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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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Building a Better Benefits Package

Posted By Connie Jabara, Employee Benefit Professionals, Monday, July 31, 2017

BioKansas members are a very diverse assortment of organizations from across the region, from single person startups all the way to enterprise size multinationals.  One of the primary roles we play within the community is to facilitate connections between relevant industry groups.  This may include connecting organizations to 1) potential future employees 2) potential collaborators 3) potential funding sources or even to 4) knowledgeable and effective service providers who can help our members navigate certain aspects of their businesses.  This Thursday, we are hosting one of these providers, Employee Benefit Professionals, for a Lunch & Learn on how to develop a benefits package that can help you recruit (and retain) productive employees.  We hope you’ll consider joining us for lunch and a great presentation on the ever-changing world of employee benefits. 
-From Dennis Ridenour, CEO of BioKansas


As a business owner, you know that your employees are crucial to your success.  You appreciate your employees and the work they do for you.  When people feel appreciated they are happier, and happy employees tend to be productive employees.  As a business owner, you also understand the effort, stress, time and money that goes into finding, hiring and training a new employee.  What if you could offer benefits that show your employees how valuable they are to your organization and how much you appreciate their hard work, thereby reducing employee turnover and increasing employee satisfaction? 

It is estimated that 78% of employees base their job decision on the benefits package. At Employee Benefit Professionals, we help you build a benefits package that not only helps you recruit new talent, but keep the talent you have happy and healthy!  In addition to health insurance, dental and vision, you can also offer other benefits similar to large corporations without breaking your bank account.  Benefits such as life insurance, legal protection, critical illness, accident insurance, and even pet insurance can be offered at no cost to you!

Join us for an interactive presentation on August 3rd to learn about how we help our clients build custom benefit packages unique to their business’ and their employees’ needs!  We can work with companies who have 1 employee or 1000 employees.  You provide the awesome career, we will help you discover benefits that will help you keep your employees happy, healthy and productive!  Click HERE for more information and to register.
-From Connie Jabara, Independent Life and Health Insurance Broker at Employee Benefit Professionals

Tags:  Benefits  Connect  Education 

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MATC Critical Environment Technologies

Posted By Barb Wenger, MATC Director of Bioscience, Tuesday, July 18, 2017

Note from BioKansas: One of our primary functions at BioKansas is to act as a connector between industry and education.  To this end, we work to align the curriculum of our educators with the evolving needs of our members.  There are many efforts across the region to teach, adequately train and develop the future workforce for our industry, but most of those programs are focused on training the scientists or technicians.  We think MATC has identified a true area of need with their training and certification programs outlined below, which target those whose job it is to service and maintain the laboratories, clean rooms and other critical facilities of our members.  We think this is a great example of surveying industry, identifying a talent gap, and then quickly developing a program to address that gap.  For more information on this program or how it was developed in conjunction with industry input, please contact Barb Wenger, MATC Director of Bioscience, who contributed the piece below.  


Since 2016, Manhattan Area Technical College (MATC) has been working to create a flexible Biohazardous Risk Reduction training for non-science workers in high containment environments. As the future National Bio and Agro-Defense Facility (NBAF) campus and the Animal Health Corridor bring more biotechnology companies to the Kansas-Missouri area, the need for construction and mechanical workers for these high containment facilities is growing. At the same time, the highly specialized environments necessary for biohazardous work create an inevitable gap in industry safety procedures designed to address a wider range of buildings. Thus, increased employment opportunities bring with them a growing need for risk reduction and safety training for high containment personnel. As a recipient of the U.S. Department of Homeland Security’s NBAF Think & Do Challenge, MATC has designed a Biohazardous Risk Reduction training option to provide safety skills training for Operations & Maintenance technicians, contractors, and others who work in and around critical environments. The goal of this training is to minimize workers’ exposure to occupational injuries and deadly pathogens by developing safety skills and raising awareness of potential hazards.

“From the beginning it has been our intent to make certain we understand the needs and standards of NBAF so that we can offer training within their required guidelines,” said Barbara Wenger, MATC Director of Bioscience.

MATC recently piloted two successful Biohazardous Risk Reduction Training sessions and hopes to begin offering the course to the public on a regular and recurring basis.

The next step for MATC is to develop its Critical Environments Facility Technician training program. This program, built on an HVAC foundation will enable current facility technicians to use their trade skills within critical environments such as cleanrooms, data centers as well as BSL3-BSL4 facilities. “MATC has been a terrific partner to NBAF. Their work is helping us lean in to important operational planning”, said NBAF Operational Planning Manager, Timothy Burke.

 “We recognized early on that there will be a host of partners in academia, private industry, and beyond who support NBAF. This further motivated us to develop the most relevant and impactful training possible,” said Wenger.

For more information on MATC’s Biohazardous Risk Reduction program or their Critical Environments Facility Technician training program, please contact Barb Wenger or visit http://www.manhattantech.edu/cet/critical-environment-technologies.   

Tags:  Education  Training  Workforce Development 

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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!

Dennis
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.

Kansas
Senator Pat Roberts
Senator Jerry Moran

Missouri
Senator Claire McCaskill
Senator Roy Blunt

Tags:  Advocacy 

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Overcoming Culture Limitations: Molecular Testing for Skin and Soft Tissue Infections

Posted By Michelle Altrich, Tuesday, July 11, 2017

Recent developments in molecular technology have given us new tools to aid in the diagnosis of chronic skin and soft tissue infections (SSTIs).  Amid growing discussions around how molecular testing can help wound care, Target Enriched Multiplex Polymerase Chain Reaction – a PCR amplification technology to detect multiple targets simultaneously – has emerged as a solution to significantly aid in the identification of key bacterial pathogens responsible for non-healing SSTIs.

Culture has been the standard method for diagnosis; however, culture has limits.  Despite optimal specimen collection, culture bias and false negative results can be a real problem.  Commensals may overgrow cultures and obscure the presence of pathogens.  Some bacterial species will flourish under culture conditions, while others won’t be detected.  Biofilms, an ongoing issue for chronic wound care, are inherently polymicrobial — culture can’t identify these pathogens effectively. So it’s not that culture is wrong, it is incomplete.   Culture limits our understanding of the true microbial composition of SSTIs. What pathogens are we missing?  What pathogens are we not treating?

Molecular testing adds improved depth of information, and the advantages over culture are several-fold. Turnaround time is one of the most critical.  PCR results are available in less than a day.  Ongoing antibiotic treatment does not interfere with molecular detection, and bacterial pathogens that are difficult to grow in culture are detected reliably by molecular techniques.

Based on the “IDSA Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections” efforts should be focused on “Rapid and specific diagnostic assays for identification of microbes”.  Molecular methods meet many of the requirements to fulfill this need.

Viracor offers a same day TEM-PCR panel* that detects common bacterial pathogens—offering clinicians a faster, more sensitive and comprehensive assessment of complex bacterial infections within a wound.  For a complete list of pathogens, please visit us online. Ruling in and out the presence of specific bacterial infections in SSTIs is clinically significant.  It reduces unnecessary antibiotic utilization and costs, and increases patient satisfaction—resulting in greater clinical value and effectiveness.

*Same day (within 8 to 12 hours of receiving specimen), Monday through Saturday.

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Welcome to the NEW BioKansas website!

Posted By Dennis Ridenour, Tuesday, June 27, 2017
Updated: Monday, June 26, 2017

Welcome to the NEW BioKansas website!  You may have noticed more emails from Matt and I over the past few months, as we have put more focus on keeping our members current on the latest events and news relevant to our industry.  In addition to finding notes from us in your inbox more often, we’ve worked hard to build a website that will highlight the region, the work BioKansas does to strengthen the climate for science and research both locally and nationally, and the amazing members we have that are changing the world through research and innovation.  Here are just a few highlights you’ll begin to see on the website and in your inbox:

  • Blog entries (like this one), as well as guest blog posts from others who actually know how to write and have more important things to say.  If you are interested in writing a post about a topic relevant to the regional life science community, please contact us
  • More up-to-date content, including industry news from local, regional and national sources
  • BioKansas events with online registration, attendee lists and event recaps/photos
  • A community calendar that includes events from partner and community organizations around the region
  • A career center that includes both local and national opportunities
  • Legislative updates and ways to take a more active role in science advocacy at both the state and federal levels

Matt and I are very excited to engage more of our members and more employees of our member organizations.  Soon you’ll see us organizing events focused on different functional areas of industry, including life science HR, supply chain and diversity.  And you’ll see more efforts to involve scientists from all levels in outreach to and education of legislators and other decision makers.  As the non-profit with the largest life science and healthcare membership in the region and now a new website and more comprehensive set of engagement tools, BioKansas is delivering on our mission To Connect, Educate and Advocate!

Tags:  Connect 

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