Skin holds off nearly all infections, but no match for biofilms

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Bacterial infections are a glitch.

The marvel that is the human immune system keeps us safe from billions of microscopic organisms every day. Skin may not look like much more than a soft and fragile surface, but intact and healthy, it represents an impenetrable wall, equipped with security sensors, armed guards, and decked out in a variety of traps, snares and proximity mines for good measure.

Cheer up kid, it’s worse than it looks. If we can get past the pattern-recognition receptors, those murderous macrophages, pools of acid sweat and gooey oils, those infernal helper bacteria— traitors!— and these new-fangled antimicrobial peptide bombs... we’ll still have all the internal defenses to deal with. But, we gotta’ job to do, kid... you didn’t wanna’ live forever, did you?Innate immunity is formidable: The result of an evolutionary arms race with pathogens that has spanned several hundred million years. The human immune system is really a combination of two overlapping systems: innate and adaptive immunities. While both are important, the ancient innate immune response is comprised of nonspecific defense mechanisms that form the first response to pathogens. Adaptive immunity is much more specific; it learns to specifically target pathogens we have already encountered and, therefore, are likely to encounter again.

Bacterial pathogens only stand a chance when things go wrong. And any medical procedure presents an opportunity for things to go wrong.

A breach in the skin—from a cut, for instance—creates the possibility for surrounding pathogens to enter the body. This is why, given the option, surgical procedures, like implanting a medical device, aren’t just performed anywhere. If cleanliness is next to godliness then the operating room is a holy temple. If bacteria get through that first line of defense, they can cause tissue or organ specific infections or even systemic infections with fatal outcomes.

XKCD.comImplanted medical devices are a double-edged sword, then. On one hand, they are a modern miracle of biomedical engineering; providing a synthetic solution where nature has failed. On the other hand, they represent a literal chink in the armor.

For reasons that aren’t yet completely understood, opportunistic pathogens are highly attracted to these implanted medical devices. Once discovered, the bacterial invaders quickly go to work colonizing the implant until a mature community, or biofilm, is established.

If the bacteria are allowed to establish a biofilm, it has successfully beaten the immune response. About the only option left is to relinquish the territory and hopefully contain the bacteria to that one location in the body. And because antibiotics are impotent against bacterial biofilms, the only effective solution is total removal of the implanted device along with any infected surrounding bone and muscle tissue. If that doesn’t sound bad enough, the patient is also at a significantly increased risk for recurrent infection on any new device.

But if a medical device could be imbued with its own innate immunity, then the implant would be more like human skin. The implant could prevent bacterial attachment and inhibit biofilm formation.

Researchers have long been focused on discovering ways to prevent bacterial biofilm formation on medical devices by modifying the material surface properties. But what if the best solution is simply to think of the implant surface as an extension of the natural surfaces in our body? The first line of defense for these natural surfaces isn’t special patterning or unique physical properties, but innate immunity.

Guangshun Wang, PhD, at UNMC, has designed antimicrobial peptides to coat the surface of metallic orthopedic implants, and specifically target MRSA. Not only do these proteins prevent MRSA biofilm formation, but they also recruit host immune cells to help clear any opportunistic bacteria.

The preliminary data looks promising, with impressive effectiveness against MRSA biofilms. Dr. Wang is now seeking corporate partners to sponsor additional proof-of-concept research specifically focused on coating orthopedic implants. The hope is that by adding these peptides to the implant’s surface, Dr. Wang’s technology will effectively imbue the medical device with its own first line of defense.

 

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UNMC-UNO Innovation Accelerator meets for first time

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The first UNMC-UNO Innovation Accelerator Gathering was held earlier this week, an event that was organized in part by the UNMC Department of Emergency Medicine's Research Coordinator, Thang Nguyen (at left). UNeMed's Michael Dixon (upper right) and Deepak Khazanchi, Associate Dean of UNO's College of Information Science and Technology. were also on hand.

The first UNMC-UNO Innovation Accelerator Gathering was held earlier this week, an event that was organized in part by the UNMC Department of Emergency Medicine’s Research Coordinator, Thang Nguyen (at left). UNeMed’s Michael Dixon (upper right) and Deepak Khazanchi (lower right), Associate Dean of UNO’s College of Information Science and Technology. were also on hand.

OMAHA, Neb. (Feb. 21, 2018)—The University of Nebraska Medical Center hosted today the first UNMC-UNO Innovation Accelerator Gathering, a small meet-and-greet between the College of Medicine’s Department of Emergency Medicine and the University of Nebraska at Omaha’s College of Information Science and Technology.

The informal meeting was held in the Linder Reading Room at the Michael F. Sorrell Center. The stated goal was the hope of fostering more collaborative projects between the two campuses.

“We wanted to get the channel open so there are no road blocks because there are so many great ideas,” said event organizer Thang Nguyen, MSN, FNP-C. Also a doctoral candidate at UNMC, Nguyen is the research coordinator for UNMC’s Emergency Medicine program, and an Advanced Practice Provider for Nebraska Medicine’s emergency department.

At the meeting, departmental leaders outlined for the group major areas of research interest and clinical expertise. They also suggested how those areas of interest and expertise might overlap, perhaps opening the door to future collaborations.

Michael Dixon, PhD, UNeMed’s President and CEO, also addressed the group with brief remarks. He explained how the University’s tech transfer and commercialization office in Omaha can help support the innovations that might grow from those collaborations.

“We just want to be a resource for you,” Dixon told the group. “Hopefully help commercialize your inventions and ideas into products that can go market and actually do what we all want them to do, which is help people live healthier lives.”

Future meetings are not yet planned, but a steering committee was established to help guide potential collaborators, ideas and projects.

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Nebraska lands top Pipeline awards

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Kansas City, Missouri (Jan. 25, 2018)—Nebraska entrepreneurs  were the toast of the show at a regional entrepreneurial awards ceremony last week, receiving recognition for entrepreneurial leadership, best pitch, growth and the Innovator of the Year.

During Pipeline’s annual The Innovators awards ceremony, Omaha startup founder and Nebraska native Evan Luxon was named the 2017 Innovator of the Year. Luxon, the co-founder of Centese—formerly known as Esculon—also won the Innovator Pitch Competition.

Last fall, Centese was among the first startup companies to sign on with UNMC’s incubator program, UNeTech. Centese is developing a self-cleaning chest tube that would be less likely to become blocked or clogged.

Nebraska also claimed the Entrepreneurial Leadership awards for the continued support and advocacy from the University of Nebraska, Nelnet, Prairie Ventures and Linseed Capital. The University of Nebraska’s Pipeline sponsorship includes contributions from UNeMed, UNeTech and the University’s tech transfer office in Lincoln, NUtech Ventures.

Pipeline is an entrepreneurial mentoring program in the Midwest that offers a handful of highly selective entrepreneurial fellowships each year. Fellows in the Pipeline program received hands-on training from successful entrepreneurs and mentors from around the region and across the nation. The program helps fellows refine their business plans, raise money and dramatically improve their chances for ultimate success.

The program culminates with the annual Innovators awards celebration.

Nebraska won a fourth award, the Pipeline Entrepreneur Growth award, which was presented to Lincoln resident and Bulu Box co-founder Paul Jarrett.

This also marked the first year that a UNMC student was selected to represent the University of Nebraska system in Pipeline’s Spotlight Entrepreneur program. The program allowed four student entrepreneurs to present their business plans at the pitch competition and to be recognized before an estimated 600 attendees at the awards show.

William Payne, a UNMC doctoral student of pharmaceutical sciences, presented his company, Simple Vet Solutions. It’s a software service that eliminates the extra time and energy required to meet FDA regulations for animal medications.

Simple Vet Solutions, according to the executive summary in the business plan, offers “secure and compliant management of veterinary prescriptions and feed directives for any size of livestock operation, veterinary practice, or feed distributor.”

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UNO, UNeMed expand tech transfer relationship

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OMAHA, Neb. (January 22, 2018)—The University of Nebraska at Omaha and UNeMed, the technology transfer office at the University of Nebraska Medical Center, have signed a new services agreement for UNeMed to be the exclusive agent for UNO.

“We’ve worked with UNeMed in the past, and it always went well,” said UNO Associate Vice Chancellor Scott Snyder, PhD “We wanted to make that process easier and more efficient for everyone, and this arrangement does that.”

Dating back to the mid-1990’s, UNeMed has received about 50 new inventions from UNO inventors. Most UNO inventions, however, are more recent, emanating from UNO’s cutting edge Department of Biomechanics. Perhaps one of UNO’s more noteworthy innovations led to the creation of a new startup company, Avert, which promises to help athletic teams quickly and accurately diagnose concussions.

The new arrangement with UNeMed removes many institutional hurdles, allowing faculty, students and staff at UNO to work directly with the technology licensing experts at UNeMed.

Michael Dixon

“This is perfect for us,” UNeMed president and CEO Michael Dixon said. “We have a long history of working with UNO, and many UNMC researchers have strong collaborative ties to UNO. Hopefully, this will allow us to partner more with UNO researchers and help develop their innovations into products that can have a positive impact in the market.”

Common at virtually every major university in the nation, technology transfer offices work to protect the discoveries, innovations and inventions of their researchers. Tech transfer offices like UNeMed help identify industrial partners that can bridge the funding gap between a discovery and a product on store shelves.

“To have the expertise and experience of the people at UNeMed at our disposal is a huge asset,” Snyder said. “This should be a huge boost for many of our faculty, students and staff that want to see their ideas developed into products that help people.”

Initially established in 1991 as the tech transfer office for the University of Nebraska Medical Center, UNeMed now serves all University faculty, students and staff at both Omaha campuses and the College of Dentistry in Lincoln. UNeMed’s sister office, NUtech Ventures, serves the remainder of the University’s resources in Lincoln and Kearney.

Working primarily with academic researchers and inventors, UNeMed protects University discoveries and innovations, securing 489 patents over the last quarter century. With 106 years of combined technology development and commercialization experience, UNeMed staffers help propel those innovations through development into products that help improve the lives of people everywhere.

Virtual Incision’s robots are on the verge of transforming complicated, highly invasive open surgeries into relatively simple laparoscopic procedures.

Common routes to commercialization include establishing relationships with industrial partners for sponsored research agreements, signing licensing agreements with established commercial entities or building new startup companies. For example, a UNMC surgeon and a UNL engineer collaborated on a surgical robotic device to create Virtual Incision, a biomedical startup. Virtual Incision recently announced a successful Series B financing round of $18 million.

Virtual Incision is just one of 58 new startups UNeMed has help build in its 26-year history. UNeMed has also helped UNMC secure an additional $6.32 million in sponsored research while processing more than 1,330 new inventions from University faculty, staff and students.

Those 1,330 inventions eventually resulted in 230 licensing agreements over the years, which amounts to a track record that helped place the University of Nebraska 35th out of 230 in a recent report from the Milken Institute, a non-partisan think tank. The placement puts UNeMed, NUtech Ventures and the University of Nebraska in the top 15th percentile.

The 2017 report ranked the University of Nebraska’s tech transfer efforts ahead of such institutions as the Mayo Foundation (36), the University of Wisconsin (39), Ohio State University (55), and the University of Iowa Research Foundation (59), to name a few.

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How we can help: Licensing and startups

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by Catherine Murari-Kanti, UNeMed | January 10, 2018

Part seven of a series

As part of UNeMed’s research commercialization activities, we routinely seek industrial partners to license University of Nebraska innovations. For this purpose, the University and industrial partners set up license agreements that describe the rights and responsibilities related to the use and exploitation of the intellectual property.

Licensing associates at UNeMed diligently market and license Nebraska’s technologies to appropriate industrial partners. Licensing significantly reduces researchers’ devotion of time and money. The licensee generally has significant financial, physical and labor resources to commercialize University intellectual property, allowing the masses to benefit from technologies developed at the University of Nebraska.

License agreements usually cover four key areas:

  • They stipulate that the licensee will diligently seek to bring the University’s intellectual property into commercial use for the public good.
  • Plan specified milestones that hold the industrial partner to keep up with the development and commercialization of the technology.
  • Financial obligations like up-front license fees, milestones, royalties and minimum payments and maintenance fees. Agreements sometimes make licensees responsible for paying all incurred and future patent expenses.
  • Provisions for a reasonable monetary return to the University.

Inventors participate in any financial returns from a license in terms of earned royalties, milestone fees and minimum royalties. In addition, inventors enjoy the satisfaction of knowing their inventions benefit the general public.

License agreements vary in length and complexity depending on a of myriad factors such as the type of licensed technology, scope of patentability, the particular industry involved and the relationship between the licensee and licensing parties.

Under certain conditions, UNeMed will license technologies and assign all its rights back to the inventor to develop the technology. This usually leads to the development of a startup.

A few factors when considering a startup company:

  • Is your technology is in its nascent stages and requires additional development before a licensee can take it over?
  • How much is it going to costs to develop the technology and if investors would be willing to put that money in?
  • Is it possible for the inventor to develop multiple products from the same technology, maybe even target different markets – providing a larger competitive advantage?

The choice to establish a new company is a joint decision made by UNeMed and the inventor.

Of course, we do not expect you to do this alone. UNeMed will advise and provide the right coaches and resources to help set up the startup.

The primary inventor on the New Invention Notification form is typically the founder of the company. Most faculty will wear two hats–one as faculty and one as the CEO of the startup. Very rarely does a University of Nebraska faculty leave to run a startup. Faculty involvement of any kind in a startup is reviewed for conflict of interest.

It is important to remember that a startup is like a baby. Startups require a considerable amount of tender, loving care to grow and develop. The primary inventor will need to champion the effort in setting up a management team and recruiting other members required for the company to survive and eventually thrive.

UNeMed has a list of successful startups and is consistently playing an active role in educating, advocating and mentoring new entrepreneurs.

This was the final installment in a series of blog posts covering the many services UNeMed provides for faculty, students and staff at UNMC and UNO. Here’s the full list of topics:

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The year in review: Highlights from 2017

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by Charles Litton, UNeMed | December 27, 2017

It’s time to close the books on another year of tech transfer and commercialization at the University of Nebraska Medical Center. As is our custom, we like to take this time to look back on the year that was, and reflect on some of the more important stories, developments, most popular posts and other highlights from UNeMed in 2017.

1. Innovation Week

Innovation Week continued its dominance as a popular destination at UNeMed.com, and for good reason. The week is an annual showcase for all of UNMC’s and UNO’s innovations throughout the year—including the 2017 Most Promising New Invention and the Emerging Inventor of the year. Pediatric ophthalmologist Donny Suh, M.D., was named the 2017 Emerging Inventor, and co-inventors Mark Carlson, M.D., Jingwei Xie, PhD, and Shixuan Chen, PhD, won the Most Promsing New Invention award for a sponge made from nanofibers. Innovation Week 2017 also combined the popular Shareholder Meeting event with the Innovation Awards ceremony.

2. Sam Sanderson, 63

Sam Sanderson, PhD

The UNeMed family suffered a tough loss with the unexpected death of Sam Sanderson, unmatched for his enthusiasm and passion. As an inventor, Sanderson stood out to UNeMed staffers as the poster child for dogged determination and boundless tenacity. Every meeting with him left us with smiles, and a resurgent optimism. Our only consolation of his loss is that his technology and startup company, Prommune, continues…and hopefully will for a long, long time.

3. Industry Partnering Day

For the second consecutive year we offered this low-key event, focusing this time on medical devices. The continued success of the event encouraged us to consider ways to expand. A future announcement will detail our future plans. Spoiler Alert: The Midwest Regional Drug Development Conference is coming soon!

A prototype of a new one-handed syringe Donny Suh, M.D., invented and developed at the University of Nebraska Medical Center.

4. Technology Portfolio

A PDF version of our entire technology portfolio was among our most popular new offerings this year. Hard copies quickly disappeared from the office, and web traffic to specific technologies swelled to unexpected numbers, including ChimeRscope, Lab Safety Posters, a motion capture system, a cardiovascular disease blood test and Emerging Inventor of the year Donny Suh’s Precision Syringe.

5. UNeTech

Launched in late 2016, UNeTech announced its first four projects by the end of summer. A new joint institute at UNMC and UNO, UNeTech was designed to identify promising University startups and nurture them through the so-called “Valley of Death.”

 

6. Grant Program lifts UNMC Innovations

An internal review of a little-known funding program led to this revealing post. It turns out the Proof-of-Concept, or POC, grant program has delivered much-needed jolts of capital to University inventors and startups. The review shows the program is a clear success, leading technologies deeper into development of things like advanced prototypes and renewed industrial interest.

7. The other side of CRISPR

A popular blog post from Joe Runge, J.D., UNeMed’s Director of Business Development, tackled the growing concern around the gene-editing tool known as CRISPR/CAS9. The post covers what CRISPR can and can’t do: Primarily it’s great at cutting genetic material, but generally useless for inserting new material. The larger point in Runge’s piece is that a UNMC innovation adds that insertion functionality, which stands to make CRISPR a vastly more powerful tool.

Honorable Mention:
The addition of licensing associate Catherine Murari-Kanti, PhD, provided an unmistakable boost to UNeMed.com traffic. Some of the year’s most popular posts revolved around her, beginning with the announcement of her promotion from an intern to full-time staff. She also penned popular articles about the Association of University Technology Managers’ annual conference and her ascendance from student to teacher in UNeMed’s popular Tech Transfer Boot Camp program.

Classics
Several posts from previous years remain popular and relevant, particularly those that focus on day-to-day operations and legal issues associated with intellectual property.
1. The importance of technology transfer
2. How to determine who is an inventor on a patent: Unraveling inventorship vs. authorship
3. Technology transfer 101: Defining research commercialization
4. What you need to know about royalty distribution

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How we can help: Patents

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by Catherine Murari-Kanti, UNeMed | December 20, 2017

Part six of a series

What does UNeMed generally patent?

The United States Patent and Trademark Office issues three types of patents in the United States: utility, design and plants. Utility patents cover new and useful processes, machines, articles of manufacture or compositions of matter. Design patents cover new, original and ornamental designs for an article of manufacture. Plant patents cover new plant varieties.

Does UNeMed patent naturally occurring substances?

Generally, you cannot patent a naturally occurring substance. A natural substance only in its isolated form or a variation of the natural substance maybe patentable if the inventor is able to demonstrate substantial, non-obvious modifications that offer advantages of using that variant.

Who is an inventor? Who decides who can be the inventors on a patent?

It is important to note that authors on a publication don’t necessarily become inventors on a patent application. An inventor is anyone who takes part in the conception of the idea in the patent claims of the application. Willful misrepresentation of inventorship could lead to invalidation of intellectual property rights. UNeMed works with the patent attorneys to make sure the patent application has the appropriate inventors.

How are provisional patent application used?

Our inventors often have novel, non-obvious and useful ideas, and wish to share them at conferences or with potential licensees or investors. In such circumstances, once the invention is disclosed to UNeMed, a provisional patent application is filed as a protective place-holder to protect the University of Nebraska’s intellectual property. Provisional patent applications have a lifespan of one-year and are never prosecuted. This time allows the inventor to gather data while preserving patent rights. At the end of one year the data collected would allow UNeMed to prepare a non-provisional patent application.

What is the patent process at UNeMed?

UNeMed works with outside counsel to prepare and file patent applications. The patent attorney and licensing associates will review the patent application and confirm an accurate list of inventors. Once an application has been filed, it may take the USPTO anywhere between one and three years to respond. USPTO patent examiners rarely accept the application and issue the patent upon the first review. They almost always reject all or most of the claims listed in the application. The examiner’s written explanations for rejecting claims are called “Office Actions,” and a final resolution can sometimes take several years of back-and-forth between a patent attorney and the USPTO.

What about foreign or international patent protection?

Depending on the type of technology, UNeMed may file for a foreign patent to protect commercial rights in specific countries. Because patent laws vary in foreign countries, it’s not uncommon for an inventor to lose foreign patent rights because they did not first protect their innovation before publicly disclosing the invention.

What is the timeline and expense of patent protection?

A fair estimate is about three years or longer. Filing for a non-provisional patent can cost $10,000-$15,000, but they can soar much hig her. Patent prosecution and filing in foreign countries only add to the expense. For example, an invention with patents in the United States, China and Europe might accrue more than $40,000 or more in patent expenses.

Does UNeMed pursue patent protection in the absence of a licensee?

UNeMed will often take the risk of applying for a non-provisional patent application before a licensee is identified. If UNeMed can find a licensee during patent prosecution, further patent prosecution and expenses are passed on to the licensee.

What happens if I share an invention with another university?

The technology you develop with another inventor will be co-owned between the two Universities. The licensing team at UNeMed will file an inter-institutional agreement that will identify one of the universities to take lead on protecting and licensing.

Where can I go to get more information?

Contact UNeMed at unemed@unmc.edu with any questions. You can find more information on patents and intellectual property here and here.

 

This is part of a series of blog posts covering the many services UNeMed provides for faculty, students and staff at UNMC and UNO. Next up is our final installment, which will startups and licensing. Here’s the full list of topics:

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Nebraska medical startup, Virtual Incision, raises $18 million

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OMAHA, Neb. (December 15, 2017)—Virtual Incision Corporation, a startup company born from a collaborative research project at the University of Nebraska, completed an $18 million round of fund-raising, officials announced Tuesday.

“Virtual Incision is a perfect example of what the University of Nebraska can do when we work together,” University of Nebraska President Hank Bounds, PhD, said. “Multiple researchers from multiple campuses and areas of expertise, coming together to create something that makes the world a better place: That’s the power of Nebraska.”

The funds will support manufacturing and clinical trials that can allow Virtual Incision to secure FDA approvals in the United States. Virtual Incision has already performed successful procedures in humans during feasibility testing last year.

Virtual Incision is a product of the collaboration between the University of Nebraska Medical Center’s chief of minimally invasive surgery, Dmitry Oleynikov, M.D., and Shane Farritor, PhD, a professor of engineering at the University of Nebraska-Lincoln. Oleynikov and Farritor are co-founders of the company, which licensed the technology from UNeMed, the University of Nebraska’s technology transfer and commercialization arm in Omaha.

Virtual Incision’s device is not yet commercially available, but it could change the future of surgical robotics and minimally invasive surgery.

“Virtual Incision demonstrates the kind of positive impact the University can have,” said Jeffery Gold, M.D., Chancellor of UNMC and UNO. “We can talk about the benefits of new jobs and the boost to the local economy, but the important thing for me is they’ve built a medical innovation that can improve lives around the world. I think that alone is enough to make all Nebraskans proud.”

Most surgical robots today are large, mainframe-like robots that reach into the body from outside the patient. They can be overly complex, often require dedicated spaces and weigh thousands of pounds—making them virtually permanent fixtures wherever they are placed.

UNMC surgeon Dmitry Oleynikov (left) and UNL engineer Shane Farritor test a surgical robot prototype during a recent trial in Omaha. Their collaboration created a startup company, Virtual Incision, which hopes to make major surgery—like a bowel resection—a laparoscopic procedure.

Virtual Incision’s two-pound robot platform features a small, self-contained surgical device that is inserted through a single midline umbilical incision in the patient’s abdomen. The technology is designed to use existing tools and techniques familiar to surgeons, and does not require a dedicated operating room or specialized infrastructure.

Because of its much smaller size, the robot is expected to be significantly less expensive than existing robotic alternatives for laparoscopic surgery. Virtual Incision’s technology promises to enable a minimally invasive approach to surgeries performed today with a large open incision.

This most recent funding success was the second or Series B round of financing for Virtual Incision. Virtual Incision closed its Series A round in 2010 with $2 million. More recently, Virtual Incision closed a follow-on round with $11.2 million in 2015, which led to the successful feasibility trial and first-in-human tests.

“It’s tremendous that their vision has been validated by significant external investment,” said James Linder, M.D., President of Nebraska’s University Technology Development Corporation. “They are role models for academic faculty and staff at the University of Nebraska who strive to commercialize inventions. Bringing new technology to the benefit of patients is the ultimate validation.”

The device is designed for colon resection, a procedure to treat patients with lower gastrointestinal diseases including diverticulitis, pre-cancerous and cancerous lesions of the colon, inflammatory bowel disease and colon polyps that are too large to be removed endoscopically.

In the future, Virtual Incision’s platform might also be used for gall bladder removal, hernia repair, colectomy and other abdominal surgeries, Oleynikov said.

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How we can help: Intellectual Property

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by Catherine Murari-Kanti, UNeMed | December 13, 2017

Part five of a series

Bench to market can happen in one of two ways, both with the same ultimate goal: Developing the invention into a final product.

The most common path is protecting the intellectual property, and licensing the invention and its rights to a company. The other option is to build a new startup company around the innovation.

Either way, protecting the intellectual property that comes out the University of Nebraska is of utmost importance to UNeMed.

Intellectual property are inventions or materials that may be protected under the patent, trademark or copyright laws. Like any owned property, intellectual property can be bought and sold and, unfortunately, stolen. At UNeMed, we work closely with our inventors to make sure we effectively protect intellectual property that stems from University research.

UNeMed typically works with four different types of intellectual property:

Patents

Enumerated in the Constitution by the Founding Fathers, , a U.S. patent gives inventors a legal, although temporary, monopoly. Most patents are valid for 20 years. During that time, patent holders have the right to exclude others from making, using, selling, offering to sell and importing the patented invention. A patentable invention could be a process or method, a machine, an article of manufacture, or a composition of matter.

UNeMed mostly uses patents to protect Nebraska’s intellectual property related to new inventions in research tools, devices, compounds and drug formulations. UNeMed seeks industrial partners who can either sponsor research to improve the invention, or take over the patent rights to develop the product on their own.

Stay tuned for the next installment of this series, which will take a more in-depth view on patents.

Copyrights

Authors of “original works of authorship” are protected by copyrights.  This includes literary, dramatic, musical and artistic works, as well as computer software. This protection is available to both published and unpublished works.

Copyrights are automatically secured for tangible mediums such as a book, software code or video. Sometimes, UNeMed waits to register a copyright till a commercial product is ready for manufacture. Copyright protection generally extends through the author’s lifetime plus 70 years, depending on several other factors. At UNeMed, most copyrighted works are things like software applications or educational materials.

Trademarks

A trademark includes any word, name, symbol, device, or combination that is used in commerce to identify and distinguish the goods of one manufacturer or seller from those manufactured or sold by others. Company logos can be an example of trademarks.

Trademarks make it easy to remember who produces a product. Golden arches that appear along the roadside alert people that a McDonalds ahead. There is no mention of the name “McDonalds” on the golden arches, but the symbol clearly differentiates them from other fast food restaurants.

Trademarks are registered at the United States Patent and Trademark Office and generally become protected as soon as they are adopted by the organization and used in commerce, even before registration.

Trade Secrets

The first things that comes to mind when thinking of a trade secret is Coca-Cola and its vault that holds the recipe for the inestimable carbonated beverage, or the composition of WD-40 or the recipe for Twinkies or Listerine. A trade secret is any information that is valuable, at least in part, due to its secrecy and which the owner maintains reasonable efforts to keep the secret.

This is part of a series of blog posts covering the many services UNeMed provides for faculty, students and staff at UNMC and UNO. Our next installment will dive a little deeper into patents. Here’s the full list of topics:

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UNMC student picked as Pipeline Spotlight Entrepreneur

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OMAHA, Neb. (December 11, 2017)—William Payne, a doctoral student of pharmaceutical sciences at UNMC, was recently selected as the University of Nebraska’s top choice to present his business plan at the largest entrepreneurial conference in the region next month.

Payne’s business plan rose to the top of a selection process that pulled the best proposals from all University of Nebraska campuses. He will join three other “Pipeline Spotlight Entrepreneurs” who will pitch their ideas during Pipeline’s annual Innovation Awards on Jan. 25, 2018, in Kansas City. Other Spotlight Entrepreneurs will represent the University of Kansas, the University of Missouri and Washington University in St. Louis.

Pipeline is an entrepreneurial mentoring program in the Midwest that offers a handful of highly selective entrepreneurial fellowships each year. Fellows in the Pipeline program received hands-on training from successful entrepreneurs and mentors from around the region and across the nation. The program helps fellows refine their business plans, raise money and dramatically improve their chances for ultimate success.

The four students selected as Pipeline Spotlight Entrepreneurs will receive similar guidance, with regional and national mentors helping the entrepreneurs refine their company pitches. The final test will come during Pipeline’s annual conference next month. There, the student entrepreneurs will get the rare opportunity to propose their ideas to a room full of potential investors and partners.

UNMC’s Payne will present his startup company, Simple Vet Solutions.

“Will has already accomplished something that many entrepreneurs struggle with,” said UNeMed President and CEO Michael Dixon, who also serves as a mentor for Pipeline. “He went out and identified a real problem, then he created a real solution. And, he already has people that are paying real money for that solution. Sounds simple enough, but those are three critical elements that don’t always come together for entrepreneurs.”

Payne partnered with his veterinarian father, Bert, to create Simple Vet Solutions. It’s a software service that eliminates the extra time and energy required to meet FDA regulations for animal medications.

Simple Vet Solutions, according to the executive summary in the business plan, offers “secure and compliant management of veterinary prescriptions and feed directives for any size of livestock operation, veterinary practice, or feed distributor.”

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How we can help: Agreements

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by Catherine Murari-Kanti, UNeMed | December 6, 2017

Part four of a series

Collaboration is encouraged and celebrated in the scientific process. Collaboration, however involves the exchange of material or ideas. Inventors and owners could lose their ideas or their materials if they aren’t protected properly.

Confidential Disclosure Agreements and Material Transfer Agreements are therefore vital to the innovation and collaboration process.

Material Transfer Agreements:

Material Transfer Agreements or MTAs are contractual documents between the University of Nebraska and external entities for the exchange and use of tangible research material. The terms of an MTA should allow a researcher to perform experiments, publish data and exert rights to ownership without conflicting with the University’s policies.

Simple MTA terms between universities are usually negotiated between the technology transfer offices, and can be accomplished in as little as a few days, in some cases. More complicated MTAs may require weeks of negotiation. This ensure that the researcher’s rights are protected and that they retain their ability to commercialize at a later point.

At Nebraska, tangible materials can include molecular biology reagents, cell lines, recombinant mice, devices or even software.

The inventor or researcher plays an important role in drafting and negotiating the MTA.

Describing research plans and the use of transferred materials will allow UNeMed’s contract manager to file an MTA that will closely serve the researcher’s purposes. Researchers are required to read, review and sign the final document.

To expedite the process researchers will need:

  1. Information related to the source of funding
  2. Original source of the materials (or any portion of the material)
  3. A description of the intended research making use of the materials
  4. Names, addresses and other pertinent information on the receiver or sender of the materials

Confidential Disclosure Agreements:

Also called NDAs or non-disclosure agreements, Confidential Disclosure Agreements, or CDAs, enable University of Nebraska faculty, students or staff to speak with a third party.

For example, if you are an investigator or researcher, you may want to share a new research discovery with a friend who works in the industry. You think that industry input is important in pivoting your research in the right direction. But, if you share your research without first having a CDA in place, you jeopardize your research and its commercialization potential. Filing a CDA protects your work and allows you to share unpublished information with academic collaborators or commercial partners.

UNeMed actively markets University inventions to respective industries. If a company expresses interest, the licensing team sets up a CDA with the company. CDAs further enable discussion of business development information or early-stage scientific collaboration.

Premature public disclosure can limit or even remove patent rights. A simple CDA can prevent that.

To set up an MTA or a CDA contact UNeMed at 402-559-2468 or at unemed@unmc.edu.

This is part of a series of blog posts covering the many services UNeMed provides for faculty, students and staff at UNMC and UNO. Our next installment will dive a little deeper into intellectual property. Here’s the full list of planned topics:

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How we can help: Our Process

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by Catherine Murari-Kanti, UNeMed | November 22, 2017

Part three of a series

Once an invention arrives in our inbox, our process begins and it is assigned to one of the licensing team members. They will set up a time to meet with the inventor and learn more about the innovation.

UNeMed will then search for “prior-art,” looking for evidence that the invention might already exist. If the invention was used in some other technology or was mentioned elsewhere, then it is not novel. .

UNeMed also performs “competing searches” that seek other inventions that perform the same job as the new invention.

Finally, market analysis and research then tells UNeMed staff what products are currently available, and what the market currently needs.

All of this information is presented to the Science and Technology Advisory Committee for a full review and discussion about the invention’s merits and potential. The committee will then discuss the best course of action for the technology and make a final recommendation.

Inventions with prior art are typically “closed” unless an inventor can find a new approach that makes the innovation novel. UNeMed clearly articulates all the reasons why an invention will be closed, ideally informing a new course of study for innovative researchers.

If an invention is not ready for commercialization then it is classified as “additional research needed.” UNeMed will discuss what additional needs will make the invention ready for protection and market success.

There are certain inventions where UNeMed seeks to know the market’s mind. This is when UNeMed moves the invention into “market” status. Marketing activities are done confidentially and industry feedback is recorded and shared with the inventor. This helps the inventor shape the innovation into something the market needs.

And then there are the novel, non-obvious and useful inventions. These are inventions and discoveries that didn’t have any prior art and there is a clear need on the market. When this happens, UNeMed takes all precautions to protect the invention, which includes filing patent applications or other forms of intellectual property.  UNeMed will also start actively marketing the technology for market feedback and potential licensing partners who can fund further development.

This is part of a series of blog posts covering the many services UNeMed provides for faculty, students and staff at UNMC and UNO. Our next installment will dive a little deeper into exactly what happens when UNeMed receives a new invention notification. Here’s the full list of planned topics:

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Solving the tech transfer data problem

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by Steve Schreiner, UNeMed | November 15, 2017

Tech transfer offices generate reams of data, but apparently have no good way to manage it. I’ve had a relatively large number of conversations with academic, private and government contacts who asked about our system, and how it compares to what they currently use.

I came away with two broad, somewhat obvious generalizations: There is no single solution in use across TTOs, and most offices are unhappy with their current solution.

No surprises there, but despite the overall dissatisfaction there does appear to be a great deal of angst about making a change. Even for something better. A significant financial investment was often made for some of these solutions, and abandoning them seems to be a great waste of limited resources.

I have heard about products costing tens of thousands of dollars, with substantial additional costs for any customization. I know of “homegrown” systems created more than a decade ago that no one really knows how to update or fix.

Everyone agrees they need a better way of managing their data.

But few know how to proceed.

In 2007, we embarked on finding a system that would take care of our data needs, while allowing customization and growth as we evolved. Starting from Excel spreadsheets and tables of numbers in Word documents, we set out to establish a solution that would serve our office and support the new way that UNeMed was going to operate.

We set out to find a solution that would allow for the collection, management and use of data generated from all of our combined functions. Whether it be invention evaluation, patenting or marketing and licensing, we hoped to find something that could handle it all, while being nimble enough not to control or drive how the office would work. We wanted something responsive, not restrictive.

I agreed to help the office find this golden goose, but then I was put in charge of the search after the loss of key player to another TTO. Knowing very little about the first system we decided to test, I was left to determine its applicability to our office. I had some IT background, mostly some lower level programming in college, which made me the office expert. I was hesitant to fill such a role, but it was a resource the office needed, so I dug in to see what it, and I, could do.

That was more than 10 years ago, and we continue to use and develop that same system today. It has changed and evolved over the years, and almost daily we think of new, better ways to employ it.

The solution we chose was Salesforce CRM.

Why? At first I wasn’t sure. It seemed capable but daunting in its application.

People in the office asked, “What can it do?” But that was the wrong question. More appropriate: “What can’t it do?”

The answer after all this time: Nothing that I know of.

I’ve spent the last 10 years learning how to make it serve our needs, and those requirements continue to change. That is one of the most powerful aspects of the system. I can modify it in small ways, or completely scrap a function that was previously in place.

Does it take time? Sure.

But remember, we wanted a system that was responsive. As the office changes, our system can change to stay relevant, and reflect our current way of operating.

The most important thing I tell those who ask about Salesforce is that it is a platform. If you want an out-of-the-box solution for a tech transfer office, Salesforce is not what you want. But with an investment in time and thought, it can empower your data; allowing you deeper analysis and memories of all that your TTO does. It can help your people manage their workload and time.

From invention evaluation, to IP prosecution, to marketing and licensing, to agreement compliance, it can do it all…how you want it done. Most of it can be done with basic, in-house IT expertise. But if you need something specific that’s beyond your ability, consultants and local user and developer groups are everywhere to help you out.

People ask me: “What can it do?”

I respond: “What do you want it to do?”

Believe it or not, I’m serious.

This was the first part of a planned series on TTO data management. Future installments will include how UNeMed uses Salesforce to handle invention disclosures and federal reporting requirements, intellectual property, marketing, licensing, contract compliance. and a few other functions performed by UNeMed.

 

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How we can help: Inventions

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by Catherine Murari-Kanti, UNeMed | November 15, 2017

Part two of a series

An invention is a new discovery, concept, design, device, composition, and system or software program. Typical UNMC inventions include therapeutics, diagnostics, drug delivery platforms, medical devices, new uses of existing drugs, medical devices, research tools, educational materials and software.

What sets an invention apart is the difference from what’s already out there. An invention has product value, a good intellectual property position, and good commercial potential.

How do I submit my inventions?

To disclose an invention to UNeMed, you simply fill out a New Invention Notification. Once the form is completed and signed by all inventors, you can email the disclosure to unemed@unmc.edu.

It’s important that you disclose your invention to UNeMed BEFORE any public disclosure is made.

The new invention notification creates a written, dated record of your invention. The form also helps UNeMed evaluate the invention’s potential for commercial applications and possible intellectual property positions. The form also ensures compliance with U.S. federal laws, University policy and the policies of several research-funding agencies.

What is a public disclosure?

A public disclosure can include published papers, oral and poster presentations, any seminars, abstracts, funded grant applications, or open dissertation defenses. This also includes sharing the idea with fellow colleagues or friends.

A public disclosure can result in the loss of foreign patent rights and limits UNeMed to one year from the disclosure date to secure U.S. patent rights. Loss of foreign patent rights can decrease the value and overall appeal of a technology.

The easiest (and best) way to protect your rights is to work with UNeMed. Disclose your discoveries to UNeMed before presenting or publishing.

Why submit your inventions and discoveries to UNeMed?

New invention submissions open the communications between you and UNeMed. From there, UNeMed can determine if an invention requires protection, and begin the hunt for commercial partners to help fund further development.

It also helps UNeMed disclose all federally funded inventions to the appropriate government agencies.

All information disclosed in a new invention notification are confidential, and access is strictly limited to UNeMed’s professional staff.

What happens after I submit my invention?

A member of UNeMed’s licensing team will meet with inventors to discuss the details and applications of the invention. Meeting with inventors helps UNeMed better understand the invention, and conduct a full analysis to determine the best course of action.

UNeMed will then convene its Science and Technology Advisory Committee, for a final review of the invention and examine its potential to obtain effective IP protection, stimulate business interest, and contribute to economic development.

The technology manager assigned to the invention will then take any recommendations that come from the committee and discuss potential options for moving the invention forward.

This is part of a series of blog posts covering the many services UNeMed provides for faculty, students and staff at UNMC and UNO. Our next installment will dive a little deeper into exactly what happens when UNeMed receives a new invention notification. Here’s the full list of planned topics:

 

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Breakthrough research suggests potential treatment for autism, intellectual disability

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by Liz Kumru, UNMC

A breakthrough in finding the mechanism and a possible therapeutic fix for autism and intellectual disability has been made by a University of Nebraska Medical Center researcher and his team at the Munroe-Meyer Institute (MMI).

Woo-Yang Kim, PhD, associate professor, developmental neuroscience, led a team of researchers from UNMC and Creighton University into a deeper exploration of a genetic mutation that reduces the function of certain neurons in the brain.

Dr. Kim’s findings were published in this week’s online issue of Nature Neuroscience.

“This is an exciting development because we have identified the pathological mechanism for a certain type of autism and intellectual disability,” Dr. Kim said.

Recent studies have shown that the disorder occurs when a first-time mutation causes only one copy of the human AT-rich interactive domain 1B (ARID1B) gene to remain functional, but it was unknown how it led to abnormal cognitive and social behaviors.

Autism spectrum disorder (ASD) impairs the ability of individuals to communicate and interact with others. About 75 percent of individuals with ASD also have intellectual disability, which is characterized by significant limitations in cognitive functions and adaptive behaviors.

There are no drugs or genetic treatments to prevent ASD or intellectual disability; the only treatment options focus on behavioral management and educational and physical therapies.

The team created and analyzed a genetically modified mouse and found that a mutated Arid1b gene impairs GABA neurons, the ‘downer’ neurotransmitter, leading to an imbalance of communication in the brain.

GABA blocks impulses between nerve cells in the brain. Low levels of GABA may be linked to anxiety or mood disorders, epilepsy and chronic pain. It counters glutamate (the upper neurotransmitter), as the two mediate brain activation in a Ying and Yang manner. People take GABA supplements for anxiety.

“In normal behavior, the brain is balanced between excitation and inhibition,” Dr. Kim said. “But when the inhibition is decreased, the balance is broken and the brain becomes more excited causing abnormal behavior.

“We showed that cognitive and social deficits induced by an Arid1b mutation in mice are reversed by pharmacological treatment with a GABA receptor modulating drug. And, now we have a designer mouse that can be used for future studies.”

Next steps for Dr. Kim and his team are to even further refine the specific mechanism for autism and intellectual disability and to identify which of the many GABA neurons are specifically involved.

Dr. Kim’s research was supported by a $1.7 million grant from the National Institute of Neurological Disorders and Stroke and a $400,000 Institutional Development Award (IDeA) from the National Institute of General Medical Sciences of the National Institutes of Health.

Team members were: Eui-Man Jung, post-doc research associate, and Channabasavaiah Gurumurthy, PhD, associate professor, MMI; Jeffrey Jay Moffat, graduate research assistant, pharmacology/experimental neuroscience, UNMC; and Shashank Dravid, PhD, associate professor, and Jinxu Liu, pharmacology, Creighton University.

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UNMC researcher studying nanofiber sutures to prevent surgical site infections

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$1.3 million NIH grant seeks to determine if vitamin D can produce infection-fighting peptide

by Tom O’Connor, UNMC

Jingwei Xie, Ph.D, a biomedical engineer at the University of Nebraska Medical Center, has been awarded a four-year, $1.3 million grant from the National Institutes of Health (NIH) to study the nanofiber-based local delivery of immunomodulating compounds for prevention of surgical site infections (SSIs). The nanofiber sutures contain vitamin D, which is thought to be able to induce production of an infection-fighting peptide at the surgical site.

If proven successful in transgenic mice, the nanofiber sutures could represent an important advance in the prevention of SSIs, a multibillion-dollar challenge each year in the United States.

The grant is through the National Institute of General Medical Sciences, one of the institutes of the NIH.

Pictured are (from left) UNMC and UNO Chancellor Jeffrey Gold, Jingwei Xie, Mark Carlson, and UNeMed President and CEO Michael Dixon. Late last month, Dr. Xie, along with Dr. Carlson and Shixoun Chen (not pictured), were awarded UNeMed’s Most Promising New Invention award of 2017 for a nanofiber technology.

Dr. Xie, who is an assistant professor in the UNMC Department of Surgery – Transplant and the Holland Regenerative Medicine Program, is the principal investigator on the grant. He is collaborating with Adrian F. Gombart, PhD, associate professor, biochemistry and biophysics, in the Linus Pauling Institute at Oregon State University (OSU).  OSU is conducting the testing on the humanized transgenic mice for its part of the study.

“This is an exciting project,” Dr. Xie said. “SSIs are a very common problem affecting as many as 300,000 patients per year in the U.S.. If we could reduce these infections, it would be a major breakthrough.”

SSIs include infections in the area of the skin where the incision is made, infections below the incision in muscles and tissues surrounding muscles and infections in other parts of the body involved in the surgery.

SSIs are the most common and costly of all hospital-acquired infections, accounting for 20 percent of all hospital-acquired infections. They occur in an estimated 2 percent to 5 percent of patients undergoing inpatient surgery. The estimated annual incidence of SSIs in the U.S. ranges from 160,000 to 300,000, and the estimated annual cost ranges from $3.5 billion to $10 billion. On average, a SSI increases the hospital length of stay by 9.7 days.

The nanofiber sutures contain 25-hydroxyvitamin D3 (25D3) and the pam3CSK4 peptide. A peptide is a compound consisting of two or more amino acids linked in a chain; pam3CSK4’s function is to activate a cell’s toll-like receptor, which in turn triggers immune responses, in which vitamin D plays a key role.

The research, which was published in the journal Nanomedicine recently, showed the nanofiber sutures released 25D3 – the same form of the vitamin that’s measured in the blood when a patient’s vitamin D levels are tested – on a sustained basis over four weeks. The sutures released pam3CSK4 via an initial burst followed by a four-week prolonged release.

“When the toll-like receptor is activated, you induce a particular enzyme to convert 25D3 to its bioactive form, known as 1,25-dihydroxy vitamin D3 (1,25D3), that activates the vitamin D receptor,” Dr. Gombart said. “When activity increases, that increases expression of vitamin D receptor target genes, one of which produces the LL-37 peptide, which kills microbes by disrupting their membranes.

“The idea is, if you were to have an infection, the sutures would activate the toll-like receptors and start increasing production of 1,25D3 from the 25D3 that’s being released from sutures – so you get both local induction and an increase in the production of the antimicrobial peptide.”

Dr. Xie said the anti-infective sutures currently in use contain triclosan, an antibacterial and antifungal agent also found in a variety of consumer products.

The nanofiber sutures can deliver a variety of bioactive compounds to minimize infection risk, optimize healing and minimize scarring, while circumventing some of the problems seen with anti-infective sutures containing triclosan.

When used frequently, triclosan sutures have resulted in bacterial resistance, Dr. Xie said. In addition, the triclosan sutures also have a wide range of potential health risks including endocrine disruption, impaired muscle function, liver damage and the development of cancerous tumors.

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