BIOTECHNOLOGY FOR THE 21st CENTURY:
NEW HORIZONS

1. INTRODUCTION


Introduction Contents


PREFACE

Scientific knowledge of the living world has grown exponentially for the past 50 years. A great deal is known now about the structure and function of living cells, how they retain and transmit genetic information, and how they respond to chemical and physical signals. From this knowledge base, through fundamental research supported largely by the U.S. Government, the tools of modern biotechnology have been forged.


Textbox 1:Biotechnology Defined
Biotechnology is a set of powerful tools that employ living
organisms (or parts of organisms) to make or modify products,
improve plants or animals,or develop microorganisms for specific
uses. Examples of the "new biotechnology" include the industrial
use of recombinant DNA, cell fusion, novel bioprocessing techniques,
and bioremediation.

Biotechnology has been employed by humans for millennia; traditional applications include production of beer, cheese, and bread. But the recent developments in molecular biology have given biotechnology new meaning, new prominence, and new potential. It is this "new biotechnology" that has captured the attention of scientists, financiers, policymakers, journalists, and the public, even though the revenue it generates is as yet only a fraction of that produced by traditional biotechnology. Through the use of advanced tools, such as genetic engineering, biotechnology is expected to have a dramatic effect on the world economy over the next decade.

A variety of U.S. industries, primarily the agriculture and pharmaceutical sectors, already are profiting from this trend; an estimated $7 billion in sales were generated in 1993 as a result of the new biotechnology. These sales are expected to reach approximately $50 billion in the next decade. The United States leads the world in technological innovation and new company formation in biotechnology. The biotechnology industry is responsible for approximately 100,000 high-skill jobs generated by 1,300 biotechnology firms.(1)

Examples of new products derived from modern biotechnology include tomatoes with an extended shelf life and a drug, tissue plasminogen activator, used to dissolve blood clots during heart attacks. But these innovations offer only a hint of the enormous potential of biotechnology. Many other new products are also in development, including disease-resistant plants, "natural" pesticides, environmental remediation technologies, biodegradable plastics, novel therapeutic agents, chemicals, and enzymes that will reduce the cost and improve the efficiency of industrial processes.

A coordinated Federal research effort can provide the leverage needed to fulfill the broad promise of biotechnology, which may well play as pivotal a role in social and industrial advancement over the next 10 to 20 years as did physics and chemistry in the post-World War II period.

The Federal Role in Biotechnology

The Federal Government has propelled the development of modern biotechnology by supporting research that led to the cloning of the first gene in 1973 and the subsequent development of DNA sequencing technologies. A strong foundation has been laid that places the United States at the forefront of biotechnology research. Critical to continued innovation in all spheres of biotechnology is an ongoing Federal commitment to basic research into fundamental life processes, as well as support for the requisite infrastructure.


Textbox 2:Biotechnology Comes of Age
For the first time ever, a biotechnology company has been
awarded the Presidential National Medal of Technology, the high-
est honor given in the United States for achievement in science and
technology. Amgen received the award in December 1994 for bringing
to market two widely successful medicines - - EPOGENTM (Epoetin
alfa) and NEUPOGENTM (Filgrastim) -- which vastly improve the quality
of life of patients with cancer and kidney disease.

To date, the Federal investment in biotechnology has been focused primarily in the health field. Figure 1 shows that approximately 80 percent of the Federal biotechnology investment supports health-related projects and basic research that is broadly applicable but often health oriented. Much of this support comes from the National Institutes of Health (part of the Department of Health and Human Services), as indicated in Figure 2.

The results of health-related biotechnology research are having a profound impact on medicine and health care, providing improved approaches to the diagnosis, treatment, and prevention of disease. While health-related research must remain a national priority, researchers are poised to build on the foundation in basic science to bring the power of biotechnology to bear in other fields. At present, as Figure 1 shows, only 12 percent of the Federal investment in biotechnology research supports applications outside the health arena.(2)

This report presents the overall Federal perspective on biotechnology issues, opportunities, and priorities in areas beyond health that need to be addressed by funding agencies and the research community. The report is the result of a planning effort by the Biotechnology Research Subcommittee (BRS) of the Committee on Fundamental Science of the National Science and Technology Council (NSTC).(3) The BRS is an interagency committee charged with coordinating the Federal investment in biotechnology.

Because biotechnology research is broadly applicable to diverse government missions and goals, it is supported by 13 Federal departments and agencies, all represented on the BRS (4):

Agency for International Development (USAID)
Department of Agriculture (USDA)
Department of Commerce (DOC)
Department of Defense (DOD)
Department of Energy (DOE)
Department of Health and Human Services (DHHS)
Department of the Interior (DOI)
Department of Justice (DOJ)
Department of State (DOS)
Department of Veteran Affairs (DVA)
Environmental Protection Agency (EPA)
National Aeronautics and Space Administration (NASA)
National Science Foundation (NSF)

This report is aimed at a wide audience, including the U.S. Congress, Executive Branch officials, industry, and academic institutions.

The Federal Government is one of three partners, along with the industrial and academic communities, in the collaborative venture that is biotechnology research and development. The government's role is to sponsor research that will generate new knowledge and to ensure that technological advancement contributes to the overall public good and national welfare. Support of basic research generates innovations, from which previously unanticipated products may arise. The private sector completes the technology development cycle and ensures distribution of beneficial products to consumers.

Report Structure

The resources of Federal agencies, as well as expertise from the private sector, were brought together to identify opportunities in four rapidly developing areas of biotechnology research. Each area is addressed in a separate chapter of this report, which identifies priorities for Federal investment and summarizes current directions and specific research opportunities. (Related activities of each BRS agency are summarized in the Appendix.) The chapters emphasize multidisciplinary, long-term research, which will be essential in order to enhance the efficacy of existing biotechnologies and develop new ones.

The four areas highlighted are agricultural biotechnology, environmental biotechnology, manufacturing/bioprocessing, and marine biotechnology and aquaculture. The concluding chapter of the report outlines infrastructure needs -- facilities, human resources, databases, and mechanisms for collaboration and information exchange. A sophisticated infrastructure is required to support all areas of biotechnology research.

Based on the common themes identified in the four areas, the BRS identified three overarching priorities for Federal investment in biotechnology research. Pursuit of these priorities will ensure the development of a strong research base, which in turn will facilitate product commercialization and help maintain U.S. leadership in biotechnology.

Overarching Priorities


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