Translating Medical Discoveries from Concept to Commercialization

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Medical discoveries can save lives, but they come at a price.

“It costs a tremendous amount [of money] to bring drugs to market,” said Bart Chernow, vice provost for technology advancement, professor of medicine and vice president for special programs and resource strategy at the University of Miami Miller School of Medicine, estimating a price tag of between $800 million and $1.2 billion for each new drug. “For medical devices, it costs far less, but is still expensive.”

The challenges of making new medicines and treatments available to the public was the subject of “Translating Medical Discoveries from Concept to Commercialization,” a panel discussion held during the University of Miami Global Business Forum Jan. 15 – 16, 2009.

To effectively develop and sell new products in the marketplace, Chernow said, medical researchers and universities need to forge ties with industry. With this in mind, it's important for medical scientists to think like entrepreneurial innovators. “Innovation is absolutely the key to providing the best in [health] care,” Chernow stated. “Thomas Edison once said, ‘I never perfected an invention that I do not think about in terms of the service it may give to others. I find out what the world needs and I proceed to invent it.’”

Richard Cote, professor of pathology at the University of Southern California, believes he has found one such “sweet spot:” a filter, developed through nanotechnology, that can detect minute traces of cancer tumor cells circulating in the bloodstream.

“If a tumor cell is in a sample of blood,” he said, “we are likely to capture it.”

Cote, formerly director of the Biomedical Nanosciences Initiative at USC, explained that even proven treatments are often ineffective in dealing with cancer. “Our best drugs in breast cancer, for example, work only about 30 percent of the time now,” he said. “So we are treating our patients with drugs that are not only expensive and have side effects, but are not working.”

One reason for this situation, Cote said, is that current technology can’t reliably measure the extent of metastasis in the body of a cancer patient. An accurate count of cancer tumor cells circulating in the blood can help oncologists determine which treatments are effective in individual patients — not only increasing the odds of survival but saving money that would have gone to ineffectual treatments.

The trick, though, is distinguishing between a cancer tumor cell and normal blood cells. “We are looking for a single tumor cell in a background of millions and billions and trillions of normal blood cells,” said Cote. “It is really hard to do.”

Enter nanotechnology. Taken from the Greek word for ‘dwarf,’ nanotechnology works with materials that are 10-9 meters (a billionth of a meter) in size — so small as to be on a molecular scale. At that size, Cote said, material takes on the physical properties of whatever it comes in contact with, such as an abnormal tumor cell floating in the blood stream. “Think about a sensor that allows for the detection of hundreds or thousands of reactions in a small space,” he explained. In the last couple of years, Cote’s research team — which includes engineers and physicists as well as medical scientists — has developed a filter composed of nano-sensors that can detect circulating cancer cells 85 to 90 percent of the time.

In tests using .75 ml blood samples spiked with various cancer cells, Cote’s nanotechnology filter was compared to Veridex’s CellSearch, a system now on the market. The result? The nano-filter detected 11 out of 11 breast cancer cells while Veridex got only 6 out of 11. For prostate cancer calls, the nano-filter spotted 27 out of 28 cells while Veridex found only 14 out of 28. And the nano-filter captured 10 out of 12 colon cancer cells versus 4 out of 12 caught by Veridex. “We are seeing more cells in more locations,” Cote said. The nano-filter can also filter larger samples of blood, increasing the likelihood of early cancer detection, when far fewer circulating tumor cells are present.

Cote expects the FDA to approve his team’s nano-filter technology soon. A $30 million grant helped them get this far. But just because a medical discovery is groundbreaking doesn’t necessarily mean hospitals and doctors will buy it.

“It is one thing to make discoveries, but it is a completely different thing to disseminate those ideas,” Cote said.

By “disseminate,” Cote doesn’t mean simply writing a paper about a discovery. “Papers die,” he said. For the public to actually benefit from the finding, a new medical product has to be “commercialized” and used by doctors and their patients.

In order to get these discoveries to the public, the University of Miami has created what Chernow called “UM Innovation to help foster technology advancement.”

“Why should institutions like the University of Miami commercialize products?” he asked rhetorically. “First, to bring discoveries to the patient to relieve suffering. Making a discovery by itself is nice and it goes on your resume, but making it into a product helps people.”

Medical innovation, though, is a risky business. A discovery might seem like a good idea but after years of testing and heightened expectations, turn out to be a dead end. Medical innovators, warned Chernow, should “never fall in love with an idea.”


By Erik Bojnansky