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February 2015 Issue

Editor's Note


The new year is off to a great start as the Utah legislative session is in full swing, BioUtah continues to develop our educational programs on behalf of our members and we are actively pursuing a new CEO.
On January 26th, the legislature commenced the 2015 Legislative Session. BioUtah’s Legislative Policy Committee is actively engaged as we pursue additional, ongoing funding for the TCIP program this session. The committee has also prioritized the need to identify and support positive initiatives that promote the goals of the life science industry and mitigate the impact or defeat initiatives that could potentially threaten the industry.  We welcome member participation as we explore initiatives, such as the Right to Try bill.  
Also, as the ISO 9001 is at the Final Draft International Stage (FDIS), the fifth of a six stage process, and is anticipated to be published by the end of 2015, we want to provide our members with the necessary tools to ensure successful transitions within your organizations. BioUtah has partnered with Master Contol to host a series of compliance clinic roundtables in the upcoming months to discuss the specific implementation changes in detail.  Organizations are granted a three-year transition period after the revision has been published to migrate their quality management system to the new edition of the standard. Please feel free to utilize this opportunity to get ahead of the process.
BioUtah’s Executive Board is currently accepting resumes of qualified, interested individuals for the Chief Executive Officer position until Friday, February 13th. Interested parties can visit Bioutah.org for more information. The Search and Selection Committee is actively receiving, screening and interviewing candidates. We anticipate a thorough and seamless recruitment process as we welcome our next leader that will help to elevate BIoUtah to the next level.   



Susannah Hutchins
Director of Operations
BioUtah

IMPORTANT BIOUTAH MEMBERSHIP NOTICE

Dear BioUtah Members:
 
This notice is to advise you about important tax information regarding your BioUtah membership. The Tax Reform Act of 1993 made the portion on dues paid to organizations that is spent to lobby the states and federal government nondeductible for income tax—and requires this to be disclosed to members with their dues invoice information, or the organization must pay an excise tax.
 
BioUtah computes 10.1 percent of membership dues in 2014 to be nondeductible for your company’s income tax due to BioUtah’s lobbying efforts.  If you were a member in 2014, this nondeductible portion can be rolled over to your 2015 income tax filing.
 
If you have any questions, please do not hesitate to call me at 801.867.4061, or email me at susannah@bioutah.org.
 
All the best,
 
Susannah Hutchins
Director of Operations
BioUtah

Special Article


AMBIGUITIES IN ISO 9001: 2015 INITIAL OBSERVATIONS PART II
By David Hoyle         *Article Recommended by MasterControl

 

David Hoyle, the author of the best selling ISO 9001 Quality Systems Handbook and other management systems books, offers his unique observations on ISO 9001:2015  Committee Draft (CD). 

In this second article, I’m looking at areas of possible confusion and ambiguities in ISO 9001 (2015). My first article can be found at ISO 9001: (2015) Initial Observations.

AMBIGUITY OVER THE MEANING OF A QUALITY MANAGEMENT SYSTEM

Among the definitions in section 3 in ISO 9001 (2015) is the definition of a management system which goes like this: “set of interrelated or interacting elements of an organisation to establish policies and objectives and processes to achieve those objectives”.  Hence a quality management system would appear to be a system that establishes quality policies and quality objectives and quality processes to achieve those quality objectives.  But when one reads this closely it reads as though the system only establishes policies, objectives and processes; it does not read as though the system includes the processes and if it doesn't include the processes, what indeed are its outputs and outcomes?

READ MORE...

BioUtah Special Compliance Clinic Series

Utah Life Science News


Cities looking to attract innovative businesses and top employees could learn a lot from Draper, Utah.

The board of directors of BioUtah today announced that it is seeking a new CEO to guide the progressive life science industry association to its next stage of regional, national and...

SALT LAKE CITY, Jan 22, 2015 (BUSINESS WIRE) -- BioUtah today announced that Ivy V. Estabrooke, Ph.D., executive director of the Utah Science Technology & Research Initiative (USTAR), and Val Hale, executive director of the Utah Governor's Office of Economic Development (GOED), have been appointed to the BioUtah board of directors.

Doctors at Intermountain Medical Center are hoping the device created by BioFire Diagnostics in Salt Lake City will help cut back on the spread of the flu this year.
Medical device tax opponents’ $29 billion question
Plenty of people in Washington want to get rid of the tax. They just need to figure out how to pay for it.

National Life Science News


Congress tackles medical device tax 
Congress tackles medical device taxHerald Palladium (subscription)WASHINGTON - It flew through the Republican-run House in 2012, and a year later 79 of the Democratic-led Senate's 100 members...
Report: Regulatory Innovation Should Adapt to New Health Economy
PwC report highlights why regulatory innovation should adapt to new health economy as consumers and drug and device manufacturers are changing practices...

Edwards Lifesciences CEO Mussallem on showing value of products, medical-device tax repeal
Since 2000, Michael Mussallem has served as chairman and CEO of Irvine, Calif.-based Edwards Lifesciences, a medical-device manufacturer best known for marketing heart valves. Modern Healthcare reporter Jaimy Lee spoke with...
Life Sciences Alert FDA Issues Draft Guidance on General Wellness Products | JD Supra
On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general wellness products,” from regulation by FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The carve-out applies to products that:
How do you Ensure the Proper Manufacture of a Combination Product? FDA Explains 
New guidance issued by the US Food and Drug Administration (FDA) offers an extensive set of recommendations on how members of the pharmaceutical industry can comply with a rule regarding the proper manufacture of combination products.
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Bulletin Board

FOUNDATIONS IN PERSONALIZED HEALTH CARE
(MDCRC 6150)
 
5:30 – 7:00 PM
Monday, February 9, 2015
HSEB 4100B
 
— Faculty, staff, students and the interested public are welcome to attend.
— Please forward and post the attached flyer in your area.
— CME and registration permissions and info: meghan.lynch@hsc.utah.edu
— Sponsored by the University of Utah Program in Personalized health Care and the Center for Clinical and Translational Science.
 
~~~
 
On the Agenda:
 
“ALIGNING CLINICAL & RESEARCH SERVICE LINES TO SUPPORT PHC Part I”
 
Presented by:
 
"METABOLISM, OBESITY & DIABETES"
TIMOTHY GRAHAM, MD
Assistant Professor,
Medicine, Biochemistry and Nutrition

University of Utah
 
"INFECTIOUS DISEASE"
ANNE BLASCHKE, MD, PHD
Associate Professor
Department of Pediatrics
University of Utah
 
“NEUROSCIENCES”
STEFAN PULST, MD
Professor
Department of Neurology
University of Utah
 
 

ASIA-PACIFIC DEVICE SUMMIT

We would like to extend a $60 discount on the registration price to BioUtah membership. Simply enter BIOUTAH into the discount code field to receive it. Indicate that you are attending the summit when booking at the Hilton Mission Valley to receive the discounted rate.
 

March 5–6, 2015
Hilton San Diego Mission Valley
 
The San Diego Event to
Meet Top Device Experts from the Asia-Pacific
AsiaPacificDeviceSummit.com

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.

 
CLICK HERE to learn how to the SSAC makes you stronger!

 


 

 

 

 

 

31st Annual Investors Choice®

 

Venture Capital Conference


The Wayne Brown Institute would like to invite you to all of the 31st Annual Investors Choice® Venture Capital Conference Events in February 2015. 



 

 

The Wayne Brown Institute is excited to announce Mr. Bill Reichert, Co-founder of Garage Tech Ventures with Guy Kawasaki, as the Keynote Speaker for the 31st Annual Investors Choice® Conference. Read his bio here.

 
Conference Events:
 
Upstairs at Gallivan Hall
6:00pm - 9:00pm
239 S. Main, Salt Lake City, UT 84111
 
See our Sponsors: Click Here
Keynote Speaker: Bill Reichert
Zermatt Resort
8:00am - 5:00pm
784 W Resort Dr., Midway, UT 84049
 
Zermatt Resort
12:00pm - 4:00pm
784 W Resort Dr., Midway, UT 84049
 
 
Deer Valley Ski Resort
9:00am - 2:00pm
2250 Deer Valley Dr., Park City, UT 84060
 
Please register for each event you would like to attend. The "How to Raise Money" - Special Edition is included in the Investors Choice® Conference Registration.
 
 
 
 
 
WHAT IS INVESTORS CHOICE®? The purpose of the Investors Choice® Conference is to create jobs by creating new wealth, something Angels and Venture Capitalist do every day.  Join us on February 12th, for the premier venture conference in the Intermountain West. Check out 25 venture-ready deals that have been carefully screened and meticulously mentored.   Enjoy plenty of networking, and after the event, join us for a Ski Day with lunch and race at Deer Valley.
 
 
Utah is one of the country's hottest venture markets with more active funds than the rest of the region combined.  Come experience why Utah is "The Venture Hub" of the Intermountain area.
 
 
IS IT WORTH YOUR TIME? Definitely! WBI has been investors largest, and most consist source for deal flow in the Intermountain West. The Institute’s 850+ alumni companies have generated over $8.5 billion in financial transactions since 1983. Companies such as Omniture, Sonic Innovations, Myriad Genetics, and Ancestory.com are WBI alumni and past presenters. Angel companies such as Catheter Connections, Domain Surgical, Panoptic Security, Radiate Media and many others were sourced through WBI. Come network with Sorenson Capital, Signal Peak Ventures, Epic Ventures, Pelion Partners and many more
 
 
 

 

Founding Sponsor:

 

201 South Main Street

Salt Lake City, Utah 84111

Tel: (801) 595 -1141

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Join us for one of WBI's upcoming

"How to Raise Money" Seminars

 

Raising capital for your company can be a complex process laden with pitfalls and setbacks.
 
Get answers to your questions:
  • Is my business ready for funding?
  • What is the best source for it?
  • How do I get access to it?
  • What are the key elements to secure it? 
These are the questions that challenge every entrepreneur.  This event is the first step in addressing those challenges and getting your business going.  Come learn and network with investors and members of Utah and Idaho's Venture Community.
 
This seminar will run two hours and covers:
  • The investment landscape in Utah and Idaho
  • Getting your business ready to solicit capital
  • What investors look for in companies
  • A serial entrepreneur's perspective on the challenges of raising capital

 

Utah Events

 

Salt Lake City 

April 22nd, 2015

3:00 p.m. - 5:00 p.m.

 

Registration will soon open for this event. Mark your calendars and tell a friend. 

 

 

Date: 04/22/2015
Time: 3:00 - 5:00 pm


Jones Waldo
170 South Main Street
15th Floor 
Salt Lake City, UT 84101

 

Thank You To Our Sponsors!

Title Sponsor:

 

 

 Additional Sponsor: 

 

 

 Strategic Partners: 

 

     

 

 

Idaho Events

 

Boise 

February 19th, 2015

3:00 p.m. - 5:00 p.m. 

Our panel for this event includes regional angel and venture capital investors, successful entrepreneurs, and professionals from the venture community that will share insights on what it takes to raise capital for your venture.
 
 

 

 

Date: 02/19/2015
Time: 3:00 - 5:00 pm


The Zions Bank -6th Floor
800 West Main Street
6th Floor 
Boise, ID 83702

 

Thank You To Our Sponsors!

 

 

Strategic Partners:

 

 

After the presentation; investors, entrepreneurs, presenters, and all other attendees are welcome to network. Don't miss this great networking opportunity! Pre-Register and save $10 today.
 

 

Please share the opportunity of these events with your friends by forwarding this email to them. 

 

Copyright 2014 Wayne Brown Institute. All Rights Reserved.

Copyright © 2015 BioUtah, All rights reserved.


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