Uncharted waters

WASHINGTON - The inauguration of George W. Bush at week's end will thrust much of the biotechnology industry into unfamiliar territory: the bulk of today's companies, as well as the technologies they are based on, were created during the Clinton administration, and many biotech leaders have never experienced a political and regulatory environment other than the one created by the political appointees and policies of the Clinton years.

Biotech will find itself facing a Republican White House which takes office committed to pro-life, anti-abortion policies and with a promise to enact a prescription drug benefit for senior citizens. It is also an administration that won an election with heavy financial support from the pharmaceutical industry and has vowed big increases in spending for biomedical research.

The challenge for the industry will be to try to ensure that the impact on biomedical innovation is a critical consideration in policy making on prescription drugs, FDA, NIH and other issues. In a White House that isn't likely to dress itself in "new economy" rhetoric and that will be trying to demonstrate its effectiveness by getting legislation enacted quickly, this may prove difficult.

In particular, the increased delegation of authority in the Bush administration will intensify the need of the biotech industry to focus on a large number strategic relationships with key personalities in the executive branch and Congress.

The wave of change

It is difficult to exaggerate the scope of change that the industry experienced from 1992 to 2000. Advances in science in the Clinton years include sequencing the human genome and the emergence of the genomics industry, the cloning of Dolly, the development of effective AIDS treatments, and advances in the use of stem cells. The NIH budget soared and the FDA was "reinvented" and "modernized." The dotcom bubble burst just as gene sequencing breakthroughs highlighted the promise of biotech, with the resulting biotech bull market capping an eight-year period in which some 250 companies went public in the U.S.

Although the

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