From Ideas to Innovations

5 teams of Duke investigators receive Coulter Awards to prepare health-related discoveries for commercialization June 26, 2014

June 26, 2014

When Duke chemistry professor Michael Therien’s lab created a nano-crystal that responded to radiation in a predictably linear manner, they assumed it would be useful in measuring radiation doses during cancer treatments. Therien and Ian Stanton, his former graduate student leading the effort, teamed up with Terry Yoshizumi, head of the Health Physics Group at Duke University. Together, they incorporated the nano-crystal into a nano-scintillator fiber optic dosimeter – a device that measures radiation doses in real-time.

But that wasn’t enough.

“To really develop a practical device, we need to include patients,” said Therien. “But Terry and I are not clinicians.”

To continue developing their idea, Therien and Yoshizumi reached across another academic boundary to Junzo Chino, an assistant professor of radiation oncology. “He turned out to be a great addition to the team,” said Therien. “The partnership has the right chemistry between us.”

Money and Support to Prepare Ideas for Next Steps

In June, 2014, Chino, Therien and Yoshizumi (pictured from left to right) were one of five teams that received grants from the Duke-Coulter Translational Partnership Grant program to help move ideas from the lab to the clinic. Each team receiving a grant included at least one faculty member from the Pratt School of Engineering and one from the Duke School of Medicine. This year’s funded research ranges from the creation of radiation dosimeters and self-cleaning catheters to possible new treatments for epilepsy, glaucoma and Duchenne Muscular Dystrophy.

The Coulter Awards, with their unique partnership between biomedical engineers and clinicians, are one way Duke accelerates the translation of discoveries from an exciting idea to an innovative new product or therapy. In addition to dollars, the Coulter Awards include project management, market assessments, regulatory assistance and other advice from the Duke Translational Research Institute to help prepare the project for commercialization.

“Our goal is to provide the critical funding and business acumen to prepare a discovery to move from being a valuable basic science project to an idea that can be funded by the marketplace and moved into clinical care,” said Barry Myers, director of the Coulter Awards Program.

Since the Coulter Award program began at Duke in 2007 with funding from the Wallace H. Coulter Foundation, 20 of the 26 funded projects have advanced to pre-clinical efficacy studies in animal models or advanced to human studies. These projects have garnered more than $153 million in funding from other sources to help them move closer to commercialization. Additionally, seven of the past investigative teams have spun off companies to further develop the products.

Duke President Richard H. Brodhead lauds the impact that projects like these can have at Duke and beyond.

“The visionary contribution of the Coulter Foundation has been to build a bridge between pure curiosity-driven research and the engineering innovations that can make an enormous impact on people’s lives,” he said. “The Coulter partnership helps Duke to realize its commitment to knowledge in service to society.”

 

The Coulter Awards range from $60,000 to $250,000. The following teams received the 2014 awards for these projects:

 

Real Time, In-Vivo, Radiation Dose Monitoring

Michael Therien, William R. Kenan Jr. Professor of Chemistry; Terry Yoshizumi, Professor of Radiology; Junzo Chino, Assistant Professor of Radiation Oncology

Approximately 1.5 million Americans are treated for cancer every year with radiation therapy. Of vital interest to the doctors planning their care is ensuring that the prescribed dose of radiation is delivered to tumors while minimizing the radiation delivered to nearby normal tissue.

Therien, Yoshizumi and Chino have created a prototype of a dosimeter that can be placed inside the body next to a radiation source to measure radiation doses during therapy. This device gives real-time feedback, making it easier for radiation oncologists to ensure that the prescribed dose of radiation is delivered to the right place.

The team has already shrunk the prototype dosimeter from the size of an electrical cord to that of a needle, allowing the device to be placed next to a tumor with extraordinary accuracy. Their next step is to develop and test the device’s accuracy when radiation is delivered with an external beam.

“The Coulter Award will support the clinical trials that we need to complete to gather more safety and efficacy tests,” said Chino. “These trials will ensure that we are getting clinically useful readings.”

 

Genetic Correction of Duchenne Muscular Dystrophy

Charles Gersbach, Assistant Professor of Biomedical Engineering; Edward Smith, Assistant Professor of Pediatrics

Current investigational therapies for Duchenne Muscular Dystrophy involve life-long administration of treatments that temporarily address the genetic defect in dystrophin, an essential musculoskeletal protein. Drs. Gersbach and Smith are using a recently invented genome editing technology called CRISPR (clustered regularly interspaced short palindromic repeats) to modify the DNA sequence in the dystrophin genome to repair the disease-causing defect. This approach has been validated in cultured cells. The Coulter Award will allow them to expand the results to animal models of Duchenne Muscular Dystrophy.

“We have proof of principle, and some interest from the market, but we need more data on efficacy,” said Gersbach. “By facilitating the generation of data, the Coulter Award will take this idea from an interesting scientific finding to an idea a company can put into its developmental pipeline.”

 

Nanoparticle Technology and Retroject Delivery for Treatment of Glaucoma

Jennifer L. West, Fitzpatrick Family University Professor of Engineering; Molly Walsh, Assistant Professor of Ophthalmology

Glaucoma patients normally have a daily regimen of eye drops to deliver medication to the eye that prevents a build-up of pressure that can cause blindness. West and Walsh have developed a device that stabilizes the eyeball so that an ophthalmologist can inject a drug into the veins near the surface of the eye and have it travel into the tissues affected by glaucoma. The injection includes tiny nanoparticles designed to release their payload of medication continuously for several months, eliminating the need for daily eye drops.

Walsh and West received Coulter funding in 2013 to develop the initial device and nanoparticle drug. This second year of funding will fund continued investigation of the safety and efficacy of the nanoparticles in rabbits and complete a Phase I clinical trial in humans. The investigators will also work with the Duke Translational Research Institute to apply for regulatory approvals from the FDA and prepare applications for follow-on funding from the NIH Small Business Technology Transfer (STTR) program.

 

Anti-infection Urinary Catheter

Gabriel Lopez, Professor of Biomedical Engineering, Mechanical Engineering and Material Science; Howard Levinson, Associate Professor of Surgery and Pathology

For millions of hospitalized patients who require a plastic tube to eliminate their urine, catheter-associated urinary infection is a large risk: these infections account for 30 to 40 percent of all hospital infections. One common cause of these infections is the formation of biofilm inside the catheter – a film that provides a haven for bacteria.

Lopez and Levinson, along with Xuanhe Zhao, professor of mechanical engineering at Duke, have developed a new catheter design that eliminates the biofilm by creating catheter walls that can be inflated inward. The physical change of the surface of the catheter dislodges the biofilm, breaking it into small bits washed away by the urine the catheter carries.

The Coulter funding will allow Levinson and Lopez to manufacture fully-functioning catheters and test them in a Phase I clinical trial to demonstrate safety and efficacy. The data they collect will assist in pursuing licensing and follow-on funding from existing catheter manufacturers or entrepreneurs, as well as data for future grants to study other uses of this anti-biofouling technology.

Prevention of Temporal Lobe Epilepsy

James McNamara, Professor of Neurobiology; G. Allan Johnson, Charles E. Putman Professor of Radiology, Physics and Biomedical Engineering

In the 1990s, Duke pediatric neurologists discovered a biomarker – a physical change in the brain – that appears to predict which patients would go on to develop temporal lobe epilepsy after a first seizure. Drs. McNamara and Johnson (pictured right) have recreated that biomarker in animal models. Now they can study the signaling process which, if interrupted immediately after a major seizure, appears to prevent the damage that leads to temporal lobe epilepsy. Under McNamara’s leadership, the team is testing small molecule drugs that selectively inhibit this signaling pathway in animal models. Their goal is to find a drug that can prevent the brain from developing temporal lobe epilepsy. Johnson, who founded Duke’s Center for In Vivo Microscopy  in 1986, brings his expertise to the table in using imaging techniques to examine the effect of the drugs by monitoring the predictive biomarker.

“We are following a less traditional path, going from a clinical finding of a biomarker, back to preclinical work and then to drug discovery,” said Johnson. “But that’s the beauty of the Coulter Award. It triggers us to talk across disciplines and cultural gaps to find out what needs to be done.”