Former Pennsylvania congressman James Greenwood has assumed the post of president of the Biotechnology Industry Organization (BIO). BIO represents more than 1,000 member organizations across three major areas of research and development: healthcare, food and agriculture, and industrial and environmental biotechnology. Carl B. Feldbaum, president of BIO from its inception in 1993, has retired.

“The biotechnology industry is dedicated to solving humanity’s toughest problems; it’s creating cures for heartbreaking diseases, improved crops for better nutrition, and clean biofuels for a better environment,” said Greenwood. “In 2004, the industry delivered on all fronts, with dozens of new products reaching consumers.”

The future looks bright for the next generation of companies and products as well. Investment in private biotechnology companies — almost all of them small research-and-development firms funded by venture capitalists — hit a record $5 billion in 2004, while the industry as a whole raised more than $20 billion.

“These investments are funding discovery and development of products across the biotech spectrum — new crops, new industrial processes for consumer goods, and new therapies in virtually every major disease category, including infection, diabetes, obesity, cardiovascular disease, neurodegenerative disorders and cancer,” said Greenwood. “This industry has never been financially stronger or scientifically more innovative. Our momentum as we enter 2005 is impressive.”

FDA Approves Breakthrough Therapies

The FDA in 2004 approved 32 new therapeutic products discovered, developed or marketed by biotechnology and related companies, according to a BIO analysis. The approvals include the first cancer drug designed to stop the growth of the blood vessels that feed tumors (Avastin), two cancer drugs targeting a cancer growth factor (Erbitux and Tarceva), and new medicines for multiple sclerosis, macular degeneration, and pain. (See the attached chart for details.)

“More than 800 million patients have benefited from biotech medicines and vaccines already, and millions more will benefit in the future.” said Greenwood. “Literally hundreds of products are in the development queue.”

Biotech companies also are leading a revolution in molecular diagnostics, including pharmacogenomic products that get the right drugs to the right patients. 2004 ended with the FDA’s approval of a first-of-its-kind genotyping test that helps doctors and patients select medications and doses for treatment of cardiac disease, psychiatric disease and cancer.

At the earlier end of the pipeline, two critical fields of research — biodefense and embryonic stem cells — both got a boost in 2004. The new federal BioShield law provides $5.6 billion over 10 years to procure vaccines, therapies and other products critical to protecting against bioterrorism. At the state level, California voters passed a $3 billion, 10-year initiative to fund embryonic stem cell research. Because embryonic stem cells can become any type of body cell, they have great potential for replacing cells, tissues and organs ravaged by disease and injury. Already, these cells have reversed paralysis in animal models.

Biotech Agriculture Expands

Biotech crop adoption continued to soar in 2004, nine years after the introduction of the first biotech staple crops. In the United States, biotech varieties accounted for 85 percent of soybeans, 76 percent of cotton, and 45 percent of corn. Six biotech crops (canola, corn, cotton, papaya, soybean and squash) were found to increase U.S. grower incomes by $1.9 billion and crop yields by 5.3 billion pounds, while reducing pesticide use by 46.4 million pounds, according to a new study from the National Center for Food and Agricultural Policy.

The impact of biotech crops is rapidly expanding in the rest of the world. A December study from food and trade policy analyst C. Ford Runge found that biotech crops are now being grown in 18 countries, and research and development is being conducted in another 45 countries. The global commercial value of biotech crops grown in the 2003-2004 crop year was $44 billion, according to the study.

“Biotechnology lifts farmer income and cuts erosion and pesticide use, benefits that farmers both here in the U.S. and in developing countries appreciate,” said Greenwood. “Moreover, growth will continue: The pipeline is packed with agricultural products that will further increase yields — and deliver health and safety benefits to consumers.”

Those products include drought-tolerant wheat, crops with higher levels of protein and antioxidants, livestock free of E. coli and immune to mad cow disease, and fish with higher levels of healthy fat and lower levels of contaminants such as mercury.

Milestones for Industrial & Environmental Biotech

A third major sector of biotechnology — industrial and environmental (I&E) biotech — is making giant strides in clean energy production and green manufacturing, bringing biotech to everyday products such as clothing, plastic cups, laundry detergent and vitamins. I&E replaces conventional manufacturing techniques with bioprocesses that generate less waste, consume less energy and, in many cases, save money.

“With these applications, biotechnology is providing the tools for sustainable, environmentally sound economic growth,” said Greenwood. “That’s revolutionary, not evolutionary, and the future impact could be of an even greater magnitude than biotech’s contributions to healthcare and agriculture.”

That impact starts with energy. April 2004 brought the first commercial production of bioethanol — ethanol made from agricultural wastes and grasses with the help of biotech enzymes. BIO member Iogen Corp. of Ottawa, Canada, produced the fuel using wheat straw. According to the Natural Resources Defense Council, bioethanol could supply half of America’s transportation fuel needs by 2050 if development is aggressive.

“We could cut both greenhouse emissions and our dependence on imported oil, all while boosting income for America’s farmers and creating new jobs in the nation’s heartland,” said Greenwood. “The future will bring energy security and economic growth, thanks to biotechnology.”

2004 brought other milestones in industrial and environmental biotechnology. DuPont joined forces with a British sugar producer, Tate & Lyle, to make a synthetic polymer for textiles using corn instead of petroleum. And Maxygen subsidiary Codexis signed an agreement with Pfizer to provide access to its technology for finding biotech solutions to improve small-molecule drug manufacturing processes.

Also in 2004, BIO published New Biotech Tools for a Cleaner Environment, a report analyzing the potential impact of industrial biotech on conventional manufacturing. Among other things, the study found that biotech processes can reduce toxic sludge waste volumes and energy requirements in paper bleaching by 40 percent; slash water usage for textile finishing by up to 60 percent and air emissions by almost 50 percent; and can cut air emissions associated with production of vitamin B2 and the antibiotic cephalexin by 50 to 80 percent.

Outlook Bright

With a spate of new products hitting the market, Ernst & Young projects industry revenues will rise almost 20 percent, to $51.4 billion, in 2005. That growth is driving employment gains that are expected to outpace the general economy at least through 2012, according to calculations based on U.S. Labor Department statistics.

“Growth is accelerating in dozens of regions in America, and it encompasses both startups and large-cap firms,” said Greenwood. “That record of growth will help BIO in the coming months as we pursue a policy agenda designed to ensure the financial markets and regulatory system continue to support this innovative industry, which has come so far, so fast, but still has a long way to go.”

About BIO

BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.