Maintaining Confidentiality: Confidential Disclosure Agreements

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by Bill Hadley, UNeMed | July 3, 2012

On December 12, 1980, Congress enacted legislature commonly known as the Bayh-Dole Act. This legislature contributed to a major change in university facilitated research and development.  Under the Bayh-Dole Act,   universities may now retain title to inventions created under federally-funded research programs. Based on this policy, the act has helped generate a significant increase in the amount of patents and licenses owned by U.S. research universities. (See, McCowery, David C., et al. The Effects of the Bayh-Dole Act on U.S. University Research…, pp25-29).

Accordingly, after the passing of the Bayh-Dole Act, universities’ policies regarding intellectual property began to change. For example, universities began requiring researchers to report inventions created through university research programs in order to protect valuable intellectual property (See, UNMC Policy No: 8000(7)(H)).  Moreover, with the increase in the number of patents held by universities, many institutions were forced to update their procedures for protecting their intellectual property rights.

One method of protecting intellectual property is the confidential disclosure agreement (CDA), also known as a nondisclosure agreement (NDA) or secrecy agreement. The CDA protects the exchange of confidential information that is not yet ready for patenting or publication. This protection is invaluable since unprotected disclosure may result in a loss of U.S. and foreign patent rights.

As discussed previously, unprotected disclosure of university research and development may bar patentability under United States Patent Law. To help protect U.S. and foreign intellectual property rights, researchers should be careful about discussing the details of their research.

When discussing research that is not publicly known, researchers should consult with UNeMed and use the CDA to help protect against disclosures that may bar patentability. By using a CDA researchers can show that any disclosure that was made to a party to the agreement was not meant to be public, but was, in fact, confidential.

How can you, as a researcher, benefit from a CDA?

CDAs can be very useful in furthering research and development. The confidentiality provided by CDAs allows the parties to the agreement to openly share information concerning the research project, even if the information is not yet published or patented.

This open exchange increases the progression of the research project. While the project progresses, the possibility for finding scientific breakthroughs and marketable intellectual property also increases.

The progression of research and development can mean not only an increase in knowledge, but also an increase in University revenue. This is because with more marketable intellectual property discovered, more licensing agreements will be formed. From those licensing agreements, royalties will be paid and UNMC researchers generally receive a portion of the net royalties.  Royalty distributions and licensing agreements will be the topic of discussion in future posts.

Steps for entering into a CDA

There are usually three different scenarios when a CDA will be used. First, when another organization wants to receive confidential information from UNMC; second, when UNMC wants to receive confidential information from another organization; and third, when UNMC and another organization collectively want to share confidential information with each other. The following generally outlines the steps for each scenario:

  1. A UNMC researcher plans to enter into discussions about research being conducted at UNMC with another organization (because that organization needs information from UNMC, UNMC needs information from that organization, or they both need information from the other).
  2. The UNMC researcher should not disclose any confidential information, but should obtain that organization’s contact information as well as a description of the information to be discussed (if the need for information lies with UNMC alone, the researcher can request the organization’s standard CDA as well).
  3. The UNMC researcher should contact Jack Mayfield, Contract Specialist at UNeMed, jack.mayfield@unmc.edu, and provide the organization’s contact information and the description of information to be discussed (and the organization’s standard CDA, if applicable. See steps 2 &4).
  4. UNeMed will then send our standard CDA for the organization’s review (unless it is the case that UNMC unilaterally needs information from the other organization; in that case, the other organization usually provides their standard CDA).
  5. The UNMC and the organization accept the terms as they are, or they enter into negotiations to reach mutually agreeable terms.
  6. UNeMed sends the CDA to the UNMC researcher to read and review for acknowledgment of special conditions. The UNMC researcher should sign the CDA and return a signed copy to UNeMed (via email or campus mail).
  7. UNeMed then signs the CDA and sends a copy of the fully executed agreement to both the researcher and the other organization. The UNMC researcher may then discuss the confidential research information, as outlined in the CDA, with the other organization.

For questions regarding CDAs or any of the above procedures, contact: Jack Mayfield, Contract Specialist at UNeMed, jack.mayfield@unmc.edu.

Nothing in this post should be construed as legal advice.  It has been developed by the UNeMed staff as an educational resource for faculty, staff, students, and other personnel associated with the University of Nebraska Medical Center.  While all information contained herein has been thoroughly fact-checked, this site is provided on an “as is” and “as available” basis.   Neither UNeMed nor the University of Nebraska Medical Center make any representations or warranties of any kind, express or implied, as to the site’s operation or the information, content or materials included on this site.   To the full extent permissible by applicable law, UNeMed and the University of Nebraska Medical Center hereby disclaim all warranties, express or implied, including but not limited to implied warranties of merchantability and fitness for any particular purpose.   Neither UNeMed nor the University of Nebraska Medical Center will be liable for any damages of any kind arising from the use of or inability to use this site. You expressly agree that you use this site solely at your own risk.

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UNeMed welcomes aboard Dr. Madsen, our Entrepreneur in Residence

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OMAHA, Neb. (June 29, 2012)—UNeMed, the technology transfer office for the University of Nebraska Medical Center (UNMC), is pleased to announce the addition of Gary Madsen, Ph.D. to the position of Entrepreneur in Residence.

In this role, Dr. Madsen will help identify promising UNMC technologies that have the potential to form the basis of a new startup company. He will be responsible for establishing partnerships between industry, faculty, clinicians and funding sources in order to develop new business ventures based on novel technologies.

Dr. Madsen holds a Ph.D. in Medical Microbiology from Creighton University School of Medicine in Omaha, NE. “I’m very pleased to be back in Nebraska and look forward to helping UNeMed commercialize the exciting biotechnology discoveries coming out of the Medical Center.  I truly believe that there is great potential for dramatic expansion of the vibrant biotech community in the Cornhusker State.”

He joins the UNeMed team following a successful career in biotechnology product and business development. Dr. Madsen comes to us from Madison, Wisconsin where he recently formed a consulting firm, Biotech Resolutions. Previously, he worked in several biotech companies in Madison, such as Gilson, Third Wave Technologies (Hologic), Promega and EraGen Biosciences. Dr. Madsen started his biotechnology career at Abbott Laboratories diagnostics division in suburban Chicago and then served as Vice President of R&D at IDEXX Labs in Westbrook, Maine.

Dr. Madsen comes to UNeMed with over 30 years of experience in building new technologies into real diagnostic and life science products. He will provide UNeMed with his knowledge and support on licensing, product development, manufacturing, and new technology commercialization.

Dr. James Linder, President of the University Technology Development Corporation states, “The Entrepreneur in Residence program was funded by the University of Nebraska to enable UNMC, and other campuses to bring unique skills to the process of technology development and commercialization.  Dr. Madsen has a wealth of industry experience that will help UNeMed staff, and the faculty bring  our inventions into clinical use.”

About UNeMed:

UNeMed is dedicated to working with the faculty and staff of UNMC to commercialize innovative ideas that have the potential to improve public health for Nebraska residents and beyond. Through collaborations with established industrial partners or through the creation of new companies, UNeMed’s focus is on the transfer of new and improved products and processes from the research bench to the market place.

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Oops, I did it again: Public Disclosure

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by Bill Hadley, UNeMed | June 26, 2012

Part of our work at UNeMed includes reading through the published research from UNMC. When we identify a possible invention we immediately contact the researcher so we can begin evaluating the invention. We recognize that the primary concern of our faculty is their ability to publish on their research. As an institution of higher learning, the dissemination of knowledge from its faculty is clearly – and rightfully – UNMC’s highest priority. On the other hand, the patent law discourages inventors from disclosing their innovations to the public prior to filing an application for a patent – often with strict penalties.  Managing this conflict is one of UNeMed’s most important functions.

As you might imagine then, due to these conflicting paradigms, we are constantly balancing the desires of our faculty to publish with the university’s desire to commercialize upon the value of their research. When there is an unavoidable conflict between the ability to publish and the ability to patent, the publication rights must come first. When looking at disclosures that come out of the university – in terms of publications, presentations, or posters, to name a few – we are primarily concerned with eliminating “enabling public disclosures” of patentable subject-matter. If a given disclosure is both ‘public’ and ‘enabling’, it can have severe ramifications on the patentability prospects of an invention contained therein. That being said, a researcher armed with a prior knowledge of the patent law – and some foresight – can navigate these oft-confusing waters and successfully publish their work and preserve their patent rights at the same time.

With that in mind, let’s look at what, exactly, constitutes an enabling public disclosure, what the effect of such a disclosure is, and how you can take steps to prevent an inadvertent disclosure of your invention.

A disclosure is “public” if interested members of the public could obtain access to the disclosure of the invention if they so desired (Constant v. Advanced Micro-Devices Inc. , 848 F.2d 1560 (1988)). Note that under this standard there is no requirement that members of the public actually accessed the information and all that is required is that they could have.  Thus, a single copy of a graduate thesis, which sat on a library shelf for a number of years in a university library without being checked out, was found to be a public disclosure because the university had a catalog system which would have allowed a member of the public to find the thesis, were they so inclined (In re Hall , 781 F.2d 897 (1986)).

A disclosure is “enabling” if it teaches someone of ordinary skill in the art how to devise the invention without undue experimentation (Struthers Scientific & Intern. Corp. v. Rappl & Hoenig Co., 453 F.2d 250 (1972)). Examples of enabling disclosures that commonly take place in an academic setting are research presentations, journal submissions, federal grant applications (which may or may not be considered “public” based on the application’s availability under a Freedom of Information Act request), postings on individual lab websites, a thesis or dissertation, and meetings with companies or colleagues outside of UNMC where there is no confidentiality agreement in place.

The relevant statute when one looks at public disclosures of an invention is 35 U.S.C. § 102(b). Assuming, for the moment, that the claimed invention meets the threshold criteria of novelty, usefulness, and non-obviousness, 35 U.S.C. § 102(b) provides another restriction relating to the inventor’s use of the patented invention prior to their application for a patent.

There is a lot packed into §102(b), but the take-home message is this: to be eligible to receive a patent in the U.S., the claimed invention must not have been previously publicly disclosed (by the inventor or anyone else) more than one year prior to the date of application. Thus, for a U.S. patent, a public disclosure starts a clock: an inventor has one year from the date of the enabling public disclosure to file for patent protection – whether the invention is ready or not. (This rule will be subtly changed under the America Invents Act. When the relevant provision comes into effect, we will update this post accordingly. For now, however, this is the applicable rule.)

For patents filed in a foreign country, the Patent Cooperation Treaty (“PCT”) specifies, among other things, rules relating to patent eligibility.  Rule 64 of the PCT is even less forgiving than §102(b); under Rule 64.1(a) , for patents filed internationally, there is no one-year grace period. Any written disclosure of the claimed invention prior to the filing date automatically removes eligibility to receive a patent. This means that as soon as you publicly disclose your invention, you lose the international patent rights and your work will no longer be protected in the international market.

If these rules seem rather vague, you are clearly reading them properly. Fortunately, there are a number of steps that can be taken to prevent an enabling public disclosure of a potentially patentable invention. While there is a grace period for a U.S. patent, given the strict rules internationally, we always strive to protect patentability prior to any enabling public disclosure.

The easiest way to protect your rights (and UNMC’s) is to work with us. If you believe your research may contain potentially patentable subject-matter, please contact UNeMed. We are always interested to hear about your research and we deal with this issue on a daily basis. Odds are, we can provide guidance in a matter of minutes. If, after discussing your research, we think that a patent is possible, we can look at the type of disclosure that you would like to make and take steps designed to preserve future patent rights (such as filing a provisional patent application or putting in place a confidentiality agreement).

Finally, here are some other things you may want to keep in mind in order to prevent an inadvertent enabling public disclosure of your patentable invention:

  1. Consider sending UNeMed journal manuscripts, speech notes, or poster images prior to submission or public display. Often we can review these in a matter of hours and provide feedback or file a provisional patent application.
  1. Let us know if industry contacts you about your research or to contract for your services.  A simple CDA can protect against an accidental slip of the tongue without hindering your relationship with the company.
  1. When submitting a state or federal grant application, list as confidential the pages of the application which contain a description of potentially patentable subject-matter and write “CONFIDENTIAL” on each identified page.
  1. To preserve confidentiality of a thesis, request that the thesis be kept in a secure section of the library and not be made available to the public until patent protection is in place.
  1. Oral disclosures such as departmental seminars or thesis defenses may also be public disclosures, based on the ability of a member of the public to attend. If a potentially patentable invention will be discussed in one of these meetings, you may want to contact UNeMed.

UNeMed strongly supports the UNMC community’s interests in public dissemination of knowledge, academic freedom, and open collaboration. Fortunately, with a little foresight, it is possible to fulfill all of these prerogatives while preserving patent rights in the results of that work. If you are contemplating a public disclosure of your research and feel that there may be patentable subject-matter discussed therein, please don’t hesitate to contact us. Rest assured, we share the same goals you do and will be happy to discuss all avenues available to satisfy both your and UNMC’s interests.

 

Please leave any questions or suggestions you may have in the comment section below.  You can also shoot me an email at bill.hadley@unmc.edu. I will be happy to address any thoughts you may have.

 

 

Nothing in this post should be construed as legal advice.  It has been developed by the UNeMed staff as an educational resource for faculty, staff, students, and other personnel associated with the University of Nebraska Medical Center.  While all information contained herein has been thoroughly fact-checked, this site is provided on an “as is” and “as available” basis.   Neither UNeMed nor the University of Nebraska Medical Center make any representations or warranties of any kind, express or implied, as to the site’s operation or the information, content or materials included on this site.   To the full extent permissible by applicable law, UNeMed and the University of Nebraska Medical Center hereby disclaim all warranties, express or implied, including but not limited to implied warranties of merchantability and fitness for any particular purpose.   Neither UNeMed nor the University of Nebraska Medical Center will be liable for any damages of any kind arising from the use of or inability to use this site. You expressly agree that you use this site solely at your own risk.

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UNeMed at BIO2012 convention

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UNeMed is looking forward to the BIO2012 convention in Boston next week.

Come visit us at booth 2722! We have prepared new materials that highlight our diverse portfolio of intellectual property. In addition to printed materials, this year we will be handing out flash drives containing information about UNeMed and key technology that represents significant advances in biomedical and clinical technology being developed at UNMC.

We will also be participating in the BIO Partnering Business Forum. If you’re looking for some 1 on 1 time with us, this is the perfect opportunity to meet up with us.

Don’t forget to follow us on Twitter @UNeMed so you can stay up-to-date with the latest happening at the convention. We will be using #bio2012 to connect with everyone at BIO2012.

Hope to see you there!

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What is a Patent?

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by Bill Hadley, UNeMed | July 19, 2012

As many of you reading this blog already know, our primary goal here at UNeMed is to commercialize technology developed at UNMC.  In order to do this, we take technologies generated from research performed on campus and partner with outside companies – or spin out start-ups – in order to develop the technology to the point where it is able to be used, sold, distributed or otherwise utilized in the public interest.

While we could spend weeks blogging about the nuances of the commercialization process  – and intend to do so! – I would like to take a few moments to discuss the cornerstone of UNeMed’s commercialization efforts:  patents.  An understanding of what patent rights are – and what they are not – is essential to appreciating the commercialization process.

The basis for the U.S. patent system is found in Art. 1, § 8 of the Constitution, which states:

“Congress shall have power…to promote the progress of science and the useful arts by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries…

At its core, this clause represents two competing interests.  On one hand, we want innovators to invest their time, resources, and creativity into developing new and useful inventions that will contribute to society.  On the other, we want society to understand, improve upon, and ultimately benefit from the innovator’s work.

To this end, the patent system strikes a balance.  In return for their creative and financial investments, as well as their willingness to disclose the nature of their innovation to the general public, Congress has granted inventors a time-limited monopoly over the use of a patented invention for a period of 20 years from the date of application to the United States Patent and Trademark Office (USPTO).  In return, all patents are published for public study and evaluation, and, after the 20-year monopoly has expired, become freely usable.  In this way, society as a whole benefits from the creation and disclosure of the invention, while the inventor himself has the opportunity to  capitalize on his rights to the invention under the government-sanctioned monopoly.

With the intent behind the patent system firmly in hand, let’s turn now to the scope of the monopoly granted by an allowed patent.  Under 35 USC § 271(a), a patent provides its owner with the exclusive rights to do the following:

  1. Make the patented invention
  2. Use the patented invention
  3. Sell the patented invention
  4. Offer to sell the patented invention, and
  5. Import the patented invention

In other words, a patent does not authorize or entitle the patent holder to make, use, sell, offer to sell, or import their invention; it only gives the owner the power to prohibit others from doing so.  I’m going to repeat that one more time, so it’s clear:

A patent does not give its owner the right to do anything except prohibit others from making, using, selling, offering to sell, or importing the patented invention.

Thus, receipt of a patent is in no way a guarantee or indication as to the value or profit-generating abilities of the invention. Instead, patents allow inventions which have independent value to the market to capitalize on that value without fear of a competitor copying the invention and undercutting the patent holder’s market share.

This description is only the tip of the iceberg when it comes to understanding how the patent system functions.  There are myriad other nuances, rules, procedures, and technicalities that exist in our domestic patent system and these complications only increase when one considers filing for foreign patents.

While I will be discussing many of these topics in the coming weeks, keep in mind that these entries are not intended to make experts out of the reader.  Instead, they will (hopefully) provide you with a passing familiarity with the relevant terms, procedures, and rules, in the hopes of providing context for understanding the overall university technology commercialization process.

If that encourages a few of you to take advantage of the services UNeMed provides, so much the better.

 

Please leave any questions or suggestions you may have in the comment section below.

You can also shoot me an email at bill.hadley@unmc.edu.

I will be happy to address any thoughts you may have.

Nothing in this post should be construed as legal advice.  It has been developed by the UNeMed staff as an educational resource for faculty, staff, students, and other personnel associated with the University of Nebraska Medical Center.  While all information contained herein has been thoroughly fact-checked, this site is provided on an “as is” and “as available” basis.   Neither UNeMed nor the University of Nebraska Medical Center make any representations or warranties of any kind, express or implied, as to the site’s operation or the information, content or materials included on this site.   To the full extent permissible by applicable law, UNeMed and the University of Nebraska Medical Center hereby disclaim all warranties, express or implied, including but not limited to implied warranties of merchantability and fitness for any particular purpose.   Neither UNeMed nor the University of Nebraska Medical Center will be liable for any damages of any kind arising from the use of or inability to use this site. You expressly agree that you use this site solely at your own risk.

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University Startup Seminar is Wednesday, May 30, 2012

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OMAHA, Neb. (May 28, 2012)—Most students are led to graduate school by dreams of making a significant discovery or inventing a lifesaving drug. However, slightly  less than half of all graduates receiving a PhD degree will continue to pursue their dreams in academic institutions, according to statistics. However, this doesn’t mean that the rest have to say goodbye to their dreams. An alternative career in a biotech startup is one of the opportunities that may turn out as rewarding.

Join us at noon on May 30th in the DRC Auditorium to learn about career opportunities in a biotech startup company. Dr Zagit Gaymalov will speak about what it takes to start a business and what it’s like to run one. Dr Gaymalov received his PhD degree from UNMC Pharmaceutical Sciences Graduate Program and continues his career as a technology transfer professional with UNeMed Corporation and CEO of NeuroNano Pharma, a biotech business he started with his PhD advisor Dr Alexander “Sasha” Kabanov.

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UNeBlog, UNeMed’s Technology Transfer Blog

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by Agnes Lenagh, UNeMed | May 28, 2012

WELCOME!

We’re excited to launch this blog to share our enthusiasm for enhancing the development of UNMC technologies on a more personal level.

This blog will serve many purposes – to inform the UNMC community what UNeMed is doing, share news about technology transfer and commercialization, elaborate on methods and best practices to protect inventions, and report on research development and available programs and new opportunities.

We also hope that the UNeBlog will incite some new ideas that will assist in the development of basic research toward clinical stages.

The topics that will be covered will be divided into 6 searchable categories including:

We’re eager to share this journey with everyone at UNMC.

If you have a new idea or would like your technology transfer questions addressed on our blog, please let us know

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DNA analyzing device goes from idea to market — all in Nebraska

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Read the original article here: https://www.omaha.com/article/20120223/MONEY/702239955

by Roger Buddenberg, Omaha World-Herald

OMAHA, Neb. (Feb. 20, 2012)—Connie Ryan was watching one of the “CSI” shows on television recently when she heard the investigator lament that a perp was likely to slip through the cops’ fingers because a tiny bit of DNA evidence would take hours — hours! — to analyze.

“I thought, we ought to call them,” she said. Because it shouldn’t take that long anymore.

Her Omaha company, Streck Inc., has just brought to market a laboratory device that dramatically speeds up the task. More important, the gizmo was invented, developed into a salable product and built in Nebraska — an example, Ryan said, of the kind of homegrown inventor-entrepreneur collaboration that can rev up the state’s economy, create jobs and even revive America’s beleaguered manufacturing sector.

She thinks that’s a message Nebraska’s policy makers and its wealthy — its would-be venture capitalists — ought to hear.

But first the device. It’s called a thermal cycler.

It can rapidly and precisely heat and cool a minute trace of DNA — a fleck of blood or a snippet of virus — thus multiplying it through a process called polymerase chain reaction so that it’s big enough to be analyzed. This copying process is a quarter-century old, but until now has taken an hour or two per batch.

That’s fine if you’re not in a hurry.

But if you are, say, a cop tracking a murderer or a hospital rushing to diagnose a lethal disease or to see whether perishable transplant tissue is compatible — speed is vital, Ryan said. Her company’s machine, called the Philisa Thermal Cycler, cuts the time to 15 minutes.

The first Philisa has just been sold for about $10,000 to a government agency that wants to remain anonymous because it is about to publish research involving the machine, Ryan said. About a dozen other Philisas are getting tryouts with hospitals and other potential customers.

The goal, she said, is to sell 50 in the next six months. And she’s confident, based on Streck’s 41-year track record of identifying the lab problems of the white-coated crowd, then devising solutions for them.

Getting to this point, though, wasn’t simple. And Ryan thinks the tale holds some lessons:

The idea for the speedier thermal cycler was born about eight years ago with three University of Nebraska-Lincoln academics, Hendrik Viljoen, a professor of chemical biomolecular engineering, and two colleagues, Joel TerMaat, then a doctoral candidate, and Scott Whitney, then a post-doctoral fellow.

They formed a company, but it was little more than an idea worked out in a Lincoln garage using cobbled-together materials such as drinking straws from a nearby 7-Eleven, Viljoen said.

What it needed, Ryan said, was someone with money and the know-how to turn the idea into a marketable product. That’s where Streck came in. It bought the startup in March 2010, put TerMaat and Whitney on the payroll and hired Viljoen as a consultant.

Playing matchmaker for this deal were two arms of the university devoted to commercializing scholars’ ideas, NUtech Ventures and UNeMed, as well as a member of Nebraska Angels, a group that investigates early-stage investment opportunities.

One more ingredient was required to make the device a practical reality, Ryan said: plastic tubes of just the right shape and thickness to hold the DNA samples. After all, you can’t keep using straws from the 7-Eleven.

Again, a Nebraska company filled the bill, she said. Streck turned to HTI Plastics, an injection-molding firm founded in Lincoln in 1985.

“People sometimes underestimate the technology that exists in this state,” Ryan said. “We really have some amazing companies.”

What’s necessary to replicate this story, she said, is more money, nerve and entrepreneurial know-how.

The ideas are plentiful — “there are tons of interesting things happening at our universities,” she said.

And so is the money. “We have a lot of wealthy people in this community. . I think wealthy people want to make a difference. Investing in our state is a great way.”

Facilitators can help, such as UNL’s Innovation Campus, now taking shape on the former state fairgrounds, she said.

But the real shortage, she said, is entrepreneurial — people able to sift through ideas, pick ones that are good risks, then put in the money and hard work needed to turn them into market-worthy products. And good Nebraska manufacturing jobs.

Contact the writer: 402-444-1140, roger.buddenberg@owh.com

Read the original article here:   https://www.omaha.com/article/20120223/MONEY/702239955

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Smartphone app developed by Munroe-Meyer’s Keith Allen

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OMAHA, Neb. (Dec. 23, 2011)—A smartphone application developed by the Munroe-Meyer Institute’s Keith Allen, Ph.D., that will help children with autism communicate more effectively is being licensed by UNMC. The app focuses on evidence-based natural teaching procedures. BehaviorApp, LLC — a Lincoln-based smartphone app development company — will create the app, which could be available for use by March.

UNMC Today Announcement https://app1.unmc.edu/publicaffairs/todaysite/sitefiles/today_full.cfm?match=8853

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Nebraska seeing more cash for startups

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From the Lincoln Journal-Star

LINCOLN, Neb. (Nov. 28, 2011)—Nebraska has long lagged behind the rest of the nation when it comes to financing for startup businesses.

More than one ranking has put the state near the bottom — or in some cases at the bottom — in venture capital funding. And other forms of financing such as angel investments and seed capital also can be hard to find.

But that may be changing.

Within the past few months, nearly $60 million in new public and private funds has become available for startup and other small businesses.

Nebraska Global Investment Co. — a venture capital firm that finances the creation and development of software companies in Nebraska — earlier this year closed its fund at $37.3 million, about $7 million more than it hoped for and about $10 million less than it could have raised.

Add to that more than $21 million in federal and state money targeted at startup companies, entrepreneurs and innovation, and you’ve suddenly got a bigger pot.

“It’s a good problem to have,” said Dan Hoffman, executive director of Invest Nebraska. The nonprofit group has a contract with the state to create angel investment funds to match a one-time infusion of $12.6 million from the federal government.

Of the money, $9 million is for loans for existing startup companies, and $3.6 million is for equity or convertible debt investments in startup companies that must be matched by private angel fund investments.

The idea of states taking equity investments in startup companies may seem like a new or novel idea, but it’s actually something that has been going on for several years.

“Most of the other states have been doing this for quite some time,” Hoffman said.

The reason the state is stepping forward now is because an economic study showed Nebraska officials what those in the business community have known for a long time: The state lags in financing opportunities for startup companies.

The Battelle Institute study recommended the state come up with an angel investment tax credit and help facilitate the formation of a private sector-driven innovation and technology development organization, as well as create a private sector-driven venture financing entity.

Gary Hamer, the interim director of the Nebraska Department of Economic Development, said the state took the Battelle recommendations very seriously.

The Legislature approved a tax credit for angel investors, and the state nearly quadrupled the amount of money available to startup companies and early stage businesses.

Hamer said it’s not really any big change in the way the state goes about economic development, as it has always had a big emphasis on helping small, homegrown businesses.

But people usually hear only about the economic development “home runs,” such as PayPal in LaVista and Verizon Wireless in Lincoln.

“Over time, if you put enough money into startups, you’re gonna have some home runs,” Hamer said.

Whether the recent infusion of money is enough is up for debate.

Patrick Smith, the chief operating officer of Nebraska Global and one of its founding partners, said the nearly $60 million “really does not scratch the surface” of the available capital that’s out there.

“There is significantly more capital available in the state than this, including early funders for startups,” Smith said.  “The difference (with the new money) is more publicity, legislation and general public acknowledgment around wanting more startup activity and entrepreneur activity.”

Smith said the federal and state money will fill a niche in early funding rounds when a business may be too small to appeal to early stage investors such as angel investors. Also, the matching funds for seed capital investments can act as a multiplier for smaller investments.

“If there is a small round on a very early stage idea, doing some matching funds made available from the feds or state can be beneficial,” he said. “However, the dollars become less meaningful when you have substantially larger rounds or are in later stages of investment.”

Smith, however, said he’s also concerned about how the government money will be spent.

Specifically, he said, he’s concerned it may not generate additional business activity and instead will go to companies that have been turned down by other investors.

“I would hazard a guess that any loud voice regarding the lack of capital available, in part, came from people who sought capital with poor ideas and businesses that never should have received any funding,” Smith said.

“It will be an interesting retrospective on the use of dollars if they go toward deals that all others have passed on for good reason. I would love to think we are wrong and that a lot of additional successful activity is created, but I am not certain how to reconcile how that may happen at this point.”

Hoffman of Invest Nebraska said that’s where his organization comes in.

“That’s the reason why the department has partnered with Invest Nebraska,” he said.

The organization’s board of directors has venture capitalists, entrepreneurs and others with the necessary expertise.

Hoffman also said that similar state government-nonprofit partnerships in other states have proved successful.

 

Government money for startups

Federal money (one-time funds that the state has two years to use)

Nebraska Progress Loan Fund: $9 million

Nebraska Progress Seed Fund: $3.6 million

State money

Nebraska Operational Assistance Act: $250,000

Nebraska Economic Gardening Program: $200,000

SBIR Initiative: $1 million

Nebraska Innovation Fund: $3 million

Nebraska Research and Development Program: $2 million

Microenterprise Technical Assistance: $300,000

Microenterprise Financial Assistance: $700,000

InternNE Internship Grants: $1.5 million

Source: Invest Nebraska

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UNeMed Innovation Week Award Ceremony Celebrates Innovation at UNMC

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OMAHA, Neb. (Nov. 11, 2011)—Hundreds gathered in Omaha last week to recognize local inventors and researchers in science fields as part of the UNeMed Innovation Week. Research, newly developed equipment and innovations in technology were among the top award winners at the week-long event.

The event was the culmination of an entire year’s worth of research and gave awards, licensing and patents to recognized award recipients. The event was hosted and put on by UNeMed, a corporation part of the University of Nebraska Medical Center. Since UNeMed was founded in 1991, it has worked with researchers to bring innovative ideas from the laboratory to the marketplace and helps provide licenses, patents and grants to these researchers

“Innovation Week culminates in the awards ceremony,” said Steve Schreiner, Licensing and Marketing director of UNeMed. “We invite everyone we can onto campus and we invite everyone who submitted an idea to us. We acknowledge each of those. There are 70 to 100 people on that list. The awards ceremony highlights who on campus has submitted an idea to UNeMed.”

Early in the week, speakers and scheduled events focused on UNeMed’s work. What started as a small event a few years ago now sees nearly 200 guests and it continues to grow. Schreiner said Innovation Week is entrepreneurial itself because it started small and on its own and grew to the size it is today.

The Innovation Week program works as a way to help patent the ideas of innovative researchers and developers in the science field. People who have ideas go to UNeMed and pitch these ideas. The best ones are selected for grants, licensing and patents and are recognized at the Innovation Week event.

The awards are broken into three categories. The first category is devoted to special awards to the ideas that are most promising. Schreiner said these awards are the ones with the most potential and would have the biggest impact, not necessarily produce the most money. This award is given each year and the winners receive $10,000 in unrestricted grants to use for research and funds.

The second category is called the emerging inventor award and provides $25,000 in unrestricted research grants to someone on the campus that’s working in an innovative area that will bring commercial value to the office. This was only the second year this award was given. This year’s winner of the emerging inventor award was Amar Natarajan, Ph.D., an associate professor at the Eppley Institute. Natajaran’s research focuses on anti-cancer compounds.

The emerging inventor award isn’t provided every year and in years it isn’t handed out, a lifetime achievement award is given. So far, two lifetime achievement awards have been given.

Another award was the most promising new invention award. Dr. Stephen Bonasera, an assistant professor at the University of Nebraska Medical Center College of Medicine, was awarded the most promising new invention award. In addition to these honors, UNeMed releases patents to seven researchers and licensed technologies for ten others.

Up until recently those involved with Innovation Week have been solely individuals working in the University of Nebraska system. However, Schreiner said that the field has expanded to include inventors from outside the university. Schreiner said by opening up Innovation Week to others, more ideas can be given the chance to receive grants, patents and licensing that normally would not.

“We’ve begun taking on external (outside the University of Nebraska system) customers and we try to work with them on a pay basis,” Schreiner said. “Now we can actually work with them and we can actually treat them like our own inventers [and they benefit].”

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UNeMed Emerging Inventor, Amarnath Natarajan, discusses his research

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Amarnath Natarajan, Ph.D., stood up and walked to a white board covered in red, black and green, hand-drawn chemistry diagrams.  “If you really are interested, I can tell you about this all day,” the associate professor in the Eppley Institute said.

He cleared a section of the board and began to draw lines and ovals that symbolize proteins, cancer cells and a compound he and his team have designed that has the potential to make cancer cells sensitive to treatment by blocking the inter cellular communication mechanisms.  The longer he talked, the faster he drew. He explained how his compound works and why it shows promise as a way to treat pancreatic cancer, one of nature’s most efficient human killers, as well as other forms of cancer.

His excitement took him back to his younger days in India when his science class dissolved coins in acid to learn about metals.  “I was amazed to learn about the elements contained in coins,” Dr. Natarajan said.  That one experiment ignited a curiosity that led him to organic chemistry and, eventually, create his own compounds.

His first compound was conceived around Thanksgiving of 1996 in his laboratory at the University of Vermont, where he hid from the cold. He had recently moved from his native India and never experienced temperatures below 75 degrees. Inside the warm laboratory, while others ate turkey and watched football, he worked on his novel compound that would serve as part of a new drug.

Since that day he has discovered several other compounds, including the one to treat pancreatic cancer, yet the feeling of discovery never gets old, he said.  “I still get excited when I or someone on my team discovers a new compound,” Dr. Natarajan said. “I truly love discovering something new.”

Dr. Natarajan isn’t the only one excited by his work.  He came to UNMC at the request of Hamid Band, M.D., Ph.D., professor and associate director of translational research in the Eppley Institute.  The two met when Dr. Band – then a faculty member at Northwestern University — visited the University of Texas Medical Branch in Galveston, where Dr. Natarajan worked at the time.  Their discussion soon turned to collaboration on Dr. Band’s work in breast cancer.

When Dr. Band came to Omaha a couple years ago, he suggested Dr. Natarajan consider doing the same.  After a visit to the medical center, Dr. Natarajan decided UNMC offered a lot in terms of opportunity and potential, so he moved his team from Texas to Omaha.  “As a biologist, it’s been very exciting to have a chemist on hand to add his input and expertise into our work,” Dr. Band said. “He’s a tremendous asset and stands to significantly aid us in our quest to battle cancer and help patients.”

One of Dr. Natarajan’s biggest assets is his willingness to expand his knowledge and expertise to other areas of medical science, Dr. Band said.  “He actually taught himself biology,” Dr. Band said, with a tone of admiration n his voice.

With his new expertise, Dr. Natarajan has bridged the two traditionally separate fields of chemistry and biology in a manner that could benefit many.  One of just a few medicinal chemists on the UNMC campus, Dr. Natarajan has the expertise and skills to make UNMC a player in the world of cancer drug discovery, said Michael Dixon, Ph.D., president and CEO of UNeMed, UNMC’s technology and transfer arm. UNeMed recently honored Dr. Natarajan with its Emerging Inventor Award for his compound.

The creation of novel compounds has led to some incredibly profitable developments at several universities, Dr. Dixon said.  He points to Florida State University, where a team of scientists led by Robert Holton, Ph.D., created a synthetic version of the cancer drug, Taxol –  a discovery that led the school to receive $350 million in royalties.  “The compounds Dr. Natarajan is developing have never been created before and could lead to powerful new treatments for cancer,” Dr. Dixon said. “This is good news all around as it benefits patients and could significantly affect UNMC economically.”

The potential for financial windfall is intriguing for Dr. Natarajan, but it doesn’t drive him. No, the fuel for this fire has been the same the whole time.  “My interest goes beyond chemistry, beyond biology, beyond cancer,” Dr. Natarajan said. “I’m interested in science, period. That’s what excites me.”  It always has.

He’s here to help

If you’re a researcher and you need a compound made, Amarnath Natarajan, Ph.D., wants you to call him.   “We are always open to collaborations and exploring ways to help others in their research,” Dr. Natarajan said.  “We’re open to pretty much anybody.”  Dr. Natarajan and his team now work with Eppley Institute’s Hamid Band, M.D., Ph.D., and Tony Hollingsworth, Ph.D., professor and director of pancreatic cancer research.  Dr. Natarajan has created compounds that have helped with Dr. Band’s breast cancer research and have shown promise in Dr. Hollingsworth study of how to better treat pancreatic cancer.

He’s also in conversation with several other campus researchers about making compounds to help advance their research.  Dr. Natarajan is interested in helping any researcher, regardless of field of study, who has a need for a new compound.  “Our skill set is that we can make small molecules, which later may become the basis of drugs and treatments,” Dr. Natarajan said.

“If you need small molecules made, that’s a job for us.”

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2011 Innovation Week – Calendar of Events

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Poised for a patent change

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by Ross Boettcher, Omaha World-Herald

The plan to dramatically shift the U.S. patent system is prompting mixed reactions from Midlands companies and universities preparing for the changes.

After President Barack Obama signs into law the America Invents Act — the first major patent system overhaul in nearly 60 years — the country’s system will flip from a first-to-invent to a first-to-file system, bringing the U.S. in line with most other nations around the world.

For those who aren’t scientists, intellectual property attorneys or inventors, here’s what the legislation passed by Congress on Thursday means:

Under first-to-invent, entrepreneurs and inventors had a one-year grace period to determine whether their inventions were worth filing patents on. During that time, they could meet with investors or corporate partners and get a better understanding of how valuable their invention might be. If the idea leaked to another inventor or company and it filed a patent first, the initial inventor would have an opportunity to prove that he was the original inventor by keeping logs that prove when the idea was born.

Under the America Invents Act, the patent goes to the first inventor or company to file for an idea or product even if not the first to conceive it.

The new system is aimed at relieving a backlog of patent filings, curbing costly patent litigation and stimulating innovation.

Officials at some Midlands businesses that are heavily tied to patented technology, ideas and products said they’re leery that the new law could favor large corporations and change the way small companies and inventors innovate and assess whether their creations are worth patenting.

“The read that we have is that the first-to-file is going to force companies to file a lot quicker than you normally would. And maybe more often,” said John Gustafson, president and chief executive of Prairie Ventures, a private Omaha-based holding firm with operating companies in publishing, telemedicine, medical technology, business intelligence, staffing and social networking.

“We’re going through and reviewing our (intellectual property) portfolio and evaluating what filings we may want to accelerate instead of waiting until the end of the one-year period,” Gustafson said.

Ryan Grace, a patent attorney who represents Omaha-based ConAgra Foods Inc., said large companies are positioned to take advantage of the first-to-file system because they have more money to spend on filing more patents more often and larger legal teams to help handle that volume increase.

But some small firms and individual inventors, Grace said, will thrive in a first-to-file system because they weren’t properly documenting the development of their inventions under the first-to-invent system, making it impossible to prove that they were the first.

“To them, it was a first-to-file system before,” Grace said.

Other business officials agree that the changes overall improve the system.

Nebraska’s largest patent-holder, with 80 patents secured from 2006 to 2010, Lincoln’s J.A. Woollam Co., takes a big-picture perspective and says the United States is simply falling in line with the rest of the world.

“My personal belief is that it will change the way we file (patents) for sure and what we disclose and don’t disclose,” said Greg Pribil, an engineer at J.A. Woollam, which develops spectroscopic ellipsometer technology for testing materials with light.

“But as far as the grand scheme of things, I don’t think we’re too concerned. Considering that it’s (first-to-file) everywhere else, we already have to deal with that.”

Connie Ryan, the president of Streck Labs, which produces clinical laboratory products and received 39 patents from 2006 to 2010, said Streck has long supported the first-to-file system because it will streamline the patenting process and cut down on expensive litigation.

“We’ve believed in it for a long time,” Ryan said. “All the rest of the world is first-to-file. Only the U.S. is first-to-invent.”

Streck Labs, Ryan said, has spent millions of dollars on litigation involving patent infringement. In 2002 and again in the past year, Streck went to federal court to protect its patents. One case was settled by a California company for a reported $39 million plus royalties. In the second case, a jury decided in Streck’s favor.

Pioneer Hi-bred, the international seed company headquartered in Des Moines, also thinks the legislation is an improvement over the existing law.

“While it is not perfect, we believe it better aligns the U.S. with international patent systems,” a company spokeswoman said in a statement. “Ultimately, improvements like this will help encourage innovation and job growth.”

Some other large, patent-holding Midlands firms have been largely silent on the issue. A spokeswoman declined to comment for Atlanta-based payment processing giant First Data, which has significant operations in Omaha. A spokesman at West Corp., the Omaha-based provider of voice- and technology-based business outsourcing services, also declined to comment.

Many of the nation’s large companies — including Apple, Microsoft, IBM, Google, General Electric and Johnson & Johnson — supported passage of the America Invents Act.

The U.S. Chamber of Commerce, the United Steelworkers and the Association of American Universities also favor the change.

Much of the debate in the six years it took to pass the patent revisions centered on issues related to money.

Because of inventors needing to file more patents frequently under the first-to-file policy, Nita Lovejoy, associate director of the Iowa State University research foundation, expects more of the university’s budget to be allocated toward patent filing. Typically, Iowa State spends between $800,000 and $900,000 on patents. When the bill becomes law in 18 months, Lovejoy expects that number to exceed $1 million.

Lovejoy said the updated system could cause some problems for universities to find corporate sponsors to back their inventions because it’s critical that information about the invention or idea not leak into the wrong hands. “There’s going to be more questions about value of what we have.”

But for the most part, Lovejoy said, the results will be positive for ISU.

“We are fortunate that we’re self-supporting and have some funds to be able to meet these challenges, but we don’t want to frivolously start filing on everything,” Lovejoy said. “I’m sure we’ll be doing some analysis of how we’re reviewing inventions as they come in.”

Michael Dixon, president and CEO of UNeMed Corp., which helps bring inventions from the University of Nebraska system to market, said the passing of the reform will be a boon for the U.S. Patent and Trademark Office as long as the money gained by patent fees are kept within the patent system. The money, he said, is expected to hire more patent office employees, update software programs and increase the number of satellite offices across the country.

“I think the biggest reason that most universities are in support of this is the fee diversion,” Dixon said. “The patent and trademark offices have been used as a piggy bank for years, funding other programs. By now allowing them to keep the fees they charge it will help clear out the backlog of patents in the system. That’s the biggest benefit to the reform, for us.”

Sen. Chuck Grassley, R-Iowa, was a longtime supporter of patent reform, primarily because he sees it eliminating patents that allow companies to find loopholes in the tax system or hold exclusive rights to use loopholes.

“More and more legal tax strategies are unavailable or more expensive for more and more taxpayers,” Grassley said in a statement after the bill’s passage. “We have to protect the right of taxpayers to have equal access to legal tax strategies.”

The Senate passed a final version of the bill on Thursday with rare bipartisan support. Nebraska Sens. Ben Nelson, a Democrat, and Mike Johanns, a Republican, and Iowa Sen. Tom Harkin, a Democrat, joined Grassley in voting for final passage. The bill had passed the House in June.

Obama signaled his support most recently in his Thursday night address about job creation, calling the bill “the kind of action we need.”

“You passed reform,” he told Congress, “that will speed up the outdated patent process so that entrepreneurs can turn a new idea into a new business as quickly as possibly.”

Contact the writer:

402-444-1414, ross.boettcher@owh.com

twitter.com/rossboettcher

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Gov. Heineman signs Talent & Innovation Initiative Bills into law

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LINCOLN, Neb. (May 24, 2011)—Governor Dave Heineman today signed the final measures of a four-part legislative package into law. The Talent and Innovation Initiative was a 2011 legislative priority for the Governor and introduced by several State Senators on his behalf. The initiative is aimed at advancing business innovation and strengthening workforce recruitment efforts in Nebraska.

“The Talent and Innovation Initiative is about enhancing technology and innovation, and growing and attracting new, technology-focused companies to Nebraska,” Gov. Heineman said. “It puts a laser-like focus on growing Nebraska’s innovation economy. With this initiative, Nebraska has one of the strongest public policy strategies in place to advance business recruitment and development.”

Based on 2010 recommendations made in a comprehensive review of Nebraska’s economic climate, the Talent & Innovation Initiative was developed to better leverage existing funds and enhance momentum in developing industries positioned to benefit from technology and innovation. Programs contained in the bills will be implemented by the Nebraska Department of Economic Development.

LB 386, the Nebraska Internship Program, introduced by Sen. Lavon Heidemann of Elk Creek, takes effect June 1. It is a partnership with Nebraska businesses to create new internship opportunities for college and university students. Funded with $1.5 million a year in job training funds, and matched by eligible companies, the program will create opportunities for 500 to 750 juniors and seniors studying at four-year institutions or students in their second year at a Nebraska community college to gain job experience.

Awards will be made on a first-come, first-serve basis to companies creating new internship opportunities, which are capped at 10 per business. Internships will pay at least minimum wage and range from 12 week to year-long programs.

LB 387, the Business Innovation Act, introduced by Sen. Galen Hadley of Kearney, intended to help businesses develop new technologies to enhance quality job opportunities in the state. It will provide competitive grants for research at Nebraska institutions, new product development and testing, and help expand small business and entrepreneur outreach efforts.

It will expand grant opportunities within targeted industries to help businesses providing matching funds with prototype development, commercialization and applied research in the state and provide assistance for microenterprise projects. The law takes effect Oct. 1.

LB 388, the Site & Building Development Fund, introduced by Sen. John Wightman of Lexington, takes effect Oct. 1 and is intended to help increase industrial and commercial sites available and ready for business development. Communities will provide matching funds toward projects that can involve demolition, new construction and rehabilitation. State funding will be focused on land and infrastructure costs with 40 percent of funding available to non-metro areas.

LB 389, the Angel Investment Tax Credit, introduced by Sen. Abbie Cornett of Bellevue, is effective for the current tax year. It encourages investment in high-tech and other startup enterprises in Nebraska by providing refundable state income tax credits to qualified investors investing in qualified early-stage companies. Capped at $3 million annually, the program requires a minimum investment of $25,000 for individuals and $50,000 for investment funds. Eligible small businesses must have fewer than 25 employees, with the majority based in the state.

Additionally, the Governor signed LB 345, the Small Business Innovation Act sponsored by Sen. Danielle Conrad of Lincoln, which provides additional tools and technical assistance for entrepreneurs across Nebraska.

Gov. Heineman said, “I want to thank the many senators who supported these proposals, the business community and other private sector leaders. This is about making investments that will develop new career opportunities in innovative and technologically-advanced sectors.”

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KUDOS award to Valerie Gunderson

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OMAHA, Neb. (May 20, 2011)—On behalf of the Board of Regents, UNeMed Business Manager Valerie Gunderson was presented a KUDOS award by Chancellor Harold Mauer.

Her supervisor and nominator, James Linder, M.D., executive director of the UNeMed Corporation and professor of pathology and microbiology, said, “As the ‘administrator’ of UNeMed (the technology transfer office for UNMC), Val has helped to grow the unit during periods of recruiting and staff realignment. She has helped communicate the mission of UNeMed to our internal customers (faculty and staff) and to our external partners (UNL, UNO, Creighton University, the Omaha Chamber of Commerce and private business). These interactions are carried out with the highest quality work and represent UNMC in an outstanding manner.” Dr. Linder also said, “Val is known to virtually all administrative personnel on campus because of the years of service she has provided at UNMC. From implementing the Electronic Residency Application Service for all medical students to creating the awareness among faculty of grant transfer opportunities, Val is part of the administrative bedrock that allows UNMC to accomplish its mission.”

Another nominator, Michael Dixon, Ph.D., director of UNeMed, said, “Val has the unique ability to bridge the scientists, lawyers, business professionals, paralegals, marketing specialists and administrative associates in our group to ensure that the ‘job gets done and on time.’ She also always knows the right person or department to contact for anything.”

Today, Valerie Gunderson has brought her husband, Scott Gunderson and her direct supervisor and nominator, Dr. Jim Linder.

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