BioUtah welcomes Kelly Slone as our new President & CEO!
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March 2015 Issue

Editor's Note


As spring ushers in new life all around us, BioUtah is blooming with newness as well. In April, we welcome Kelly Slone to our association as President and CEO. Kelly is relocating from Washington, DC, but as a Utah native, she is very familiar with the Utah landscape. As a savvy advocacy professional specializing in public policy, lobbying and political strategy, Slone brings a myriad of talents and experience. She also understands the unique challenges associated with the regulatory and reimbursement atmosphere. Most recently, Slone served as Vice President of Government Affairs with the National Venture Capital Association (NVCA). We are excited to have her leadership join our team.

Also new this year is the ISO 9001: 2015 standard, expected in autumn.  In anticipation for this dramatic change, BioUtah has partnered with Master Control to provide a conduit for training and exploration of the upcoming standard. The first two sessions have been extremely successful and we would encourage regulatory professionals to mark their calendars for this extraordinary opportunity Training details can be found in this issue.

BioUtah is continually seeking opportunities to benefit our members. In this edition are details about a possible funding opportunity presented through the Utah Trade Representative for China as well as information about a Utah trade mission to Japan in April. Please note the bulletin board as many of our partners and associates have activities that may be beneficial to your organization. 



Susannah Hutchins
Director of Operations
BioUtah

BioUtah Recruits Kelly Slone as Next President and CEO to Elevate Utah’s Life Sciences Ecosystem

The BioUtah Board of Directors today announced that it has selected Kelly Slone as the new President and CEO to lead BioUtah as it expands its vision, programming and leadership of the life science community in Utah.

“During our recruitment process, the search committee explored a broad spectrum of candidates from Utah and across the country. Through that process we uncovered a wealth of talent, but when push came to shove, Kelly Slone stood out from the rest as our candidate of choice,” said Gary Crocker, Chairman of the BioUtah Search and Selection Committee. “A native of Utah, Kelly not only has the policy expertise, but she knows what it takes to run an effective advocacy organization that delivers real value to its members. In Kelly, we have recruited the pinnacle of talent and pedigree—a real star that will drive BioUtah and the Utah life sciences community to the next level.”

 

Special Notice


 

Seeking Investment? 
 
The Utah Governor's Office of Economic Development works tirelessly to encourage Foreign Direct Investment (FDI) in the state. As part of this effort, GOED employs Foreign Trade Representatives (http://business.utah.gov/news/strategic-changes-made-business-outreach-efforts/) in Isreal, Mexico, China and Europe. These Trade Representatives help solve import/export issues and represent Utah-based companies in all foreign business matters.
 
Recently, Cynthia Chen, Utah Trade Representative for China, reached out to GOED and BioUtah in hopes of identifying potential investment opportunities on behalf of two very large Chinese companies. More specifically, these companies are looking for biotech and medical device companies seeking investments in the $5-30M range. BioUtah would like to answer the call by submitting Executive Summaries of member companies seeking investment in this range.
 
If you are interested in submitting your Executive Summary, please send a current, non-proprietary Executive Summary and relevant contact information to: susannah@bioutah.org by March 31st, 2015.
 
Note: All participants will be required to assess if potential investors are accredited according to Federal Securities laws established in Rule 501 of Regulation D and as amended by the Dodd-Frank Wall Street Reform and Consumer Protection Act.

Article


Getting Ready for ISO 13485:201X (Part 1)

by Lisa Weeks, Marketing Communications, MasterControl
 

As most of you know, ISO 13485–Quality Management Systems—Requirements for Regulatory Purposes is being revised. ISO 13485:201X, as the final revision is being referred to, is expected to be available in late 2015 or early 2016. Understandably, this is causing anxiety for medical device manufacturers, many of whom are still struggling to conform to the current version of the standard. With this in mind, let’s review the basics of the ISO: 13485. In future posts, we’ll examine why the standard is being updated, and the most significant changes you can expect to see. 
What is ISO 13485?
ISO 13485 is a series of requirements that help medical device manufacturers develop a quality management system. According to the official ISO 13485 standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.”1

READ MORE...

BioUtah Special Compliance Clinic Series

Utah Life Science News


Becky Lockhart remembered on Rare Disease Day at Capitol
SALT LAKE CITY — “On Jan. 5, we got a potential diagnosis. On Jan. 6, they confirmed the disease. And on Jan. 17, Becky passed away.”
In a speech commemorating Utah’s second annual Rare Disease Day, Rep. Curt Bramble, R-Provo, again mourned the recent loss of House Speaker Becky Lockhart to Creutzfeldt-Jakob Disease.

Making Utah's Life Sciences Industry a Global Leader

"There has never been a brighter, more exciting time to be in Utah's life sciences community," says Richard Linder, Chairman of the Board of Directors of BioUtah, the state's independent life science association, reflecting on the hiring of Kelly Slone as BioUtah's new president and CEO.

BioUtah was launched in 2012 to elevate the stature and influence of Utah's life science industry on the national and global stage and serves Utah's medical device, diagnostics, and bio-tech/pharma healthcare communities through networking, advocacy and education programs. The industry employs about 26,000 Utahns and is one of six economic clusters the state is focused on growing.
 

National Life Science News


 

AdvaMed claims that the medical device tax will wind up costing the U.S. economy 195,000 jobs, citing a survey of 55 of its medical device company members.

The national medical device industry lobby today claimed that the medical device tax enacted as part of Obamacare will wind up costing the U.S. economy 195,000 jobs and hamstring medtech firms’ R&D efforts.


U.S. Securities and Exchange Commission (SEC) enforcement director Andrew Ceresney had a simple message for pharmaceutical companies during a speech at the annual Pharmaceutical Compliance Congress on Tuesday: Don't mess around with investors when it comes to disclosing dealings and communications with the FDA.
CRS Report: Medical Device Tax Burden Falls on Consumers
The Congressional Research Service recently released a report on the Medical Device Tax in the Affordable Care Act. It fairly enumerated most of the critiques of the tax, which are wide-ranging and substantial. (Here was Tax Foundation’s critique, written by one of my colleagues.) It also stated the principal argument for the tax – essentially, that it’s a source of revenue for the government.
Medical devices—and the patients who use them—would substantially benefit from a National Medical Device Postmarket Surveillance System (MDS), charges a new report authored by the Brookings Institution's Engelberg Center for Health Reform with support from the U.S. FDA.
AbbVie's $21 billion deal to buy Pharmacyclics shows big pharma's hunger for new drugs at a time when research at smaller biotechnology companies is driving some of the most promising advances in medicine.
A new study finds that female PhDs in most math-related sciences do not experience gender discrimination, but that women academics in life sciences and psychology are less likely to get tenure or promotions than their male counterparts.
Women looking for equal pay, recognition for hard work, and career advancement might be wise to study engineering, mathematics, or computer science. The idea seems contradictory, considering frequent reports that the playing field isn’t level for women academics. But research by Shulamit Kahn, a School of Management associate professor in the markets, public policy, and law department, and three colleagues has discovered that women faculty working in math-intensive science fields, geoscience, engineering, economics, mathematics/computer science, and physical science (GEEMP), now feel just as fulfilled professionally as their male counterparts, despite still being underrepresented. Their research has found that while gender discrimination formerly was “an important cause of women’s under-representation in scientific academic careers, it has ceased being a valid cause of women’s under-representation in math-intensive fields.”
 
 
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Bulletin Board

 
 
http://image.s6.exacttarget.com/lib/fe8c1273756d0d7575/m/1/OHRP+logo+-+approved+-+EDITTED.png               http://image.s6.exacttarget.com/lib/fe8c1273756d0d7575/m/1/CIRI+logo+-+approved+-+EDITTED.png               http://image.s6.exacttarget.com/lib/fe8c1273756d0d7575/m/1/UCD+logo+-+approved+-+EDITTED.png               
 
Denver skyline background image.png
 
 
OHRP FORUM IS NEXT WEEK!
"Next Era Strategies to Elevate Human Research Protection"
OHRP RESEARCH COMMUNITY FORUM
THURSDAY, MARCH 12, 2015
Registration and Breakfast - 7:00am
Program - 8:00am to 5:00pm
DENVER MARRIOTT CITY CENTER
1701 California Street | Denver, Colorado 80202
The U.S. Department of Health and Human Services' Office for Human Research Protections (OHRP),
Catholic Health Initiatives Institute for Research and Innovation and the University of Colorado, Denver,
invite you to attend this informative and dynamic one-day forum.
Click Here to Download the Program Agenda

Click Here to Complete Your Hotel Reservations

Click Here to Register - $150 per attendee
Researchers, research coordinators, Institutional Review Board (IRB) members and staff, institutional officials,
other public health service agencies, emerging bioscience companies entering human research
and anyone with an interest in research involving human subjects
should consider registering today.
WE LOOK FORWARD TO SEEING YOU IN DENVER!
For more information about the conference, please visit the event web site, call (720) 568-3615
or email ElevateHRPDenver2015@catholichealth.net.
 
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Colorado Medical Society through the joint sponsorship of St. Anthony Hospital, and Catholic Health Initiatives Institute for Research and Innovation.  St. Anthony Hospital is accredited by the Colorado Medical Society to provide continuing medical education for physicians.
               
St. Anthony Hospital designates this live educational activity for a maximum of  6.5 AMA PRA Category I Creditsâ„¢.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.
 
Catholic Health Initiatives Institute for Research and Innovation (CIRI) is authorized to award 6.5 hours of pre-approved ACHE Qualified Education credit (non-ACHE) for this program toward advancement, or recertification in the American College of Healthcare Executives.  Participants in this program wishing to have the continuing education hours applied toward ACHE Qualified Education credit should indicate their attendance when submitting an application to the American College of Healthcare Executives for advancement or recertification.
 
 
EDUCATIONAL LEARNING OBJECTIVES:
1.     Discuss the fundamentals of research involving human subjects
2.     Describe processes that can improve efficiencies related to the design, conduct and oversight of research involving human subjects
3.     Apply regulatory guidance to modern research practices

 
 
 
 
 
FOUNDATIONS IN PERSONALIZED HEALTH CARE
(MDCRC 6150)
5:30 – 7:00 PM
Monday, March 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:
 
“Integrating Informatics Operationsto Support Personalized Care and Research”
Presented by:
“Building Natural Language Processing Systems to Find the Right Clinical Information for Personalized Healthcare”
WENDY CHAPMAN, PHD
Chair, Biomedical Informatics
University of Utah
 
“ClinVar – a Repository of Clinical Variants”
KAREN EILBECK, PHD
Associate Professor
Department of Biomedical Informatics
University of Utah
 
“Clinical Decision Support”
KEN KAWAMOTO, MD, PHD
Assistant Professor
Department of Biomedical Informatics
University of Utah
 

The Wayne Brown Institute is the nation’s oldest and most successful non-profit, 501(c) (3) venture accelerator in assisting entrepreneurs in their quest for capital. To date, of the over 700 groundbreaking high tech companies that have presented in a WBI program, 70% have raised over $7.5 billion dollars in financial transactions, accounting for ½%-1% of venture capital deal flow in the United States.  According to an independent study, Utah based WBI alumni companies in 2008 generated over $1.3 billion in sales, $49 million in State tax revenue, and supported over 15,000 jobs.   Also, as compiled in the MountainWest Capital Network 2008 - 2012 Deal Flow Book, 101 WBI alumni participated in venture capital and angel transactions exceeding $565 million and creating/supporting over 38,000 direct and indirect jobs.  Visit WBI on the web at www.venturecapital.org.
 
 
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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!
2015 MDMA Annual Meeting
 

2015 MDMA Annual Meeting Export to Your Calendar

4/29/2015 to 5/1/2015

When: Apr 29 - May 1
Where: The Liaison Capitol Hill
415 New Jersey Ave NW
Washington, District of Columbia  20001
United States
Contact: Sheri DeVinney 
sdevinney@medicaldevices.org 
Phone: 202-354-7171

 

Registration Information
Online registration is available until: 4/30/2015
Details

 

 

REGISTER TODAY! 

MDMA 2015 Annual Meeting

 

           

          

 

Plan to attend MDMA's 2015 Annual Meeting in our Nation's Capital, Apr 29th - May 1st, 2015. MDMA's Annual Meeting will cover key issues impacting the United States' leadership position in med tech innovation, and how we can all help shape the regulatory and legislative agendas. This year's meeting will provide the latest on regulatory, reimbursement, compliance and international trends, as well as share powerful stories of how med tech is improving patient care.

Value of Attending

  • Engage industry executives, government officials and expert panelists on critical issues
  • Hear first-hand updates on the latest news and must have information for med tech CEOs
  • Build relationships while networking with over 200 med tech CEOs and senior executives

  

 

                                                    

                                         

 

 

 

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.

2015 STEM Voice Video Competition - NOW OPEN!

The STEM Voiceâ„¢ Video Competition is nation-wide opportunity for kids in grades 5-12 to artistically explore the importance of STEM. The competition is managed by the Coalition of State Bioscience Institutes, CSBI, a group of non-profits focused on life sciences education, entrepreneurship and workforce development.  A special thanks to the Amgen Foundation for supporting the Coalition of State Bioscience Institutes and its programs.

The competition encourages you to be creative and use video to show how much you love STEM. Act it out, create an animation, sing it but, make sure it is appropriate for all ages. One semi-finalist from Middle School (grades 5-8) and one semifinalist from High School (grades 9-12) will be selected from each of the three regions. Each semifinalist (6 total) will receive a $500 cash award. Two grand prize winners (one from Middle School and one from High School) will receive $1,000 cash awards.

Eligibility:
• Must be in grades 5 - 12 and under 18 years of age;
• Middle School contest is for students grades 5-8; High School contest is for students grades 9-12;
• United States legal resident;
• Cannot be related to employees of STEM Voiceâ„¢ Video Competition Administration 

Application Deadline: April 17th 2015

Application: http://form.jotform.us/form/50227077830149

APPLY for STEM Voice Video Competition HERE!

Forms:
Terms & Conditions
Media & Privacy Release
Judging Criteria

Please contact your Regional Coordinator if you have any questions.

Regional Coordinators:
East Coast Competition
(States: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, Pennsylvania, Delaware, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, Washington D.C., West Virginia, Alabama, Tennessee, Puerto Rico)
MdBio Foundation
Attn: Jennifer Colvin
jcolvin@mdbiofoundation.org  

Central Competition
(States: Illinois, Indiana, Michigan, Ohio, Wisconsin, Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota, Arkansas, Louisiana, Oklahoma, Texas, Kentucky, Mississippi)
iBIO Institute EDUCATE Center
Attn: Ann Reed Vogel
ann.vogel@ibioinstitute.org

West Coast Competition
(States include: Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming, Alaska, California, Hawaii, Oregon, Washington) 
Biocom Institute
Attn: Liisa Bozinovi
lbozinovic@biocom.org

A special thanks to the Amgen Foundation for your support of the Coalition of State Bioscience Institutes and its programs.@AmgenFoundation

Copyright © 2015 BioUtah, All rights reserved.


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