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

Editor's Note


April is full of excitement for all of us at BioUtah! The Utah 2015 Legislative Session has come to a close and we are thrilled to announce that our efforts to secure an additional $1M in funding for the TCIP program were successful! We would like to express gratitude for all those that were participatory during these efforts. We couldn’t have done it without you! We will continue our efforts in this arena as we work with GOED to refine the program administration process. In this edition of the newsletter, you will find a legislative update from Chris Bleak with RRJ Consulting, our lobbying entity, detailing more extensively further outcomes from this session impacting our life science community.

Also in April, we will continue our Compliance Clinic discussions led by Walt Murray with MasterControl regarding the upcoming ISO 9001:2015 standard – our 3rd part of this educational series. Consistent without our efforts to keep our members informed, our May Compliance Clinic will feature Peter Knauer delving into the new 13485:2016 standard coming out next year. Please see the events portion of the newsletter for our other activities and events from our partners as well.

In anticipation of our new CEO, Kelly Slone, coming on board, we have had numerous requests from members who are eager to meet her. On Thursday, April 30th we invite you to join us as we welcome Kelly and introduce her to the Utah life science community at a networking mixer in her honor. Kelly is eager to begin collaborating with our members and partners, to elevate Utah’s life science community. We hope you will all join us!



Susannah Hutchins
Director of Operations
BioUtah

Recap of 2015 Utah Legislative Session


By Chris Bleak, RRJ Consulting

The 2015 Utah Legislative Session has adjourned.  This session will largely be known for the legislation passed dealing with anti-discrimination and religious liberties as well as a transformation of the way the state funds transportation and a significant criminal justice reinvention initiative designed to reduce recidivism and increase rehabilitation. It was a very successful session for the life sciences industry and BioUtah including a significant increase in the Technology Commercialization and Innovation Program (TCIP).
 
There were significant issues dealt with that impact the life sciences.  The Legislature appropriated an additional 1 million dollars to the TCIP program, which is run by the Governor’s Office of Economic Development (GOED).  The goal of TCIP is to grant money to companies that are in the process of developing a technology and help move it towards commercialization.  The grants now prioritize applicants who have won SBIR or STTR grants.  There is more work to be done both on the funding and application of TCIP grants but BioUtah is grateful that the Legislature prioritized additional money to this worthy program.
 
We must now turn our attention to working with GOED on improving the TCIP program so that the money appropriated will have the broadest impact possible.
 
The Legislature also passed HB 94, sponsored by Representative Gage Froerer and Senator Evan Vickers.  This bill is known as the Right to Try legislation.  The legislation allows a terminally ill patient in consultation with their physician to obtain an investigational drug or device to potentially improve their chance at survival. 
 
Two other significant bills that were debated this session were SB 169 the Contact Lens Consumer Protection Act Amendments and HB 279 the Prescription Notification Amendments or biosimilars bill.  BioUtah was neutral on both of these bills this year but wanted to share some information as they have an impact on many of our members.
 
The Contact Lens Consumer Protection Act bill was run at the behest of 1-800-Contacts.  The bill would prohibit manufacturers from setting uniform pricing policies.  The argument centered around whether it was appropriate for a manufacturer to set a price on a medical product that required a prescription because the consumer was unable to shop around for a different product.  The bill passed the Legislature and is awaiting signature from the Governor.
 
HB 279 also passed the Legislature.  Utah has had a biosimilars bill but it was set to sunset this year.  The new bill allows a pharmacist to substitute an interchangeable biological product if the FDA has determined a product is interchangeable. 
 
There is a growing recognition about the importance of the life sciences industry here in the State of Utah.  We look forward to continuing our discussion with policymakers and will update you on future opportunities to share the exciting things happening in your companies.

Special Webinar



Experts Provide Overview of Upcoming ISO 9001:2015 Standards

ISO experts Walt Murray and Peter Knauer provide a review of where ISO 9001 came from, how it developed and where it is going this year.  Change is coming; in this first video of a three-part series, you’ll learn why the ISO 9001 update is occurring and how pharma companies should prepare for its impact.  The new standard reflects an international orientation, affecting all kinds of manufacturing organizations.

 View the Webinar (no form required): Discussion on ISO 9001:2015 Part 1 of 3

Discussion on ISO 9001:2015 Part 1 of 3

Webinar Description

In 18 minutes this overview describes:
  • The seven reasons causing the update
  • The nature of the compatibility of ISO 9001 with other ISO standards
  • The three parts of the ISO/IEC Directive
  • Exclusions and inclusions in the revised standard
  • How risk-based thinking is incorporated into the standard
  • How the structure of the standard will change
  • Why a quality manual is no longer required
  • The significance of process orientation to the revision
 

BioUtah Special Compliance Clinic Series

Utah Life Science News


Researchers to Tackle Lower Back Pain Affecting Millions of Americans
Intermountain Healthcare to play key role in multi-million dollar back pain study funded by Patient-Centered Outcomes Research Institute
​Salt Lake City â€“ A research team with Intermountain Healthcare’s Physical Therapy Services will study interventions for chronic lower back pain as part of a national, multi-site study that has been approved for a $14 million funding award from the Patient-Centered Outcomes Research Institute (PCORI).
Medical Device Start-Up Celebrates Important Milestone

PenBlade, a developer and manufacturer of safety scalpels, graduated from their space at BioInnovations Gateway on Wednesday, March 5th. The company has outgrown the space they have been occupying at BiG, and will be headed to Church and State for further expansion.


Top 12 Hot Spots for Tech Startups and Workers (Outside San Francisco and Silicon Valley)
It’s not exactly news that the San Francisco Bay Area is a hot spot for tech startups, but let’s say you’re ambitious, talented and armed with a great idea but you don’t want to move there. What other places should you consider?

Dynatronics Corporation reports that Richard J. Linder has been appointed to its Board of Directors, effective March 23, 2015. Linder’s appointment fills the vacancy created by the passing in November 2014 of board member Joseph Barton.
Myriad Genetics Announces Prolaris Test Biopsy Results From EMPATHY-P Study
Myriad Genetics Inc. announced that results from the EMPATHY-P clinical study of Prolaris in patients newly diagnosed with prostate cancer will be highlighted at the 30th Annual Congress of the European Association of Urology.
Myriad and AstraZeneca Expand Research Collaboration on Lynparza
SALT LAKE CITY, April 1, 2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced the expansion of its companion diagnostic collaboration with AstraZeneca. Under the terms of the expanded agreement, Myriad's BRACAnalysis CDx test will be used to prospectively identify which patients with metastatic pancreatic cancer may respond to treatment with Lynparza? (olaparib).1 Lynparza is a PARP (poly-ADP ribose polymerase) inhibitor being developed by AstraZeneca. More than 48,000 people are diagnosed with pancreatic cancer and more than 40,000 will die from the disease each year in the United States.2
A. Scott Anderson: Scientific research, development are crucial to Utah's economic future

Never in the history of the world has science and technology been so exciting as it is today — or so important. Never has basic scientific research been so integral to solving problems, creating jobs and maintaining a strong economy.



 
 

National Life Science News


House Speaker John Boehner of Ohio speaks to members of the media during his weekly news conference on Capitol Hill in Washington on March 26, 2015. (AP Photo/Andrew Harnik) **FILE**

A bipartisan group of House freshmen urged Speaker John A. Boehner Tuesday to fast-track a bill to repeal Obamacare’s tax on medical device makers, arguing the levy is shackling a job-creating industry.


Does the FDA's system for approving medical devices work?
Three health care experts, including a former FDA deputy commissioner, recently sat down with the Wall Street Journal, to discuss whether or not the FDA needs to reevaluate their regulations when it comes to medical devices.

FDA Approving Devices Faster
It took about half as long for a device to win FDA approval in 2014 versus 2013.
Griping about FDA approval times has long been a favorite pastime of medical device executives, but if 2014 is any evidence, that complaint may soon disappear. FDA is getting faster at approving devices, and the speed up can’t yet be chalked up to accelerated approval pathways.
European Court ruling on product liability for defective medical devices
On 5 March 2015, the European Court of Justice issued a preliminary ruling on two issues arising under the EU Product Liability Directive in a case involving defective pacemakers and defibrillators. Despite the wide range of issues arising under this directive, the Court has had only a few occasions to construe its ambiguous terms. This case, however, provided an opportunity to the Court to settle key issues relating to the defect test and the scope of damages compensable under the directive.
Senator Markey Introduces Legislation to Repeal Medical Device Tax
Revenue-neutral proposal fueled by ending tax breaks and free-drilling loopholes for oil and gas companies
Washington Senator Edward J. Markey (D-Mass.) introduced legislation that would repeal the medical device tax and pay for the repeal by ending tax giveaways and closing free-drilling loopholes for oil and gas companies. The “No Taxation on Device Innovation Act” eliminates the 2.3 percent medical device excise tax in the Affordable Care Act and pays for repeal by ending more than $29 billion in tax breaks for oil companies, free-drilling loopholes and taxpayer subsidies for the oil and gas industry over the next decade. The United States is home to more than 7,000 medical device companies that directly employ more than 400,000 individuals in high-skilled and high paying positions and indirectly support nearly two million additional U.S. jobs. In Massachusetts alone, the industry directly supports 23,900 jobs and approximately adds $17.6 billion to the Commonwealth’s economy. The oil and gas industry, whose top five companies made $93 billion in profits in 2013 alone, will receive more than $70 billion in tax breaks and subsidies over the course of the next decade.
FDA Launches Drug Shortages Mobile App
Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.Drugs in short supply can delay or deny needed care for patients. Drug shortages may also lead health care professionals to rely on alternative drug products, which may be less effective or associated with higher risks than the drug in shortage.
 
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                     Bulletin Board

 
 

The Bench-2-Bedside is the most popular and dominant student program at the Center for Medical Innovation. Student teams form into multidisciplinary start-up companies and are given the task of identifying an unmet clinical need. Teams are given access to over 100 University physicians and industry leaders to serve as their consultants, mentors and stakeholders. The teams have six months and $500.00 to develop medical device concepts that address their identified need. In that six-month time period students will have evaluated the IP landscape, prototyped their design and constructed a business plan.

We would like to invite you to our 5th annual competition, held April 8 at the Utah State Capitol where the teams will be presenting their projects for the $71,000 in prize money. Please look for our invitation below.  RSVP at cmi.uofuhealthsciences.org or 801-585-5905.

We look forward to seeing you there,

Megan McIntyre
Associate Director, Education
Center for Medical Innovation  |  University of Utah Health Sciences
Main: (801) 587-7281; Mobile (801) 808-2724
cmi.uofuhealthsciences.org
 
It is our pleasure to inform you that Dr. Matt Portnoy,  NIH SBIR-STTR Program Manager and Director will be in Salt Lake City on Tuesday, April 28 as a guest of USTAR's SBIR-STTR Assistance Center (SSAC).
 
As SSAC clients, you are the first to hear of this exciting opportunity. Dr. Portnoy will hold a free lecture from 1:00-2:30 p.m. which will be of value to all companies within the SBIR-STTR sphere.  
 
We encourage you to register early - limit 2 people per company. Please see the information provided and do not hesitate to reach out with any questions. We look forward to seeing you on April 28th
 
Thank you for your continued support of the SSAC.
SSAC Team
 
 
 
 
Utah's SBIR-STTR Assistance Center (SSAC)
Located at and in partnership with Salt Lake Community College
Miller Corporate Partnership Center
9750 South 300 West
Sandy, UT 84070
Phone: 801-957-5249
Email: UtahSBIR-STTRCenter@Utah.gov

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.

 
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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