‘Valley of Death’ funding program lifts UNMC innovations

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Greg Gordon, M.D., aligns a prototype of his patented Lock-Block radiation shield during a round of early tests. Dr. Gordon built his own startup company, Radux Devices, around inventions designed to better protect physicians from radiation.

OMAHA, Nebraska (Feb. 21, 2017)—Officials at the University of Nebraska Medical Center reviewed their use of the Nebraska Research Initiative’s Proof-of-Concept or POC grant funding program. The review found that despite its relatively modest use, the program has consistently delivered powerful results.

POC grants focus on research innovations and discoveries in danger of slipping into an academic research limbo known as the “Valley of Death.” Innovations that slide into this no-man’s land are usually too advanced to warrant additional funding from various federal agencies, but still too early in development to attract commercial or industrial funding.

The POC grant program at the University of Nebraska was created to fill those gaps for research projects. The program is most often used at UNMC for new biomedical discoveries that have high potential to “improve healthcare for Nebraska and beyond,” said Michael Dixon, the CEO at UNeMed, which performed the review.

“This is one of the few sources of gap funding we have,” Dixon said. UNeMed is the technology transfer and commercialization office for UNMC. UNeMed also works with inventors at the University of Nebraska at Omaha.

“Without POCs,” Dixon added, “we’d have more than a dozen technologies just dying on the vine. That’s a dozen potential treatments, cures and better outcomes that industry just isn’t ready to invest in. But they’re all moving forward now thanks to this program, and several are now receiving financial support from industry. That’s a huge credit to our leaders in the legislature and at the University. They made it happen.”

Over the five-year history of the program, 17 grants totaling $2.78 million have been approved for UNMC and UNO biomedical innovations.

More specifically, the grants led directly to the creation of four startups companies; four new partnerships with biomedical companies; at least $525,000 in additional federal research funding; and another $1.3 million from industrial partners to support of University research. And one UNMC startup company, armed with data produced from a POC-funded study, was able raise an additional $300,000 from outside investors.

POC grants at UNMC and UNO have also led to advanced prototypes of medical devices and drug treatments that move the technologies closer toward their first clinical trials and product launches.

Approval for a POC grant typically requires significant feedback from a potential industrial or commercial partner who is interested in developing the technology.

For example, a company might be interested in a UNMC innovation, if only the researcher could show the result of a particular test. That test result alone could determine whether a new cancer drug or medical device advances closer to market. But with no additional research funds, the innovation will often lie in wait, rarely seen or heard from again.

The POC grants often pay for those additional tests, delivering the results needed to move a technology closer to market.

“The companies interested in these technologies, they just aren’t always in a position to handle the risk of paying for these additional studies,” said UNeMed’s Director of Business Development, Joe Runge. “These tests aren’t just things we pull out of our ears. This is in line with the things that industry needs to see before investing significant time and treasure.”

A new simulator invented at the University of Nebraska Medical Center uses video game technology to teach laparoscopic surgery to residents pressed by work hour restrictions.

Reducing the amount of risk involved for companies is a large part of what makes the program successful, said David Jackson, the University of Nebraska’s Vice Provost who administers the Nebraska Research Initiative and its POC program.

“This is high risk for us too,” Jackson said, “but if someone doesn’t take the risk, then these technologies stay dormant. Just to leave a technology on the table is a lost opportunity.”

He added: “We take that risk because of the potential for moving technologies out the door in a way that’s going to benefit all Nebraskans.”

The NRI was originally created in 1988 as a state-funded program to build research capacity and expertise throughout the University system. Later, in 2011, a small portion of that funding was directed to POC grants, or what Dixon at UNeMed calls “Valley of Death funding.”

About 6 percent of the NRI budget goes to POC funding at all campuses in the University of Nebraska system, Jackson said.

“Looking back, the state deserves a ton of credit for their foresight in setting up the NRI to begin with,” Dixon said. “It helped grow this research engine to the beast it is today. I can’t imagine what this POC program might lead to in another 20 years; what the biomedical sector in Nebraska might look like; all the jobs it might produce. It could be transformative for our local economy, not to mention all the medical benefits we might see.”

At UNMC, all of UNeMed’s approved POC grants resulted in eliminating unknowns and uncertainties for potential industry partners.

“We try to be judicious, and have partners in mind,” Jackson said. “I don’t count it a failure if something like a prototype doesn’t work. That tells you to stop the work, and move in a new direction. What’s a failure in my mind is if something gets funded that doesn’t answer a question industry needs.”

The first POC grant at UNMC, awarded in late 2011, funded a study that created the data necessary to support FDA clearance for a clinical trial. The technology is a unique drug that could allow doctors to diagnose, treat and track tumors in patients who suffer some of the most deadly forms of cancer.

The clear path to a clinical trial helped attract a serial entrepreneur from Kansas City who used the technology to create a startup company, Calidum, Inc. Calidum is now raising funds to perform the trial.

Another POC paid for a small clinical trial related to Parkinson’s disease. The trial yielded such encouraging results that a major pharmaceutical company is interested in repeating the study in a larger group of patients.

Two grants were awarded for UNO innovations created at the Biomechanics Research Building. One innovation led to an advanced prototype of a special insole that fits in a hospital slipper. Sensors within the insole then help predict the risk of falls for at-risk patients.

A look at the earliest version of a prototype developed by biomechanics researchers at the University of Nebraska at Omaha for detecting an exacerbation of chronic obstructive pulmonary disease. A POC grant from the Nebraska Research Initiative help create a wearable, advanced prototype that is expected to enter second clinical trial later this year.

A look at the earliest version of a prototype developed by biomechanics researchers at the University of Nebraska at Omaha for detecting an exacerbation of chronic obstructive pulmonary disease. A POC grant from the Nebraska Research Initiative help create a wearable, advanced prototype that is expected to enter second clinical trial later this year.

The other UNO-related grant paid for a study of chronic obstructive pulmonary disease or COPD. The study produced so much information that researchers had to create a new invention just to interpret the data stream. That simple solution could be applied to several other inventions at UNOs biomechanics facility.

Yet another UNMC innovation led to a million-dollar research collaboration with a major pharmaceutical firm on a long-acting HIV treatment.

Various contractual and confidentiality agreements prevent UNeMed from disclosing company names and some technology details.

Other POC projects include:

  • A validation study for Radux Devices, a UNMC startup, proved the effectiveness of two devices that protect physicians from radiation exposure during procedures that require continuous x-ray imaging. Radux plans its first product launch later this year.
  • A project that identified an entirely new molecule to target treatment-resistant pancreatic cancer.
  • A study for a blood test to predict coronary artery disease.
  • A small grant that paid to train UNMC personnel how to operate a new portable simulator for minimally invasive procedures. The training tool is expected to go through its first round of public testing later this year at Creighton University.
Click here to see all POCs at UNMC and UNO
Complete list of POC grants secured by UNeMed at the University of Nebraska Medical Center and the University of Nebraska at Omaha.

Tumor-targeted drugs for prostate cancer imaging and molecular radiotherapy
Approved: Oct. 10, 2011
Amount: $172,839
Principal Investigator: Janina Baranowska-Kortylewicz, Ph.D.
Summary: Novel radiopharmaceutical compound targeting specific cancer cells for the better treatment, diagnosis and tracking of tumors in the prostate, breast and ovaries. Such a targeted approach is expected to dramatically reduce harmful side-effects while improving treatment effectiveness.
Outcome: Funds used to complete all pre-clinical studies, and allowed the successful submission of an Investigative New Drug application to the FDA, which would allow a phase one clinical trial in prostate cancer patients. The clear path to a clinical trial attracted an entrepreneur from Kansas City who created a startup company, Calidum Inc., with an exclusive license for the technology. Calidum is currently raising funds to support the clinical trial.

Dentotropic mouthwash formulation for the prevention and treatment of dental caries and periodontal diseases
Approved: Feb. 2, 2012
Amount: $243,000
Principal Investigator: Dong Wang, Ph.D.
Summary: A new nanoparticle formulation for the treatment of oral diseases allows for extended and localized delivery that improves the effectiveness of existing drugs while reducing unwanted side-effects.
Outcome: Funds supported tests that showed apparent effectiveness of the compound. Further studies—including toxicity and stability—are required for further commercial development. Discussions with potential commercial partners are ongoing.

Immunoprotection for Parkinson’s disease
Approved: Nov. 1, 2013
Amount: $150,000
Principal Investigator: Howard Gendelman, M.D.
Summary: A vaccine strategy capable of slowing the progression of Parkinson’s disease
Outcome: Funds were used to support a clinical trial that explored one key component  of the vaccine called an adjuvant. Tests showed the adjuvant alone was enough to transform the immune profile of Parkinson’s patients. More than $100,000 additional funds were provided by a major pharmaceutical company to further support the clinical trial, and discussions are underway to expand the tests in a larger groups of patients.

Resorbable stent to assist in arteriovenous fistula maturation
Approved: May 15, 2012
Amount: $85,000
Principal Investigator: Marius Florescu, M.D.
Summary: A new device that improves success rates for AV fistulas, a procedure that joins an artery and a vein for the purpose of creating a portal to be used in dialysis for patients with failing kidneys.
Outcome: Funds paid for first successful fistula creation in animals and led to an advanced prototype with several potential clinical partners expressing an interest in the final design. The research in now planning a new study with the improved prototype.

Use of gait analysis to assess the likelihood of falls in at-risk populations
Approved: Sept. 4, 2012
Amount: $82,500
Principal Investigator: Nick Stergiou, Ph.D.
Summary: A system of sensors worn by a patient that can detect and record neuromuscular information. The information can then be analyzed to detect conditions such as Parkinson’s disease, peripheral artery disease, and the susceptibility of elderly patients to falls.
Outcome: Funds paid for a study of the device, and based on the positive results of the tests, a medical device company signed an agreement for exclusive rights to the underlying patents. They are currently working on applying for additional funding to support a clinical trial with a more advanced version of the prototype.

NanoART for preclinical safety assessment
Approved: March 1, 2013
Amount: $225,000
Principal Investigator: Howard Gendelman, M.D.
Summary: Funds helped test and develop novel long-acting nanoformulations for anti-HIV medications.
Outcome: Nanoformulations developed by this grant helped produced a partnership with a major pharmaceutical firm that has contributed more than $1.18 million in additional research funding. If previous studies are verified by an independent third party as expected, the collaboration would also expand to a much wider and deeper examination of the technology and its capabilities.

Novel antibodies for MUC4: applications in structure-functional analysis, and diagnosis and therapy of human cancers
Approved: May 1, 2013
Amount: $100,000
Principal Investigator: Surinder Batra, Ph.D.
Summary: Measuring a protein called MUC4 could help improve and refine the diagnosis and treatment strategies of some type of cancers, including pancreatic, lung, breast, ovarian and cervical.
Outcome: Results from the studies led to the creation of a startup company, Sanguine Diagnostics. The studies paid for by the POC grant led to additional work support through NIH grants. Sanguine also built on the findings of the POC studies to secure two Small Business Technology Transfer grants from the federal government, totaling $525,000. Sanguine is planning additional studies as they work toward developing better tissue diagnostic tools.

ARRESS and Lock-Block
Approved: June 27, 2014
Amount: $250,000
Principal Investigator: Greg Gordon, M.D.
Summary: Devices are designed to protect healthcare providers from repeated radiation exposure while reducing strain and stress on a provider’s joints and muscles through improved ergonomics.
Outcome: Funds supported a study that provided documented proof of assumed advantages of new devices. Complaints of musco-skeletal injury, fatigue and injury were reduced for physicians using the system. Radiation exposure levels were also significantly reduced, while workflow in the operating room also improved. Radux, the startup company built on the innovations, used the data to attract investors, putting Radux on the fast-track to an expected product launch this spring.

Drug candidates for Paf1/PD2: A novel target to restrict its comprehensive role in drug resistance of pancreatic and ovarian cancer stem cells
Approved: March 1, 2014
Amount: $250,000
Principal Investigator: Surinder Batra, Ph.D.
Summary: A protein associated with pancreatic cancer, pancreatic differentiation factor 2 or PD2, was identified as a key player in the development and recurrence of pancreatic and ovarian cancers.
Outcome: Funds supported a multi-campus collaboration that leveraged the super-computer at UNO’s Holland computing center to simulate potential drug candidates targeting PD2. After creating an accurate computer model of PD2, researchers successfully identified potential candidates. Based on those results, one pharmaceutical company has expressed a substantial interest in proposed follow-on studies, although additional funds are necessary to move forward.

MAA-adduct isolation and identification of the adducted macromolecule (analyte)
Approved: July 1, 2014
Amount: $100,000
Principal Investigator: Geoffrey Thiele, Ph.D.
Summary: A protein known as MAA, short for malondialdehyde-acetaldehyde, appears to differentiate between a relatively benign form of artery disease from a more lethal form that can result in a sudden and unexpected heart attack. Studies show a simple blood might be used to more accurately predict risk of the more dangerous variety of coronary artery disease.
Outcome: Funds paid for a study to develop a more accurate blood test. Five additional leads were developed in the study, which helped establish collaborative agreements with two commercial partners, including the creation of a new startup company, HealthCheck Diagnostics.

Improve Potency and oral bioavailability of the lead compound 13-197
Approved: Feb. 16, 2015
Amount: $250,000
Principal Investigator: Amarnath Natarajan, Ph.D.
Summary: NF-kB signaling plays an important role in the development and progression of numerous diseases. A novel inhibitor of NF-kB, 13-197, had demonstrated potent anti-proliferative activity.
Outcome: Based on feedback from industry representatives, POC funds were used to develop more potent and drugable analogs of 13-197. All tests are not yet complete, but one pharmaceutical company has already expressed a strong interest in pursuing any new leads generated from the POC study.

Approved: Nov. 1, 2015
Amount: $9,000
Principal Investigator: Joseph Siu, Ph.D.
Summary: An ultralight laparoscopic simulator for the training of surgical residents that is a less expensive and portable.
Outcome: Funds supported the creation of a training program for laboratory personnel as the technology continues moving toward its first round of “alpha” testing later this year.

Novel pyrrolomycins as anti-anthrax and anti-MRSA agents
Approved: March 7, 2016
Amount: $250,000
Principal Investigator: Rongshi Li, Ph.D.
Summary: A new compound showed great potential as a highly potent antibacterial agent against anthrax and methicillin-resistant Staphylococcus aureus, MRSA.
Outcome: Grant funded studies are still ongoing.

Reliability of portable device to measure respiration and step rates
Approved: March 7, 2016
Amount: $76,410
Principal Investigator: Jennifer Yentes, Ph.D.
Summary: A new platform that measures the relationship between breathing and walking shows the potential to predict when chronic obstructive pulmonary disease, COPD, suddenly flares up into a potentially deadly episode known as an exacerbation.
Outcome: Funds supported a clinical test that produced an unexpected amount of data, which lead to an improved algorithm to interpret and process all the information. The POC results led to an improved version of the wearable device and second clinical study that will held at the University of Alabama-Birmingham and the University of Michigan.

Development and applications of quantifiable sympathetic vasomotion
Approved: Aug. 1, 2016
Amount: $200,052
Principal Investigator: Irving Zucker, Ph.D.
Summary: A system for assessing the accuracy and effectiveness of renal denervation as an alternative treatment for high blood pressure.
Outcome: Studies are on-going. Based on earlier tests, a major medical device company is interested in the platform, and plans to visit campus later this year to review the results of the current study.

Pupillary examination using a simulated training model of the eye
Approved: Jan. 5, 2017
Amount: $80,636
Principal Investigator: Deepta Ghate, Ph.D.
Summary: A virtual and augmented reality simulator for examining pupils and pupillary disorders. The simulator is designed to teach medical students, residents, and other health care professionals how give a proper pupil examination and properly diagnose various diseases.
Outcome: Grant allowed the creation of a collaborative licensing agreement with a major medical simulator company, which will develop the simulator and incorporate into their existing line of products.

Development of the Aquablade catheter for treatment of aortic dissection
Approved: Jan. 23, 2017
Amount: $210,000
Principal Investigator: Jason MacTaggart, M.D.
Summary: The Aquablade is a device that uses high-pressure water to cut tissue inside an artery or vein. It is initially being developed for the treatment of aortic dissections.
Outcome: Grant will focus on the development of a functional prototype through a collaboration with a medical device manufacturing group. Once the prototype is developed additional tests will be conducted in UNMC labs.

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