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July 2014 Issue

Note from the COO


Dear BioUtah members,

I want to share some exciting news with you regarding two upcoming events we have scheduled for the second half of 2014.
 
The first event is our inaugural International Regulatory Pathways Summit, to be held on Thursday August 28th. This event focuses on strategies for our Utah based life science companies to develop and enter markets outside the United States. As many know, the US FDA tends to be one of the more difficult agencies for medical devices to gain market approval. Overseas markets remain attractive but to some are unattainable due to the unknown nature of the regulatory pathways. This three-quarter day event (lunch included) highlights these pathways for the European Union, Australia/Pacific and BRIC (Brazil/Russia/India/China) markets. We have an exciting slate of speakers lined up, all of which are seasoned experts in their respective market areas. To cover costs, a nominal fee will be charged.

 
The second event is our annual Life Science Summit, slated for November 5th. This all day event has rapidly become the largest life science conference in Utah, with over 350 people attending last year. Our programming this year will be more compelling than ever; with nationally noted speakers and three independent tracks on Device/Diagnostics, Biopharmaceuticals and Regulatory/Compliance. This year, we are featuring speakers from a wide representation of our life science community, including Beckin-Dickinson, Actavis, Merit Medical, PathWise and Edwards Lifesciences, to name a few. We will also feature multiple networking opportunities (including a social hour) and  exhibitors from local and national organizations.

Please look for our email flyers for more information. Registration will begin soon for both events.

Hope to see you at both of these exciting events!
 
Regards,
 
Peter Knauer
Chief Operating Officer
BioUtah

Special Guest Article


A WELL-KEPT SECRET
How to Cut Taxes and Insurance Costs in One Fell Swoop

By Bruce Lefavi,
Owner and President of Bruce A. Lefavi Wealth Management

 
If you’re anything like me, you hate paying taxes and steep insurance bills. Well, I’ve found a way to save a considerable amount on both by setting up what’s called a captive insurance company. In fact, I think this is such a powerful tool that I plan to set one up myself. I pay expensive premiums for my Errors & Omissions insurance, and I haven’t had a claim in 34 years. What a waste of money!
 
With a captive insurance company, you can insure risks to protect your business and increase your tax deductions for premiums you pay to your own captive. Your captive can keep any insurance payments not used for claims. I want that for myself, and maybe you should too.
 
Read More....
 

Special Guest Article


Broker LogoCyber Security for Medical Devices and Life Science Companies


Many medical devices and life science companies contain configurable embedded computer systems that can be vulnerable to cyber-security breaches. In addition, as medical devices are increasingly interconnected via the Internet, hospital networks, other medical devices or smartphones, there is an increased risk of cyber-security breaches, which could affect how a medical device operates.

The Food and Drug Administration (FDA) has recently become aware of cyber-security vulnerabilities and incidents that could directly impact medical devices and life science companies, including:

Read More...

Utah Life Science News



Why Utah's Low Unemployment Rate is So Remarkable
The news on Friday that Utah's unemployment rate is at the lowest level since 2008 is remarkable by itself. Couple that with the fact that some cities in America have unemployment rates above 20%, and the news becomes absolutely amazing. 

Utah's unemployment rate dropped to 3.6% last month, which is the lowest since November of 2008. Additionally, job growth is sitting at 2.9% as the state added ore than 37,000 jobs last month.

World Trade Center Utah Seminar Focuses on Intellectual Property Protection

“Patents, trademarks, service marks and copyrights are only as good as your ability to enforce them.” That was one insight a gathering of Utah business leaders learned during a “Protecting Your Intellectual Property Rights” seminar at World Trade Center Utah on June 24.

Taught by Kenneth Horton, a member of the Intellectual Property section in the law firm Kirton McConkie, and David McKenzie, intellectual property counsel at Fusion-io, the seminar focused on topics such as obtaining and protecting intellectual property rights in the United States and globally; best practices and common mistakes; remedies for counterfeiting, piracy, and trade secret theft; law enforcement resources for intellectual property protection and enforcing intellectual property rights in the U.S. and abroad; patents, trade secrets and obtaining/maintaining trademarks and copyrights.


BioUtah Member Discount for MDMA's 7th Annual Medical Technology Executive Forum Sept. 25, 2014

Plan to attend MDMA’s 7th Annual Medical Technology Executive Forum on September 25th at the Crowne Plaza Cabana in Palo Alto, CA. 
BioUtah Members receive $100 off registration! 
This must-attend one day interactive forum will bring together more than 150 CEOs and senior executives to discuss the critical issues that affect product commercialization and the common challenges faced by med-tech companies today.  Industry experts and government officials will address investment options, FDA reform, reimbursement challenges and much more.
Register today to ensure your spot at this unique event for medical device entrepreneurs.  For additional information, contact Sheri DeVinney at sdevinney@medicaldevices.org or call 202-354-7171.

Many hospitals struggle to understand their own cost data
BY JULIE APPLEBY, KAISER HEALTH NEWS  

SALT LAKE CITY – When a car rolls off an assembly line, the automaker knows exactly what parts, labor and facilities cost. Not so in health care, and now some health executives are trying to change that.

Although U.S. hospitals account for the single largest chunk of the nation’s $2.7 trillion in health spending, few of them can say how much it actually costs them to care for every patient they admit.

“To think that health care is this ‘ginormous’ business that doesn’t understand costs is mind-blowing,” said Vivian Lee, senior vice president for health sciences at the University of Utah, an academic medical center with four hospitals and 1,330 physicians. In 2012, Lee was stunned when she challenged senior managers and physicians to find ways to reduce spending, and “they said, ‘We don’t know what it costs, so how can we manage it?’”


China Trade Mission 2014 Utah International Trade and Diplomacy ITDO GOED
CHINA TRADE MISSION 2014
SEPTEMBER 15-19, 2014

The Governor’s Office of Economic Development invites all Utah businesses interested in growing their global markets in China to apply to join us on the China Trade Mission 2014.

Utah has strong ties to China, nearly one third of all students learning Chinese in the United States are doing so in Utah, which is more than any other state in America. Additionally, Utah’s former Governor, Jon Huntsman Jr., served as U.S. Ambassador to China from 2009 to 2011. This trade mission will continue building on our valued China-Utah relationships.



Healthbox Expands Program to Salt Lake City, Partners with Intermountain and HealthEquity
Healthbox, a leading business accelerator focused on healthcare, is bringing its accelerator program to Salt Lake City this September. Applications are being accepted from healthcare technology, device, and diagnostics companies through July 20th at http://www.healthbox.com.
Accepted companies typically receive a $50,000 seed investment, collaborative workspace, and access to the Healthbox local and national network.
Through partnerships with Intermountain Healthcare, HealthEquity, Zion’s Bank, and BD (Becton, Dickinson and Company), Healthbox is sourcing companies that meet the needs of a rapidly changing healthcare industry. The companies selected for the program will have unique access to Healthbox strategic partners, thereby gaining an understanding of the key challenges plaguing these organizations and how to adapt their solutions to truly solve these challenges.

Introducing our New Learning Partner!

BioUtah is proud to welcome our new learning partner, Life Collaborative - Building 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 which is rewarded to individuals who demonstrate comprehension in any of its broad spectrum of topics - BioTech, MedTech, Pharmaceuticals, Project Management, Quality, Regulatory, Sales & Marketing, Finance, Team Leadership, and more.

CLICK HERE to learn more about what BioUtah's affiliation may mean for you.


National Life Science News


iphone 5c

Smartphones test stress hormone

Stress hormone tests through smartphone apps will be a reality pretty soon. This is going to make things easy for many doctors who suffer from stress.

People working on the project have said that they are very close from launching several apps that will take care of many frequent issues that people face almost on daily basis. These researchers say that the app on smartphone will be easy to use and anyone can use them.


SBA LOGO

SBA Awards $2 Million in FAST Grants to 22 Universities & Organizations to Support R&D, Small Business Innovation

The U.S. Small Business Administration (SBA) today awarded FAST grants totaling $2 million to 22 state and local economic development agencies, business development centers, colleges and universities.  These grants will support programs for innovative, technology-driven small businesses under SBA's Federal and State Technology (FAST) partnership program. 


Will Sunshine Act mean marketing shift? Waiver for doc CME payments could boost education grants
CMS rule that exempts drug and medical-device companies from having to disclose indirect payments to physicians for accredited continuing medical education could prompt manufacturers to shift their marketing dollars toward CME and away from direct promotional programs for their products, experts say.
Researchers at Intermountain Medical Center develop new smartphone technology and app to diagnose and monitor adrenal gland dise

Quick, easy, inexpensive cortisol testing should soon be available on all smartphones

Diseases of the adrenal gland have long been difficult to diagnose. But now, researchers have found an affordable and easy way to diagnose and monitor endocrine diseases of the adrenal gland by using saliva and a smartphone. Credit: Intermountain Medical Center
Researchers have developed a device that uses any smartphone to measure the cortisol concentration in saliva. The device was presented Tuesday, June 24, at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and the Endocrine Society in Chicago.

FDA Does Not Plan To Regulate Medical Device Data Systems

On Friday, FDA issued draft guidance saying that it considers medical device data systems to be safe and does not intend to regulate such tools,FierceHealthIT reports (Bowman, FierceHealthIT, 6/20).
The draft guidance marks a shift in FDA policy, as the agency as recently as January 2011 had said that medical device data systems are among the highest-risk technologies in health care.

Filling Information Gaps for Women in Medical Device Clinical Trials
By: David Strauss, M.D., Ph.D. 

At FDA’s Center for Devices and Radiological Health (CDRH), results from clinical trials often serve as the foundation for our decisions to approve the most important medical devices—devices, such as implantable heart devices, that carry the greatest risk to patients and have the potential to save or sustain life. 

United States Medical Devices Market

United States' global leadership in the medical device industry is reflected in the global export market. US boasts 7 out of the world's top 10 leading medical Original Equipment Manufacturers (OEMs), by revenue, in 2012. This list includes such titans of the orthopaedic industry as Johnson & Johnson, Medtronic, and Stryker. At the same time, according to S&P Healthcare's "Products and Supplies" report published February 2014, domestic medical device OEMs earn between 40% and 50% of their revenues outside of the United States.

Selling abroad clearly offers a number of advantages. For example, there is the opportunity to offset currency fluctuations. A strengthening US dollar makes US goods relatively more expensive and generally translates into reduced sales and revenues in overseas markets. Conversely, US medical device manufacturers benefit from a weakening US dollar when entering foreign markets. By way of illustration, according to EY's "Pulse of the Industry 2012" report during 2010-11, an estimated 40% of revenues garnered by the top 10 US medical device manufacturers came as a result of beneficial exchange rates. In fact, in 2012 the United States was the largest exporter of medical devices.


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Bulletin Board

BIOMAN 2014 Conference

Date: 
July, 2014

 
 

9th Annual NBC2 BIOMAN Conference

July 14-17, 2014

Hosted by Salt Lake Community College, Salt Lake City, UT

 

Join NBC2 in Salt Lake City, Utah, for BIOMAN 2014!  BIOMAN is an exciting and educational conference packed with engaging keynote presentations, interactive panel discussions, hands-on biomanufacturing workshops, industry tours, the annual Vendor Show of Biomanufacturing Equipment and Supplies, and much more.

For information about travel, conference logistics, and the greater Salt Lake City area, please visithttps://sites.google.com/site/bioman2014travelinfo/home 

NBC2 is pleased to announce that 10 sponsorships are available for first-time BIOMAN attendees.  If you are interested in receiving a sponsorship, please contact Jennifer Imbesi at jimbesi@mc3.edu.

Conference registration is now open!  Be sure to review the agenda and session abstracts.  You may change your workshop selections at anytime before the start of BIOMAN.  Also note: you must sign up for the same workshop track for all afternoon workshops, as these sessions are three-day workshops, with each day building on the previous.

 

Click here to register.  

 

Agenda at a Glance.pdf

Detailed Agenda with Session Abstracts.pdf

Registration Rates and Details.pdf

Additional Information.pdf

We look forward to seeing you at BIOMAN 2014!

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.

 

Life Sciences Compliance Program - West Coast Immersion

U.S. Compliance Certification Program for Smaller Life Sciences Companies

PROGRAM SCHEDULED for September 8-10, 2014 | San Francisco, California

 
SETON HALL LAW:
Your First and
Last Stop for
Compliance Education

PROGRAM OVERVIEW

This three-day educational program immerses attendees in the statutes, regulations, and other guidance that comprise the body of law known as "fraud and abuse law," as well as other healthcare-related laws and regulations, to help the audience understand the legal underpinnings of the compliance programs they develop and enforce.

WHO SHOULD ATTEND

Professionals working for smaller pharmaceutical, biotech, medical device and diagnostics companies – particularly those working in a compliance, legal, regulatory or, medical affairs role. This program is also valuable for sales, marketing, grants and related areas, as well as outside counsel who represent life sciences companies and private equity and venture capital firms that fund these companies.

PROGRAM DETAILS

  1. Program faculty includes law professors, in-house compliance officers, high-level government, and private lawyers who are experts in pharmaceutical and medical device fraud and abuse issues.
  2. Session topics include Federal and State False Claims Acts, Federal Anti-Kickback Statute, the Food, Drug & Cosmetic Act (FDCA), Data Privacy (HIPAA, HITECH, and others), Food & Drug Administration Amendment Act of 2007 (FDAAA), International Anti-Corruption Laws, Prescription Drug Marketing Act of 1987 (PDMA), PhRMA Code and AdvaMed Code, the federal Sunshine Law, federal and state marketing and disclosure laws, OIG compliance guidance, and much more.
  3. Attendees receive extensive resource materials that will aid them in their ongoing compliance efforts.
  4. Attendees will receive a certificate issued by Seton Hall Law School upon completion of the Program, and may apply for approximately 20 CEUs for HCCA and SCCE certification and/or NY and NJ CLE credit.

LOCATION
SAN FRANCISCO, CALIFORNIA

 

 
 
 
 
 
 
 

COST & REGISTRATION

Tuition for the Program: $2,500. Register here.

REQUEST INFORMATION

To request more information regarding the Life Sciences Compliance Certification Program, please click here to submit a 'Request for Information' form.  You may also contact us at healthlaw@shu.edu or call 973-642-8871.


Partners

  Colorado Bio Science AssociationBayBioBio Utah   
Copyright © 2014 BioUtah, All rights reserved.


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