Charles M. Balch, MD, FACS, shared the far-reaching results of entrepreneurship.

The road to entrepreneurship is undoubtedly filled with challenges. For surgeons, such an endeavor is even more difficult, given time constraints, institutional policies, and federal regulations.

"With the proper education and working relationships, we can work through these issues and have valuable partnerships," said Charles M. Balch, MD, FACS, professor of surgery, University of Texas Southwestern Medical Center, Dallas, and professor of surgery, oncology, and dermatology, Johns Hopkins Medical Institutions, Baltimore, MD.

During Tuesday morning's Medical Industry Breakfast, Dr. Balch was among a panel of surgeons who shared their expertise in navigating rewarding paths. He pointed to areas where the commercialization of intellectual property has been beneficial in improving patient care. For example, while he was at the University of Alabama (UAB), he was part of the discovery of a monoclonal antibody that detected a marker on natural killer cells and T lymphocytes.

"We could not have made this available at a commercial level, but because it was made available worldwide it spawned many other scientific studies beyond our narrow area of human T cell differentiation as it applied transplantation and tumor immunology," Dr. Balch said.

Beyond being used in the understanding of a variety of diseases, because this antigen is expressed predominantly in the nervous system, it is now used as a biomarker for neuroendocrine tumors and various brain cancers. For some years, it was the largest revenue producer of intellectual property for UAB, he added.

"There is a bidirectional value for which we who can develop intellectual property—whether it's drugs, devices, diagnostics, or new knowledge—need an outlet to expand that and to commercialize it for distribution. It could not be done in a single academic center for the most part," said Dr. Balch, adding that in converse, industry benefits as it produces new products that need to be tested by the surgical community.

Research into the direct inflammatory activity of TNF led Kevin J. Tracey, MD, FACS, to find ways to inhibit TNF.

One such entrepreneur is Kevin J. Tracey, MD, FACS, a neurosurgeon known for his contributions to inflammation research.

"I'm a passionate inventor. What drives me in the morning when I get up is I want to make something that is going to help someone in the future," said Dr. Tracey, president of the Feinstein Institute for Medical Research and professor and president of the Elmezzi Graduate School of Molecular Medicine, Manhasset, NY.

His research into the direct inflammatory activity of tumor necrosis factor (TNF) led him to find ways to inhibit TNF, seeking to learn how to make a molecule that would block or regulate the amount of cytokines produced during inflammation—CNI-1493.

Along the way of understanding how this agent can work at the molecular level to prevent cytokine release, he and his team made what he called a shocking discovery. In animal models, they could attenuate TNF production in the brain, but vanishingly small amounts of this material in the brain completely blocked whole volume TNF production.

"This made no sense. We ruled out pituitary. We ruled out steroids," Dr. Tracey said. "It turned out when we cut the vagus nerve, the drug in the brain no longer controlled whole volume TNF production."

That insight led his team to begin manipulating the electrical activity of the vagus nerve to control inflammation. In fact, they have developed nerve stimulators to suppress the release of inflammation-causing cytokines, even making a small vagus nerve stimulator to treat inflammatory disease. In September 2011, the first was implanted in a 45-year-old man with severe rheumatoid arthritis, who was essentially housebound. He has since had a tremendous clinical response. The results will be presented at the American College of Rheumatology Annual Meeting in November.

Christopher Capelli, MD, vice-president for technology based ventures, the University of Texas MD Anderson Cancer Center, Houston, TX, is responsible for commercializing new products and services at MD Anderson and for establishing and managing collaborations with industry partners around technology-based health care ventures. He provided attendees with guidance for exploring entrepreneurship.

"You cannot go out and start a company and say it's me against the world," Dr. Capelli said. "Be a part of the team. Get the institution involved. Get the legal people involved. Make them a part of your commercialization team. They want active innovators."

"Innovation is important–absolutely—but in trying to do this activity, it's all about the money. An idea is good, but it has to respond to a market opportunity. When you do that, you have an innovation."