Three Olmsted County Teams Advance in MN Cup Business Competition

Three companies from Olmsted County advanced to the MN Cup Semifinals: NanoDev Therapeutics, Zerda, and JATS.

MN Cup is the largest annual venture competition in the state of Minnesota.  The contest is in its twelfth year of running and will award out $402K in seed funding.  1,500 companies entered the competition in 2016.  The pool was whittled down to 80 semifinalists, announced in the beginning of June.  MN Cup culminates with the Final Awards Reception held during Twin Cities Startup Week September 19-25th. 

Selected semifinalists span eight divisions: Energy/CleanTech/Water, Food/Ag/Bev, General, HighTech, Life Science/HealthIT, Social Entrepreneur, Student, and newly added Youth.

NanoDev Therapeutics was selected as a semifinalist in the Life Science/Health IT division.  This business is a hybrid of Mayo Clinic and MNPHARM/Garden Fresh Farms teams.  Garden Fresh Farms was the Energy/CleanTech/Water Division MN Cup winner in 2013.

Zerda advances in the HighTech Division. 

JATS, a women-led group, will advance in the Youth Division.  

The Power of Risktaking and Playing and Active Role in Your Healthcare

Alicia seemed to be in pain all the time.  She felt a stinging ache right under her ribs.  But, like most of us, she didn’t want to miss any work.  She decided to power through the pain as best she could.  Finally, the discomfort was just too constant for her to ignore.  She paid a visit to her regular physician and received several different diagnoses, including acid reflux and stomach ulcers and was sent home.

So she did go home, but the pain continued.  The discomfort became so strong that she could no longer lay on her side without severe pain.  That’s when she knew that something was truly wrong.

Alicia returned to her physician and began a series of tests and procedures that would last for well over the next year.

Initial assessments revealed that her white blood cell count was through the roof.  More shockingly, CT scans showed a gaping hole and abscess in her colon, or large intestine.  Alicia was immediately admitted to the emergency room.  Her skin was numbed and a tube was inserted into her body to begin draining the abscess in her colon.  The remaining hole was suctioned to remove as much fluid substance as possible, an extremely painful procedure even with a local anesthetic. 

Even after putting Alicia through that much excruciating discomfort, the doctors were not able to drain as much of the abscess as they wanted.  Finally, a tube with a balloon was infiltrated into Alicia’s body to try and drain even more from the abscess.

Alicia’s parents became increasingly concerned throughout this process.  This was their daughter going through all this pain.  They felt that something about how these events and procedures unfolded just wasn’t right.  Alicia’s mother, who worked at a major medical device manufacturer, consulted with her boss, a gastrointestinal surgeon, about Alicia’s condition.  They all agreed.  It was time to remove Alicia from the small hospital system in which she was being treated.

Alicia later told me that she didn’t realize how bad her situation really was at that point.  She was willing to just hang in there are see if the treatments worked at this regional hospital, something that myself and other readers may have leaned towards.  You’re in the hands of doctors.  They should know what’s best for your health, right?

“When you go through something like this, you’re in a lot of pain.  So you’re not thinking the most rationally about things.  Sometimes you’re just thinking, what’s going to not cause me any more pain than I’m dealing with right now?” Alicia explained.

You always need your mom and dad, no matter your age.

With the help of Alicia’s parents, she was transferred to a much larger hospital system where she and her family hoped she would receive better care.  In this new hospital system, Alicia was diagnosed with both Crohn’s Disease and colitis, a very rare combination.  Alicia had previously been diagnosed with Crohn’s- an inflammatory bowel disease (IBD) that causes inflammation of the digestive tract lining- in her 20s and had been taking medications for the past ten years.  Colitis is also an IBD but leads to longer lasting digestive tract inflammation and ulcers, quite an uncomfortable, painful combination.

Alicia and her family now hoped she was on the right track and that her new team of doctors would be able to relieve her pain.

She was placed on a mixture of antibiotics to clear up infections that had occurred from the previous abscess.  Her new medical team- a mix of an internal medicine doctor, gastrointestinal doctor, and gastrointestinal surgeon- collaborated and synthesized a plan to better Alicia’s health, constantly informing her of her choices and the associated risks. 

Alicia’s new medical team again tried to drain abscesses that had formed in her colon- she now had two- but they weren’t successful.  The damage was so severe that the injured part of her colon had to be removed.  So Alicia had a three-inch incision made in her body and a diseased portion of her colon excised.

After a major surgery like this one, or really any surgery, you hope that there are no more.  That there will be no repeat experience.  Unfortunately, that wasn’t the case for Alicia. 

After the first surgery, Alicia’s doctors decided they needed to go back in and remove more of the colon.  But this was going to be a big surgery, much more invasive than the previous.

What choice did she have?  Alicia went under the knife for what was the third time in this whole process.  A very large incision was made to remove even more of the damaged colon.  Then she was sewn back up and hooked to two external draining tubes.  She had a PICC line inserted into her heart to deliver antibiotics.  She was forced to use a colostomy bag and stayed in the hospital for a nine-day recovery process.  During this time, her medical incision became infected and had to be packed twice a day.  Finally, she was sent home to heal.

But Alicia wasn’t quite finished yet. 

Yet another abscess was detected in her colon, right next to her stomach.  Fortunately, this time she didn’t need a major surgery.  Her team placed a stent into the abscess, allowing the mass to drain into her stomach.  The abscess emptied into Alicia’s stomach for weeks.  It started to shrink and eventually flattened out. 

The process worked phenomenally, but “everything was too traumatized,” Alicia explained.  Her body had had enough.  The surgeries plus the stent-mediated drainage was a difficult procedure for Alicia’s system, but she powered through.  Thanks to her family, her incredible medical team, and her willpower, Alicia finally began to heal.

Or so she thought.

Five months later, the now familiar pain returned to her stomach, a pain so sharp at times that she was reduced to tears.  Alicia made her sixth total trip to the emergency room.  Scans revealed that her colon had narrowed to the size of a pinhead. 

Alicia’s colon had shrunk down to a 1/4th opening; most healthy colons are two inches wide.

Alicia’s medical team discussed the prospect of another surgery, re-admitting her to that long, traumatic process once again.  This time, however, she had another option to surgery.  She could try an experimental procedure and have a stent placed into her colon to try and enlarge its width.  A member of Alicia’s medical team was one of the few specialists in the country who could perform this technique.

When I asked Alicia how she felt about doing an experimental treatment, if she was worried that it wouldn’t work or might even cause harm, she said she would have been pretty skeptical if she had not been subject to so many surgeries along this journey.

“I’ve already been through so much.  But there was no guarantee that this is going to work either.  So I might have to go through this and they might have to do the surgery anyway. …We just didn’t know if my system would be able to handle another big surgery.  So they thought [the experimental procedure] was the best option,” she explained.

Alicia had two stents placed in her colon to open it up and stuck to a careful diet so nothing got snagged in the stent while it did its work.  She handled the procedure remarkably well.  Her colon remained open with the help of the stents.  When her team felt that she was ready, the stents were removed and Alicia’s colon stayed open.

Now, thanks to the experimental procedure, Alicia is on the mend.  It’s been about two years since the stents were removed from her body.  Every few weeks, she still receives drug infusions.  She still is on prescription medications.  She still has to have checkups every six months.  But she’s made it.

I asked Alicia what she learned from this process that might help others who are faced with similar frightening decisions about their health.

“I think one of the first things is don’t just immediately assume that the first person that you’re going to is knowing what they’re doing and doing the best thing. …Don’t take the first answer as your only answer,” she advised.

For Alicia, her family played a vital role throughout this process.  She was in so much pain, she often wasn’t hearing the conversations with her medical team.  “So I think in that situation, not dealing with it on your own and making sure that somebody else you trust is there to help you with it,” she said.

I was so honored to share the stories of both Alicia and Katherine over the past few weeks.  The amount of bravery it took to tell these stories to one person is bold.  But both women felt that spreading their stories of suffering and perserverance to even more people could hopefully do some good, even if it was to inspire a single person.  

Every day we are faced with decisions.  Some are monumental, some are not.  Some involve a large degree of risk and mettle.  It’s how we respond to these types of decisions that forge our character.  These women both had amazing stories of risk-taking to share.  They are the real innovators, the true medical entrepreneurs blazing new and uncharted trails.  The rest of us are just following in their stead.  Without someone to test and take a chance on the medical innovations that we create, we could go nowhere.

Techstars Chicago's Troy Henikoff Delivers Lessons on Startup Ecosystem Growth

Last week was a busy one for innovation in Rochester.  The last BioAM Founders Series was held Tuesday night.  Three Techstars++ companies- LiquidLandscape, Nebulab, and Solenica- and Techstars++ interns spent the week interfacing with the Rochester community.  Techstars++, Mayo Clinic, and DMC also brought in Troy Henikoff to speak and impart some wisdom and advice from his many years of experience building up Chicago’s entrepreneurial ecosystem. 

When Troy struck out on his own, Chicago was an entrepreneurial desert.  There were entrepreneurs.  But they had no supportive infrastructure for business growth.  Troy built up a design consulting company from scratch in this environment, which was eventually acquired by Medline.  He built and ran three more startups afterwards- SurePayroll.com, Amacai, and OneWed.com.  SurePayroll was acquired by Paychex for over $100M in 2011, which was huge at the time for Chicago.  But even at the time of this exit, there was no real support structure for Chicago’s entrepreneurs.  Companies born in Chicago were leaving to build their businesses elsewhere.  Troy, and others in the community, felt there had to be a way to keep these companies in Chicago.

Troy was always an entrepreneur.  As a boy he cut lawns, delivered papers, and did whatever he could to raise $87 and buy half of a sailboat with a childhood friend, a passion that would consume him until his early 20s.  While in college, Troy thought that designing sailboats might not be the best way to make the world a better place.  He briefly considered designing helicopters and submarines, until he discovered this involved sitting in a cubicle all day, spending eighteen months to design a single hinge.  It just didn’t seem all that appealing any more.

Troy decided to take a huge leap and open up a design consulting firm in Chicago, where he was born and raised.  He was twenty-one-years old, straight out of college, and had no real opportunity costs.  What did he have to lose? 

This was in 1986.  The word entrepreneur was not thrown around in Chicago all that much at the time.  This was twenty-three years prior to things like Shark Tank.  Without any entrepreneurial infrastructure, Troy built up his companies in Chicago.

During this time, he mentored a group of students at Northwestern University who created a company called Next Big Sound.  He watched the company struggle for a year to gain momentum before they were accepted to the Techstars Acclerator in Boulder, Colorado in 2009.  Next Big Sound left Chicago and never came back.  The company was very successful and was recently acquired by Pandora.

Next Big Sound wasn’t the only startup to speed out of Chicago and never look back.  Troy continued to see Chicago-born startups leave to build their business elsewhere because the city had no support system, no real depth, to support entrepreneurs.  It was time for a change.

Troy co-founded Excelerate Labs, in a sense a startup for startups, to being to accelerate entrepreneurial growth in Chicago and keep Chicago talent in the city.  Excelerate began to build up that innovation ecosystem and infrastructure that was lacking.  For the first time, Excelerate offered entrepreneurs exposure to leading experts and investment opportunities.  Excelerate facilitated knowledge flow from experienced business leaders to Excelerate Founders.  Thirty companies graduated from the accelerator in three years, netting $35 million in capital. 

Excelerate Labs became Techstars Chicago in 2013.

If Excelerate Labs laid the groundwork for entrepreneurship in Chicago, 1871 raised it up into the rafters.  1871 opened up in 2012 and to date is the largest coworking space in Chicago.  Two thousand entrepreneurs work out of this massive space on a daily basis, and Troy runs the whole thing.

Chicago has transformed since Troy first launched his entrepreneurial career there.  The city has rapidly grown over just the past five years from an entrepreneurial desert to an oasis.  Now Chicago has 1871.  They have Built In Chicago, a news platform that serves as the voice of the Chicago’s startups and has unified the community.  They have investment funds like Impact Engine, FireStarter Fund, and The Starter League.  Chicago’s startups have created real economic value in the city, generating over $80 billion in transactions over the past few years.

Troy has witnessed a revolution in Chicago’s startup scene and has a pretty good idea of what it took to change this landscape.

He says a community needs all the right ingredients for the startup ecosystem to be successful.  This includes a mix of universities, funding sources, entrepreneurs, and big corporations.  And these pieces should all have some sort of presence in one space, like 1871.

Successful startup communities also need to have entrepreneurs as their leaders and should not rely on legislation to cause change.  Entrepreneurs work on a different time scale and think in terms of long, even generational, commitments and not in terms of individual transactions, which can be especially demoralizing for entrepreneurs working without pay.  The payoff is in the long run.  The value is in the stable, robust ecosystem being created.

Moving away from this transaction view is key to encouraging all the different factions- the entrepreneurs, the corporations, the city councils- to work together to build a successful startup ecosystem.  Everyone benefits from an economically strong community in the long run. 

The Chicago startup scene went from pretty much nothing to a robust ecosystem in only five years.  Why can’t we do that in Rochester?  What’s stopping us? 

As an entrepreneur myself who recently moved back to Rochester for the opportunities which I believe lie within this city, for the opportunities housed in this movement to build the startup infrastructure, it was encouraging to look around a packed room at Troy’s talk and see so many other faces inspired to take this journey.

It may take us more than five years to reach whatever entrepreneurial success looks like to Rochester, but we’ll fight to get there.

Former Mayo Clinic CIO Abdul Bengali Speaks about Future of Healthcare at Last BioAM Founders Series

BioAM wrapped up its final Founders Series with a bang last Tuesday night, hosting Abdul Bengali, former CIO of Mayo Clinic and healthIT aficionado. 

Mr. Bengali was born and raised in Karachi, Pakistan and became interested in this wacky new thing called computers as a youth.  In 1968, he traveled to the United States to study computer science and has been here ever since.  He met his wife, who incidentally was from Minnesota, during his studies at California State Polytechnic University.  The couple moved to Minnesota after his graduation in 1973 with the dream to have a two story house, a fireplace, and two children.

Mr. Bengali took a job in programming at Mayo Clinic in 1977, which began his thirty-five-year career at the medical institution.  He retired from the position of Chief Information Officer (CIO) in 2012.

He recently leveraged his experience in healthIT to launch a startup called DocHelp.com, which he likens to the Expedia of healthcare.  DocHelp.com brings transparency to the healthcare system, allowing consumers to book appointments with care providers using the platform without having to call the office directly or request an appointment.

Mr. Bengali sees healthcare as an industry in transition, moving from a fee-for-service to a pay-for-value model.  But what will it take for healthcare to evolve?  Mr. Bengali thinks that entrepreneurs and startups, just like the ones emerging in Rochester, will play a significant role in this healthcare transformation.

Right now, we have an explosion of medical information in healthcare.  We have the ability to collect the same amount of gene mapping data and genetic information in one year as we did in the past one-hundred years combined.  This power gives healthcare provides a lot more information about each patient, but it also increases the number of facts needed to render a clinical decision.  Moving into the future, how will the healthcare system synthesize all this information together to make these clinical decisions and render good patient outcomes?

Mr. Bengali believes that healthcare will reach a point in its evolution where it has to start thinking of information as a service.  Take the old TV Guides as an example.  These books were just pages of information about the week’s television lineup.  They themselves did not offer any programming, they just synthesized all the information about the television that week into one space.  In a similar manner, healthcare has reached the point where samples taken during an exam can be sent off and deconstructed to gain another level of knowledge and information that’s useful to the healthcare provider for clinical decision making.

Mr. Bengali sees several major trends occurring in healthcare right now.  He thinks that healthcare will have to revamp its business model, where eventually providers will need to post their outcome, safety, and patient satisfaction records.  He also sees a drive in millennials to access healthcare online, on their own terms.  Lastly, he sees a huge need for self-service in healthcare, which is where his own startup falls into place.  3.4 billion medical appoints are made annually in the United States.  1.2 billion of those could be self-service.

Medical Device Startup LifeSAVR Solutions is Developing a New Guidewire to Improve Aortic Valve Repair

Jordan Pollack saw a problem.  While he, and his three other LifeSAVR Solution Founders, were in graduate school at the University of Michigan, they observed a transcatheter aortic valve replacement (TAVR) surgery at Beaumount Hospital in Royal Oak, Michigan.  This minimally invasive procedure uses a catheter and guidewire to replace diseased aortic valves in the heart.  But the only way to visualize this internal procedure, and ensure correct placement of the new valve, was through fluoroscopic guidance, or fluoro.  Using fluoro, the whole procedure is visualized in real time by X-rays projected on a screen above the patient.  Fluoro and physician experience are the only way to know that the replacement valve is in the right location before it’s deployed.  Jordan and his other classmates felt there had to be some better way to ensure proper valve placement during TAVRs that didn’t rely solely on just a 2D image and a good bit of guessing.

Aortic valve disease, or aortic stenosis, is a large problem in the US and is especially prevalent in the elderly.  One study estimated that every one in eight people over the age of seventy-five in has moderate to severe aortic stenosis[1]. 

 Aortic stenosis involves a narrowing of the aortic valve from calcification or plaque buildup.  There are a total of four valves in the heart: the tricuspid, pulmonary, mitral, and aortic valves.  These valves open in only one direction to allow unilateral blood flow through the heart.  The aortic valve connects the left ventricle to the aorta, the largest artery in the body, to funnel blood from the heart out into the vasculature.  If the aortic valve is narrowed, the left ventricle has to work harder to pump blood, which leads to improper blood perfusion to the body, weakening the heart tissue and leading to a high morbidity rate if left untreated.

Replacement of the aortic valve via open heart surgery is the gold standard for aortic stenosis treatment.  During this process, patients are opened up, the old, diseased aortic valve is excised, a new valve is sutured into place, and the patient is closed back up.  These replacement valves implanted during surgery are usually metal based and inserted during a procedure that lasts for several hours.  Afterwards, patients usually have a two-week hospital stay, followed by several weeks of recovery.

 However, there’s another option on the market, at least for high risk US patients.  “One of the biggest technologies and treatment modalities that came storming out of the market is TAVR, which is transcatheter aortic valve replacement,” explains Jordan.

TAVR first hit the market in Europe in 2006-2007 and entered the US commercially in 2011.  TAVR was given FDA approval in the US only for high risk patients with aortic stenosis, those for which surgery would be too risky to complete. 

Approximately 300 to 500K elderly US patients are eligible for this minimally invasive procedure.  As opposed to open heart surgery, TAVR is a catheter lab procedure that takes ninety minutes or less to complete.  During the procedure, a three-meter guidewire is traced up an artery, usually the femoral artery in the leg, with fluoro guidance.  The guidewire runs all the way up the artery to the aorta, through the diseased valve, and into the left ventricle.  The operating physician then uses a balloon to expand the damaged, narrowed valve.  The balloon is removed and the new, prosthetic valve is traced along the guidewire path with a catheter, until it reaches the diseased valve.  Most current valves used in TAVR are self-expanding and made up of valve leaflets from pig or cow pericardium, as opposed to the metallic valves used in open heart surgery.

TAVR has been successful and there are promising results from clinical trials in high risk patients.  “The push is to make TAVR the goal standard to completely replace open heart surgery,” explains Jordan.

There are some potential issues with TAVR that have slowed down the process for the procedure to become the standard of care for aortic stenosis treatment.  “The big thing is longevity.  No one really knows how long these valves [used in TAVR] will last,” says Jordan.  The field is just beginning to see the first patients who have had TAVR replaced valves for ten years. 

The other problem compared to open heart surgery is the general…murkiness of the whole process.  Physicians aren’t opening up a person like in open heart surgery and are relying on fluoro and 2D images to determine if a valve is in place before it’s deployed- a process that leads to 3-5% of TAVR valves being acutely misplaced, which can lead to perivalvular leak.

Valves can also be chronically misplaced, where they are just slightly misaligned or shift overtime from excessive calcification.  Besides health implications to the patient, misplaced valves are pricey.  Each valve costs $40K to replace, which has to be assumed by the hospital system in cases of valve misplacement by the physician.

“That’s really the problem that we’re trying to solve, is valve misplacement during the TAVR procedure,” explains Jordan.

Jordan and his three-person team of University of Michigan graduates founded LifeSAVR Solutions and are developing a product called the Corfinder; “cor” is the Latin word for heart.  Their product will provide “quantitative, adjunctive confidence for physicians to know that he or she has place the valve properly.”  The Corfinder is not meant to replace fluoroscopic guidance or physician experience, but to complement them.  The team is creating this specialized guidewire, the Corfinder, with a series of sensors along the distal tip.  The Corfinder will help to refine detection of the native valve during TAVR procedures and ensure better alignment between the annulus, or base, of the new prosthetic valve and old, diseased valve.   

The LifeSAVR Solutions team is currently in the technology and feasibility stage of the process.  They are incorporating the tiny sensors onto the guidewire and are getting the product down to a functional form factor.  

Jordan has found some great resources in the Twin Cities to help the team with this process.  In CoCreateX, he found a group where he could interact with people doing similar types of things.  However, “…the biggest community that’s provided me with connections is the Jewish community,” he notes. 

 


[1] http://www.edwards.com/eu/procedures/aorticstenosis/Pages/prevalence.aspx

Student Makers, Join us at ArchHacks HealthTech Focused Hackathon this Fall in St. Louis

Are you a student who likes using your hands to create things?  Do you want to gain some real-life learning experience outside of the classroom?  ArchHacks might be just the thing for you.  Co-organizers Stephanie Mertz, Allen Osgood and their team have turned this previously school-specific hackathon into a regional event and expect to pull in five times as many students for the competition as in previous years.

Here are the top ten things you need to know about ArchHacks:

1.     ArchHacks is a 48-hour, weekend hackathon held November 4-6th at Washington University in St. Louis, Missouri.  Students from all over the region are expected to come together during this event to build their very own tech projects.  The hackathon, previously called WUHack, is in its third year of running and has grown in size with each edition.

2.     Participants are college or university level students at least 18 years of age.  Prizes, as always, will be awarded at ArchHacks.  But, restricting the participation to students gives the hackathon an “education centered view.”  “Prizes are fun, but we want [the students] to be rewarded for thinking about new problems,” explains Stephanie.

3.     Students should expect to be actively engaged throughout the weekend and learn hands-on skills.  The event opens with a dinner for all participants, where students who came into St. Louis without a team will be able to meet others and form partnerships.  Next, an opening ceremony will introduce the event’s top sponsors, lay out the expectations, and describe the weekend’s activities.  Students will then break up into their teams to decide what problem they would like to spend the next forty-five hours of the weekend thinking about.  “That will involve going to mentors and getting feedback on the problems that they’re interested in solving.  And then they’ll use the time until Sunday to get feedback from professional mentors who will be available throughout their time there,” says Stephanie.  Then finally on Sunday, students will demo their projects to judges, the other students, and people just interested in seeing these creations.  The event concludes on Sunday with a closing ceremony where prizes will be awarded.

4.     Between 600-800 students are expected to attend the 2016 ArchHacks.

5.     HealthTech is the theme for this year’s ArchHacks competition.  This focus gives students from all different disciplines the opportunity to create something that could actually impact people’s health and well-being.

6.     St. Louis is a pretty relevant place to hold a HealthTech-centric hackathon.  St. Louis is packed with medical students, including those at Washington University in St. Louis, one of the top medical school destinations in the country.  Many corporate leaders in the HealthTech space, including Arch Hacks’ lead sponsor Express Scripts, call the city home, as well as numerous startups in health-related fields.  “It’s really a unique combination that St. Louis has where we have the expansive medical background, the corporate resources, and startup drive, and the technical talent, all in one area,” explains Stephanie.  “We thought that here in St. Louis, we were uniquely poised to bring the resources together to enable [a HealthTech themed hackathon].”

7.     The ArchHacks application process takes a quick, painless 10 minutes.  The application is mainly in place to ensure that ArchHacks only accepts the number of students that they can host.  The form asks some basic questions to gage students’ interest in the event and background and to address any necessities or accommodations, like dietary restrictions, that students may have to ensure that everyone has a great time at the event.  “If you haven’t been to a hackathon, that’s ok.  We’re just interested in what other things you may have been involved in,” explains Stephanie.  Students are encouraged to email ArchHacks at info@archhacks.io with any questions.   

8.     The whole process is free, from the application to the food.  “We want to be able to give free or partially reimbursed transportation for all students who are accepted and make sure that we can offer them really great food while they’re here, so that way nothing is out of pocket for them. …We don’t want anyone’s ability to pay be barrier to this,” says Stephanie.

9.     A hackathon is a one-of-a-kind, hands-on, skills building experience.  “I think what’s really unique about going to a hackathon is the environment you’re in.  Of course, you can take a weekend and wall yourself up in an office and work on something all weekend.  But at a hackathon, you’re surrounded by professionals from all backgrounds that really help you to accelerate not just your learning, but ability to build things,” explains Stephanie.  A hackathon applies the pressure to not only build something functional in 48 hours, but to create something that is actually useful to end users, a component that’s often left out in normal university coursework.

10.  ArchHacks has a great social media presence, delivering the most up-to-date information.  ArchHacks’ marketing specialist, Marni, keeps the Facebook, Instagram, and Twitter feeds flowing.  The ArchHacks website is also a great source of information with frequently updated FAQs based on emailed questions.

You don’t have to be a student to participate in ArchHacks in some form.  For any professionals in the area, there are some great sponsorship and mentorship opportunities available.

Are you a student in the Rochester, Minneapolis/St. Paul, or Winona area interested in attending ArchHacks?  Contact Jamie Sundsbak at bioamroch@gmail.com.  We are looking to charter a bus to transport students from the area down to St. Louis, free of charge to students.

Rochester Residents Given Chance to Change Urban Environment with Call for Proposala

You could play a role in the future of Rochester and have a physical structure of your own creation on display in the city. 

PlaceMakers Prototyping Idea Jam held last Wednesday night wants to make this possible.  The event brought together Rochester residents to collaborate, integrate, and create prototypes- or models testing a concept- to form a healthier, more connected, urban environment.

The event, co-hosted by Destination Medical Center, Rochester Art Center, and Rochester Downtown Alliance, put public design right into the hands of the Rochester community, giving anyone a chance to walk in the door with an idea and turn it into an actual physical structure on the streets of Rochester in only three months.

The Prototyping Idea Jam was facilitated by Ray Boyle and Jake Levitas, co-founders of Our City, a non-profit run out of Oakland, California that works with communities to utilize public design to improve cities. 

But what exactly is public design?  Public design is something that’s created by the public, with the public, for public good, in public space, as explained by Our City.  Public design uses public infrastructure and the built environment in an outdoor space to change some aspect of that environment, in this case, to create a healthier city. 

This Prototyping Idea Jam is part of the PlaceMakers Open Call for Proposals, where Rochester residents- or really anybody- can submit public design concepts that utilize Rochester’s built environment to create a vision of a healthier city.

A previous prototyping workshop held in April identified seven core values that Rochesterites think are vital to a healthy city: nature, connection, accessibility, inclusivity, art, and food.  Applicants are encouraged to create a prototype that encompasses one, or more, of these focal areas. 

The Open Call for Proposals ends June 17th, so get your applications in soon!  Ten selected projects will receive a stipend of $2,000 and have the option to fundraise more capital if needed.  Three projects will also be selected for storm water management on the 3rd Street Ramp.  Two additional projects will focus on the 3rd Street Parking ramp concrete underside. 

Teams have until September to build a 12’x12’x12’ prototype of their idea.  The prototypes will be showcased in the public PlaceMakers Prototyping Festival September 15th-17th along 3rd Street between Broadway to 3rd Avenue SW.

At least fifty people walked in the door for the Prototyping Idea Jam last week.  And not many left until well after the three-hour session was over. 

For the average person, it’s pretty hard to conceptualize transforming some structure you see on your daily walk into something new.  Something that people would actually want to interact with that reflected one of these seven core values.  I was a skeptic going in, thinking I would just sit by passively and listen to what ideas other people developed. Our City walked everyone through an open exercise to get the creative juices flowing, and pretty soon everyone was scribbling away, drawing out their ideas.  Some were insightful and beautiful.  Some were ugly.  Some were just weird.  Some looked like a drunk kindergartener drew them.  Wait…that was mine. 

But the point is, everybody in that room came up with some idea, whether they chose to share it or not.  Everybody developed a concept that had the potential to change Rochester’s urban environment.

What public design ideas did Rochester citizens envision to change their urban environment to support a healthier, more connected, inclusive city?  One person came up with an idea for art filled bike lanes.  There was a concept for portable gardens.  A live social media and event feed that could contain giant emojis.  A stationary bike that played music when pedaled.  Painted artwork and poetry that would appear under certain weather and environmental conditions.

At the end of the night, nine teams formed to support some of these ideas and hopefully submit an application in the upcoming weeks.

The Open Call for Applications is not limited to the people who were in that room last Wednesday night.  It’s open to all of us.  Do you have a great prototype idea that could benefit the city’s health?  Do you want to see some change?  This is our opportunity to take- or leave- to see some change and help to mold an evolving urban environment. 

For more information and details about the prototype application, click here.  Teams will also be looking for help and experts as these projects move forward.  Keep checking social media to see how you can help.

Name of New Rochester Incubator Revealed at very Last BioAM Event

“The entrepreneurial community in Rochester that exists right now is like seeds scattered everywhere. Now, it’s time for those seeds to germinate and Rochester’s entrepreneurial community to bloom,” says Jamie Sundsbak, BioAM Founder and major shaper of Rochester’s innovation community.

Jamie has seen entrepreneurism in Rochester evolve over the past five years with the launch of the Mayo Clinic Business Accelerator and Cube coworking.  But he still felt that there was an unmet business development need between these two points. 

He, along with Area 10 Labs owners Hunter and Traci Downs, are developing and will soon launch a brand new business incubator right in Rochester.  “Basically, we want to make it easy.  If you have a great idea and you want to pursue a passion, we want to try and remove as many barriers as possible to get you started and get you moving as fast as possible and hopefully, ultimately, succeed,” says Jamie.

The idea for the incubator came right from the Rochester community.  And there’s no better time than now to launch this thing.

“I’ve always had in my mind an ideal vision of what a business incubator would look like in this city.  I’ve traveled around places like Boulder, Colorado and Kansas City.  I’ve seen incubators working very, very well.  I wanted to take some of those good ideas and bring them back,” explains Jamie.  He’s been sitting on the incubator idea for a long time, and finally all the pieces have fallen into place.

The new incubator will be housed in the historic Conley-Maass Building- which is owned by the Downses- where Jamie, Hunter, and Traci will collaborate to support budding Rochester businesses.  The incubator will be the first building in the Discovery Square region of downtown Rochester, which “added an incentive to have something like this in that space…for the larger vision of what Discovery Square will be,” explains Jamie.

The services and business development structure provided by the incubator have yet to be finalized, but will likely be flushed out and unveiled over the next month.  “We have ideas that we would like to test with potential customers to see if there’s a good fit, because Rochester’s a little bit of an atypical place as well. …We’re just trying to figure out what’s best for Rochester and what fits,” says Jamie.

“With a business incubator, what we’re trying to do is really find some people with some great ideas in the community.  They may have already formed a business.  They might be in the initial stages of starting a business.  But, we really want to go from idea to product and just provide a space for them to be able to scale,” explains Jamie.

Companies are anticipated to stay within the incubator for two and a half to three years, which will fluctuate depending on the type of business.  The incubator will provide some sort of mentorship structure, pulling from shared connections at the local, state, and national level.  The incubator likely will not provide seed capital to incubating businesses, but will connect and encourage companies to seek out funding sources like MNvest, venture capitalists, and angel investor networks.  The large physical space is still in the conceptual stage, but will likely be divided into dedicated desks, semi-private offices, and “hot desks” for day-to-day drop-in use.

It’s time for Rochester’s entrepreneurial community to enter into the blossoming phase and continue to diversify to create a stable economy.  The city houses budding opportunities in the life science, tech, and even food entrepreneurial spaces.

“I would love to see a network of these incubators strength across the city. …What would an incubator look like around a community kitchen?  Or tech styles?  Or a wet lab space?  I could see these specialty incubators sort of popping up.  I think that will happen in the next ten years for sure,” predicts Jamie.

To better serve this diversifying entrepreneurial base, BioAM will also evolve.

“BioAM was intended to grow life science entrepreneurship in Rochester. …I would bring in great life science founders to give talks.  I’d look into the audience and half of the audience were not life science entrepreneurs, but were people who were tech entrepreneurs who were just interested in entrepreneurship in general.  So I started thinking of ways that we could grow an organization to encompass not only life science entrepreneurs, but all entrepreneurs in the city,” says Jamie. 

As part of this shift, BioAM will be resorbed into a larger organization to better support the changing entrepreneurial scene in Rochester.  The group will keep a “bio” name and still hold life science specific events.  But the larger organization will also have complementary tech and general entrepreneurship arms to encompass all of Rochester’s innovators.  Maybe even a branch for food entrepreneurs is in the future.

Jamie admits that leaving his position at Mayo Clinic and trying to launch a business accelerator is risky.  But for him, it wasn’t really a choice to make, but perhaps more like his true path.

“I always felt in spending the last almost five years with BioAM, promoting entrepreneurship, deep down inside when I looked in the mirror that I was kind of a fake.  Because I always had a stable job.  I can host an event and then go back to work and have a job.  Here’s a guy that’s standing in front of between ten to seventy people at every event saying how awesome entrepreneurship was, and how we need it in Rochester, and how we need to do to something.  But I’m getting a paycheck and I’m not breaking out on my own to start something new. …I want to lead by example.  I don’t want to be the guy saying, ‘Hey, go out and do some really risky stuff.  Oh, by the way I’ll be here at Mayo if you need me’.  I want to be the person who’s right there in the trenches with people, taking those risks and living through that.  And I think that will help grow the ecosystem even more because they’ll see not only me, but other great people in the community begin to emerge and to really do great things that aren’t dependent on larger organizations in town.”

“That’s hopefully going to provide encouragement for a lot of other people to do that and create this virtuous cycle of people who hopefully become successful, or at worst fail and learn from it and be able to feed back into the ecosystem and encourage that next group of people forward.”

Sona Mehring Spreads Positive Social Media #SayItForward Compaign at TEDxUMN

“There are billions of connections in the brain, infinite moments and memories, collections of pulses and synames of electricity. All it takes is the right energy to reawaken an old idea and turn it into something new”

This was the essence of the TEDxUMN talks on April 29th at the University of Minnesota. The highlighted talks in this series of articles are by no means fully comprehensive of the event, but most relevant for those interested in entrepreneurship.

Our first speaker, Sona Mehring, spoke about using technology to emotionally connect with others with #SayItForward.

Sona Mehring is the CEO and Founder of CaringBridge, a non-profit social media network that connects patients with loved ones during their health journey through a free personal website. As a computer programmer with loved ones going through a health crisis, Sona wanted to create a solution to use technology to emotionally connect in a meaningful way.

Never in the entirety of human history have we been able to connect with so many different people on so many different platforms. Mehring cites different studies from the University of California, Berkeley showing increases in overall well-being and happiness when sending or receiving a text from a loved one and performing small acts of kindness, which increase the likelihood of repeat behavior. Despite all this evidence, there is large number of cases where individuals reported feelings of isolation and depression due to virtual (non-physical) interaction using social media.

It’s important to remember that technology is a tool, its value is not in its existence, but its utility. We can use social media to bully as easily as we can to form new connections filled with compassion and empathy. People are social creatures and desire genuine social interactions. The tools we use for communications don’t have to correlate with isolation and loneliness, void of feeling and filled with vapid chatter. We can give technology a new way of being meaningful and intentional. We can be there for our loved ones and listen to their stories.

In the case of health crises, there often is a feeling of hopelessness that comes with watching a loved one go through immense pain and not being able physically do anything about the situation. In circumstances that can’t be fixed, we can practice skills of creating positive, open space and giving our loved ones full support by simply being present.

Mehring has suggested a positive revolution where we all take part in #SayItForward, a play on words of the “pay it forward” concept. Random acts of kindness through words facilitated by social media. A thoughtful post or a comment to connect us closer to one another or at the very least, brighten someone else’s day.  An excuse to post inspirational quotes with the standard sunset picture.

Mehring makes a call for action: Say it forward to make the world a little more beautiful.

PCSK9 Inhibitors Bring Good News to Nearly Half of Patients Currently at Risk for Heart Disease — If They Can Afford It

The strategy for cardiovascular disease prevention is currently changing in a big, expensive way. Many cardiologists are hopeful that PCSK9 inhibitors will soon bring an end to high cholesterol, effectively changing cardiology forever. Unfortunately, the pharmaceutical companies that developed these potentially miraculous drugs have priced them at a whopping $14-15K a year, more than fifty times the price of statins, the current standard of care[1]. This high price point will lead to the highest therapy cost the United States has ever seen[2] — a cost that will affect all Americans, especially lower income individuals.

Cardiovascular disease is the number one killer of Americans, causing around 610,000- or roughly one in every four- deaths each year[3]. One of the best indicators available for cardiovascular health is low density lipoprotein cholesterol (LDL-C), or  “the bad cholesterol”, levels. If you can get that magical number down below 70-130 milligrams per deciliter (mg/dL) depending on your risk category, then you are considered to have a low risk for cholesterol buildup in your blood vessels and a reduced risk of heart disease[4].

For some people, reaching that number simply requires switching to a “Mediterranean diet” and getting more exercise. However, for many people it requires medication[5]. Currently, statins are the drug category of choice for lowering LDL-C levels.

Unfortunately, statins simply do not work for everyone, leaving a patient care gap of 25-40%.

While there are some steps that can be taken to aid these patients, such as stacking the non-statin therapy ezetimbe with a statin for additional LDL reduction, these combination therapies often still don’t get the job done. For a disease that causes 610,000 deaths a year, a patient care gap of 40% is, simply put, a big, scary deal.

The good news: PCSK9 inhibitors may be just the therapy to close that gap.

PCSK9 inhibitors are antibodies that can help regulate the body’s metabolism of LDL-C. They latch onto a protein called proprotein convertase subtilisin/kexin type 9, or PCSK9, which binds to the LDL-receptors, tagging them for destruction in the liver and keeping cholesterol levels high. By binding to PCSK9, the PCSK9 inhibitors allow the LDL receptors to continue binding to LDL, resulting in a lowering of cholesterol.

More good news: PCSK9 inhibitors are particularly good at lowering LDL-C in the patients who need it most — the ones who currently have no other options. Since the invention of these inhibitors, several trials have shown PCSK9 inhibitors decrease LDL-C in patients with familial hypercholesterolemia (FH), a genetic condition that leads to high cholesterol unmanaged by statins.    

In light of these trials, the FDA approved the use of two PCSK9 inhibitors this past summer for use in patients with FH or clinical atherosclerotic cardiovascular disease (ASCVD).  These patients have already had heart attacks or strokes due to plaque buildup in their arteries and do not benefit from statin therapy [6]. It is estimated that 5-10M people have either FH or ASCVD[7]. At roughly $15K annual cost per person for either PCSK9 inhibitor, the price to insurance companies and the people they represent- and charge- will be astronomical.

But that’s just the beginning. Many cardiologists, pharmaceutical companies, and insurance companies alike expect that those 5-10M people are just a small sliver of the population for whom these drugs will eventually be prescribed[8].  If this is the case, it means that a huge number of people will potentially be prescribed PCSK9 inhibitors in the near future, at great expense. Estimates for the cost to the U.S. healthcare system of such an expansive prescription base for these expensive drugs are between $100-150B per year[9]. PCSK9 inhibitors are by no means the most expensive per-use medications on the market, but at their current price point they are the most expensive drugs that require a lifetime of continued use.

Many people wonder why drugs like the PCSK9 inhibitors and other “biologics” are so expensive. Part of the answer is the high cost for a continued cycle of research and development for newer and better drugs. The making of the antibodies is expensive. Drug trials done properly are also expensive and require a wide range of participants to demonstrate broad spectrum efficacy. In fact, the drug companies do not make money unless their drug works well[10]. In the end, it’s a balancing act between the economics of these high cost medications and the ethics of the inherent decreased access to care.

The United States government does not govern the price of drugs —  the market does. In places like Europe or Canada, the costs of these drugs would never be set so high because they are set by the government. In fact, the European version of the FDA, the European Medicines Agency, rejected PCSK9 inhibitors until their prices were halved[11].

In America, specialty drugs like cancer drugs and those for Hep-C are inherently in low demand, which allows for a higher price only as long as the consumer, which is the insurance company in the United States, is willing to pay for it. If these conditions are met, that price point remains.

This high price point does provide some overall benefits. By consumers paying more here than in other countries for drug use, the United States foots the majority of the bill for the entire world when it comes to research and development of new drugs[12]. Drugs like the PCSK9 inhibitors may be significantly more expensive in the United States than in Europe, but the revenue from prescription drug use in the United States has a global health impact. So the question becomes: is this a fair situation for Americans? Perhaps not — especially for those who cannot afford it. Yet, there is currently no other option if we support the continued development of novel medications.

The regulation of drug prices by the government has been in the national limelight lately, with people ranging from Martin Shkreli of Turing Pharmaceuticals, who raised the price of the AIDS-related drug Daraprim from $13.50 to $750 per pill overnight, to Bernie Sanders and Hillary Clinton who have been expressing a need for change on Twitter and in their campaign platforms[13].

Shkreli argues that his price increase for Daraprim was a consequence of this model: the economic necessity for research and development. In September, the BBC called Shkreli the “most hated man in America”[14] and his face was all over the news. Hillary Clinton tweeted her outrage at him. Is there any difference between Shkreli’s 5000% price hike and the insanely high prices of such important drugs like the PCSK9 inhibitors?

The difference is in the need for R&D. Daraprim was developed over 40 years ago, unlike the brand new PCSK9 inhibitors, and is sufficient, unlike statins. Although Daraprim does treat a rare condition  and has a low demand, the production cost to Turing Pharmaceuticals is very low, unlike the PCSK9 inhibitors.

So, what about PCSK9 inhibitors? Do the economic and ethical factors of such a novel and important pharmaceutical dictate and permit their extremely high ticket price? Only Amgen and Regeneron, the pharmaceutical companies selling them, seem to say yes[15]. Pharmacies that stock the drugs, government agencies that study drug prices, and cardiologists are in agreement that the price point of the PCSK9 inhibitors is simply too high, even for a drug that so greatly reduces LDL-C[16], especially considering the possibility that they will be used by so many millions before the end of the decade.

People like Martin Shkreli give “Big Pharma” a worse reputation than it deserves, but he’s not the only culprit. When considering the price of drugs, the price of research and development and the demand must be considered. If the United States accepts the lion’s share of the responsibility for worldwide medication research and development, the costs to consumers in the United States may become untenable in this age of costly pharmaceuticals.

The introduction of PCSK9 inhibitors to the drug market could truthfully bring an end to high cholesterol and dramatically reduce cardiovascular disease across the world. However, Americans simply cannot bear the economic weight when the drugs cost each user nearly $15K annually for the rest of his or her life. The price must be reduced, but only time will tell by what means such a change will occur.

 

Bibliography

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MNvest Provides Source of Previously Untapped Capital for Minnesota Entrepreneurs and Small Business Owners

The passage of MNvest legislation will boost startups in Minnesota, grant all entrepreneurs access to previously unattainable capital, and allow everyday Minnesotans to invest and support local businesses.

MNvest is a Minnesota law permitting equity, or investment, crowdfunding for the masses.  “As opposed to a Kickstarter or Indiegogo approach, where you’re getting some kind of reward or a product for your participation, you’re actually buying a share in the entity you’re supporting,” explains Scott Cole, volunteer Board Member at MNvest.org, a 501(c)(4) organization supporting and promoting investment crowdfunding in Minnesota.

We’re all entrepreneurs here.  Raising capital and finding investment streams is difficult, but vital, for survival.  Gaining access to accredited investors through a traditional Initial Public Offering (IPO)[1]  is expensive and complicated, often beyond the reach of startups, which severely limits access to capital.  MNvest looks to simplify the fundraising process for entrepreneurs and increase the velocity of investments through equity crowdfunding.

The MNvest legislation will unleash a realm of investment opportunities to the Minnesotan entrepreneur and small business owner, offering additional flexibility for capital financing in the startup and traditional business sectors.  In the life science space, the MNvest platform could be used to complete some upfront project or create a minimal viable product.  MNvest is perfect for small businesses that don’t necessarily have a tangible product or gift to give to supporters, which is vital for donation-based crowdfunding campaigns.  Companies using the MNvest platform might be your traditional businesses like hardware stores, coffee shops, or breweries that offer more of a service than a concrete product and benefit from having a built in local constituency, providing additional capital options for startups and small businesses beyond the traditional channels.

MNvest legislation provides all Minnesotans an opportunity to invest in local businesses and entrepreneurs and put their money right into the hands those who need it most, without having to be a qualified accredited investor. 

Equity crowdfunding was legalized in the United States with the passage of the Jumpstart Our Business Startups (JOBS) Act in 2012.  However, without new rules to accommodate non-accredited investors, this legislation only benefited provided accredited investors, the wealthiest three percent of Americans, with investment opportunities.  Congress charged the Securities and Exchange Commission with creating new rulesa platform where non-accredited investors- more of the everyday person- could participate in equity crowdfunding.  However, to date no regulations have been finalized[2] .  The passage of MNvest will provide a much more attractive mechanism to make investments accessible to a wider range of Minnesotans.

“This allows you and I and any average person who doesn’t have a bunch of money to make that equity investment,” explains Scott.  It provides the opportunity for the average Minnesota to invest in businesses and people right in their neighborhood, keeping the money local. 

Want to support that running store or craft shop on the corner?  MNvest makes that possible, democratizing investment opportunities.  “For small businesses trying to raise money, this is an opportunity to bring in local supporters in to help fundsupport their businesses, to invest in their business, and to have the transaction side of that be easy for the investor and inexpensive for the business,” explains Scott. 

MNvest makes it possible to funnel capital flow from both accredited and non-accredited Minnesotan investors through a streamlined, virtual portal system.

Currently, there are no limitations or guidelines[3]  for the amount of money that can be raised through MNvest online portals.  Issuers- people or businesses raising the money- will set some amount that they want to raise through the MNvest portals. Equity raised will then sit in escrow until some percentage of that total set amount is reached for the issuer “to be responsible for the intention for using the money”.  This amount it likely to be set by the issuer at 75-85% of the total funds to be raised, whatever minimal amount the business needs to be functional or reach some end goal.  Just like in Kickstarter, the money sits in escrow until the total sum of capital is raised.  If that goal is not reached, the funds are all returned to the investors.

For any potential equity investors, it’s important to recognize that no exchange is currently provided for underoffered by MNvest and any funds provided to an entitycash flow should be viewed as a long term investment in the success of the business.  “In this scenario, if you make an investment in the local coffee shop or local hardware store, or whatever that local business is, it might be that your investment is just to know that you are able to go to that hardware store, know that it is still going to be there serving your community.  But the anticipation isintention was for the business community to create anthe exchange so that a person like yourself and me could redeem our shares at some point in the future at a gain,” explains Scott.

The MNvest legislation was signed into law by Governor Mark Dayton last June, and quickly passed through the Minnesota House and Senate.[4]   The legislation hit a snag in the Commerce Department as new rules and processes needed to be created to support MNvest, but the final version of the law and regulations are expected to be released any day now.  And then it’s off to the races.

NowAfter the base legislation is passed, the next step for MNvest.org is spreading the word, building a community around the created legal infrastructure, and most importantly finding issuers and portal operators to start using and trying out the system.  The group will launch a new, updated website in the near future with lots of information for people wanting to invest or raise capital through athe MNvest approved platform.

MNvest holds great potential for the Minnesotan life science entrepreneur and startup.

“…I am really interested where the startup community wants to plug themselves into this initiative.  In the life sciences…I would really be anxious to learn who the prospects are that might be willing to give this a try.  And even if we are not quite ready, meaning that there is not a portal ready to begin having a conversation with the prospects, and laying out the understandings that are needed so that we are closer to being ready when the portals are ready,” says Scott.

Are you an entrepreneur interested in trying out MNvest to help finance your business?  Contact MNvest.org at info@MNvest.org or click here to become a registered portal operator.

Sneaky Salmonella's ability to survive in dry foods challenges common perceptions of food risk

Salmonella. We’re all familiar with the bacterium that stops us from eating raw cookie dough and has us double- and triple-checking our meat thermometers. Common knowledge tells us that if we follow certain precautions, we can avoid a terrible bout of food poisoning. However, it is becoming increasingly evident that salmonella can also survive for several months in dry foods such as nuts, dry milk, crackers, and chocolate, revealing that it may be a greater threat to food safety than generally understood.

The public has been aware of the risks of salmonella for decades. Every year, salmonella is responsible for approximately one million cases of foodborne illness and three hundred eighty annual deaths in the United States, with risk of further complications in young children and the elderly. Usually, infected individuals experience symptoms such as fever, diarrhea, and abdominal cramps for four to seven days and recover without treatment.

Despite the associated threats, salmonella is not considered one of the more dangerous bacteria. Salmonella awareness literature, such as that presented by popular outlets such as foodsafety.net and webmd.com, commonly state that it is only a risk in raw meat and dairy, and so long as one cooks the food and cleans contacted surfaces, the risk is minimal.  In the past, it was often assumed that these precautions against salmonella were sufficient.

However, scientists studying salmonella have found that it can actually survive in a wide variety of host environments, including in the dry foods that sit on shelves. Most recently, Wonderful brand pistachios have been recalled due to salmonella outbreaks in several states, including Minnesota. These nuts are sold in many grocery stores and sit on shelves in countless households, thus demonstrating the need for greater awareness of salmonella in dry foods. Although it is not known exactly how these dry foods become contaminated, it is likely that salmonella capitalizes on the close quarters in industrial processing plants to travel from animal feces, to animal meat and dairy products, and eventually to dry foods.

Several recent studies have examined the extent to which salmonella can survive in a variety of dry environments; it was previously believed that a wet environment was required for survival. A current study from the lab of Dr. Irene Hanning at the Department of Food Science and Technology at the University of Tennessee examined the how different conditions- including acidity, temperature, and water content- affect salmonella survival.

Their primary finding was that salmonella is incredibly versatile and can adapt to a wide variety of environments, which explains how it can travel from a cow’s intestines, to soil, to a factory, to packaged food, and finally into humans. The study also found that not only could salmonella survive for long periods of time in dry foods, which was a relatively new discovery, but also that living in dryer environments actually makes the bacteria more resistant to the heat inactivation typically used to make foods safe during processing.[5] It is likely that this variable ability to survive at higher temperatures, which depends on the moistness of the environment, contributes to processing plants’ inability to fully eradicate salmonella from drier foods.

A second study done by the team of Dr. Larry Beuchat at the Center for Food Science and Technology at the University of Georgia looked into the ability of salmonella to survive in dry snack foods. Researchers in Beuchat’s lab exposed different varieties of peanut butter and cheese based cream-filled crackers to salmonella.  They found that the bacteria was able to colonize and survive in all of the food products, living the longest in cheese-filled crackers, likely due to the dryer environment. These studies show that salmonella is no longer something that we can combat with thorough baking and cleaning practices alone.

Since the beginning of 2016, two salmonella outbreaks have spread across the United States in dry food products, both reaching Minnesota. The first contamination discovered was in RAW Meal Organic Shake and Meal Products, causing illness for thirty-three people in twenty-three states. The second was in Wonderful pistachios, causing illness for eleven people in nine states.

This widespread contamination of dry food products is concerning for a number of reasons. First, unlike meat, consumers often buy products like nuts and consume them without heating to temperatures that would kill the bacteria. As a result, if a dry food product is contaminated, illness is significantly more likely.

Second, salmonella can live for up to six months in dried foods, many of which have a long shelf life. Consequently, even if there are recalls on contaminated foods, many people will have the tainted product in their homes for weeks or months, extending the window in which salmonella could cause illness from the damaged foods if consumers are not made aware of the recalls.

Third, and perhaps most importantly, these outbreaks raise questions about whether sanitation standards in food processing plants are taking salmonella’s presence and increased temperature resistance in dry food products into account. According to Dr. Linda Harris, the Associate Director at the Western Institute for Food Safety and Security at the University of California, Davis, it only takes the ingestion of ten salmonella cells to make a person sick. So perhaps the standards for food products like chicken and eggs, which will be cooked by consumers thus eliminating any remaining salmonella, are not high enough for products such as pistachios, which will be eaten without any additional preparation.

This may be a moment for major food processing companies to reexamine their food safety practices. Enforcing more stringent inactivation measures for dry food products could be a step toward avoiding future outbreaks. However, perhaps a more immediate first step is to change household knowledge about salmonella. Greater public awareness of the potential dangers of salmonella in dry foods could be instrumental in preventing unpleasant, and potentially deadly, food poisoning for families across the nation.

 

Bibliography

Andino, A., & Hanning, I. (2015). Salmonella enterica: Survival, Colonization, and Virulence Differences among Serovars. The Scientific World Journal, 2015, 520179. http://doi.org/10.1155/2015/520179

Center for Disease Control. (2016). Retrieved from http://www.cdc.gov/salmonella/montevideo-03-16/index.html

Diez-Gonzalez, F. (Speaker). (2016, March 15). “Exploring the Secrets to Salmonella’s Success” MPR News. Retrieved from http://www.mprnews.org/story/2016/03/14/salmonella

Harris, L. (2009). Building a Better Understanding of Salmonella in Pistachios. Retrieved from http://www.foodhaccp.com/1news/050109o.html

 Mann, D. (2015). Survival of Salmonella in Cookie and Cracker Sandwiches Containing Inoculated, Low-Water Activity Fillings. International Association for Food Protection. Retrieved from https://iafp.confex.com/iafp/2015/webprogram/

HIV Evades Previously Successful Gene Editing Treatment, Causing Disease Resistance

On March 4th, a research team from Temple University successfully removed latent human immunodeficiency virus (HIV) from infected human cells using an emerging gene editing technology called CRISPR-Cas9 (2), a promising treatment that could improve the quality of life for millions (1). By April 19th, a competing team demonstrated that HIV could mutate to escape CRISPR-Cas9. Rather than discrediting Temple University’s findings, the competing research demonstrates process as a core tenet of science and underscores the importance of collaboration.

More than 35 million people in the world are infected with HIV and that number continues to grow (1).  Once HIV enters the body, it targets key immune cells, such as T-cells, and incorporates HIV genetic information into the host genome. At this stage, HIV can remain latent- the viral DNA exists in the host genome but is not being used to produce more HIV (4). In its active form, HIV replicates using the host cell’s own mechanisms and destroys T-cells.

HIV targets a specific subset of T-cells, called T-helper cells (TH cells), that are responsible for fighting infection.  Acquired Immunodeficiency Syndrome (AIDS), HIV’s deadly successor, occurs when HIV has drastically reduced the TH cell population to the point that the body’s immune system is ineffective (5).

Currently, HIV is managed through antiretroviral treatment that prevents viral replication within the body6. This prevents HIV from spreading to other cells and can aid in restoring the TH cell population. While antiretroviral therapy has been effective in prolonging and improving the quality of life, the drugs are expensive and must be taken vigilantly for the remainder of one’s life. Antiretroviral treatment does not eradicate HIV in its latent stage and some strains of HIV have developed resistance to the treatments6. At this point in time, HIV is impossible to cure.

CRISPR offers the unique opportunity to remove HIV in its latent stage from the genome of cells, effectively curing cells of infection and preventing reinfection by the virus. 

The advent of CRISPR-Cas gene editing technology marked a huge advance in modern science.  Clustered regularly interspaced short palindromic repeats (CRISPR) and the CRISPR associated proteins (Cas) provide immune protection to bacteria, but have recently been harnessed as a potent gene editing technology (3). CRISPR-Cas systems are capable of modifing DNA in cells, including human cells. CRISPR has the potential to edit out genes responsible for detrimental human diseases as well as making genetic modifications that prevent mushrooms from browning on the shelf of a grocery store. The applications of CRISPR are seemingly limitless.

Upon CRISPR’s release, researchers at Temple University were immediately interested in using CRISPR-Cas9 to treat and possibly cure HIV.  The Cas9 protein can be “programmed” to target removal of specific segments of a genome using a genetic template created by researchers (3).

At Temple University, Rafal Kaminski and his team used CRISPR-Cas9 to effectively remove HIV from the genome of human TH cells in a petri dish, the first step to making modifications in a living organism. The CRISPR-Cas9 treatment prevented HIV infection of treated human THcells and inhibited viral replication in peripheral blood cells from HIV+ samples. Kaminski  and his team had not only cured cells of latent HIV infection, they had prevented other cells from being infected by the virus.

The possibility of curing HIV using CRISPR-Cas9 was within reach. However, scientific breakthroughs rarely happen in one fell swoop and it was not long before a different research team found flaws in Rafal Kaminski’s model.

Six weeks later, Zhen Wang of McGill University published evidence that HIV develops evasion resistance to CRISPR-Cas9 technology. The introduction of Cas9, while fostering deletion of HIV in some THcells, caused mutations in others that promoted HIV resistance and increased viral infectivity. These mutations occurred exactly where Cas9 bound to the DNA targeted for removal, indicating that Cas9 is responsible for the mutations. The mutated HIV replicated more quickly than control HIV, increasing the potency of the virus and the potential for infection (2).

Collectively, this research suggests that CRISPR-Cas9 technology requires some fine tuning before it will be successful for treating HIV. Several labs have confirmed the findings of Kaminski, including Wang, but there is no doubt that the CRISPR treatment must undergo revision. Wang suggested that targeting multiple sites within the HIV genome with a variety of templates may prevent the dangerous mutations that currently occur.

A room full of scientists will earnestly declare that science is a process, not simply a collection of facts. Science is driven by the kind of discussion demonstrated by Rafal Kaminski and Zhen Wang; no one is expected to have the answer right on the first try. Wang’s findings do not invalidate CRISPR-Cas use in HIV treatment, but advise caution. As is true with most things in science, harnessing CRISPR-Cas technology to treat HIV will be a process.

 

References

1.     Kaminski, R., Chen, Y., Fischer, T., Tedaldi, E., Napoli, A., Zhang, Y., Karn, J., Hu, W., and Kahili, K. (2016). Elimination of HIV-1 Genomes from Human T-lymphoid Cells by CRISPR/Cas9 Gene Editing. Scientific Reports. 6.

2.     Wang, Z., Pan, Q., Gendron, P., Cen, S., Wainberg, M., and Liang, C. (2016). CRISPR/Cas9-Derived Mutations Both Inhibit HIV-1 Replication and Accelerate Viral Escape. Cell Reports. 15. 481-489.

3.     Jink, M., Chylinski, K., Fonfara, I., Hauer, M., Doudna, J., and Charpentier, E. (2012). A Programmable Dual-RNA-Guided DNA Endonuclease in Adaptive Bacterial Immunity. Science. 333. 816-821.

4.     Douek, D. C., Roederer, M., and Koup, R. (2009). Emerging Concepts in the Immunopathogenesis of AIDS. Annu Rev Med. 60. 471-484

5.     Okoye, A.A., and Picker, L.J. (2013). CD4+ T cell Depletion in HIV Infection: Mechanisms of Immunological Failure. Immunolo Rev. 254. 54-64.

6.   National Institute of Health AIDSinfo. (2016). HIV Treatment: The Basics.

Showdown Between Two Groundbreaking Scientists Determines the Future of Genome Editing Technology

The United States Patent and Trademark Office (USPTO) currently has to resolve a billion dollar patent battle over a genome editing tool called CRISPR/Cas9. Jennifer Doudna of University of California, Berkley and Feng Zhang of the Broad Institute both claimed they made the major discoveries to the CRISPR system. With the potential to edit human genomes and cure genetic diseases at stake, the patent battle over CRISPR has become the center of attention for scientists worldwide.

CRISPR- or clustered regularly interspaced short palindromic repeats- is a genome editing technology that allows biologists and medical researchers to precisely edit parts of the genome along with a protein called Cas9, which acts as molecular scissors to cut DNA at specified locations [1]. Other genetic editing techniques such as transcription activator-like effector nuclease (TALEN) and zinc finger nuclease (ZNF) have been around since the early 2000s, but the simplicity and efficiency of CRISPR has led it to become the superior genome editing technology.

CRISPR’s genomic editing capability has a wide range of potential functions. One major application is genetically modifying foods and crops; CRISPR can be used to genetically modify the common white button mushroom to gain resistance to browning [2]. Additionally, CRISPR has the potential to cure genetic diseases and be used as a cancer treatment. While much research must be done before this is possible, many scientists think CRISPR can revolutionize therapeutics.

The CRISPR legal battle arose when the Broad Institute paid extra to expedite the patent process, giving them several patents that cover the use of CRISPR in eukaryotic organisms. This would allow them to use the technology in all multicellular organisms, ranging from mice to humans. Dr. Doudna and UC Berkeley filed an earlier patent application, but the Broad Institute argued that the application of CRISPR in eukaryotes was strictly speculation in Dr. Doudna’s work.

While the Broad Institute was the first to receive the patent, lawyers from UC Berkeley argued that Dr. Zhang and the Broad Institute overstated their discoveries in the patent application and never demonstrated or documented such genetic capabilities, specifically the use of tracrRNA- an RNA molecule that activates the DNA cutting segment of the CRISPR/Cas9 system. In addition, UC Berkeley lawyers pointed out that Dr. Zhang omitted several co-inventors from the patent application, which they argue was “deceitful intent”.

Both Dr. Doudna and Dr. Zhang were groundbreaking scientists even before the CRISPR discovery. Dr Doudna was awarded the prestigious Alan T. Waterman Award for her work in RNA crystallization and function while working at Yale University. Comparatively, Feng Zhang was featured in 35 Innovators Under 35 in 2013 for his work with optogenetics- a technique which uses light intensities to control light-sensitive cells- to cure psychiatric diseases in mouse models.

Despite their accolades, the influence of money cannot be overlooked, especially in a case this monumental. A 2015 report from the renowned global market research firm MarketsandMarkets projected the global genome editing market to be worth $3.5B by 2019 [3], a $2.7B increase from 2014. Additionally, the report stated, “By technology, the market is divided into CRISPR, TALEN, ZNF, antisense technology, and other technologies. Of these, CRISPR will account for the largest and the fastest-growing segment of the global genome editing market by 2019.”

Due to the financial potential, many scientists are investing in CRISPR-focused biotechnology companies. Dr. Doudna and Dr. Zhang, along with leading geneticist George Church, cofounded a biotechnology startup called Editas, which plans to use the CRISPR system to create personalized human therapeutics. The patent battle led to Dr. Doudna leaving this company and starting a rival biotech startup called Caribou Biosciences, Inc.

While the financial implications of the CRISPR breakthrough are immense, many people around the world are more concerned about the ethics behind the new technology. Since her CRISPR paper was published, Dr. Doudna has traveled all around the country discussing the issues of human modification with fellow scientists, congressmen and women, and even White House Officials. The major concerns are the implications of editing human eggs, sperm, and embryos.

 The Napa Bioethics Forum, a small consortium of scientists including Dr. Doudna, met in the spring of 2015 and have since urged researchers to avoid using CRISPR in human research until the precision and capabilities of the technology have been further explored [4].

Despite the recommendation by Dr. Doudna and the Napa Bioethics Forum, Chinese researchers led by Junjiu Huang, a genomic engineer at Sun Yat-sen University, have studied the use of CRISPR in nonviable embryos, or embryos that cannot result in live births. Only a fraction of the embryos maintained the genetic manipulation, while others showed incorrect cuts within the DNA[5]. These results point to the serious challenges with CRISPR and demonstrate that more research must be done before it is applied to human therapeutics.

The potential of CRISPR is promising, but no one knows how far the technology will progress. With the potential to make billions of dollars in human therapeutics on the line, the patent battle over CRISPR will only become more heated.

 

Bibliography:

Baltimore, D. et al. (2015). A prudent path forward for genomic engineering and germline gene modification. Science Perspective. http://science.sciencemag.org/content/348/6230/36.full

Begley, S. (2016). Clash of scientific titans: CRISPR hits the courts, with money and prestige at stake. STAT. https://www.statnews.com/2016/03/08/crispr-patent-fight/

Begley, S. (2016). In the CRISPR patent fight, the Broad Institute gains edge in early rulings. STAT. https://www.statnews.com/2016/03/18/crispr-patent-dispute/

Doudna, J. (2015). Genome-editing revolution: My whirlwind year with CRISPR. Nature Comment. http://www.nature.com/news/genome-editing-revolution-my-whirlwind-year-with-crispr-1.19063

Gill C. (2016). Gene-edited mushroom created by Penn State researcher is changing GMO dialogue. Penn State News. http://news.psu.edu/story/405406/2016/04/19/research/gene-edited-mushroom-created-penn-state-researcher-changing-gmo

Jinek, M., et al. (2012). A Programmable Dual-RNA-Guided DNA Endonuclease in Adaptive Bacterial Immunity. Science 337, 816-820.

Liang, P. et al. (2015). CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes. Protein & Cell 6. 363-372.

Marketsandmarkets.com (2015). Genome Editing / Genome Engineering Market by Application (Cell Line Engineering, Animal & Plant Genetic Engineering), Technology (CRISPR, Antisense, TALEN, Zinc Finger Nuclease) & End User (Biotechnology & Pharmaceutical, CRO) - Global Forecast to 2019.

Regalado, A. (2015). CRISPR Patent Fight Now A Winner-Take-All Match. MIT Technology Review. https://www.technologyreview.com/s/536736/crispr-patent-fight-now-a-winner-take-all-match/

Servick, K. (2016). Accusation of errors and deception fly in CRISPR patent fight. Science Community.

http://www.sciencemag.org/news/2016/03/accusations-errors-and-deception-fly-crispr-patent-fight

Yeadon, J., (2014). Pros and Cons of ZNFS,TALENS and CRISPR/CAS. The Jackson Laboratory Blog Post.  https://www.jax.org/news-and-insights/jax-blog/2014/march/pros-and-cons-of-znfs-talens-and-crispr-cas

Mayo Clinic Business Accelerator Startup grandPad Takes Strides in Senior Market

The mantra that drives Scott Lein, CEO and Co-Founder of GrandPad, to build intuitive, transparent, and engaging technology that enables seniors to enjoy life to the fullest.

The GrandPad tablet fills a key technological void: a mobile device that is not only user friendly for seniors, but truly connects seniors with their loved ones. Every aspect in the design of GrandPad has been tailored to suit the senior demographic, assuming absolutely zero prior computer experience, so much so that GrandPad stands by their “90/90” rule: A 90-year-old can fall in love with GrandPad within 90 seconds of opening the box. 90 seconds: the approximate length of time it takes to turn on and get through step two of an iPad set-up process.

How can a 90-year-old fall in love with GrandPad within 90 seconds of opening the box?

First, the device arrives pre-charged and instantly turns on; there is no “on” button. This alone prevents any negative first impressions with suspicions of complicated technology. Second, the tablet arrives pre-configured and set-up with ultra-fast Verizon 4G LTE connectivity. Absolutely no “set-up” for the GrandPad is required. Thus, during the 90 second trial window, rather than configuring Wi-Fi networks, setting up Apple IDs, etc., the senior is experiencing the feel of the device – a 7” tablet, in a non-slip case- and, using a special stylus designed for seniors, is interacting with the device by moving through the various easily seen applications.

GrandPad easily allows seniors to:

1)   place phone and video calls

2)   receive and send email via voice recognition

3)   view family photos and videos

4)   take and send pictures using the built-in camera

5)   see the current weather for each family member’s location

6)   play a variety of games

7)   listen to music

8)   “lookup” anything via Wikipedia

9)   and call an Uber.

The result? They fall in love. The countless pictures uploaded to Facebook and Instagram throughout the family get automatically pushed to GrandPad, making sure Grandma and Grandpa are constantly in the loop. They can place a hassle-free video call and easily stay involved and connected to their family. Finally, Grandma and Grandpa have a device that keeps them simply connected to their family.

The GrandPad Journey

After Scott first introduced his 80-year-old mother to Skype, the video calls were an instant hit and quickly became a regular part of their weekly routine. However, over time the calls that had brought so much joy to both Scott and his mother crept further and further apart. Something was always wrong. Skype needed to be updated. The network modem needed to be restarted. The PC froze. An unrelated application went awry and demanded precedence.

These “normal” issues are solved with secondhand precision by tech savvy “youngsters”, but present a very real roadblock for less computer literate seniors. Indeed, these challenges left Scott’s mother constantly confused and eroded her self-confidence. Skype video calls went from bringing joy to being psychologically and physiologically harmful.

The problem was clear: technology is built for people 20 years of age, not 90 years of age. Nevertheless, conventional wisdom says that seniors just need to be trained, they need to be pushed, and they need to try harder. After all, seniors are very smart people, there’s no reason they can’t adapt. Unfortunately, this just isn’t true. When Scott realized there was no technological solution for seniors, GrandPad was born.

Solving this technological problem wasn’t exactly straightforward, but began without preconceived notions regarding what the solution should be. Instead, Scott and his son- Issac Lein, GrandPad Product Designer and Co-Founder- approached the process very scientifically and allowed the solution to reflect the problem.

For example, after quickly realizing a tablet was the best form factor, what was the right size? Many iterations later, the 7-8” size was ultimately chosen as providing the best balance between weight, screen real-estate, and portability. Prototypes were built, tested, and the results were carefully recorded. These results, in turn, influenced the resulting prototype, and the “build, test, learn” cycle continued. In what must have been a dizzying initial 6 months, over 1,000 iterations of prototypes and software were cycled through.

Minnesota Connection

Scott grew up on a farm in Decorah, Iowa- a small town about 1-hour south of Rochester, Minnesota. Scott attended Luther College in Decorah, Iowa where he double majored in computer science and business. After college, Scott worked in the Minneapolis-St. Paul area for nearly 22 years where he held an executive position with BestBuy for over 7 years, as well as positions with Target and Accenture. His relocation to Silicon Valley occurred roughly 6 years ago following a 3-year stint living in Charlotte, North Carolina.

Today, Scott splits his time between Orange County and Wabasha, where he owns a home. Despite Scott’s part-time Midwest residency, there’s clearly good reason to consider himself a “mid-west guy.”

Although GrandPad originally grew out of the Mayo Clinic Business Accelerator (and remains a current tenant), the organization is split, roughly 50/50, between Orange County and Minneapolis. The Orange County division houses the technological aspects, whereas the Minneapolis division houses the operational aspects of the company. Although separated by ~1900 miles, this company division seems to make a lot of sense. Technological innovation is the heartbeat of Silicon Valley and first class customer care is instinctive for Minnesotans.

The Future

Currently there are approximately 20 million seniors in the US and this population is expected to increase more than two fold, to ~70 million, by 2030. Accordingly, it doesn’t take a mathematician to understand the market for GrandPad users will follow a similar trajectory. Expanding globally, this market cap increases roughly 10 fold and therefore, on solely the basis of potential customers, the future for GrandPad is very bright.

Very few companies are targeting the senior demographic, leaving this particular market relatively untapped. Although Scott Lein and GrandPad are shaping up to be leaders in the tablet market, it remains unknown whether or not other technology platforms targeted at seniors will also gain a foothold.

Advice

For aspiring technology entrepreneurs, Scott offers two pieces of advice. First, identify your goal and focus everything you do around that very specific goal. Critical to success is doing one thing well – “don’t be an inch deep and a mile wide”. Startups lack two precious resources: time and money. Accordingly, do not be afraid to say no to anything that does not directly support your mission. Second, put the customer first, resolving any issues that arise ASAP. Technological innovation should be customer driven, and this simple, yet fundamental point, should be imprinted into the DNA of your company and employees.

Lessons in Community Collaboration- What can Biotech Centers Learn from the Cooperative Efforts of Ceva, Grafton Scientific Staffing, and Johnson Country Community College?

In Kansas City, Kansas, the cooperative efforts of large vaccine producer Ceva,  Grafton Scientific Staffing, and Johnson County Community College led to significant benefits for all three parties. 

Ceva has better-trained employees and less employee turnover.  Grafton Scientific Staffing has an expanded market niche.  And Johnson County Community College is able to train new biotech employees and help them maintain employment, which is in line with their mission.

Depending on how far back you want to go, you can say that “the story began” when Johnson County Community College (JCCC) was first established in 1967.  Or you can say the story really began when a prominent research facility, Stower’s Institute for Medical Research, was established in Kansas City in 2000 and a strong biotech training program at JCCC was required with various levels of certifications and degrees to provide the institute with skilled workers.

This particular story began, however, when French company Ceva bought a local Kansas City vaccine company in 2005 and began to build on its vaccine expertise.  Ceva absorbed many biotech graduates from JCCC but consistently needed more trained workers than were available.  The need for skilled workers was acute and projected to continue into the future.

Ceva needed trained workers but didn’t have time for them to complete one of the usual biotech training programs at JCCC, which were two to four semesters in length.  [B1]  

Ceva spoke to scientific staffing agencies in the area and asked, “What can you do to help us?”  Grafton Scientific Staffing actually took the lead in solving the problem; they spoke with Ceva and Ceva spoke with JCCC. 

JCCC determined Ceva’s needs and developed a curriculum that fit the vaccine developer’s time constraints.  Grafton assumed actual responsibility for the students, providing them as contract employees to Ceva until their training was completed[B2] .  Ceva cooperated with JCCC and made arrangements for the contract employees to complete thirty-five hours of training over two weeks, being absent from the plant during those training hours.

To date, ten[B3]  training sessions have been completed.  New employee retention at Ceva is much improved. Grafton has defined itself in a new way in the KC scientific staffing market.  And JCCC is able to fulfill its mission to a greater degree.

This is a happy story, but what were the tough points along the road?  What were the places at which people needed to demonstrate creativity and flexibility, so that these relationships could develop? 

First, it should be mentioned that before the new training and employment structures were developed, Ceva, Grafton, and JCCC already had long-standing relationships.  The different parties felt that they could rely on each other.  Dr. Luanne Wolfgram, a microbiology professor at JCCC, was particularly known to provide excellent training for people entering biotech fields. 

Still, even given this history and level of trust, all parties were called upon to be creative and flexible during the process.  First, Ceva needed to articulate its needs and repeat those needs until someone, in this case Grafton, heard and responded.  Grafton actually took a leadership role in suggesting a new type of training process and persuaded Ceva and JCCC to try it.  Dr. Luanne Wolfgram at JCCC needed to demonstrate extreme flexibility, as the training of Grafton-based potential hires occurred on a “pop-up” basis, whenever a critical number of new students accumulated.  Dr. Wolfgram has a full time job even without squeezing in this on-the-spot training, so her flexibility was key.  Ceva needed to be flexible in finding a way for the Grafton-based new hires to be absent from the plant as much as needed to accomplish their training.

In short, these creative responses, which resulted in well-trained and more stable new biotech employees, first required that all parties had a history with each other and trusted each other.  A further critical requirement was that all parties were willing to take some risk, venture into unknown territory, and yield when necessary.

Bioagriculture Startup MNPHARM Develops Plant-Based Individualized Cancer Treatment

Imagine seeing an individualized medicine treatment grow right before your eyes.  Dave Roeser and MNPHARM want to make that happen.  Using indoor agriculture technology developed in sister company Garden Fresh Farms, MNPHARM harnesses the power of plants to produce personalized immunotherapy treatments.  The emerging company uses genetically modified tobacco plants to generate plantibodies- or plant-based drugs- and is well positioned to make strides in the rapidly developing plant biologics market.

Vaccines are powerful public health tools that protect the body from infection, prevent the spread of disease, and train the immune system to home in and destroy antigens.  White blood cells play a major role in the immune response.  Specialized white blood cells called lymphocytes are the main cell types responsible for acquired immunity, where the body recognizes and “remembers” foreign antigens- proteins present on the cell surface that can elicit an immune response.  After exposure to certain antigens, B lymphocytes produce and secrete specialized proteins called antibodies.  These antibodies can bind to the antigens, leading to eventual cell destruction.

Antigens help the body recognize its own cells from infectious microbes or damaged and diseased cells.  After exposure to “non-self” antigens on foreign microbes, the immune system develops memory toward these infectious particles, quickly shutting down potential infection if the microbe should re-enter the body.  Most vaccines are composed of weakened or dead microbes, which introduce these “non-self” antigens to the immune system, allowing B lymphocytes to mass produce antibodies specific to those infectious microbes and protect the body against future infections. 

Conventional vaccines are produced from chicken eggs; a typical vaccine manufacturing company burns through about $600,000 of chicken eggs in a single day.  This type of vaccine development takes about six months, a slow process that allows little flexibility to pivot production if the infectious viral strain mutates and hampers the ability to address key public health issues in a timely manner.

MNPHARM uses a disruptive approach to generate plantibodies, or plant-based vaccines.  Instead of chicken eggs, MNPHARM uses tobacco plants as vaccine-production factories.  MNPHARM’s plantibody approach leads to a much faster, cheaper, and safer vaccine production than conventional methods.  This method uses no animal products, eliminating the risk of microbial contamination in the final product.  Most important, the plantibody vaccines are generated in only six days, not six months.

MNPHARM’s plantibodies are produced in small batches by design, making them perfect to treat rare diseases.  Plantibodies may play a vital role in the individualized medicine space and MNPHARM is well positioned to break into the cancer vaccine market with this technology.

Immunotherapy- medicinal treatments that boost the power of the immune system- is a very active area of cancer research.  Unlike preventative vaccines which stop a disease from ever appearing, therapeutic vaccines attack a disease while it’s occurring.  Cancer therapeutic vaccines can target and destroy tumor cells and even prevent cancer recurrence.  These vaccines can stimulate the body’s immune system to detect, home in, and extinguish cancer cells already present in the patient.

Cancer cells by definition are foreign substances that are recognized by the immune system through a couple different mechanisms.  These cells can present higher levels of “self” antigens than healthy cells, have antigens on their cell surface which are not normally found in that specific tissue, and can present novel antigens from gene mutations.

Dave Roeser and colleagues developed innovative, disruptive technology to grow plants indoors in a cheaper, resource-efficient manner at Garden Fresh Farms.  But they always dreamed of using the technology for cancer treatment.  MNPHARM uses the same rotating garden technology already proven in Garden Fresh Farms to grow their tobacco plants and produce plant-based medicine in Minnesota all year long.     

The whole process starts with bacteria and a little bit of molecular cloning.  With MNPHARM technology, a tumor sample is taken from a cancer patient and processed using the MNPHARM biopsy kit.  DNA specific to the cancer cell is isolated, which codes for cancer-specific antigens.  The DNA is spliced into a cloning vector- a piece of circular double-stranded DNA that does not insert into the bacterial genome and synthesizes its DNA independently from the bacterium’s own genetic material.  The tobacco plants are infiltrated with the bacteria and the plant synthesizes the cancer antigen from the vector-containing DNA.  After just six days, the tobacco leaves are ground up and the antigens extracted and purified to get the final plantibody product.  This individualized plantibody can be used to treat patients and hopefully elicit a strong enough immune response to kill the cancer cells presenting that specific antigen.

MNPHARM is currently in collaboration with Mayo Clinic to further develop these plant-based individualized medicinal treatments.  How amazing would it be to walk through the Mayo buildings and see 8x4 foot rotating drums of tobacco plants, synthesizing your own personalized medicine?  In less than one week a patient could visit the clinic, have a biopsy taken, and receive specialized treatment, a process not possible without this disruptive technology. 

Business is on the upward trajectory for MNPHARM.  The company competed proof of concept of their technology in December 2015.  They are scaling up a vaccine-production facility in Maplewood and hope to eventually set up shop in Rochester.

Garden Fresh Farms uses Indoor Aquaponic System to Sustainably Farm in Minnesota all Year Long

Maplewood-based Garden Fresh Farms provides a disruptive solution to conventional farming.  Their unique system allows for sustainable, year-long, indoor farming, providing 24-hour fresh food to consumers regardless of location.

I had to opportunity to learn about Garden Fresh Farms and spin off company MNPHARM from Founder Dave Roeser at the Worthington Bio Science Conference a few weeks ago.  Garden Fresh Farms uses a novel, aquaponic system to grow produce.  In this system, both plants and fish are grown in a symbiotic water system.  The fish naturally create waste products, or fertilizer, which is pumped through the Garden Fresh closed system to the plants.  The plants use the fertilizer to grow and in turn also purify the water.  The cleaned water is then pumped back to the fish holding tanks, completing the loop.

Garden Fresh Farms uses aquaponics to grow produce through two different systems.  The first is a vertical system, where plants are grown on densely packed shelving straight up into the air.  These indoor farmers also grow plants in orbiting gardens- large eight by four foot rotating drums.  Currently, Garden Fresh Farms grows lettuce and herbs using these systems but is looking to expand in the near future.

The Garden Fresh farming methods use far less resources than traditional outdoor methods.  The plants are grown at much higher density than is possible with normal agriculture.  The vertical growth shelving units are packed tightly together, allowing four shelves to obtain light from one fixture.  The orbiting gardens can also be stacked nine feet high.  These features allow plants to be grown at very high density; Garden Fresh Farms can grow an equivalent one hundred acres of crop in a one square acre building.

Garden Fresh Farm’s disruptive growing structure minimizes the amount of resources needed for plant growth.  Their system uses 90% less water and 50% less energy than traditional outdoor farming methods.

It’s no secret.  Winter is a rough time in Minnesota to find good, fresh produce.  The food is often overripe and looks like it’s been there all week.  However, if you stumble upon Garden Fresh Farms produce in your local Lunds & Byerlys or Kowalski’s, the produce will be extremely fresh, even in January.  Twenty-four hours fresh to be exact.

Often the problem with produce distribution is getting the food that very last mile to the consumer.  Farms are often in rural areas, far from dense concentrations of people.  With the Garden Fresh Farms system, produce can be grown anywhere.  Right now, the company grows food in a warehouse in Saint Paul.  They can harvest their product in the morning, send it off to a distribution center by noon, and have the food on the shelves the very next day.  This whole process reduces food spoilage and waste and increases the nutritional value of the food.

The indoor growth system also means that all Garden Fresh Farms products are pesticide-free, a huge bonus for many consumers.

Garden Fresh Farms not only provides local, fresh food.  The company also has a deep-rooted social component. 

Garden Fresh Farms provides year-long farming jobs.  A total of twenty-five jobs would be created by converting one pole barn into a Garden Fresh Farms indoor growth facility.  The company has their very first public-private partnership in the works to begin in June 2016 in New England.  Garden Fresh Farms will convert an old, unused building into a farming factory, providing the over 30M people within a 100-mile radius of that site with local, fresh produce.  And jobs.

Garden Fresh Farms is a Community Supported Agriculture (CSA) farm.  Consumers can buy produce directly from the company to support local farmers.  In Garden Fresh Farm’s program, consumers sign up for 12-week increments and receive weekly bags of fresh produce plus recipe ideas.  The bags can be dropped off at several locations around the Twin Cities area. 

The benefits of the Garden Fresh Farms system don’t stop there.  The company’s unique produce growing process could actually help fight climate change.

Plants need carbon dioxide to grow.  Plants use carbon dioxide during photosynthesis- the process by which green plants convert sunlight into chemical energy which is used to power cellular functions.  Plants store the chemical energy generated during this process as the carbohydrate glucose, which later can be converted into the essential cellular fuel ATP.

Plants love carbon dioxide.  But we humans usually think of the substance in a negative manner.  Carbon dioxide is a greenhouse gas and makes up the largest percentage of all greenhouse gas emissions.  Excessive carbon dioxide production alters Earth’s normal carbon cycle and adds the heat trapping gas to the atmosphere, contributing to the gradually warming planet.

During photosynthesis, green plants use light and water to make their own food from carbon dioxide.  Plants use up the carbon and release oxygen at the end of the process, sequestering something that we don’t want and transforming it into something useful.

Farms are usually in rural areas, often very close to ethanol plants which produce carbon dioxide byproducts, something the Earth definitely does not want.  However, with the Garden Fresh Farms system, this carbon dioxide byproduct could be pumped to the indoor farms and sequestered by the growing produce through photosynthesis.  The plants could actually be used to “recycle” these carbon dioxide byproducts and convert it to something more useful for us all- food.

Garden Fresh Farm’s disruptive technology has earned them several awards and national recognition.  The group won the 2013 MN Cup Clean Tech and Energy Division and also won the Midwest Regional Clean Tech Open Competition and National Clean Tech Open Global Forum that same year.  In 2014, the company earned a Progress Minnesota Award, Eureka! Award, Green Products award from Saint Paul, and Sustainability Award from the City of Maplewood.

Two years ago, Garden Fresh Farms developed and launched a company called MNPHARM using the same aquaponics technology.  Check back later when we talk about MNPHARM and the potential to use tobacco plants as individualized medicine platforms.     

The final four are just the beginning: Rochester’s first Youth Startup Weekend cultivates youthful enthusiasm for entrepreneurship

During the third weekend of March, Rochester teens had an exciting opportunity to learn entrepreneurial skills and to become part of the Startup Weekend global phenomenon by creating and pitching their own startups. The ultimate goal was for each team to develop a fledgling startup with a Minimum Viable Product (MVP), or be on track to produce one, by the end of the 54-hour competition.

Despite hectic student schedules and a late-season snow, eager teens gathered at University Center Rochester on Friday evening, March 18th, for Rochester’s very first Youth Startup Weekend. From the initial pitch session and team formation through Sunday afternoon’s final pitch competition, the young participants were stretched and challenged, actively learning important entrepreneurial concepts and skills through the Startup Weekend format of collaboration, adaptation, and rapid iteration based on customer feedback.

Opening Night: Initial Pitches and Team Formation

Startup Weekends are fast-paced, immersive experiences—this one was no exception. Lessons in key entrepreneurial principles began immediately, even before the initial pitch round.

After explaining the key concept of a MVP—the simplest version of a startup’s product or service that still delivers its core functionality to the customer—emcee Michael Norton introduced the teens to the anatomy and art of the pitch. The teens then participated in a rapid-fire group brainstorming and pitching activity to get their creative juices flowing.

Next, the initial pitch round kicked off the 54-hour countdown.

Teen participants had sixty seconds to pitch their ideas to peers. In addition to identifying a problem and proposing a solution, each pitcher explained to the group why his or her particular solution was unique and what kind of team and skills would be needed to build that solution. Individual participants pitched fourteen ideas in all, after which all the participants voted to determine which ideas would move forward.

Teen participants were instructed to vote not by choosing which ideas they thought were the best in the abstract, but instead by choosing the three projects that they most wanted to work on during the weekend. That self-selecting process emphasized the concept of “Team >> Idea”—that having a strong team excited to work on a project is a better driver for a startup’s success than is an idea by itself.

Final Pitch Competition

The fast-paced weekend culminated Sunday afternoon with a Shark Tank-style pitch competition. The four teams pitching were DyverseUniverse, Smashoid, VolunTappr, and CampStarter.

Smashoid’s “fun and feverish” mobile game Dot Smash targeted socially connected entertainment. Each of the other three teams, however, created a tech-based platform or tool for fostering and strengthening real-life community connections. DyverseUniverse pitched a non-profit diversity outreach organization targeted to middle schoolers. VolunTappr pitched an app to connect volunteers with fellow community members or organizations in need of assistance. CampStarter pitched a website through which teens could share skills and interests by organizing their own summer camps.

Judging and Awards

The judges were local experts Emily Benner, Senior Vice President of Research and Product Development at Preventice Solutions; Dr. Mustaqeem Siddiqui, a Mayo Clinic physician and a Medical Director with Mayo’s Global Business Systems division; and Andrew Danielsen, Director of Business Development at Mayo Clinic Ventures.

The judging criteria consisted of three key elements for entrepreneurial progress: customer validation, MVP design and execution, and business model development.

Although the judges acknowledged the teens’ relative inexperience, their questions probed how well each team had practiced those three entrepreneurial elements while refining its initial startup idea and developing its MVP.

The judges’ questions themselves were important learning experiences for each team. In particular, the judges emphasized the importance of developing a clearly defined value proposition, identifying a customer base, obtaining useful feedback, differentiating oneself from competitors, and, of course, generating revenue.

The judges presented four awards, one for excellence in each of the three categories and an overall grand prize.

DyverseUniverse was recognized for Excellence in Customer Validation, Smashoid for Excellence in Business Model, and CampStarter for Excellence in MVP Design.

VolunTappr won the grand prize for overall excellence.

In addition to the public recognition, VolunTappr’s prizes include a legal consultation from Rochester law firm Dunlap & Seeger and the opportunity to interview for a Techstars++ residency. Now rebranded as Volunteerium, the all-female team is developing their app further in order to enter Technovation[MN]’s upcoming Appapalooza pitch competition.

Promoting an entrepreneurship culture in Rochester and Southeast MN

Perhaps the most exciting moment of all came Sunday afternoon when emcee Michael Norton asked, “who learned something new this weekend?” Both the student participants and the adult mentors raised their hands.

The Rochester Youth Startup Weekend organizers hope that the enthusiasm sparked by this exciting and successful event will generate additional momentum for holding a second Startup Weekend in November 2016, open to participants of all ages from Rochester and Southeast Minnesota.

By making Rochester’s Youth Startup Weekend a reality, these eager teens have gained extremely valuable new skills, self-knowledge, and a growing entrepreneurial mindset that they can apply in all areas of their lives—and of course we hope that some of these exciting projects will continue.

The teen participants also showed the adults that it’s possible to take the risk of giving ideas a chance to grow!

University of Minnesota Symposium gives Cutting-Edge Insight into the State of Neuromodulation

On April 14th and 15th 2016, The 4th annual Neuromodulation Symposium was hosted in Commons Hotel by the University of Minnesota. The Symposium is a yearly event where the brightest neurologists, engineers, scientists, and researchers from all over the world gather together to share new findings on neuromodulation, neuroprosthetics and solutions to many neuropathologies like Parkinson disease, stroke, paralysis, major depression, tinnitus, and epilepsy. The Symposium consisted of honorary speakers, panel discussions, and a poster contest showcasing hundreds of selected entries in a rigorous triple round judging process. 

Among the cookies, coffee and nearly record breaking 500 attendees, the most important discussion that takes place every year addresses the challenges that the field faces and how to move forward. It also is the perfect time to professionally vent about what problems and struggles we currently face with neuromodulation.

The State of Technology

In past years, the major issue with neuromodulation was simply determining the relative areas of the neural system to stimulate. Often considered as “dirty stimulation” since most of the equipment wasn’t very sophisticated for the task at hand, the goal was to find the structures to stimulate and create some positive outcome for the patient. Additionally, devices and software to visually and spatially image the brain were needed (better functional magnetic resonance imaging, fMRI, and functional near-infrared spectroscopy, fNIR).  Today, the technology still isn’t at the level of detail that it needs to be, but has improved greatly.

Most of the products that are currently available are either for sensing or stimulation. In the case of Parkinson’s, the focus of stimulation is to increase motor control or rehabilitate motor function. However, the voltage stimulation required to elicit a motor reaction is at the detriment 

of cognitive function. Cognitive function is not well studied and defined and more difficult to observe in comparison; the immediate consequences have yet to be analyzed. For most physicians, restoring physical ability is a major priority for patients with severe levels of disease. 

The primary issue with neuromodulation now is increased accuracy of devices that can sense and stimulate simultaneously, rather than one or the other. This is arguably best done with non-invasive therapy and devices using Transcranial Magnetic Stimulation (TMS), Transcranial direct stimulation (tCDS), Electroencephalogram (EEG), and ultrasound. The goal is to be able to treat and offer patients safe, noninvasive, cost-effective therapies that they could do in the comfort of their homes at some point in the future. While these therapies are presumably safer in the sense that there are no lesions and bleeding, the accuracy is often compromised due to external artifacts and noise present in the data compared to more invasive therapies such as deep brain stimulation (DBS).

Generalized or Individualized medicine?

In addition to creating more accurate and easier to use tools, the field has moved towards more generalized medicine in hopes of serving a vast majority of patients. Trends are very helpful but they oversimplify the complexity of the issues at hand; these diseases are incredibly complex. No two patients are alike. Simply meeting one Parkinson’s patient means just that, you only know one Parkinson’s patient and have exposure to only one expression of Parkinson’s disease. Physicians can’t make such assumptions for the sake of a more streamlined treatment process, as that would risk misdiagnoses. One could argue the need for more individualized and personalized care despite the logistical difficulty of feasibly accommodating multitudes of patients.

Building radios with biology: Physiologists versus Engineering Mindsets

This might hae been the biggest frustration and schism in the group. Most of the attendees of the Neuromodulation Symposium fell into one of two general categories: biologist/physiologist or engineer. Despite both fields being in STEM, the approaches towards solutions are very different, and for some reason we all can’t be friends. Engineering embodies a very linear thought process, whereas biology is holistic in thinking. Both have their merit and are valid in their own respects. Take building a radio for example. If you ask a physiologist and engineer to build a radio, the engineer will start by looking at the design already made for them and put the parts together accordingly. They know the circuitry and placement because it's laid out.  They even know why it works when it does work. The physiologist will poke around in the dark until they discover a circuit that functions with no means of explaining why. This is poetic metaphor for the human body as a puzzle.

Engineers think the body can be simplified and analyzed to its constituent parts. That all it takes to solve these diseases is adding more RAM or a better sensor, or creating a more detailed computer rendered model, but that’s not enough. Physiologists on the other hand, cherish the complexity of the body but have no idea how to read the data of the new devices to determine any conclusions to suit both themselves and their patients’ needs. Simply put, no one knows and understands what the other does or thinks. The lack of communication is problematic and frustrating.

Oddly enough, the biggest complaint throughout the Symposium was that we aren’t where we should be technologically despite decades of research. As much as many of us would love to live in a world that mirrors science fiction with all the answers written in the next chapter, it’s important to remember that complexity allows and calls for flexibility. There’s isn’t one solution based on one type of thinking to solve the human brain puzzle. The issue is multifaceted and interdisciplinary and needs solutions that mirror its complexity. But based on the siloed nature of university research institutions and industry, there aren’t spaces that foster interdisciplinary thought and practice. We don’t get the opportunity to share and learn outside of symposiums like this. Without these spaces and opportunity, we are being denied a more in-depth understanding of the brain and its function.

The need for science journalism and better public awareness

Despite the plethora of research done in the field of neuromodulation, only 3% of physicians will recommend it as a legitimate treatment option to their patients. It seems that there is an exclusive club for neuromodulation. If you know about you’re in, but everyone else isn’t allowed in on the secret. It’s easier as physician working in the academic setting at a top tier research institution where the latest research is at their fingertips. However, clinicians don’t necessarily have the same type of access to the research. Now it’s not entirely a problem of access per se, but that a good number of physicians are conservative towards new (experimental) therapies without enough evidence supporting the efficacy. Above all else, beneficial patient outcome is the highest priority.  Increasing awareness and availability about the research going on with neuromodulation will better aid physicians in making more educated decisions toward possible treatment options for their patients.