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OCTOBER 2016 ISSUE

BioUtah Upcoming Events:


OCTOBER
October 20: Legislative Policy Committee meeting @ 8:30 AM
 
 NOVEMBER

November 2: 
Regulatory, Quality and Compliance Committee meeting @ 12 PM location TBA

November 10: Understanding Non-Solicitation, Confidentiality And Non-Compete Agreements in Utah
Presenting: Maralyn English and Rand Bateman, Snow Christian & Martineau

November 17: Legislative Policy Committee meeting @ 8:30 AM 


DECEMBER

December 8: BioUtah Legislative Awards Luncheon @ Alta Club

 


Note from the President
Dear Friends and Colleagues,

 
Thanks to everyone who attended the annual Utah Life Science Summit last week. Hopefully you enjoyed networking with your colleagues and found the program interesting and valuable.  It was so nice to see Utah’s life science community come together and listen, learn, recognize and honor individuals within our community. 
 
Once again, I want to extend a big thank you the summit sponsors and the planning committee for all their support, hard work and great ideas.  BioUtah is very appreciative of everyone’s support and efforts!!
 
Visit bioutah.org where we have posted all the pictures and presentations from the sessions. 
 
BioUtah is always looking at ways to improve and add greater value to its members and welcome your feedback and ideas on how we can make next year’s summit even better.  Please go to the post-summit survey and let us know how we can improve.

 
 
Kelly Slone
 

Kelly Slone
President & CEO, BioUtah

 
Post-Summit Survey
Please take a minute to answer a 2 question survey about your summit experience.
ULSS 2016 PICTURES
Click HERE to see all ULSS 2016 pictures

BioUtah Members Host Two Successful Networking Events:

One of BioUtah’s top priorities is to provide valuable networking opportunities for Utah’s life science community.  In September, Rob Etherington, President and CEO, Clene Pharmaceuticals, hosted a biotech industry focused networking event.
 
Edwards Lifesciences hosted and Lefavi Management sponsored a “women in life science” networking event where approximately 60 individuals attended and Mayor Jackie Biskupski, spoke about her successful career pathway in Utah.


White Papers




How to Successfully Complete an FDA Inspection


For many manufacturers, facility inspections by the U.S. Food and Drug Administration (FDA) can be very difficult, and findings over the course of an inspection can have significant consequences. Depending on the severity of the findings and the manufacturer’s response to findings, the agency can issue warning letters, consent decrees or fines and initiate
injunctions, seizures and criminal prosecution.

With proper preparation, however, the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario. This white paper identifies key steps that manufacturers, life science companies and other organizations operating in FDAregulated environments should take before, during and after an FDA inspection to ensure a successful audit.


BioUtah News


Governor Herbert and the Life Science Industry Officially Launch the Medical Innovations Pathway (MIP) Initiative

With great excitement, on September 27, the life science industry stood side-by-side with the Governor, education leaders and students to announce a new Medical Innovation Pathways initiative where students will be able to train with life science industry leaders.  Below are the links on the news stories about the launch. 
 
http://www.ksl.com/?sid=41645648&nid=148&title=new-program-helps-high-school-students-get-jobs-in-life-sciences
 
http://kutv.com/news/local/new-health-sciences-pathways-program-for-high-school-students
 
http://www.sltrib.com/news/4403494-155/utah-launches-program-to-train-high
MIP Industry Partners Participate in Pathway to Professions Career & Technical Education Showcase:
On October 12-13, BioUtah and several MIP partners participated in the first Pathways to Professions Career & Technical education showcase to educate teachers, parents and students about the MIP and provide the opportunity for students to sign up for the program.  The event also provided hands-on learning experiences and access to industry professionals.  Thank you to all the MIP industry partners who participated.
Pathway to Professions CTE Showcase Pictures
State & National Life Science News
Dynamic duo: Biochemists describe cooperative halves of life-critical enzyme
LOGAN, UTAH, USA - Oft-repeated adages praise the virtue and added efficiency of cooperative effort: "Many hands make light work," "Together, we're greater than the sum of our parts" and the like. Utah State University biochemists and colleagues report a tenacious enzyme that uses a similar principle to break nitrogen's unrelenting bonds and convert the life-critical gas into ammonia to fuel the world's food supply.

Life Science Companies, Education Partners Join to Launch Medical Innovations Pathways
Gary R. Herbert, along with USA Funds, Utah life science industry partners, the Governor's Office of Economic Development and the Department of Workforce Services announced the launch of the Utah Medical Innovations Pathways program.

Xenoscope™, the Revolutionary Cost-effective Laparoscope, Wins FDA Fast Track Clearance
SALT LAKE CITY, Oct. 4, 2016 /PRNewswire/ -- Xenocor, Inc., an emerging leader in developing a new, revolutionary medical imaging platform that provides the most cost‐effective high definition laparoscopy solutions, announced today that its first product, the Xenoscope, was 510(k) cleared by the U.S. FDA for marketing and distribution. The Xenoscope is the first single-use disposable laparoscope that will be offered in a sterile condition.

Medical device makers rally to save their ‘go-to guy’ in Congress
WASHINGTON — With lawmakers bearing down on drug and device companies over prices, the industry can’t afford to lose any friends on Capitol Hill. And when it comes to medical devices, the industry might not have a better friend than Minnesota Congressman Erik Paulsen.

Are Golden Tickets That Speed Drugs Through FDA Worthwhile?
Sarepta Therapeutics was awarded a voucher for a fast-track drug review by the Food and Drug Administration when the company's medicine for Duchenne muscular dystropy was approved Sept. 19. Now Sarepta is looking to sell the voucher to the highest bidder.

Life Science Leaders Who Feel the Right Kind of Fear
In the world of betting on the future, life sciences find themselves in a storm, with huge opportunities, like CRISPR gene editing, and immense obstacles, such as soaring drug prices, that call for leaders of extra intensity who are imbued with a sense of crisis.

 

Bulletin Board


MEDICAL DEVICE MANUFACTURING: Processes & Practices
The medical device industry is growing with over 100 established companies in the state of Utah! The Medical Device Manufacturing: Processes and Practices certificate program includes a series of courses addressing the competencies outlined by the medical device industry and covers basic core knowledge and skills required for entry-level positions.  Each course content aligns with national industry-recognized standards.
Click here for course information & registration
Download program details



DRUG DEVELOPMENT BOOT CAMP
November 16-17, 2016 

The Harvard Club  |  Boston, MA

The Boot Camp is a very intensive training program designed for those that have relevant experience in research and development of New Chemical and New Biological Entities. This is a very challenging program because of the content, but also because of the amount that must be accomplished in two full days. Participants that complete the Boot Camp can be proud of their accomplishment and the Certificate of Completion that they have earned.
Register Here

INTERNATIONAL BIOFEST 2016
October 24-27, 2016 | Melbourne, AUS

International BioFest 2016 will be the largest-ever gathering in Australian life sciences, with three major conferences coming together in one week in one place as one integrated network.

International BioFest 2016 is expected to attract over 2,500 delegates to attend the academic, industry and investor events in Melbourne from 24 – 27 October 2016. The event will be a celebration of Australian and international life sciences and highlight Melbourne as one of the world’s great biotech hubs.
Register Here
 




2nd Annual GENOME EDITING & ENGINEERING CONFERENCE
February 2-7, 2017  |  San Diego, CA

The conference brings together the key industry leaders and researchers to address the concepts, challenges & applications of the genome editing tools like CRISPR/Cas9, TALENs. 
Register Here
 


 

Copyright © 2016 BioUtah, All rights reserved.


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