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October 2015 Newsletter

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October 2015

Note from BioUtah President & CEO,
Kelly Slone


Dear Members,

The stage and agenda are set…now all we need is you there!  We hope to see you on November 5th at the Utah Life Science Summit.  We have worked diligently to put together a stellar group of speakers that will be highlighting some of the hottest topics impacting the life science industry. 

BioUtah’s Summit will also provide unparalleled networking opportunities, featuring presentations from top industry, government and education leaders. There will be two plenary sessions over breakfast and lunch and three sessions of multiple topics that fit the interests for all our members through the day. We will have service provider booths as well as innovation exhibits showcasing Utah’s most promising innovation. Some additional highlights include:

Andrew Croshaw, President, Leavitt Partners, will be the breakfast keynote and will focus on navigating the new healthcare economy and the challenging times of transitioning from a fee-for-service model to value-based health care delivery models.
 
We are honored to have Governor Gary Herbert as our lunch keynote.  He will also present BioUtah’s Annual Life science awards and STEM Action Center scholarships.
 
Jeff Shuren, Director for the Center for Devices and Radiological Health (CDHA)will participate via video conference, highlighting FDA’s priorities for next year’s FDA user fee reauthorization and will answer questions from the participants. 
 
Latonya Mitchell, Regional Director, HHS/FDA and Ginger Sykes, SCSO, HHS/FDA will participate in a roundtable discussion and provide an FDA update on FDA’s regional efforts and priorities and initiatives.
 
Vivan Lee, M.D., Ph.D, Dean of University of Utah School of Medicine and CEO, University of Utah Health Care, will highlight University of Utah’s leadership and development of heathcare outcomes.  
 
There will also be several participatory sessions that include learning about the hottest promising research and innovations coming out of Utah’s universities, discussing key public policies impacting the industry, providing a dialogue on global market trends and key regulations challenging the industry.  There will also be an investor/CEO and entrepreneur mentoring session.  Please see the full agenda, speakers and participants on our website at http://utahlifesciencesummit.com/program/. Look forward to seeing you all there!!!!
 
Two additional events important to our members are coming up as well.  On October 14th, the Governor’s Office of Economic Development (GOED) and BioUtah are hosting a life science luncheon roundtable discussion for Governor Herbert and several life sciences community leaders to discuss key issues important to the life science industry.  Also, on October 20th, BioUtah has scheduled a life science education breakfast briefing on Capitol Hill.  The focus of the briefing is to educate key legislators, government and business community leaders on the important role the life science industry plays in Utah’s economy, the leadership role Utah’s life science industry plays in medical innovation and the key policy issues that are important for the future growth of the industry.  BioUtah will also release the “State of the Industry Life Sciences Report” at this event.   
 
We are excited to have such an active role supporting your organizations and the life science community and welcome your feedback to better serve you. 
 




Kelly Slone
President & CEO
BioUtah

 

Utah Life Science Summit 2015 Agenda and Registration Links
Register Here



For a limited time BioUtah is extending a free enhanced directory listing upgrade to all current members and any companies that join before October 30th, 2015!

Make the most of your BioUtah membership with an enhanced directory listing. This upgrade provides the ability to customize your member page and stand out in the directory.It allows direct links to your website,the addition of graphics and video as well as other useful features (see chart below).

To activate your enhanced directory listing, click this link - susannah@bioutah.org


This offer, valued at $250, ends on October 30th. Act today!



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TCIP Application Process Suspended
GOED opened the current TCIP solicitation round on August 3rd of 2015. As the solicitation round was preparing to close on September 1st it was brought to our attention that there may have been some issues with the technology that was used to accept applications. Over the past few weeks our office realized the significance of this problem and realized that there were many applicants that were potentially excluded from applying. After review with our legal counsel we have determined that the only fair and equitable way to proceed forward will be to suspend the current grant solicitation and reopen that solicitation at a later date.


While the date of the reopening of the 2016 solicitation is not yet known, please know that we have and will be working tirelessly to reopen the application with the necessary changes as soon as possible. Let us also assure you that if you have already submitted your application the application for the new solicitation will look extremely similar to the application you already submitted and any changes made will not disqualify you from resubmitting your application. Please know that any changes will only strengthen the program and create a more competitive, fair, and equitable opportunity for entrepreneurs in all industries and in all stages of the commercialization lifecycle while fulfilling our mission of job creation and economic development in the state of Utah.


Once we have set dates for the reopening of the solicitation you will be personally notified by email of the reopening. Any and all additional information or communication regarding the suspended or reissued solicitation will be sent via email in a timely manner.  We apologize for any inconvenience this may have caused you and ask for your patience as we continue to work to reopen the solicitation. 
 
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CALL TO ACTION
The Governor and Utah State Legislature have unveiled the latest medicaid expansion plan known as UtahAccess +.  The plan includes expansion of medicaid up to 138% of poverty as envisioned in the Governor’s original Healthy Utah plan but UtahAccess + pays for the State match with an assessment on provider groups.  These provider groups include hospitals and doctors as well as a gross receipts tax on durable medical equipment, medical suppliers and drug manufacturers.  Although a bill has not yet been released with the more specific details, they have presented an outline of the plan and financial assessment (You can see those details here).
 
The legislative Health Reform Task Force will meet on Tuesday, October 6th at 3:00 pm in Room 30 of the Utah House Building to further discuss the plan and take public comment.  You can attend in person or listen to the task force online here.  BioUtah is coordinating closely with those companies that are affected and plan to testify at the hearing.  It is important that we show the negative consequences that this plan could have on our emerging life science industry.  We welcome any additional comments or thoughts that you might have as well as your participation at this hearing to help the life science industry be heard.

Medicaid Funding PDF 
Medicaid Overview PDF 
​Medicaid Waiver PDF 

Post-Caucus Media Q&A Session via YouTube




PUBLIC POLICY  NOTICE

 
Recently, CMS released a Preliminary Payment Determination recommending that many innovative laboratory tests be repriced resulting in payment cuts of 30 to 90%. See link to the chart details the companies, lab tests, and proposed payment cuts. This payment recommendation is counter to the CMS expert Advisory Panel recommendation in August and most all the stakeholder recommendations. 
 
Additionally, there are significant concerns with the PAMA Proposed Rule and 2015 "Gapfill Final Determinations" which were also released last week. The PAMA Proposed Rule provides a very narrow definition of an Advanced Diagnostic Laboratory Test (ADLT) which would make it nearly impossible for any new tests to meet this standard. These decisions also negatively impact any of the Next Gene Sequencing oncology tests.
 
BioUtah will working with other stakeholder groups, including The Coalition for 21st Century Medicine who released the following press release, and will consider submitting comments on these proposed cuts which will need to be submit by the end of October.  Please let us know if you would be interested in helping us shape our comments.  


 
 
 

For Immediate Release
September 27, 2015
 
Contact:
Jasmine Nazarett
Communications
202-879-5594
Jasmine.Nazarett@deweysquare.com
 
Coalition for 21st Century Medicine united in opposition to the Centers for Medicare & Medicaid Services’ 2016 Preliminary Determination
Stakeholders are concerned about potential negative impact on precision medicine 
 
Coalition’s message is loud and clear: innovation that improves patients’ outcomes is the way forward
 
Washington, D.C. –  On Friday, September 25, 2015, the Centers for Medicare & Medicaid Services (CMS), which administers the Medicare program, released the Preliminary Determinations for the Calendar Year 2016 Clinical Laboratory Fee Schedule (CY2016 CLFS) for new test codes, including new codes for several well-established, Medicare covered advanced diagnostic laboratory tests (ADLTs) developed and performed by members of the Coalition for 21st Century Medicine (C21). In the CY2016 Preliminary Determinations, CMS recommended payment rates that, if finalized, would represent drastic reductions in payment rates of C21 company tests of up to 91-percent. These CMS proposed rates are contrary to the agency’s policies and precedent.
 
The CMS proposed rates depart from CMS’s own precedent over the past several years to delegate ratesetting for these complex tests to the local Medicare Administrative Contractors (MACs).  The MACs have established rates for these tests through careful consideration of a number of factors, including market rates and resources.  CMS can and should adopt the MAC-established rates for these tests.  The MAC-established rates are consistent with the market-based ratesetting policies and procedures enacted by Congress under the Protecting Access to Medicare Act (PAMA), which are scheduled to go into effect in 2017.
 
The CMS proposed rates are not consistent with CMS’s own policies about ratesetting for new tests and are inconsistent with recommendations from nearly all stakeholders as well as CMS’s recently established Advisory Panel on Clinical Diagnostic Laboratory Tests. 
 
CMS is seeking comments on the CY2016 CLFS Preliminary Determinations—these are not final rates. C21 is confident that we shall convince CMS to adopt the previously established MAC rates when the Final Determinations are published later this year. C21 will be responding to the proposed rates in writing and by meeting with CMS staff and other administration officials.
At a time when the White House is pressing forward with initiatives to advance precision medicine, it is surprising and troubling that CMS would propose drastic cuts to payment rates for some of the leading edge precision medicine tests. 
 
Allowing the proposed rates to stand would seriously risk continued innovation in precision medicine, and will have a negative impact on patient management.

 
For the lastest news and information about all the life science sectors go to BioUtah's Newsroom
 

Utah Life Science News

Greg Bell: Fixing health care the 'Utah way'

We have a young, highly educated workforce, a low cost of living and business-friendly policies. Those are just a few of the qualities that make Utah such an attractive place to expand or relocate a business. But there’s another important attribute that’s garnering more and more attention: high-quality, low-cost health care
Intermountain Healthcare Opens Advanced Hospital-Based Simulation Center

SALT LAKE CITY, Utah — Intermountain Healthcare has joined the ranks of other premiere institutions like Duke University and Johns Hopkins by opening a new state-of-the-art simulation center to annually train hundreds of current and future doctors, nurses and healthcare technicians.
Intermountain Precision Genomics lab new in St. George

DNA is the blueprint of life. DNA stores biological information and heredity material in genes and chromosomes — genomes. DNA is used to solve crimes, discover paternity, and find missing branches in family trees.
Tolero Pharmaceuticals Announces Mechanistic Data Describing the Activity of Alvocidib within a Time-sequential Regimen at Two Hematology Conferences
SALT LAKE CITY--(BUSINESS WIRE)--Tolero Pharmaceuticals, Inc., a late-stage pharmaceutical company developing treatments for serious hematological diseases, today announced that data for its lead clinical candidate, alvocidib, was presented at the Society of Hematologic Oncology (SOHO) 2015 Annual Meeting and the 2015 American Society of Hematology (ASH) Meeting on Hematology Malignancies. The presentations describe the nonclinical data supporting the mechanistic rationale for combining alvocidib in a time-sequential regimen with cytarabine and mitoxantrone (FLAM) in the setting of acute myeloid leukemia (AML). The results from these studies demonstrate that alvocidib, as a CDK9 inhibitor, exerts its activity through a cell cycle-independent mechanism. Alvocidib inhibits super enhancer-regulated transcription of MCL-1 that places AML cells in a heightened state of sensitivity to apoptosis-inducing agents, such as cytarabine and mitoxantrone. These findings are supported by the validated clinical activity of the FLAM regimen in multiple Phase I and Phase II clinical trials. These data are also consistent with the finding that the MCL-1-dependent biomarker of high NOXA sensitivity predicts for response to FLAM in AML patients. NOXA is a protein antagonist of MCL-1 and sensitivity of cells to NOXA is a direct functional measurement of MCL-1 dependency.
 
National Life Science News
Lobbying at White House to delay meaningful use stage 3
OMB, HEALTH GROUPS HUDDLE AT WHITE HOUSE: A group of health care lobbyists are meeting with Office Management and Budget officials today to urge the government to hit the pause button on Stage 3 meaningful use rules, a source tells eHealth's David Pittman. The meeting was organized by Senate Finance Committee Chair Orrin Hatch at the urging of officials from Intermountain Healthcare, the mammoth hospital system residing in Hatch’s home state, Utah. Doctors and hospitals have been pleading with HHS to hold off on finalizing Stage 3 rules, fearing their publication will ossify the program at a time when 90% of eligible providers haven’t attested to Stage 2. The Stage 3 rule went to OMB for clearance a few weeks ago, so queries now must be addressed to the White House.

Congress is in on the act too: At least 30 members have signed a letter imploring HHS and OMB to freeze the Stage 3 rule, and an insider says another 30 are expected to add their names by today, when the letter, which is being circulated by Reps. Renee Ellmers, Tom Price and David Scott, goes to the administration.
Medtronic’s Ireland Move Results in Lower Taxes
Medical-device company transfers $9.8 billion to U.S. at 5% tax rate

In a sign of how Medtronic PLC is benefiting from moving its headquarters to Ireland from the U.S., the medical-device company said it is paying $500 million in U.S. income tax on $9.8 billion of cash and investments that it has transferred to the U.S. from its overseas subsidiaries.
Medical device lobbyist tapped to lead PhRMA
A medical device lobbyist is expected to take over as head of the pharmaceutical industry’s largest trade group, according to a source.

Steve Ubl, president and CEO of AdvaMed, will “more than likely” take over as president and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA), the source said.
High-Cost Generic Drugs — Implications for Patients and Policymakers
It is well known that new brand-name drugs are often expensive, but U.S. health care is also witnessing a lesser-known but growing and seemingly paradoxical phenomenon: certain older drugs, many of which are generic and not protected by patents or market exclusivity, are now also extremely expensive. Take the case of albendazole, a broad-spectrum antiparasitic medication. Albendazole was first marketed by a corporate predecessor to GlaxoSmithKline (GSK) outside the United States in 1982 and was approved by the Food and Drug Administration (FDA) in 1996. Its patents have long since expired, but no manufacturer ever sought FDA approval for a generic version. One reason may be that the primary indications for the drug — intestinal parasites, neurocysticercosis, and hydatid disease — occur relatively rarely in the United States and usually only in disadvantaged populations such as immigrants and refugees. In late 2010, the listed average wholesale price (AWP) for albendazole was $5.92 per typical daily dose in the United States and less than $1 per typical daily dose overseas.
 
                     Bulletin Board

Intellectual Property Breakfast Seminar: Patents & Trade Secrets

Where: Miller Campus 

           9750 South 300 West

           Sandy, UT 84070

Day/Date: Tuesday, October 13, 2015

Time: 7:30AM - 9:30AM

Building: Miller Professional Development Center Room: 209/213

Cost: FREE; Breakfast Provided

Join us to hear from patent expert, Erik Ericksen, from Thorpe, North and Western.

 

Learn how to protect your inventions and know-how. This IP Seminar covers both Patents and Trade Secrets. After attending this seminar, you will know when to get a patent. You will also know when to forego a patent and protect your business through trade secrets. 

REGISTER HERE
Translating Cancer Epidemiology: From Cells To Clinic And Population
conference


We are pleased to announce our new partnership with the Life Science industry’s most well-regarded and prestigious professional development practitioners –
Life Collaborative: Building Healthy Careers in Life Sciences.

Life Collaborative offers a suite of eLearning resources to help prepare you for a career, or advance the one you’ve already got, in the Life Science industry. The Life Collaborative curriculum was created and validated by real-world industry practitioners and, to that end, is backed by a Certificate of Achievement. Life Collaborative topics include - BioTech, MedTech, Pharmaceuticals, Project Management, Quality, Regulatory, Sales & Marketing, Finance, Team Leadership, and more.

Members Receive as much as a 45% Discount

To get started in your e-learning program, please select from one of the options below:

Professional programs are designed for individuals who are currently employed full time in a Life Science organization and are not seeking employment.

Student / Job Seeker programs are designed for individuals who are interested in transitioning into a Life Science company.

Note that the Life Collaborative has partnered with the MedTech and BioTech Veterans Program (MVPvets.org) to provide scholarships to transitioning veterans. If you, or your company, are interested in learning more about MVPvets, email Info@MVPvets.org.

 

If you have questions about which program to select, or would like to learn about the Life Collaborative corporate licensing program, or custom learning management options, please email info@lifecollaborative.com or call 760-444-9460.

 

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