Status of the Infrastructure of Information Resources Supporting U.S.

Chapter 32

Status of the Infrastructure of Information Resources Supporting U.S. Biotechnology Ronald A. Rader

Downloaded by TUFTS UNIV on March 25, 2018 | https://pubs.acs.org Publication Date: January 7, 1988 | doi: 10.1021/bk-1988-0362.ch032

OMEC International, Inc., 727 15th Street, N.W., Washington, DC 20005

The infrastructure of information resources supporting U.S. biotechnology needs improvements in a number of areas. Existing resources do not meet the needs of many users and uses. Information resources need to be developed for safety assessment, international competition, public information, and other areas. Biotechnologyinvolved organizations need to initiate and improve their information centers, systems, resources, expertise and services. Information resources are a limiting factor affecting organizations' and national innovation, competitiveness, decision making, protection of intellectual property and obtaining patents, regulatory affairs, research, development, and commercialization in biotechnology. The U.S. biotechnology information infrastructure i s the sum of a l l the nation's r e a d i l y available information resources, services, and professional expertise, both within organizations and p u b l i c l y a v a i l a b l e . Although not contributing d i r e c t l y to the bottom l i n e , r e a d i l y accessible, high q u a l i t y information resources, services and professionals have a great impact on organizations' and nations' c a p a b i l i t i e s , productivity, actions and reactions, and competitiveness . Chemistry and toxicology/pharmacology are areas where a strong infrastructure of information resources exists i n the U.S. Chemic a l , toxicology, and pharmacology information resources are a v a i l able i n abundance and t a i l o r e d to diverse needs, often with high degrees of s p e c i a l i z a t i o n and sophistication, such as in-depth subject indexing, r e g i s t r y and nomenclature systems, substructure searching, and structure and a c t i v i t y p r e d i c t i v e systems. The state of the infrastructure of information resources i n biotechnology may be compared with that of toxicology and related l i f e and chemical sciences as of about ten or more years ago (1). P r i o r to the mid-1970's, there were very few toxicology information resources available. Federal information a c t i v i t i e s mandated by the 0097-6156/88/0362-0375$06.00/0 © 1988 American Chemical Society

Phillips et al.; The Impact of Chemistry on Biotechnology ACS Symposium Series; American Chemical Society: Washington, DC, 1988.


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Toxic Substances Control Act, the National Cancer Act, and other s o c i e t a l e f f o r t s to regulate and define chemical-related public and environmental health threats from the mid-1970's to the present have resulted i n a very healthy array of information resources. Simil a r l y , a c t i v i t i e s and resources i n other l i f e sciences, e s p e c i a l l y the biomedical sciences, have grown and a healthy array of informat i o n resources developed, many with federal support. Yet, few and inadequate biotechnology-oriented information resources e x i s t . More and better information resources are required to support the development of biotechnology into the $40-100 b i l l i o n industry i t i s predicted to be i n the U.S. i n the year 2000. In general, those biotechnology information resources which are a v a i l able lack the s o p h i s t i c a t i o n required for many uses and users. There are a number of factors which have contributed to t h i s situation, and a number of factors which should lead to development and a v a i l a b i l i t y of more and better biotechnology information resources. S o u r c e s and

Flow o f I n f o r m a t i o n

in

Biotechnology

A excellent overview of information sources and information flow i n biotechnology has recently been published i n second e d i t i o n (2.) · Brief descriptions of most private sector information sources may be found here, along with much introductory and explanatory text. The biotechnology information marketplace i s e a s i l y seen to be charact e r i z e d by a very large number of primary sources of information, such as journals, meetings, conferences and proceedings, books, technical reports, and trade publications. Other sources of i n f o r mation for biotechnology include a number of often c o s t l y newsletters, consultants and experts. A large proportion of biotechnologyoriented information resources are devoted to commercial and comp e t i t i v e news and information reporting, as demonstrated by the large number of company d i r e c t o r i e s available, and the commercial orientation of a large proportion of available s p e c i a l i z e d biotechnology abstracting and indexing services, as shown i n Table I. Table I.

Some Major Biotechnology-specific Secondary Sources

Name

Orientation

Source

Abstracts i n BioCommerce BioBusiness Biotechnology Research Abstracts Current Biotechnology Abstracts Derwent Biotechnology Abstracts Pascal Biotechnologies Telegen

Commercial Commercial Scienfific Scientific Scientific Scientific Commercial

Britain U.S. U.S. Britain Britain France U.S.

Note: A l l but B i o B u s i n e s s , and d a t a b a s e form.

a database, are a v a i l a b l e i n p u b l i c a t i o n

B i o t e c h n o l o g y i s a m u l t i d i s c i p l i n a r y , fragmented a c t i v i t y i n v o l v i n g t h e i n t e r f a c e o f many s c i e n t i f i c and commercial a c t i v i ties. The d i v e r s e s c i e n c e s upon which b i o t e c h n o l o g y b u i l d s and t o



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which the biotechnologist needs information access includes many chemical and b i o l o g i c a l sciences and technologies, including microbiology, biochemistry, genetics, molecular biology, toxicology, pharmacology, and bioengineering. Also, biotechnologists require information about regulations, safety assessment, environmental e f f e c t s , commerce, funding sources, patents, and other types of information. This fragmentation becomes even more apparent, when one r e a l i z e s the diverse application areas of biotechnology, including i n d u s t r i a l a c t i v i t i e s i n pharmaceuticals and diagnostics, a g r i culture, food, energy, waste processing, and commodity and specialty chemicals. The fragmented nature of biotechnology, combined with i t s r e l a t i v e newness as a d i s t i n c t a c t i v i t y , i s a contributing factor to the lack of biotechnology information resources. This often fragmentary interplay of d i s c i p l i n e s and s p e c i a l i s t s i s r e f l e c t e d i n the numerous professional and trade organizations representing s c i e n t i s t s and i n s t i t u t i o n s involved i n U.S. biotechnology. To date, neither professional nor trade associations i n biotechnology have taken s i g n i f i c a n t active roles i n developing s p e c i a l i z e d information resources, a common s i t u a t i o n for such organizations i n many other f i e l d s . Secondary sources, notably abstracting and indexing p u b l i c a tions and bibliographic databases, are information resources rout i n e l y organizing and summarizing information about documents and t h e i r contents. Besides scanning of journals, these are usually the main means for keeping up with developments and f o r retrospective searching of the l i t e r a t u r e . Some major secondary publications and databases s p e c i f i c a l l y oriented to biotechnology are shown i n Table I. Examination of these and others reveals that they univers a l l y are spin-off or derivative (subset) products from major broader coverage s c i e n t i f i c information services, and/or are primari l y oriented to covering commercial news and a c t i v i t i e s i n biotechnology. Indexing and subject access i n most secondary and other b i o technology and related information resources i s rather p r i m i t i v e . Subject indexes either involve very simple and general c l a s s i f i c a t i o n schemes, employ keywords (no controlled indexing), or employ the c l a s s i f i c a t i o n and indexing schemes of t h e i r parent broader coverage resources. There has been l i t t l e development of c l a s s i f i c a t i o n and indexing systems s p e c i f i c a l l y f o r biotechnology information and access to the l i t e r a t u r e . The lack of c l a s s i f i c a t i o n and nomenclature schemes adversely affects the whole informat i o n infrastructure by making information r e t r i e v a l and resources coordination more d i f f i c u l t and haphazard, and keeping information organization and exchange on very basic, s i m p l i s t i c l e v e l . In the area of protein and nucleotide sequence databases, current resources are struggling to keep up with the published data, have reduced the amount of other information (annotations) recorded, capturing only the minimum data, and do not cover patents and commercial products. In fact, there are very few biotechnology i n f o r mation resources, whether bibliographic or other types, which s e r i ously deal with b i o l o g i c a l technologies and products, rather than broad basic science or commercial a c t i v i t i e s .


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Biotechnology Information Resources Marketplace Biotechnology information resources have yet to successfully establ i s h t h e i r niche i n the U.S. marketplace for a number of reasons. Many biotechnology information resources f i n d greater interest, market penetration, and t h e i r major markets i n foreign countries, p r i m a r i l y Japan and Western Europe. Perhaps, the most important reasons f o r a sluggish U.S. demand and market f o r biotechnology information resources are: a general lack of recognition of the value of information resources as a strategic long- and short-term asset; lack of knowledge and exposure to s p e c i a l i z e d information resources among those most involved i n biotechnology; and lack of highly v i s i b l e national programs and a c t i v i t i e s . U.S. organizations involved i n biotechnology, including most biotechnology companies, are r e l a t i v e l y weak i n information resources, c a p a b i l i t i e s , and expertise. Biotechnology companies with a library/information center or an even p a r t i a l l y dedicated informat i o n professional are a d i s t i n c t minority. This s i t u a t i o n occurs even i n well-funded biotechnology companies with considerable research and development a c t i v i t y . In some cases, a l o c a l university l i b r a r y performs online searching and f u l f i l l s document requests on demand. For the most part, information handling i s a haphazard and unorganized a c t i v i t y . Exceptions to t h i s s i t u a t i o n may be found i n the established pharmaceutical and chemical firms becoming involved i n biotechnology, most of which have information c e n t e r s / l i b r a r i e s and information s p e c i a l i s t s thoroughly integrated into t h e i r research, development, marketing, and regulatory a f f a i r s e f f o r t s (3). Biotechnology executives and researchers, when questioned about the need f o r information services and resources within t h e i r organization, very often reply that they are on the cutting-edge or forefront of t h e i r p a r t i c u l a r areas of research and development, go to a l l the right meetings, and keep i n touch with the right people. Many f a i l to recognize the value and provide support for building and providing information resources, services, and expertise within t h e i r organization. Executives and researchers complain they have more information than they can assimilate, and mistake t h i s for the information they may r e a l l y need and that others i n t h e i r organizat i o n should have long-term ready access to. Biotechnology companies, on the whole, do not budget f o r i n f o r mation handling and organization, as do more established companies involved i n pharmaceutical and chemical research and development. This i s probably due to: t h e i r r e l a t i v e l y recent entry into the comm e r c i a l i z a t i o n and regulatory phases of product and process development; t h e i r not making p r o f i t s , yet; and the history of most s t a r t up companies' researchers and executives coming from academia or other biotechnology companies. Established chemical and pharmaceut i c a l industries spend on the order of 2% of t h e i r research and development budget for library/information center and related resources and s t a f f , but t h i s i s not observable i n biotechnology companies. A s i t u a t i o n of information r i c h vs. information poor may arise or presently exist i n biotechnology. An e l i t e of larger biotechnology and other companies may be better able to conduct c o s t - e f f e c t i v e research, commercialization, regulatory a f f a i r s , obtain and defend


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patents, and survive i n the world marketplace. With the history of most s i g n i f i c a n t biotechnology innovations and developments a r i s i n g from small companies, u n i v e r s i t i e s , and research i n s t i t u t i o n s , t h i s may have broad strategic implications for these organizations and U.S biotechnology. Some biotechnology companies are finding that they need to develop t h e i r own information resources. Some major biotechnology companies have become information vendors through commercialization of i n i t i a l l y in-house information resources. Examples include Abstracts i n BioCommerce o r i g i n a l l y developed by Celltech i n B r i t ain, the AGRIBUSINESS database developed by Pioneer Hybrid, and the BioScan corporate a c t i v i t i e s directory developed by Cetus Corpora t i o n . Many companies are finding that organized information i s a marketing asset. Often, companies d i s t r i b u t e extensive b i b l i o g r a phies, and some operate online electronic mail networks r e l a t i n g to t h e i r products. These trends w i l l l i k e l y continue. The very nature of biotechnology complicates information han d l i n g and the protection of inventions through patents. For ex ample, there are many ways to define and characterize biotechnologyrelated organisms, t h e i r products and components, and processes. One can i d e n t i f y and describe organisms and t h e i r products based on sequences and structures of DNA/RNA and proteins, uses and applica tions, observable c h a r a c t e r i s t i c s and appearance, metabolic a c t i v i t i e s , and other parameters. Terminology used i n biotechnology i s far from standardized, and may be purposefully ambiguous or unclear to broaden and obscure boundaries of patent coverage (A). Only a few of many patent and i n t e l l e c t u a l property issues i n biotechnology have been resolved i n the U.S. and foreign countries' courts.


f

I n t e r n a t i o n a l Competition

i n Biotechnology

Information

The U.S. presently i s the leader i n most aspects of biotechnology, due primarily to the considerable basic biomedical and l i f e sciences research e f f o r t s of the federal government and a strong entrepeneur a l i n d u s t r i a l sector of biotechnology start-up companies which have b u i l t upon t h i s research (5.) . Similarly, many large and established chemical, pharmaceutical, biomedical, a g r i c u l t u r a l and other U.S. firms have become very involved i n biotechnology research, develop ment, and commercialization. However, a number of foreign governments have targeted biotech nology as an important area where they are developing coordinated national e f f o r t s to challenge U.S. research and market preeminence. Development of information resources i s formally recognized as an important component i n these e f f o r t s . 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 B r i t i s h Library f o r several years (ϋ.) . EBIP sponsors an annual meeting concerning biotechnology information, provides information services on demand, a s s i s t s inquirors with information acquisition, and i s a c t i v e l y analyzing and reviewing the information requirements of i t s member countries' research and commercial i n s t i t u t i o n s . EBIP has sponsored studies, including assessments of the f e a s i b l i t y of a computerized information system



380


for European culture c o l l e c t i o n s (collections of viable samples of microorganisms) and an information system on enzymes and enzyme engineering. The U.K. has recently implemented online access to i t s various culture c o l l e c t i o n s ' holdings. The Japanese government has well established and coordinated i n d u s t r i a l biotechnology research and development programs and research centers with a number of associated s p e c i a l i z e d information centers and activités. A branch of the Japanese government has recently outlined development plans for an integrated protein data network. These foreign government-supported e f f o r t s are too new to assess t h e i r impact on international competition, but are worthy of our attention. Also, most of the s p e c i a l i z e d secondary information resources shown i n Table 1 and many others originate i n Europe. International competitiveness and encouragement of innovation are ever growing issues i n the U.S. Information resources are not a solution to U.S. problems i n these areas. However, information resources need to be recognized as a l i m i t i n g factor f o r competitiveness and innovation at both the organizational and national level. Federal Biotechnology

I n f o r m a t i o n R e s o u r c e s and

Activities

The federal government i s the single main organization responsible for and involved i n biotechnology. Biotechnology o r i g i n a l l y developed from f e d e r a l l y funded research, which remains the primary impetus for biotechnology research and development a c t i v i t y i n the U.S. and the reason for acknowledged U.S. leadership i n the f i e l d . Federal agencies spent over $2 b i l l i o n d o l l a r s for biotechnology and related research i n F i s c a l Year 1986 and t h i s l e v e l of spending w i l l l i k e l y be maintained (2-iD · Despite major U.S. interests and investments i n biotechnology, generally, the federal government has not i n i t i a t e d development of biotechnology information resources to support national needs and federal mandates. OMEC International, Inc. has recently completed i t s Federal Biotechnology Information Network (FBIN) project with p a r t i a l fede r a l funding. This has resulted i n publication of the Federal Biotechnology Information Resources Directory (1), describing over 470 federal biotechnology-relevant information resources, and the Federal Biotechnology Program Directory (1Q.) , describing over 470 biotechnology-relevant research, regulatory, technology transfer and other federal programs and activités. Together, these provide the f i r s t comprehensive description of the infrastructure of federal resources and programs supporting and a f f e c t i n g biotechnology, exclusive of f a c i l i t i e s . From t h i s project and other experience, a number of general conclusions may be reported regarding federal biotechnology informat i o n resources and a c t i v i t i e s : 1) There has been no s i g n i f i c a n t 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 s p e c i f i c for biotechnology. Rather, they support underlying or related basic research, or more generalized regulatory or other agency a c t i v i t i e s .



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3) E x i s t i n g biotechnology-related information resources, on the whole, are r e l a t i v e l y stagnant, receiving l i t t l e a d d i t i o n a l funding f o r q u a l i t a t i v e or quantitative improvements. 4) There exist i n s u f f i c i e n t information resources to appropriately support biotechnology-related public health and environmental safety assessments. Information resources do not exist or are not r e a d i l y available to a s s i s t persons i n information gathering and assessment to evaluate the effects of releases of g e n e t i c a l l y engineered or other novel microorganisms and t h e i r products i n the environment and marketplace. 5) Many agencies formerly active i n chemical and b i o l o g i c a l informat i o n resources development and information dissemination are now s i g n i f i c a n t l y less active i n these areas. This i s most notable among the regulatory agencies. This general s i t u a t i o n may be due to the p o l i t i c a l climate for deregulation. Many p o l i c y and programmatic decision-makers are not favorably disposed to informat i o n resources, recognizing that information resources are required and may be used to support development of regulations and spot p o t e n t i a l and developing problems. Major ongoing federal biotechnology-specific information resources and a c t i v i t i e s include: GENBANK and other nucleotide sequence database systems; the Protein I d e n t i f i c a t i o n Resource (PIR) protein sequence database; the Microbial Strain Data Network (MSDN), a directory to culture c o l l e c t i o n s ' holdidngs; and the National L i brary of Medicine's biotechnology information research program and Biotechnology Information Resources Directory, to be an online database and published directory of worldwide information resources. Biotechnology

S a f e t y and

Oversight

Information

Resources

The lack of biotechnology information resources, accessible informat i o n , and infrastucture development i s already having an adverse impact on U.S. biotechnology. This i s most obvious i n 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 e s p e c i a l l y biotechnology, require well-developed, comprehensive, coordinated, sciencebased regulations to e s t a b l i s h public and industry confidence i n regulatory and oversight actions and procedures. Currently, important regulatory and safety assessment are performed on a case-bycase basis by a handfull of persons with experience and/or credent i a l s i n t h i s area. The Biotechnology Sciences Coordinating Committee (BSCC) has been formed and a coordinated framework for federal regulation i s being put i n place. However, there are few, i f any, information resources available to a s s i s t i n assessments of novel biotechnology products and organisms or make t h i s information a v a i l able to the biotechnology community and general p u b l i c . The lack of biotechnology product and process safety-related information resources i s l i k e y to make i t s e l f more evident as more l e g a l , regulatory, and safety-related delays, uncertainties, and misjudgements. Even at t h i s early stage i n the development of U.S. biotechnology, a number of procedurally based, obstructive lawsuits



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T H E IMPACT OF CHEMISTRY ON

BIOTECHNOLOGY

have successfully diverted and delayed federal, academic, and indust r y t e s t i n g and commercialization plans. Both small biotechnology companies and large, established chemical firms have made s i g n i f i cant mistakes i n the design of premarket t e s t i n g strategy, protocols, and information provided (or not provided) to government agencies and the p u b l i c . Although the slowly advancing unresolved and uncoordinated nature of regulation and oversight within and among the federal and other government agencies i s a major factor i n regulatory and j u d i c i a l delays and uncertainties, the general lack of organized and accessible information i s surely a strong contributing f a c t o r . No f a t a l or other s i g n i f i c a n t biotechnology-related accidents or adverse environmental modifications have occurred yet, but there are ample examples to be taken from the chemical industry of unidentif i e d and misassessed hazards r e s u l t i n g i n mishaps, public and environmental health hazards, and corporate l i a b i l i t i e s . In p a r t i a l response to t h i s situation, OMEC International has recently publ i s h e d Biotechnology Regulations: E n v i r o n m e n t a l R e l e a s e Compendium, a compilation of U.S. federal, state, and l o c a l regulations, laws, and guidelines concerning releases i n to the environment of genetic a l l y engineered microorganisms (11). The

NRC

Committee on B i o t e c h n o l o g y

Nomenclature and

Information

Organization

A workshop sponsored by the National Library of Medicine (NLM) of the National Research Council Committee (NRC) on Biotechnology Nomenclature and Information Organization was held i n May 1986 (12)· Various subcommittees examined the state and relevance of chemical and b i o l o g i c a l nomenclature, the organization of biotechnology information, and developed a number of recommendations. Major recommendations included: 1) A l l federal agencies involved i n biotechnology should continue current and i n i t i a t e new programs and a c t i v i t i e s i n biotechnology information. This could involve the establishment of information centers of excellence i n biotechnology which might develop and provide information resources, conduct research related to b i o technology information, and provide r e f e r r a l services. 2) The NLM should catalyze national and i n t e r n a t i o n a l e f f o r t s to coordinate and develop standardized subject vocabularies (for terminology and subject indexing schemes) for biotechnology d i c i plines, and a uniform nomenclature i n the form of r e g i s t r i e s for organisms, clones, genetic elements, and other biotechnology mat e r i a l s and products. 3) The NLM should e s t a b l i s h a "database of databases" f o r biotechnology and expand i t s role as an information resource center. This would involve expansion of the DIRLINE database, NLM's online d i r e c t o r y of biomedical and other information resources. Work i n t h i s area w i l l be i n i t i a t e d t h i s F a l l . 4) NLM should develop a cross-referencing system and a thesaurus (subject c l a s s i f i c a t i o n scheme) for biotechnology information resources. A cross-referencing system would work i n tandem with the "database of databases" to f a c i l i t a t e use of common data elements, compatibilities, and data sharing among databases, and


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a l s o a i d s e a r c h e r s i n i d e n t i f y i n g and l o c a t i n g s o u r c e s o f d e s i r e d t y p e s and forms o f d a t a and i n f o r m a t i o n . 5) The NLM s h o u l d f a c i l i t a t e n e t w o r k i n g among d a t a b a s e systems and e s t a b l i s h " t r a n s p a r e n t " i n t e r f a c e s among them. The r e p o r t emphasized t h a t t h e f e d e r a l government needs t o r e c o g n i z e t h e importance o f b i o t e c h n o l o g y i n f o r m a t i o n as a n a t i o n a l r e s o u r c e v i t a l t o s c i e n c e , t e c h n o l o g y , commerce and o t h e r n a t i o n a l i n t e r e s t s . The Committee r e c o g n i z e d t h e need f o r d e f i c i t and f e d e r a l budget r e d u c t i o n , b u t r e p o r t e d t h a t t h e economic advantages o f d e v e l o p i n g , p r o c e s s i n g , and d i s s e m i n a t i n g b i o t e c h n o l o g y i n f o r m a t i o n f a r outweigh the c o s t s . Biotechnology deserves a high standard of i n f o r m a t i o n r e s o u r c e s and f e d e r a l i n v o l v e m e n t i n t h e s e , much as o t h e r d e v e l o p i n g t e c h n o l o g i e s have a f e d e r a l l y - s p o n s o r e d common denominator o f i n f o r mation resources. The Committee r e p o r t e d t h a t v o c a b u l a r y i n b i o t e c h n o l o g y i s s u b o p t i m a l . T h i s i n c l u d e s t h e t e r m i n o l o g y u s e d by s c i e n t i s t s , such as t h e f a b r i c a t e d terms u s e d f o r t r a n s p o s a b l e g e n e t i c e l e m e n t s , t h e undeveloped o r nonexistent nomenclatures f o r b i o t e c h n o l o g y products and p r o c e s s e s , and t h e b i o l o g i c a l and c h e m i c a l n o m e n c l a t u r e s now i n use. R e g i s t r i e s need t o be d e v e l o p e d f o r c l o n e s , g e n e t i c e l e m e n t s , and o t h e r m a t e r i a l s u s e d i n b i o t e c h n o l o g y t o p r o v i d e u n i q u e and unambiguous i d e n t i f i e r s and d e s c r i p t i o n s . B i o l o g i c a l n o m e n c l a t u r e c u r r e n t l y p r o v i d e s taxonomic d e s c r i p t i o n s o f whole organisms and does n o t e x t e n d t o t h e i r components o r below t h e s p e c i e s l e v e l , which i s t h e l e v e l a t which b i o t e c h n o l o g y f u n c t i o n s . S i m i l a r l y , c h e m i c a l n o m e n c l a t u r e i s n o t o r i e n t e d t o complex macro- and m u l t i m o l e c u l a r b i o l o g i c a l m a t e r i a l s . These n o m e n c l a t u r e s b r e a k down when a p p l i e d t o recombinant organisms, c e l l l i n e s , g e n e t i c e l e m e n t s , m o d i f i e d p r o t e i n s , a n t i b o d i e s and o t h e r b i o t e c h n o l o g y m a t e r i a l s .

Congressional

Activities

New programs and s i g n i f i c a n t r e o r i e n t a t i o n s o f f u n d i n g and p r i o r i t i e s w i t h i n f e d e r a l agencies are d i f f i c u l t without C o n g r e s s i o n a l mandates o r o t h e r h i g h - l e v e l d i r e c t i v e s . As d i s c u s s e d above, much o f t h e U.S. i n f r a s t r u c t u r e o f i n f o r m a t i o n r e s o u r c e s i n t h e c h e m i c a l and r e l a t e d l i f e s c i e n c e s may be t r a c e d t o laws p a s s e d i n t h e m i d 1970' s . C o n g r e s s i o n a l a c t i o n s a r e l i k e l y t o be r e q u i r e d t o i n i t i a t e s i m i l a r a c t i v i t y i n biotechnology information. Rep. Pepper has i n t r o d u c e d t h e N a t i o n a l B i o t e c h n o l o g y I n f o r m a t i o n Ac_L (H.R. 393) i n C o n g r e s s . The b i l l would e s t a b l i s h a N a t i o n a l Center f o r Biotechnology Information w i t h i n the N a t i o n a l L i b r a r y o f M e d i c i n e and p r o v i d e a d d i t i o n a l f u n d i n g o f $10 m i l l i o n / y e a r . The b i l l does' not c o n t a i n much d e t a i l about s p e c i f i e d programs and a c t i v i t i e s . I t i s p r i m a r i l y o r i e n t e d t o t h e m o l e c u l a r b i o l o g y and b i o m e d i c a l r e s e a r c h communities and N a t i o n a l I n s t i t u t e s o f H e a l t h (NIH) a c t i v i t i e s . A c t i v i t i e s m e n t i o n e d i n t h e b i l l and supp o r t i n g m a t e r i a l s i n c l u d e n u c l e o t i d e and p r o t e i n sequence d a t a b a s e s , development o f i n f o r m a t i o n r e s o u r c e s f o r gene mapping, and t h e c o o r d i n a t i o n and i n t e g r a t i o n o f computer-based i n f o r m a t i o n r e s o u r c e s . R e s o u r c e s and programs f o r s a f e t y assessment, i n t e r n a t i o n a l c o m p e t i t i v e n e s s , p u b l i c information, technology t r a n s f e r , r e g u l a t o r y coord i n a t i o n , c l a s s i f i c a t i o n schemes and r e g i s t r i e s a r e n o t s p e c i f i c a l l y a d d r e s s e d . I t w i l l be i n t e r e s t i n g t o f o l l o w t h e e v o l u t i o n o f t h i s


384

T H E I M P A C T OF C H E M I S T R Y O N B I O T E C H N O L O G Y

b i l l and the l e v e l of e f f o r t to be directed to the c r i t i c a l applied and technological information needs of biotechnology. Those con cerned with biotechnology information should take note of t h i s b i l l and p a r t i c i p a t e i n i t s formulation and debate.


Recommendations

The author endorses the NRC Committee's recommendations, e s p e c i a l l y the f i r s t c a l l i n g for recognition of biotechnology information as a national asset and establishment of information centers of excellance. The NRC Committee had a d i s t i n c t biomedical orientation, properly r e f l e c t i n g the interests of i t s sponsor and the predomi nance of biomedically-oriented biotechnology within the federal and private sectors. Many of the same findings also apply to c r i t i c a l biotechnology information needs for agriculture, commerce, energy, and defense. Besides the Committees recommendations, and the general r e quirement that biotechnology organizations upgrade t h e i r information resources, the author suggests prompt federal and private sector attention t o : 1) Establishment of series of information centers c o l l e c t i n g , trans l a t i n g , organizing, and assessing foreign biotechnology scien t i f i c and commercial information and developments; 2) Extensions of indexing and c l a s s i f i c a t i o n schemes used by estab l i s h e d information resources, e s p e c i a l l y abstracting and indexing services, to better cover biotechnology; 3) Execution of user needs surveys, market studies, and assessments of available options and p r i o r i t i e s i n U.S. biotechnology i n f o r mation resources development; 4) Assessment by the federal government of the cost-effectiveness and appropriate means to a s s i s t the development, improvement and public release of private and nonprofit sector information r e sources; 5) Support f o r development and implementation of biotechnology information resources within the National A g r i c u l t u r a l Library (NAL), Department of Commerce, and Department of Energy to p a r a l l e l and keep up with the development of biomedically-oriented i n formation resources; 6) Establishment of at least one information center and b i b l i o graphic and factual databases concerning the safety, r i s k assess ment, and regulatory a f f a i r s of biotechnology products, proc esses, and materials; and implementation of an emergency r e sponse-capable information center and online database for b i o technology and i n d u s t r i a l microbiology. 7) Development of knowledge-based and expert systems, and other information resources to supplement U.S. manpower and educational d e f i c i e n c i e s and needs i n bioprocessing, fermentation, and other areas of r e l a t i v e foreign dominance i n biotechnology (ϋ, 13.) ; and 8) Establishment of federal and private sector clearinghouses to f a c i l i t a t e public access to biotechnology and related information. In summary, biotechnology i s a r e l a t i v e l y new, diverse, major scien t i f i c and commercial a c t i v i t y i n the U.S. and throughout the world. The infrastructure of information resources supporting U.S. biotech-



32. R A D E R


385

nology needs improvements on a number of levels, requiring e f f o r t s by a l l involved organizations - the federal government, the biotech nology and information industries, and research i n s t i t u t i o n s . Greatest needs are for establishment and expansion of information c o l l e c t i o n , organization, and services within biotechnology-inten sive organizations, e s p e c i a l l y U.S. biotechnology companies and research i n s t i t u t i o n s , and the recognition and coordinated action of federal agencies to promptly address biotechnology information resource needs and problems. Federal implementation of safety, regulatory, and international information resources i s required to protect the considerable U.S investment i n biotechnology. Although many author recommendations concentrate on the federal role and a c t i v i t i e s , the private sector needs to become involved i n a l l aspects of these a c t i v i t i e s to assure understanding of biotechnology as a diverse technological and commercial, and not just as a b i omedical research-oriented a c t i v i t y . Literature Cited 1. Kissman, H. M. and Wexler, P . , "Toxicology Information Systems: A H i s t o r i c a l Perspective,"Journal of Chemical Information and Computer Sciences, 25(3), pp. 212-217, Aug. 1985. 2. C r a f t s - L i g h t y . Α . , Information Sources i n Biotechnology, 2nd e d i t . , Nature Press, New York, 1986. 3. Brown, H. D . , "A Drug i s Born: Its Information Facets i n Pharma c e u t i c a l Research and Development," J. Chem. Info. and Comp.

Sci.,

v o l . 25, pp. 218-224, 1985. 4. Meyers, N . , "Biotechnology Patents: Don't Say Just What You Mean," Nature, v o l . 324, p. 504, Dec. 11, 1986. 5. Office of Technology Assessment, Commercial Biotechnology: An International Analysis, OTA-BA-218, Government P r i n t i n g Office, January 19, 1986. 6. Cantley, M . , "Bio-Informatics i n Europe: Foundations and Vi sions," Swiss Biotech., v o l . 2, no. 4, pp 7-10, 13-14, A p r i l ,

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, v o l . 4, pp. 522-525, June, 1986. 9. OMEC International, Federal Biotechnology Information Resources Directory, Washington, DC, 1987. 10.OMEC I n t . , Federal Biotechnology Programs Directory, Washington, DC, 1987. 11.Strauss, H. S., Biotechnology Regulations: Environmental Release Compendium, OMEC I n t . , Washington, DC, 1987. 12. Committee on Biotechnology Nomenclature and Information Organiza t i o n , 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 I n t . , Washington, D . C . , 1985. RECEIVED July 30,

1987


Status of the Infrastructure of Information Resources Supporting U.S.

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