Biotechnology: What it is, what it is not, and the challenges in reaching a national or global consensus

This article is the 17th in a series of articles on the nature of biotechnology and its related industries (for a listing of the previous articles go to www.csuchico.edu/csuperb). The series is designed both to facilitate the understanding of the industry by the academic educational and research training sector as well as to better define the consequent educational, discovery and applied research, and developmental research-training needs of future employees. This article addresses in greater detail a previously referenced significant impediment to fully grasping the current and future societal contribution of biotechnology, i.e. the definition of the term. Governments around the world are embracing biotechnology as the next major technological engine for economic growth. But while the industry has experienced impressive growth globally, it has sparked a number of international challenges and controversies as governments seek an optimal balance between rewarding innovation and ensuring the broadest possible access to the benefits of technology. The nascent biotechnology community has demonstrated its capacity to discover, develop, manufacture, and increasingly sell new life-saving therapeutics for cardiovascular disease, cancer, neurological conditions, and infections, including hepatitis, AIDS, and a number of other human maladies, including an ever expanding plethora of inflammation-based conditions. Bolstered with the past advances in genomics, and looking forward to the next incredible decades riding on the proteomics bandwagon, linked to the explosion of other members of the -omics family and with a greater understanding of human development, senescence, and aging, researchers worldwide are accelerating the rate at which biotechnology is transforming our society in not only healthcare but also in a variety of related areas. Because biotechnology seeks to understand and manipulate life itself at the molecular level, the field (note: not a discipline!) provokes far more profound dilemmas than any other technology previously conceived, except perhaps nuclear technology [1]. The public debate on the application of new biotechnologies has accelerated substantially since 1997, after being sub rosa in the 80s. Regardless of the intense debate, an element of biotechnology upon which nearly everyone agrees is that the field is at the beginning of a technology curve whose upside potential appears limitless. Falling into the area of disruptive technologies [2], it is clear to all that the best days of biotechnology are ahead of us, not behind us. Studies of the biotechnology industry and the evolution of new biotechnologies and their net economic benefit have taken a number of paths. There have been social science approaches that have analyzed the field's development: from a political science/economic viewpoint; from the industry as a unique cluster of networks (leading to its designation as the “network industry”); from the impact of the industry on other existing technologies; from the impact of the technologies on other industries; and from the impacts of the companies that are discovering and deploying new biotechnologies on other companies [2, 3]. There have been many statistical studies conducted by regions, states, and countries evaluating indicators and benchmarking standards of various industries that have allowed the continual monitoring of those particular industries' growth and change and success. Understandably, policy makers have great interest in conducting such economic studies that highlight the impacts and the growth of a particular industry. Most recent economic studies of the impact of new technologies have focused upon the widespread impacts of the information/communications technology (this U.S. industry has a workforce of ∼2.6 million as compared with the current 220,000 for the biotechnology industry). Measuring impacts and economic performances are mandatory because they underpin the development of government policies for the stimulation of business, innovation, and national science and technology, including the creation of tax incentives and resources for federal research support, research training, regional, state, and country infrastructural enhancements, etc. Accurate assessment of the current state of biotechnology is considered to be absolutely essential, especially, as this “technology” continues to develop and diffuse with such pronounced acceleration. The demand from state and country policy makers for measurements of industrial and academic biotechnology performance is growing with extraordinarily rapidity, and studies have been blooming in many U.S. and global sectors. This phenomenon is best evidenced by the recent activities of the globally focused Organization for Economic and Cooperative Development's (OECD,11 The abbreviation used is: OECD, Organization for Economic and Cooperative Development. www.oecd.org) Working Party on Biotechnology and its ad hoc Committee on Biotechnology Statistics. The Working Party on Biotechnology is composed of representatives from the highest echelon of member OECD countries' governmental executive branch-based science and technology experts, whereas the latter is comprised of official governmental statisticians from each of the member OECD countries (the OECD being an official global organization composed of the 30 most wealthy countries in the world and in which the United States plays a very significant role). The development of indicators for measuring the impact of biotechnology on sustainability (economic, environmental, health, agricultural, and social impacts) is a major priority for OECD member countries. Examining the economic impacts of biotechnology is not as straightforward a process as one might expect. Assessing measurable impacts of biotechnology always first involves examination of many variable economic features of the firms deploying biotechnology and producing biotechnological products and services. Notably, last year the U.S. Department of Commerce and the Bureau of Labor Statistics conducted the first ever analysis of the U.S. biotechnology industry [4]. Examining the aggregate growth and productivity performance contributions of these firms, either nationally or globally, with measures of input, output, employment, patents, R&D, exports, or innovation can be relatively straightforward, but one must carefully consider the modifier “ … can be.” Complications arise in several areas, such as the means and success by which countries officially designate and label company types (in the United States, this was done previously under the Standard American Industrial Classification System, now replaced by the North American Industry Classification System (www.bls.gov/bls/naics.htm), but which is uniformly recognized as being suboptimal), the high degree of churning that occurs in the biotech sector, as well as other contributing factors such as the complex statistical approaches, hurdles that are too complicated to delve into in this article (e.g. designation of output measures, input measures, whether a company is a biotechnology company that performs biotechnology R&D or whether it just uses biotechnology, etc.). But, by far the most complicating feature of any statistical evaluation of any elements of the past, current, and future biotechnology industry depends on one simple and, up to this time, massive hurdle: consensus on just what biotechnology is. In past articles in this series, this author has referred to this complicating definitional feature only en passant and by highlighting the similarity of biotechnology's definition to a well-known definition used in the past by U.S. Supreme Court Jurist Stewart Potter as regards pornography: it is difficult to define, but you know it when you see it. The bottom line is that there is no consensus of what biotechnology is or what it is not, and this reality and the differences in definitions deployed by organizations, departments, agencies, states, and federal governments have severely compromised any comparative studies and analyses of the economic or other impacts of the industry. As a stellar example of misdirected labeling of biotechnology by governments as they struggle to measure the extent of the investment of public resources in biotechnology, and the return thereon, just before the budgetary doubling of the U.S. National Institutes of Health, the organization claimed that over 80% of its total extramural research funding was for biotechnology. Now, this may be useful for garnering the attention of the U.S. Congress, but it has no positive contribution to understanding the field. The difficulty in understanding what biotechnology is or what it comprises is nowhere better demonstrated than in the 33 public universities in California, which have (fortunately) no more than three degree programs at any level that are labeled biotechnology, the reason being differences in interpreting what biotechnology is and what a so-labeled degree really represents. This has resulted in most degrees involving biotechnology being labeled as a Degree in X, with a Specialization in Biotechnology. Each country, state, or organization with not inconsiderable due diligence has cobbled together a cluster of meaningful words and phrases in an attempt to identify biotechnology and get a “grasp on the beast,” desiring to get a frame of reference on which to build decision-making regarding resource allocation, comparative analyses, and many of the other features described above, including many aspects of importance to the academic sector such as funding for research, research-training, training, and education. Below are the official definitions used by various OECD member countries. Notably, many of the citations are working documents from the OECD and other agencies. Some definitions have two parts, a single definition and then a list-based definition entailing the types of technologies. Several countries have also tried to classify companies into various categories, and the reader should note the wide variation in what countries consider to be a biotechnology company. Some countries are struggling with the preparation of other types of hopefully helpful lists that can be used for classification purposes and for defining who and what should be measured in biotechnology performance assessment. These include: specific lists of disciplines, research “items,” disease foci, specific techniques, applications, types of biotechnology companies, etc. Biotechnology means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. Biotechnology is simply the use of microorganisms, and plant and animal cells, to produce materials such as food, medicine, and chemicals that are useful to mankind. Biotechnology is defined as the application of science and technology to living organisms as well as parts, products, and models thereof, to alter living or nonliving materials for the production of knowledge, goods, and services [5]. Biotechnology has been defined as the application of science and engineering to the direct or indirect use of living organisms, or parts of products of living organisms, in their natural modified forms“ [5]. Canada also uses a list of technologies as an added component (Table I, see also Ref. 6). Agbio Aquacultural Bioinformatics Environmental Food processing Human health The OECD definition has been adopted (see below). Pharmaceuticals Diagnostics Biomaterials Food and feed Industrial enzymes Agro Service companies Biotechnologies—technologies for and by living organisms—aim to improve the well-being of humanity as well as its nutritional and natural environment [5]. France also uses a list of technologies as an added component (Table I, see also Ref. 6). The OECD definition has been adopted (see below). Therapeutics Diagnostics Biomaterials Suppliers Plant biotechnology and nutrition Animal health and transgenic animals Environmental Platform technologies and contract research The application of biological knowledge relating to genes and cells in order to develop useful products, processes, or services such as new medicines and therapies, cloning, genetically modified foods, and enhanced crops. It encompasses an ever-growing range of laboratory techniques for the alteration and manipulation of molecules, genes, and cells and often involves the harnessing of biological processes for a particular purpose such as the biological synthesis of pharmaceutical compounds [8]. The application of science and technology to living organisms (as well as partial organisms, organism products, models, etc.) in order to develop, produce, and/or change living material and nonliving material, for the purpose of producing knowledge, products, or services [5]. Agbio Nutriceuticals Cosmetics Environmental Pharmaceuticals Diagnostics Platform technologies Biofood and beverages Biomedicine Biochemistry Bioelectronics and machinery Bioprocessing technology and bioengineering Bioenvironment Bioenergy and resources The science of the production processes based on the action of micro-organisms and their active components and of production processes involving the use of cells and tissues from higher organisms [5]. The application of science and technology to living organisms as well as parts, products, and models thereof to alter living or nonliving materials for the production of knowledge, food, drugs, and other products and services and to improve the quality of life. New Zealand also uses a list of technologies added component (Table I, see also Ref. 6). Human health Bioinformatics Agbio Food processing Aquaculture Mining/energy/petrochemicals Forest products Environmental Companies whose primary commercial activity depends upon the application of biological organisms, systems, or processes or on the application of specialist services to facilitate the understanding thereof [5]. Agbio Biodiagnostics Environmental Human healthcare Service providers Technology service providers The application of molecular and cellular processes to solve problems and create goods and services. It includes a diverse collection of technologies that manipulate cellular, subcellular, or molecular components in living things to make products or discover new knowledge about the molecular and genetic basis of life, or to modify plants, animals, and microorganisms to carry desired traits. Such technologies include, but are not limited to: genetic engineering (e.g. recombinant DNA, gene therapy, cloning, antisense); hybridoma technology (to produce monoclonal antibodies); PCR or PCR amplification; gene mapping; DNA sequencing; restriction length polymorphism analysis; and protein engineering [4]. Human health Animal health Agricultural and aquacultural/marine Marine and terrestrial microbial Industrial and agriculturally derived processing Environmental remediation Natural resource recovery Note that the U.S. Department of Commerce is currently re-evaluating the list of company types and that it will be expanded to include bioinformatics and research tool companies, as well as modified to clarify the cross-cutting microbial and terrestrial areas. Biotechnology is defined as those companies whose primary commercial activity depends on the application of biological organisms, systems, or processes [10]. The use of cellular and molecular processes to solve problems or make products [11]. The biotechnology industry is built upon fundamental breakthroughs in the understanding of genetic and biological processes to develop new means of diagnosing and treating disease [12]. The Ernst & Young definition is linked to the identification of so-called ”Entrepreneurial Life Sciences Companies,“ that is commercial companies whose main business purpose is to research, develop, and sell products, technologies, and services on the basis of modern biotechnology. The fields of application lie in the field of healthcare (therapeutics and diagnostics), agriculture, food, biotechnology fine chemicals, and basic goods production as well as environmental protection. These sectors are generally referred to collectively as the “Life Science Industry.” Modern biotechnology means all innovative methods, processes, or products that mainly involve the use of living organisms or their cellular and subcellular components and that use research results in the field of biochemistry, molecular biology, immunology, virology, microbiology cell biology or environmental technology, and process engineering within the framework of a causative interpretation [13]. The European Commission has adopted the OECD definition, but with a list-based definition, a “Taxonomy of Biotechnology” (q.v., Table I at www.cordis.lu/rtd2002/indicators/publications.htm). Biotechnology is any technique that uses living organisms or parts of organisms to make/modify products, improve plants or animals, or develop microorganisms for specific use [14]. Biotechnology makes products and processes for the diagnosis, treatment, and cure of human disease, as well as the development of genetically customized animals, plants, and food [15]. Animal ag Aquaculture Bioinformatics Biomass conversion Biomaterials Biosensors/bioelectronics Bioseparations Cell culture Clinical diagnostics Commodity chemicals Contract research organizations (regulatory) Contract research Cosmetics/beauty and health products Drug delivery systems Energy Environmental testing/treatment Equipment Food Fungi Gene therapy Immunological products Marine natural products Medical devices Plant agriculture Production/fermentation Proteomics Reagents Specialty chemicals Testing/analytical services Therapeutics Toxicology Vaccines Veterinary The OECD uses a statistical definition of biotechnology that has two parts, a provisional single definition and a second list-based definition [17]. The provisional single definition of biotechnology is as follows: The application of science and technology to living organisms as well as parts, products, and models thereof to alter living or nonliving materials for the production of knowledge, goods, and services. DNA (the coding): genomics, pharmacogenetics, gene probes, DNA sequencing/synthesis/amplification, genetic engineering. Proteins and molecules (the functional blocks): protein/peptide sequencing/synthesis, lipid/protein glyco-engineering, proteomics, hormones, and growth factors, cell Cell and culture and cellular and gene therapy, of that use organisms or their cellular, subcellular, or molecular components to make products or modify plants, animals, and micro-organisms to carry desired of technology development, disease treatment, and a understanding of living organisms, including cell therapy, genetic engineering systems, and of the of definitions and lists into the complicated decision-making a consensus on a recognized definition of biotechnology. It also as to as well as is the better of in the term. The OECD has this process in the definition, and it will in the next The previous OECD definition, now over has been but it is and has also problems in international biotechnology as well as monitoring other governments will their definitions to the future OECD at as regards their policy and statistical The U.S. definition will as a of this The extent to which U.S. federal funding will modify their is to the academic such definitional will in the creation and of and these will in the process at the and that occurs in U.S. higher most see the biotechnology industry as cell culture and and not the that there are over in the biotechnology industry. as referenced in previous articles in this series, either in or the identify biotechnology with biology, which is a major as is demonstrated in Table which in an ever-growing a list of technologies under the biotechnology It has been used as of the OECD It is not considered to be but The working definition of biotechnology under the biotechnology of the is: diverse collection of technologies that both on the of and manipulate organisms, or cellular, subcellular, or components to discover new knowledge, to solve and to create models thereof, goods, products, and As the reader can this is not for a of what biotechnology really In order to get the of biotechnology, it is that a definition be a definition such as the above, a list of company types (the of Biotechnology is the most global and a provisional list of biotechnologies and processes (Table all three of these in and hopefully in whether one is an academic a member or development a a member of the or the of the one can then the and impacts of the field. Several on the of the U.S. and biotechnology industries in the reader will definitions of the industries and technologies under the biotechnology The and Life Science The Technology and Science for the The of The of the life science industry for Life Sciences and on biotechnology, and Industry on U.S. and global in the biotechnological in that includes the by the OECD on the definition of OECD for Technology and Industry Committee for and of the on Biotechnology Statistics at the OECD, on from the OECD for Technology and Industry Committee for and will that the countries have currently adopted the definition of New The Biotechnology Industry Organization has a that the expanded and the future of industrial biotechnology, which has the of the human therapeutics for a

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