Future R&D Environments (Compass series)

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The ability of structural or functional materials to contact blood or other tissue without damaging it is critical for artificial and hybrid organ design. The effect of synthetic material composition, form, and surface properties on normal tissue growth is key to generating replacement tissues or guiding tissue growth in situ.


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Finding substrates that can adsorb macromolecules without denaturing them is a requirement for biochip development. New synthetic material matrices can create opportunities for controlled drug release systems or selective membrane barriers. Because of enormous progress in materials science, discussed in detail below, new methods are being rapidly developed for designing materials with well-defined bulk and surface properties at size scales from the molecular to the macroscopic.

Instrumentation for analyzing surface properties is providing increasingly detailed information on the dynamics of the interactions between biologics and surfaces, which can be fed back into the materials design process. Some of the areas likely to benefit from these developments are described in the next few sections.

Assays Surfaces are critical to microarray technologies. For example, arrays manufactured by spotting nucleic acid probes must be prepared so as to anchor the probes while not adsorbing the targets; arrays of protein probes must bind tightly, but not so tightly as to alter the secondary or tertiary structure of a probe.

Proteins are generally more sensitive to the properties of substrates than are nucleic acids, and they tend to denature at interfaces, a problem whose severity increases as the ratio of surface area to sample volume increases. At present, different systems use different surfaces, which makes quantitative comparison of assays difficult.

The accuracy of gene identification, quantitation of gene expression level, and sensitivity of the various assay systems are not yet uniform across biochip sources.

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However, finding the best surface for a specific application is quickly moving from art to science. If they are, it will be possible for these assays to be more uniform, facilitating their medical use. Tissues The development of methods to grow various tissues is proceeding at a moderate pace. Sophisticated scaffoldings have been developed on which to attach and grow cells. These scaffoldings, frequently made of biodegradable polymers, have very specific geometric forms and are usually impregnated with growth factors or other solutes not only to ensure cell growth but also to control cell orientation and induce patterns of aggregation that mimic natural tissues and promote normal cell function.

Epithelial tissue grown this way is already available as a commercial product for the treatment of severe burns, and a great deal of progress has been made in promoting the re-endothelialization of synthetic vascular grafts. There has also been a good deal of laboratory success in the generation of neurons. These successes have, in almost all instances, involved culturing already differentiated cells. The current experiments with adult stem cells and the recently altered federal policy on the support of embryonic stem cell research promise very rapid progress in the near future in the generation of an increasingly broad range of tissue types, with improvements in both function and longevity of the tissues produced.

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Progress is likely to depend on our ability to predict the longterm behavior of these tissues from short-term observations of the physical and chemical interactions between cells and the matrices on which they are grown. Usually this involves a perm-selective boundary through which chemical signals from the bloodstream can pass, stimulating the cells to produce proteins or other molecules that can pass back into the bloodstream but not allowing the active constituents of the immune system to reach the cells.

The technical challenges are the design of the perm-selective membranes, the matrix for the support of the cells, and the system for maintaining them in a viable state. The last decade has seen major advances in designing artificial pancreases that can carry out at least some functions of the liver. New materials and new understanding of mammalian cell and cell membrane phenomena should accelerate progress in this area in the next decade, and stem cell research may well provide a new, much larger source of cell material for these devices, removing what has been a significant limitation in their design thus far.

Advances in immunology and molecular biology lead us to expect substantial progress in this direction during the next decade. In particular, progress in understanding anergy—the process by which cytotoxic cells can be made tolerant to, rather than activated by, specific antigenic signals— offers, for the first time, a realistic hope for effective immunosuppression without continuous drug therapy. In addition, progress in pathway mapping, especially as related to apoptosis, or cell death, opens the possibility of targeting specific cytotoxic T cells cells that mediate rejection for programmed death.

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Even if the rejection problem is solved, however, the limited availability of human tissue or organs for transplant remains a problem. It is a problem more social than technical, in that organ and tissue donation in the United States and most other countries is well below the theoretical level.

Therefore, if a significant breakthrough in the number of transplants is to occur in the next decade, there will have to be both a solution to the rejection problem and breakthroughs in tissue engineering that allow the synthesis of a large number of human tissues and organs. An alternative approach is xenotransplantation, the use of animal cells and organs to replace or assist failing organs in humans. This area is heavily funded by the pharmaceutical industry.

However, it is also controversial. This last objection, or at least the broad public resonance with it, is somewhat mitigated if primates are not the source of the transplants.

However, it seems at best uncertain, and at worst unlikely, that the broad range of objections coming from different directions will be overcome in the next decade. Medical Devices and Instrumentation The advances in materials science and information technology that are making such a profound difference in molecular and cellular biology and tissue engineering have been equally important for the development of new, experimental measurement techniques and new medical devices. When combined with new sensors that take advantage of nuclear and atomic signals—for example, nuclear magnetic resonance and positron emission tomography—they allow the imaging of chemical interactions and processes, such as inflammation and substrate metabolism.

Indeed, recent initiatives of the National Institutes of Health and the National Science Foundation, as well as private foundations, have already produced molecular imaging data that could allow significant insights into active physiologic and pathologic processes at the organ and cell levels. The miniaturization of optical devices and electromechanical systems has also made possible new devices for minimally invasive surgery and for remote tissue manipulation. These are already routinely used, but there is every indication that there will be an enormous expansion in their use in the next decade, with microchips embedded in MEMS systems to create quasi-autonomous microsurgical tools.

Since these technical advances are also likely to result in reduced morbidity and reduced costs for hospitalization, this is one area of medical technology where the market signals are expected to foster further technical developments. One implication of these developments is that the distinction between diagnostic instrument, or monitor, and therapeutic device is rapidly becoming blurred. Implanted defibrillators combine the function of heart monitor and heart regulator.

Microsurgical tools for cataract removal can navigate themselves into position by measuring local tissue characteristics and then perform their surgical function. The next 10 years are likely to see a great proliferation of such devices. This has led to the introduction of telemedicine: diagnosis of a patient by a physician hundreds of miles away using images transmitted either by digital or analog signal and—even—robot-mediated remote surgery.

In this area, as well as in therapeutics, investigators sometimes work for or start companies to develop the devices they are testing, creating potential conflicts of interest. The ethical implications of this and other commercially relevant medical research will have to be addressed to protect the interests of patients, researchers, and research institutions and to avoid patient injuries and public backlash. A number of companies are working on ways to automate the process by allowing monitors that are implanted in the patient or merely connected to implanted sensors to transmit their signals remotely to computers that can record the information, automatically make adjustments through chips embedded in therapeutic devices implanted in the patient, or advise the patient on changes in drug regimens or on other adjustments that he or she should make.

At present, the technology is at an early stage, and there are a number of different approaches to its design and use. What the approaches have in common is that they provide the patient with a certain degree of health care autonomy, which is becoming attractive to more and more patients. From a technical point of view, one of the greatest challenges in improving the usefulness of these systems is the lack of compatibility among different monitoring systems and the lack of uniformity between these products and large hospital or laboratory information systems.

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Groups are working on the development of uniform digital data and patient record systems which, if adopted, are likely to stimulate a rapid expansion in the use of these technologies, many with new chipbased diagnostic devices that put the patient more directly in charge of his or her health.

A more immediate force for autonomy is the Internet and the information it provides. Indeed, it has been noted that the most popular sites on the Internet are those that provide health information.

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Individuals are able to know or to believe they know more about their condition and their options than was previously the case. The Internet changes the nature of the communication between patients and their healthcare providers. The main concern here is the reliability of information from Internet sites.

In addition to the authentic scientific data and professional opinions that are available, much misinformation and commercial information also find their way to patients. If adequate quality control and standards are instituted, the Web will be a major force for autonomy.

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Two interesting and important questions face the field in the next decade. Who will take responsibility for validating the accuracy of information on the Web? How will that validation system be implemented? Much of the information is based on federally funded research, and federal agencies have Web sites with authoritative and up-to-date health information. Using many of the same highthroughput techniques and data management systems, the genomes of a number of plant species have already been sequenced. Some of the uses of the newly available genetic information also parallel the way the information is used in human medicine—determining genetic proclivity for certain diseases, understanding the paths of action of certain diseases, and identifying the patterns of gene expression during development.

But applications have gone much further in plants and animals because genetic modification has always been a major activity in agriculture to improve flavor, yield, shelf time, pest resistance, and other characteristics. Genomics merely adds a new set of tools for making those improvements.


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  5. A number of transgenic crops and animals have already been produced, and in the United States, a large fraction of the planted crops in corn and wheat is genetically engineered. There are three quite different ways in which genomics can be and is being used in new species development. First, rapid genetic assays can be used to quickly monitor the effects of standard cross-breeding, cutting down enormously on the time previously required to grow the cross-bred tissue to a sufficient state of development that its characteristics can be ascertained.

    These assays can also provide much more information on changes in the genome that are not obvious in easily observed plant characteristics. Some argue that this, in itself, will provide such an improvement in breeding that laboratory modification of plant or animal organisms will not be necessary. The other two applications of genomics involve the creation of genetically modified organisms GMOs —organisms that are modified by introducing genes from other species.

    In the first of these, the modification is equivalent to that produced by traditional cross-breeding techniques—a new organism whose genetic structure combines desirable features from each of the two parent organisms. The major advantage to this approach is the speed and selectivity with which the new cross-bred species can be created with recombinant DNA technologies.

    In the second of the recombinant DNA approaches, the organism is modified by the addition of a gene not natural to the species, which may allow the plant to produce a pesticide or herbicide, or alter its nutritional value or its taste or attractiveness as a food. Social reaction against GMOs has been strong, especially in Europe, and the ultimate determinant of how widely GMO technology will be used in the future may well be political.

    On the other hand, the commercial potential of GMOs, as well as their value in meeting food needs, particularly in the developing world, and in minimizing some of the environmental consequences of excessive fertilizer, pesticide, and herbicide use suggest that there will be a strong drive in the next several years to establish their safety. It is likely that this effort will stimu- 21 PUSH FACTORS late much greater efforts in modeling ecological systems and will certainly require the development of low-cost techniques for measuring trace concentrations of various organic substances under field conditions.

    As a result, materials science and engineering has emerged as one of the most important enabling fields, making possible some of the advances in medical care discussed above, many of the performance improvements in information technology discussed below, and innovations in energy production, transportation, construction, catalysis, and a host of other areas. It seems very likely that developments in materials science will continue to come at a rapid rate in the next decade and will continue to play a vital role in many other fields of science and technology.

    Discussed below are examples of what the committee believes are some of the most promising trends in this field. Nanotechnology Although the term nanotechnology is relatively new, developments that have made possible products with smaller and smaller features have been under way since the concepts of microelectronics were first introduced in the early s. Progressively finer-scaled microelectronic components and microelectromechanical devices have been produced using optical lithography to cut and shape superimposed layers of thin films.

    However, these optical methods have a resolution limit of about nanometers nm. Nanotechnology aims at fabricating structures with features ranging from nm down to 1 nm. Nanostructures are particularly attractive because physical properties do not scale with material dimensions as the nanoscale range is approached. This means that if the structure, including size, shape, and chemistry, can be controlled in this size range, it will be possible to develop materials exhibiting unique biological, optical, electrical, magnetic, and physical properties.

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    This also allows considerably more customization, making it possible to imitate nature. For example, considerable research is being pursued in examining hydrogen-bonding interactions similar to those in DNA as orienting forces. Applications in which these assembling interactions upgrade low-cost engineering polymers to incorporate a functional component are suggested. Self-assembly and controlled three-dimensional architectures will be utilized in molecular electronics, highly specific catalysts, and drug delivery systems.

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