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June 2014 Issue

Note from the President


We are in the midst of a high-impact month for BioUtah and the Utah life science community.
           On June 4, global life science thought leader Steve Burrill addressed a large group of top leaders from industry, government and education in an event that was extremely well received by those in attendance (see review by Jessica Barrett in this issue). This event, which outlined some of the most significant trends and development on the global life science landscape, would not have been possible without broad and timely from support life science organizations in the state.
            BioUtah wishes to offer special thanks to:

  •          Myriad Genetics, Utah's largest homegrown life science company (lead sponsor) 
  •          early-stage life science investment firm Crocker Ventures
  •          Intermountain Healthcare's Transformation Lab
  •          Lineagen, a diagnostics leader in autism spectrum disorders and other developmental delays
  •          leading Utah medical device anchor Edwards LifeSciences
  •          regulatory advisory firm PathWise
  •          clinical laboratory Sorenson Genomics
  •          University of Utah innovators the Scientific Computing & Imaging (SCI) Institute and the Center for Medical Innovation
  •          Saarland Economic Development Corp., Utah's key strategic partner in Europe
  •          PhRMA/The Kenney Group.

            At its June 10 executive board meeting, BioUtah elected a new board chair and a new vice chair. Serial medical device entrepreneur Richard Linder, co-founder of BioUtah and current chairman and CEO of Conextions Medical, was elected chairman of the executive board. Rich is one of the most active champions of Utah's life science community on the local and national stages. George Hamilton, senior VP of business development for Intermountain Healthcare, one of the world's most effective, respected and integrated healthcare systems, was elected vice chair. 
            Enormous thanks to our inaugural chair and co-founder, Merit Founder and Chief Executive Fred Lampropoulos, for lending his credibility, influence and support to the establishment of BioUtah; and to Nelson Labs CEO Jeff Nelson for his exceptional and dedicated service as vice chair and compensation committee chair.
            We are excited about the year ahead under the direction of Richard and George. I have no question that they will help usher in a time of expanding influence for BioUtah, including two major 2014 initiatives. The first is a new strategic plan for Utah's life science sector, building upon and refining the 2012 Utah Cluster Acceleration Program (UCAP) Life Science Plan. The second is a major marketing campaign for Utah's life science community, in the form of a full-size glossy magazine. We intend to release both publications at the 2014 Utah Life Science Summit in November. We look forward to a high level of engagement from leaders in the state's life science industry, government and education communities in both of these efforts.
            BioUtah is also pleased to announce a new partnership with HireLifeScience (www.HireLifeScience.com), to publish a comprehensive set of job listings on the BioUtah site (www.BioUtah.org). Users will be able to search a broad range of Utah life science job listings on the BioUtah site for free, including full job listings. Member companies who want to publish job listings on the site will receive a 15-percent discount from HireLifeScience. All jobs on the site are from the actual hiring companies, not third parties. Only jobs in Utah will be listed, but all listings will be posted nationally and worldwide through the HireLifeScience network. The BioUtah/HireLifeScience jobs board is scheduled to go live Monday, June 23.

All the best,

Kimball

Kimball A. Thomson

President & CEO

BioUtah

Special Report


By Jessica Barrett
VP, Business Development, ApolloDx


On June 4, G. Steve Burrill presented at a BioUtah Master Series event his clear vision about the status of our healthcare system and the transition we are making to precision medicine using technology that enables people better access to healthcare, real-time diagnostic results and the use of evidence-based data to improve outcomes while decreasing costs.
          


Bill Pagels, Steve Burrill and Jessica Barrett

Steve described the current state of the biotech and healthcare industries and gave examples about how they are impacting and transforming each other.  According to Burrill, the biotech industry is currently undergoing massive consolidation and large companies are not investing in innovation, they are just purchasing validated and vetted innovations developed by smaller entrepreneurial companies that enable access to healthcare, improve outcomes and lower costs.  At the same time, our healthcare system is transforming from disconnected providers, patients and payors to the practice of patient-centered precision medicine that is personalized and predictive providing high value.  Incentives, mostly financial, are forcing the transition to promoting health and wellness with patient involvement.
           The transition from treating diseases to managing health involves collaboration among researchers providing insight into disease prediction and prevention, biotech companies providing innovation, healthcare providers practicing personalized evidence-based medicine across the continuum, payers incentivizing better outcomes and individuals managing their health.  This transition will decentralize healthcare to wellness care, where individuals receive local and remote support from appropriate healthcare providers that will be receiving advice from medical professionals.
         Steve provided all attendees with a copy of his newly released book “Transforming Healthcare”, which is Burrill’s 28th annual report on the life sciences industry.

Quality’s Role in Drug Approvals

Quality’s Role in Drug Approvals
Quality-related issues are one of the most common reasons for
 market entry delay. Where does your product rate on this scale?
By Theresa Allio, Ph.D.
 
In a recent review, I summarized the underlying reasons contributing to delayed market entry for 51 product applications submitted to CDER between 2009 and 2012.1  Reasons cited in the complete response letters issued for these applications covered a number of areas, including safety, efficacy, regulatory, labeling and quality related issues.  Quality- related issues were one of the most prominent reasons for delay of market entry with deficiencies being cited in 20/51 (39%) of applications.  GMP inspection failures and data deficiencies contributed equally to the quality citations.  The prominence of quality-related issues in the delay of product approvals emphasizes the importance of robust quality programs in drug development. Understanding what elements have posed as hurdles in past development programs will help a sponsor avoid these pitfalls in the future.
Read More...

Utah Life Science News


Northrop Grumman Grants Promote Science, Technology, Engineering and Math Education in Salt Lake
www.marketwatch.com
SALT LAKE CITY, June 9, 2014 /PRNewswire/ -- Northrop Grumman Corporation NOC -0.68% has awarded grants worth $1,800 to support science, technology, engineering and mathematics (STEM) educational programs in Salt Lake City metropolitan area schools.
 
Utah Intellectual Property Law Firm Workman Nydegger Adds Atlanta Office,
Workman Nydegger managing partner Jonathan Richards announced Monday that the firm is opening an office in Atlanta. The office, located in the mid-town area at 1075 Peachtree Street NE, will be managed by Robert L. Florence* who was previously with the Atlanta office of McGuireWoods.
 

Huntsman Cancer Institute begins work on $105 million research wing
www.sltrib.com

University of Utah’s Huntsman Cancer Institute has begun construction on a $105 million research wing dedicated to the study of childhood and family cancers –– an investment coinciding with deep cuts in...

How to Prepare for a Quality Audit
shop.pathwise.com

This webinar will discuss current trends in FDA audits, what the FDA is looking for during an inspection, and how your organization can prepare.

The Top 6 Pains in DHF Management
 
By Matthew M. Lowe
Executive Vice President, MasterControl Inc.
In my experience working in medical device product development and product management, maintaining the design history file (DHF) posed daunting challenges because it was a process that continued throughout the lifecycle of a product. Even years after a medical device is launched, it’s not uncommon for the technical lead to revisit the DHF because the product is undergoing an iteration or it’s being launched in another part of the world.

The Bright Future of Quality and Compliance
By Craig Gygi, Executive Vice President, Operations, MasterControl Inc. 
Quality and compliance stand at a crossroads. It’s the same crossroads that many other professional fields have navigated. Remember when computers entered the mainstream of business?
 

Developing a Timely and Effective CAPA System
PATHWISE BLOG
Maintaining a robust corrective and preventive action (CAPA) system remains one of the top priorities of medical device and pharmaceutical companies. Not only is such a system needed to keep up with increasing regulatory scrutiny, but the implementation and documenting of CAPAs is an essential step in ensuring products are upheld to a level of quality that is necessary to remain competitive in the industry.


New USTAR Executive Director Named

The USTAR governing authority and Gov. Gary Herbert have named Ivy V. Estabrooke to lead the organization. She replaces former executive director Ted McAleer, who stepped down in January. Estabrooke’s appointment has been confirmed by the Utah Senate and she is expected to begin her transition into the position in June.


National Life Science News


 

FDAnews is pleased to announce that Steven Silverman, Director, Office of Compliance, CDRH, FDA has been selected to present the keynote address at the 11th Annual Medical Device Quality Congress.
 
 
SBIR Funds Speed the Delivery of Breakthrough Treatments and Cures
www.biotech-now.org
Today, BIO’s Executive Vice President of Emerging Companies Cartier Esham presented testimony to the U.S. House of Representatives Committee on Small Business regarding oversight of the Small Business Innovation Research and Small Business Technology Transfer Programs (SBIR/STTR).

Medical Device Companies' Future Remains Bright, Albeit Slow Penetrationwww.
benzinga.com

Industry Overview According to a report published by reportlinker.com, the medical devices industry is expected to grow by 6.1% CAGR through 2017, reaching approximately $302B...

The U.S. Food and Drug Administration needs to change if it wants America’s patient care to be on par with the rest of the world.

Senator King takes on the medical device industry in Congress!
groundreport.com

On June 3, 2014 Senator Angus King of Maine addressed the United States Senate, during an Executive session on the budget regarding the need for...


Why Congress should nix the medical device tax and raise cigarette taxes instead

Senate Republicans say the excise tax on medical devices should be repealed. They have a point, writes Len Burman, and taxes on cigarettes should be raised instead.


Pharmaceutical Industry On The Cusp Of Change
GuruFocus.com
Industry On The Cusp Of Change, Stocks: NYSE:TARO, release date:Jun 02, 2014

'RIGHT-TO-TRY' LAWS GIVE HOPE TO TERMINALLY ILL
05/31/2014 at 7:21 PM
The right to try experimental, potentially life-saving drugs is coming soon to a state near you, giving fresh hope to terminally ill patients who have run out of treatment options.
A recently published market report indicates that the use of robots in a number of industries has more than tripled in the past five years and by 2018, robots are projected to be used for 27 percent of new line installations for medical device primary packaging. For the pharmaceutical industry, robo…
Opinion: Medical device tax is cutting jobs, R&D and U.S. investment, survey shows
 
By Stephen Ubl, president & CEO,AdvaMed

The 2.3% medical device excise tax implemented in January 2013 as a part of Obamacare has already had a negative impact on jobs, R&D and investment, writes AdvaMed president & CEO Stephen Ubl.


Identifying and Mitigating Liabilities in Medical Device M&A | The National Law Review
www.natlawreview.com

Medical device mergers and acquisition (M&A) transactions are accelerating as greater regulatory clarity develops and review times shorten in the U.S. Food and Drug Administration (FDA)...
LiSenators to FDA: Stop using draft guidance to make substantive policy changes
www.foodnavigator-usa.com

Four US Senators have written to Food & Drug Administration (FDA) commissioner Margaret Hamburg to express their concern about the agency’s use of draft guidance documents to make “substantive...
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