Got an idea for a new drug to treat antibiotic-resistant tuberculosis? Or maybe a diagnostic test for cancer? A new medical device to treat sepsis (blood poisoning)? How about a nutraceutical (product containing herb- or food-based nutrients) for a dietary supplement?
Researchers at Oregon State University are investigating these and other advancements in health care. But, before innovations can wind up in your medicine cabinet or in a doctor’s hands, they need to pass through a landscape that is foreign to most scientists: business and government regulation.
That’s where Mark Lieberman and John Turner, co-directors of the OSU Advantage Accelerator, serve as guides. They connect researchers and innovators with experts in business development and regulatory policy. Their six-month training programs at the Accelerator provide a road map from lab to marketplace.
For startups in the life sciences and health care, government oversight comes down to the U.S. Food and Drug Administration (FDA). “When it comes to new drugs, the FDA is concerned with three things: that it’s pure, that it’s safe and that the efficacy is appropriate,” says Lieberman. “Those are the big three for the FDA.”
To satisfy FDA criteria requires deep pockets and plenty of time. It can take, on average, $1 billion and 10 years or more to bring a new drug to market. New medical devices — whether a heart valve or a tongue depressor — usually take less time (three months to two years) to get regulatory approval.
It’s also critical to know the market. Researchers can zero in by surveying potential customers. “As a business person, how do I know what you want to buy if I haven’t spoken to you?” says Lieberman. “The market is always your guide. The market determines whether you’re successful or not.”
That knowledge, he adds, can be captured by developing what is known as a “minimally viable product,” a version that allows a team to collect valid data with the least effort.
The OSU Advantage Accelerator provides a convenient back porch where researchers can explore their innovations in a safe, supportive environment. “There is a progression about who you tell, but this is an open forum,” says Turner. “Inventors can get feedback, and as appropriate, we can bring in a broader base of people. Early-stage investors are very interested in coming here and looking under the hood.
“The pipeline from OSU is exciting,” he adds. “It’s a matter of recognizing the opportunities for capital investment and partnering with the right companies.”
