Genetically engineered (GE) animals provide innovative technologies that are
transforming public health through biomedical, food and environmental
applications, according to a scientific report released today at the BIO
2008 International Convention.
The report, Genetically Engineered Animals and Public Health ' Compelling
Benefits for Health Care, Nutrition, the Environment and Animal Welfare,
details how GE animals are enhancing human health, food production,
environmental protection, animal health and cutting-edge industrial
applications. The report was authored by Scott Gottlieb, MD, of the American
Enterprise Institute, and Matthew B. Wheeler, PhD, of the Institute for
Genomic Biology, University of Illinois at Urbana-Champaign. Dr. Gottlieb
and Dr. Wheeler are experts in the field of genetic engineering of animals.

Genetic engineering is the deliberate modification of the animal's genome
using techniques of modern biotechnology. By incorporating genes from other
organisms in a process called transgenesis, GE animals are being developed
to address five broad goals:

1. Advance human health: GE animals will improve human health by producing
novel replacement proteins, drugs, vaccines and tissues for the treatment
and prevention of human disease.

2. Enhance food production and quality: Animals that are genetically
engineered will have improved food production capabilities, enabling them to
help meet the global demand for more efficient, higher quality and
lower-cost sources of food.

3. Mitigate environmental impact: GE animals will contribute to improving
the environment and human health by consuming fewer resources and producing
less waste.

4. Optimize animal welfare: Genetic engineering offers tremendous benefits
to the animals by enhancing the health, well-being and welfare of the animal
itself.

5. Improve industrial products: Genetic engineering can produce high-value
industrial products, such as spider silk, for both medical and defense
applications.

'There are now dozens of products under development derived from genetically
engineered animals that hold promise of benefit to human health,' says Dr.
Gottlieb. 'But the practical benefits of this technology have not yet
reached American patients and consumers primarily because of regulatory and
political obstacles rather than the limits of science.'

The authors make a strong case for creating a regulatory pathway for
commercialization of these beneficial technologies. The report illustrates
how the production of GE animals promises benefits in both biomedicine and
agriculture. But Gottlieb and Wheeler agree that the science requires
regulations that bridge the divide between food and biomedical products.

'Until we resolve how we are going to deal with the food capabilities of
this science, the medical applications will remain largely undeveloped and
many opportunities for curing and treating disease will go unrealized,' said
Dr. Wheeler. 'These promising technologies are now dependent on
science-based regulatory framework to govern how these animals can also
provide food and agricultural benefits.'

The Biotechnology Industry Organization (BIO), which commissioned Gottlieb's
and Wheeler's report, supports the application of a strong science-based
regulatory process to the regulation of GE animals and their products, based
on the Food Drug and Cosmetic Act's New Animal Drug framework.

'The FDA has worked closely with the industry and academia on the diverse
applications of the technology for over ten years, and it has mapped the
road forward with a rigorous science-based framework,' says Dr. Barbara
Glenn, BIO's Managing Director for Animal Biotechnology. 'Clearly the
societal benefits of GE animals are fascinating. Decision makers in the
federal government should advance the publication of the regulatory process
for GE animals so we're able to achieve the promises of the technology.'

A copy of the full report, Genetically Engineered Animals and Public Health
' Compelling Benefits for Health Care, Nutrition, the Environment and Animal
Welfare, is posted at www.bio.org.

About BIO
BIO represents more than 1,200 biotechnology companies, academic
institutions, state biotechnology centers and related organizations across
the United States and in more than 30 other nations. BIO members are
involved in the research and development of innovative healthcare,
agricultural, industrial and environmental biotechnology products. BIO also
produces the BIO International Convention, the world's largest gathering of
the biotechnology industry, along with industry-leading investor and
partnering meetings held around the world.

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