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2018 Bioscience & Innovation Day Recap

Posted By BioKansas, Thursday, February 8, 2018

Last week, BioKansas and the Enterprise Center of Johnson County led a sizable delegation to Topeka for Bioscience & Innovation Day at the Capitol.  The day featured small group meetings with legislators throughout the morning, a legislator lunch featuring talks from the ECJC, JCB Laboratories and KCAS Bioanalytical & Biomarker Services, and a short debrief session where attendees discussed takeaways and action items. 

BioKansas would like to thank Shahira Stafford and Ron Seeber of the Kansas Agribusiness Retailer's Association for their help in coordinating the day's schedule, as well as Merck Animal Health and the ECJC, who helped to sponsor the Welcom Breakfast and Legislator Lunch, respectively.  We also must acknowledge Melissa Roberts of the ECJC, who was key to the success in organizing and marketing the event.  With her help, we were able to assemble an impressively large (more than 50 strong!) and diverse delegation who collectively educated legislators on the need for resources and continued support for innovators and innovative tech and life science companies in the state.  Melissa has written up a great summary of the messaging we heard that day, which is included below. 

Going forward, BioKansas will continue to engage with the legislature throughout the remainder of the session, and we will be in contact with our membership for additional follow up opportunities and/or when the need arises.  If you are interested in joining the BioKansas Public Policy Committee, please let us know.  The committee is integral in helping guide the organization’s positions on legislation and policy, and meets once a month while the legislature is in session. 


Melissa Roberts
Vice President, Strategy & Economic Development
Enterprise Center in Johnson County

This was the first time that we’ve collaborated with BioKansas on an event like this—it was a resounding success and collaboration strengthened both our messages. I’ve attached the leave-behind we used so that you can see what issues we promoted. We had almost 50 innovators in Topeka yesterday, meeting and greeting members of the legislature and speaking to a group over the lunch hour. In the morning, we were joined by Majority Leader Don Hineman, who shared his thoughts with us. Then, we broke out into small groups and met with 38 members of the legislature.

Here are some of the messages that came across loud and clear:                             

  1. The focus of the legislature right now is on the K-12 funding formula, which has large-scale implications on the state budget for years to come. There’s very little ability to talk about additional appropriations or workforce development issues until the next budget cycle, which will be the 2019 session (for FY20).
  2. There is a broad sense of optimism that the state is nearing the end of our financial crisis and that the legislature will be able to “get back to governing” again towards the end of the session. Many in leadership agreed that this is a great time to begin the conversation about what future appropriations to support this community could look like, and expressed an interest in being involved in that process.
  3. We were able to identify some legislative advocates who will be part of future efforts to include innovation and entrepreneurship funding priorities in the FY20 budget, many of whom have expressed interest in participating in an Innovation Caucus. We are working to organize a future meeting now, and I’ll keep you in the loop as that effort progresses.
  4. All legislators who were in office two years ago immediately recognized Angel Tax Credits as the policy that they had last heard from this community about. They were all quick to bring that up, which is a great indicator that our messaging has made an impact in the past.
  5. All legislators we talked to recognized that Commerce is desperately underfunded, and that resource crunch is impacting incentives like the Angel Investment Tax Credit. We will continue to stay in close contact with Commerce to understand how we can best help  them communicate changes in the implementation of this credit to entrepreneurs and investors.

Please feel free to get in touch with any questions, thoughts or suggestions for next year!

 Attached Files:

Tags:  Advocacy  Education  Entrepreneurship  Workforce Development 

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The Importance of the Graduate Student Tax Waiver

Posted By Dennis Ridenour, President & CEO, Wednesday, December 13, 2017

By now, you're likely aware of the tax bill that is wending its way through Congress.  One change our members have identified that could have a major impact on both educational access and workforce/talent development is the elimination of the graduate student tax waiver.  Please see below to read our recent outreach to Kansas legislators, asking them to keep this crucial provision in any tax legislation that moves forward.  

Dear Kansas Representative/Senator:
As a representative of the life science and healthcare industries in the state of Kansas, and on behalf of the nearly 27,000 students who attend graduate school in the state of Kansas, I’m writing to ask that Congress not consider graduate student tuition waivers as taxable income.  As you know, in addition to a small stipend to help cover living expenses, graduate students in STEM fields (science, tech, engineering and math) often have their tuition waived in exchange for having the student teach, or perform research for the school.  Currently, this waived tuition is not taxed as income.  However, a provision in the recently approved House bill would change that, adding the amount of waived tuition to the student's taxable income.  If passed, this will have a profound impact on the ability of students to earn advanced degrees, and, subsequently, the talent pipeline that feeds into the industries these students hope to work in.  
As an M.S. degree holder, I can speak firsthand to the benefit this tuition waiver provides for graduate students, who already exist on a relatively meager stipend and who shouldn’t have to worry about finding enough money to cover taxes on money that they won’t actually see.  If this waiver is eliminated, we could see a drastic decrease in the number of students who are able to afford graduate school at Kansas institutions such as the University of Kansas, Wichita State, Kansas State, Emporia State, Pitt State, Fort Hays State and the University of Kansas Medical Center.  This could cause a profound decrease in the qualified talent available to the life science, healthcare and biotech industries across the country and in Kansas.  
During the reconciliation process, please ask your House/Senate colleagues who are Conferees to remove this clause of the tax bill, and continue to support education, and access to it, for students in Kansas and across the country.  Please do not hesitate to reach out if BioKansas can help provide more information or connections to students who would be directly impacted.  
Thank you for your time, and I hope we can count on your support.

Dennis Ridenour
President & CEO, BioKansas


Tags:  Advocacy  Education  Workforce Development 

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A Story of David and Goliath, Bio Sciences-style

Posted By Nancy Zurbuchen, Thursday, September 28, 2017
Updated: Thursday, September 28, 2017

At one time or another, most startup founders face frustration and road blocks, seemingly coming at them from all sides.  An unsupportive family member, being turned down for investment or a loan, unable to find qualified employees.  This is normal stuff, and entrepreneurs get creative at finding other ways to make it work.

However, sometimes entrepreneurial progress is stopped cold by federal government regulation, and this is especially true for the highly regulated bioscience sector. What’s a small bio start-up to do against a big bureaucracy? Complain to anyone who will listen? Call your Senator? Hire an attorney, for heaven’s sake? What you should absolutely do is contact the Office of Advocacy -- and that’s me, your new Region 7 Small Business Advocate.

Our sole purpose is to look out for the interests of startup companies, entrepreneurs, and small business. The Office of Advocacy employs a group of really sharp, engaged attorneys who are specialists in all of the regulatory areas, such as intellectual property, employment issues, OSHA regulations, food and drug, safety, international commerce, etc. They work directly with legislators and government agency employees who are writing new laws / rules / regulations, to help ensure that its effect on small business is taken into consideration to avoid unintended consequences. Advocacy also works to change existing regulations that are over burdensome to small business.

Think of the Office of Advocacy as a resource; we also have decades of small business research data that might be helpful to your bio start-up.

-Nancy Zurbuchen, Small Business Advocate, Region 7 (MO, KS, IA, NE)
Small Business Administration (SBA) // Office of Advocacy
(314) 539-6615

Nancy and the regional SBA Office of Advocacy recently hosted a regulatory roundtable in Overland Park to help identify specific regulatory barriers to small business growth.  She'll be featured in Kansas City again on October 10th, when she will participate as a panelist at our Women in Science & Entrepreneurship event.  Click here for more information and to register.

Tags:  Advocacy  Connect  Education  Entrepreneurship 

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Senate Passage of FDA User Fee Package Important Victory for Patients, Medical Innovation

Posted By Biotechnology Innovation Organization, Thursday, August 3, 2017

Washington, DC (August 3, 2017) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement regarding passage of the Food and Drug Administration Reauthorization Act (FDARA) by the U.S. Senate today:

“The user fee program reauthorization package passed by the Senate today is an important victory for patients and for the next generation of medical innovation. This legislation will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. It also ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development.

“The reauthorization of the biosimilars user fee program, including steps to improve communication between the FDA and Sponsors throughout application review, will create a more robust and competitive marketplace for biosimilar therapies, following an appropriate period of exclusivity for innovator biologic products.”

“The legislation also contains a number of provisions that will accelerate and incentivize the entry of generic medicines to the market, which will help to contain costs through increased competition while improving consumer choice. These provisions are consistent with proposals endorsed by BIO to drive smarter spending within our healthcare system without harming incentives for innovation.

“We commend the leadership of Senate HELP Committee Chairman Lamar Alexander and Ranking Member Patty Murray for their tireless bipartisan efforts in advancing this important legislation, as well as that of their counterparts on the House Energy and Commerce Committee, Chairman Greg Walden and Ranking Member Frank Pallone.

“We look forward to working with the FDA and other stakeholders to ensure that the important patient-centric advances contained in this legislation are most effectively implemented.”  

Tags:  Advocacy  BIO 

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BIO2017 Recap: BioGENEius and Beyond

Posted By BioKansas, Friday, July 14, 2017

Last month, the BioKansas team traveled to San Diego for the BIO2017, one of the largest gatherings of biotechnology and pharmaceutical professionals in the world.  This year, the convention hosted more than 16,000 attendees from more than 70 countries.  In the past, BioKansas has taken large delegations to the event, hosted two story pavilions and brought in local and national celebrities as guests and guest speakers.  While our presence over the past three years has been dramatically toned down, the connections we make and the impacts we make continue to be significant. 
One of the most amazing things to happen to the Kansas delegation at BIO2017 was that Erin Smith, our Kansas BioGENEius from Shawnee Mission West, won the International BioGENEius Challenge.  We’ve enjoyed having Erin as a consistent presence in the Kansas BioGENEius competition over the past three years: she was runner up as a freshman and won here sophomore and junior years.  Her project this year, titled “A Novel, Telemedicine Diagnostic Tool for Parkinson's Disease: The Use of Digital Action Units Generated by Spontaneous and Posed Facial Expressions”, involves the use of facial recognition software and algorithms to diagnose Parkinson’s Disease using facial metrics that Erin identified and measured.  Erin winning the International Competition is truly amazing and a testament to the strength of high school research in the Shawnee Mission School District, in Kansas City and across the region.  Erin is continuing to do amazing things; she is currently in Boston attending a six week summer program at the Massachusetts Institute for Technology (MIT).  We can't wait to see the things Erin accomplishes and the mark she leaves on this world!

We also enjoyed putting on an informal BioKansas reception at a touristy spot in San Diego called Kansas City BBQ.  While the connection to Kansas City is noticeable from the name alone (the owners, Martin & Cindy Blair, are KC transplants), Kansas City BBQ is also famous for being the filming location of the bar scenes in the movie Top Gun (You've Lost That Lovin' Feelin!)The Kansas delegation enjoyed some good BBQ, great conversation and a nice tour of the bar and all of the Kansas memorabilia.

While at BIO, we also heard many updates on some of the most pressing legislative topics relevant to our industry, including biosimilars (passed in MO in 2016 and KS in 2017), healthcare, drug pricing, FDARA (FDA Reauthorization Act), MDUFA/PDUFA (Medical device/pharmaceutical drug user fee agreements) and others.  While BioKansas is a 501(c)(3) and is limited in what we can do in regards to advocacy, awareness of these topics and issues is an important piece of what we do for our membership.   
Here were a few other highlights from the trip:

· Shane Schaeffer, CEO of Cingulate Therapeutics, presenting Cingulate’s ADHD products during the company presentations. Cingulate is focused on the development of new products for the treatment of central nervous system and neurobiological disorders.

· Joshua Sestak, President & CSO of Orion Bioscience, presenting during the Startup Stadium on Orion’s Soluble Antigen Arrays (SAgAs) technology.  Orion is focused on the development of technologies capable of treating a wide range of autoimmune diseases. 

· David Cameron, former Prime Minister of the United Kingdom, taking part in a candid discussion with Jim Greenwood, President of BIO, on topics ranging from healthcare to Brexit to Trump.

· Dinner & Drinks at Half Door Brewing Company – What a great little gem with a large selection of some really awesome beers!  Check out this spot right in the middle of San Diego next time you’re out there!

President & CEO

Every conference I’ve been to has had the same feeling, you go to your sessions and wait until they’re done to go explore the city that you’re in. It never fails – 90% of the reason you go to these things is to try new foods and see new places. Yet the 2017 BIO Convention was not one of those conferences, even with it being held in San Diego. 

The first thing I noticed during the Council of State BIO Affiliates (CSBA) was how many attendees had come back time and time again, some of them over 20 times! And they exuded the same energy that the first timers came with. The second thing I noticed was how broad the reach of BIO is. Not only are there visitors from all over America, but from all corners of the world. Which I took note of again when I had to navigate through a Taiwanese reception just to get to the bathroom. I also realized that human health, animal health, and the planet’s health are all in good hands. We have some very intelligent and talented students ready to take the reins in the near future, especially highlighted by Shawnee Mission West’s Erin Smith, the Kansas BioGENEius and winner of the 2017 International BioGENEius Challenge.

This convention really is something to behold, not just because of the size and scale, but what happens between the attendees. Some are there purely to meet others and grow their individual networks. But so many more are there to discover new technologies, new methods of everyday practices, and new ways to impact the life sciences. It gave me the ability to see some of our member companies in a new light, to watch them interact and show other companies what they’re working on. It was refreshing to see so many people developing new approaches to problems that have plagued humanity, the planet, and even our businesses for so long.

So while you may not need to attend 20 times, I can guarantee that you will get value every time you attend the BIO Convention. You will meet so many great people from every corner of the world, it will give you motivation and a new sense of why we are all here and why what we do is so important. Like I said, this is no ordinary convention. There’s amazing people, incredible technologies, and dynamic conversations going on 24/7. And, of course, don’t forget the food!

Matt Falk
Manager, Events & Marketing

Tags:  Advocacy  BIO  BioGENEius  Connect 

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US Senate MUST PASS the Food and Drug Administration Reauthorization Act (FDARA)

Posted By BioKansas, Wednesday, July 12, 2017

The Food and Drug Administration Reauthorization Act (FDARA) would, among other provisions, reauthorize the vital authority for FDA to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs, and biosimilars.

The current user fee agreements are set to expire on September 30, 2017.   These agreements, including the fees that help supplement the Food and Drug Administration (FDA), play an imperative role in the timely review of new product applications.

This is non-controversial, bipartisan legislation that needs to be acted upon. We applaud the House of Representatives for passing the FDARA by a voice vote earlier today.  While we are encouraged by such action in the House, Senate action remains uncertain.

In June, the Senate HELP Committee voted almost unanimously to move the bipartisan bill forward and the Chairman and Ranking Member of the Committee are committed to ensuring timely passage, but the bill has yet to secure a scheduled vote on the Senate floor prior to the recess.

A lapse in authorization of these programs would be devastating for patients, as they may not get timely access to true breakthrough therapies.  Prescription drug user fees, collected under the authority of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BSUFA), comprise nearly 70% of FDA’s resources for the review of applications for approval of new drugs and biologics, and of biosimilars.  Failure to renew these programs in a timely way will result in the immediate loss of this essential revenue.

The impact of this loss of nearly three-quarters of the funds used for review will result in reviewers being laid off and applications not being reviewed.  Today, user fees support nearly all of the FDA medical and scientific staff who review applications, and with this large number of reviewers, FDA is able regularly and consistently to meet the goal of completing its review in no more than 12 months from application submission.  This is literally impossible without user fees.

Promising new drugs and biologics, exciting new gene therapies, cures for debilitating infectious diseases, life-extending cancer therapies – approval on all of these will be forced to wait until FDA has time and is able, with less than 1/3 of its staff and its resources, to complete them.  Biosimilars – widely believed to be a pathway to more affordable treatments for serious illnesses – will be delayed, perhaps for two or three years.

PDUFA, since its creation in 1992, has provided greater consistency, certainty and predictability in the FDA’s human drug review programs. Upon enactment, review times dropped by as much as three-fold in the first five years and have not increased.  The creation of PDUFA has ensured American patients are among the first in the world to have access to new drugs.

Please let your Senators know that timely passage of the FDARA is a priority for patients.  Thank you.

Senator Pat Roberts
Senator Jerry Moran

Senator Claire McCaskill
Senator Roy Blunt

Tags:  Advocacy 

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