BioUtah August Newsletter
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Utah's New, Independent Life Science Association
August 2013 
Note from the President
On July 31 at the Alta Club, a group of top Utah investment experts joined two prominent Silicon Valley investors—biotech specialist Anand Mehra of Sofinnova Ventures and serial medical entrepreneur and Stanford prof Peter Fitzgerald of TriVentures—for a candid, wide-ranging exploration of the perils and opportunities of the current life science funding environment.
 
One of the recurring themes of our discussion was the present state of Utah’s biotech, pharmaceutical, diagnostics and drug delivery industries. The suggestion was made—as it frequently is—that Utah should focus the great majority of its resources and energy on medical devices, with a respectful nod to the state’s diagnostics presence.
 
Near the end of the discussion, we reflected on the reality that before the late 1950s, Utah did not appear on many radar screens as a potential major medical device destination. Then came Utah’s golden age of devices, when Titan figures like Willem Kolff, James LeVoy Sorenson, Homer Warner and Dale Ballard rapidly and fundamentally changed the landscape of the state, creating an abiding identity for Utah as a place to establish a medical device company or major division. These and subsequent leaders created companies that attracted major divisions of such anchors as Bard, Edwards Life Sciences, BD, GE Healthcare, Watson (now Actavis) and Cephalon (now Teva).   
 
To date, Utah has not been a traditional hub of pharma and biotech, which require significantly greater capital resources and longer time horizons than do devices. I have heard people speculate, at the Alta Club event and elsewhere, that we may be approaching something of an inflection point for Utah’s pharma/biotech community. There are deals that are quietly working their way into sizable early funding rounds, a growing cadre of exceptional leaders capable of scaling significant companies that could ultimately attract major biotech and pharma anchors. Were these things to happen, Utah would be in a position to become a rising star in this highest-impact industry arena. In turn, the state would become a magnet for the transformative people, capital and companies that would quickly establish critical mass.
 
May it be so.   
 
All the best,
 
Kimball
 
Kimball Thomson
President & CEO
BioUtah


BioUtah Perspective

A Conversation with John Langell, M.D., Ph.D., M.P.H.

Executive Director, Center for Medical Innovation, University of Utah

By Kimball Thomson 


JOHN LANGELL, M.D., PH.D.M.P.H., executive director of the University Center from Utah’s new Center for Medical Innovation (CMI)

In July 2012 Vivian Lee, the University of Utah’s SVP for health sciences, tapped the multifaceted John Langell, an innovative chief surgeon and professor in the dispersed fields of surgery, management and bioengineering with Stanford and NASA bona fides to lead the University’s newly created Center for Medical Innovation. The Center was created to help guide and inspire medical entrepreneurs within and outside the University. Recently BioUtah took advantage of the opportunity to engage Dr. Langell in a conversation about the mission and life science focus of the Center from medical devices to therapeutic video games.

  

BioUtah:         What are some of the chief areas of focus for your teams at the University of Utah’s Center for Medical Innovation now?

John Langell:    Right now we’re very much engaged in some of our greatest core competencies: imaging interface, digital medical therapeutics, medical applications and device development, and nanotechnology. Those are really the biggest things coming out of our programs right now.

 

BioUtah:    Can we drill down on some of the exciting things happening within these areas of expertise?

Langell:        First, nanotechnology fabrication is taking off.

Second, the Scientific Computing & Imaging Institute (SCI) continues to do world-class things with the software and imaging interface.

 Third, there is strong expertise here in device development and FDA regulatory processes. We get tapped a lot for this. For example, the Korean Government asked us to put together an executive course to teach executives how to negotiate FDA processes.

On the digital interface side, we’re developing the production of video games that are used for medical therapeutics. Some of them have been shown to be more efficacious than medicine! And they don’t have the regulatory difficulties that many drugs do because they’re not tested.

We are currently the number one game development university program in the country. We’ve developed a partnership with the University Medical Center so we can actually completely produce the games, take them to the various treatment centers and test them to show medical efficacy. Then they can be launched out into industry and into the patient care system. That has become a big strategic focus for us.

 

BioUtah:           What are some of the more compelling medical video games?

Langell:         One game, funded by the Department of Defense, is a game called Snowland that uses 3-D virtual reality glasses. Patients use it three times a day. They took soldiers with severe chronic pain syndrome from improvised explosive devices that were missing limbs or burns. They typically have huge narcotic requirements.  They ran a controlled test on the efficacy of controlling chronic pain relief and found that the game was more efficacious than the narcotics were.

There are also games being developed that study the brain, looking at physiologic imaging of brain activity during passive and active interaction, and developing regimens that motivate and incent users to modify their behavior in efficacious ways. Others create an appealing virtual three-dimensional video game world that again incents injured patients to engage in activities that optimize positive outcomes undefined by empowering users to choose their own virtual environments and reward them for engaging in positive activities, such as walking uphill to strengthen their legs.

A student developed a game that teaches autistic children how to make positive daily decisions by incentivizing them with fun and enjoyment. Another encourages young diabetes patients by linking their gaming performance by giving their video game characters super powers for healthy blood sugar levels, weakness for high blood sugar.

I think digital therapeutics have great potential because we are poised to be able to do that well. It is a brand-new field and the FDA is trying to figure out how to regulate it right now. It requires programmers who know how to make really quality outstanding games and University Utah’s number one in the country. Their games come out as high-quality finished products. It is an area worthy of investment, from the universities, the state, donors and institutional investors.

The possibilities for driving positive outcomes are virtually limitless through this medical gaming approach.

 

BioUtah:           Can you discuss the remaining potential for the Utah Population Database? Is Utah losing an advantage there?

Langell:          The population database is a unique database, and right now it is something that can be leveraged. The downside is that its caretakers have been so slow to move forward that we are starting to lose the advantage. There are now places in Europe that have as many entries as we do, or more. I think that politics associated with that database have been inhibitory. And because of that I’m not sure that we’re going to be able to overcome it. Unless somebody moves fast were going to lose our advantage very, very quickly.

 BioUtah:              What do you see as the University system’s role in helping make Utah a world-class destination for entrepreneurs and for life science executives?

Langell:                We provide resources and sometimes capital so they can train their workers for the skills and skillsets that they really need to succeed in the marketplace. We can educate and train the current staff and executives in areas that they don’t have skills right now, but will be beneficial to their organization going forward.  We can also do sponsored research that they may lack the resources or bandwidth to do in-house.  There are many ways to fund this. They can supply the fees necessary to cover graduate student stipends and pay for the work of professors for the development, and the company gets first rights for intellectual property.

Looking at the big picture, it is really our goal to serve as a partner, as a central node in partnership with BioUtah and the Governor’s Office of Economic Development (GOED) to support our life science industries. Our primary focus is education. We have exceptional faculty and student resource experts in the sciences, and we are thrilled to work with companies in ways that are beneficial for all involved, in developing regional economic development and job creation. An aligned strategy is crucial here between industry, government and the universities. Government has to decide where it wants the state as a whole to focus and be willing to put in the resources, industry has to be aligned with the same strategy and all this has to fit with what the University’s strategy is in executing its mission.

We are not here primarily as a conduit to get companies’ products into the market through purchase by our hospital. But we are here to help, and have them help us in a collegial and collaborative relationship.

 

BioUtah:           Are you seeing encouraging signs of industry involvement at the University now?

Langell:              Yes, in many areas. For instance, one of the things we are working on right is finding life science industry leaders to step forward as mentors and sponsors for the Bench to Bedside entrepreneurial development program. Levoy Haight of Summit Medical has agreed to donate funds to a scholarship fund. We’d love to have many other life science leaders get involved investing time and resources to help develop our students as business leaders who can translate research into market value. 


Compliance Corner -White Paper 






 

Bulletin Board


Dear Utah Senate and Congressional Teams:

 

On behalf of my colleagues at the Salt Lake Chamber, Utah Valley Chamber, Utah World Trade Center and Utah’s life science association, BioUtah, I am writing to share a letter our organizations together sent to the new U.S. Trade Representative, Ambassador Michael Froman. In the attached letter, we encourage Ambassador Froman to be mindful and protective of the interests of life science innovators in Utah and throughout the U.S. We hope that you will find our shared message to

 

Thank you for service to Utah’s innovation community and your strong support of the intellectual property protection that is so crucial to the creation and capture of value for Utah’s innovators and the people throughout the world that they serve.

 

Very best,

 

Kimball Thomson



Orphan Drug Tax Credit Support Letters

 



 

CRAM (Clinical Research And Methods) seminar… Wednesday August 21st, 2013.  
Topic:   Office of the VP for Research: Annual Update

Presented by:   Thomas N. Parks, PhD
                        Vice President for Research, University of Utah

Join us for a discussion about the many roles of this office, what’s new and how it is relevant to you and your research

Date:                Wednesday August 21st , 2013

 

Location:         Health Sciences Education Building – Room 2600

 

Time:               Noon – 1:00pm

 

Lunch is provided, so please RSVP by August 16th if possible.


CONFERENCE: "Perspectives in Translational and Clinical Research"

Presented by the American Association of Pharmaceutical Scientists 
Rocky Mountain Discussion Group
 
Monday, August 5, 2013
8:30 am – 5:30 pm
Breakfast and lunch provided
Program agenda attached
 
HSEB Alumni Hall (Room 2120)
On the University of Utah Health Sciences Center campus
Map and directions: http://tinyurl.com/hseb-uu
 
Student/Trainee: $15
AAPS Member: $30
Non-Member: $35
 
Poster Session: Submit abstracts for "encore" posters (presented at other conferences) to Catherine.Sherwin@hsc.utah.edu by Monday, July 29.
 
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2013 CLINICAL PHARMACOLOGY WORKSHOP SERIES
CME credit available
Detailed schedules attached
 
"Clinical Pharmacology Workshop"
Leader: Michael Spigarelli MD, PhD
Professor of Pediatrics, Medicine and Pharmacy
Director, Clinical Trials Office
University of Utah
 
Tuesday, August 6
8:00 am – 4:30 pm
HSEB Room 2120
On the University of Utah Health Sciences Center campus
Map and directions: http://tinyurl.com/hseb-uu
 
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"Pharmacometrics Workshop"
Leader: Catherine Sherwin, PhD, FCP
Associate Professor of Pediatrics / 
Division of Clinical Pharmacology
Clinical Trials Office
University of Utah
 
Wednesday, August 7
8:00 am – 4:30 pm
HSEB Room 2120
 
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"Statistical Workshop"
Leader: Alfred Balch, PhD
Associate Professor of Pediatrics / 
Division of Clinical Pharmacology
University of Utah
Thursday, August 8
8:00 am – 4:30 pm
HSEB Room 2120

Thursday, September 26, 2013
5:30-8:00PM
Governor’s Residence at the Boettcher Mansion 
(400 East 8th Avenue Denver, CO)

 
Join CBSA and CCIA for the 3rd Annual Oktoberfest at the Governor’s Residence.  Local breweries will showcase their sustainable brews and seasonal flavors for 250 biotech and cleantech professionals.  You will have the opportunity to mix and mingle with professionals in two of Colorado’s fastest growing industries.

$35 Member/ $50 Non-Member
 
 

Headlines


 
House Republican Freshmen Push to Repeal Tax on Medical Devices That Helps Fund Obamacare
The nearly 40-member House Republican freshman class is pressing party leadership to finally allow action on a bill to repeal a 2.3 percent excise tax on medical devices that was enacted to help pay for President Obama's health care plan.


 
AdvaMed Applauds Senate Legislation Exempting FDA User Fees from Sequestration - AdvaMed
WASHINGTON, D.C. –Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement after the introduction in the U.S. Senate of bipartisan legislation (S.1413) exempting FDA user fees from cuts under sequestration:

English: Checking the blood pressure by using ...
US Medical Device Industry In Critical Condition
Medical devices are something of an orphan sister to the glamour of drugs, but they include some of the genuine miracles of modern medicine: pacemakers, artificial joints, replacement heart valves, scanners, and radiotherapy machines. The United States has been the global leader in medical devices, one of the few major industries that both boasts a net trade surplus and is a job-creator. The sector employs 400,000 Americans directly and is indirectly responsible for almost 2 million more that supply and support the highly-skilled workforce.  Most important, its products are essential elements of modern medical care, including everything from CT scanners and pacemakers to blood pressure cuffs and robots used by surgeons.

WASHINGTON, D.C. –Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement today following the introduction in the U.S. House of Representatives of bipartisan legislation that would exempt FDA user fees from cuts under sequestration:


On March 21, 79 U.S. Senators voted to repeal the medical device excise tax.
To keep the issue top-of-mind, would you write a simple "Thank You" to your Senator. Simply click on your representative's name to say thanks and to remind them to include tax repeal in all forthcoming tax reform initiatives.


 
 
GOEDs International Trade and Diplomacy Office Leads Trade Mission
The Governor’s Office of Economic Development sees new opportunity for Utah businesses and entrepreneurs on the other side of the Pacific: this time, in Southeast Asia. Brett Heimburger, the Governor’s Office of Economic Development’s regional director for Asia, is leading a delegation looking to develop business partnerships and find new avenues into the Philippines.
 
Patent Docs: Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test
On Friday, Sen. Patrick Leahy (D-VT) sent a letterto Dr. Francis Collins, the Director of the National Institutes of Health (NIH), "to urge [the Director] to consider using march-in rights under the Bayh-Dole Act to ensure greater access to genetic testing for breast and ovarian cancer."  The Bayh-Dole Act, which was enacted in 1980, created a uniform patent policy among the many federal agencies that fund research, enabling small business and non-profit organizations -- including universities -- to retain title to inventions made under federally funded research programs.  In commemorating the Act's 30th anniversary in 2010, the U.S. Patent and Trademark Office noted that "[t]he legislation is credited with the creation of thousands of new companies and billions of dollars of direct benefits to the U.S. economy" (see "USPTO Recognizes 30th Anniversary of Bayh-Dole Act").

 2 Competitors Sued by Genetics Company for Patent Infringement
Myriad Genetics is suing competitors that have begun to offer genetic testing for breast cancer risk after the Supreme Court’s ruling last month that human genes cannot be patented.
 
 
Mass. Senate kills amendment to evaluate the impact of the medical device excise tax | MassDevice

The Massachusetts Senate votes 25-to-14 to strike down an amendment that would have required state officials to team up with state medical device makers to evaluate the impact of the 2.3% federal excise tax.

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed),released the following statement in response to tax-writing committee Chairmen Camp and Baucus as they begin their nationwide listening tour in favor of a simpler, fairer U.S. tax code:


The tax on medical device makers’ gross receipts helps fund health care reform as Congress seeks elusive alternatives.
Myriad Genetics Sues Ambry to Halt Rival Breast Cancer Test 
Myriad Genetics Inc., a provider of tests for breast cancer risk, filed a lawsuit today to shut a competitor that set up shop last month after a mixed U.S. Supreme Court ruling on patents for genetic material.
Klobuchar, Franken call for repeal of medical device tax to be included in comprehensive tax
Washington, D.C. – U.S. Senators Amy Klobuchar and Al Franken today (Monday, July 8) called for the repeal of the medical device tax to be included in comprehensive tax reform.

 

Article

Events Calendar

Upcoming Events
UKTI Event 
08 Aug 2013
12:00 PM - 2:00 PM (MDT)
The Alta Club, 
100 E South Temple, SLC, UT


FEATURING: 
Dr. Adam Hill, top UK medtech sector expert
Dr. Hill will discuss a range of essential topics, from the NICE technology appraisal process to current funding challenges and opportunities, NHS updates, and the overall state of the UK life sciences sector. 

COMPLIANCE CLINIC: Lean in a GXP Environment

LEAN IN A GXP ENVIRONMENT:The Compatability Quandary

The flexibility & responsiveness of a Lean culture within a rigorously regulated GXP environment

FEATURING: Jeff Hone, Nelson Laboratories

COST:
BioUtah Members: FREE
Non-Members: $35





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