When Doctor Kubota proposed creating an oral pill to treat an eye disease, his chance of success was precisely 1 in 30,000. Those are the statistical odds of turning any new molecule into a commercial drug. The pharmaceutical industry thought he was crazy for trying. From their perspective, his approach to making a pill did not make common sense. There were simply too many challenges to overcome.
The doctor thought differently. He was a physician, not a drug developer. He saw how difficult it was for even a person with perfect vision to apply a topical solution in just the right dosage where needed. To overcome the problem he thought, “Even a person with low vision can take a pill.” That made perfect sense to him.
To pursue his vision, 35-year-old Kubota left the relative comfort of his research post at the University of Washington in 2002 to launch biotech startup Acucela from the basement of his house. For the first six months, he financed his new venture out of his own pocket.
Two years earlier he had left his native Japan for the US. The thought of starting a company had not occurred to him, but he wanted to be around the best scientists in the field of biomedicine. The US fit that bill. There, biotech startups abounded. In Japan, however, top talent remained siloed within hierarchical companies tied to lifetime employment.
Developing a new drug to halt the progression of a potentially blinding eye disease, called dry age-related macular degeneration (dry AMD), was just the kind of challenge he relished. It had so many moving parts requiring multi-disciplinary skills. Accomplishing that involved determining chemical structures, running clinical trials, understanding regulatory frameworks, raising finance, building teams and the like.
Kubota built a research team that identified the molecule ‘emixustat hydrochloride’ as a new drug candidate. After conducting pre-clinical trials to determine the molecule worth testing on people, a newly created development team embarked on a long journey of clinical trials. That process, which determines if the drug is both safe and effective, took about ten years and is still ongoing.
When it came to float the company, a listing on NASDAQ was considered. But most of the firm’s original investors were from Japan. They wanted to trade shares on a local and familiar exchange. Also, the Japanese biotech sector was enjoying a small boom. Professor Shinya Yamanaka had recently received the Nobel Prize in Medicine for his discovery that mature cells could be converted to stem cells. All told, it made better sense to list in Japan. Earlier this year, Acucela raised $142 million on TSE Mothers through an initial public offering. The funds are earmarked for commercializing the drug.
Future success is still not guaranteed. “Drug development, gaining the needed approvals, and achieving commercial success is a long and complex process, but we remain satisfied with our progress,” says Kubota with the satisfaction of having taken his project from early-stage research to its current late-stage development.
Kubota credits entrepreneurial success at Acucela to collaboration rather than harmonization, where a bright, hungry and hardworking team of multicultural scientists drives innovation around core values. Many are émigrés and first generation Americans trying to establish themselves in the country. Team members are encouraged to express differing opinions that are aligned with the firm’s goals. “The more diverse thoughts we have, the better off we are,” says Kubota.
He adds with a twinkle, “There is even one ‘creationist’ on the team.”
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