July 2015 Issue
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Note from BioUtah President & CEO, Kelly Slone

BioUtah’s Public Policy Priorities

Thanks to everyone who attended our recent public policy focus group meetings.  BioUtah’s Legislative Policy Committee is in the process of identifying the top federal and state public policy priorities for our members.  We need to submit recommendations for the Governor’s FY 2015-16 budget in August.  The two priorities BioUtah will be pushing are continued funding for the TCIP and BioInnovations Gateway funding along with state investment and tax incentives that benefit the growth of the life science industry in Utah.  

We have put together a public policy matrix (below) that puts the key issues into four categories; lead, partner, watch and emerging issues.  This matrix will hopefully provide a roadmap to ensure BioUtah is focused and leading the right set of issues for it members.  

We plan to finalize these priorities in early August and will be proactive in educating and advocating this set of policy priorities on behalf of our membership.  In August, we plan on set up meetings with our Congressional delegation during their August recess as well as work with GOED to include our priorities in the Governor’s budget.  We have decided to schedule our “Utah Life Science Education Day” for mid-October.

Please review these priorities and let us know if we have captured the right set of issues for our membership and let us know if you would be interested in participating in our education and/or lobbying efforts.   I always welcome your input and please email me directly, Kelly@bioutah.org.

Kelly Slone
President & CEO

June 18, 2015

AdvaMed Cheers House Passage of Trade Promotion Bill

WASHINGTON, D.C. – Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement praising House passage of bipartisan legislation to modernize and renew Trade Promotion Authority (TPA):

“Passage of this bipartisan legislation in the House is great news for patients worldwide, who will have greater access to the life-changing innovations produced by America’s medical technology companies, and for our industry, one of the drivers of the U.S. economy.

“With $42 billion annually in exports, the medical technology sector is one of the few American manufacturing industries that maintains a positive balance of trade. Medical technology markets in India, China, Japan and Europe are already worth more than $150 billion each year and offer tremendous opportunities for additional growth. However, this growth depends on the development and approval of trade agreements that provide a level playing field for U.S. companies and improve access to the global market.

“The U.S. Trade Representative is currently working to advance priority issues for the medical technology industry as part of the Trans-Pacific Partnership (TPP) and the Transatlantic Trade and Investment Partnership (TTIP), both of which will greatly improve market access to medical technology in these regions. The TPA legislation builds a foundation for these agreements and ensures the U.S. has a prominent seat at the table when future free trade agreements are negotiated.

“Of significance in the bipartisan TPA bill is a principal negotiating objective to improve procedural fairness in medical technology reimbursement. This provision aims to increase transparency and opportunity for the participation of stakeholders in the development of regulations and ensure that government reimbursement regimes are transparent, ensure procedural fairness and provide full market access for U.S. products. Similar provisions are included in the U.S.-Korea Free Trade Agreement.

“We look forward to swift passage of TPA in the Senate so that it can proceed to the president’s desk for his signature.

# # #

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.


7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

by Ginette Colazzo
President of Ginette M. Collazo, Inc.
Human Reliability Consultancy
As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of failures and defects.  Sadly, little is known about the nature of these events mainly because the quest for answers ends where human error investigations should begin. This situation has become very evident to regulators and GMP enforcement agencies are being more critical of the approach, result, and effectiveness of corrective and preventive actions or CAPAs when dealing with human performance issues. In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations.
Usually the focus of error investigations relies on explaining what happened and who was involved. This is necessary to understand the problem. Nevertheless, this is not enough when it comes to addressing these kind of failures. Instead, we need to explain the reason why it happened.


By Hilary Ingoldsby Whitesides
June 9, 2015

After a successful career in Washington D.C., Kelly Slone never expected to find the perfect job back home in Utah. When it started its search, BioUtah never expected find a president and CEO with Slone’s level of expertise. For both sides it seems to be a perfect—if unexpected—match.

Utah Life Science News

Prepare for two exciting days of: Learning from leading health care companies on how to navigate an industry that requires demonstrating value, Networking with over a hundred companies across the health care spectrum, Gaining unique insights from Governor Mike Leavitt, LP FuturePanel members and special guests, and Bobsledding and other adventure activities.

Genomics England Selects University of Utah and Omicia Technology for 100,000 Genomes Project
Genomics England announced that it will be using technology co-developed in a partnership between the University of Utah and Omicia, and exclusively commercialized through Omicia, to interpret the DNA of Britons as part of the 100,000 Genomes Project, a national effort to hasten creation of diagnostics and treatments that are tailored to a person’s genetic make-up.
The U.S. health care system is often compared to European systems in unflattering terms, yet European countries are also under increasing pressure to increase their quality of care and efficiency. (Shutterstock)My view: Collaborations on the rise between Utah and French health care systems
The U.S. health care system is often compared to European systems in unflattering terms, yet European countries are also under increasing pressure to increase their quality of care and efficiency. Many are looking to the United States for innovative, proven solutions. There is much that we can learn from each other. A newly formed collaboration involving Utah’s Intermountain Healthcare and the French government is providing one vehicle for that learning.
Tute Genomics
Tute Genomics Raises $3.9M to Enable Genome-guided Medicine
Tute Genomics,  a cloud-based platform that can rapidly analyze and annotate personal genomes has raised over $3.9 million in Series A funding from a strategic group of investors, including internationally recognized Intermountain Healthcare, an integrated network of 22 hospitals and 185 physician clinics. Other major investors include Healthbox, a platform for innovation and entrepreneurship in healthcare, and China-based Tencent, one of the largest Internet companies in the world.

National Life Science News
Let's Repeal The Dumbest Levy Of All Time: The Obamacare Excise Tax On Medical Devices
The once-dominant U.S. medical device industry has been damaged by a devastating 2.3% excise tax imposed as part of ObamaCare. It’s past time that the tax was repealed.

Medical devices may not be as glamorous as blockbuster drugs, but they include some of the genuine miracles of modern medicine: pacemakers, artificial joints, replacement heart valves, scanners, and radiation-therapy machines. The United States has been the global leader in medical devices, one of the few major industries that both boasts a net trade surplus and is a job-creator. The sector employs 400,000 Americans directly and is indirectly responsible for almost 2 million more that supply and support the highly-skilled workforce.  Most important, its products are essential elements of modern medical care, including everything from CT scanners and pacemakers to blood pressure cuffs and robots used by surgeons.
Can Congress override a veto on repeal of medical-device tax?
Barack Obama and the White House threaten vetoes daily on bills under consideration in the Republican-controlled Congress, especially those impacting Obama’s signature health-care system. That threat may end up backfiring on Obama when it comes to the medical-device tax. The House took action yesterday on the most unpopular funding mechanism in ObamaCare, repealing it outright on a 280-140 vote. That’s just shy of the two-thirds necessary, but the GOP has some reserves on this vote:
US FDA finalizes 510(k) exemptions for some Class I and II medical devices
The US Food and Drug Administration has finalized plans to exempt some “well understood” Class I and II medical devices from 510(k) premarket notification requirements, according to new guidance from the agency.
Leaked: What’s in Obama’s trade deal
A recent draft of the Trans-Pacific Partnership free-trade deal would give U.S. pharmaceutical firms unprecedented protections against competition from cheaper generic drugs, possibly transcending the patent protections in U.S. law.
Drew Clark: Innovation debate between rival visions promotes progress and useful arts
“Innovation” is among the most highly prized civic and commercial virtues today. So much so that opposing sides in policy contests each claim its mantle.

Nowhere is this truer than in now-bubbling debate on Capitol Hill in Washington over patent reform. This isn't a battle of David against Goliath. It's a battle of Goliath against Goliath.
Bulletin Board

Leavitt Partners Annual Member Summit is two days of networking and collaborative discussions with recognized national experts in health care.

Prepare for two exciting days of: Learning from leading health care companies on how to navigate an industry that requires demonstrating value, Networking with over a hundred companies across the health care spectrum, Gaining unique insights from Governor Mike Leavitt, LP FuturePanel members and special guests, and Bobsledding and other adventure activities

Leavitt Partners Annual Summit attracts executives and leaders from prominent companies and organizations across the health care industry. These companies are finding solutions to thrive in a health care world that demands results based on value.

At Leavitt Partners, we understand the emerging role of value in health care and the significance of this development to the future of your organization. Our insights and tools in this vital arena can help you make smart decisions, successfully navigating from today’s uncertainty to tomorrow’s prosperity.

The Utah Global Forum will help businesses learn how to export successfully, adapt to today’s global marketplace and succeed in untapped markets.


The Utah Global Forum will facilitate the dialogue on how businesses can expand beyond local borders and develop a strategy of expansion into the global marketplace through importing opportunities and service exports. The program offers an incredible breadth of content, bringing experts from across industry, all with a single objective: move Utah businesses to the global business stage to meet the challenges of today’s business environment. 


Register Here...

We are pleased to announce our new partnership with the Life Science industry’s most well-regarded and prestigious professional development practitioners –
Life CollaborativeBuilding Healthy Careers in Life Sciences.

Life Collaborative offers a suite of eLearning resources to help prepare you for a career, or advance the one you’ve already got, in the Life Science industry. The Life Collaborative curriculum was created and validated by real-world industry practitioners and, to that end, is backed by a Certificate of Achievement. Life Collaborative topics include - BioTech, MedTech, Pharmaceuticals, Project Management, Quality, Regulatory, Sales & Marketing, Finance, Team Leadership, and more.

Members Receive as much as a 45% Discount

To get started in your e-learning program, please select from one of the options below:

Professional programs are designed for individuals who are currently employed full time in a Life Science organization and are not seeking employment.

Student / Job Seeker programs are designed for individuals who are interested in transitioning into a Life Science company.

Note that the Life Collaborative has partnered with the MedTech and BioTech Veterans Program (MVPvets.org) to provide scholarships to transitioning veterans. If you, or your company, are interested in learning more about MVPvets, email Info@MVPvets.org.


If you have questions about which program to select, or would like to learn about the Life Collaborative corporate licensing program, or custom learning management options, please email info@lifecollaborative.com or call 760-444-9460.

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