Frontiers of Innovations and Regulations
03 Nov 2017
7:30 am

Registration Opens

8:00 am - 9:15 am

Opening Session

Welcome and Brief Remarks

Kelly Slone, President and CEO, BioUtah and Dirksen Lehman, Corporate Vice President, Public Affairs, Edwards Lifesciences and Out-going Chairman, BioUtah Board of Directors
Dirksen Lehman
Kelly Slone

Welcome Address

Governor Gary Herbert

Breakfast Keynote Address

We will be honored to have Tom Polen, President of BD, be our Breakfast Keynote.
Tom Polen
9:15 am - 9:30 am

Networking Break

9:30 am - 12:00 pm

Morning Session

EU’s Medical Device Regulation (MDR) and Clinical Evaluation Reports

Overview and Implementation Strategies
Anita Dalrymple – moderator
Kerri Casino
Angela Grosklags, RN MSN VA-BC

Medical Device Single Audit Program (MDSAP)

Understand the New Requirements and Benefits and Risks Associated with Participating in the New Single Audit Program
Alex Butler
Timothy W. Lee
Uwe Degenhardt

LS Talk #2: Utah Life Science Innovations-Hot Entrepreneurs and Companies to Watch!

Denver Lough, MD, PhD
Chris Gibson, PhD
Rob Etherington
Shawn Fojtik

LS Talk #4: Life Sciences Outlook for the 2018 Utah Legislative Session

Chris Bleak – moderator
Phil Dean
Representative Robert Spendlove

Clinical Needs Finding/Ethnographic Research

Before the development of any new solutions begins, must first identify and understand the opportunities that are associated with your strategic focus area.  The process of identifying opportunities requires you...
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John Langell, MD, PhD, MPH

Product Reimbursement Fundaments

Understanding the reimbursement landscape early on in the development will help determine whether or not the existing healthcare payment infrastructure will accommodate a new solution to the clinical need it...
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John Langell, MD, PhD, MPH

Stakeholder & Market Analysis

The stakeholder & market analysis, you systematically examine the direct and indirect interactions of all parties involved in financing and delivering care to the patient.  Including understanding which of their...
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Shawn Fojtik
11:30 am - 12:00 pm

Networking Break

12:00 pm - 2:00 pm

BioUtah Annual Meeting Luncheon

Luncheon Keynote: Utah’s Life Sciences Economic Footprint

We will be honored to have Natalie Gochnour, Associate Dean, David Eccles School of Business and Director, Kem C. Gardner Policy Institute, University of Utah, be our Luncheon Keynote.
Natalie Gouchner
1:45 pm - 2:00 pm

Networking Break

2:15 pm - 4:00 pm

Afternoon Session

Clinical Trials – What Could Possibly Go Wrong?

Robert R. Harrison – moderator
Brad Wyman, PhD
Patricia Santos-Serrao, RAC
Peter Knauer

Entrepreneur and Investor Speed Dating Session

Joseph Urban, MD
Nilay Thakar
Ted McAleer
Nickolas Mark
Ron Heffernan
David Hanaman
Libble Ginster
Dustin Cook
Gunther Branham
Brad Bertoch
Phil Grimm
Barry Hanover

Building A Strong Workforce/ Medical Innovation Pathway Session

Angela Tymofichuk – Moderator
Pat Vaughn
Marion Eckersley
Melisa Stark
Tamara L. Goetz, PhD

Regulatory Basics

Regulatory issues play a critically important role in the ultimate success of a new technology.  Understanding the regulatory landscape early in the innovation process is essential.  Come get an overview...
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Spencer Walker, MSc

Quality Systems Basics

Understanding the key components of a quality systems (21 CFR 820 & ISO 13485) and why early implementation of certain subsystems is of strategic importance to managing a business.  Also...
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Spencer Walker, MSc