REMINDER: Registration for Utah Life Science Summit 2013 is now open!
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Utah's New, Independent Life Science Association
October 2013 
Note from the President

In the wake of today’s federal government shutdown, U.S. medical device companies remain subject to the Affordable Care Act’s much-maligned 2.3 percent excise tax. This morning, the Senate voted to reject twin House proposals to repeal the device tax.
Despite a 79-20 vote (alas, symbolic) expressing disapproval of the device tax earlier this year, the President and key Senate allies Harry Reid and Max Baucus have vowed to oppose any proposal that would repeal the tax without finding an alternative way to pay for it—disregarding the undeniable reality that the tax’s cost in jobs and innovation will dwarf the revenue it creates for the affordable care act. AdvaMed, MDMA and others anticipate that the tax may kill as many as 250,000 jobs over the next decade.
                Utah’s senior Republican Senator, Orrin Hatch, has partnered with his Democratic colleague, Minnesota’s senior Senator Amy Klobuchar, to author a bill that would repeal this monstrosity. Despite political headwinds, Senators Hatch and Klobuchar have shared with BioUtah leadership that they remain optimistic that the tax can be repealed this year, potentially as part of a future debt-ceiling resolution.
                However this political drama plays out, BioUtah and the state’s life science community will remain engaged in building one of the world’s most vibrant life science centers for innovation in devices, diagnostics, biotech and specialty pharmaceuticals. These efforts, and the state of the sector, will be explored at the 2013 Utah Life Science Summit, presented by BioUtah. We invite all of you to join us at this, the state’s premier life science annual event.
                We will see you at the Summit!
 
All the best,
 
Kimball

Kimball Thomson
President & CEO
BioUtah   
BioUtah Perspective:
A Conversation with Bill Pagels
CEO & Founder, 3 PDx



Bill Pagels
By Kimball Thomson

After a long, productive career developing and launching diagnostic assays at DuPont, J & J, Boston Scientific and a variety of smaller companies, Bill Pagels decided to put his rich experience to work creating a highly innovative diagnostic device. To launch 3PDx, this Utah transplant and Ph.D. biochemist gathered a team of seasoned industry pros, together with his two sons. The company’s flagship product is a small, lightweight and easy-to-use electrochemical detection device that quickly measures a diverse range of analytes, from ions and drugs to genes, cells and proteins. 
         During the course of his career, Dr. Pagels has co-developed and commercialized 18 products and product lines in the areas of infectious disease and cardiovascular diagnostics. Fully a dozen of these products have obtained FDA approval, and two won the R&D 100 Award for best technology of the year. A multifaceted professional with experience in medical diagnostics, product development, regulatory/QA, marketing and business development, he was responsible for a $450 million global vascular product line at Boston Scientific. In the entrepreneurial realm Dr. Pagels has served as CEO of Wasatch Nanopore Sensors, COO of Philotek and CBO of Celux Scientific.
         BioUtah recently had the opportunity to sit down with this rigorous yet amiable scientist and entrepreneur.
 
BioUtah:         What is uniquely valuable about your core product?
Bill Pagels:     The unique value of 3PDx’s iTestmDx™ Platform is that it is an easy-to-use mobile diagnostic (mDx) system that provides and transmits laboratory-quality results in <10 minutes.  iTest’s fast and accurate results speeds time to diagnosis, which improves patient outcomes, reduces healthcare costs and increases patient satisfaction.
           3PDx’s iTest mDx Platform assimilates several powerful technologies that in combination provide the ability to decentralize diagnostic testing traditionally performed by central laboratories in the hospital and/or reference laboratories.  iTest empowers medical professionals with the ability to diagnose patients while they are still with the patient thereby accelerating appropriate treatment.  The smart device (smartphone, tablet computer, etc.) serves as the ‘brains’ driving the diagnostic system and provides the ability to display the results, as well as transmit them real-time to the laboratory information system (LIS) and/or hospital information system (HIS) in a HIPAA-compliant manner.  By incorporating patients’ individual test results immediately into their personal health records maximizes the effectiveness of medical treatments and wellness.
 
BioUtah:         What problem were/are you working to solve?
Pagels:            3PDx’s focus is on a $40B problem in the US: diagnosing MRSA (methicillin resistance Staphylococcus aureus), a common hospital acquired infection not effectively controlled with existing technology.  35.8M people annually present in hospitals in the US.  2M of them acquire an infection upon presenting and 100,000 of these people die because the antibiotics used to treat these infections are becoming increasingly less effective due to natural bacterial resistance and over-prescription.  Currently, the typical turnaround time (TAT) when diagnosing MRSA in a patient is approximately 5 hours if the patient and the lab performing the testing are within the same hospital; however, if the specimen needs to be sent out to a different  laboratory, results may not be available for days. 
            This long TAT to results delays diagnosis and appropriate treatment.  In contrast, 3PDx’s first diagnostic test is for screening MRSA provides test results in minutes.  Empowering medical staff to screen patients for MRSA and get real-time results provides benefits that translate into lowering costs by isolating the appropriate patients, which improves bed and patient management, as well as improves patient safety and satisfaction.  In addition, it eliminates time, effort and resources to prep specimens for the lab.
MRSA screening is the first of many tests that 3PDx will develop for in vitro diagnostics. 
 
BioUtah:         What validating responses have you received from investors, potential strategic partners, customers and/or other key stakeholders?
Pagels:           Like many young companies, we have probed for interest in our platform technology for multiple applications, Including in vitro diagnostics, as mentioned, military diagnostics and companion diagnostics (testing drug levels for patients undergoing therapeutic intervention).  Just last week, we met with a consortium of successful manufacturers/distributors of in vitro diagnostic equipment in Europe  who will bring our iTest mDx Platform for screening MRSA through clinical evaluations, regulatory filings and then to hospitals that they have been selling to for decades in 25 countries.  They have clearly stated that iTest is the future of diagnostics and they are presently considering investing in 3PDx to support commercialization of our technology. 
             Physicians are looking for diagnostic kits that will improve upon the effectiveness of flu testing which are notoriously poor in sensitivity.  A Flu-iTest has been in very high demand from the large group of medical professionals who 3PDx has contacted in performing market research leading to our MRSA test.  One leading infectious disease physician confirmed this by saying current antiviral therapies for influenza have modest efficacy overall and are recommended to be used within 48 hours of the onset of symptoms, making rapid and accurate diagnosis of paramount importance.  Current diagnostics for influenza are time consuming, costly and have less than ideal performance characteristics.  iTest could address these problems. 
            We have contacted three of the top 10, largest pharmaceutical corporations and they have immediately responded favorably to iTest for companion diagnostics (CDx).  One corporation with a leading oncology drug stated that a mobile companion diagnostic (which 3PDx has branded as mCDx™) can help keep patients in a narrow range of maximum therapeutic effectiveness. Another corporation said that iTest could help enroll patients in clinical trials more quickly thereby reduce the cost of performing these clinical trials. This is a market that is exploding in collaboration between diagnostic and pharmaceutical corporations.  The worldwide market size for CDx is $2.3B in 2013 but will be $3.45B in 2015 and over $19B by 2023 according to a recent research firm.  
               Over the past few months, we have met frequently with representatives from the Department of Defense (DoD) regarding the use of iTest for a number of applications.  They are highly interested in a robust diagnostic platform that is easy to use, provides fast and accurate results and automatically transmits geotagged data by untrained soldiers and first responders in emergency situations.  Unlike current diagnostic technologies, the iTest Platform is a small, lightweight, battery operated mobile device with consumables that are thermally stable in harsh environments plus the assay development time is rapid, which is crucial for detection of emerging pathogens. 
              The iTest’s unique ability, to transmit test results from the test site to remote locations lends itself to a number of applications, including use in the BioWatch Program.  The BioWatch Program is a $1B program to protect US citizens from biological and chemical agent exposure, currently used in 34 US cities over the past ten years.  In the next 10 years, BioWatch will expand to well over 100 cities with a budget of $5.8B.  The challenge with the current technology is that it takes 12-36 hours to get the test results from samples collected.  The Department of Defense estimates that in this time period, the death rate of those exposed to the biothreat agent will be 45-58%.  The only satisfactory solution to this unacceptably long delay is a faster test like iTest.  A representative from the Pentagon has stated that iTest “touches a number of high priority bells and whistles that the Administration talks about all the time.”  [Kimball, see the other attachment for additional quotes from Tom Phillips].  Representatives from Utah’s Dugway Proving Grounds are actively seeking funding to support 3PDx’s work on developing these testing capabilities. 
 
BioUtah:         What accomplishments are you happiest about so far?  What are you most excited about now and in the near future?
Pagels:            I am most delighted to have assembled and assimilated a first class team that is combined of highly experienced, accomplished professionals and very talented student engineers all of whom are dedicated to pushing 3PDx to success with a collective energy that is rarely seen.  We have the privilege of attracting world-class scientists and professionals with 30 years of distinguished medical device experience, who are working on a consulting or part-time basis at 3PDx. 
               What I’m most excited about now is that we have a clear path to completing many components necessary for clinical evaluations in the spring of 2014. 
               For the near future, we are using our technology and with the brilliant ideas of our technical team, we have designed a HIV diagnostic that for the first time since the beginning in the epidemic in the early ‘80s, a ‘complete’ HIV-1 and HIV-2 diagnosis can be made at the point of care.  When developed, this HIV-iTest has the potential of saving US healthcare tens of billions of dollars for US healthcare. 
              We will begin work on mCDx (mobile companion diagnostics) next year that has the ability to maintain patients in a narrow therapeutic range.  This will enable pharmaceutical companies the ability to bring more effective drugs to market quickly.
 
BioUtah:         Who do you anticipate will be your early adopters, and how will they use your product?
Pagels:            Our primary focus is on in vitro diagnostics for healthcare providers.  Medical professionals in hospitals use the iTest mDx Platform to screen patients for MRSA so that they can quickly diagnosis colonized patients.  For example, MRSA screening is now required for everyone entering a hospital in the UK and nine states in the US.  It is only by using a rapid MRSA screening test that colonized patients can be identified, isolated and treated.
                Pharmaceutical companies will use iTest for retaining the strongest drug candidates longer within the drug development process than previously ascertained.  Although this runs counter to the current thinking in drug development because drug companies are usually trying to whittle down the many possible candidates to a choice few, the outcome of this process often is a group of safer but less effective drugs.  We expect pharmacos to be early adopters because they realize that some of their best candidates are more efficacious than those that would normally be retained within the pipeline…as long as these more effective drugs have an accompanying companion diagnostic.  Therefore, 3PDx will propose to these drug companies that they reconsider some of these formerly disregarded, powerful candidate drugs for continued development.  This represents a ‘research application’ of 3PDx’s technology (in developing a companion diagnostic).  No regulatory approval is required for research applications.  Pharmacos could be, therefore, early adopters. 
 
BioUtah:         What do you need to happen in order to get the mainstream market adoption you are seeking?
Pagels:           We need three primary things:
1.      Complete product development of iTest mDx Platform for screening MRSA. 
2.      Complete product design for the iTest mDx Platform as defined by healthcare providers. 
3.      Continue market development in Europe and then in the US through traditional and digital marketing tools and strategies. Connect with KOLs (Key Opinion Leaders) to perform evaluations of our product(s) versus existing standard assays followed by these KOLs presenting their findings at scientific conference and in the printed scientific literature. 
 
BioUtah:         What do you anticipate as a potential meaningful exit for you? (Acquisition, IPO, building a major company…)
Pagels:            3PDx anticipates that there will be multiple exit opportunities such as selling off/licensing developed assays to larger companies that have interests in specific applications.  For example, when 3PDx has developed a mCDx assay, a specific pharmaceutical company will be the only company interested in purchasing this assay and may be required to do so for regulatory filings to the FDA.  This pharmaco may be interested in full commercial rights and ownership of the developed assay.  A major multi-national healthcare corporation has stated that if 3PDx developed a specific test for heart attacks, they would purchase the test.  The military diagnostics application of iTest is also another exit opportunity.  3PDx’s intentions are to focus on clinical diagnostics as applied to increasingly decentralized market segments eventually leading to consumer testing. 
               3PDx expects that such licenses and exits will be conducted in parallel to building a significant company in the rapidly growing digital/medical diagnostics space.
 
BioUtah:         What brought you to Utah? What keeps you here? What do you hope for the state’s life science community? 
Pagels:            Attraction to Utah.  I was recruited by a smart attorney leading a small diagnostics company that had spun out world class technology from the University of Utah to perform, like iTest, testing in many diagnostic segments.  The company had attracted very talented technical people who had developed the system to performance levels better than a San Diego-based company that was eventually purchased for $1.7 billion in 2007. 
            What retains me in Utah. Quality of living is highly attractive to us.  My family calls this ‘home.’  We have dear friends here; our kids have significant others who live here.  The University of Utah is a great school in areas in which our kids have career interests. 
            Hopes for Utah’s life science community. At the very core of most of us, we would say, ‘At least s/he has their health.’  This is a fundamental truth.  I can see nothing more important to dedicate one’s career’s work to than addressing needs to maximizing the well-being of humans everywhere.  The beginning of creating a better life for individuals is diagnosing one’s state of wellness/sickness.  I can only hope that Utah’s life science community continues to embrace the importance of diagnostics as well as pharmaceutical sciences as well as medical devices so that Utah’s stake in this neverending mission of improving the quality of human life remains as vital to us as inividuals as it is for the State’s economy. 
            I hope that under its new leadership, BioUtah will flourish by incorporating continually more of the life science companies in Utah into its membership.  I hope that BioUtah will lead the charge in developing Utah into a nationally recognized hub of life science expertise and innovations.  Sure, we have have had some notable successes.  However, Utah has a long way to go to compete with the likes of Boston, Minnesota, San Diego and San Francisco.  I would love to know that Utah was destined to be a fifth area competing with these other areas.  When we have reached this lofty level, I think there will be a critical mass and infrastructure that will produce many great advances to benefit the quality of our human existence!
 
 
 


BIOUTAH WILL HONOR THREE INDIVIDUALS THIS YEAR AT OUR ANNUAL SUMMIT:
Click Here to Nominate Before October 4th Deadline!

The Willem J. Kolff Lifetime Achievement Award

This award honors "Extraordinary Vision, Creativity, Rigor and Service to Humanity."  Past winners include: Stephen Jacobsen, Mario Capecchi, and the late Homer Warner. 


The BioUtah Institute Distinguished Service Award

This award honors outstanding contribution at any level of their respective organizations, from individual contributor to management, for integrity and commitment to excellence. 


The Outstanding Contributor in Public Policy - New this year!

This award honors individuals who have worked to improve the legislative and regulatory environment for Utah's life science sector.

 
Headlines
Cardiac Biomarker ST2 Proves Far Superior To Galectin-3 In A Head-to-Head Study

FDA’s “Mobile Medical Apps” Guidance: What’s in? What’s out? 

Pharma & Biotech News for September 2013 

BIO Announces National Science Foundation Track Featuring 10 Emerging Biotech Companies at 12th Annual BIO Investor Forum


New medical device extremely effective at preventing HIV in women

Amy Klobuchar, Orrin Hatch warn against repealing medical device tax now


Why the domestic medical device industry’s growth is slowing


Three big mistakes medical device companies make when pitching VCs


Medical-Device Makers See EU Rules Slowing U.S. Approvals


New Grant Helps Utah Businesses Grow

HEALTH-MONITORING APPS TO BE REGULATED BY FDA

U.S. needs to let kids fail for success


Why Product Life Cycle Is Critical in Medical Device Design Control

FDAnews Announces: FDA Recordkeeping, Dangerous Documents and Writing for Compliance(TM) 

FDA finally makes final UDI rule: 7 changes medical device manufacturers + physicians should know

FDA posts final guidance on electronic source data

Hoopes Vision Surgeon First in Utah to Implant New Light Adjustable Artificial Lens
 
Intermountain Ranks #7 Among Nation's Innovators in Technology
Events Calendar
When: 02 Oct 2013
7:30 AM - 5:00 PM (PDT)
Location: HILTON HOTEL
777 Convention Way Anaheim, CA 92802
 

 
When: 04 Oct 2013
5:30 PM - 7:30 PM
Location: John A. Moran Eye Center
65 Mario Capecchi Drive Atrium Salt Lake City, UT 84132
 
Utah's New Frontiers: The Future of Vision

Join business and community leaders, philanthropists, private and institutional investors interested in learning how Utah is doing things that could shape the global landscape of science, blindness and medicine.

 
When: 09 Oct 2013
3:30 PM - 5:00 PM
Location: Snowbird Cliff Lodge
Little Cottonwood Canyon, UT
 
Afraid of Global Regulations? Don't Be!
 
Enjoy a BioUtah and MasterControl joint offering during MasterControl's 2013 Summit at Snowbird.

A presentation by Peter Knauer - Senior Project Consultant, MasterControl, Inc.

This session will take a look at the similarities and contrasts between U.S. and international regulatory agencies (specifically, the FDA and EMEA) and explore some of the required pathways for medical device and biopharma products. Key takeaways include:

- comparison of FDA and EMEA regulations
- contrast of FDA and EMEA regulations
- understanding of GHTF/ICH, 21 CFR 820, ISO 13485, and ISO 14971
- understanding of the role of ISO guidances
- understanding of the FDA’s latest thinking on ISO/ICH
 
 
 
When: 06 Nov 2013
8:00 AM - 5:30 PM
Location: Grand America Hotel
 
Open for Registration!
 
Our annual BioUtah Summit Conference will be held on November 6th at the Grand America Hotel in Salt Lake City, UT.
 
See http://www.bioutah.org/2013-summit/ for agenda, speakers and more information.
 

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