By Lisa Seachrist

Washington Editor

WASHINGTON - The Biotechnology Industry Organization (BIO) has developed a seven-priority focus to steer the organization through the first years of the 21st century.

The plan was developed during a meeting of BIO's board of directors and its executive committee in San Francisco in early January, and details the ways in which BIO will endeavor to the meet the needs of its diverse member companies until the year 2004. Those focus areas range from capital formation to intellectual property concerns to bioethics.

"We are working on a new approach; biotechnology is not new to Congress any longer," Carl Feldbaum, BIO's president, told BioWorld Today. "That really represents changes in the biotechnology industry itself. The message has changed from the promise of biotechnology to the performance of biotechnology."

The first of the focus areas in BIO's new strategic plan will be capital formation, whether in the form of tax reforms, National Institutes of Health funding or partnering missions to Japan and Europe. Feldbaum said that enhancing biotech companies' ability to raise capital is a priority BIO "puts very high on the list."

In addition, the organization will seek to ensure the global regulatory environment is amenable to biotech. At home, that means ensuring the timely implementation of the FDA Modernization Act (FDAMA) and working within Congress to ensure the agency has ample funds to do its job. Internationally, BIO will take an active role in the Biological Weapons protocol and the Bio Safety protocol.

"Obviously important to the largest companies and the smaller emerging companies is the issue of reimbursement," Feldbaum noted. "We will oppose any attempt at drug price controls. Investors need to know that there is a return down the road for their investments and price controls limit or eliminate that return."

Medicare reforms and third-party payor issues will also occupy a significant place on BIO's reimbursement agenda.

While reimbursement is key to companies once they have a marketable product, intellectual property serves as the lifeblood needed to develop that product in the first place. Feldbaum said that the board and executive committee agreed the organization should work to strengthen patent protections, starting with the restoration of patent term lost with the General Agreement on Tariffs and Trade (GATT). The Hatch-Waxman Act, which returns patent term for some time lost at FDA, is scheduled to be reconsidered this year as well.

Sheep-clone Dolly brought bioethics issues to the forefront two years ago, but privacy, genetic discrimination and human embryonic stem cell research have become increasingly debated issues. Feldbaum said bioethics issues will play a major role in the organization's fifth priority area of public acceptance of and education about biotechnology.

"We are working on three recurring themes: the cost of drugs, biotech food and biotechnology as an investment," Feldbaum said. "We are working on a major effort to get the benefits of biotechnology up to the forefront."

Finally, the board ratified initiatives to enhance member recruitment and retention as well as organizational development efforts.

"When we talk to member companies and ask them what's the most useful thing we do, the bigger companies say our governmental advocacy," Feldbaum said. "Our smaller companies say our networking efforts and our purchasing program. But the smaller companies are increasingly recognizing the importance of governmental advocacy."

Feldbaum noted that the board also decided to participate more actively in the implementation of the strategic plan by sitting as chairs or members of each priority committee.

"This is a very welcome development," Feldbaum said. "It really represents the maturing of the organization. Before, everyone was struggling just to survive. Now, an increasing number of CEOs want and can afford to be more actively involved."

Feldbaum said that BIO staff was revamping its 1999 plan to reflect the beginning of the new five-year plan. n