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Biotech Must Have Predictable Regs, More Capital, More Talented Workers to Thrive


Xconomy Seattle — 

Last week, a group of executives and leaders from state life sciences trade associations across the country, including myself, gathered here in Seattle to discuss the policy landscape at both the federal and state levels. Part of our agenda for the meeting, which took place at Amgen’s Helix campus along Elliott Bay, was to discuss the implications of a new study conducted by Battelle and commissioned by the Council on American Medical Innovation (CAMI) outlining the policy changes necessary to maintain a thriving life sciences and biotech industry in the United States.

And as a state with a thriving life sciences industry, the study also had very specific implications for Washington.

The study, for which I was interviewed, identifies four key challenges that we must address in order to maintain our leadership: 1) lack of consistency and predictability in the review and approval of new medical products and uncertainties in reimbursement; 2) shortfalls in private investment for company formation, R&D and related manufacturing job growth; 3) gaps between research and translation of medical innovation into new treatments; and 4) limitations in the U.S. bioscience talent pool.

The most important conclusion from the study and our resulting meetings in Seattle is that we cannot take for granted the strength and growth we have witnessed in the life sciences and biotechnology sectors so far. Our leadership in these industries as a state and as a country is ours to lose. We are beginning to experience some regulatory and financial limitations that are not good signs for sectors that have been among the few bright shining areas in an otherwise dim economic picture.

A warning shot went up this week: If we don’t take steps now to relieve policy pressure on life sciences, we face the serious risk of losing our global leadership in these areas.

Many within Washington state have a stake in this leadership, and as evidenced by the nearly 60 interested community members who joined us for the event: Lee Huntsman from Life Sciences Discovery Fund, John Gardner from Washington State University, Bob Drewel from the Puget Sound Regional Council and Carolyn Busch from state Senate Majority Leader Lisa Brown’s staff, to name a few.

U.S. Rep Jay Inslee, whose House district covers parts of Kitsap, Snohomish, and northern King County, continues to be a champion for innovation and the need to support the life sciences and therapeutic development, as well as education. Congressman Inslee—named Legislator of the Year by the Biotechnology Industry Organization (BIO)—added the following during our conversation:

“I am happy to join you in making a very strong call for public involvement to make sure that private genius reaches fruition. I think the study we will hear about today basically has one fundamental conclusion, and that is that with all the private genius we have in America, it won’t reach fruition without public involvement. And we’re here to say that America needs to have a full-court press on an innovation agenda around biotechnology to really reach that private genius and allow it to blossom.

“We have this perfect storm of the biggest creation of new science in world history in life sciences just at the moment when we have a reduction in private capital to reach the fruition of that private genius. So it is up to us in Congress, and in The White House, and Governors Mansions, and State Legislatures to really adopt a new innovation agenda.”

The life science sector in Washington is now one of our state’s top five sectors and one of our fastest growing jobs producers. The industry itself resides in more than 70 cities statewide. The Battelle report showed that the biomedical sector outpaced all other sectors in job growth from 2001 through 2008 nationally. And even more exciting—and the reason why Washingtonians should care about these study findings—is that jobs in the life science sector in our state grew at nearly twice the national average during the same time. Impressive by any standard.

Tom Clement, chairman and co-founder of Kirkland-based Pathway Medical Technologies, an innovator of technologies for the treatment of vascular disease painted a clear picture of the challenges. He lives these issues every day in his business as he attempts to steer through cumbersome regulatory processes, maintain a strong and educated talent pool and remain competitive.

Tom summarized the sentiment of the entire group when he said: “The life science ecosystem is our future, yet it is hurting for several reasons including a lack of early stage—or ‘Valley of Death‘—investments, a shrinking talent pool and an uncertainty in the regulatory environment. That is why I, along with the other industry leaders you see here today, stand in support of a national policy that recognizes the importance of the life sciences sector to our nation and to our state. It’s time to make real changes to ensure that the life sciences remain a strong and thriving jobs engine in our economy.”

The Battelle Study is just the beginning. We have a lot of work to do in this country and this state to ensure continued success. We will be working both within the life sciences community and with our neighbors to build consensus around a policy platform that will keep us on the current growth trajectory. On behalf of the biotech and life sciences community here in Washington state, I’m committed to that program because the alternative is simply unacceptable. It’s ours to lose.

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