Chapter 6 Contents

PREFACE

PHYSICAL INFRASTRUCTURE NEEDS

• Facilities
• Instrumentation
• Repositories
• Databases and Reference Standards

HUMAN RESOURCES NEEDS

• Training and Career Development

PREFACE

Research is the primary focus of the Federal investment in biotechnology, but just as the physical infrastructure of bridges, roads, and other public works is required to support the Nation's economic vitality, the infrastructure for biotechnology research is critical to the research enterprise. As documented in Chapter 1 (Figure 1), support for infrastructure accounts for only about 8 percent of the total Federal investment in biotechnology research.

Neglect of infrastructure needs ultimately results in decreased productivity and lost opportunities. The Federal commitment to meet these needs should be long-term, stable, and allocated on the basis of merit. This chapter describes the infrastructure, including both physical and human resources, needed for biotechnology research. Acute needs in the specific research areas examined in this report are highlighted.

PHYSICAL INFRASTRUCTURE NEEDS

Facilities

Funding for facilities has been very low across all agencies. In fiscal year (FY) 1993, only $53.7 million was invested across the Federal Government. Deterioration of existing facilities and lack of funds for new facilities for biotechnology research threaten to limit progress. The broader problem of the deterioration of academic research facilities has caught the attention of the Administration and the Congress, resulting in a substantially increased appropriation for academic infrastructure in the FY 1995 budget of the National Science Foundation.

The total scope of this problem cannot be dealt with adequately by any individual agency. While specialized needs must continue to be supported to the extent possible through existing programs, a coordinated interagency effort to upgrade research facilities is needed. There are a number of urgent needs specific to biotechnology research:

• Synchrotron facilities and neutron facilities for structural biology research need to be upgraded and constructed.

• Researchers need to have access to containment facilities for recombinant DNA research at the P-3 and P-4 safety levels. This need is especially acute in some areas of the country and for academic institutions with relatively small, but nonetheless important, commitments to biotechnology research.

• Plant growth chambers and greenhouses need to be constructed, repaired, and replaced.

• Animal facilities need to be constructed, renovated, and maintained to meet animal care guidelines and regulations emanating from the Animal Welfare Act.

• Large, specialized containment facilities, analogous to greenhouses, for bioremediation research, need to be provided to permit controlled growth of microorganisms as well as contamination studies on scales that mimic those of natural sites. In addition, one or several examples of large contaminated natural environments should be selected as field sites for bioremediation to permit studies on appropriate physical and temporal scales over long time periods.

Instrumentation

Equipment and instrumentation are critical not only to support the research of high-caliber scientists, but also to help attract and train the next generation of biotechnology researchers and technologists. Typically, the equipment and instrumentation required for biotechnology are very sophisticated and therefore expensive to acquire, operate, and maintain.

One cost-effective solution to this problem is development of instrumentation centers available to researchers from government, academia, and all industry sectors. Many different types of instruments are required:

• Specialized chemical hoods, large fermentors, and autoclaves are needed to deal with large volumes of contaminated materials in environmental research.

• New, highly sensitive and portable analytical instruments are needed for in situ bioremediation monitoring.

• There are needs for capital-intensive instrumentation, such as X-ray crystallography and nuclear magnetic resonance equipment, computer capabilities (particularly the coming generation of parallel processors), and advanced mass spectrometers for use in manufacturing/bioprocessing research.

• There are needs for specialized equipment for the collection, maintenance, husbandry, and cultivation of marine organisms; specialized fermentation and process-recovery equipment capable of withstanding the corrosive effects of sea water, for the production of marine products; and improved sampling equipment (e.g., submersibles) and techniques to replace indiscriminate, mass collections of organisms in the field.

• Equipment and associated instrumentation is needed for culturing of, and bioprocessing with, marine organisms and organisms from extreme environments, including hyperbaric environments.

Funding for the acquisition of state-of-the-art equipment for biotechnology research must be made available. In addition, two related issues faced by academic institutions must be addressed:

• Universities have trouble obtaining funds for equipment maintenance.

• Universities have difficulty taking advantage of Federal instrumentation grants which require matching funds.

Repositories

New and expanded repositories are needed to hold and preserve the many specimens and large amounts of data crucial to biotechnology research. There are many acute needs:

• Germplasm for agricultural research must be collected, characterized, and maintained.

• Genetic stock centers are needed for marine organisms and other nontraditional organisms. The wide range of organisms apart from those traditionally used in laboratory research represents a biotechnology resource that must be developed if the United States is to maintain its strong leadership in biotechnology.

• Repositories must be developed for recombinant DNA reagents generated in genome projects as well as for specialized purposes.

• Repositories are needed for expanded microbial collections and particularly to store mixed cultures that prove promising as bioremediation agents. Current repository practices focus on the storage of pure cultures; the requirements for long-term storage of mixed cultures are poorly understood and must be developed.

• Repositories for marine organisms are needed to make these organisms accessible for biotechnology research. Genetically homogeneous strains of selected organisms at various developmental stages -- embryos, larvae, juveniles, and adults -- should be produced and made available on a year-round basis.

• International efforts should be made to coordinate culture storage and collection activities so that international standards for technical information can be developed and the exchange of data and cultures maximized.

Databases and Reference Standards

A critical issue in biotechnology is how to manage the massive amounts of information generated and ensure that user communities have access to the data in a useful form. The solution lies in development of publicly accessible, relational databases, such as those that allow scientists to search across plant, animal, and microbial kingdoms for similarities in DNA sequences. These public databases open the door to discoveries about the fundamental nature of living organisms and ultimately to development of new biotechnology applications. The use of databases as integral tools in biology is in its early stages, and the existing database infrastructure is unlikely to provide an adequate resource base for the future. There are several specific needs:

• New and enhanced databases are needed to store and make available information about genomes, macromolecular structure, biological processes, collections of organisms, engineering design parameters, and other topics of interest to biotechnology researchers. These databases should be interactive, allowing manipulation of the data for process modeling and product design.

• International efforts in database development are essential, and information must be accessible to researchers from all nations. Interagency collaboration in support of computational sciences will help fulfill this need.

Reference standards for quality assurance of biotechnology-based measurements are also important. Reference standards assure accuracy and reliability in biotechnology research and commercialization and allow critical measurements to be compatible among different laboratories. Reliable production of high-quality data reduces the need for duplication of data.

Available reference standards for assigning measured values to proteins, glycoproteins, and DNA fragments are inadequate. Standards for measurement in quality assurance would have a major impact in a broad range of research areas, from genome projects to manufacturing. Quality assessment and comparability of results across different laboratories will be a rapid growth area and major tool for dissemination of information and technology transfer.

HUMAN RESOURCES NEEDS

Innovation and progress in biotechnology depend on the existence of a supportive, thriving intellectual climate. Broad-based education is needed to provide a continuing supply of well- trained researchers. The challenges of biotechnology require problem solving that crosses traditional disciplinary boundaries. Programs to provide retraining and interdisciplinary training of scientists and technical/vocational staff are essential.

Federal agencies should expand training grants that link the disciplines underpinning biotechnology (e.g., biochemistry, microbiology, structural biology, genetics, ecology, engineering) and should support technical/vocational education to provide a work force familiar with the concepts and tools of biotechnology.

The Federal Government also should encourage universities to sustain education and training in disciplinary sciences while recognizing the need for communication and collaboration among disciplines. Experience shows that highly specialized undergraduate and graduate technicians, engineers, and scientists often lack the broad fundamental skills necessary for successful multidisciplinary investigation. This is especially true for specialists in molecular biology.

Training and Career Development

Training and career development is the infrastructure area promising the greatest overall impact on biotechnology. Programs are needed to enhance public literacy concerning biotechnology, as well as to attract and retain students in biotechnology-related science and engineering through pre and postdoctoral levels, and to retrain individuals with experience in other disciplines for careers in biotechnology.

There are several general needs in undergraduate, graduate, and continuing education programs:

• Training is needed at the interfaces of biotechnology- related disciplines involving biologists, biochemists, computer scientists, physicists, chemists, materials scientists, geologists, hydrologists, and engineers.

• Training is needed in theoretical and computational biology.

• Training should include study of nontraditional organisms for biotechnology.

In addition, there are two types of education and training that require special emphasis:

• Training programs are needed for mid-level technical personnel. Several agencies have programs to recruit and train independent investigators for the future. Relatively little attention has been given, however, to the large number of mid- level technical workers that will be required to transfer research results to applications. This type of training should not be ignored in planning for future personnel needs in biotechnology. Specialized vocational training for biotechnologists is only one approach, however. A broader solution may lie in encouraging colleges and universities to reinstate laboratories as integral parts of basic science courses.

• There is also a need for education and training to promote general scientific literacy. A training issue specific to agricultural biotechnology is the need to maintain support for scientific progress by assuring a knowledgeable public. For many Americans, the promise of biotechnology remains in the realm of science fiction, but as foods derived from the new biotechnology enter the marketplace, biotechnology is moving out of the laboratory and becoming a matter of debate in the community. Consumers need objective information and education to help them form opinions. The successful commercialization of products derived from the biotechnology research endeavor depends on broad-based agricultural biotechnology education for students in K-12 and for the general public. Programs are needed to develop and disseminate educational materials about biotechnology and foster open discussions of new developments and applications.

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