From the Lab Bench to the Patient

One day, Geoffrey Thrope asked Warren Grill if he was working on anything interesting or useful. Grill thought about it, and replied that that by using electrical stimulation, he had developed a way to prevent laboratory animals from peeing.

That was six years ago.

Fast-forward to the present, and the technology based on Grill’s laboratory research has recently been sold to medical device giant Medtronic for more than $40 million. During those six years, Grill, Thrope and their team guided their vision through a challenging, yet ultimately fulfilling, journey of translating an idea that originated in the laboratory into the development of a technology that doctors can use to treat their patients.

That original conversation took place in Grill’s lab at Case Western Reserve University in 2002; he came to Duke two years later as Associate Professor of Biomedical Engineering, where he continues the same line of research. Grill’s research focuses on neurostimulation, an approach that uses low level electric currents to directly influence the functioning of the nervous system. At the time, Grill was studying the effects of neurostimulation of the pudendal nerve, which is involved in control of bladder function.

Thrope, a former biomedical engineer at Case Western, was at the same time pursuing his interests in neurostimulation through a company he formed known as NDI Medical. The company’s interest was also in neurostimulation, but not necessarily coming up with its own new ideas. Rather, its mission is to identify, nurture and act as a “chaperone” to assist scientists and engineers wanting to bridge the divide between academia and the business world.

“When I first met Warren, I told him that he was doing excellent work, but it was all in the laboratory,” Thrope recalls. “I challenged him to see of we could gets something out of the lab and into the market as a viable therapy that could be used by clinicians. He certainly took up challenge.

“I find that there is a wide chasm between my research colleagues and the commercial world,” Thrope continued. “That fascinated Warren. He’d say ‘I think I do meaningful research and publish the findings in scientific journals, however I don’t really know how to commercialize these ideas.’ That’s where we come in.”

Grill also serves as Chief Scientific Officer of NDI.

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“I wanted to stay in academia,” Grill said. “Geoff helped me realize that publishing results was important, but not sufficient if we wanted ultimately to treat persons with diseases or disorders. The end result, getting a concept out of my lab moving toward the marketplace, exceeded all of my expectations, as did the length and process of doing the transfer.”

As fate would have it, NDI’s Vice President for Regulatory Affairs and a Pratt BME graduate (’86), Julie Grill, is also Warren Grill’s wife. She runs NDI’s satellite office in Chapel Hill and performed much of the work navigating the maze of government requirements and regulations.

Thrope and the Grills concede than many scientists might be discouraged from pursuing ideas because of all the real or perceived regulatory hurdles. Many others prefer the life of a bench researcher.

For Julie Grill, who spent time at the Food and Drug Administration reviewing applications for medical device approvals before joining NDI, , this is a challenge she relishes. From her perspective, scientists working with NDI can go about their work in the lab while she guides them through the regulatory red tape.

“Many researchers I talk to say that the regulations are so intimidating and daunting because there are so many things outside of their control to worry about,” she said. “That’s why we partner with them. Ultimately, the goal of science is discovery. If there is an opportunity to take scientific findings and create meaningful therapies – that’s in everyone’s best interest.”

Thorpe, the Grills, and other members of the NDI team devised a detailed plan to address the variety of hurdles to be cleared, whether they were governmental or financial. It was almost as if the science end of things was only the first of many steps.

“Out philosophy is to incubate a concept,” Thrope explained. “Is there a commercial product out there like it? What are the regulatory barriers? Is the investment community willing to provide financial support? Are there intellectual property issues to overcome? What does the product look like? What unmet need is there that this concept will fill? All these questions need to be answered.”

Specifically, the product that emerged from Grill’s research that will become a part of Medtronic’s line-up is called the MEDSTIM Bladder Pacer System. It is designed to treat a patients’ overactive bladder, a common cause of urinary incontinence. The system uses an implanted pulse generator and electrode that deliver electrical stimulation to the pudendal nerve.

The results of a recently completed clinical trial at three sites – including Duke Hospital – showed that the device reduced instances of incontinence and the urgency of the need to urinate. The National Institute of Health estimates that urinary incontinence afflicts more than 13 million Americans.

As the largest transaction in the company’s short history, the proceeds from Medtronic will be plowed back into NDI’s efforts to discover and develop new technologies that make use of neurostimulation. Other areas the company is pursuing include peripheral pain management, stimulators for use during surgery, and restorative treatments for patients impaired by neurological conditions such as stroke.

In addition to his work on bladder function, Grill is also interested in the application of neurostimulation to the brain to treat movement disorders.

Thrope believe his company serves as important partner for laboratory scientists who have great ideas, but may be wary – whether by inclination or workload – to pursue commercialization on their own.

“It can be a very hard job to be a professor at a university,” he said. “You are responsible to teach, recruit students, write grants, and interact with other faculty members. That’s a load. The average professor works more hours than general public appreciates. The demands of the position are complex. With all that, business is not necessarily top of mind.”