In this issue...
Would you like to be involved in the WBBA’s educational programming for the year? If so, join us on the WBBA Program Committee! The committee meets monthly to discuss and refine the programming the WBBA brings you each year. You just have to be a member to participate. Contact Darcy Jacobson for more information.
Did you know...
WBBA HAS MOVED!
We've moved to 1551 Eastlake Avenue East in Seattle – a new hub for life sciences innovation, collaboration, and networking.
Washington Small Business Credit Initiative to spur $300M in new lending and investment
The Washington State Department of Commerce has been awarded $19.7 million from the U.S. Treasury to launch three new programs intended to spur investment and lending to small businesses around the state. Two of those programs may directly benefit small life science companies. The Capital Access Program (CAP) Fund ($6 million) will be administered by Commerce. The other meaningful program for our industry is the W Fund ($5 million) of a projected $25 million venture fund to invest in early-stage technology, life sciences and information technology. Read more.
Senator Scott White Memorial Fund
Senator Scott White passed away suddenly in October. During his brief and impressive legislative career, he was a leading voice for both K-12 and Higher Education. Education is essential if we are going to develop the talent needed to fuel the continued growth of the life sciences in Washington. Senator White leaves behind his wife Alison and their two young children. A memorial fund has been set up at Wells Fargo for Senator White’s two young children. If you would like to make a contribution, you may send a check to: Scott White Memorial Fund, PO Box 95675, Seattle WA 98145-2675.
Washington Members of Congress take action on policy supportive of Washington's life sciences industry
“Robust investment in NIH is vital…”
Thank you to Congressman Jay Inslee and Rick Larsen. They joined others who “strongly value the role of the National Institutes of Health (NIH) in generating medical breakthroughs and promoting job creation…” The letter called for the House to protect NIH funding as Senate negotiations move forward." Read more.
FDA Reform Package on Medical Device Review and Approval Process
Thank you to Congresswoman Cathy McMorris Rodgers, a member of the House Committee on Energy and Commerce, for her work on legislation to ensure timely access to critical life saving, life changing medical technology. The Energy & Commerce Committee introduced the “FDA Reform Package to Protect American Patients, Jobs, and Medical Innovation” and identified ten specific solutions to the top ten chanllenges slowing access to vital medical devices. Read more.
Legislation Introduced to Streamline the FDA De NOVO Classification Process for Medical Devices
Senate Bill 2. 1943 woudd create a de novo process with a well-defined regulator process and more efficient classification process for novel low-to-moderate-risk medical device technology. Read more.
Congressional Medical Technology Caucus and FDA Medical Device Regulatory Issues
Thank you to Congressman Jay Inslee and Congresswoman Cathy McMorris Rodgers for signing on to a letter from the bipartisan, bicameral Congressional Medical Technology Caucus to express concerns about regulatory issues facing the medical device industry. The letter to FDA Commissioner Margaret Hamburg, M.D. cited data about the increase in the average time to approve a 510(K) applicattion as well as the increase in costs to get new products approved to the patients who need them. The MedTech Caucus shares patient safety as a primary concern but supports a “least burdensome approach” to approval without crippling the industry working to develop products to improve patient health and address unmet medical needs. The letter outlined strategies to streamline the device approval process and make it more predicatable. Read more.
The Food and Drug Administration (FDA) released a report containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans. The report is meant to address concerns about the medical product development pipeline, one of the most pressing challenges facing the biomedical industries.
A new FDA-wide Innovation Initiative promises to redouble the agency’s efforts to encourage innovations that will promote public health as well as strengthen the American economy.