41Days
21Hours
13Mins
14Secs

Subscribe for updates

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

 



Download Summit 2016 Printable Agenda

 


 

Program

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

Welcome

By Kelly Slone, President & CEO BioUtah
Kelly Slone

Governor’s Keynote Address

We will be honored to have Governor Gary Herbert be our Opening Session keynote speaker.
Governor Gary Herbert

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
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...
Read More
Ronald Rakos, PhD, MBA, RAC

LS Talk #1: 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...
Read More
John Langell, MD, PhD, MPH

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...
Read More
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...
Read More
Alexandra Jantzen

LS Talk #4: 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...
Read More
Christopher E. Campbell
Kevin Madden

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. ...
Read More
Beth Halpern
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

LUNCHEON KEYNOTE ADDRESS

Patient-Focused Innovation in Today’s Healthcare System
Michael A. Mussallem
2:00 pm - 2:30 pm

Networking Break

2:30 pm-4:30 pm

Afternoon Session

Inclusion of Patient Preference Information in FDA Submissions

In 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...
Read More
Sharon Segal, PhD

Medical Innovation 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...
Read More
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...
Read More
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...
Read More
Beth Halpern

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...
Read More

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...
Read More
4:30 pm - 5:00 pm

Closing Session

5:00 pm - 6:30 pm

Offsite Reception – Optional

Speakers

Location

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

 

Recent News

Tickets

Early-Bird Non-Member Registration
275.00 USD

Receive a $50 discount for registering early! Reserve your seat today while still available!

Early-Bird Registration Closes Aug. 31st

Book Now
Early-Bird Member Registration
225.00 USD

Receive a $100 discount as a BioUtah Member for registering early! Reserve your seat today while still available!

Early-Bird Registration Closes Aug. 31st

Book Now
Exhibitor Pass
1,050.00 USD

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


BioUtah Member  –  $900

Non-Member –  $1,050

Book Now

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.

Learn More

What we do

Donec id elit non mi porta gravida at eget me tus. Sed posuere consectetur estat lobo rtis. Cum sociis natoque.

Learn More

Why us?

Donec id elit non mi porta gravida at eget me tus. Sed posuere consectetur estat lobo rtis. Cum sociis natoque.

Learn More