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News Beat March 2020
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News Beat March 2020 - Life Science Washington

March 2020


You are part of a vibrant community of life science professionals. This newsletter helps keep you connected to that community and informs you of industry news, transactions, and upcoming events.


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2020 LEGISLATIVE RECAP


Over the past three months, Life Science Washington’s lobbying team has been busy in both Washington, DC and the state capital. In that time period, we have seen the medical device tax repealed and the state legislature complete its short, 60-day session on Thursday, March 12th. Here’s a summary of the issues we have been working on for you.

2020 State Legislature

Consumer Data Privacy (2SSB 6281) – Consumer data privacy was a primary focus of the legislature this year. The primary target of these bills was to give consumers access to review, modify and control their person information. While giving consumers the ability to review and modify information held by Big Tech companies may be a great idea, it would cause serious problems for medical data related to patient records, clinical trials, and FDA monitoring, which is already regulated by HIPPA. To ensure that medical data was treated effectively, we built a healthcare privacy coalition that included: Life Science Washington, the Washington Hospital Association, AdvaMed, BIO, and PhRMA to present a coordinated voice on healthcare data privacy issues. The approached worked well.

The coalition’s legal experts developed legislative language that would align state policy with existing healthcare regulations and exempt healthcare and life science organizations that comply with HIPPA. The primary privacy bill to make it through the session was Senator Carlyle’s 2SSB 6281. We were able to get all of the language that we requested included in the bill. While the bill passed the Senate almost unanimously, it stalled in the House over enforcement issues. Nevertheless, we believe that the healthcare language included 6281 is some of the best in the nation and can serve as model legislation for other states going forward.

Biosimilars Prescriber Notification Sunset (HB2251) — This is technical legislation that extends the interchangeable biological product notification requirement (to enable the continued prescription of biosimilars) from August 1, 2020, until August 1, 2025. It passed both chambers and we expect the Governor to sign it.

Gene Editing Study Bill (HB2273) — Gene editing is not well understood and the specter of ‘designer babies’ caused some members to call for regulating genome editing. This bill was introduced to open a dialogue on the topic. We worked with the sponsor to strengthen the bill and we testified on the topic. This provided an opportunity to educate legislators about the incredible potential of gene editing technology and the fact that the FDA and other institutions have effective frameworks in place to ensure the ethical development of gene editing technology and medicines in the United States.

Washington’s Cancer Research Endowment (CARE Fund) — Due to the CARE Fund’s unique funding model, the CARE fund needed new budget authority and supplemental funding this year. The Governor’s budget fixed the budgeting problems and the final budget appropriated an additional $7.5 million for the CARE fund.

Career Connect Washington Funding — Career Connect Washington, which works with employers and industry groups including Life Science Washington to develop career pathways for high school students, received an additional $1.5 million in supplemental funding.

Science & Technology Caucus Briefing — Life Science Washington organized a briefing for the State Legislature’s Science & Technology Caucus on Washington’s life science industry. We kicked-off the presentation with LSW’s new video, which was followed by a panel discussion with Leslie Alexandre and LSW Board Members Margaret McCormick and Nancy Whiting who helped legislators better understand what it takes to bring a new therapy to market as well as how tax policy impacts life science companies.

WSU Vancouver Life Sciences Building (Design) – The new building’s design budget got its full $4 million.

Battery Stewardship Program (HB 2496) — Often, we have to play defense to make sure member companies aren’t inadvertently impacted by legislation targeting others. That was the case with a battery recycling bill aimed at having battery manufacturers take responsibility for keeping batteries out of landfills. Without an exemption, medical device manufacturers that produce devices with batteries in them, would have been responsible for setting up complicated, expensive, closed loop (take back) programs to collect the batteries in their devices. So, we worked with AdvaMed to ensure that medical devices were exempted from the bill.

Washington Healthcare Authority Emerging Therapies Working Group — The Healthcare Authority (HCA) has been convening an Emerging Therapies Working Group to think about how to handle and fund new “emerging therapies” such as cell and gene therapies. After telling the legislature and a range of stakeholders last year that they would convene the emerging therapies working group, industry was surprised to see the HCA create a closed-to-the public internal panel that has mostly focused on high cost drugs. Life Science Washington successfully fought to have the HCA open some of the meetings to the public, we testified at the fall meeting, and coordinated with BIO to provide testimony at the most recent meeting in February. After dismissing industry for much of the process, the HCA did engage with industry at the last meeting and has asked for additional input going forward.

Federal Policy

Medical Device Tax Repealed! — After almost a decade of advocacy (including a flurry of emails and phones calls throughout December) by Life Science Washington and of our coalition partners, the final bipartisan budget package that was signed by the President on December 20th permanently repealed the 2.3% medical device tax.

This repeal has been a top priority of Life Science Washington (LSW) since it was originally enacted in 2010 as part of the Affordable Care Act. LSW participated in a comprehensive, multi-year advocacy campaign that was closely coordinated with our national partners AdvaMed, MDMA and MITA. Our efforts included direct engagement with our Congressional delegation on the issue through a combination of regular meetings with Congressional staff in Washington DC, organizing LSW member sign-on letters to our delegation, hosting CEO Roundtables with Members of Congress, and facilitating local company tours.

This win is a reminder that big public policy changes often take years to achieve, but it also shows what can be accomplished when we all work together to advocate for a clear, consistent policy change year after year.







WELCOME NEW LIFE SCIENCE WASHINGTON MEMBER COMPANIES!

• adMare BioInnovations • Brooks Applied Labs • Consulate General of Canada •

• Covance Inc. • Morair Medtech, LLC • Neoleukin Therapeutics • Solius •

• TRUEbenefits, LLC an Alera Group Company •




BARDA BAA

BARDA BAA


BARDA is investing in an array of medical countermeasures to diagnose, treat, or protect against the 2019 novel coronavirus under the BARDA Broad Agency Announcement (BAA-18-100-SOL-00003). Specifically, BARDA is pursuing the following products or technologies:


  • Diagnostic assays for human pan-coronaviruses
  • Vaccines for novel coronavirus
  • Therapeutics for novel coronavirus
  • Ventilators
  • Immunomodulators or therapeutics targeting lung repair
  • Pre-exposure and post-exposure prophylaxis for novel coronavirus exposure
  • Respiratory protective devices

To learn more, including targets for product maturity under this announcement, see the newly revised BARDA Broad Agency Announcement.





DRIVe EZ-BAA

DRIVe EZ-BAA


To spur innovation, BARDA has issued its business-friendly, streamlined Easy Broad Agency Announcement (EZ-BAA) for molecular diagnostics and nonclinical assays.


The diagnostics must leverage FDA-cleared platforms and have a viable plan to meet requirements for the FDA to consider Emergency Use Authorization within 12 weeks of an award.


To learn more, see the Novel Coronavirus EZ-BAA.




Federal Market Research

MARKET RESEARCH INITIATIVE


If you are interested in partnering with the federal government on a COVID-19 medical countermeasure, submit your ideas to a platform that reaches a host of potential federal partners! Submit a brief description and supporting materials through the Market Research Initiative.





The U.S. Response to Coronavirus: Summary of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020


  • $836 million for the National Institute of Allergy and Infectious Diseases (NIAID), which conducts research on therapies, vaccines, diagnostics, and other health technologies, at the National Institutes of Health (NIH).
  • $61 million for the Food and Drug Administration (FDA) for the development and review of vaccines, therapeutics, medical devices and countermeasures, address potential supply chain interruptions, and support enforcement of counterfeit products.
  • $20 million is for the Small Business Administration (SBA) disaster loans program to support SBA’s administration of loan subsidies that will be made available to entities financially impacted as a result of the coronavirus.







DRIVe EZ-BAA

LIFE SCIENCE WASHINGTON INSTITUTE presents:


2020 LUNCH & LEARN STARTUP SERIES


Life Science Washington Institute is hosting a series of Lunch & Learns focused on answering the burning questions researchers and entrepreneurs have as they grow their idea from concept to commercialization. Each month, we will cover a different topic with a discussion led by a subject matter expert or experienced entrepreneur. The monthly Lunch & Learn events will be an introduction to a quarterly Deep Dive Workshop hosted at the LSWI offices. These events are free and open to any one interested in learning more about startups and entrepreneurship! Lunch will be provided.





December Washington State Investment Activity

WASHINGTON STATE INVESTMENT ACTIVITY

A monthly report summarizing transactions and trends in Washington state. This report includes a continually updated list of angel funding, VC deals, M&A Activity and strategic partnership formations.







more Calendar

4/16/2020
Life Science Industry Seattle Networking Event - April 2020

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