Ronald A. Rader
Manager of Information Services, OMEC International, Inc.,
727 15th St., N.W., Washington, DC 20005
International Competition in Biotechnology Information
The U.S. presently is the leader in most aspects of biotechnology, due primarily to the considerable basic biomedical and life sciences research efforts of the federal government and a strong entrepeneural industrial sector of biotech- nology start-up companies which have built upon this research (5). Similarly, many large and established chemical, pharmaceutical, biomedical, agricultural and other U.S. firms have become very involved in biotechnology research, development, and commercialization. However, a number of foreign governments have targeted biotechnology as an important area where they are developing coodinated national efforts to challenge U.S. research and market pre- eminence. Development of information resources is formally recognized as an important component in these efforts.
The European Communities (Common Market) has sponsored the European Biotechnology Information Program (EBIP), recently accorded permanent funding status and renamed the Biotechnology Information Service, within the the British Library for several years (6). EBIP sponsors an annual meeting concerning biotechnology information, provides information services on demand, assists inquirers with information acquisition, and is actively analyzing and reviewing the information requirements of its member countries' research and commercial institutions. EBIP has sponsored studies, including assessments of the feasiblity of a computerized information system for European culture collections (collections of viable samples of microorganisms) and an information system on enzymes and enzyme engineering. The U.K. has recently implemented online access to its various culture collections' holdings.
The Japanese government has well established and coordinated industrial biotechnology research and development programs and research centers with a number of associated specialized information centers and activites. A branch of the Japanese government has recently outlined development plans for an integrated protein data network. These foreign government-supported efforts are too new to assess their impact on international competition, but are worthy of our attention. Also, most of the specialized secondary information resources shown in Figure 1 and many others originate in Europe.
International competitiveness and encouragement of innovation are ever growing issues in the U.S. Information resources are not a solution to U.S. problems in these areas. However, information resources need to be recognized as a limiting factor for competitiveness and innovation at both the organizational and national level.
Federal Biotechnology Information Resources and Activities
The federal government is the single main organization responsible for and involved in biotechnology. Biotechnology originally developed from federally funded research, which remains the primary impetus for biotechnology research and development activity in the U.S. and the reason for acknowledged U.S. leadership in the field. Federal agencies spent over $2 billion dollars for biotechnology and related research in Fiscal Year 1986 and this level of spending will likely be maintained (7-8). Despite major U.S. interests and investments in biotechnology, generally, the federal government has not initiated development of biotechnology information resources to support national needs and federal mandates.
OMEC International, Inc. has recently completed its Federal Biotechnology Information Network (FBIN) project with partial federal funding. This has resulted in publication of the Federal Biotechnology Information Resources Directory (9), describing over 470 federal biotechnology-relevant information resources, and the Federal Biotechnology Program Directory (10), describing over 470 biotechnology-relevant research, regulatory, technology transfer and other federal programs and activites. Together, these provide the first comprehensive description of the infrastructure of federal resources and programs supporting and affecting biotechnology, exclusive of facilities.
From this project and other experience, a number of general conclusions may be reported regarding federal biotechnology information resources and activities:
1) There has been no significant development or discussion of new, needed information resources for biotechnology (with some exceptions noted below).
2) Most federal biotechnology-related information resources and programs are not specific for biotechnology. Rather, they support underlying or related basic research, or more generalized regulatory or other agency activities.
3) Existing biotechnology-related information resources, on the whole, are relatively stagnant, receiving little additional funding for qualitative or quantitative improvements.
4) There exist insufficient information resources to appropriately support biotechnology-related public health and environmental safety assessments. Information resources do not exist or are not readily available to assist persons in information gathering and assessment to evaluate the effects of releases of genetically engineered or other novel microorganisms and their products in the environment and marketplace.
5) Many agencies formerly active in chemical and biological information resources development and information dissemination are now significantly less active in these areas. This is most notable among the regulatory agencies. This general situation may be due to the political climate for deregulation. Many policy and program decision-makers are not favorably disposed to information resources, recognizing that information resources are required and may be used to support development of regulations and spot potential and developing problems.
Major ongoing federal biotechnology-specific information resources and activities include: GENBANK and other nucleotide sequence database systems; the Protein Identification Resource (PIR) protein sequence database; the Microbial Strain Data Network (MSDN), a directory to culture collections' holdings; and the National Library of Medicine's biotechnology information research program and development of an online database directory of worldwide biotechnology research information resources.
Biotechnology Safety and Oversight Information Resources
The lack of biotechnology information resources, accessible information, and infrastucture development is already having an adverse impact on U.S. biotechnology. This is most obvious in the related areas of regulation and oversight of research and premarket testing, safety and hazard assessment, information dissemination, and public (mis)perception and (mis)understanding of biotechnology-related hazards. New, innovative technologies, and especially biotechnology, require well-developed, comprehensive, coordinated, science-based regulations to establish public and industry confidence in regulatory and oversight actions and procedures. Currently, important regulatory and safety assessment are performed on a case-by-case basis by a handfull of persons with experience and/or credentials in this area. The Biotechnology Sciences Coordinating Committee (BSCC) has been formed and a coordinated framework for federal regulation is being put in place. However, there are few, if any, information resources available to assist in assessments of novel biotechnology products and organisms, or make this information available to the biotechnology community and general public.
The lack of biotechnology product and process safety-related information resources is likely to make itself more evident as more legal, regulatory, and safety-related delays, uncertainties, and misjudgements. Even at this early stage in the development of U.S. biotechnology, a number of procedurally-based, obstructive lawsuits have successfully diverted and delayed federal, academic, and industry testing and commercialization plans. Both small biotechnology companies and large, established chemical firms have made significant mistakes in the design of premarket testing strategy, protocols, and information provided (or not provided) to government agencies and the public.
Although the slowly advancing unresolved and uncoordinated nature of regulation and oversight within and among the federal and other government agencies is a major factor in regulatory and judicial delays and uncertainties, the general lack of organized and accessible information is surely a strong contributing factor. No fatal or other significant biotechnology-related accidents or adverse environmental modifications have occurred, yet, but there are ample examples to be taken from the chemical industry of unidentified and misassessed hazards resulting in mishaps, public and environmental health hazards, and corporate liabilities. In partial response to this situation, OMEC International has recently published Biotechnology Regulations: Environmental Release Compendium, a compilation of U.S. federal, state, and local regulations, laws, and guidelines concerning releases in to the environment of genetically engineered microorganisms (11).
The NRC Committee on Biotechnology Nomenclature and Information Organization
A workshop sponsored by the National Library of Medicine (NLM) of the National Research Council Committee on Biotechnology Nomenclature and Information Organization was held in May 1986 (12). Various subcommittees examined the state and relevance of chemical and biological nomenclature, the organization of biotechnology information, and developed a number of recommendations.
Major recommendations included:
1) All federal agencies involved in biotechnology should continue current and initiate new programs and activities in biotechnology information. This could involve the establishment of information centers of excellence in biotechnology which might develop and provide information resources, conduct research related to biotechnology information, and provide referral services.
2) The NLM should catalyze national and international efforts to coordinate and develop standardized subject vocabularies (for terminology and subject indexing schemes) for biotechnology diciplines, and a uniform nomenclature in the form of registries for organisms, clones, genetic elements, and other biotechnology materials and products.
3) The NLM should establish a "database of databases" for biotechnology and expand its role as an information resource center. This would involve expansion of the DIRLINE database, NLM's online directory of biomedical and other information resources. Work in this area has been initiated.
4) NLM should develop a cross-referencing system and a thesaurus (subject classification scheme) for biotechnology information resources. A cross-referencing system would work in tandem with the "database of databases" to facilitate use of common data elements, compatibilities, and data sharing among databases, and also aid searchers in identifying and locating sources of desired types and forms of data and information.
5) The NLM should facilitate networking among database systems and establish "transparent" interfaces among them.
The report emphasized that the federal government needs to recognize the importance of biotechnology information as a national resource vital to science, technology, commerce and other national interests. The Committee recognized the need for deficit and federal budget reduction, but reported that the economic advantages of developing, processing, and disseminating biotechnology information far outweigh the costs. Biotechnology deserves a high standard of information resources and federal involvement in these, much as other developing technologies have a federally-sponsored common denominator of information resources.
The Committee reported that vocabulary in biotechnology is suboptimal. This includes the terminology used by scientists, such as the fabricated terms used for transposable genetic elements, the undeveloped or nonexistant nomenclatures for biotechnology products and processes, the biological and chemical nomenclatures now in use, and the lack of basic reference sources concerning biotechnology products. Registries need to be developed for clones, genetic elements, and other materials used in biotechnology to provide unique and unambiguous identifiers and descriptions. Biological nomenclature currently provides taxonomic descriptions of whole organisms and does not extend to their components or below the species level, which is the level at which biotechnology functions. Similarly, chemical nomenclature is not oriented to complex macro- and multi-molecular biological materials. These nomenclatures break down when applied to recombinant organisms, cell lines, genetic elements, modified proteins, antibodies and other biotechnology materials. The lack of available sources for information about biotechnology products is a hindrence to the development of the biotechnology industry.
New programs and significant reorientations of funding and priorities within federal agencies are difficult without Congressional mandates or other high-level directives. As discussed above, much of the U.S. infrastructure of information resources in the chemical and related life sciences may be traced to laws passed in the mid-1970's. Congressional actions are likely to be required to initiate similar activity in biotechnology information.
Rep. Pepper has introduced the National Biotechnology Information Act (H.R. 393) in Congress. The bill would establish a National Center for Biotechnology Information within the National Library of Medicine and provide additional funding of $10 million/year. The bill does not contain much detail about specified programs and activities. It is primarily oriented to the molecular biology and biomedical research communities and National Institutes of Health (NIH) actitivities. Activities mentioned in the bill and supporting materials include nucleotide and protein sequence databases, development of information resources for gene mapping, and the coordination and integration of computer-based information resources. Resources and programs for safety assessment, international competitveness, public information, technology transfer, regulatory coordination, classification schemes and registries are not specifically addressed. It will be interesting to follow the evolution of this bill and the level of effort to be directed to the critical applied and technological information needs of biotechnology. Those concerned with biotechnology information should take note of this bill and participate in its formulation and implementation.
The author endorses the National Research Council Committee's recommendations, especially the first calling for recognition of biotechnology information as a national asset and establishment of information centers of excellance. The NRC Committee had a distinct biomedical orientation, properly reflecting the interests of its sponsor and the predominance of biomedically-oriented biotechnology within the federal and private sectors. Many of the same findings also apply to critical biotechnology information needs for agriculture, commerce, energy, and defense.
Besides the Committees recommendations, and the general requirement that biotechnology organizations upgrade their information resources, the author suggests prompt federal and private sector attention to:
1) Establishment of series of information centers collecting, translating, organizing, and assessing foreign biotechnology scientific and commercial information and developments;
2) Extensions of indexing and classification schemes used by established information resources, especially abstracting and indexing services, to better cover biotechnology;
3) Execution of user needs surveys, market studies, and assessments of available options and priorities in U.S. biotechnology information resources development;
4) Assessment by the federal government of the cost-effectiveness and appropriate means to assist the development, improvement and public release of private and nonprofit sector information resources;
5) Support for development and implementation of biotechnology information resources within the National Agricultural Library (NAL), Department of Commerce, and Department of Energy to parallel and keep up with the development of biomedically-oriented information resources;
6) Establishment of at least one information center and bibliographic and factual databases concerning the safety, risk assessment, and regulatory affairs of biotechnology products, processes, and materials; and implementation of an emergency response-capable information center and online database for biotechnology and industrial microbiology.
7) Development of knowledge-based and expert systems, and other information resources to supplement U.S. manpower and educational deficiencies and needs in bioprocessing, fermentation, and other areas of relative foreign dominance in biotechnology (5, 13); and
8) Establishment of federal and private sector clearinghouses to facilitate public access to biotechnology and related information.
In summary, biotechnology is a relatively new, diverse, major scientific and commercial activity in the U.S. and throughout the world. The infrastructure of information resources supporting U.S. biotechnology needs improvements on a number of levels, requiring efforts by all involved organizations - the federal government, the biotechnology and information industries, and research institutions. Greatest needs are for establishment and expansion of information collection, organization, and services within biotechnology-intensive organizations, especially U.S. biotechnology companies and research institutions, and the recognition and coordinated action of federal agencies to promptly address biotechnology information resource needs and problems. Federal implementation of safety, regulatory, international, and technology transfer information resources is required to protect the considerable U.S investment in biotechnology. Although many author recommendations concentrate on the federal role and activities, the private sector needs to initiate and become involved in all aspects of these activities to assure understanding of biotechnology as a diverse technological and commercial, and not just as a biomedical research-oriented activity.
1. Kissman, H. M. and Wexler, P., "Toxicology Information Systems: A Historical Perspective," Journal of Chemical Information and Computer Sciences, 25(3), pp. 212-217, Aug. 1985.
2. Crafts-Lighty. A., Information Sources in Biotechnology, 2nd ed., Nature Press, New York, 1986.
3. Brown, H. D., "A Drug is Born: Its Information Facets in Pharmaceutical Research and Development," J. Chem. Info. and Comp. Sci., vol. 25, pp. 218-224, 1985.
4. Meyers, N., "Biotechnology Patents: Don't Say Just What You Mean," Nature, vol. 324, p. 504, Dec. 11, 1986.
5. Office of Technology Assessment, Commercial Biotechnology: An International Analysis, OTA-BA-218, Government Printing Office, January 19, 1986.
6. Cantley, M., "Bio-Informatics in Europe: Foundations and Visions," Swiss Biotech., vol. 2, no. 4, pp. 7-10, 13-14, April, 1984.
7. Office of Technology Assessment, Public Funding of Biotechnology Research and Training, (in press), workshop held Sept. 9, 1986, Washington, DC.
8. Perpich, J. G., "A Federal Strategy for International Industrial Competiveness," Bio/Technology, vol. 4, pp. 522-525, June, 1986.
9. OMEC International Inc., Federal Biotechnology Information Resources Directory, Washington, DC, 1987.
10. OMEC International Inc., Federal Biotechnology Programs Directory, Washington, DC, 1987.
11. Strauss, H. S., Biotechnology Regulations: Environmental Release Compendium, OMEC International Inc., Washington, DC, 1987.
12. Committee on Biotechnology Nomenclature and Information Organization, National Research Council, Biotechnology Nomenclature and Information Organization, National Academy Press, 1986.
13. Zaborsky, O. R., and Zubris, D. K., Biotechnology Engineers: Status Report 1985, OMEC International Inc., Washington, D.C., 1985.