay analysis; detection methods; chip architectures

  • electronics and computing: protein-based devices; biocomputing; biomolecular hybrid devices

  • materials: tissue engineering; biologically inspired materials and processes; hybrid materials

  • logistics: miniaturization of biological devices; functional foods; biological energy sources; renewable resources

  • therapeutics: genomics and proteomics; drugs and vaccines; drug delivery systems

OVERARCHING CONCLUSIONS

The biotechnology industry now surpasses the aerospace industry in market capitalization, research expenditures, and complexity, and the research and development (R&D) budgets of the large pharmaceutical companies dwarf the Army’s R&D budget. Unlike traditional defense developers, commercial developers in biotechnology are “discovery-oriented”; that is, they are pursuing developments in many directions as determined by the marketplace, which so far is predominantly medical. The Army, however, has become used to managing and influencing R&D directed toward specific procurement objectives.

Conclusion 1. To keep pace with the unprecedented rate of discovery and the anticipated increase in biotechnology developments, the Army will have to establish new, effective partnerships with the emerging biotechnology industry, participate in research, leverage research and developments in the commercial sector, and develop its internal capabilities (organization and personnel) to act on opportunities as they arise.

The biotechnology industry is much less dependent on the military for its existence than other industries with which the Army and other services have routinely interacted. Therefore, the Army will have to use different mechanisms for involving industry in meeting Army needs.

Realizing new applications for biotechnology in a nonmedical area—armor, for example—will require the application of biological disciplines to areas outside traditional medical technology. Although most Army medical applications are similar to (sometimes identical to) civilian applications, nonmedical applications will be much more difficult to identify and influence.

Recommendation 1. The Army should adopt new approaches toward commercial developers to accommodate



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Page 73 8 Conclusions and Recommendations This chapter presents the committee’s conclusions and recommendations. It begins with a discussion of overarching issues, continues with specific recommendations for Army investment, and concludes with other findings on topics encountered during the study. The committee considered opportunities afforded by biotechnology in application categories relevant to soldier operations in the present and foreseeable future through 2025. In keeping with national policy, the study did not consider offensive biological weapons; however, the committee believes that all biotechnology development should be undertaken with defenses against such weapons in mind. As requested in the Statement of Task, the committee considered technologies likely to be important to the Army in the next 25 years. As a framework for its evaluation of prospective and applicable biotechnologies, the committee developed a list of enduring Army applications, with topics listed in alphabetical order ( Table 8-1). BIOTECHNOLOGY DEVELOPMENT AREAS The committee evaluated biotechnology developments in five broad application categories: sensors; electronics and computing; materials; logistics; and therapeutics. The following areas in each category were then identified as providing significant opportunities for the Army: sensors: assay analysis; detection methods; chip architectures electronics and computing: protein-based devices; biocomputing; biomolecular hybrid devices materials: tissue engineering; biologically inspired materials and processes; hybrid materials logistics: miniaturization of biological devices; functional foods; biological energy sources; renewable resources therapeutics: genomics and proteomics; drugs and vaccines; drug delivery systems OVERARCHING CONCLUSIONS The biotechnology industry now surpasses the aerospace industry in market capitalization, research expenditures, and complexity, and the research and development (R&D) budgets of the large pharmaceutical companies dwarf the Army’s R&D budget. Unlike traditional defense developers, commercial developers in biotechnology are “discovery-oriented”; that is, they are pursuing developments in many directions as determined by the marketplace, which so far is predominantly medical. The Army, however, has become used to managing and influencing R&D directed toward specific procurement objectives. Conclusion 1. To keep pace with the unprecedented rate of discovery and the anticipated increase in biotechnology developments, the Army will have to establish new, effective partnerships with the emerging biotechnology industry, participate in research, leverage research and developments in the commercial sector, and develop its internal capabilities (organization and personnel) to act on opportunities as they arise. The biotechnology industry is much less dependent on the military for its existence than other industries with which the Army and other services have routinely interacted. Therefore, the Army will have to use different mechanisms for involving industry in meeting Army needs. Realizing new applications for biotechnology in a nonmedical area—armor, for example—will require the application of biological disciplines to areas outside traditional medical technology. Although most Army medical applications are similar to (sometimes identical to) civilian applications, nonmedical applications will be much more difficult to identify and influence. Recommendation 1. The Army should adopt new approaches toward commercial developers to accommodate

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Page 74 TABLE 8-1 Prospective Army Applications Application Description Camouflage and concealment Biomaterials with stealth characteristics; nonilluminating paints and coatings. Combat identification Biological markers to distinguish friendly soldiers. Computing DNA computers to solve special problems; biologic models to suggest computer algorithms. Data fusion Associative memory and other protein-based devices; artificial intelligence. Functional foods Additives to improve nutrition, enhance digestion, improve storage characteristics, enable battlefield identification, reduce detectability; edible vaccines; fast-growing plants. Health monitoring Devices to provide feedback on soldier status, enable remote triage, and augment network of external sensors to provide intelligence on chemical, biological, or environmental agents. High-capacity data storage Rugged computer memories for individual soldiers. High-resolution imaging High-resolution alternatives to semiconductor imagers. Lightweight armor Protection for soldiers and combat systems; systems with living characteristics, such as self-repairing body armor. Novel materials Biologically inspired materials; biodegradable consumables; genetically engineered proteins; renewable resources. Performance enhancement Cortical implants; computer input and display interfaces; prostheses control; sensory enhancement; antidotal implants; gene-expression monitoring; performance-enhancing drugs. Radiation-resistant electronics Protein-based components; biomolecular hybrid devices; biomolecular diodes; bio-FETs (field effect transistors). Reductions in size and weight Cell-based processes; molecular electronics; biochips; nanotechnology. Sensing battlefield environments Laboratories-on-a-chip to detect and identify chemical, biological, and environmental threat molecules on the battlefield; coupling of diagnostic and therapeutic functions. Sensor networks Remote sensors mounted on vehicles and carried by soldiers to augment threat intelligence. Soldier therapeutics Drugs to counteract shock; genomics-based, directed therapies; optimized responsiveness to vaccines. Soldier-portable power Biological photovoltaics; cell-based energy systems. Target recognition Protein-based devices for pattern recognition; artificial intelligence. Vaccine development Reduced development and production times for small-scale requirements to respond to diseases encountered in exotic locales. Wound healing Engineered skin, tissue, and organs; wound dressings and treatments to curtail bleeding and accelerate healing. cultural differences between the government and the biotechnology industry. Mechanisms that would encourage fruitful relationships between government and industry include contracts that allow businesses to use regular business practices and protect intellectual property rights for nongovernment applications; government funding to mitigate the technical risks of producing prototypes; and minimal requirements for noncommercial, government accounting and audits. These measures would alleviate some of industry’s reservations about government contract regulations, restrictions on trade, and the possible negative perception of working with the military on “biological things.” In addition to working relationships with companies, the Army will have to form novel relationships with small and large industry organizations and other government agencies with the same or similar interests. Essential government partners include the National Institutes of Health (NIH), Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC). Making the most of these new relationships will require that the Army develop and maintain its own expertise in bioscience and bioengineering, both to contribute to and gain insights from the biotechnology community and to build on existing expertise and established relationships between the Army medical community and industry. Conclusion 2. Although medical applications are not the focus of the present study, the commercial markets for medical applications will determine the direction of developments in biotechnology in both medical and nonmedical categories. Engineers and scientists will necessarily become experts in areas that extend biology to other disciplines. To influence developments in Army-significant, nonmedical areas, Army personnel will have to expand their understanding of the role of biology. Future developments in biotechnology will be accomplished by groups of engineers and biological and physical

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Page 75scientists working together. To leverage discoveries and developments with the highest likelihood of payoff, the Army will need sophisticated in-house expertise in biologic disciplines related to genomics, drug discovery, biosensors, biomaterials, and other specialized areas. Monitoring commercial developments will require broader expertise than is normally required to conduct research. To develop and maintain the needed range of biotechnology expertise, the Army will require both a pool of educated personnel and a strong, in-house experimental program. Recommendation 2a. To operate effectively in the multidisciplinary environment of future biosystem development, the Army will have to invest in education. In addition to its existing expertise in medical research and development, the Army will need a cadre of science and technology professionals capable of translating advances in the biosciences into engineering practice. Ideally, these professionals will serve in a mix of permanent and rotating positions. The permanent positions would ensure full-time expertise and continuity of focus on biological developments outside the Army. The rotating positions would enable the Army to interact with key segments of the biotechnology industry and would ensure that the Army remains involved in the latest commercial developments. In short, this cadre of experts would monitor developments, enable the Army to identify new opportunities, publicize Army requirements, evaluate alternative biotechnologies, and otherwise influence the course of developments beyond traditional medical applications to future nonmedical applications. Recommendation 2b. The Army should conduct a study that focuses on future biomedical applications. The study should explore biological implants, biocompatibility, medical biomaterials, medical defenses against chemical and biological agents, and pharmacogenomics. These will have farreaching implications for future military operations but were outside the range of expertise represented on the study committee. PRIORITIES FOR RESEARCH The opportunities in biotechnology discussed in this report are summarized in Table 8-2. Each item includes the committee’s recommended investment priority, estimated time frame for realization (i.e., midterm [5 to 15 years] or far term [15 to 25 years]), and level of commercial interest. The Army should be especially vigilant in monitoring technologies with high commercial interest in anticipation of industry developments that might be leveraged to meet the Army’s needs. The committee recommended an investment priority of high, medium, or low for each biotechnology area covered by the study. Army investments in research can be catalytic and serve the purposes of both the Army and society as a whole. Commercial technology developments may also go a long way toward addressing Army needs. The committee recommended a “high” investment priority if the technology applications are likely to fill a perceived void for the Army on future battlefields, if the biotechnology appears to offer the most promising avenue toward solving an Army problem, and if the biotechnology is not likely to be developed by industry. A “medium” investment priority was recommended in areas where an Army-sponsored research activity can be used to help open windows on commercial developments; such activities might be conducted as in-house basic research or in the context of cooperative agreements with academia or industry. A “low” priority for investment was assigned to biotechnology areas that should be monitored by an Army expert but do not appear at this time to justify research funding. Conclusion 3. Five biotechnology areas meet the criteria for high-priority Army investment. These biotechnologies are highly likely to support applications for predicted, Army-unique mission requirements in the next 25 years. In addition, the committee identified four other areas with significant military potential in which focused research investments would help to surmount barriers to developments. Recommendation 3a. The Army should focus its research in the following high-priority areas in which developments are likely to be accelerated by Army investment: three-dimensional (volumetric) memory for rugged data storage self-replicating systems for wound healing small-scale vaccine production shock therapeutics vaccine stratification by genomics and toxicogenomics Recommendation 3b. The Army should support basic research in the following areas to overcome barriers to development: determination of target threat molecules for sensors proteins for radiation-resistant electronics hierarchical design models for bioinspired materials structural interfaces for device substructures Conclusion 4. Most of the biotechnology areas with high potential for the Army are subjects of ongoing research and development by government and/or industry. Continued research in these areas is highly likely to result in near-term advances that will be important for future Army applications. Regardless of the priority assigned by the committee, a biotechnology area may still be important to the Army because opportunities arising from advances in the fundamental biosciences may appear on the horizon with little or no

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Page 76 TABLE 8-2 Biotechnology Development Areas Development Area Biotechnology Investment Priority Time Frame Commercial Interest Assay Analysis Microfabrication/microfluidics medium midterm high Affinity reagents medium midterm high Detection Methods Optical detectors low midterm high Detector arrays of affinity molecules; DNA chips; protein chips; medium midterm high Protein-Based Devices Optical-holographic high-density memories low midterm medium Three-dimensional volumetric memories high midterm low Associative memories and processors medium midterm medium Artificial retinas low midterm low Pattern-recognition systems medium midterm low Spatial light modulators low near term low Biocomputing Biological models medium far term low DNA computers low far term low Biomolecular Hybrid Devices DNA-based optical-signal processing low midterm medium Biomolecular diodes low midterm low Tissue Engineering Cartilage repair and replacement medium midterm high Neural bridging low far term medium Self-replicating systems high far term medium Stem cells medium far term high Synthetic biomaterials low far term medium Portable, artificial, assisting devices low far term high Bioinspired and Hybrid Materials Biologically produced materials medium far term medium Biomineralization: organic/inorganic nanocomposites low far term medium Hierarchical systems; biocomposites medium midterm medium Miniaturization Technologies Microreaction technologies low midterm high MEMS-based microfluidic systems medium midterm high Biochip architectures low midterm high Biological nanotechnology medium far term high Functional Foods Genetically engineered foods low near term high Edible vaccines medium midterm medium Biological Sources of Energy Biological photovoltaics medium midterm medium Renewable Resources Renewable fuels medium midterm high Nonmedical specialty products based on engineered organisms low near term medium Ecological life-support systems low midterm low Genomics and Proteomics Genomics data-gathering techniques medium midterm high Gene-expression monitoring medium midterm high Protein profiling low midterm medium Biospectroscopic instruments; terahertz spectroscopy and analysis low midterm high Vaccine stratification by genomics and toxicogenomics high midterm high Therapeutic Drugs and Vaccines Small-scale vaccine production high midterm low Small-molecule and protein therapeutics low midterm high Genomics-based vaccine developments high midterm high Shock therapeutics high midterm medium Drug Delivery Biocapsules low midterm high Implantable antidotes midterm midterm midterm Somatic gene therapy low far term high

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Page 77 warning. It is also possible that development of a particular biotechnology by a potential adversary would increase its importance to the Army. Recommendation 4. The Army should monitor near-term developments in all of the biotechnology areas listed in Table 8-2, regardless of the investment priority. The list should be updated to accommodate new opportunities as they arise. BARRIERS NOT AMENABLE TO RESEARCH The committee identified several barriers to the development of biotechnologies that could not readily be overcome by more research. These include: collection mechanisms for target threat molecules ethical and privacy issues that could limit the application of genomics and other biotechnologies and public perception that genetically modified organisms are undesirable increasing globalization of development and manufacturing expertise certification of biomaterials and nonmedical devices length of clinical trials required for development of vaccines Conclusion 5. Miniaturized, biologically based sensing devices could significantly counter “unseen” threats on the battlefield. Timely sensing of biological, as opposed to chemical, agents will require a broad-based network of both internal and external sensing devices. These devices will require development of micro/nanotechnologies, as well as testing facilities to validate the resulting products. Many of the necessary micro/nanotechnologies will only be developed in response to clearly defined Army (or other DOD) requirements. Recommendation 5. To influence the direction of commercial developments, the Army should immediately devise strategic and tactical concepts for the detection of target threat molecules and identify Army-unique battlefield requirements for internal (health monitoring) and external (environmental monitoring) sensors. The tactical concepts should address sensing, monitoring, and networking capabilities, as well as interfaces with tactical intelligence systems. Conclusion 6. The Army can take advantage of commercial developments in gene-expression monitoring and proteinprofiling systems and techniques that could lead to devices and technologies for monitoring threats to soldiers in the field (as mirrored via gene expression in response to external stimuli) and provide a foundation for new methods of improving soldier training and performance. Recommendation 6a. The Army should optimize geneexpression-monitoring techniques for soldier applications, especially for the detection of target threat molecules through toxicogenomics. Recommendation 6b. The Army should develop predictors of individualized immune responses to vaccines so that they can be tailored to genotypes. It should lead the way in laying the groundwork for the open, disciplined use of genomic data to enhance soldiers’ health and to improve their performance on the battlefield. Conclusion 7. The Army, and the country as a whole, are becoming increasingly dependent on foreign sources for many critical therapeutic materials, such as wound treatments, vaccines, and pharmaceuticals. At the same time, federal and state regulations have restricted both military and civilian research and development in therapeutics. In exceptional circumstances, national defense needs might warrant special dispensation from these regulations, and the Army should have legal recourse for requesting exceptions. For example, in urgent cases, the Army simply cannot wait until developers can meet the extremely high (>99.99 percent) effectiveness demanded by federal regulators and civilian consumers for new therapeutics. In such cases, the development of vaccines and antidotes, quasimedical devices, and biotechnology products for nonmedical uses could be accelerated to meet specific military requirements. Recommendation 7a. Although the cost of investing in manufacturing infrastructure would be prohibitive, the Army should develop and maintain a database of global manufacturing capabilities, including the biology, processes, and equipment necessary to produce critical therapeutic materials. This database should also include key upstream and downstream aspects of the pharmaceutical industry, such as the status of clinical trials. Recommendation 7b. The Army should define and petition the government to certify special processes for rapid development and approval of biotechnology applications that meet exceptional Army and other defense needs. The Army and the Department of Defense must have the ability to identify exceptional requirements and expedite the development of products that could potentially benefit soldiers confronted with an urgent threat or special need. Conclusion 8. Developments in cell biology, immunology, molecular genetics, and genomics have led to new concepts that could greatly improve the safety and efficacy of vaccines and reduce the time and lower the cost of vaccine de-

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Page 78velopment and production. The Army must be able to respond to threats with vaccines and antibiotics in weeks rather than years. As the pace of genomics advances quickens, the Army will be hard pressed to take advantage of the many opportunities for providing better vaccines more quickly. Reducing the time involved in clinical trials, which routinely involve large populations, should be a high priority. Recommendation 8a. The Army should build on its strengths in the development of vaccines by funding new technological approaches that could shorten the time for the development and production of vaccines in response to observed pathogens. These include engineered virus-based vaccines and other genomics developments, such as DNA vaccines, cell-based vaccines, and monoclonal antibodies. Recommendation 8b. The Army should explore (1) using transgenics to shorten the clinical trial phase for defining toxicity and (2) using pharmacogenomics to shorten the time for Phase III clinical trials.