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The times are changing, with Washington being the new Wall Street, and billions in federal money heading to the life sciences sector, and lots of unresolved questions around regulation. That was the theme Thursday night at the Convergence: The Life Sciences Leaders Forum in Newport, R.I. Four panelists from industry and the public sector discussed the changes during a forum entitled, “The shifting winds of policy and regulation in the Obama Era.”
There was general agreement that Washington has supplanted Wall Street as the most powerful financial center in the country. With that in mind, the panel moderator Scott Kirsner, a Boston Globe columnist, believed the biggest single change for the region’s biotech industry is the more than $8 billion recently voted by Congress to supplement the National Institutes of Health’s research grant budget. However, the effect probably won’t be felt this year. Moreover, another major change is the new leadership at the U.S. Food and Drug Administration. However, he noted, “It’s still too early to tell what will happen at the FDA.”
Indeed, the new FDA administrators are “just getting settled in,” said panelist Steve Usdin, senior editor of BioCentury. The new leadership is very focused on public health and “will be receptive to what the life sciences industry wants and will align with it if life sciences wants to drive public health.” Other major issues include a transparency initiative seeking to make public more information around clinical trials and to emphasize comparative effectiveness in drugs.
There is also major game-changing pending congressional legislation, which will cover energy, financial market overhaul and health-care reform, noted panelist Alan Eisenberg, executive vice president of emerging companies at the Biotechnology Industry Organization. “Any one of these can suck the oxygen out of capital,” he noted. No matter what, in the short term, it will be tough for financing, as “capital markets are really problematic.” However, he noted, there is some secondary financing being conducted, which may be a move in the right direction.
The biotechnology industry itself is “going through a difficult time,” even while the government resolves such issues as patent reform and the use of biologics drugs. “There are opportunities and risks in that legislation,” said Usdin.
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