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August 2014 Issue

Note from the President


Yesterday BioUtah held its inaugural International Regulatory Pathways conference. Those in attendance were treated to informative presentations by Phil Triolo on the regulatory perspective from the U.S., Michael Rinck, PhD on the EU, Linda Chatwin on BRICs Countries and Grant Bennett on Australia/Pacific, with a final panel discussion led by BioUtah's COO and resident regulatory expert, Peter Knauer. 

The energy and talent that each of these groups brought to Utah's life science sector has resulted in a vibrant, growing industry association that continues to grow in stature and influence. Currently, BioUtah is working on a spate of compelling projects and initiatives, including the fifth annual Utah Life Science Summit; the inaugural Utah Life Science glossy publication, which will be unveiled at the Summit; a new and expanded Utah life science strategic plan, which BioUtah is coordinating in partnership with the Governor's Office, Utah System of Higher Education and the Department of Workforce Services; and an extensive new mentor network for entrepreneurial companies throughout the state. 
 
We are also active on the national stage, as the official Utah representative for BIO, MDMA and AdvaMed, collaborating with other state and regional associations to develop a better national environment for life science companies. 
 
This is an exciting time for BioUtah and the life science community we serve. We look forward to building great things with our growing community of members!
 
All the best,
Kimball Thomson
President & CEO 
BioUtah and BioUtah Institute

Article


Drug Supply Chain Security Act (DSCSA) Implementation Plan

By Peter Knauer and Moj Eram

This article discusses the implementation aspects of the new Drug Supply Chain Security Act (DSCSA), which was signed into law (Title II of Public Law 113-54) by President Obama on November, 27, 2013. The Act intends to build a comprehensive, standard electronic and interoperable system to identify and trace prescription drugs in the US.1

Since the formation of the first FDA Counterfeit Drug Task Force in 20032, the agency has been engaged in efforts to improve and enhance the security of the drug supply chain at multi-level efforts that involves all stakeholders. The aim is to protect US patients from ineffective, counterfeit, low quality and unsafe drugs that enter to the market. Counterfeit, mislabeled, adulterated, or otherwise compromised prescription drugs pose serious public health safety concerns that are being addressed through the new Act. These drugs may be contaminated or contain faulty ingredients, inaccurate dosage, inactive ingredients or toxic ingredients. As a result of these drugs entering the market, patients risk their health by unknowingly using these faulty products.

READ MORE...

Special Notice


Utah Life Science News


ApolloDx to Demo Revolutionary New Mobile Diagnostic Platform
SALT LAKE CITY Aug. 20 2014 /PRNewswire/ -- ApolloDxâ„¢ today announced it will unveil and demonstrate their revolutionary mobile diagnostic platform during a special event at the company's office in Salt Lake City Utah on September 5 2014. The event which will start at 10:00 a.m. will also be LiveStreamed on the ApolloDx website www.apollodx.com
Acute myeloid leukemia drugmaker closes $14.2M, focuses on personalized medicine
Tolero Pharmaceuticals, a Salt Lake City, Utah drug developer, has set its sights on ramping up the commercialization and development efforts of its acute myeloid leukemia treatment, which will enter Phase 3 trial sometime next year.

Q Therapeutics Invited to Present at the Swedish-American Life Science Summit 2014

SALT LAKE CITY, UT-- Q Therapeutics, Inc., an emerging biotechnology company developing innovative cell therapy products for the treatment of debilitating diseases of the central nervous system, today announced that the Company has been invited to present at the Swedish-American Life Science Summit 2014 to be held in Stockholm, Sweden on August 20-22, 2014.


For Utah businesses who want to expand internationally, the question is not whether there is a market for Utah products and services—there is. The questions often lie with navigating the barriers of legal, tax and accounting issues, all of which can make a company lose key profit margins.



IMC heart patient is first in Utah to receive new pacemaker

MURRAY, Utah (ABC 4 Utah) - Heart patients here in Utah now have access to some of the most advanced technology in the world. A Utah woman just became the first to receive a leadless pacemaker which requires no surgery.


 
 
The Utah Technology Council (UTC) (http://www.utahtech.org) today announced A. Scott Anderson, Alan Hall and Kirk M. Ririe as its inductees into the 2014 UTC Hall of Fame. These Utah executives will be honored on November 7 at the Grand America Hotel in Salt Lake City at the annual celebration of the technology industry.
Senators call for guidance on biosimilar biological products

A group of senators called for the Obama administration to clarify the FDA’s policy on the approval of biological products that are deemed interchangeable with previously licensed products.



In a push to meet a critical shortage of talent in the life sciences areas in the state of Utah, Utah Valley University will soon begin offering a new graduate certificate in regulatory affairs this fall. UVU is the only academic institution in Utah that will offer this program thus far.

National Life Science News


Margaret Hamburg, M.D.
Clinical Trials: Enhancing Data Quality, Encouraging Participation and Improving Transparency

By: Margaret A. Hamburg, M.D.
Today FDA is announcing important steps that the agency plans to take to enhance the collection and availability of clinical trial data on demographic subgroups – patient populations divided by sex, race/ethnicity or age.


Report: The IRS is having trouble with the medical device tax

A U.S. Treasury report on Obamacare’s medical device tax reveals that the IRS is having problems figuring out which companies should be paying the 2.3% sales tax and that the tax bureau is only collecting about 76% of the tax it thinks is owed.


Kalorama: Tax Savings Not Only Benefit to Medtronic-Covidien Deal
NEW YORK, Aug. 18, 2014 /PRNewswire/ -- US-based Medtronic said it would purchase Ireland-based Covidien for $42.9 billion (press release: http://bit.ly/1qsbFqb), combining two of the world's biggest medical device makers and helping Medtronic savings with a headquarters change.  Kalorama estimates the deal will come just short of creating the largest device company based on 2013 revenues in its Global Market for Medical Devices, 5th Editionreport, released last year.   According to Kalorama, Johnson and Johnson is the largest device company at $28.5 in 2013, but if the new combined company has a strong year of sales, rankings could change.
FDA Notifies Congress of Framework for Long-Awaited Guidance on Laboratory Developed Tests and Issues Final Guidance on Companion Diagnostics
 
 
After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress on July 31, 2014 that it intends to issue a draft guidance document entitled, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and an accompanying draft guidance document entitled, “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).” The notice, which may be found here, includes the anticipated details of the draft guidance documents (“Draft Guidance”).1

 
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Bulletin Board

 
 
The Diagnostic Revolution Begins

ApolloDx to Demo Revolutionary New Mobile Diagnostic Platform

CLICK HERE  to register to attend or Watch Live Stream of Event
 
CLICK HERE  for Event Press Release
 
ApolloDxâ„¢ will unveil and demonstrate their revolutionary mobile diagnostic platform during a special event at the company’s office in Salt Lake City, Utah, on September 5, 2014. The event, which will start at 10:00 a.m., will also be LiveStreamed on the ApolloDxwebsite, www.apollodx.com.

“We believe our mobile diagnostic platform will transform diagnostic testing,” said Jared Bauer, Co-Founder and Managing Partner of ApolloDx. In addition to its broad applications, the ApolloDx system will be an exceptionally cost-effective solution, with significant time- and cost savings compared to the current requirement of sending specimens to a centralized laboratory.

From the finest hospitals to the most remote villages the platform will provide quality point of care diagnostics for healthcare providers, agricultural organizations, biotech and pharma companies, as well as government agencies. Registration for the event can be found below.

Date: Friday, September 5, 2014
Time: 9:30 am - 10:30 am MST
 
9:30 am MST -  Light breakfast: Delicious variety of European-style croissants and beverages
10:00 am MST - Presentation with live video streaming

Location:
ApolloDx Corporate Office
310 E 300 S
Salt Lake City, UT 84111
www.apollodx.com

Special Guests:
  • John C. Nelson, MD OB/GYN, Former President of AMA, Member of the Advisory Committee to the Director of NIH, Senior Advisor and Member of Future Panel at Leavitt Partners, Chief Medical Officer at TruClinic and Medical Officer at Genelex
  • Kimball Thomson, President & CEO at BioUtah
  • Kevin Jessing, Life Science Cluster Director - Utah Governor's Office of Economic Development (GOED)
ApolloDx
310 E 300 S / Salt Lake City, UT 84111 USA
Ph: (801) 652-6334
Web: www.ApolloDx.com
 
white hat promo 1

The West was won by innovators, investors, and prospectors who understood  the value of discovery and accepted the challenge of investing in new frontiers.  

Join us to meet a new generation of biotech and healthcare pioneers at  White Hat Investors 2014, the first annual biotech and healthcare investor conference that showcases the best of the Rocky Mountain & Southwest Region.

Bioindustry Associations from across the Rocky Mountain and Southwest Region are coming together to present an opportunity  for Angels, Venture Capitalists and Strategic Investors to connect with the best biotech and healthcare investment opportunities from across the Rocky Mountain & Southwest states at White Hat Investors 2014 in Phoenix, Arizona on September 17 & 18, 2014.

Presenting Companies will be selected from the region’s emerging innovator leaders in the fields of:

    • Diagnostics
    • Therapeutics
    • Medical Devices
    • Health IT

The initial list of presenting companies is now available.  

  Click here to see who you will learn about at White Hat.

Who should attend?

    • Angel Investors
    • Venture Capital Firms
    • Institutional Investors
    • Strategic Investors
    • Supporting Organizations

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   
  • When
    25 Sep 2014
  •  
     
  • Location
    Crowne Plaza Cabana Hotel 4290 El Camino Real Palo Alto, CA 94306
 

AdvaMed2014. The MedTech Conference. Access. Insight. Oppotunity.

 
 
 
AdvaMed2014. The MedTech Conference. Access. Insight. Oppotunity.
October 6-8, 2014
McCormick PlaceChicago, IL

Register and submit Company Presentation applications today!
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advamed2014
Access. Insight. Opportunity.
October 6 - 8, 2014 | McCormick Place | Chicago, IL

Register now and save up to $600 for AdvaMed 2014!
Early registration ends today, July 31. With more than 30 educational panel sessions, plenary sessions that include former Secretary of State Hillary Rodham Clinton, unparalleled networking opportunities, Sector MeetUps, and more than 60 exhibitors, there are many reasons to register now and save your spot at AdvaMed 2014: The MedTech Conference.

Last Call for Company Presentations
Today is also your last chance to submit a Company Presentation application! Click here to apply.
Company Presentations allow innovative, early-stage medical device and diagnostic companies to connect with venture capital and angel investors, business development executive and other strategic partners. Take advantage of the access to exclusive networking, gain valuable exposure and advance your financing and strategic business development objectives.

Copyright © 2014 BioUtah, All rights reserved.


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