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Thursday, October 6  | 7am – 5pm
Calvin L. Rampton Salt Palace Convention Center, Suite 355


Download Summit 2016 Printable Agenda




Frontiers of Innovations and Regulations
06 Oct 2016
7:00 am - 8:00 am

Registration and Check-in

8:00 am - 8:50 am

Opening Session


By Kelly Slone, President & CEO BioUtah
Kelly Slone

BioUtah’s vision driving Utah’s leadership in medical innovation

Speakers: George Hamilton, Intermountain Healthcare / BioUtah’s Outgoing Chairman & Dirksen Lehman, Edwards Lifesciences / BioUtah’s Incoming Chairman
George Hamilton
Dirksen Lehman

Governor’s Keynote Address

We will be honored to have Governor Gary Herbert be our Opening Session keynote speaker.
Governor Gary Herbert
8:50 am - 9:00 am

Stretch Break

9:00 am - 10:25 am

Session 1

International Regulations: New CE Mark Requirements per EU’s new Medical Device Regulations

The proposal to replace the European medical device directives for CE Marking with new EU regulations has completed significant progress within the EU legislative process and is moving towards finalized...
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Ronald Rakos, PhD, MBA, RAC

LS Talk #1: 2016 Presidential and Congressional Election Preview

Two leading political and policy strategists will share their insights on the state of the Presidential and Congressional races, as well as what the various outcomes could mean for business...
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Christopher E. Campbell
Kevin Madden

LS Talk #2: Utah’s AncestryDNA’s Smashing Success Story

AncestryDNA has been blazing the trail in developing a genetic database that is changing the healthcare landscape in how consumers manage their health and screen for different diseases.  Ken Chahine...
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Ken Chahine

LS Talk #3: Utah Life Science Innovation Trends

Innovation never sleeps. To be successful one must constantly adapt, learn and act. Here is an opportunity to learn at the feet of 2 stars in the medical innovation space...
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Nate Rhodes – Moderator
Ashok (AK) Khandkar, PhD
David J. Bearss, PhD
10:25 am - 10:45 am

Networking Break

International Regulations: Clinical Evaluation under EU’s new Medical Device Regulations per MEDDEV 2.7.1 Rev 4

In June of 2016, Revision 4 of MEDDEV 2.7/1, Clinical Evaluation replaced the December 2009 Revision. The new guidance includes more detailed and expansive requirements for clinical data. This presentation will...
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Alexandra Jantzen

LS Talk #4: U of U’s Center for Medical Innovation (CMI)

The Center for Medical Innovation has an attractive model that has been emulated internationally and has gone where few have gone before. Students are our future. They dream big, and...
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John Langell, MD, PhD, MPH

LS Talk #5: Adapting to the New Health Care Landscape

Nationally recognized panelists will discuss securing coverage and market access in the health care current environment.  Various stakeholders in the health care delivery system often have different definitions of value. ...
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Ken Reali
Beth Halpern – Moderator
Thomas Royer, MD, FACPE
Louis Jacques, MD
12:20 pm - 12:30 pm

Stretch Break

12:30 pm - 2:00 pm

BioUtah’s Life Science Awards Luncheon


Patient-Focused Innovation in Today’s Healthcare System
Michael A. Mussallem

BioUtah Awards Ceremony

We are honored to have Senator Orrin Hatch and Representative Robert Spendlove at the 2016 BioUtah Awards Ceremony.  Senator Orrin Hatch will be presented with an award in recognition of...
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Senator Orrin Hatch
Representative Robert Spendlove
2:00 pm - 2:30 pm

Networking Break

2:30 pm-4:30 pm

Afternoon Session

Inclusion of Patient Preference Information in FDA Submissions

8uoIn 2012, the CDRH announced the Patient Preference Initiative for devices to better understand and evaluate the patient perspective in the development and review of medical devices. This program has...
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Diana Salditt
Sharon Segal, PhD

Medical Innovations Pathway

BioUtah was recently awarded a $193K UCAP Grant to develop a Medical Innovation Pathway (MIP) for high school students and retain adults interested in a career in life sciences.  The...
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Jana Evans
David Gardner
Lars Mouritsen
Val Hale
Denise Bell
Sandra Hemmert
Ben Hart

The Value of BioUtah’s Service Providers

Utah has a wealth of resources in our own backyard. Come meet the array of service providers available to help take your innovation to the next level! This session will...
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3:30 pm - 3:45 pm

Stretch Break

Use of Post Market Data to Support Pre-Market Approvals

In the device approval pathway, finding the right balance of premarket and post-market data collection facilitates timely patient access to important new technology without undermining patient safety. The FDA issued...
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Ken Reali
Elisabeth McOmber

Utah’s Life Science Entrepreneurs and Investor Speed Dating – continued

Selected Utah life science start-up companies will have the opportunity to provide company pitches with several investors.  For those not participating, you are welcome to stop by and come listen...
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USTAR Technology Entrepreneurship Services

USTAR Technology Entrepreneurship Services: USTAR supports the pipeline of innovative technology ideas to establish new products and companies across the state. USTAR will provide an overview of all the USTAR...
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Ivy Estabrooke

The Value of BioUtah’s Service Providers – continued

Utah has a wealth of resources in our own backyard. Come meet the array of service providers available to help take your innovation to the next level! This session will...
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4:30 pm - 5:00 pm

Closing Session

Summit Wrap-up

Kelly Slone
5:00 pm - 6:30 pm

Offsite Reception – Optional

Beer Hive

128 Main St, Salt Lake City, UT 84101



Calvin L. Rampton Salt Palace Convention Center
100 S W Temple, Salt Lake City, UT 84101


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Exhibitor Pass
1,050.00 USD

Includes 2 Summit Exhibitor entrances & a 6′ x 30′ skirted table

BioUtah Member  –  $900

Non-Member –  $1,050

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Who is BioUtah?

BioUtah is an independent, non-profit 501(c)(6) trade association serving Utah’s life science industry. Our primary members include organizations focused on research and development, manufacturing and commercialization or provide supportive services to life science technologies and treatments.

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What we do

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Why us?

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